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630 | 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:
- Iron overloaded male or female patients with primary or secondary hemochromatosis
- Age: 4 years and older
- Patients with desferrioxamine toxicity or allergy (e.g. visual or hearing defects,
bone abnormalities, reactions at injection site)
- Patients unable or unwilling to comply satisfactorily with regular desferrioxamine
administration on 5-7 days/week
- Combination treatment: patients not sufficiently chelated with desferrioxamine or
deferiprone monotherapy
- Patients must be willing to undergo routine screening including medical history,
physical examination and hematology, biochemistry and other laboratory tests
- Written informed consent
Exclusion Criteria:
- Children under 4 years of age
- Female and male of reproductive age, sexually active but not taking adequate
contraceptive precaution
- Woman who are pregnant or breast-feeding
- Patients with HIV
- Patients with active hepatitis requiring treatment
- Patients with severe hepatic failure, cirrhosis
- Patients with neutropenia (neutrophils less than 1.5 exp9/l, MDS: less than 0.5
exp9/l)
- Patients with thrombocytopenia (platelets less than 100 exp9/l, MDS: less than 20
exp9/l)
- Patients with decompensated heart failure (LVEF less than 40% or patients under
continuous cardiac medication)
- Patients with severe renal failure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients | NCT00349453 | Contradiction |
4,485 | 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:
1. B-ultrasound or magnetic resonance imaging (MRI) examination confirmed that the
subject has adenomyosis, and the uterus is less than 10 weeks of pregnancy;
2. Visual analogue scale (VAS) of adenomyosis-associated pain> 0 points; with or without
menorrhagia (PBAC≥100 points);
3. Women between 18 and 50 years old who currently have no childbearing requirements;
4. Normal or cervical cytology results without clinical significance (results within 6
months before the screening period);
5. Willing to choose a barrier method of contraception if contraception is needed;
6. Be tested voluntarily and sign the informed consent.
7. No menopause
No menopause
Exclusion Criteria:
1. HB<90G/L
2. Undiagnosed abnormal vaginal bleeding or endometrial lesions;
3. Pregnancy and lactation women and those who are preparing to give birth when taking
the medication or within 6 months of stopping the medication;
4. Malignant tumors (including the reproductive system and other systems);
5. The patients with severe heart, liver, kidney disease and adrenocortical
insufficiency;
6. The results of follow-up laboratory test indicate abnormal clinical significance;
7. The allergic persons or those who have been allergic to multiple drugs, or are
allergic to active ingredients or any excipients of the study drug;
8. Suffering from any disease or condition that may cause the study drug to alter
absorption, accumulate excessively, affect metabolism, or change the excretion
pattern;
9. Having clinically significant depression within the current or most recent year;
10. People who regularly take analgesics due to other underlying diseases;
11. Ketoconazole, itraconazole, erythromycin, rifampicin, corticosteroids (hydrocortisone,
prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, phenobarbital,
carbamazepine, etc.), griseofulvin, non-steroidal anti-inflammatory drugs (aspirin,
acetaminophen, etc.) that are being used and cannot be stopped during the study;
12. Previous use of hormone drugs, including: a. use of GnRH agonists within 6 months
before the screening period; b. use of progestins or danazol and other long-acting
hormones within 3 months before the screening period; c. use of oral
contraceptive-like short-acting hormones within one month before the screening period;
13. Patients who participated in other clinical trials within 3 months before the
screening, or who are considered inappropriate to participate in the study by other
investigators.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis | NCT03520439 | Contradiction |
1,790 | 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. Early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma
(intestinal type)
2. Preoperative investigation with magnifying endoscopy and / or EUS predicted to be
mucosal lesion
3. Any tumor size if the early gastric cancer has no ulceration
4. Tumor size ≤ 3cm if the early gastric cancer has ulceration
Exclusion Criteria:
1. Gastric cancer with preoperative magnifying endoscopy and / or EUS predicted to beyond
submucosal invasion
2. Poorly differentiated or signet ring cell adenocarcinoma
3. Age > 80 or < 16
4. Pregnancy
5. ASA > IV
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.
Subject must be at most 80 Years | Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer | NCT03136354 | Contradiction |
1,223 | 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. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by :
- positive cytology for malignant cells in the fluid.
- patients well known for malignancy, with exudative pleural effusion with no
alternative diagnosis.
- pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
- microscopic intraoperative findings suggestive of pleural malignancy.
2. Patients who underwent prior to involvement in the study, draining of the pleural
fluid with symptomatic improvement.
3. Patients with rate of fluid accumulation less than 30 days.
4. Patient who signed informed consent about being involved in the study.
Exclusion Criteria:
1. Patients under the age of 18 years.
2. Female patients who are Pregnant or nursing.
3. Patients with rate of pleural effusion accumulation is more than 30 days.
4. Patients who didn't show clinical improvement post proper draining of the fluid
5. Patients who are hemodynamically or respiratory unstable.
6. Patients with Empyema.
7. Patients who are non functioning/ not active according to the Performance status.
8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.
9. Patient who underwent pneumonectomy at the side of the fluid.
10. previous pleurodesis at the side of pleural effusion.
11. Chylothorax in the initial pleural tapping.
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 90 Years | Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis | NCT02825095 | Entailment |
229 | 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:
1. RIF patients (RIF is defined as the absence of a gestational sac on ultrasound at 5 or
more weeks after 3 embryo transfers with high quality embryos or after the transfer of
≥10 embryos in multiple transfers);
2. Out of phase dating patients;
3. FET in natural cycle;
4. Single blastocysts embryo transfer;
Exclusion Criteria:
1. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine
mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine
fibroids (submucosal fibroids, non-mucosal fibroids> 4 cm and/or endometrial pressure);
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 38 Years | Personalized FET in RIF Patients With Displaced Dating | NCT03910582 | Contradiction |
876 | 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:
Inclusion Criteria for Erosive Hand OA
- Subject is a male or female between 40-80 years of age (inclusive) at the time of
signing the informed consent form.
- Subject meets the American College of Rheumatology (ACR) classification of
osteoarthritis: Hand pain, aching, or stiffness and 3 or 4 of the following features:
Hard tissue enlargement of 2 or more of 10 selected joints, Hard tissue enlargement of
2 or more distal interphalangeal (DIP) joints, Fewer than 3 swollen
metatarsophalangeal (MCP) joints or Deformity of at least 1of 10 selected joints where
The 10 selected joints are the second and third DIP, the second and third proximal
interphalangeal (PIP), and the first carpometacarpal joints of both hands.
- Subject has erosive disease on at least 1 PIP or 1DIP joint as demonstrated by imaging
evidence [can include X-ray, ultrasound or magnetic resonance imaging (MRI) evidence].
- Subject has active disease in at least one hand, with at least two soft tissue swollen
and tender PIP and/or DIP joints in the affected hand by clinical examination within
the past 3 months. If only one hand is affected by HOA and meets the inclusion
criteria, the affected hand should be documented at screening and used for all
assessments. In cases where both hands are affected by HOA and both meet the inclusion
criteria, then the dominant hand should be documented at screening and used for all
assessments.
- Subject's self-reported average hand-pain intensity over the past 7 days must be at
least '4' on a 0-10 Numerical Rating Scale (NRS).
- Subject must have negative titer rheumatoid factor (RF) and anti- Cyclic Citrullinated
Peptide (CCP) antibody.
- Subject must have a personally signed and dated written informed consent form prior to
admission to the study.
- Subject must be verbally fluent and literate in English.
- Subject must be able to attend and participate in two 45 minute telephone or video
call (Skype or Facetime) interviews (either on the same day or separate days).
Inclusion Criteria for Non-Erosive Hand OA
- Subject is a male or female between 40-80 years of age (inclusive) at the time of
signing the informed consent form
- Subject meets the American College of Rheumatology (ACR) classification of
osteoarthritis: Hand pain, aching, or stiffness and 3 or 4 of the following features:
Hard tissue enlargement of 2 or more of 10 selected joints, Hard tissue enlargement of
2 or more distal interphalangeal (DIP) joints, Fewer than 3 swollen
metacarpophalangeal (MCP) joints, Deformity of at least 1 of 10 selected joints where
the 10 selected joints are the second and third distal interphalangeal (DIP), the
second and third proximal interphalangeal, and the first carpometacarpal joints of
both hands.
- Subject has at least 1 finger joint (DIP or PIP) with K-L ≥ 2 [by x-ray in last 12m].
Participant's self-reported average hand-pain intensity over the past 7 days must be
moderate to severe (≥4 on a 0-10 Numeric Rating Scale [NRS] or ≥40mm on a 0-100mm
Visual Analog Scale [VAS]). If only one hand is affected by hand osteoarthritis (HOA)
and meets the inclusion criteria, the affected hand should be documented at screening
and used for all assessments. In cases where both hands are affected by HOA and both
meet the inclusion criteria, then the dominant hand should be documented at screening
and used for all assessments.
- Subject is unwilling or unable to take non-opiate analgesics, or is inadequately
controlled by non-opiate analgesics (non-opiate analgesics include Tramadol)
- Subject must have negative titer rheumatoid factor (RF) and anti-CCP antibody
- Subject must have a personally signed and dated written informed consent form prior to
admission to the study
- Subject must be verbally fluent and literate in English
- Subject must be able to attend and participate in two 45 minute telephone or video
call (Skype or Facetime) interviews (either on the same day or separate days)
Inclusion criteria for subjects taking part in real-time data capture:
- Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or
android] or tablet which has video, audio/microphone and photographic capabilities and
access to either the Apple app store or Google play store to download the app.
- Subject is willing and able to take part in the real time data application task and
respond to a series of questions/tasks fielded via the application over the course of
seven days.]
- Subject would feel comfortable recording short videos of themselves and providing
audio commentary in response to app questions/tasks.
Exclusion Criteria:
Exclusion Criteria for Erosive Hand OA
- Subject has history of any clinically significant inflammatory disease other than
inflammatory osteoarthritis, especially, but not limited to, rheumatoid arthritis or
spondylarthropathies.
- Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium
pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other
inflammatory rheumatological or autoimmune disorders.
- Subject has had a clinical suspicion of, or previous investigation for CPPD or
pseudogout, or history of chondrocalcinosis.
- Subject has any injury, medical or surgical procedure to the affected joint(s) that
may interfere with evaluation of the target hand osteoarthritis joint(s).
- Subject has great difficulty hearing, reading or speaking.
- Subject has an uncontrolled psychiatric condition (example, schizophrenia,bipolar
disorder) or mental condition rendering the subject unable to understand the nature,
scope, and possible consequences of the study or likely to have difficulty
participating in two 45 minute interviews.
- Subject has severe physical, neurological or cognitive deficits that might prohibit
the ability to participate in an interview about the experience of their hand
osteoarthritis and completion of a questionnaire.
- Subject is currently or has previously been enrolled in a clinical trial for OA in the
past 6 months.
Exclusion Criteria for Non-Erosive Hand OA
- Subject has erosive disease on any proximal interphalangeal (PIP) or distal
interphalangeal (DIP) joints as evidenced via X-ray, MRI or ultrasound
- Subject has history of any clinically significant inflammatory disease other than
inflammatory osteoarthritis, especially, but not limited to, rheumatoid arthritis or
spondylarthropathies
- Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium
pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other
inflammatory rheumatological or autoimmune disorders
- Subject has had a clinical suspicion of, or previous investigation for CPPD or
pseudogout, or history of chondrocalcinosis
- Subject has any injury, medical or surgical procedure to the affected joint(s) that
may interfere with evaluation of the target hand osteoarthritis joint(s)
- Subject has great difficulty hearing, reading or speaking
- Subject has an uncontrolled psychiatric condition (e.g., schizophrenia, bipolar
disorder) or mental condition rendering the patient unable to understand the nature,
scope, and possible consequences of the study or likely to have difficulty
participating in two 45 minute interviews
- Subject has severe physical, neurological or cognitive deficits that might prohibit
the ability to participate in an interview about the experience of their hand
osteoarthritis and completion of a questionnaire
- Subject is currently or has previously been enrolled in a clinical trial for hand OA
in the past six months
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 80 Years | Subject Insights to Understand the Hand Osteoarthritis (HOA) | NCT03271203 | Entailment |
4,162 | 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:
- Patients (including obstructive azoospermia and non-obstructive azoospermia) in need
of sperm retrieval (PESA, TESE) for ICSI.
Exclusion Criteria:
- Have not finished the process of sperm retrieval techniques.
- Malformation of genital organs (e.g. spermatic cord, testicle)
- Anxious, alcoholic patients.
- Patients giving a history of personality disorders.
- Patients who abuse drugs.
- Disagree to participate in the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 100 Years | The Acceptance, Safety, and Efficacy of MadaJet Versus Needle Injection for Sperm Retrieval in Patients With Azoospermia | NCT03181243 | Contradiction |
6,472 | 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:
1. Male or female research participants aged 18 or higher.
2. Patients with chronic persistent facial erythema (at least 1 month before baseline
[Day 1 hour 0]) of rosacea (with no restrictions to subtypes of rosacea), or
originated from other dermatological condition, including, but not limited to
seborrhoeic dermatitis, ulerythema ophryogenes, keratosis pillaris, microneedling,
fractional radiofrequency, post-peeling treatments (medium depth and deep) or
post-laser (ablative laser). Diagnosis is based on the investigator clinical
judgement.
3. Clinician Erythema Assessment scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1
prior to study treatment administration.
4. Patient Self-Evaluation scores 2 (mild), 3 (moderate), or 4 (severe) at Day 1 prior to
study treatment administration.
5. Female patients with childbearing potential and negative pregnancy test at baseline.
These patients should use a highly efficient contraceptive method during the study:
combined oral contraceptives (estrogen and progesterone) or implanted contraceptives,
or injectable contraceptives (with a stable dose for at least 1 month before study
enrolment), bilateral tube ligation, hormonal intrauterine device (inserted at least 1
month before study entry), strict abstinence (at least 1 month prior to study entry
and agreement in continuing throughout the study), or vasectomized partner (at least 3
months prior to study entry).
6. Female patients without childbearing potential (e.g., before menstruating,
post-menopausal [absence of menstrual bleeding for 1 year prior to study entry],
hysterectomy, or bilateral oophorectomy, less than one year after menopause).
7. Patients willing and able to fulfill the protocol requirements and duration.
8. Patients who understand and sign the Informed Consent Form at study inclusion, before
any study procedure is carried out.
Exclusion Criteria:
- Any research participant that meets one or more of the following criteria is not eligible
for the trial:
1. Female patients who are pregnant, breastfeeding or planning for pregnancy.
2. Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives,
systemic anesthetics or alpha agonists.
3. Patients who started or changed their doses of tricyclic antidepressants, cardiac
glycosides, beta-blockers or other anti-hypertensive agents, in the 3 months prior to
study entry.
4. Current diagnosis of Raynaud syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, coronary or cerebral insufficiency,
hepatic or renal failure, sclerodermia, Sjögren syndrome, or depression.
5. Any chronic or severe uncontrolled disease or medical chronic which may interfere with
the interpretation of the study results, or may present a significant healthcare risk
to the patient, if he/she participates in the study in accordance with the
investigator judgment. (e.g. endocrine tumors, chromocytomas, systemic diseases that
cause vascular erythema).
6. Known or suspected allergies or hypersensitivities to any of the components of the
study treatments, including the active substance of brimonidine tartrate (see summary
of product characteristics).
7. Patients who received, applied or ingested the following treatments in accordance with
the time period specified before Day 1:
- Topic facial treatments or procedures:
Any dermatological/surgical facial procedure - 4 weeks. Immunomodulators (e.g.
Methotrexate, Cyclosporin) - 4 weeks. Mirvaso® - 4 weeks.
- Systemic treatments:
Isotretinoin - 6 months. Immunomodulators - 90 days. Phototherapy - 4 weeks.
8. Exposure to excessive ultraviolet radiation within a week before Day 1 visit.
9. Presence of beard or excessive facial hair at Day 1, which interferes with the study
treatment or study assessments and refusal to remove it during the study period.
10. Patients who do not wish to abstain from the use of forbidden medication or excessive
exposure to ultraviolet radiation during the study period.
11. Vulnerable research participants (as deprived of freedom), in accordance with Section
1.61 of the International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use - ICH for Good Clinical Practices.
12. Current participation in any other clinical study with a drug or device OR
participation within 30 days prior to Day 1 OR in an exclusion period of a previous
clinical study (when possible).
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 Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema. | NCT02856919 | Entailment |
4,476 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. Participant in the Discovery Elbow Multi-center Study
2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study
Exclusion Criteria:
1. Patient is not a Discovery Elbow Multi-center Participant
2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Discovery Elbow Long-Term Survivorship | NCT01308463 | Entailment |
283 | 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:
- A positive pregnancy test result.
- Single intrauterine pregnancy.
- Gestational age by last menstrual period of 6-10 weeks in patients with regular cycles
and sure of her last menstrual period date.
- History of recurrent pregnancy loss which is defined as three or more consecutive
pregnancy losses.
Exclusion Criteria:
- Women who are uncertain of her last menstrual period date.
- Women with irregular menstrual cycles.
- Multiple pregnancies
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss | NCT03178682 | Contradiction |
3,443 | 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:
- Age 18-70
- Body weight recorded in EHR in the prior month from a primary care setting.
- Last BMI in EHR either ≥30 kg/m2 or between 25.0-29.9 kg/m2 with documented
weight-related comorbidity (hypertension, type II diabetes, pre-diabetes,
dyslipidemia, sleep apnea).
- Weight ≤ 375 lbs.
- Self-report sending and receiving at least one text message per month for past 6
months.
- Not currently enrolled in comprehensive behavioral weight loss treatment.
- Respond "no" to question asking if they would like to enroll in a comprehensive weight
loss program in the next month
- Has not engaged in self-weighing ≥ 5 times per week on average over prior month.
- Not pregnant, breastfeeding, or planning to become pregnant in next 6 months.
- Not currently undergoing radiation or chemotherapy for cancer.
- No history of eating disorders.
- Interested in enrolling in low-burden self-weighing intervention.
- Able to read and understand English without help
Exclusion criteria:
- History of Congestive Heart Failure or heart attack in past 6 months.
- Planning to move out of the region in the following 12 months
- Answer incorrectly on an attention check/ validation survey item
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 | Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY) | NCT04751656 | Entailment |
3,367 | 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:
1. Participants aged 18 to 74 years (inclusive) at screening.
2. Provision of signed and dated written informed consent (with the exception of consent
for genetic and non-genetic research) prior to any study specific procedures.
3. Body mass index (BMI) between 27 and 35 kg/m^2 (inclusive) at screening.
4. Hemoglobin A1c (HbA1c) range of 6.5% to 8.5% (inclusive) at screening (Note:
Participants may be re-tested for the HbA1c entry criterion only once.).
5. Willing and able to self-inject study drug for the duration of the study.
6. Diagnosed with type 2 diabetes mellitus with glucose control managed with metformin
monotherapy where no significant dose change (increase or decrease >= 500 mg/day) has
occurred in the three months prior to screening.
7. Female participants must have a negative pregnancy test at screening and
randomization, and must not be lactating.
8. Female participants of childbearing potential who are sexually active with a male
partner must be using at least one highly effective method of contraception from
screening and up to 4 weeks after the last dose of study drug.
Exclusion Criteria:
1. History of, or any existing condition that, in the opinion of the investigator, would
interfere with evaluation of the study drug, put the participant at risk, influence
the participant's ability to participate or affect the interpretation of the results
of the study and/or any participant unable or unwilling to follow study procedures
during the run-in period.
2. Any participant who has received another study drug as part of a clinical study or a
glucagon-like peptide-1 (GLP-1) analogue containing preparation within the last 30
days or 5 half-lives of the drug (whichever is longer) at the time of screening.
3. Concurrent participation in another study of any kind and repeat randomization in this
study is prohibited.
