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5,151 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
i) osteopenic postmenopausal Caucasian women following Dmab treatment ii) assignment to
treatment with alendronate in an effervescent tablet formulation following Dmab
discontinuation
Exclusion Criteria:
i) secondary osteoporosis; ii) diseases that could affect bone metabolism iii) medications
that could affect bone metabolism iv) chronic kidney disease (stage >3b) and/or liver
failure v) neoplastic disease vi) hypersensitivity to alendronate or to any of the
excipients vii) abnormalities of the esophagus and other factors which delay esophageal
emptying such as stricture or achalasia viii) inability to stand or sit upright for at
least 30 minutes ix) hypocalcaemia x) confirmed esophagitis
Female
Subject must be at most 90 Years | Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation | NCT04338529 | Contradiction |
1,720 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- men and women, aged 18-55 years
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular,
endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder, e.g., no DSMIV Axis 1
diagnosis in 2 preceding years, except nicotine dependence in smokers)
- drink less than 21 drinks/week for women and less than 35 drinks per week for men
- have not used marijuana in the past 30 days and have not met criteria for dependence
in the past 2 years
- do not suffer from claustrophobia or any MRI contradictions
- nonsmokers (smoked < 40 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL
both at intake evaluation and on scan day)
- smokers (smoked at least 10 cigarettes/day for at least one year with an FTND>3, urine
cotinine >150 ng/mL and CO >12 ppm at intake)
Exclusion Criteria:
- psychosis
- presence of acute or unstable medical or neurological illness. Subjects will be
excluded from the study if they present with any history of serious medical or
neurological illness or if they show signs of a major medical or neurological illness
on examination or lab testing including history of seizures, head injury, brain tumor,
heart, liver or kidney disease, eating disorder, diabetes.
- regular use of any psychotropic drugs including anxiolytics and antidepressants and
other over-the-counter medications and herbal products within the last six months
- pregnancy/breast feeding (as documented by pregnancy testing at screening or on days
of the imaging studies),
- suicidal ideation or behavior
- pacemaker or other ferromagnetic material in body.
- use of medications which affect dopamine transmission within 2 weeks of the PET study
- participation in other research studies involving ionizing radiation within one year
of the PET scans that would cause the subject to exceed the yearly dose limits for
normal volunteers
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm | NCT01699607 | Entailment |
4,693 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Premenopausal (defined by having had menstruation the last six month)
- If amenorrhea with levonorgestrel intrauterine device, the woman should be < 45 years
old
- Hysterectomy planned due to a benign condition
- Hysterectomy does not require morcellation it is allowed to divide the uterus into 2-3
pieces, given that the orientation of the specimen is still possible for the
pathologist)
- Written consent is given
- Can communicate in Norwegian or English at the Norwegian study sites, and Finnish,
Swedish or English at the Finnish study site.
Exclusion Criteria:
- Gynecological cancer present at the time of inclusion
- Use of gonadotropin-releasing hormone agonist or antagonist within the last 3 months
prior to the ultrasound evaluation
- Prior endometrial ablation or resection
- Postmenopausal status or no menstrual bleeding for the last 6 months, or amenorrhea
with levonorgestrel-intrauterine device and age >45 years.
- Need for morcellation of the uterus
Female
No healthy subjects accepted to join the trial.
Subject must be at most 52 Years | Validation of the Adenomyosis Calculator | NCT04135118 | Entailment |
1,301 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Must have completed Study 111-206 on investigational treatment (BMN 111 or placebo).
2. Parent(s) or guardian(s) are willing and able to provide written, signed informed
consent after the nature of the study has been explained and prior to performance of
any research related procedure. Also, subjects under the age of majority are willing
and able to provide written assent (if required by local regulations or the IRB/IEC)
after the nature of the study has been explained and prior to performance of any
research-related procedure. Subjects who reach the age of majority in their country
while the study is ongoing will be asked to provide their own written consent again
upon reaching the legal age of majority.
3. Are willing and able to perform all study procedures
Exclusion Criteria:
1. Permanently discontinued BMN 111 or placebo prior to completion of Study 111-206
2. Have a clinically significant finding or arrhythmia on ECG that indicates abnormal
cardiac function or conduction or QTc-F > 450 msec
3. Require any investigational agent (except BMN 111) prior to completion of study period
4. Current therapy with antihypertensive medications, angiotensin-converting enzyme (ACE)
inhibitors, angiotensin II receptor blockers, diuretics, beta-blockers,
calcium-channel blockers, cardiac glycosides, systemic anticholinergic agents, GnRH
agonists, any medication that may impair or enhance compensatory tachycardia,
diuretics, or other drugs known to alter renal or tubular function
5. Pregnant or planning to become pregnant (self or partner) at any time during the study
6. Concurrent disease or condition that, in the view of the investigator, would interfere
with study participation or safety evaluations, for any reason
7. Have a condition or circumstance that, in the view of the investigator, places the
subject at high risk for poor treatment compliance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Months old.
| An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia | NCT03989947 | Contradiction |
6,029 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
The patients to be included will be outpatients who meet all of the following criteria. No
specific gender is asked.
<For the observation period>
1. Patients who have "heartburn" 2 days a week or more for consecutive weeks during 3
weeks prior to pre-observation screening. If a day of screening and a day of starting
observation (date of registration) are different, heartburn must continuously be
present during the in-between period.
2. Patients who meet both 1) and 2) below; 1) The symptom is a burning sensation arising
from the stomach or the lower chest.
2) The symptom tends to appear frequently or is aggravated after eating, when bending a
body forward, and/or when pressing on the abdomen.
(3) Patients categorized in "grade M" (discoloring type: minimal change) according to the
Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
(4) Patients who are 20 years old or older at the time of obtaining consent. (5) Patients
who are informed of the objective and details of the study and give written consent for
study entry.
<For the treatment period>
1. Patients who have "heartburn" on 2 days a week or more in 7 days immediately before
the treatment period (during the observation period).
2. Patients with "heartburn diary" that is completely filled out for 7 days until the
treatment period (during the observation period). If the observation period is 8 days
or longer, those with heartburn diary of which entries are fulfilled 80% or more
during the observation period.
3. Patients with 80% or better drug compliance for antacids during the observation
period.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study.
1. Patients who cannot keep adequate entries of heartburn diary by themselves.
2. Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
3. Patients who have a complication or history of psychiatric or psychosomatic disease
(e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those
who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic
treatment).
4. Patients who have undergone Helicobacter pylori eradication therapy, and less than 6
months have elapsed from the end of H. pylori eradication therapy to the beginning of
the observation period. : The same day 6 months earlier, and the day at the end of 6
months earlier if it is at the end of month.
5. Patients with open gastric or duodenal ulcer.
6. Patients with acute gastritis.
7. Patients with a history of any surgical intervention that affect peptic secretion
(e.g., upper gastrointestinal tract resection and/or vagotomy).
8. Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
9. Patients with scleroderma.
10. Patients with a history or complication of angina pectoris.
11. Patients who work at night (working for a night-shift).
12. Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to
pre-observation screening
13. Patients who need NSAIDs (except topical preparations), steroids (except topical
preparations), and/or aspirin treatment every day
14. Patients receiving dialysis therapy
15. Patients with a serious complication such as cardiovascular disease (e.g., myocardial
infarction), hematological disorder (e.g., aplastic anemia), renal disease (e.g.,
acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant
tumor.
16. Patients with known hypersensitivity to antacids or PPIs.
17. Patients who are pregnant or those with childbearing potential, or those who wish to
become pregnant or are lactating during the study period.
18. Patients receiving another investigational drug or those who received another
investigational drug within 6 months prior to pre-observation screening : Registration
is allowed on the same day of 6 months earlier, and the day at the end of 6 months
earlier if it is at the end of month.
19. Patients who are judged to be ineligible for the study entry by the investigator or
subinvestigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease | NCT00165646 | Entailment |
3,956 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Able to provide written informed consent to participate in the study
- Willing and able to comply with all study requirements and instructions of the site
study staff
- Male or female, 40 years to 85 years old (inclusive)
- Must be ambulatory
- Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of
OA and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is
not older than 6 months prior to the date of screening
- Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the
WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at screening
- Moderate to moderately-severe OA pain in the index knee (even if chronic doses of
nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks
prior to screening, have been/are being used)
- No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an
efficacy measure
- No known clinically significant liver abnormality e.g. cirrhosis, transplant, etc.)
Exclusion Criteria:
- As a result of medical review and screening investigation, the Principal Investigator
considers the patient unfit for the study
- A history of allergic reactions to human albumin (reaction to non-human albumin such
as egg albumin is not an exclusion criterion)
- A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
sodium caprylate)
- Presence of tense effusions
- Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
joint replacement in the affected knee, as assessed locally by the Principal
Investigator
- Isolated patella femoral syndrome, also known as chondromalacia
- Any other disease or condition interfering with the free use and evaluation of the
index knee for the duration of the trial e.g. cancer, congenital defects, spine OA)
- Major injury to the index knee within the 12 months prior to screening
- Severe hip OA ipsilateral to the index knee
- Any pain that could interfere with the assessment of index knee pain (e.g. pain in any
other part of the lower extremities, pain radiating to the knee)
- Any pharmacological or non-pharmacological treatment targeting OA started or changed
during the 4 weeks prior to randomization or likely to be changed during the duration
of the study
- Use of the following medications:
1. No IA injected pain medications in the study knee during the study
2. No analgesics containing opioids. NSAIDs may be continued at levels preceding the
study and acetaminophen is available as a rescue medication during the study from
the provided supply
3. No topical treatment on osteoarthritis index knee during the study
4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
(treatment such as Aspirin and Plavix are allowed)
5. No systemic treatments that may interfere with safety or efficacy assessments
during the study
6. No immunosuppressants
7. No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg
prednisolone, the dose must be stable)
- Any human albumin treatment in the 3 months before randomization
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | AP-003-A A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee | NCT01839331 | Entailment |
5,149 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5
years post bilateral oophorectomy).
- Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate,
risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
- BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5
as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior
fragility fracture. For participants with a history of a prior fragility fracture
(except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.
- Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of
randomization.
Exclusion Criteria:
- Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
- History or current evidence of hip fracture.
- History of malignancy ≤5 years prior to signing informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Active parathyroid disease. Participant with a documented history of parathyroid
disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at
screening.
- History of thyroid disease not adequately controlled by medication.
- Current treatment with anti-seizure medication, with indices of calcium metabolism not
within normal limits.
- Prior treatment with strontium-containing products; intravenous bisphosphonates;
cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater
than 1 mg/day for more than 2 weeks.
- Use of following medications within the 6 months prior to the screening visit:
activated vitamin D; estrogen, with or without progestin, at a dose high enough to
have systemic effects; raloxifene or other selective estrogen receptor modulator
(SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of
intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84);
growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for
more than 2 weeks; cyclosporine for more than 2 weeks.
- Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human
immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene)
>10,000 IU daily, unless willing to discontinue this dose during the study.
- Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4
inducer within 4 weeks of screening.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076) | NCT01803607 | Contradiction |
1,729 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- No prior wrist or elbow injuries on the dominant side of his/her body
- Ability to complete study in one sitting of 90-120 minutes
- Between the ages of 18 years and 100 years
- Ability to follow directions and speak and read English
Exclusion Criteria:
- Prior wrist or elbow injuries on the dominant side of his/her body
- Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist
surgeries are excluded
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 100 Years | A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation | NCT04130425 | Entailment |
5,140 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- recent proximal 2-segment humerus fracture (0-8 days post fracture)
- no surgical treatment at fractured site
- signed informed consent
- postmenopausal female and male patients aged 60 - 85 years
- established osteoporosis as defined by BMD measured with DXA-technology (dual energy
X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the excipients.
- Pre-existing hypercalcemia
- Severe renal impairment (eGFR< 35ml/min)
- Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the
bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
- Unexplained elevations of alkaline phosphatase
- Prior external beam or implant radiation therapy to the skeleton
- Patients with skeletal malignancies or bone metastases should be excluded from
treatment with teriparatide.
- any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody,
SERMs)
- any prior strontium ranelate therapy
- any prior TPTD of PTH 1-84 therapy
- malignancies ≤ 5 years except basalioma
- hypo-/hypercalcemia
- baseline 25-OH vitamin D3 level ≤10 ng/ml
- prosthesis at fractured and contralateral humerus
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | Teriparatide for Fracture Repair in Humans | NCT02091492 | Contradiction |
4,060 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion criteria:
Inclusion Criteria for OA patients:
Study participant will be recruited from rheumatology outpatient clinics and primary care:
1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of
knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal
anti-inflammatory drugs
5. participants between 35 and 90 who will be undergoing knee replacement surgery or
arthroscopy for osteoarthritis or knee surgery for fractured tibia/femur/fibula with
osteoarthritis
Inclusion criteria for Early OA Patients
Study participant will be recruited from rheumatology outpatient clinics and primary care:
1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of
knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal
anti-inflammatory drugs
5. Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee
surgery
Inclusion criteria for Healthy control subjects
1. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a
comparator group
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 90 Years | Understanding Pain Perception in Osteoarthritis | NCT02603939 | Entailment |
3,192 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Confirmed diagnosis of moderate to severe dry eye associated with either
Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal
limbal cell deficiency
- A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
- Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning
perfect ocular comfort and 1 meaning severe ocular pain)
- Ability or the resources to insert and remove the study lenses
- An OSDI score greater than 42
- A willingness to sign an informed consent
Exclusion Criteria:
- No dry eyes or mild dry eyes
- A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
- Dry eye comfort score of greater than 50 on a visual analog scale
- Unable to insert or remove the study lenses (or have a family member do so)
- Have an OSDI score less than 42
- Has been diagnosed with neurotrophic keratopathy in either eye
- Unwilling to enroll in the study, and unwilling to provide signed informed consent to
participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Senofilcon A Lenses in Moderate to Severe Dry Eye Disease | NCT04096898 | Entailment |
3,440 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Criteria Inclusion:
- age> 18 years,
- patients with type 2 diabetes mellitus diagnosis;
- able to express consent to the study.
Exclusion Criteria:
- Nobody
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| New Patient Support Program in Type 2 Diabetes | NCT03752567 | Entailment |
5,986 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- All Adult patients with clinically diagnosed with Gastroesophageal Reflux Disease
(GERD) without alarm features (heartburn and acid regurgitation)
- Age more than 18 years at the time of written consent
- Those who provide written consent with their own free will
- Both treatment naïve and treatment experienced patients will be included. Treatment
experienced patients should not be taking any proton pump inhibitors for 2 weeks to
allow for washout period.
Exclusion Criteria:
- Patients that have alarm features as defined by the Philippines Guidelines for GERD
(dysphagia, odynophagia, weight loss, anemia, hematemesis, family history of
esophageal adenocarcinoma, nocturnal choking, abdominal mass, recurrent/frequent
vomiting, chest pain)
- Patients with atypical GERD symptoms (cough, laryngitis, chest pain, etc.)