4. Any participant who has received any of the following medications prior to the start
of the study:
- Herbal preparations or drugs licensed for control of body weight or appetite
- Opiates, domperidone, metoclopramide, or other drugs known to alter gastric
emptying
- Antimicrobials within the quinolone, macrolide or azole class
- Any change in antihypertensive medication
- Aspirin (acetylsalicylic acid)
- Paracetamol (acetaminophen) or paracetamol-containing preparations
- Ascorbic acid (vitamin C) supplements
5. Severe allergy/hypersensitivity to any of the proposed study treatments, standardized
meals, or excipients.
6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight
loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the
participant has been treated with daily SC insulin within 90 days prior to screening.
7. Acute pancreatitis, pancreatic amylase, and/or pancreatic lipase > 3 × upper limit of
normal range (ULN); history of chronic pancreatitis; or serum triglyceride levels > 11
mmol/L (1000 mg/dL) at screening.
8. Significant inflammatory bowel disease, gastroparesis or other severe disease or
surgery affecting the upper gastrointestinal tract (including weight-reducing surgery
and procedures), which may affect gastric emptying or could affect the interpretation
of safety and tolerability data.
9. Significant hepatic disease (except for nonalcoholic steatohepatitis (NASH) or
non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or
participants with any of the following results at screening:
- Aspartate transaminase (AST) >= 3 × ULN
- Alanine transaminase (ALT) >= 3 × ULN
- Total bilirubin (TBL) >= 2 × ULN
10. Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60
mL/minute/1.73m^2 at screening.
11. Poorly controlled hypertension defined as:
- Systolic blood pressure (BP) > 160 mm Hg
- Diastolic BP or >= 90 mm Hg
12. Any clinically important abnormalities in rhythm, conduction, or morphology of the
resting 12-lead ECG or any abnormalities that may interfere with the interpretation of
serial ECG changes.
13. Prolonged QT intervals corrected for heart rate or family history of long QT-segment
at screening.
14. PR (PQ) interval prolongation, intermittent second or third-degree atrioventricular
(AV) block, or AV dissociation.
15. Persistent or intermittent complete bundle branch block.
16. Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke
within 3 months prior to screening, or participants who have undergone percutaneous
coronary intervention or a coronary artery bypass graft within the past 6 months or
who are due to undergo these procedures at the time of screening.
17. Severe congestive heart failure.
18. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary
thyroid carcinoma or multiple endocrine neoplasia.
19. Hemoglobinopathy, hemolytic anemia or chronic anemia or any other condition known to
interfere with the interpretation of HbA1c measurement.
20. History of neoplastic disease within 5 years prior to screening, except for adequately
treated basal cell, squamous cell skin cancer, or in situ cervical cancer.
21. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and
human immunodeficiency virus (HIV) antibody.
22. History of substance dependence, alcohol abuse, or excessive alcohol intake.
Participants who use benzodiazepines for chronic anxiety or sleep disorders may be
permitted to enter the study.
23. Symptoms of depression or any other psychiatric disorder requiring treatment with
medication.
24. History of severe allergy/hypersensitivity, including to any component of the
investigational product formulation or other biological agent, or ongoing clinically
important allergy/hypersensitivity.
25. Blood/plasma donation within 1 month of 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 74 Years | A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus | NCT03745937 | Contradiction |
4,799 | 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. Persistent subjective peripheral tinnitus (unilateral or bilateral) following
traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery,
inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer
than 3 months prior to randomization
2. Age ≥ 18 years and ≤ 75 years (≥ 14 years and ≤ 75 years at selected sites);
3. Negative pregnancy test (woman of childbearing potential);
4. Willing and able to use adequate hearing protection, respectively to refrain from
engaging in activities or work involving loud noise exposure where sufficient hearing
protection is not possible or ensured;
5. Willing and able to protect ear canal and middle ear from water exposure as long as
tympanic membrane is not fully closed.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
1. Fluctuating tinnitus;
2. Intermittent tinnitus;
3. Tinnitus resulting from traumatic head or neck injury;
4. Presence of chronic tinnitus;
5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing
loss;
6. History of repeated idiopathic sudden sensorineural hearing loss or history of
acoustic neuroma;
7. Ongoing acute or chronic otitis media or otitis externa;
8. Other treatment of tinnitus for the study duration;
9. Known hypersensitivity, allergy or intolerance to the study medication or any history
of severe, abnormal drug reaction;
10. Women who are breast-feeding, pregnant or who are planning to become pregnant during
the study;
11. Women of childbearing potential who are unwilling or unable to practice contraception,
such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with
a partner who has been vasectomised for at least three months;
12. Concurrent participation in another clinical study or participation in another
clinical study within 30 days prior to randomization.
Other protocol-defined 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 75 Years | AM-101 in the Treatment of Acute Tinnitus 2 | NCT01803646 | Entailment |
5,014 | 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 diagnosed with ET by the Consensus Statement on the Classification of
Tremors,From the Task Force on Tremor of the International Parkinson and Movement
Disorder Society.
Exclusion Criteria:
- Lack of capacity to consent to participate in the project.
No condition on gender to be admitted to the trial.
| Chinese ET Registry (CETR) | NCT04198246 | Entailment |
5,571 | 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:
- Both sexes, more than 20 years and less than 70 years old patients with overweight
(BMI>27) or obesity (BMI<35). Available for a spa treatment during 18 days, and a
follow-up period of 14 months
- Voluntary to participate to the study,informed consent form signed after appropriate
information
- Affiliation to the social security system or equivalent
Exclusion Criteria:
- Previous spa therapy for weight problems
- Pregnancy
- Major eating disorders (compulsive over eating)
- Poor french proficiency
- Involvement in another clinical trial
- Other contra-indications to spa therapy (severe general weakness, inflammatory bowel
disease, cirrhosis, severe disability, psychosis and dementia, or Immunodeficiency,
cancer in progress).
- Refusal to consent
- Refusal of spa treatment
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 70 Years | Maâthermes: Spa Treatment for Overweight and Obesity | NCT01258114 | Contradiction |
4,063 | 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:
- people aged 45 years or more
- subjects diagnosed with knee OA according to the clinical criteria of the American
College of Rheumatology
- subjects diagnosed with grade II or III OA during radiologicalexamination as defined
by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA
- subjects with tenderness in the medial tibial plateau area
- subjects who had pain on one side of the knee.
Exclusion Criteria:
- patients with a history of spinal stenosis, evidence of neurologic disease by history
or physical examination, or secondary causes of arthritis (inflammatory or metabolic)
- those who had a surgical intervention or intra-articular injection in the affected
knee in the previous 6 months
- any contraindication to extracorporeal shock wave(pregnancy, cancer, coagulation
disorders, inflammatory disease, pacemakers, or other electronic implants).
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.
| Radial Versus Focused Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis | NCT03921749 | Entailment |
6,723 | 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:
- Patient must be above 21 and below 60 years of age
- Patient must be of ASA I or ASA II classification
- Patient who requires single tooth extraction
- Patient whose tooth to be extracted is bounded by adjacent teeth
- Patient who is suitable for dental implant therapy after extraction
- Patient with any pre-existing infection or abscess at the site of tooth
extraction must be treated and resolved first prior to inclusion in the study
Exclusion Criteria:
- · Patient with known allergy to biopolymer materials
- Patient who are smokers
- Patient who has undergone therapeutic radiation for head and neck malignant
disease
- Maxillary lateral incisor and molars; or mandibular central and lateral incisor
extraction sites
- Extraction sites with insufficient vertical bone height for implant placement
without additional bone grafting (such as sinus lift procedure)
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 60 Years | 3D Printed Scaffold Device for Ridge Preservation After Tooth Extraction | NCT03735199 | Contradiction |
3,317 | 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. | - ELIGIBILITY CRITERIA:
To participate in this screening study, a patient must have a history of anterior segment
disease. Patients of all ages are eligible.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Screening for Research Subjects With Anterior Segment Diseases | NCT00088348 | Entailment |
2,997 | 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:
Inclusion criteria for 3RP intervention:
1. Being the parent of at least one elementary school aged child with a diagnosed
specific learning disability
2. Age 18 or older
Exclusion Criteria:
Exclusion criteria for participation in 3RP group:
1. Being the parent of a child with a severe mental or physical disability up to the
discretion of the principal investigator
2. Unable or unwilling to sign the informed consent documents
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities | NCT02772432 | Contradiction |
6,780 | 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:
- Adult patients (≥ 18 years of age) suffering from mild (FVIII or IX >5 %), moderate
(FVIII or IX 1-5 %) or severe (FVIII or IX <1 %) haemophilia A or B
- Submitted written consent to participate in the study
Exclusion Criteria:
- Patients suffering from other bleeding diseases
- PWH without written consent
- PWH < 18 years of age
- Secondary osteoporosis
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Osteoporosis and Haemophilia | NCT04524481 | Entailment |
6,213 | 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:
- Patient with clinical symptomatology suspecting COVID-19, that is to say: severe
dyspnea, and/or serious extra pulmonary signs (myalgia, diarrhea, etc.) OR
- Patient with clinical symptomatology (cough or dyspnea or fever with ENT signs) AND at
least one of the following comorbidities: COPD stage 1 or 2 (dyspnea usually absent or
for marked efforts), Asthma with daily inhaled corticosteroid therapy,
Immunosuppression or cancer during chemotherapy, Coronary history, Heart failure
(Stages 2 and 3, dyspnea with moderate or low effort), Obesity (BMI> 30), Type 1 or 2
diabetes, cirrhosis from Child B, pregnant woman in the 3rd trimester.
- Patient with a phone monitoring of at least more than 2 calls, if no aggravation of
disease.
Exclusion Criteria:
- Person deprived of liberty by judicial or administrative decision
- Person being subject to a legal protection measure
- Person who expressed opposition to participating in the COVIDADOMEVA study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Risk Factors Worsening COVID19 for Out-patient With Home Monitoring | NCT04380662 | Contradiction |
1,853 | 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 = 18 years old
- patients carrying a adenocarcinoma of the stomach or cardia histologically proven
- locally advanced tumour which may not be treated surgically or metastatic tumour
- the patients having a stenosante tumour responsible for a disphagy had to have a
tumoral ablation or a prosthesis or a probe of food,
- measurable lesions according to criteria RECIST (specify measurement by spiral scanner
of largest diameter of with less the one lesion of size higher than 1 cm) or
appraisable but nonmeasurable (lesions < 1 cm, ascite, pleural effusion...)