- Patients already taking proton pump inhibitors for the past 2 weeks
- Patients who scored less than 8 on the FSSG questionnaire
- Patients who have undergone gastroesophageal surgery
- Patients who are poorly compliant to medications
- allergy to PPI or vonoprazan
- With serious comorbidities, such as but not limited to: heart failure, renal failure,
malignancy or hepatic failure
- Pregnant, breastfeeding or possibly pregnant
- Patients that would not provide consent
- Patients who are unable to complete the FSSG Questionnaire independently
- Patients who are unable to follow up at designated periods
- Patients taking rilpivirine or atazanavir.
- Patients with elevated baseline liver function tests (more than twice the upper limit
of normal)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features | NCT04028466 | Entailment |
5,186 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Patients with osteoporosis (T-score values below -2.5)
Exclusion Criteria:
- Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc
prolapse, or any trauma to the back area
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 60 Years | Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial | NCT04646863 | Entailment |
3,909 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
Patients diagnosed with knee OA according to the criteria of the American College of
Rheumatology (ACR), and were considered as stage 2 and 3 according to Kellgren-Lawrence
criteria.
Exclusion Criteria:
Exclusion criteria were previous knee surgery, malignancy, circulation disorder, and
conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental
disorder, scar tissue, or metal implants.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 80 Years | A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis | NCT03806322 | Entailment |
3,285 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- IgG4-related disease patients or
- Sjogren syndrome patients or
- Healthy subjects
Exclusion Criteria:
- Presence of autoimmune or inflammatory associated disease
- Age less than 18 years
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease | NCT02899039 | Entailment |
6,525 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Have a diagnosis of hemophilia A or B with inhibitors.
2. Be 12 - 65 years of age inclusive
3. Be capable of understanding and willing to comply with the conditions of the protocol
or have a legal guardian who is capable of understanding and complying with the
conditions of the protocol
4. Have read, understood, and documented written informed consent/assent
5. Be able to provide medical evidence through prior medical history of previous
inhibitor levels
6. Be willing and able to use the ATHN mobile application or a paper diary to document
BEs and medication usage
Exclusion Criteria:
1. Have a disorder of hemostasis in addition to Hemophilia A or B
2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its
ingredients
3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins
4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not
approved for this use by the FDA
5. Have had implantation of an investigational medical device within the prior 6 months
6. Have received an investigational drug within 30 days of the baseline visit
7. Have an elective surgical procedure planned during the duration of their participation
in the study*
8. Have any life-threatening disease, or other disease or condition which, in the
investigator's judgment, could pose a potential hazard to the patient or interfere
with study participation or study outcome (e.g., a history of non responsiveness to
bypassing products or thromboembolic disease)
- Should a participant require an unplanned surgery, the participant will not be
withdrawn from the study unless the investigator deems it necessary. Instead, the
participant will receive standard of care treatment as determined by the
attending physician. If the participant is not withdrawn from the study, the
participant's participation in the study will be paused until the investigator
feels it is safe for them to continue.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors | NCT04647227 | Contradiction |
2,987 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Known or suspected allergy to fish with either positive specific s-IgE or skin prick
test to one or more fish species
- Either positive specific s-IgE or spin prick test to one or more fish species and
never eaten fish.
Exclusion Criteria:
- Serious chronic disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 20 Years | Allergy Against Different Species of Fish in Children and Adolescents Allergic to Fish | NCT02365168 | Contradiction |
1,026 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
Patients must elicit 3 of the 6 symptoms to be included:
- forty five years of age and over.
- stiffness for less than thirty minutes;
- crepitus;
- bony tenderness;
- bony enlargement;
- no palpable joint warmth.
Exclusion Criteria:
- previous lower limb joint injection within three months;
- previous hip or knee joint replacement;
- any severe cognitive, cardio- respiratory, musculoskeletal or neurological - diagnosis
that prevents participants from exercising;
- insoles or braces;
- ligament instability;
- participants with a body mass index (BMI) over 40 will be issued with a choice of
completing in the study or being managed by the National Health Service weight
management service;
- other minor health related issues will be assessed prior to the commencement of the
study to ensure safe practice.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Mixed Methods Assessment of Exercises for Knee OA | NCT02734342 | Entailment |
1,646 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- ages 18-60 years old
- Control group: normal, healthy volunteers
- Amputee group: unilateral, transradial myoelectric prosthesis users
Exclusion Criteria:
- elderly > 60
- children < 18
- pregnant women
- persons with shoulder impairments, injuries, or problems
- bilateral upper limb amputees
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Study of Compensatory Motion While Using an Upper Limb Prosthesis | NCT00417352 | Entailment |
6,706 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Age: 18 to 75 years
- Gender: No restriction
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally
and/or restoratively hopeless) in the maxillary anterior region (first premolar to
first premolar)
- Subjects must be able and willing to follow instructions related to the study
procedures
- Subjects must have read, understood and signed an informed consent form
Exclusion Criteria:
- More than 1 mm of recession present on the tooth planned for extraction and inclusion
in the study
- Reported allergy or hypersensitivity to any of the products to be used in the study
- Severe hematologic disorders, such as hemophilia or leukemia
- Active severe infectious diseases that may compromise normal healing
- Liver or kidney dysfunction/failure
- Currently under cancer treatment or within 18 months from completion of radio- or
chemotherapy
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or
more)
- Subjects with a history of IV bisphosphonates
- Subjects with uncontrolled diabetes, defined as Hba1c > 7.0
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be
excluded
- Pregnant women or nursing mothers
- Heavy smokers: Subjects who have smoked >10 cigarettes per day within 6 months of
study onset
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions
that may affect the outcomes of the study will not be included in the study.
NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is
permitted. Use of such medications will be reviewed and recorded by the investigator.
- Any other non-specified reason that from the point of views of the investigators will
make a candidate not a suitable subject for the study (e.g. limited mouth opening).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Periodontal Phenotype Study (Tooth Extraction) | NCT02668289 | Contradiction |
150 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male sex
- Age between 18 and 45 years
- Acquired HH forms
- HH after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma,
craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). Infiltrative
disease (hemochromatosis, granulomatous disease, histiocytosis, and sarcoidosis), OR
- HH due to pituitary adenoma-related mass effect, in case of cured or controlled
hormone hypersecretion
- Total testosterone serum levels below the normal ranges (lower than 3 ng/mL)
- No androgen replacement therapies in the last three months before enrolment
- No hyper-secretion of other pituitary hormones
Exclusion Criteria:
HH forms, such as:
- Combined pituitary hormone deficiency
- Genetic syndromes (e.g., Prader-Labhart-Willi, CHARGE, Lawrence-Moon- Bardet-Biedl)
- Iatrogenic HH forms, such as traumatic pituitary stalk interruption syndrome,
irradiation, high dose corticosteroids, and anabolic steroids
- Drug abuse and major systemic diseases
- Chronic severe liver disease
- Concomitant illnesses which could interfere with the study participation
- Active malignancy diseases
- Known or possible androgen-dependent tumors for example male breast carcinoma or
prostatic carcinoma
- Cardiac failure, hypertension, renal dysfunction, migraines, or epilepsy. (since
aggravation or recurrence may occasionally be induced as a result of increased
androgen production)
- Haematocrit <40% or >54%
- Congenital HH are excluded since these genetic forms of HH could be related to other
systemic or pituitary diseases, which could bias the selection of patients.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men | NCT04189133 | Entailment |
2,558 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- Children aged 1 day to 18 years presenting to the ED.
Exclusion Criteria:
1. Serious medical condition requiring emergent medical care or resuscitation
2. Parental refusal to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 18 Years | The Effect of Medical Clowns on Blood Pressure Measurement in Children Presenting to the Emergency Department | NCT03143088 | Entailment |
3,604 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Young women aged 12 to 25 years living in Beni-Suef city of Egypt. the urban
Metropolitan of Beni-Suef City was classified according to the socioeconomic level of
its quarters to low, middle, and high levels. Out of each level, one quarter was
selected randomly, by a card withdrawal, where households residing these quarters were
chosen using a random start. For the rural villages surrounding the urban
Metropolitan, three villages were selected randomly; one on the road to the North, one
on the road to the West, and the last one on the road tothe South. Each village was
clustered roughly into two sites; one to the East of the water channel and one to the
West of the same water channel
Exclusion Criteria:
- Women from other places in Egypt.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 25 Years | Prevalence of Female Circumcision Among Young Women in Beni-Suef, Egypt | NCT03381612 | Entailment |
6,461 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Have persistent facial erythema on the cheeks of at least moderate severity.
- Women must not be able to bear children
Exclusion Criteria:
- Have more than 12 inflammatory lesions on the face
- Previous treatment of facial skin with lasers or electrocauterisation within 2 months
prior to entering the study
- Have facial hair that makes it difficult to evaluate rosacea on the face Other
protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients | NCT01449591 | Entailment |
5,034 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Clinical diagnosis of Parkinson's Disease
- Presence of PD-related tremor
- Currently using Cannabis for management of tremor
- Obtaining Cannabis in accordance with Washington State law
- Willing to log activities and experiences
- Willing to wear a motion sensor
- Able to attend 2 on-site visits
Exclusion Criteria:
- Presence of active infection within 5 days prior to enrollment
- Presence of unusual stressor within 5 days prior to enrollment
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Cannabis and Parkinson's Disease Tremor: A Natural History Study | NCT02028858 | Entailment |
2,217 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- (123 items and 1 item from 4-7 are met simultaneously) :
1. Meet the 2015 ACR/EULAR classification diagnostic criteria for gout
2. Acute gouty arthritis
3. Age ≥18
4. Repeated attacks and prolonged pain (more than 1 month);
5. poor response or intolerance to colchicine or NSAIDs;
6. Liver and kidney dysfunction;
7. Old age;
Exclusion Criteria:
- 1) History of gastrointestinal bleeding and active ulcer 2) The application history of
glucocorticoids and ACTH in 1 month before screening 3) Pregnancy and lactation 4)
Drug and alcohol abuse 5) Malignant tumor (treated or untreated within 5 years) 6)
Mental illness inability to communicate or have language barriers and inability to
fully understand and cooperate 7) negligent compensatory heart failure, unstable
angina pectoris, stroke, transient ischemic attack, myocardial infarction, and severe
arrhythmia occurred within 6 months 8) The investigator did not consider it
appropriate to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Treatment of Refractory Gout With ACTH or Methylprednisolone | NCT04808856 | Contradiction |
1,054 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Subjects with heart failure and at the age of 18 (inclusive) to 80 (exclusive)
- Subjects with NYHA Class II-IV with dyspnea
- Subjects with left ventricular ejection fraction (LVEF) of 40 percent or below on the
echocardiogram
- Eligible subjects who meet the criteria, are capable of participating in the study,
and provide written informed consent to study participation after receiving a clear
explanation about the study objective and nature
Exclusion Criteria:
- A subject who cannot understand or does not agree to the study contents
- Subjects with conduction defect of 2nd degree or above atrioventricular block
- Subjects with heart rate less than (<) 60 beats at rest
- Subjects with systolic blood pressure < 100 mm Hg at rest
- Subjects with renal failure (serum creatinine > 2.0 milligram per deciliter [mg/dL])
- Subjects with unrecovered pulmonary edema
- Subjects with history of myocardial infarction or stroke within 3 months
- Subjects with history of coronary intervention or coronary bypass within 6 months
- Subjects with heart failure due to mitral valve without valve replacement or aortic
valvular disease (excluding moderate or less severe mitral insufficiency secondary to
left ventricular expansion)
- Subjects with history of valve replacement within the past 6 months
- Subjects with history or scheduled heart transplantation
- Subjects with reversible obstructive pulmonary disease
- Subjects with other cases where beta blockers are contraindicated
- Any surgical or internal disease that may put the subject at a higher risk due to
study participation or may interfere with the subjects compliance to study
requirements or completion of the study, based on the judgment of the Investigator
- A subject with history of non-compliance to drug prescriptions or who is not willing
to comply with the protocol
- Subjects with a history of treated or untreated malignant tumor within the past 5
years
- Pregnant or lactating women
- Subjects with heart failure due to acute myocarditis
- Subjects with continuous ventricular tachycardia with history of syncope within 3
months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea | NCT01074307 | Contradiction |
428 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Woman is between 18 and 40 years of age
- Has intact uterus and ovaries
- Has regular menstrual cycles of 25-35 days duration
- Able to comply with the protocol, including frequent blood sampling, and lives within
the catchment area of the clinic
- Understands the study procedures and agrees to participate in the study by giving
written informed consent
- Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm)
with every act of intercourse, or has been sterilized with tubal ligation, or only
male partner has been sterilized with vasectomy
- Progesterone >10 nmol/L in at least one sample in the lead-in cycle
Exclusion Criteria:
- All contraindications to OC use including
- Thrombophlebitis or thromboembolic disorders
- Past history of deep vein thrombophlebitis or thromboembolic disorders
- Past or current cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Woman has a history of headaches with focal neurological symptoms
- Known or suspected pregnancy
- Aged >35 and smoker
- BMI >29
- Positive urine pregnancy test at the screening or baseline visit
- Desired pregnancy within the duration of the study
- Known hypersensitivity to progestins
- Known hypersensitivity to estrogen
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- In accordance with the Bethesda system of classification Women with a current abnormal
Pap smear suggestive of high-grade pre cancerous lesion(s), including HGSIL, are
excluded
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated
with colposcopy and biopsy and no evidence of a lesion with a severity >CIN I is
present and/or endocervical curettage is negative
- Women with a biopsy finding of CIN I should have follow up for this finding per
standard of care; women are excluded if treatment is indicated In accordance with
other Pap class systems
- Women with high grade dysplasia are excluded
- Women with low grade dysplasia or CIN I interpretation on Pap smear may participate
based on investigator discretion in accordance with local standard of care
- Breastfeeding
- Cancer (past history of any carcinoma or sarcoma)
- History of a significant psychiatric disorder, including severe depression.
- Chronic or acute liver or renal disease
- Hypertension-- controlled by medication or defined by diastolic BP 85 mm Hg or
systolic BP 135mm Hg after 15 minutes rest
- Dermatitis, psoriasis or other severe skin disorder
- Known or suspected alcoholism or drug abuse
- Clinically significant abnormalities of laboratory safety tests
- Chronic disease or history of illness that, in the opinion of the investigator, might
confound the results of the study or pose additional risk to the subject
- Woman is participating or has participated in another clinical study (involving an
investigational drug) within one month prior to enrollment.