- general state WHO < 2
- absence of insufficiency cardiac or coronary symptomatic
- absence of previous chemotherapy other that auxiliary stopped since more than 6 months
- filled questionnaires QLQ C30 and STO-22
- PNN = 1500/mm3, haemoglobin ≥ 10g/dl, plates= 100 000/mm3
- creatinin ≤ 110 micromol/l
- bilirubin ≤ 35 micromol/l
Exclusion Criteria:
- disphagy or intestinal obstruction incompatible with a treatment per os or by a probe
of food
- pregnant or nursing woman
- previous of cardiac toxicity to the 5FU or to the anthracyclines
- radiotherapy less than 3 weeks before inclusion, whatever the site
- other evolutionary cancer threatening the short-term life
- metastasis cerebral or méningée known (without obligation to seek it)
- impossibility of regular follow-up for psychological, social, family or geographical
reasons
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.
| Metastatic Gastric Cancer FFCD 03-07 | NCT00374036 | Entailment |
1,176 | 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:
- Clinical diagnosis of pleural effusion
- Pleural effusion proved by chest sonography
Exclusion Criteria:
- Conditions for which thoracentesis are contraindicated
- 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.
| Use of Procalcitonin in the Diagnosis of Pleural Effusion | NCT00172835 | Entailment |
810 | 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:
- ACR criteria: knee pain and one of the tree following conditions: Age > 50 years,
Morning stiffness< 30 minutes and articular crackling.
- osteophytes visible on knee radiography.
- knee radiography less than 3 years old: face, schuss, axial of kneecap cliché.
- Actual gonarthrosis intensity on Visual Analogic Scale > or = 30mm.
Exclusion Criteria:
- arthrosis limited to the femoro-patellar compartments.
- severe depressive syndrome, psychosis.
- Thermal cure less than 6 month before.
- Contra-indication or predictable inability to tolerate thermal cure.
- Profession lied to hydrotherapy.
- previous knee treatments:
- massage, physiotherapy and acupuncture since less than 1 month;
- infiltration since less than 3 months;
- NSAI since less than 5 days;
- analgesic since less than 12 hours;
- modification in the medicinal anti-arthrosis treatment since less than 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.
| THERMARTHROSE: Gonarthrosis and Water Cure | NCT00348777 | Entailment |
223 | 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:
1. Documented diagnosis of primary hypogonadism (congenital or acquired) or
hypogonadotropic hypogonadism (congenital or acquired).
2. Serum total testosterone < 300 ng/dL based on 2 consecutive blood samples
Exclusion Criteria:
A subject will not be eligible for study participation if he meets any of the following
criteria.
1. History of significant sensitivity or allergy to androgens, castor oil or product
excipients.
2. Clinically significant findings in the prestudy examinations.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or I-PSS
score > 19 points.
4. Body mass index (BMI) ≥ 38 kg/m2.
5. Clinically significant abnormal laboratory values
6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
immunodeficiency virus antibodies (HIV Ab).
7. History of seizures or convulsions, including febrile, alcohol or drug withdrawal
seizures.
8. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
procedure that might interfere with gastrointestinal motility, pH or absorption.
9. History of any clinically significant illness, infection, or surgical procedure within
1 month prior to study drug administration.
10. History of stroke or myocardial infarction within the past 5 years.
11. History of, or current or suspected, prostate or breast cancer.
12. History of diagnosed, severe, untreated, obstructive sleep apnea.
13. History of abuse of alcohol or any drug substance in the opinion of the investigator
within the previous 2 years.
14. History of long QT syndrome or unexplained sudden death in a first degree relative
(parent, sibling, or child).
15. Concurrent treatment with medications which may impact the absorption, distribution,
metabolism or excretion of testosterone undecanoate (TU) or place the subject at risk
for treatment with testosterone.
16. Subject has a partner who is currently pregnant or planning pregnancy during the
course of the clinical trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism | NCT02081300 | Entailment |
1,821 | 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 primary adenocarcinoma, poorly differentiated carcinoma, or
carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
3. Disease must be clinically limited to the stomach or GEJ.
4. Pre-treatment Port-a-Cath insertion obligatory
5. No prior chemotherapy.
6. No prior radiotherapy.
7. Patients must be surgical candidates as determined by the treating surgeon.
8. Adequate organ function defined as:
9. Patients must have an ECOG Performance Status < 1.
10. Patients must be able to sign the informed consent document.
Exclusion Criteria:
1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy,
endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past
5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. New York Heart Association Class III or IV heart disease.
6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized
by complications of the study treatment.
7. Pregnant or lactating women or men unable or unwilling to practice contraception are
excluded.
8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical
cancer, or superficial transitional cell bladder cancer).
9. Clinically significant hearing loss.
10. Patients with a history of seizure disorder who are receiving phenytoin,
phenobarbital, or other antiepileptic medication.
11. Patients who cannot fully comprehend the therapeutic implications of the protocol or
comply with its requirements.
12. Patients with any medical or psychiatric condition or disease which, in the
investigator's judgment, would make the patient inappropriate for entry into this
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.
Subject must be at most 75 Years | Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer | NCT00420394 | Entailment |
3,364 | 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:
- Adult patients (male or female) aged over 16 years of age presenting to NHS ENT and
hearing services with SSNHL AND
- Diagnosed with a hearing loss in one or both ears of 30 dB HL or more, over at least 3
contiguous frequencies, between 250, 500, 1000, 2000, 4000 and 8000 Hz.
AND
• Willing and able to provide written informed consent.
Exclusion Criteria:
- Patients with mixed or conductive hearing loss (CHL). CHL will be defined as a 'true'
air-bone gap of 15 dB HL or more in 3 or more contiguous frequencies between 500,
1000, 2000, 4000 Hz.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| The SeaSHeL National Prospective Cohort Study | NCT04108598 | Contradiction |
3,435 | 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:
- patients with type 2 or type 1 diabetes or stress hyperglycemia
Exclusion Criteria:
- age <18,
- patients hospitalized for diabetic complications: ketoacidosis, hyperosmolar syndrome,
hypoglycemic coma, pregnant diabetics or gestational diabetes
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.
| Governance of Diabetes Management in Non-specialistic Hospital Settings | NCT02640768 | Entailment |
6,018 | 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 during consecutive 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 this study and give written
consent for study entry.
<For the treatment period>
1. Patients who have "heartburn" 2 days a week or more during 7 days until the treatment
period (during the observation period).
2. Patients with "heartburn diary" that is completely filled out during 7 days until the
treatment period (during the observation period). If the observation period is 8 days
or longer, those with a 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.
4. Patients whose percentage of time showing pH<4.0 (% time pH<4.0) is not 0%* during the
24-hour esophageal pH monitoring at the end of observation period (at the beginning of
treatment period). *If parameters calculated from analytical program show 0.0% after
round-off, this patient cannot be entered into the treatment 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 a 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 non steroidal anti-inflammatory drugs (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 (myocardial
infarction, etc.), 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 Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease | NCT00165672 | Entailment |
4,728 | 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:
- women with indication for hysterectomy for a supposed benign uterine disease
- women with an age of 18 years or older
- women who were not pregnant at the time of presentation
- women who were appropriated medical status for laparoscopic surgery (American Society
of Anesthesiologists Physical Status classification 1 or 2)
Exclusion Criteria:
- uterine volume > 18 weeks of gestation by pelvic examination
- suspicion of malignancy
- pelvic organ prolapse > stage 1 according to POP-Q classification
- inability to understand and provide written informed consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | LESS-TLH Versus LESS-LAVH | NCT01861067 | Entailment |
242 | 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:
- at least one previous failed IVF cycle in which three or fewer follicles with a mean
diameter of 16 mm were achieved, and/or
- serum E2 level measured on the day of hCG administration was ≤500 pg/ml
Exclusion Criteria:
- day 3 serum FSH level ≥12 mIU/mL
- there is no age limit
Female
Accepts Healthy Volunteers
| Antagonist/Letrozole in Poor Responders | NCT00823004 | Contradiction |
118 | 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:
- Subject must be a male between the ages of 18 and 50 years.
- Subject must have localization-related epilepsy with complex partial and/or secondary
generalized seizures.
- Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone
levels and abnormally low scores on questionnaires of reproductive and sexual
function).
- Subject will have had a normal urogenital and rectal/prostate exam during the year
prior to entry.
- Subject will have had documentation of therapeutic range serum AED levels, a normal
CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than
twofold elevated during the 6 months prior to entry.
Exclusion Criteria:
- Subject that has taken hormones, major tranquilizers or antidepressants in the three
months prior to entry.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo | NCT00179517 | Contradiction |
6,869 | 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:
- Age 55 or greater
- Good physical health
- Memory impairment with a diagnosis of mild cognitive impairment (MCI) or Alzheimer's
disease (AD)
- Participants on stable doses of Memantine (Namenda) or cholinesterase inhibitors will
be eligible
Exclusion Criteria:
- Chronic sinus problems/allergies with chronic use of nasal decongestants or
antihistamines
- Significant neurologic disease that might affect cognition (other than AD), such as
stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of
consciousness for more than 30 minutes or with permanent neurologic symptoms
- Significant medical illness or organ failure, such as uncontrolled hypertension or
cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or
kidney disease
- Preexisting diabetes or current or previous use of hypoglycemic agents or insulin;
participants will be excluded if they have a fasting blood sugar greater than 165 on
baseline OGTT
- Clinically significant elevations in liver function tests, cholesterol, or
triglycerides
- Major psychiatric disorders (e.g., untreated major depression and schizophrenia)
- Chronic use of the following types of medications: anti-psychotic, anxiolytic, and
opiates
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.
| SNIFF 120: Study of Nasal Insulin to Fight Forgetfulness (120 Days) | NCT00438568 | Contradiction |
6,164 | 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:s
1. Recipients:
We will use the confirmed case definition of SARS-CoV-2 infection (COVID-19) with
POSITIVE rRT PCR test for SARS-CoV-2 "using one of the SFDA approved kit used in KSA"
as per current MOH / SCDPC (Waqayah) guidelines (derived from WHO and CDC ).