- Use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9
months (e.g. DMPA)
- Use of oral contraceptives within the past 1 month
- Use of concomitant drugs that may interact with the study drugs
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women | NCT00796133 | Contradiction |
3,739 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Radiographic evidence of knee OA on a standing AP X-ray
- Bilateral knee pain for at least 3 months with pain of at least moderate intensity
every day or almost every day
Exclusion Criteria:
- Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
- Folstein Mini-Mental State Examination score of less than 24
- Severe visual or hearing impairment
- Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout,
pseudogout, metastatic cancer
- Significant pain in parts of the body other than the knee or acute knee pain
- A large knee effusion or severe mechanical instability of the knee
- History of corticosteroid injection in the affected knee(s) during the preceding 3
months
- History of hyaluronic acid injection in the affected knee(s) during the preceding 3
months
- Acute or terminal illness
- Immune suppression
- Anticoagulation therapy
- Presence of a pacemaker
- Prior acupuncture treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability | NCT00417313 | Contradiction |
5,271 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- postmenopausal women with ages range from 50 to 60 years
Exclusion Criteria:
- participation in sports
- vertebrobasillar insufficiency
- poor diet
Female
Subject must be at least 50 Years old.
Subject must be at most 60 Years | Relationships Among Body Mass Index, Body Balance and Bone Mineral Density in Postmenopausal Women | NCT03280693 | Entailment |
6,707 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- a single tooth to be extracted for endodontic failure, fractures, root caries or
resorption in the maxillary and mandibular area from second premolar to second
premolar
- patient in good systemic health, with no contraindication for oral surgical
interventions
Exclusion Criteria:
- patients with impaired systemic diseases that will interfere with surgical
interventions (autoimmune diseases, uncontrolled diabetes)
- assumption of bisphosphonate
- smoking more than 10 cigarettes a day
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Soft and Hard Tissue Changes After Immediate Single-tooth Replacement | NCT03784430 | Contradiction |
2,457 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- diagnosed sarcoidosis according to WASOG/ATS/ERS guidelines
Exclusion Criteria:
- not being able to walk
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Muscle Strength and Exercise Capacity in Sarcoidosis Patients | NCT00854672 | Entailment |
5,711 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- All patients who receive easypod GH of age 1-14 years will be approached for consent
to participate in the study. Patients may have any valid cause for short stature.
These may include children with
- isolated growth hormone deficiency
- multiple pituitary hormone deficiencies
- non-growth hormone deficient conditions such as
- Small for gestational age with postnatal failure of height gain
- chronic renal failure and
- Turner syndrome. Patients will be recruited to the study irrespective of diagnosis and
will not be stratified by diagnosis at entry to the study. However, in analysis of
data, subgroup analysis may be performed on groups such as those with isolated growth
hormone deficiency, dependent on the frequency of recruitment.
All patients will be identified at the start of the study. A one month period will be
considered before the study commences to contact families for potential recruitment. Each
patient will remain in the study for 12 months. The active study duration will be 18 months
whereby all eligible patients will be recruited and followed up for a 12 month period. This
period will be followed by a buffer period to gather necessary data for analysis.
Exclusion Criteria:
- Patients on growth hormone treatment but using other growth hormone devices Patients
who are younger or older than the age limits.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 14 Years | Web-based Adherence Information Integrated Nurse-led Monitoring Clinic | NCT04244123 | Entailment |
6,857 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- AD diagnosis or AD with CVD according the criteria of National Institute on Aging and the
Alzheimer's Association workgroup and the National Institute of Neurological and
Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders
Association (NINCDS-ADRDA)
Exclusion Criteria:
- Patients with mild cognitive impairment;
- Other types of dementia, such as pure vascular dementia, frontotemporal dementia,
dementia with Lewy bodies, corticobasal degeneration;
- Severe dementia (CDR 3)
- Those who were already taking ChEI,
- If there have not been agreement between the first researcher and the treating
physician.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 59 Years old.
Subject must be at most 92 Years | The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Alzheimer Disease and Mixed Dementia | NCT02187276 | Contradiction |
3,237 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- primary or scondary Sjogren's syndrome
Exclusion Criteria:
- allergy to milk derivatives previous intake of antifungals
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome | NCT03840538 | Entailment |
6,221 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Documented COVID-19 infection (either performed on site or documented external report)
- Age ≥ 18
Arm A:
- Admission to an intensive care unit at MSK (M-11) and/or receiving mechanical
ventilation
- Absolute lymphocyte count ≤ 1.0/mm3
- As the ALC of patients with lymphoid malignancies is unreliable, they may be enrolled
at the discretion of the treating physician after review of their blood work.
Arm B:
- Arm B:Requiring 2L or more of supplemental oxygen by nasal cannula or higher to
maintain SpO2 of 95%
Exclusion Criteria:
Arm B:
- requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of N-acetylcysteine in Patients With COVID-19 Infection | NCT04374461 | Contradiction |
654 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Age >18 years
2. Previous clinical diagnosis of heart failure with current New York Heart Association
(NYHA) Class II-IV symptoms LVEF≤0.40 within 2 years prior to consent, and ≥3 months
after a major change in cardiac status (i.e. CABG or CRT).
3. Serum ferritin between 15-100 ng/ml or serum ferritin between 100-299 ng/ml with
transferrin saturation <20%
4. Hemoglobin 9.0-13.5 g/dL (males), 9-13.5 (females) at time of enrollment
5. Stable evidence-based medical therapy for HF (including beta-blocker and
ACE-inhibitor/ARB unless previously deemed intolerant, and diuretics as necessary)
with </= 100% change in dose for 30 days prior to randomization
a. Changes in diuretic dose guided by a patient-directed flexible dosing program are
considered stable medical therapy
6. Willingness to provide informed consent
Exclusion Criteria:
1. Presence of a neuromuscular, orthopedic or other non-cardiac condition that prevents
the patient from exercise testing on a bicycle/treadmill ergometer and/or inability to
achieve an RER ≥ 1.0 on screening/baseline CPET
2. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2)
3. Severe liver disease (ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x
normal)
4. Gastrointestinal conditions known to impair Fe absorption (i.e. inflammatory bowel
disease)
5. Known active infection as defined by current use of oral or intravenous antimicrobial
agents
6. Documented active gastrointestinal bleeding
7. Active malignancy other than non-melanoma skin cancers
8. Anemia with known cause other than Fe deficiency or chronic disease
9. Fe overload disorders (i.e. hemochromatosis or hemosiderosis)
10. History of erythropoietin, IV or oral Fe therapy, or blood transfusion in previous 3
months.
11. Current ventricular assist device
12. Anticipated cardiac transplantation within the next 4 months
13. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,
constrictive pericarditis or tamponade
14. Previous adverse reaction to study drug or other oral Fe preparation
15. Known or anticipated pregnancy in the next 4 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure | NCT02188784 | Contradiction |
5,787 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- DSM-IV diagnosis of nicotine dependence with psychological dependence
- Smokes at least 15 cigarettes per day for the three months prior to enrollment
- Currently not seeking treatment for nicotine dependence
- Medically healthy on the basis of physical examination and medical history, vital
signs, EKG, and laboratory tests
- Females must use an effective method of contraception for the duration of the study
Exclusion Criteria:
- DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
- Current Axis I diagnosis or current treatment with psychotropic medications within the
three months prior to enrollment
- History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety
disorders
- Currently seeking treatment for nicotine disorders
- On parole or probation
- History of seizures or head trauma with loss of consciousness, brain contusion, or
fracture
- History of significant recent violent behavior
- Blood pressure greater than 150/90
- History of eating disorders
- History of allergic reaction to any of the study medications
- Pregnant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | The Effects of Memantine and Bupropion on Acute, Reinforcing, and Conditioned Effects of Cigarettes - 1 | NCT00136747 | Contradiction |
3,206 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | - INCLUSION CRITERIA:
1. Diagnosis of primary Sjogren s syndrome based on American-European Consensus
Group Sjogren s syndrome classification criteria or healthy volunteers.
2. Both genders and all minorities.
3. Age at entry at least 18 and less than 65 years.
EXCLUSION CRITERIA:
1. Current use of medications known to significantly influence the activity of the
sympathetic or parasympathetic nervous system if they cannot be held safely at the
time of ANS testing
2. Known co-existing diagnosis of ANS dysfunction (for healthy volunteers)
3. Medications-requiring diabetes mellitus
4. Diabetic autonomic neuropathy
5. Vitamin B12, folate deficiency, requiring replacement
6. Hepatic failure (AST or ALT greater than 1.5 x upper limit of normal)
7. Renal failure (GFR less than 30 ml/min, as estimated by the MDRD)
8. Congestive heart failure (Class II-IV)
9. Refractory ventricular arrhythmias
10. Symptomatic coronary heart disease
11. Previously established diagnosis of sinus node dysfunction
12. Severe anemia (Hgb less than 8)
13. Psychosis
14. Pregnant or lactating women
15. A candidate subject is excluded if, in the judgment of the Principal Investigator,
protocol participation would place the subject at substantially increased acute
medical risk.
16. Not able to provide informed consent
Medications: A candidate subject is excluded if clinical considerations require that the
subject continue treatment with a drug likely to interfere with the scientific results i.e.
a tricyclic antidepressant or fludrocortisone. Subjects with known or suspected allergy or
hypersensitivity to any test drug are excluded from receiving that drug. Subjects who must
take medications daily in the following categories are excluded: tricyclic antidepressants,
beta blockers, barbiturates, if they cannot be safely held during testing. Subjects unable
to discontinue nicotine or alcohol temporarily are excluded. Subjects are not to
discontinue any medications before the subject or the subject s physician discusses this
with the Principal Investigator, Dr. Nikolov, or the Associate Investigator, Dr. Goldstein.
If it is decided that discontinuing medications would be unsafe, then the subject is
excluded from the study. Subjects must discontinue use of alcohol and tobacco throughout
the period of testing in the protocol.
Herbal Medicines and Dietary Supplements: Certain herbal medicines or dietary supplements
are known or suspected to interfere with the experimental results, and such herbal
medicines or dietary supplements must be discontinued before enrollment in the study. For
many herbal medicines or dietary supplements, the mechanisms of action and therefore the
possible effects on the experimental results are unknown. In cases where the subjects wish
to continue their herbal medicines or dietary supplements while on study, and search of the
available medical literature fails to identify effects that are known or expected to
interfere with the experimental results, then the subjects may participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome | NCT00565526 | Entailment |
2,831 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- ALS
- FVC >=50%
- Abnormality in upper and/or lower extremity motor function
- Not pregnant
- Disease duration <5 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis | NCT00005766 | Entailment |
6,157 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Hospitalized at the Kantonsspital Winterthur (KSW) due to COVID-19 infection
(laboratory-confirmed),
- with or without mechanically assisted ventilation
- being at risk to obtain severe illness caused by the COVID-19*
- individuals without defined risk factors but requiring oxygenation during
hospitalisation
- Agree to general consent or specific consent to subsequent use of his/her personal
health data for research purpose
- German-speaking
Exclusion Criteria:
- Presence of mental disability or impairments to reasoning or judgment
- Individuals who are immunocompromised due to medical treatment
- A documented objection of subsequent use of personal health data
Specific exclusion criteria for presence at the hospital (for evaluation and training);
criteria will be verified during the phone-based screening process. After two weeks of a
COVID-19 positive diagnosis and with four entire days the patient reports no signs of:
- fever >37.3° C
- sore throat,
- cough (productive or non-productive)
- common cold
Also, treatment-based immunocompromised patients are excluded for on-site evaluation and
training.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Quality of Life and Physical Performance After Novel Coronavirus Infection (COVID-19); | NCT04375709 | Contradiction |
6,394 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Age 18 and older.
2. Symptoms suggestive of Covid-19 infection (fever, cough, chest discomfort or loss of
smell/taste).
3. Covid-19 screening done.
4. Ambulatory without assistive devices (such as cane or walker).
5. Access to PT-Pal app via cellular phone, iPad or computer (e.g. Zoom™).
Exclusion Criteria:
1. Severe symptoms requiring referral to the Emergency Department.
2. Contraindications to exercise (cardiac disease such as diagnosed arrhythmias, on home
oxygen, or end stage organ failure).
3. Known history of poorly controlled diabetes or hypertension.
4. Active neurological or psychiatric illnesses.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Home-Based Covid-19 Rehabilitation Program | NCT04406532 | Entailment |
432 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine
spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without
pelvic pain for patients with threatened miscarriage.
Exclusion Criteria:
- medical disorders with pregnancy. History of recurrent miscarriage. Any maternal
disease that would cause an increase in CA125 level. Local gynecological disorders
e.g. fibroid. Presence of any uterine malformation. History of congenital
abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of
anembryonic sac. Absent fetal heart pulsation.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage | NCT03320213 | Contradiction |
3,718 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
Subjects will include those for whom a discontinuation trial of NSAIDs is most appropriate:
1) Veterans with knee pain despite NSAID use and/or 2) Veterans at relatively higher risk
of NSAID toxicity 55-59 as ascertained by meeting 1 or more of the following 4 criteria:
- Answer affirmatively to the question: "Do you have some knee pain on most days over
the past 3 months?"
- Have 1 or more risk factors for NSAID-induced nephrotoxicity (age greater than 60
years, atherosclerotic cardiovascular disease, current diuretic use, chronic renal
insufficiency, congestive heart failure (New York Heart Association class I-II. Note,
Class III and IV are excluded).
- Have 1 or more risk factors for NSAID-induced gastrointestinal toxicity (history of
peptic ulcer disease, age > 65 years, concurrent use of daily ASA or corticosteroids),
and are currently on a gastro-protective agent.
- Have 1 or more risk factors for NSAID-induced cardiovascular toxicity (prevalent
cardiovascular disease, hypertension, hypercholesterolemia, diabetes, smoking, family
history of early heart disease or age greater than 55 years for women).
In addition, subjects must:
- Be age 20 years or older. While the usual cut off for knee OA is approximately 40
years, the investigators chose to lower the age cutoff as younger Veterans have a
higher than expected risk of OA (see B.1).
- Have radiographic evidence of knee OA reported in the VistA electronic system.
- Be using an NSAID (other than daily ASA) for knee pain on most days of the month for
at least the past 3 months.
- Be able to understand and speak English and have a telephone.
- Be willing to engage in a CBT program, to discontinue (or replace) their NSAID, and to
restrict co-therapies to acetaminophen for 14 weeks.
Exclusion Criteria:
- Subjects desiring escalation of analgesics for their current level of knee pain as
determined by endorsement of the following statement: "Is your knee pain bad enough
that you want to talk to your doctor about taking stronger pain medications?"
- Current use of opioids and/or Celebrex.
- Current use of an NSAID (not including ASA) for a painful condition in addition to
knee OA.
- Contraindications to chronic NSAID use: current use of warfarin or antiplatelet agent
other than ASA, allergy to any NSAID, active upper gastrointestinal ulceration in the
previous 30 days, upper gastrointestinal bleeding in the past year, history of
gastroduodenal perforation or obstruction, cardiovascular event within the past 6
months (myocardial infarction, cerebrovascular event, coronary-artery bypass graft,
invasive coronary revascularisation, or new-onset angina), severe congestive heart
failure (New York Heart Association class III-IV), evidence of serious anemia,
hepatic, renal (including nephrotic syndrome), or blood coagulation disorders, and
pregnancy.
***Though the investigators are proposing a RWT - and thus will not be initiating NSAID
therapy - it would not be appropriate to continue NSAIDs (even when prescribed) in
high-risk patients. The investigators acknowledge that these exclusion criteria limit
generalizability, but the investigators feel justified to ensure subjects' safety.***
- Previous hyaluronic acid knee injections (within 6 months) or corticosteroid knee
injections (within 3 months).
- Scheduled knee hyaluronic acid or corticosteroid injections, arthroscopy, or knee
surgery.
- Co-morbid conditions that include the following: known other causes of arthritis
(infectious arthritis, rheumatoid arthritis, connective tissue disease, or psoriatic
arthritis), gout or pseudogout attack within the last 12 months, peripheral neuropathy
or cardiopulmonary disease that limits walking more than knee pain, bone metastases or
Paget's disease involving the lower extremities, and history of drug or alcohol abuse
within the past 2 years, bilateral knee replacements or knee pain in the replaced knee
only.
- Current involvement in litigation or receiving workmen's compensation.
- Hearing, cognitive impairment or mental illness, as determined by chart review that
would preclude participation in a CBT program.
- For Women of Childbearing Age: Must not currently be pregnant, agree to avoid getting
pregnant during the course of the study and should inform the study team if pregnancy
occurs at any time during study participation.
- Previous meloxicam use discontinued due to lack of effective symptom relief
- Contraindications to prolonged NSAID use, per PI discretion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Discontinuing NSAIDs in Veterans With Knee Osteoarthritis | NCT01799213 | Contradiction |
5,193 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
1. Subject is willing to provide written informed consent.
2. Ambulatory woman between the age of 50 and 85 years, inclusive.
3. The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at
either the lumbar spine or total hip
4. All subjects must have at least one of following additional the risk factors:history
of fracture（after 40 years）,parental history of hip fracture, low Body mass index
(BMI≤19kg/m^2), elderly (age≥65year)，current smoker
5. Postmenopausal defined as >2 years postmenopausal, which can be >2 years of
spontaneous amenorrhea or >2 years post surgical bilateral oophorectomy.
Exclusion Criteria:
1. Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or
osteogenesis imperfecta,which may interfere with the interpretation of the findings.
b. Paget's disease c. Cushing's disease d. Hyperprolactinemia
2. Current hyperparathyroidism or hypoparathyroidism by medical record
3. Thyroid condition: Hyperthyroidism or hypothyroidism.
4. Rheumatoid arthritis
-
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk | NCT04128163 | Entailment |
2,006 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction
with inoperable locally advanced or recurrent and/or metastatic disease not amenable
to curative therapy.
2. Measurable disease, according to the Response Evaluation Criteria in Solid Tumours
(RECIST), assessed using imaging techniques (CT or MRI)
3. ECOG Performance status 0, 1 or 2 (see Appendix 2)
4. Life expectancy of at least 3 months
5. Male or female age ≥ 18 years.
6. Signed informed consent.
7. Assessment of HER2 status (primary tumour or metastasis) by the central laboratory
prior to initiation of study treatment (see section 9.1)
8. Able to swallow and retain oral medication.
9. LVEF ≥ 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac
ultrasound.
Exclusion Criteria:
Any of the following will exclude the patient from the study:
1. Previous chemotherapy for advanced/metastatic disease (prior peri-operative
chemotherapy is allowed if at least 6 months has elapsed between completion of this
therapy and enrolment into the study).
2. Previous radiotherapy on the abdomen.
3. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
or basal cell carcinoma.
4. Patients with active (significant or uncontrolled) gastrointestinal bleeding.
5. Residual relevant toxicity resulting from previous therapy (with the exception of
alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE.
6. Creatinin clearance <50 mL/min.
7. Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L.
8. Serum bilirubin >1.5 × upper limit of normal (ULN); or, AST or ALT >2.5 × ULN (or >5 ×
ULN in patients with liver metastases); or, alkaline phosphatase >2.5 × ULN (or >5 ×
ULN in patients with liver metastases, or >10 × ULN in patients with bone but no liver
metastases); or, albumin <25 g/L.
9. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
10. History of documented congestive heart failure; angina pectoris requiring medication;
evidence of transmural myocardial infarction on ECG; poorly controlled hypertension
(systolic BP >180 mmHg or diastolic BP >100 mmHg); clinically significant valvular
heart disease; or high risk uncontrollable arrhythmias.
11. Patients with dyspnoea at rest due to complications of advanced malignancy or other
disease, or who require supportive oxygen therapy.
12. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and
short courses of oral steroids for anti-emesis or as an appetite stimulant are
allowed).
13. Major surgery within 4 weeks of start of study treatment; serious or not healing
wound.
14. Known hypersensitivity to any of the study drugs, Chinese hamster ovary cell products
or other murine or human recombinant antibodies.
15. History or clinical evidence of brain metastases.
16. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly
controlled diabetes.
17. Positive serum pregnancy test in women of childbearing potential.
18. Subjects with reproductive potential not willing to use an effective method of
contraception.
19. Any investigational drug treatment within 4 weeks of start of study treatment.
20. Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if
palliative radiotherapy given to bone metastastic site peripherally and patient
recovered from any acute toxicity)
21. Arterial thrombosis; cerebrovascular accident within 6 months prior to study
enrolment.
22. Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs.
23. Continuous use of immunosuppressive agents (for the use of corticosteroids see also
#12).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Docetaxel, Oxaliplatin, Capecitabine, Bevacizumab and Trastuzumab in Patients With Locally Advanced or Metastatic Gastric Cancer | NCT01359397 | Entailment |
1,095 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria for participants with moderate-to-high anxiety to undergo drug
intervention:
- Willing and able to provide written, signed consent after the nature of the study has
been explained, and prior to any research-related procedures.
Age is > or = 18 and < or = 79 years
No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
heart disease, cardiomyopathy), or peripheral arterial disease.
Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.
Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
medication with no dose change for 3 months.
Exclusion Criteria:
- Current use of clonidine or beta-blockers
Current use of antihypertensive medications for reasons other than hypertension (e.g.,
hydrochlorothiazide for leg edema or kidney stone prevention, beta-blockers for tremor)
Difficult to control hypertension (e.g., on 2 or 3 antihypertensive medications)
Low blood pressure (e.g., systolic BP < 110 mmHg)
Hypertensive and have not been stable on their current antihypertensive medication regimen
for at least 6 months
Blood pressure not controlled either on or off antihypertensive medications (e.g., BP >
150/100)
Current diagnosis or history of cancer, liver disease, HIV/AIDS
History of brain tumor, aneurysm or injury
Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia
History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
atherosclerosis.
Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
cigars, chewing tobacco, Hookah).
History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
(COPD).
Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Serious neurologic disorders including seizures.
History of renal failure, dialysis or kidney transplant.
Use of any investigational products or investigational medical devices within 30 days prior
to screening, or requirement for any investigational agent prior to completion of all
scheduled study assessments.
Recent flu-like symptoms within the past 2 weeks.
Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
any time during the study. A urinary pregnancy test will be done on all females. If test is
positive, the subject will be excluded.
History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
Wegener's granulomatosis.
Taking anticoagulation, anti-seizure, or antipsychotic agents.
Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
months (if no change in medication or dose in past 3 month, then subject will be eligible).
Immunodeficiency or systemic autoimmune disease.
History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
disease, Raynaud's disease).
History of co-morbid condition that would limit life expectancy to <1 year.
Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
or willing to go off of for 2 weeks prior to each study visit.
Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
Aloprim®).
Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
(Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).
Those who are currently donating blood, platelets, or plasma at the time of screening.
Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.
On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
of screening.
Any surgery within 30 days of screening
Those who currently donate blood, platelets, or plasma
Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
treatment and study compliance.
We will also enroll 36 participants ages 18-79 years (50% men, 50% women) with low or no
anxiety as control subjects to participate in only baseline testing (not participate in the
drug intervention).
Inclusion criteria:
Willing and able to provide written, signed consent after the nature of the study has been
explained, and prior to any research-related procedures.
Age is > or = 18 and < or = 79 years
No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
heart disease, cardiomyopathy), or peripheral arterial disease.
Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.
Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
medication with no dose change for 3 months.
Exclusion Criteria:
Current use of clonidine or beta-blockers
Current use of antihypertensive medications for reasons other than hypertension (e.g.,
hydrochlorothiazide for leg edema or kidney stone prevention, beta-blockers for tremor)
Difficult to control hypertension (e.g., on 2 or 3 antihypertensive medications)
Low blood pressure (e.g., systolic BP < 110 mmHg)
Hypertensive and have not been stable on their current antihypertensive medication regimen
for at least 6 months
Blood pressure not controlled either on or off antihypertensive medications (e.g., BP >
150/100)
Current diagnosis or history of cancer, liver disease, HIV/AIDS
History of brain tumor, aneurysm or injury
Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia
History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
atherosclerosis.
Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
cigars, chewing tobacco, Hookah).
History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
(COPD).
Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Serious neurologic disorders including seizures.
History of renal failure, dialysis or kidney transplant.
Use of any investigational products or investigational medical devices within 30 days prior
to screening, or requirement for any investigational agent prior to completion of all
scheduled study assessments.
Recent flu-like symptoms within the past 2 weeks.
Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
any time during the study. A urinary pregnancy test will be done on all females. If test is
positive, the subject will be excluded.
History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
Wegener's granulomatosis.
Taking anticoagulation, anti-seizure, or antipsychotic agents.
Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
months (if no change in medication or dose in past 3 month, then subject will be eligible).
Immunodeficiency or systemic autoimmune disease.
History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
disease, Raynaud's disease).
History of co-morbid condition that would limit life expectancy to <1 year.
Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
or willing to go off of for 2 weeks prior to each study visit.
Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
Aloprim®).
Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
(Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).
Those who are currently donating blood, platelets, or plasma at the time of screening.
Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.
On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
of screening.
Any surgery within 30 days of screening
Those who currently donate blood, platelets, or plasma
Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
treatment and study compliance.
We will also enroll 36 participants ages 18-79 years (50% men, 50% women) with low or no
anxiety as control subjects to participate in only baseline testing (not participate in the
drug intervention). These subjects will be either lean (body mass index < 25) or on the
obesity spectrum (body mass index > 30).
Because obesity is linked with hypertension and type 2 diabetes, enrollment of subjects may
include those with pre-hypertension or hypertension (systolic blood pressure >/= 120 - <180
mmHg- average of at least 3 measurements 2 min apart after 10 min seated resting position),
and/or pre-diabetes (defined as fasting blood glucose between 100-126 mg/dl, fasting blood
glucose of 140-199 mg/dl at 120 min of an oral glucose tolerance test, or HbA1C of 6-6.5%)
or type 2 diabetes (defined as fasting blood glucose between >126 mg/dl, fasting blood
glucose of >199 mg/dl at 120 min of an oral glucose tolerance test, or HbA1C > 6.5%). These
subjects may be taking anti-hypertensive and/or diabetes (anti-hyperglycemic) medications.
Subjects will be asked to refrain from medications the morning of the study visit, and to
bring their medications with them to take immediately following their study visit.
Inclusion criteria:
Willing and able to provide written, signed consent after the nature of the study has been
explained, and prior to any research-related procedures.
Age is > or = 18 and < or = 79 years
No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
heart disease, cardiomyopathy), or peripheral arterial disease.
Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.
Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
medication with no dose change for 3 months.
Exclusion Criteria:
Current diagnosis or history of cancer, liver disease, HIV/AIDS
History of brain tumor, aneurysm or injury
Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia
History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
atherosclerosis.
Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
cigars, chewing tobacco, Hookah).
History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
(COPD).
Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).
Serious neurologic disorders including seizures.
History of renal failure, dialysis or kidney transplant.
Use of any investigational products or investigational medical devices within 30 days prior
to screening, or requirement for any investigational agent prior to completion of all
scheduled study assessments.
Recent flu-like symptoms within the past 2 weeks.
Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
any time during the study. A urinary pregnancy test will be done on all females. If test is
positive, the subject will be excluded.
History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
Wegener's granulomatosis.
Taking anticoagulation, anti-seizure, or antipsychotic agents.
Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
months (if no change in medication or dose in past 3 month, then subject will be eligible).
Immunodeficiency or systemic autoimmune disease.
History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
disease, Raynaud's disease).
History of co-morbid condition that would limit life expectancy to <1 year.
Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
or willing to go off of for 2 weeks prior to each study visit.
Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
Aloprim®).
Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
(Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).
Those who are currently donating blood, platelets, or plasma at the time of screening.
Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.
On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
of screening.
Any surgery within 30 days of screening
Those who currently donate blood, platelets, or plasma
Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
treatment and study compliance.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 79 Years | Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System | NCT03109795 | Contradiction |
3,987 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Male patients or female patients of non-childbearing potential Age between 40 to 75
years (both inclusive).
- Body weight > 40 kg, body mass index (BMI) < 40 kg/m2.
- Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the
American College of Rheumatology.
- History of knee pain for at least 6 months and on the majority of days (> 50%) during
the preceding month.
- Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on VAS (100 mm).
- Documented need for symptomatic as needed-treatment for OA in the target knee with
systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
Exclusion Criteria:
- Severe clinical knee malalignment according to the investigator.
- Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral
side).
- Knee prosthesis already foreseen within the study period (whichever side)
- Hip prosthesis recently implanted (< 1 year) or foreseen within the study period
(whichever side).
- Previous osteotomy on the inferior limbs (whichever side).
- Surgical operation on the target knee within the 12 months prior to the screening
visit or planned during the study.
- Arthroscopy of the target knee within the 6 months prior to the screening visit or
planned during the study.
- Other pathologies affecting the knee.
- Any contraindication to MRI including the inability to undergo a knee MRI exam because
of inability to fit in the scanner or knee coil.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Patients With Knee Osteoarthritis | NCT03595618 | Entailment |
5,008 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Parkinson´s disease patients according to UK Parkinson´s Disease Brain Bank Criteria
- Essential Tremor Patients according to Movement Disorder´s diagnosis consensus
criteria.
- Healthy Volunteers: paired with PD patients by age and gender.
Exclusion Criteria:
- Contraindication to MRI
- Claustrophobia.
- Serious structural brain anomalies.
- Condition or situation in which, in the opinion of the investigator put the patient at
significant risk, which can confound the results, or substantially interfere with the
individual's participation in the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
| Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor | NCT01446939 | Entailment |
1,016 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months
2. Report of at least 3 of the following per Altman et al. (1986)
- Over 50 Years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
Exclusion Criteria:
1. Report of red flags to manual physical therapy to include: hypertension, infection,
diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema,
severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA,
osteoporosis, severe vascular disease, malignancy, etc.