1. 18 or older
2. Patient with COVID 19 confirmed as per case definition of CDC or MOH/Waqayah
3. Must have been requiring ICU care or severe or immediately life-threatening care:
i. Patient requiring ICU admission. ii. Severe disease is defined as:
1. Dyspnea
2. Respiratory frequency ≥ 30/min
3. Blood oxygen saturation ≤ 93%
4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300,
and/or Lung infiltrates > 50% within 24 to 48 hours iii. Life-threatening disease
is defined as:
1. Respiratory failure
2. Septic shock, and/or
3. Multiple organ dysfunction or failure
2. Donors:
1. 18 or older
2. Recovery from Prior confirmed COVID-19 diagnosis through NEGATIVE rRT PCR test
for SARS-CoV-2 from blood or nasopharyngeal swab - FDA IND guidance or the MOH
updated recovery protocol 15.20.22.23
3. Complete Clinical Recovery from COVID-19 at least 14 days prior to donation (FDA
IND guidance15)
4. All MOH criteria for a fit donor will be followed prior to donation.
5. All Transfusion Transmissible Infections (TTI) markers on the donor blood are
negative as per current MOH routine donor screening regulations
Exclusion Criteria:
1. Recipients:
1. Negative or non-conclusive test COVID-19 rRT PCR test for SARS-CoV-2
2. Mild symptoms
3. Hospitalization not requiring ICU admission
2. Donors:
1. Unfit to donate.
2. Multiparous or pregnant females.
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 85 Years | Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19 | NCT04347681 | Contradiction |
4,374 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Subjects with normal eyes who are not using any ocular medications.
- Be of legal age of consent and sign Informed Consent document. If under legal age of
consent, legally authorized representative must sign Informed Consent document and
subject must sign Assent document.
- Willing and able to wear spherical contact lenses for at least 5 days per week.
- Willing and able to wear spherical contact lenses within the available range of powers
of -1.00 diopter(D) to -6.00D in 0.25D steps.
- Best spectacle-corrected visual acuity greater than or equal to 20/25.
- Manifest cylinder less than or equal to 0.75D.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any active anterior segment ocular disease that would contraindicate contact lens
wear.
- Any use of systemic medications for which contact lens wear could be contraindicated
as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
- Participation in a contact lens or contact lens care product clinical trial within the
previous 30 days.
- Other protocol-defined exclusion criteria may apply.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Prospective Study of an Investigational Daily Disposable Contact Lens | NCT01295905 | Entailment |
147 | 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:
- Abnormal serum ALT on >2 occasions over at least 3 months, despite standard lifestyle
advice when appropriate, in regard to moderation of alcohol intake, weight reduction
and exercise.
- Negative serological tests for hepatitis Bs ag and C antibody.
- Alcohol consumption >21 units per week for no more than 2 week in the last year and
for no more than 3 months of the past 5 years, assessed using a lifetime alcohol
consumption questionnaire.
- Liver biopsy, performed as part of clinical management within 6 months of recruitment,
which shows all of: (a) steatosis (Kleiner grade 2 or 3); (b) NASH (combined
intralobular inflammation and hepatocyte ballooning score of >1); (c) fibrosis Ishak
stage <4; and (d) no evidence to suggest another major liver disease.
- Hypotestosteronaemia, defined by total serum testosterone <11 nmol/L . Investigators
predict that this will include about 25% of men with NAFLD as defined above.
Exclusion Criteria:
- Inability to give informed consent.
- Age <18 or >75 years.
- Symptomatic sexual dysfunction.
- Cirrhosis either on baseline liver biopsy (Ishak score 5-6) or suggested by presence
of varices, by ultrasound (small shrunken liver, ascites, splenomegaly) or by liver
decompensation (encephalopathy, abnormal serum direct bilirubin, albumin or
prothrombin time).
- Space occupying lesion on ultrasound with any suspicion of malignancy.
- Evidence of other chronic liver diseases pace occupying lesion on ultrasound with any
suspicion of malignancy.
- Prostatic nodule or mass on PR examination unless full urological examination rules
our prostate cancer
- Serum PSA or alpha feta protein above the age-specific normal range
- Carcinoma of male breast
- Taking medications (amiodarone, anti-retrovirals, sodium alproate, corticosteroids,
tamoxifen) the previous 3 months (known to improve steatosis).
- Diabetes or hyperlipidaemia, where therapy has been changed within the last 12 months
or with suboptimal control anticipating the need for change in therapy during the
study.
- Severe or complicated obesity, likely requiring bariatric surgery in next 2 years.
- LH/FSH levels, raising the possibility of primary pituitary disease.
- Subject trying to or hoping to conceive within next 18 months.
- Haematocrit of >0.54
- History of any of the following: Sleep apnoea, breast or prostate or liver cancer,
congestive heart failure, chronic renal failure (serum creatinine >150), severe
chronic obstructive airways disease, uncontrolled hypertension epilepsy depression or
migraine.
- Severe co morbidity likely in the opinion of the investigators to reduce life
expectancy to <10 years.
- Hypersensitivity to active agent or to any of the excipients.
- On long-term warfarin or heparin-based anticoagulant therapy. Treatment with
antiplatelet agents will not be an exclusion criterion, however, these will be omitted
at the time of liver biopsies, as per normal clinical practice.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) | NCT01919294 | Contradiction |
4,429 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Men or women aged 16 to 60 years of age
- Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
- Fractures ≤ 28 days post injury
- Closed fractures
- No history of previous ulnar neuropathy or elbow pathology
- Provisin of informed consent
Exclusion Criteria:
- Vascular injury
- History of previous ulnar neuropathy or elbow pathology
- Fractures more than 28 days post-injury
- Limited life expectancy due to significant medical co-morbidity or medical
contraindication to surgery
- Inability to comply with rehabilitation or form completion
- Likely problems, in the judgement of the investigators, with maintaining follow-up
(i.e. patients with no fixed address, patients not mentally competent to give consent,
etc.)
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.
Subject must be at most 60 Years | Simple Decompression Versus Anterior Transposition of the Ulnar Nerve | NCT01051869 | Contradiction |
939 | 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. Patients must consent in writing to participate in the study by signing and dating an
informed consent document
2. Patients who can communicate (exclusion of anyone who cannot understand the
questionnaire)
3. between 20 years and 80 years of age
4. BMI≤30
5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade
2-4
6. Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global
functional criteria : There is the pain of the knee and radiographic osteophyte and at
least one of the following (1) age >50 years (2) Less than 30 minutes of morning
stiffness (3) The friction When moving weighted the knee
7. Patients who agree with contraception
8. Patients who agree to stop the existing osteoarthritis treatment and to get enough
washout periods until medication time
9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis
Exclusion Criteria:
1. patients with osteoporosis
2. Preparing for Pregnancy or Pregnant women or lactating mothers.
3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C
(HCV), venereal disease research laboratory(VDRL)
4. Patients with hypersensitivity to investigator product or investigational product
component or those with a history
5. Patients who had participated in other clinical trials within 12 weeks prior to this
study
6. Patients who received any drug by intra-articular injection for treatment within 2
months prior to this enrollment.
7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure
to treat
8. Patents who started or changed the physical therapy program established within 2 weeks
before the start of the study or during the study(An established physical therapy
program may continue for the duration of the trial, provided that it does not change
in frequency and intensity)
9. Patents included in the following specific risk groups that may influence safety and
efficacy assessments at the discretion of the investigator:: septic arthtritis,
rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture,
alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis,
hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc
10. Patients who have clinically significant severe medical illnesses judged the principal
investigator
11. Patients who have been diagnosed with malignancy within 5 years before screening
(except for patients who were completely remissioned three years before screening
criteria)
12. Patients who the principal investigator consider inappropriate for the clinical trial
due to any other reasons
13. Patients who received concomitant contraindications and who have not passed the
prescribed wash-out period before participating in the clinical trial
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 80 Years | Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients. | NCT03000712 | Entailment |
1,423 | 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:
- Older adults living independently;
- medical approval.
Exclusion Criteria:
- Non-smokers;
- Non-morbidly obese;
- No history of severe hypertension;
- No history of falls;
- No orthopaedic, neurological, pulmonary, or cardiac problems.
Male
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 79 Years | Study of the Long-term Effects of Exercise on Heath Indicators in Older People | NCT01874132 | Contradiction |
873 | 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. Postmenopausal women.
2. WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to
100, with higher scores indicating greater pain.
3. English literacy.
4. Able to undergo an MRI scan
5. Diagnosed Have the following symptoms associated with knee OA based on American
College of Rheumatology clinical classification criteria for osteoarthritis (Peat
2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age,
less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness,
bony enlargement, or no palpable warmth of synovium.
Exclusion Criteria:
1. Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or
physical therapy programs for knee OA within the past 3 months.
2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or
recent stroke) precluding full participation.
3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems
(i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular
accident or stroke) and diabetes with peripheral neuropathy affecting their
sensory/balance.
4. Intra-articular steroid injection or reconstructive surgery on most severely affected
knee in the past three months.
5. Intra-articular hyaluronic acid injections on most severely affected knee in the past
six months.
6. Inability to walk without an assistive device.
Female
No healthy subjects accepted to join the trial.
| Tai Chi for Knee OA Pain Management: a Mechanistic Study | NCT04046003 | Entailment |
4,417 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Clinical diagnosis of lateral epicondylitis
- be aged ≥18 at the time of diagnosis
- be give informed consent
Exclusion Criteria:
- be have not completed the assessment process.
- elbow deformity
- psychological illness
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.
| The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis | NCT04838002 | Contradiction |
709 | 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:
- Male & female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3
months prior to screening.
- BMI ≥ 18.5 and ≤ 29.9 kg/m2.
- Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef
or eggs).
- Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.
- Radiographic evidence of grade II/III knee OA based on one of following criteria.
- Participants willing to stop the restricted supplements and medications prior to
inclusion and throughout the study period.
- Participants willing to stop any home-based remedies or any other form of topical
products intended for knee joint pain relief or any other reason for the entire study
duration.
- Willing to stop the use of study designated rescue medication 48 hours prior to all
assessment visits.
- Willing to abstain from food containing type II collagen only from cartilage, e.g.
chicken, fish, beef, pork, etc. 48 hours prior to all assessment visits.
Exclusion Criteria:
- Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders,
etc.), abnormal medical history or physical findings.
- Participants with history of type II diabetes and uncontrolled hypertension.
- Fasting Blood glucose > 125 mg/dl
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria
for osteoarthritis.
- Any history of trauma, fractures or surgery to the index joint.
- Any planned surgery (diagnostic or therapeutic intervention) to the index joint during
the participation in the study.
- Participants with deformity of the knee joint.
- Participants with a diagnosed condition which may involve or involves the index joint
that includes but is not limited to known rheumatic or inflammatory conditions such as
rheumatoid arthritis, osteomyelitis, osteoporosis, gout, and bone metastasis.
- Other pathologic lesions on X-rays of the knee.
- Current smokers or chronic alcoholics
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 65 Years | To Assess the Efficacy of Collagen Supplement in Osteoarthritis | NCT04470336 | Contradiction |
6,540 | 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:
- Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE FS
as their only source of FVIII, decision taken by the investigator to administer
KOGENATE FS. For pretreated patients with more than 100 exposure days an inhibitor
assessment within three months prior to enrollment should be available; for pretreated
patients with less than 100 exposure days an inhibitor assessment at baseline should
be available.
Male
No healthy subjects accepted to join the trial.
| EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan | NCT00932555 | Contradiction |
5,597 | 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
- Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and
be in a general, technological or vocational course,
- Aged ≤ 18 years old,
- not giving written refusal to participate in the trial,
- able to complete a questionnaire,
- overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria
(for waist circumference) and/or have a high eating disorder score, and/or express the
need for management of excess weight,
- confirmed as corresponding to the 4 previous inclusion criteria by the physician, with
elimination of adolescents with false-positive BMI (particularly athletic
adolescents),
- agree to an overweight and obesity care management program.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Overweight Management and Social Inequalities | NCT01688453 | Contradiction |
2,302 | 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:
- Established clinical diagnosis of DMD and documented dystrophin gene mutation of DMD
phenotype.
- Indication of symptomatic muscular dystrophy by protocol-specified criteria.
- Ability to cooperate with motor assessment testing.
- Stable dose equivalent of oral corticosteroids for at least 12 weeks.
Exclusion Criteria:
- Impaired cardiovascular function on ECHO.
- Prior or ongoing medical condition on physical examination, ECG, or laboratory
findings that could adversely affect subject safety, compromise completion of
follow-up, or impair assessment of study results.
- Exposure to another investigational drug or exon skipping medication within 6 months
of screening.
- Exposure to an investigational or commercial gene therapy product.
- Abnormal liver or renal function by protocol-specified criteria
Other inclusion/exclusion criteria apply.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | A Randomized, Double-blind, Placebo-controlled Study of SRP-9001 for Duchenne Muscular Dystrophy (DMD) | NCT03769116 | Contradiction |
3,749 | 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. age between 50~75 years old
2. diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of
American College of Rheumatology, ACR
3. chronic knee pain over 3 months.
Exclusion Criteria:
1. the past history with systemic joint disease, such as autoimmune disease
2. the patient with history of knee surgery or waiting for the total knee replacement
3. any disease that affect the function of lower extremities, such as trauma, tumor or
compensation of abnormal posture
4. the condition that cannot participate this study
5. the subjects non-compliance with the protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | The Efficacy of TGF for Treating Osteoarthritis of the Knee | NCT03562429 | Contradiction |
2,638 | 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:
- Male patients with a primary symptomatic unilateral inguinal hernia.
- Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or
open techniques (e.g. Lichtenstein) as judged by the treating surgeon
- Written informed consent
Exclusion Criteria:
- Previous inguinal hernia repair
- Bilateral inguinal hernia
- Femoral hernia repair
- Repair in local anesthetics,
- Previous abdominal surgery
- Children
- Emergency surgery, e.g. incarcerated hernias
- Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea
implants, claustrophobia)
- Contraindications to usage of mesh e.g. known hypersensitivity or allergy
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia
- American Society of Anesthesiologists (ASA) classification higher or equal to 3
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh | NCT02770703 | Entailment |
1,148 | 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:
Children of either gender, aged 4 to 18 years.
Obstructive HCM defined as LV hypertrophy, and an LV intra-cavitary pressure gradient
measured at cardiac catheterization of greater than or equal to 30 mm Hg at rest or greater
than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than
or equal to 100 beats per minute.
Cardiac symptoms (chest discomfort, dyspnea, lightheadedness or presyncope, syncope,
cardio-respiratory arrest, palpitations, excessive fatigue); and/or exercise duration which
is less than 10th percentile predicted for age/gender despite a trial of a beta-blocker
therapy and a trial of verapamil therapy.
EXCLUSION CRITERIA:
Other systemic diseases that prevent assessment by exercise tests and cardiac
catheterization.
Chronic atrial fibrillation.
Positive pregnancy test: A negative urine pregnancy test will be required before each
cardiac catheterization, electrophysiologic study and thallium study. Pregnant or lactating
subjects may not participate in the study due to potential teratogenic effects of
radiation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Studying the Effectiveness of Pacemaker Therapy in Children Who Have Thickened Heart Muscle | NCT00001960 | Entailment |
3,660 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- lumber pain, pain radiating to leg, motor deficits in legs, , dural signs and
symptoms, impaired nerve root mobility(straight leg raise and L3 stretch), back pain
effecting Quality of life, ODI score less than 30 and Limited range of motion .
Exclusion Criteria:
- Osteoporosis of hip, Bilateral sciatica, having anticoagulant medication, pregnancy,
patient with impaired mental status
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Cyriax Manipulation in Lumbar Derangement Syndrome | NCT04082065 | Contradiction |
3,662 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
1. Being 18 years or older;
2. Having current acute or sub-acute low back pain defined as pain that has not lasted
more than 16 weeks;
3. Minimum score of 30mm on a 100mm visual analog pain scale.
Exclusion Criteria:
Exclusion criteria consisted of the following:
1. Have any of six possible un underlying causes of low back symptoms in their history
(spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing
spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer);
2. Have undergone surgery involving the low back; (
3. Have received workers'compensation benefits within the preceding year or were
potentially involved in litigation relating to back problems;
4. Pregnancy, because of possible need for exposure to diagnostic x-rays;
5. Have participated as a subject in research previously at the trial clinic site;
6. Have received spinal manipulation within the preceding 3 months or on more than three
occasions during the preceding year.
7. Subjects with sciatica were excluded if they had any one of the following:
- Ankle dorsiflexion / plantar flexion weakness;
- Great toe extensor weakness;
- Absence of knee or ankle reflexes;
- Loss of light touch sensation in the medial, dorsal, and lateral aspects of the
foot;
- Ipsilateral straight-leg-raising test (positive result: leg pain at <60°);
- Crossed straight-leg-raising test (positive result: reproduction of contralateral
pain).
These six neurologic tests allow detection of most clinically significant nerve root
compromises resulting from L4-L5 or L5-S1 disc herniations, which together make up
more than 90% of all clinically significant radiculopathies attributable to lumbar
disc herniations (21-25). Because approximately 12% of ambulatory patients with back
pain h
8. Have symptoms of sciatica or leg pain without neurologic compromise related to lumbar
disc herniation,[5] investigators attempted to include such subjects in the trial.
The criteria described above were intended to minimize the likelihood of including subjects
with a lumbar disc herniation.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Comparison of Activator Manipulation Versus Manual Side Posture Manipulation in Patients With Low Back Pain | NCT00497861 | Contradiction |
4,792 | 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:
- tinnitus for more than 6 months
- sensorineural hearing loss
- normal otoscopy
Exclusion Criteria:
- conductive or mixed hearing losses
- A-r, A-d, B and C tympanograms
- tinnitus treatment in the last 6 months
- pregnant woman
- Vestibular Schwannoma
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients | NCT00976547 | Entailment |
3,600 | 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:
- Women with menorrhagia
- 18-49 years of age
- Regularly occurring menstrual periods
Exclusion Criteria:
- History or presence of clinically significant disease or abnormalities that may
confound the study
- History of bilateral oophorectomy or hysterectomy
- Hormone therapy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Efficacy and Safety Study of XP12B in Women With Menorrhagia | NCT00386308 | Contradiction |
3,882 | 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:
- Knee pain on most days of the previous month
- At least moderate pain on two of the five WOMAC knee pain domains in the most painful
knee
- Knee pain present for longer than 3 months
Exclusion Criteria:• House-bound or care home resident
- Dementia
- Dialysis
- On home oxygen
- Serious mental illness
- Inability to communicate in English
- Unable to give consent
- Terminal cancer
- Known diagnosis of autoimmune rheumatic diseases or psoriasis
- Knee or hip replacement, or on waiting list for knee or hip replacement
- Asthma or COPD requiring regular daily oral corticosteroids
- Unstable angina or heart failure
- Known peripheral vascular disease
- Pregnant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Knee Pain Nurse Led Package of CareTrial | NCT03670706 | Entailment |
2,971 | 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:
1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported
probable, or definite ALS defined by revised El Escorial criteria.
2. Age 18 years or older.
3. Capable of providing informed consent and complying with study procedures, in the SI's
opinion.
4. Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol
Screening Visit.
5. Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the
Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required
due to pandemic-related restrictions, Forced Vital Capacity (FVC).
6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30
days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are
permitted in the study.
7. Participants must either not take edaravone or have completed at least one cycle of
edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants
are permitted in the study.