2. History of previous surgery to the knee
3. History of physical therapy, massage therapy, chiropractic treatment, or injections
for knee pain in the last 4 weeks
4. History of a surgical procedure on either lower extremity in last 6 months
5. Two or more positive neurologic signs consistent with nerve root compression,
including any two of the following:
- Weakness involving a major muscle group of the lower extremity.
- Diminished patella or achilles tendon reflex
- Diminished or absent sensation to pinprick in lower extremity dermatome
6. Involvement in litigation or worker's compensation regarding knee pain.
7. Any condition that might contraindicate the use of electro-needling
8. The patient is pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis | NCT02373631 | Entailment |
556 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- women with poor ovarian response candidate for ICSI
- women with spontaneous normal menstrual cycle
- normal uterine cavity
Exclusion Criteria:
- women with ovarian cysts
- endometriosis
- hydrosalpinx
- endocrinological disorders as hyperprolactinemia, thyroid or adrenal disorders.
- Couples with azospermic male partner
- those with severe uncontrolled medical or metabolic disorders
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 42 Years | Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles | NCT04008966 | Contradiction |
3,910 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Diagnosis of KOA;
2. Age 40-75 years;
3. KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ in recent 3 months;
4. NRS score of pain at least more than 4 points;
5. Single/bilateral knee pain, duration of more than 6 month; If the patient has KOA on
both legs, the heavier leg is selected for study.
Exclusion Criteria:
1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy);
2. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint
cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.);
3. Oral administration of hormones within 3 month, intra-articular injection within 6
months, knee injuries or open injuries within 6 months, or knee arthroscopy within 1
year.
4. Severe acute/chronic organic or mental diseases;
5. Pregnant women, pregnant and lactating women;
6. Coagulation disorders (such as hemophilia, etc.), or the skin diseases at the site of
operation;
7. Device support treatment after knee osteoarthritis disability;
8. Participation in another clinical study in the past 3 months;
9. History of receiving acupuncture, massage, manipulation, or any medical plaster
treatment within 3 months
10. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may
be construed as non-compliance and may be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Chinese Tuina Therapy for Treatment of Knee Osteoarthritis | NCT03966248 | Entailment |
4,599 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- General good health (by volunteer history and per investigator judgment) without any
clinically significant systemic disease (including, but not limited to significant
liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract,
uterus and cervix
- Currently have regular menstrual cycles of 21-35 days by participant record
- Willing to abstain from vaginal intercourse and any other vaginal activity including
use of vaginal products (tampons, spermicides, lubricants, and douches) other than
study products:
- 48 hours before Visit 2 until six days after Visit 2
- 48 hours before Visit 3 until six days after Visit 4
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Estimated calculated creatinine clearance (eCcr) of at least 60 mL/min
- History of Pap smears and follow-up consistent with standard clinical practice as
outlined in the study manual or willing to undergo a Pap smear at Visit 1
- Protected from pregnancy by one of the following:
- sterilization of either partner
- abstinence
- same sex relationship
- condoms
- combined contraceptives (including oral, patch)
- copper IUD
- Willing and able to comply with protocol requirements including swallowing tablets
- Willing to give voluntary consent and sign an informed consent form
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within two calendar months from the last pregnancy outcome.
Note: if recently pregnant must have had at least two spontaneous menses since
pregnancy outcome
- Injection of Depo-Provera in the last 10 months or use of other progestin-only based
contraceptive (including hormonal IUD)
- Currently breastfeeding or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study products, topical
anesthetic, or to both silver nitrate and Monsel's solution
- In the last three months, diagnosed with or treated for any STI, by self report
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
HIV, or Hepatitis B surface antigen (HBsAg) Note: Women with a history of genital
herpes who have been asymptomatic for at least three months may be considered for
eligibility
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding,
discharge, etc.)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, anticoagulants or other drugs known to
prolong bleeding and/or clotting, antifungals, or antivirals (e.g., acyclovir,
valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®)
- Current or anticipated chronic use of NSAIDS, or Tylenol for the duration of the study
- Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS,
National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the
Severity of Adverse Events, or clinically significant laboratory abnormality as
determined by the clinician
- Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or which, in the opinion of the investigator, would
make participation in the study unsafe or would complicate interpretation of data
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Exploratory Pharmacodynamic Study of Tenofovir-Based Products | NCT02722343 | Entailment |
751 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
To be considered eligible for enrollment into the study, subjects must;
- Be able to give written informed consent.
- Be female and between 18 and 65 years of age.
- Be a non-pregnant female.
- Be in generally good health as determined by the investigator.
- Osteoarthritis patients must have a clinical diagnosis of moderate to severe
osteoarthritis.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
- Are less than 18 and greater than 65 years of age.
- Are pregnant females.
- Are currently taking probiotics or vitamin supplements, or have taken them in the past
14 days.
- Have a significant acute or chronic coexisting illness (cardiovascular,
gastrointestinal, endocrinological, immunological, metabolic or any condition which
contraindicates, in the investigators judgment, entry to the study).
- Having a condition or taking a medication that the investigator believes would
interfere with the objectives of the study, pose a safety risk or confound the
interpretation of the study results; to include non-steroidal anti-inflammatory drugs
(NSAIDs), steroids and vitamin.
- Individuals who, in the opinion of the investigator, are considered to be poor
attendees or unlikely for any reason to be able to comply with the trial.
- Subjects may not be receiving treatment involving experimental drugs.
- If the subject has been in a recent experimental trial, these must have been completed
not less than 30 days prior to this study.
- Have a malignant disease or any concomitant end-stage organ disease.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects | NCT01321281 | Contradiction |
2,347 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Duchenne muscular dystrophy resulting from a mutation correctable by treatment with
PRO045 confirmed by a state-of-the-art DNA diagnostic technique covering all DMD gene
exons, including but not limited to MLPA (Multiplex Ligation-dependent Probe
Amplification), CGH (Comparative Genomic Hybridisation), SCAIP (Single Condition
Amplification/Internal Primer) or HRMCA (High-Resolution Melting Curve Analysis), and
correctable by PRO045-induced DMD exon 45 skipping in cultured skin-derived
myo-converted fibroblasts.
2. Ambulant boys aged at least 5 years on the day of first dosing able to walk for at
least 230 meters in the 6 minute walking distance (6MWD) test at first screening visit
and also at the baseline visit. In addition, 2 of the 3 pre-treatment 6MWD tests
(screen 1, screen 2, baseline) must be within +/-30 metres of each other prior to
first PRO045 administration.
3. Adequate quality for biopsy (confirmed with MRI) of the lateral head of the
gastrocnemius muscle. An alternative muscle may be considered for biopsy but only
following discussion between the Principal Investigator and the Prosensa Medical
Monitor.
4. Life expectancy of at least 3 years after inclusion in the study.
5. Glucocorticosteroid use which is stable for at least 3 months prior to first PRO045
administration. Subjects must have been receiving glucocorticosteroids for at least 6
months prior to the first PRO045 administration.
6. Willing and able to adhere to the study visit schedule and other protocol
requirements.
7. Written informed consent signed (by parent(s)/legal guardian and/or the subject,
according to the local regulations).
8. In France, a subject will be eligible for inclusion in this study only if either
affiliated to, or a beneficiary of, a social security category.
Exclusion Criteria:
1. Known presence of dystrophin in ≥5% of fibres in a pre-study diagnostic muscle biopsy
(i.e. historic muscle biopsy taken prior to written informed consent for this study).
2. Current or history of liver disease or impairment.
3. Current or history of renal disease or impairment.
4. At least two aPTT above ULN within the last month.
5. Screening platelet count below the lower limit of normal (LLN).
6. Acute illness within 4 weeks prior to first dose of PRO045 which may interfere with
the study assessments.
7. Severe mental retardation or behavioural problems which in the opinion of the
investigator prohibits participation in this study.
8. Severe cardiomyopathy which in the opinion of the investigator prohibits participation
in this study. If a subject has a left ventricular ejection fraction <45% at
screening, the investigator should discuss inclusion of the subject with the Medical
Monitor.
9. Expected need for daytime mechanical ventilation within the next year.
10. Use of anticoagulants, antithrombotics or antiplatelet agents.
11. Use of idebenone or other forms of coenzyme Q10 within 1 month prior to the start of
the screening for the study.
12. Use of nutritional or herbal supplements which, in the opinion of the investigator,
may influence muscle performance, within 1 month of the study.
13. Use of any other investigational product or participation in another trial with an
investigational product, within 6 months prior to the start of the screening for the
study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 18 Years | Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy | NCT01826474 | Entailment |
2,007 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients must have histologically or cytologically confirmed diagnosis of
adenocarcinoma of the stomach, gastroesophageal junction, or lower third of the
esophagus, AJCC stage II-IIIB (gastric) or IIA-IVA (esophageal). M1a disease will be
included, but not T4 lesions.
- No prior radiation or chemotherapy including anti-EGFR or vascular endothelial growth
factor (VEGF) antibody or tyrosine kinase inhibitor treatments.
- All patients must have staging endoscopic ultrasound (EUS) prior to enrollment.
- Men or Women >18 years of Age
- ECOG performance status <2 (Karnofsky >60%, see Appendix A).
- Cardiac ejection fraction >45% by echocardiogram or MUGA scan.
- Must be able to either swallow pills or have gastrostomy tube in place for
administration of enteral medications.
- Patients must have normal organ, metabolic and marrow function as defined below:
- Hematologic function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Renal function, as follows:
- Creatinine < or = 1.5 mg/dL x ULN
Hepatic function, as follows:
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)< or = 3 x ULN
- Total bilirubin < 1.5 x ULN
Metabolic function, as follows:
- Magnesium ≥ lower limit of normal
- Calcium < or = lower limit of normal -Human IgG is known to cross the placental
barrier; therefore, Panitumumab may be transmitted from the mother to the developing
fetus. In women of childbearing potential, appropriate contraceptive measures must be
used during treatment with panitumumab and for 6 months following the last dose of
panitumumab. If panitumumab is used during pregnancy or if the patient becomes
pregnant while receiving this drug, she should be apprised of the potential risk for
loss of the pregnancy or potential hazard to the fetus.
3.1.10 Ability to understand and the willingness to sign and date a written IEC/IRB
approved informed consent form.
Exclusion Criteria:
- Evidence of distant metastatic disease.
- T4 tumor on initial staging studies.
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer
- Curatively resected non-melanoma skin cancer
- Other primary solid tumor curatively treated with no known active disease present and
no treatment administered for ³ 5 years prior to enrollment
- Relative or absolute contraindications to surgery which in the opinion of the
investigator make the patient a poor candidate for surgical resection.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to panitumumab or other agents used in study.
- Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate,
cyclosporine).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any
evidence of interstitial lung disease on baseline chest CT scan.
- History of any medical or psychiatric condition or laboratory abnormality that in the
opinion of the investigator may increase the risks associated with the study
participation or investigational product(s) administration or may interfere with the
interpretation of the results.
- Subject unwilling or unable to comply with study requirements.
- Women who test positive for serum or urine pregnancy test < 72 hours before
randomization or are breast feeding.
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus,
acute or chronic active hepatitis B infection.
- Major surgery with 28 days or minor surgery within 14 days of study enrollment.
- Men or women of child-bearing potential (women who are post-menopausal < 52 weeks, not
surgically sterilized, or not abstinent) not consenting to use adequate contraception
(per institutional standard of care) during the course of the study and after the last
investigational product(s) administration (24 weeks for women, 4 weeks for men).
- Subjects with > grade 1 neuropathy at baseline.
- Contraindication to port-a-cath placement.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma | NCT00667420 | Entailment |
1,684 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- Signed informed consent executed prior to protocol screening assessments;
- Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via
tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for
>1 year. Women who are of childbearing potential must agree to practice adequate
contraception one month before the first dose of study medication and up to Day 16 of
the study. Adequate contraception may include, but is not limited to, abstinence,
monogamous relationship with vasectomized partner, barrier methods such as condoms or
diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal
methods.);
- No history of chronic diseases, except for subjects with well-controlled hypertension
or well-controlled hyperlipidemia;
- BMI ≤30kg/m2;
- No significant medical history including diabetes or hypertension complicated by
hyperlipidemia (metabolic syndrome);
- Negative urine drug and alcohol tests at Screening; and,
- No metformin or omega-3 products within 2 months.
Exclusion Criteria:
- Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory
testing, in the judgment of the investigator;
- Allergies to fish or shellfish;
- Impaired renal function (calculated eGFR <60 mL/min);
- Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) >2x upper limits of
normal (ULN) or serum bilirubin >1.5 mg/dL;
- Requirement of prescription medication within 14 days of the Screening Visit, with the
exception of prescription medications for the prevention of pregnancy, anti
hypertensives for hypertension, or statins for hyperlipidemia. Doses of one or two
anti-hypertensives and/or a statin must be stable for >1 month;
- Normal doses of over-the-counter medications, including vitamins are allowed but not
within 3 days of Visit 2 (first day of dosing);
- Current or history of abuse of alcohol or illicit drugs within the preceding year to
the Screening Visit;
- Participation in a dietary modification or an intensive weight loss program;
- Participation in another clinical trial of an investigational product within 3 months
prior to the Screening Visit;
- Smokers (use of tobacco in the past 3 months); or,
- Donation or loss of 400 mL blood or more in the last 8 weeks.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA | NCT02113163 | Entailment |
4,177 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Subject must have the ability to understand and provide written informed consent
- Adult subjects 18 up to 50 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female of any race
- Subject demographics include a range of skin pigmentations, including at least 1
darkly pigmented subjects or 15% of the subject pool, whichever is larger.
Exclusion Criteria:
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands,
ears or forehead/skull or other sensor sites which would limit the ability to test
sites needed for the study. (Note: Certain malformations may still allow subjects to
participate if the condition is noted and would not affect the particular sites
utilized.)
- Females who are pregnant, who are trying to get pregnant or who have a urine test
positive for pregnancy on the day of the study
- Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery with continued indications of health
issues,
- emphysema, COPD, lung disease
- Subjects with known heart or cardiovascular conditions such as:
- Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings.
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus
arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury within the last 2 months,
- cancer / chemotherapy
- Subjects with known clotting disorders
- history of bleeding disorders or personal history of prolonged bleeding from
injury
- history of blood clots
- hemophilia
- current use of blood thinner: prescription or daily use of aspirin
- Subjects with Severe contact allergies to standard adhesives, latex or other materials
found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or
other medical sensors
- Unwillingness or inability to remove colored nail polish or non-clear artificial nails
from test digits.
- Other known health condition, should be considered upon disclosure in health
assessment form
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Accuracy Assessment of Beddr Oximeter | NCT03710993 | Contradiction |
104 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Female volunteers in early to mid-puberty (i.e., late Tanner I [estradiol level > 20
pg/mL], Tanner II, or Tanner III)
- Premenarcheal
Exclusion Criteria:
- Pregnancy
- Inability to comprehend what will be done during the study or why it will be done
- Hemoglobin less than 12 g/dl and hematocrit less than 36%
- Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
- Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase
(i.e., confirmed on repeat)
- Total bilirubin > 1.5 times upper limit of normal (i.e., confirmed on repeat)
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected
congestive heart failure; asthma requiring intermittent systemic corticosteroids;
etc.)
- Untreated hypo- or hyperthyroidism, reflected by persistently abnormal
thyroid-stimulating hormone (TSH) values
- Total testosterone > 200 ng/dl
- Basal (follicular) 17-hydroxyprogesterone > 200 ng/ml (in girls without a previous
diagnosis of congenital adrenal hyperplasia)
- Dehydroepiandrosterone sulfate (DHEA-S) > 800 mcg/dl
- Elevation of prolactin > 2 times upper limit of normal
- Weight less than 26 kg.
Female
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 14 Years | Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone | NCT01428089 | Contradiction |
4,696 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Non descent uterus with benign gynaecological conditions
Exclusion Criteria:
- Uterine size > 20 weeks
- Minilaparotomy was contraindicated in patients where severe adhesions might exist eg -
- Endometriosis
- Previous pelvic inflammatory disease
- Patients with one or more contraindications for LAVH were excluded -
- Cardiac or respiratory morbidity contraindicating laparoscopy
- Frozen pelvis
- Cervix flushed with vagina
Female
| Comparative Study of LAVH and Minilaparotomy Hysterectomy | NCT03548831 | Entailment |
1,053 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Overweight or obesity (BMI> 25 Kg/m2)
Exclusion Criteria:
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism,
etc.),
- Chronic inflammatory diseases
- Renal failure
- Liver failure
- Angina pectoris
- Myocardial infarction and heart failure
- Genetic heart diseases
- Thrombocytopenias
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy Overweight and Obese Subjects | NCT04264091 | Contradiction |
2,959 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Diagnosed with Amyotrophic lateral sclerosis (ALS)
Exclusion Criteria:
- Late stage ALS
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Muscle Training of Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT01504009 | Entailment |
1,485 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Any patient with spontaneous or iatrogenic esophageal wall defect
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
| Endoscopic Management of Esophageal Wall Defects | NCT04571541 | Entailment |
5,166 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Person is a women with osteoporosis who is unwilling or unable to take other
treatments for osteoporosis
Exclusion Criteria:
- Person has had a previous fracture
- Person has rheumatoid arthritis. Person has has certain types of cancer
- Person has donated blood or has been in another investigational study within the last
4 weeks
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005) | NCT00533650 | Contradiction |
2,145 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Willing and able to give informed consent.
2. Willing and able to comply with the prescribed treatment protocol and evaluations for
the duration of the trial.
3. Adult men or women ≥18 and <80 years of age.
4. Uncontrolled gout, defined as meeting the following criteria:
- Hyperuricemia during the screening period defined as sUA ≥6 mg/dL, and;
- Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the
maximum medically appropriate dose, or with a contraindication to xanthine
oxidase inhibitor therapy based on medical record review or subject interview,
and;
- Symptoms of gout including at least 1 of the following:
- Presence of at least one tophus
- Recurrent flares defined as 2 or more flares in the past 12 months prior to
screening
- Presence of chronic gouty arthritis as evidenced by either clinical signs
consistent with chronic synovitis on clinical examination or the presence of
typical gouty erosion(s) on hand and/or foot X-rays
5. Willing to discontinue any oral urate lowering therapy for at least 7 days prior to
MTX dosing at Week -4 and remain off while receiving pegloticase treatments.
6. Women of childbearing potential (including those with an onset of menopause <2 years
prior to screening, non-therapy-induced amenorrhea for <12 months prior to screening,
or not surgically sterile [absence of ovaries and/or uterus]) must have negative
serum/urine pregnancy tests during Screening and Week -4; subjects must agree to use 2
reliable forms of contraception during the trial, one of which is recommended to be
hormonal, such as an oral contraceptive. Hormonal contraception must be started ≥1
full cycle prior to Week -4 (start of MTX) and continue for 4 weeks/30 days after the
last dose of pegloticase, or at least one ovulatory cycle after the last dose of MTX
(whichever is the longest duration after the last dose of pegloticase or MTX). Highly
effective contraceptive methods (with a failure rate <1% per year), when used
consistently and correctly, include implants, injectables, combined oral
contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner.
7. Men who are not vasectomized must agree to use appropriate contraception so as to not
impregnate a female partner of reproductive potential during the trial, beginning with
the initiation of MTX at Week -4 and continuing and for at least 3 months after the
last dose of MTX.
8. Able to tolerate MTX 15 mg orally for 4 weeks (Week -4 through Day 1) prior to
enrollment.
Exclusion Criteria:
1. Weight >160 kg (352 pounds) at Screening.
2. Any serious acute bacterial infection, unless treated and completely resolved with
antibiotics at least 2 weeks prior to the Day 1 Visit.
3. Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or
chronic bronchiectasis.
4. Current or chronic treatment with systemic immunosuppressive agents such as MTX,
azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of
other corticosteroid on a chronic basis (3 months or longer) would also meet exclusion
criteria.
5. History of any transplant surgery requiring maintenance immunosuppressive therapy.
6. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA
positivity.
7. Known history of hepatitis C virus RNA positivity, unless treated and viral load is
negative.
8. Known history of Human Immunodeficiency Virus (HIV) positivity.
9. Glucose-6-phosphate dehydrogenase deficiency (tested at the Screening Visit centrally
or locally).
10. Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) <40
mL/min/1.73 m^2 or currently on dialysis.
11. Non-compensated congestive heart failure or hospitalization for congestive heart
failure within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for
acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled
blood pressure (>160/100 mmHg) prior to enrollment at Day 1.
12. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female
partner, or not on an effective form of birth control, as determined by the
Investigator.
13. Prior treatment with pegloticase, another recombinant uricase (rasburicase), or
concomitant therapy with a polyethylene glycol-conjugated drug.
14. Known allergy to pegylated products or history of anaphylactic reaction to a
recombinant protein or porcine product.
15. Contraindication to MTX treatment or MTX treatment considered inappropriate.
16. Known intolerance to MTX.
17. Receipt of an investigational drug within 4 weeks or 5 half-lives, whichever is
longer, prior to MTX administration at Week -4 or plans to take an investigational
drug during the trial.
18. Liver transaminase levels (AST or ALT) > 1.25 X upper limit of normal (ULN) or albumin
< the lower limit of normal (LLN) at the Screening Visit.
19. Chronic liver disease.
20. White blood cell count <4000/µl, hematocrit <32 percent, or platelet count <75,000/µl.
21. Currently receiving systemic or radiologic treatment for ongoing cancer, excluding
non-melanoma skin cancer.
22. History of malignancy within 5 years other than non-melanoma skin cancer or in situ
carcinoma of cervix.
23. Diagnosis of osteomyelitis.
24. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as
Lesch-Nyhan and Kelley-Seegmiller syndrome.
25. Unsuitable candidate for the trial, based on the opinion of the Investigator (e.g.,
cognitive impairment), such that participation might create undue risk to the subject
or interfere with the subject's ability to comply with the protocol requirements or
complete the trial.
26. Alcohol use in excess of 3 alcoholic beverages per week.
27. A known intolerance to all protocol standard gout flare prophylaxis regimens (i.e.,
subject must be able to tolerate at least one: colchicine and/or non-steroidal
anti-inflammatory drugs and/or low dose prednisone ≤10 mg/day).
28. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed
necessary by the Investigator, a chest X-ray may be performed during Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL) | NCT04762498 | Contradiction |
2,334 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | INCLUSION CRITERIA
- Informed consent is obtained from the parent/ legal guardian
- The participant is aged between 2 months and 50 years
- The diagnosis of DMD is genetically confirmed by CENTOGENE
EXCLUSION CRITERIA
- Informed consent is not obtained from the parent/ legal guardian.
- The participant is younger than 2 months or older than 50 years
- The diagnosis of DMD is not genetically confirmed by CENTOGENE
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Months old.
Subject must be at most 50 Years | Biomarker for Duchenne Muscular Dystrophy | NCT02994030 | Entailment |
3,144 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Dry eye symptoms OSDI score 20 or higher
- Dryness, burning or foreign body sensation moderate or higher
Exclusion Criteria:
- Severe eye diseases
- Known allergy to any of the ingredients of the product
- Laser surgery of eyes during the last year
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 70 Years | Effects of a Moisturizing Product on Dry Eye and Skin | NCT02683382 | Contradiction |
4,765 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. Adults 40 years and older
2. English as primary language
3. Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central
vascular insufficiency, small vessel circulatory disease, generalized imbalance, and
idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
4. Willingness to complete surveys and take medication as prescribed
Exclusion Criteria:
1. Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease,
vestibular migraine with headache, intracranial mass, perilymphatic fistula, or
multiple sclerosis
2. history of cholesteatoma
3. Prior ear surgery other than myringotomy and tube placement
4. Prior radiation to head or neck
5. previous use of vestibulotoxic medications where the enrolling provider determines the
drug exposure to be the cause of imbalance
6. Use of blood thinning medications
7. intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral
or retinal hemorrhage (past 3 months)
8. Pregnant or lactating females.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Trental for the Treatment of Vertigo/Dizziness/Imbalance | NCT02592863 | Entailment |
4,884 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | INCLUSION CRITERIA:
SONICS STUDY COMPLETERS:
Completed the final SONICS visit (M12) and have demonstrated maintenance of clinical
response on a stable Therapeutic Dose of levoketoconazole for at least 12 weeks prior to
study entry.
ALL OTHERS:
- Confirmed newly diagnosed, persistent or recurrent endogenous Cushing's syndrome of
any etiology, except secondary to malignancy (including pituitary or adrenal
carcinoma).
- Elevated mean 24-hour UFC levels at least 1.5X upper limit of the normative range of
the study's central laboratory assay and from a minimum of three measurements from
adequately collected urine.
- Presence of abnormal values from at least one of these two diagnostic tests:
- Abnormal Dexamethasone Suppression Test (DST) OR
- Elevated late night salivary cortisol concentrations (at least two measurements)
each greater than the upper limit of the study's central laboratory normative
range
- Non-candidates for CS-specific surgery, refuse surgery or surgery will be delayed
until after study completion and agree to complete this study prior to surgery.
- If post-surgical for CS-specific surgery, then no significant post-operative sequelae
remain and the risk of such sequelae is considered negligible.
EXCLUSION CRITERIA:
Subjects will be excluded from the study if ANY of the following criteria are met (NOTE:
exclusion criteria apply to and must be assessed in both cohorts):
- Enrolled in SONICS but have not completed SONICS through Visit M12.
- Pseudo-Cushing's syndrome based on assessment of the Investigator.
- Cyclic Cushing's syndrome with multi-week periods of apparent spontaneous CS
remission.
- Non-endogenous source of hypercortisolism, including pharmacological corticosteroids
or ACTH.
- Radiotherapy of any modality directed against the source of hypercortisolism within
the last 5 years.
- Treatment with mitotane within 6 months of enrollment.
- History of malignancy, including adrenal or pituitary carcinomas (other than low-risk,
well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely
to require further treatment in the opinion of the treating physician, or squamous
cell or basal cell carcinoma of the skin).
- Clinical or radiological signs of compression of the optic chiasm.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. | NCT03277690 | Entailment |
1,173 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Referral to interventional pulmonary services for diagnostic transbronchial cryobiopsy
for diffuse parenchymal lung disease.
2. Transbronchial cryobiopsy is determined to be appropriately indicated as determined by
consulting interventional pulmonologist.
3. Age > 18 years
Exclusion Criteria:
1. Inability to provide informed consent
2. Study subject has any condition that interferes with safe completion of the study
including:
1. Coagulopathy, with criteria left at the discretion of the operator
2. Respiratory insufficiency with DLCO < 30% or baseline requirements of oxygen >2
liters
3. Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120
beats/min, unless deemed to be stable with these values by the attending
physicians
3. Patients representing vulnerable populations (prisoners, pregnant women, etc.)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| CrYobiopsy With Radial UltraSound Guidance | NCT03506295 | Contradiction |
421 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- 18 < age < 45 year old
- Thick irregular endometrium >12 mm on trans-vaginal ultrasound
Exclusion Criteria:
- Endometritis
- Cervical opening > 1 cm
- Uterine abnormalities
- Contraindication to Misoprostol treatment
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Management of RPOC After Induced Abortion | NCT04685694 | Contradiction |
3,173 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of
Rheumatology-EULAR criteria
2. ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7
following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous,
hematologic and biologic,
3. Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥
1:320 or rheumatoid factor (RF) >20 IU/ml during screening period, measured in a
central laboratory
4. Stimulated whole salivary flow rate > 0 mL/minute
Exclusion Criteria:
1. Prior administration within the timeframe described in the protocol of any of the
following:
- Belimumab,
- Rituximab or other B cell depleting agents,
- Abatacept,
- Tumor necrosis factor inhibitors,
- Tocilizumab,
- Cyclophosphamide,
- Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil
(MMF), azathioprine, or leflunomide.
2. Meeting any of the following conditions:
- Corticosteroids: > 10 mg/day oral prednisone (or equivalent) within 4 weeks prior
to randomisation (W000); Any change or initiation of new dose of oral prednisone
(or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV,
or intra-articular corticosteroids within 4 weeks prior to randomisation (W000);
Any change or initiation of new dose of topical corticosteroids within 2 weeks
prior to randomisation (W000),
- Antimalarials: any change or initiation of new dose of antimalarials (e.g.
chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to
randomisation (W000),
- Methotrexate: > 25 mg/week of methotrexate; any initiation or change of dose of
methotrexate within 12 weeks prior to randomisation (W000); any change in route
of administration within 4 weeks prior to randomisation (W000),
- Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new
dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000),
- Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast:
any increase or initiation of new doses within 2 weeks prior to randomisation
(W000).
3. Secondary Sjögren's Syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients | NCT04605978 | Entailment |
6,477 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
Male and female 18 to 99 years of age. Chronic skin conditions (including but not limited
to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis) with at
least one active skin lesion Healthy skin (defined no clinical evidence or diagnosis of
inflammatory skin conditions)
Exclusion Criteria:
Subjects who are unable to comply with study procedures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions | NCT03198390 | Entailment |
383 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Adult patients on the general wards in need of treatment by the MET team.
Exclusion Criteria:
- age (<18 years),
- pregnancy:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams | NCT03214809 | Contradiction |
6,822 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Be able to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local privacy regulations;
2. Be male and ≥18 years of age;
3. Endogenous FVIII activity levels<1iu. as documented by a certified clinical laboratory
at the time of screening.
4. Prior FVIII exposure days (EDs) ≥150 days of any recombinant and/or plasma-derived
FVIII protein products based on historical data from the subject's record/history;
5. a. Prophylaxis subjects: have had bleeding events and/or infusions with FVIII protein
products during the last 12 weeks documented in the subjects' medical records; OR b.