8. Participants must have the ability to swallow pills and liquids at the time of the
Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow
for the duration of the study.
9. Geographically accessible to the site.
Exclusion Criteria:
1. Clinically significant unstable medical condition (other than ALS) that would pose a
risk to the participant, according to SI's judgment (e.g., cardiovascular instability,
systemic infection, untreated thyroid dysfunction, or clinically significant
laboratory abnormality or EKG changes).
Lab abnormalities include, but are not limited to: Hemoglobin < 10 g/dL, White Blood
Cells < 3.0 x 103/mm3, Neutrophils, Absolute ≤ 1000/mm3, Eosinophilia (absolute
eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (< 150 x
109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
greater than 3 times the upper limit of normal (ULN), eGFR < 30 mL/min/1.73m2,
thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.
2. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance
abuse that would impair ability of the participant to provide informed consent, in the
SI's opinion.
3. Active cancer or history of cancer, except for the following: basal cell carcinoma or
successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ,
prostatic carcinoma in situ, or other malignancies curatively treated and with no
evidence of disease recurrence for at least 3 years.
4. Use of investigational treatments for ALS (off-label use or active participation in a
clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior
to the Master Protocol Screening Visit.
5. Exposure at any time to any gene therapies under investigation for the treatment of
ALS (off-label use or investigational).
6. If female, breastfeeding, known to be pregnant, planning to become pregnant during the
study, or of child-bearing potential and unwilling to use effective contraception for
the duration of the trial and for 3 months, or longer as specified in each RSA, after
discontinuing study treatment.
7. If male of reproductive capacity, unwilling to use effective contraception for the
duration of the trial and for 3 months, or longer as specified in each RSA, after
discontinuing study treatment.
8. Anything that would place the participant at increased risk or preclude the
participant's full compliance with or completion of the study, in the SI's opinion.
9. If a participant is being re-screened, the disqualifying condition has not been
resolved, or the mandatory wash-out duration has not occurred.
10. For those participating in the optional CSF collection, contraindication to undergoing
a lumbar puncture (LP) in the SI's opinion. Participants undergoing the LP must not be
currently taking anticoagulation medications such as warfarin that would be a
contraindication to LP; aspirin and non-steroidal anti-inflammatories are allowed.
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.
| HEALEY ALS Platform Trial - Master Protocol | NCT04297683 | Entailment |
6,064 | 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:
- Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the
study (at least 2 times a week)
- Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal
disorders
- Written informed consent is a prerequisite for subject enrollment.
Exclusion Criteria:
- Gastrointestinal bleeding within 12 months prior to the study
- Difficulty swallowing (dysphagia)
- History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or
gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's
oesophagus or systemic sclerosis
- Participation in other studies within the last 30 days prior to entry or during the
study
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 | Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn | NCT01718639 | Entailment |
818 | 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. Males and females between 40 and 75 years of age, inclusive
2. BMI between 18.5 to 29.9 kg/m2, inclusive
3. Female participant is not of child-bearing potential, defined as females who have
undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy,
bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal
for at least 1 year prior to screening Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test
and agree to use a medically approved method of birth control for the duration of the
study. All hormonal birth control must have been in use for a minimum of three months.
Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control
patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing
to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
4. Self-reported pain or swelling in target knee
5. The diagnosis of mild to moderate osteoarthritis as confirmed by the Qualified
Investigator using qualifiers based on physical exam, medical history and x-ray report
qualified as mild to moderate by the radiologist
6. Agrees to refrain from taking any pain relievers during the study, except
acetaminophen as a rescue medication specified by the study site
7. Agrees to refrain from taking rescue medication for 48 hours prior to study visits
8. Agrees to maintain current diet and current exercise routine throughout the study
9. Willingness to complete questionnaires, records, and diaries associated with the study
and to complete all clinic visits
10. Provided voluntary, written, informed consent to participate in the study
11. Healthy as determined by medical history, laboratory results, and physical exam as
assessed by the Qualified Investigator (QI)
Exclusion Criteria:
1. Allergy, sensitivity, or intolerance to the investigational product's active or
inactive ingredients
2. Allergy to rescue medication
3. Women who are pregnant, breast feeding, or planning to become pregnant during the
study
4. Clinically significant abnormal laboratory results at baseline as assessed by the QI
5. Individuals who are unable to give informed consent
6. Injury in the target knee within the past 3 months
7. Intraarticular injections in the target knee within the past 6 months, or plan to have
intraarticular injections during the study
8. Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis,
septic arthritis or any other infective arthritis
9. Self-reported history of gout or pseudo gout within the past 6 months
10. Skin defects (e.g. skin and soft tissue infections that cause necrosis of the skin, or
post-burn contractures) and ulcers around the affected knee joint, as assessed by the
QI
11. History of knee surgery or replacement in the target knee, or any non-knee surgical
procedures that may impact the study outcomes as assessed by the QI
12. Individuals with muscle or skeletal disorders as assessed by the QI
13. Unstable metabolic disease or chronic diseases as assessed by the QI
14. In a state of acute exacerbation or seizure of chronic disease
15. Type I or Type II diabetes
16. History of or current diagnosis with severe cardiopulmonary, kidney and/or liver
dysfunctions, with the exception of history of kidney stones in participants who are
symptom free for 6 months
17. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on
a stable dose of medication for at least 3 months will be considered by the QI
18. Current or history of any significant diseases of the gastrointestinal tract including
diarrhea or dysentery as assessed by the QI
19. Significant cardiovascular event in the past 6 months. Participants with no
significant cardiovascular event on stable medication may be included after assessment
by the QI on a case-by-case basis
20. Self-reported confirmation of medical or neuropsychological condition and/or cognitive
impairment that, in the QI's opinion, could interfere with study participation
21. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or
radiation with a follow up that is negative. Volunteers with cancer in full remission
for more than five years after diagnosis are acceptable
22. Verbal confirmation of blood/bleeding disorders as assessed by the QI
23. Individuals with an acute infectious disease, autoimmune disease or are
immune-compromised
24. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
25. Current use of prescribed medications listed above
26. Current use of over-the-counter medications, supplements, foods and/or drinks listed
above
27. Use of medical cannabinoid products
28. Chronic use of cannabinoid products (>2 times/week) and is unwilling to stop use for
the duration of the study. Occasional use to be assessed by the QI on a case-by-case
basis
29. Alcohol or drug abuse within the last 12 months
30. High alcohol intake (average of >2 standard drinks per day)
31. Blood donation 30 days prior to screening, during the study, or a planned donation
within 30 days of the last study visit
32. Participation in other clinical research studies 30 days prior to screening
33. Any other condition, that, in the opinion of the QI, may adversely affect the
participant's ability to complete the study or its measures or pose significant risk
to the participant
Participants on the following concurrent prescribed medications and/or treatments will be
excluded during enrollment unless they have been taken off these therapies by their family
physician. In the latter event, the frequency and route of administration of use and/or
dosage may be considered by the QI on a case-by-case basis prior to recommending an
appropriate washout or their enrollment in the study.
1. Oral NSAIDs or topical application on the target knee
2. Narcotics
3. Oral corticosteroids or topical application on the target knee
4. Oral analgesics except acetaminophen as a rescue medication or topical application on
the target knee
5. Digoxin
6. Anti-hypertensive drugs
7. Anticoagulants or antiplatelet drugs
8. Medications used for OA treatment
9. Diazepam
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 | Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis | NCT04395547 | Entailment |
1,243 | 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. | DISEASE CHARACTERISTICS: Unilateral malignant pleural effusion requiring sclerosis (as
judged by the attending surgeon) At least 3 months since treatment of contralateral
effusion No chylous effusion
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Able to undergo thoracoscopy under general or local anesthesia (as determined by the
attending surgeon) Not pregnant Tests and observations must be completed within 1 week
prior to randomization (chest x-ray within 1 week prior to procedure)
PRIOR CONCURRENT THERAPY: No prior intrapleural therapy No systemic therapy within 2 weeks
prior to randomization or 2 weeks post pleurodesis Biologic therapy: Not specified
Chemotherapy: No new systemic chemotherapy for 2 weeks prior to and at least 2 weeks after
pleurodesis Endocrine therapy: No new hormonal therapy for 2 weeks prior to and at least 2
weeks after pleurodesis No concurrent steroids used as antiemetics Radiotherapy: Prior
radiotherapy allowed No radiotherapy to entire hemithorax Palliative irradiation of
symptomatic bone lesions allowed on the affected side if field does not include a
significant portion of pleura Surgery: See Disease Characteristics
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 120 Years | Talc in Treating Patients With Malignant Pleural Effusion | NCT00002622 | Entailment |
1,327 | 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. | Adult individuals of either gender with achondroplasia and their first degree relatives
(both short and average statured) of all ethnic and cultural backgrounds.
No short-statured persons with conditions other than achondroplasia.
No average-statured family members of short statured persons with conditions other than
achondroplasia.