On-demand subjects: have had ≥4 bleeding events in the last 52 weeks and/or chronic
hemophilic arthropathy (pain, joint destruction, and loss of range of motion) in one
or more joints;
6. Have no prior history of hypersensitivity or anaphylaxis associated with any FVIII or
IV immunoglobulin administration;
7. Have no measurable FVIII inhibitor as assessed by laboratory; or documented no prior
history of FVIII inhibitor after 150 EDs (family history of inhibitors will not
exclude the subject) and no clinical signs or symptoms of decreased response to FVIII
administration;
8. Have acceptable laboratory values:
1. Hemoglobin ≥11 g/dL;
2. Platelets ≥100,000 cells/μL;
3. Aspartate Transaminase（AST）, alanine aminotransferase （ALT）, alkaline phosphatase
≤2x upper limit of normal at the testing laboratory;
4. Bilirubin ≤3x upper limit of normal（ULN）;
5. Creatinine ≤2.0 mg/dL.
9. Agree to use reliable barrier contraception until three consecutive semen samples
after the administration of GS001 are negative for vector sequences.
-
Exclusion Criteria:
1. HBsAg or hepatitis B core antibody or hepatitis B virus-DNA positivity or hepatitis C
virus-RNA viral load positivity. Negative viral assays in two samples, collected at
least six months apart, will be required to be considered negative. Both natural
clearer and those who have cleared hepatitis C virus on antiviral therapy are
eligible;
2. Currently on antiviral therapy for hepatitis B or C;
3. Have significant underlying liver disease, as defined by a preexisting diagnosis of
portal hypertension, splenomegaly, encephalopathy, reduction below normal limits of
serum albumin or evidence of significant liver fibrosis (fibrosis stage ≥ 3) within
the past 6 months prior to or at screening as determined by any of the following
diagnostic modalities: AST-to-Platelet Ratio Index (APRI) >1;
4. Have serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm3. Subjects who are
HIV-positive and stable, with an adequate CD4 count (>200/mm3) and undetectable viral
load (<50 gc/mL) measured twice in the six months prior to enrollment, on an
antiretroviral drug regimen are eligible to enroll;
5. Anti-GS001 neutralizing antibody titers ≥1:5;
6. History of chronic infection or other chronic disease that the Investigator considers
to constitute an unacceptable risk;
7. Participated in a previous gene therapy research trial within the last 52 weeks or in
a clinical study with an investigational drug within the last 12 weeks;
8. Any concurrent clinically significant major disease or any other condition that, in
the opinion of the Investigator, makes the subject unsuitable for participation in the
study;
9. Bad compliance.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Gene Therapy for Chinese Hemophilia A | NCT04728841 | Entailment |
1,250 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Patients with exudative pleural effusion
Exclusion Criteria:
- Patients without pleural effusion
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 Years | Safety of Thoracoscopy in Patients With High Risk | NCT01193439 | Entailment |
1,069 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Age > = 16 yrs
- Acute syncope presentation to MAU or A+E
- 2 or more unexplained syncopes within the past 24 months including index episode
- Normal baseline ECG
- Absence of co - existing pathology requiring admission
Exclusion Criteria:
- Suspected or known heart disease
- ECG abnormalities suspected of arrhythmic syncope listed in Table 1
- Syncope occurring during exercise
- Syncope causing severe injury
- Family history of sudden death
- Sudden onset palpitations prior to syncope
Table 1: ECG Abnormalities:
- Bifascicular block (defined as LBBB or RBBB combined with left anterior or left
posterior fascicular block)
- Other intraventricular abnormalities (QRS duration >= 0.12s)
- Mobitz 1 second degree AV block (Wenckebach)
- Asymptomatic sinus bradycardia (<50 bpm), SA node or sinus pause >= 3s in the absence
of negatively chronotropic medications
- Pre-excited QRS with short PR interval (WPW)
- Significantly Prolonged QT interval
- RBBB pattern with ST elevation in V1 - V3 (Brugada Syndrome)
- Negative T waves with ST segment elevation in right precordial leads suggestive of
arrythmogenic right ventricular dysplasia
- Significant Q waves (>= 0.02s) suggestive of MI
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Eastbourne Syncope Assessment Study II | NCT00517023 | Contradiction |
4,894 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Patients suffering from a head tremor without (isolated) or with associated
- tremor in any other body parts.
- The HT must be troublesome for the patients (TRS 2 for the head tremor
- severity item).
- Patients never treated with botulinum toxin or not treated with botulinum toxin for
this indication for at least 4 months.
- Men or women aged from 18 to 80 years old.
- Social security coverage.
- Ability to provide informed consent.
Exclusion Criteria:
- Patients with tremor from cerebellar syndrome (multiple sclerosis, etc.).
- Patients with a predominant dystonic jerky or myoclonic head tremor using
- the Tsui scale (>1).
- Oral treatments for HT are allowed but must be stable during the study.
- Any contra-indication to Botulinum toxin.
- Women without efficient contraception.
- Patients under supervision or (legal) guardianship.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor | NCT02555982 | Contradiction |
1,025 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Men and women diagnosed with multiple arthritis (including CMC OA of the thumb) with
comorbidities (metabolic syndrome, i.e., OA and overweight / obesity, and/or
hyperglycemia, and/or dyslipidemia, and/or hyperuricemia, and/or hypertension).
- CMC OA joint of the thumb stages I to III as classified by Eaton et al. (4)
Exclusion Criteria:
- Missing classes or functional evaluations
- Not performing the exercises as instructed
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis | NCT03089723 | Entailment |
1,169 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Patients scheduled for a CT-guided lung or upper abdomen biopsy (including lesions in
the liver, pancreas, stomach, kidneys, adrenals, spleen, or in the peritoneum at or
above the level of the kidneys) on the SMH-CT-3M scanner when either Dr. Carlson or
Dr. Bender are scheduled.
- Lesions will need to measure 3 cm or less in maximum dimension and cannot be affixed
to the chest or abdominal wall.
Exclusion Criteria:
- Inability to cooperate with breath-holding (including cognitive impairment, poor
pulmonary function that inhibits patients from being able to hold their breath for at
least 10 seconds)
- Patients with bleeding diatheses (platelets < 50,000, International Normalized Ratio >
1.5, or activated partial thromboplastin time > twice normal)
- Lesions that abut the pleura or abdominal wall for a distance greater than 3 cm (these
lesions were assumed to be fixed in position and less likely to be affected by
respiratory motion).
- Patients with implanted medical devices (pacemakers) (this exclusion is based on the
Division of Engineering Safety Review-enclosed in application)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Optical Breath-hold Control System for Image-guided Procedures | NCT01062789 | Contradiction |
6,245 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Positive COVID-19
Exclusion Criteria:
- Incomplete medical records, degrade CT images because of patient tachypnea and motions
artifacts, also unremarkable CT scans.
No condition on gender to be admitted to the trial.
| Egyptian Initial Experience About 2019 Novel Corona Virus: Study of 48 Patients in Alexandria-Egypt Using Chest CT | NCT04382469 | Contradiction |
3,301 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Minor and adult patient.
- Patient presenting a clinical diagnosis of incomplete form of albinism with presence
of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal
hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic
nerves at the chiasm.
- Registered for the social security system.
- Informed consent signed by patient or parent of a minor patient.
Exclusion Criteria:
- Refusal to participate in research protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| NGS Panel of Incomplete Forms of Ocular Albinism | NCT04495218 | Contradiction |
2,595 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
1. Men or women ≥ 18 years of age and able to give their own consent.
2. The subject is able and willing to comply with study procedures and a signed and dated
informed consent is obtained.
3. The subject has a complex ventral hernia
4. The surgeon intends to use bioprosthetic mesh in the repair of the hernia
5. The hernia meets the definition of complex.
For this study a hernia defect will be considered complex if:
5.1. a hernia defect is large enough to require component separation to achieve
midline fascial closure under physiologic tension 5.2. or the surgical wound is class
II -potentially contaminated or class III - contaminated without signs of infection as
defined by the CDC wound classification (see Table 1) 5.3. or a patient classified as
at risk for surgical site complications by having 2 or more of the following
comorbidities:
- Current smoker or recent history of smoking
- Obesity (BMI ≥ 30)
- Type I or Type II diabetes
- Chronic Obstructive Pulmonary Disease (COPD)
- Poor nutritional status as judged by the Investigator
- Current immunosuppressive therapy
- Current and/or recent (within 30 days of planned surgery) Corticosteriod use
- Prior Mesh infection
6. Life expectancy of the patient is considered by the physician to be greater than at
least 1 year
7. The subject has no known hypersensitivity to bovine collagen
8. The subject has no obvious condition interfering with their ability to comply with the
treatment regimen
9. The subject is willing and capable of returning for all follow-up evaluations, in the
opinion of the treating physician
Exclusion Criteria:
Pre-Operative Exclusion:
1. < 18 years of age
2. Have abdominal loss of domain such that the operation would be impractical or would
adversely affect respiratory or cardiovascular function to an unacceptable degree in
the opinion of the Investigator
3. Participation in an investigational drug or device study within the past 6 weeks prior
to enrollment into this trial
4. Have a known collagen metabolism disorder or any medical condition that could
interfere with normal tissue healing process as determined by the Investigator
Intra-Operative Exclusion Criteria:
Subjects will be excluded from the study after the index operation if any of the following
exclusion criteria are met:
1. Primary closure of the skin and subcutaneous tissue is not achieved at the index
operation
2. Bioprosthetic mesh was not used in the repair for any reason
3. Primary Fascial closure unable to be obtained i.e. bridged closure
4. Unable to place the mesh in the retrorectus space (no intraperitoneal placement)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair | NCT03450473 | Contradiction |
6,233 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- COVID 19 confirmed patients.
Exclusion Criteria:
- <18 years
- Pregnant women
- Asymptomatic and normal x-ray findings subjects
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Predicting Death and ICU Admission in COVID-19 Patients in ED | NCT04371562 | Contradiction |
1,770 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Age of 18 ~ 75, with a elementary-school diploma or higher, should be able to read and
write Korean
- One who meet Rome III FD criteria* and has been suffering from FD for the last 3
months with symptom onset at least 6 months prior to diagnosis
- One or more of the following:
1. Bothersome postprandial fullness
2. Early satiation
3. Epigastric pain
4. Epigastric burning
- One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic
symptoms
- One who has normal esophagogastroduodenoscopy results within a year and been diagnosed
with FD by a specialist consultation
- One who receives no other treatments during the study
- One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion Criteria:
- One who has peptic ulcer or gastroesophageal reflux disease (GERD)
- One who has obvious signs of irritable bowel syndrome (IBS)
- One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
- One who has serious structural disease (disease of heart, lung, liver or kidney) or
mental illness
- One who has had surgery related with the gastrointestinal tract (Appendectomy more
than 6 months ago is acceptable)
- One who is pregnant or breastfeeding
- One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2
weeks before participating in the trial)
- One who is HIV-positive
- One who has a problem of malabsorption or maldigestion
- One who has difficulties in attending the trial or receiving treatments (e.g
Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder
in vision or hearing, impossibility of visit, illiterate, etc.)
- One who does not want to sign the informed consents
- One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is
taking anticoagulant therapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial | NCT01921504 | Contradiction |
4,141 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- according to the consensus of domestic experts, combined with the guidelines for the
management of adult bronchiectasis published by the European Respiratory Society in
2017;
- male or female, aged 18-70 years;
- being in the stable stage, and no acute exacerbation of bronchiectasis within the past
three weeks;
- frequency of acute exacerbation of bronchiectasis ≤3 times every year;
- signed informed consent for participation.
Exclusion Criteria:
- failing to meet the above criteria for diagnosis and inclusion;
- having developed respiratory failure with estimated survival time less than one year;
- having hemoptysis as a comorbidity;
- having complications by active tuberculosis;
- being pregnant or with severe heart, liver, or kidney dysfunctions;
- participating in other pharmacological clinical trials within the past 3 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | A Series of N-of-1 Trials of Traditional Chinese Medicine Based on Bayesian Method | NCT04601792 | Contradiction |
1,150 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Male and female patients aged 18 - 80 years old
- Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with
end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between
13 and 15 mm along with at least one other piece of evidence of hypertrophic
cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family
history of hypertrophic cardiomyopathy, or positive genetic test result.
Exclusion Criteria:
- A history of exercise-induced syncope or arrhythmias (ventricular tachycardia;
sustained or non-sustained)
- Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
- Less than 3 months post septal reduction therapy (surgery or catheter based
intervention)
- Pregnancy
- Worsening clinical status or advanced heart failure (New York Heart Association class
IV symptoms)
- A hypotensive responsive to exercise (an increase in exercise systolic BP throughout
the exercise test of < 20mmHg compared with resting values, or an initial increase in
systolic BP > 20mmHg with a subsequent fall by peak exercise of > 20mmHg, or a
continuous decrease in systolic BP throughout the test of > 20mmHg, compared with
baseline BP)
- Left ventricular systolic dysfunction (left ventricular ejection fraction < 55 % by
echocardiography)
- Coronary artery disease as evidenced by prior myocardial infarction or angina
- Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
- A chronic orthopaedic injury which limits the ability to exercise
- Subjects unable to speak English will not be recruited because of the complex
experimental studies and the need for precise communication between the volunteers and
the research staff to ensure safety.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy | NCT03335332 | Entailment |
3,012 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Molecular diagnosis of Fragile X syndrome (FXS)
- Males and females aged 12 to 60 years.
- Study participants must understand and accept experimental procedures and assent to
participate in the study signing an informed consent.
- Parents or caregivers have to understand and accept experimental procedures and sign
informed consent form.
- Use of effective contraceptive methods in female participants
- Regular menstrual cycle (26-32 days duration) in female subjects
- Moderate mental disability (IQ>40)
- Body mass index (BMI) comprised between 18.5 and 29.9 kg/m2, and body weight between
50 and 100 kg.
- Non-smokers
- Electroencephalogram record and general blood and urine analysis performed at
screening visit should be within normal values. Minor or occasional variations in
normal values are allowed if, in the opinion of Principal Investigator, taking into
account the state of the science, they are not clinically significant, they do not
pose risk for the subjects and they do not interfere in the evaluation of the
investigational product. These variations and their non-relevance should be justified
by writing.
Exclusion Criteria:
- Not fulfil inclusion criteria.
- Subjects with neurological disease other than FXS, relevant medical disease, co-morbid
mental disorder or currently taking any treatment that could interfere with cognitive
function or alter any key biomarkers and biochemical parameters analyzed.
- Having suffered from any major illness or undergoing major surgery in the last 12
months preceding the study.
- Regular ingestion of psychotropic drugs in the three months preceding the study.
Exceptions were made for single doses of symptomatic medication administered up to the
week preceding the trial.
- Current ingestion of vitamin supplements or catechins or non steroidal
antiinflammatory drug (NSAID) in the two weeks preceding the study.
- History or clinical proof of gastrointestinal, hepatic or renal problems or any other
cause that may alter processes of absorption, distribution, metabolism, or excretion
of the drug, or that might suggest gastrointestinal irritation to drug.
- Subjects following a cognitive training.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | "Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome" (TESFX) | NCT01855971 | Contradiction |
6,875 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- 1. Men and women aged 55-85 years
- 2. Diagnosis of possible or probable Alzheimer disease according to NIA-AA 2011
criteria.
- 3. Global Deterioration Scale Stadium 5-6 / 15-5 Mini-mental State examination
- 4. The patient is living with a family as a primary caregiver or a caregiver trained
to accompany adequate and all intervention and follow-up visits. Patient and caregiver
knowledge of local languages sufficient.
- 5. The patient and caregiver willing to participate in the study. There is a high
probability that patient and caregiver to complete the study.
- 6. The patient has no sensory deficits preventing evaluation.
- 7. The patient receives a stable Alzheimer Disease conventional medication. No change
in treatment at least 90 days prior to selection.
- 8. The patient receives a conventional stable medication for possible comorbidities.
No change in treatment at least 90 days prior to selection.
- 9. The subject or his legal representative give prior informed consent that includes
genetic studies of Apolipoprotein E and rs11870474.
Exclusion Criteria:
- 1. Concomitant severe neurological disease Alzheimer Disease.
- 2. Presence or history of psychiatric disorders with an emphasis on positive
behavioral disorders associated with Alzheimer Disease (aggressiveness, agitation,
delusions, hallucinations, anxiety).
- 3. Current Severe systemic disease that may prevent completion of the study.
- 4. History STROKE.
- 5. History of convulsions and use of anticonvulsants.
- 6. History of myocardial infarction, angina pectoris, cardiac arrhythmias and other
serious cardiovascular disorders such as congestive heart failure, and valvular
aneurysms.
- 7. Background Diabetes mellitus and / or pictures of hypoglycemia.
- 8. Uncontrolled hypertension (systolic> 160 mmHg and / or Diastolic> 95 mmHg).
- 9. Systemic hypotension (SBP <86 mmHg) or bradycardia (<50 beats per minute)
- 10. Bronchial Asthma History or lung diseases that cause bronchospasm or
bronchoconstriction
- 11. Kidney failure (patients with medical restrictions or income parenteral intake of
fluids).
- 12. Liver failure.
- 13. Respiratory failure (need supplemental oxygen supply)
- 14. Blood donation in the last 90 days or anemia (Hb <10g/dL)
- 15. Use connection (<30 days prior to screening) of antidepressants, sedatives and
hypnotics.
- 16. Using Alzheimer Disease experimental drugs in the last 60 days prior to screening.
- 17. Women who are pregnant or fertile
- 18. Inadequate venous access to prevent parenteral administration of infusions.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | ATP in Alzheimer Disease | NCT02279511 | Contradiction |
1,805 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
Primary registration
- Person having intact stomach after treatment of early gastric cancer or gastric
adenoma
- Person whose treated gastric cancer histological type is intestinal type.
- Person whose treated gastric cancer or gastric adenoma was curatively resected.
- Person who does not have symptoms of gastric cancer recurrence.
- Person who can declare agreement for enrollment by understanding the study and signing
the informed consent document after hearing the explanation.
- Person who can visit the hospital in accordance with the schedule.
Secondary registration
- Person who has gastric atrophy at endoscopy.
- Person who does not have symptoms of gastric cancer recurrence by endoscopy.
- Person who has intestinal metaplasia in stomach, histologically confirmed in biopsy
specimens taken under endoscopy within 8 weeks prior to taking MEK inhibitor,
Trametinib.
Exclusion Criteria:
- Person whose treated gastric cancer was diffuse or signet ring cancer.
- Person whose treated gastric cancer or gastric adenoma was not curatively resected.
- Person who has the history of other malignant disease.
- Person who had a significant improvement in metaplasia after eradication therapy for
Helicobacter pylori within one year.
- Person who had plan of eradication Helicobacter pylori in 1 year 9 months
- Person who has history of previous Trametinib or other MEK inhibitor use.
- Person who has history of hypersensitivity to excipients.
- Person who entered clinical trial and took investigational new drug within 12 weeks.
- Presence of active infection other than chronic gastritis.
- Cardiac conditions as follows:
- Uncontrolled hypertension (BP>=150/95 mm Hg despite medical therapy)
- Acute myocardial infection within 6 months prior to starting treatment
- Uncontrolled Angina (Canadian Cardiovascular Society grade II-IV even after
medication)
- Symptomatic heart failure NYHA Class II-IV
- <45% in the past
- Severe valvular disease
- <55% at present
- Atrial fibrilation in ECG with BPM=>100 Laboratory values as listed below (SI
units) Absolute Neutrophil Count <1.5x10A9/L (1500 per mm3) Platelets <100x10A9/L
(100,000 per mm3) Hemoglobin<=9.0 g /dL Serum creatinine >1.5 X upper limit of
normal (ULN) Serum bilirubin >1.5 x ULN AST or ALT > 2.5 x ULN
Ophthalmological conditions as follows:
Current or past history of retinal pigment epithelial detachment (RPED)/central serous
retinopathy (CSR) or retinal vein occlusion Intraocular pressure (IOP) > 21 mmHg or
uncontrolled glaucoma (irrespective of IOP)
Male or female patients of reproductive potential and, as judged by the investigator, are
not employing an effective method of birth control and pregnant female.
Breast feeding female Have refractory nausea and vomiting , chronic gastrointestinal
diseases (e.g . inflammatory bowel disease), or significant bowel resection that would
adversely affect the absorption / bioavailability of the orally administered study
medication.
Person who has history of hyperrefractory for Trametinib methyl sulfoxide Person who has
pneumonia under chest X-ray. Have evidence of any other significant clinical disorder or
laboratory finding that, as judgedby the investigator, makes it undesirable for the patient
to participate in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor | NCT04454476 | Contradiction |
2,932 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Caucasian male or female out-patients;
- aged 18 to 75 years inclusive;
- diagnosis of "probable" or "definite" amyotrophic lateral sclerosis according to the
El Escorial revised criteria (1);
- first symptoms of ALS by no more than 1.5 years;
- in treatment with steady regimen of riluzole for a minimum of 3 months before study
entry, and desiring its continuation;
- FVC ≥ 75% of predicted;
- no conditions known to be contraindications to the use of TUDCA;
- written informed consent.
Exclusion Criteria:
- subjects who underwent tracheostomy;
- subjects who underwent resection of gall bladder;
- subjects with signs of conduction blocks of motor nerves, sensory nerves or both on
nerve conduction study;
- subjects with clinical signs of dementia;
- subjects with active peptic ulcer;
- subjects with active malignancy;
- subjects with bulbar onset;
- female subjects who are pregnant or lactating
- subjects who have received an experimental drug or have participated in a clinical
trial within 3 months prior to screening
- employees of the investigator or study centre with direct involvement in the proposed
study or other studies under the direction of that investigator or study centre.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis | NCT00877604 | Entailment |
6,881 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Fluent in English or Spanish
- Diagnosis of aMCI by Petersen criteria or probable AD by National Institute of
Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related
Disorders Association (NINCDS-ADRDA) criteria
- Mini Mental State Examination (MMSE) score at screening is greater than or equal to 20
- Clinical Dementia Rating is 0.5-1 at screening
- Logical Memory is less than or equal to 8 for 16 or more years of education, less than
or equal to 4 for 8-15 years of education, less than or equal to 2 for 0-7 years of
education. Scores measured at screening on Delayed Paragraph Recall (Paragraph A only)
from the Wechsler Memory Scale-Revised
- Able to complete baseline assessments
- Modified Hachinski score of less than or equal to 4
- A study partner able to accompany the participant to most visits and answer questions
about the participant
- The study partner must have direct contact with the participant more than 2 days per
week (minimum of 10 hours per week) and provide supervision of drug administration as
needed
- Stable medical condition for 3 months prior to screening visit
- Stable medications for 4 weeks prior to the screening and baseline visits
- Stable use of permitted medications
- At least six years of education or work history
- Clinical laboratory values must be within normal limits or, if abnormal, must be
judged to be clinically insignificant by the investigator
- Visual and auditory acuity adequate for neuropsychological testing
Exclusion Criteria:
- A diagnosis of dementia other than probable AD
- Probable AD with Down syndrome
- History of clinically significant stroke
- Current evidence or history in past two years of epilepsy, focal brain lesion, head
injury with loss of consciousness or Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (DSM IV) criteria for any major psychiatric disorder
including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- Sensory impairment that would preclude the participant from participating in or
cooperating with the protocol
- Diabetes (type 1 or type II) requiring pharmacologic treatment (including both insulin
dependent and non-insulin dependent diabetes mellitus)
- Current or past use of insulin or any other anti-diabetic medication
- Evidence of any significant clinical disorder or laboratory finding that renders the
participant unsuitable for receiving investigational drug including clinically
significant or unstable hematologic, hepatic, cardiovascular, pulmonary, endocrine,
metabolic, renal or other systemic disease or laboratory abnormality.
- Active neoplastic disease, history of cancer five years prior to screening (history of
skin melanoma or stable prostate cancer are not excluded)
- History of seizure within the past five years
- Pregnancy or possible pregnancy
- Contraindications to Lumbar Puncture (LP) procedure: prior lumbosacral spine surgery,
severe degenerative joint disease or deformity of the spine, platelets is less than
100,000 or history of bleeding disorder
- Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa) due to LP
requirement
- Contraindications for MRI (claustrophobia, craniofacial metal implants of any kind,
pacemakers)
- Residence in a skilled nursing facility at screening
- Use of an investigational agent within two months or screening visit
- Regular use of narcotics, anticonvulsants, medications with significant
anticholinergic activity, antiparkinsonian medications or any other exclusionary
medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF) | NCT01767909 | Contradiction |
4,040 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Men and women diagnosed with primary osteoarthritis of the knee,
- Classified as stages I to III of Kelgreen and Lawrence (KL), ie any degree of
gonarthritis without obliteration of the joint space.
- With indication for clinical treatment of OA.
Exclusion Criteria:
- Patients with cognitive, psychiatric and neurological disorders or whose symptoms
during the evaluation are related or significantly interfere in the functions of
attention, memory, logical thinking, understanding and interaction with the group in
order to hinder the assimilation of the given guidelines.
Missing classroom interventions
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Project Arthritis Recovering Quality of Life by Means Education II (PARQVE II) | NCT02335034 | Entailment |
3,388 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Bilateral hearing loss equal or higher than 40 decibels
- Age 65 years old or more
- Agree to be included in the study
- Have a relative to go to the intervention with the subject
Exclusion Criteria:
- Severe organic brain impairment
- Physical or mental incapacity to understand the study questionnaires
- Structural pathology of the ear that produces hearing loss as chronic otitis media,
ear canal tumor, or tumor of the cerebellopontine angle
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Assessment of the ACE Program for Rehabilitation in Hearing Loss | NCT01846676 | Contradiction |
1,101 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Patient is 18 years and older has a clinical diagnosis of hypertrophic cardiomyopathy.
- Patient scheduled for clinically-indicated myomectomy.
- Patient has a negative family history of hypertrophic cardiomyopathy
- Patient is willing to receive results of secondary variant screen
Exclusion Criteria:
- Pregnant
- Inability to give informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy | NCT03043209 | Entailment |
397 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Ability to understand and provide a written informed consent.
- Healthy adult females between 18 and 50 years of age. Included in this group are women
with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
- Normal menstrual cycle of 26-32 days
- Agree not to attempt to become pregnant
- Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid
alcohol consumption within 48 hours of each visit
- Ability to swallow gelatin capsules Ability to complete a daily subject diary
- Willing to discontinue hormonal contraceptives and consent to use of double barrier
contraceptive techniques over the course of the study.
- Has a negative pregnancy test at the Screening and Baseline visits An exception for
the pregnancy test requirement will be granted for subjects reporting surgical
sterilization in medical history
- A Body Mass Index (BMI) between 18 and 39 inclusive
- Is available for all treatment and follow-up visits
Exclusion Criteria:
- Subject is a post-menopausal woman, defined as either; six (6) months or more
(immediately prior to screening visit) without a menstrual period, or prior
hysterectomy and/or oophorectomy
- Subject is pregnant or lactating or is attempting or expecting to become pregnant
during the 7 month study period
- Women with abnormal liver enzymes or liver disease.
- Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003,
ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
- Received an investigational drug in the 30 days prior to the screening for this study
- Women with a history of PCOS
- Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
DHEA or hormonal products for at least 2 weeks prior to screening and during the
study.
- Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of
Depo-Provera® in the preceding 6 months.
- Women currently using narcotics
- Women currently taking cimetidine or spironolactone
- Clinically significant abnormal findings on screening examination or any condition
which in the opinion of the investigator would interfere with the participant's
ability to comply with the study instructions or endanger the participant if she took
part in the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Determination of the Lowest, Safe and Effective Dose of Proellex | NCT01187043 | Contradiction |
4,811 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Male or female patients 18 years of age and older
- Patients with vestibular vertigo of known or unknown origin
- Patients who are willing and able to provide written informed consent
Exclusion Criteria:
- Patients with any condition which, in the opinion of the investigator, makes the
patient unsuitable for inclusion based on clinical judgment
- Patient with psychiatric disorders, significant neurological disorder or spinal cord
damage that would make the evaluation difficult for the investigator
- Patients who are not willing to give informed consent
- Patients with a known history of hypersensitivity to betahistine
- Patients with a history of pheochromocytoma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics. | NCT02213120 | Entailment |
5,416 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women 18 years or older in generally good health with a diagnosis of heavy menstrual
bleeding without organic pathology, requesting contraception
- Willingness to use barrier contraception (e.g., condoms) from screening to study
completion
- Willingness to use and collect sanitary protection (pads and tampons) provided by the
sponsor and compatible with the alkaline hematin test throughout study completion
Exclusion Criteria:
- Current diagnosis of organic uterine bleeding
- History of endometrial ablation, or dilatation and curettage within 2 months of Visit
1.
- Clinically significant pelvic findings (whether or not confirmed by transvaginal
ultrasound [TVU]).
- Clinically significant abnormal results of breast examination (breast palpation).
- Positive pregnancy test at Visit 1
- Less than three months since delivery, abortion, or lactation before to start Visit 1
- Other contraceptive methods
- Any disease or condition that may worsen under hormonal treatment
- Smokers over the age of 35
- Body mass index >32
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding | NCT01638923 | Entailment |
5,927 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Pregnant women gestational age less than 36 weeks with heartburn
Exclusion Criteria:
- Having medical disease that contraindicated to use study drug
- Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy | NCT02470117 | Contradiction |
Subsets and Splits