No minors less than 18 years of age.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Issues Surrounding Prenatal Genetic Testing for Achondroplasia | NCT00001536 | Contradiction |
137 | 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:
- Men who are 65-90 years of age
- Total serum IGF-1 (insulin-like growth factor) in the lower tertile for adults (56-167
ug/dl)
- Total serum testosterone of 150-550 ng/dL
Exclusion Criteria:
- BMI (Body Mass Index) 35 kg/m2 or greater
- Weight instability (>3% change in prior 3 months)
- Daily intake of total kilocalories less than or equal to 0.8X the RDA and intake of
protein between 0.8 and 1.4 g/kg/day inclusive
- Acute illness in the prior 30 days
- Resistance training (wt lifting) in the past 12 months
- Vigorous aerobic sports (Competing as a Master athlete in the prior 5 years; weekly
swimming, racquet ball, cycling, tennis, in preceding 12 months)
- Use of an anabolic agent (androgen, androgen precursor, rhGH, etc) in the preceding 12
months
- Use of medications that might affect amino acid metabolism (e.g. beta-adrenergic
blockers, beta-agonists, Ca2+ channel blockers, corticosteroids)
- Fasting sugar greater than or equal to 126 mg/dl or diabetes requiring Rx
- History of benign intracranial hypertension
- Heart failure, active angina, or myocardial infarction in the prior 6 months or
history of aortic stenosis
- Uncontrolled hypothyroidism or hyperthyroidism
- Rheumatoid arthritis, cirrhosis or active hepatitis
- History of carpal tunnel syndrome
- Prior cancer other than squamous or basal cell carcinoma of the skin
- Sleep apnea or severe chronic lung disease
- Anticoagulation with heparin or coumadin
- Blood pressure not controlled with medication to <180/95 mm Hg
- Calculated creatinine clearance <50 cc/min
- Serum prostatic antigen >4.0 or American Urological Association score greater than or
equal to 8
- Hematocrit greater than or equal 52%, or ALT >1.5X ULN
- Failure to pass a modified Bruce treadmill stress test
- Severe disability limiting strength or physical function testing
- Dementia or cognitive impairment affecting a subject's ability to provide informed
consent
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 90 Years | HORMA: Hormonal Regulators of Muscle and Metabolism in Aging | NCT00183040 | Contradiction |
3,194 | 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. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome
(1999): 1998 research report on immunological intractable diseases specified by the
Japanese Ministry of Health and Welfare)
2. Patients aged 20 years or older at time of consent
3. Patients with dry mouth
4. Patients with decreased salivation
Exclusion Criteria:
1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's
syndrome
2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant,
etc.)
3. Patients who have received rebamipide within 3 months prior to obtaining informed
consent
4. Patients who are pregnant, possibly pregnant, or lactating
5. Patients with a history of hypersensitivity to rebamipide
6. Patients who have received any other investigational drug within 3 months prior to
obtaining informed consent
7. Patients who are otherwise judged inappropriate for inclusion in the study 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.
| Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome | NCT00233363 | Entailment |
4,127 | 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:
For all patients:
1. The patient understands the study procedures and agrees to participate by signing the
consent form.
2. The patient is male or female, at least 18 years of age but no more than 80 years of
age at the entry into the study (screening visit).
For patients with asthma (groups 1 and 2)
1. The patient has a history of intermittent or persistent symptoms of wheezing,
breathlessness, chest tightness and cough. The diagnosis of asthma must have been
confirmed by a specialist in pulmonary medicine.
2. The patient fulfils one or several of the following criteria for reversible airway
obstruction, as documented during the last 5 years before the study or at screening
visit:
1. An increase in FEV1 more than 9% of predicted (or improvement by 200 mL) after
administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a
spacer, or after additional inhalation of four puffs of 20 microg ipratropium
bromide (Atrovent) administered through a large volume spacer.
2. A mean diurnal variation in Peak Expiratory Flow (PEF) of more than 15% on more
than 4 days/week for at least 2 weeks, as calculated by the following equation:
(highest PEF-lowest PEF)/mean PEF
3. An increase in FEV1 of at least 400 mL after a course of prednisolone
0.5mg/kg/day for 14 days.
4. In patients with a FEV1 more than 70% predicted, demonstrated bronchial
hyperresponsiveness to histamine, methacholine, isocapnic hyperventilation,
exercise or other indirect challenges (according to established local methods).
3. The patient is a non-smoker or has a total smoking history of less than 5 pack years.
In the case the patient is smoking, it must be less than 10 cigarettes a day and the
asthma must have started before smoking.
Specific for patients with mild to moderate asthma (group 1)
1. The patient has stable disease with minimal symptoms, no exacerbations or
hospitalisations during the last year.
2. The patient uses inhaled steroids regularly, but not more than 800 microg/day
budesonide or beclomethasone, or up to 500 microg/day fluticasone.
3. The patient uses prescribed short-acting beta agonists as needed.
4. The patient does not require treatment with long-acting beta-agonists.
Specific for patients with severe asthma (group 2)
1. The patient has been under specialist treatment for at least one year.
2. The patient requires continuous treatment with high doses of inhaled steroids. If the
patient does not take oral steroids, the inhaled dose of steroids must be more than
1600 microg/day budesonide or beclomethasone, or more than 800 microg/day fluticasone
or equivalent. In case the patient does take oral steroids, the inhaled dose of
steroids must be more than 800 microg/day budesonide or beclomethasone, or more than
400 microg/day fluticasone or equivalent.
3. The patient requires continuous treatment with long acting inhaled beta-agonists or
oral theophylline, as documented for at least one year.
4. The patient experienced at least one asthma exacerbation during the previous year.
Specific for patients with COPD (group 3)
1. The diagnosis of COPD must have been made by a specialist in pulmonary medicine. The
patient may or may not have chronic symptoms (cough, sputum production, dyspnoea).
2. The patient has a FEV1/Forced Vital Capacity (FVC) ratio of less than 70%.
3. The patient's post bronchodilator FEV1 value is more than 30% but less than 80% of
predicted.
4. The patient has a smoking history of more than 15 pack years, either as current or
ex-smoker.
5. The patient displays a negative reversibility test to inhaled bronchodilators as
defined by an increase in FEV1 of less than 9% of predicted (or an improvement by less
than 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol
inhaler via a spacer, and four puffs of 20 microg ipratropium bromide (Atrovent)
administered through a large volume spacer.
6. The patient has no history of asthma.
7. The patient has no current allergy, as shown by a negative skin-prick test.
8. The patient has used inhaled steroids in the range 800-1600 microg/day (budesonide or
equivalent) for at least 3 months prior to the study.
Exclusion Criteria:
General exclusions
1. The patient is pregnant.
2. The patient has a recent history of incapacitating psychotic disorders.
3. The patient is a current or recent past abuser of alcohol or illicit drugs.
4. The patient has a history of malignancy, is known to be positive for HIV, or other
states that are considered to interfere with study conduct or scientific
interpretations.
5. The patient cannot read or comprehend written material, or is in the opinion of the
investigator, for other reasons unlikely to understand and follow the study
procedures.
6. The patient is mentally or legally incapacitated preventing informed consent from
being obtained.
Exclusions because of pulmonary disorders
1. The patient is unable to perform acceptable spirometry, peak flow measurements and/or
complete diary cards in a satisfactory way during the period between visit 1 and visit
3B (optimisation period and prednisolone/placebo trial). If the patient is unable to
use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary
mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card.
Patients that are unable to use the mechanical meter and paper diary card during the
period between visit 1 and 3B cannot enter the follow-up year.
2. The patient has, in addition to asthma or COPD, any other pulmonary disorder that
according to the investigator would interfere with the study procedures or scientific
evaluation (e.g. tuberculosis).
3. The patient suffers from chronic hypercapnic respiratory failure as indicated by an
elevated pCO2 (>47 mm Hg or 6,25 kPa). In case of doubt this should be confirmed with
pulse oximetry or blood gas sampling.
Exclusions because of medications
1. The patient has received immunosuppressants other than corticosteroids (i.e.,
methotrexate, gold, troleandomycin, cyclosporin or any other experimental
anti-inflammatory drug) within three months of study entry.
2. The patient is currently undergoing immunotherapy.
3. The patient receives chronic oxygen therapy.
Specific exclusion criterion for patients with asthma (groups 1 & 2)
1. The patient has smoked more than five (5) pack years.
Specific exclusion criterion for patients with mild asthma (group 1) 1. The patient
requires treatment with long-acting beta-agonists.
Specific exclusion criteria for patients with severe asthma (group 2)
1. The patient is not treated with high doses of inhaled steroids (see above).
2. The patient has not had an exacerbation of asthma during the last year.
3. The patient does not require treatment with long-acting beta-agonists or theophylline
as documented during one year.
Specific exclusion criterion for patients with COPD (group 3)
1. The patient has a history of asthma confirmed by a specialist in pulmonary medicine.
Specific exclusion criteria for bronchoscopy (all groups)
1. The patient has had a severe exacerbation of asthma requiring high doses of oral
steroids during the last three (3) months.
2. The patient has had a severe exacerbation of COPD requiring intensive outpatient
treatment or hospitalisation during the last three (3) months.
3. The patient has had three or more severe exacerbations of asthma or COPD during the
last year.
4. The patient displays more than 10% fall in FEV1 at 2 minutes after inhalation of 0.9%
saline (during induction of sputum at visit 2).
5. The patient has shown signs of uncontrolled disease during the last three days, e.g.
the patient has required more than four puffs/day of rescue medication above baseline
use during the last three days. (In the case criteria 1-4 are not met, such patients
may be rescheduled for bronchoscopy in two weeks time. The start of the oral
prednisolone intervention will then be postponed by the number of days passing before
the bronchoscopy).
6. If a patient who otherwise has qualified for bronchoscopy has received more than 6 mg
per kg BW of lidocaine during the preparation for the procedure, the bronchoscopy must
be terminated and cannot be continued the same day.
7. Patients who have experienced severe bronchoconstriction or other adverse reactions at
previous attempts to perform bronchoscopy.
8. The patient has a post-bronchodilator FEV1 < 40% predicted.
9. Do not start or proceed bronchoscopy if:
- Transcutaneous oxygen saturation by pulse-oximeter < 90% (despite giving oxygen
by nasal cannula when saturation is < 94%)
- Heart frequency > 130
- Heart rhythm disturbances.
Specific exclusion criteria for induced sputum (all groups)
1. A post-bronchodilator (after administration of 4 puffs of 100 microg salbutamol
dose-aerosol inhaler via a spacer) FEV1 percent of predicted being less than 60%, or
in absolute values less than 1.0 L.
2. A peak flow variability of more than 30% during the previous four days.
3. Patients who display more than a 15% fall in FEV1 at 2 minutes after inhalation of
saline (0.9% NaCl) during induction of sputum..
4. Patients who have experienced severe bronchoconstriction or other adverse reactions at
previous attempts to induce sputum.
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 | Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease | NCT00555607 | Contradiction |
5,460 | 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:
- The study enrolled subjects who had completed the double-blind therapy in either the
XP12B-MR-301 or XP12B-MR-303 study, including scheduled evaluations, with no major
protocol violations and no study events that, in the opinion of the investigator,
would preclude the subject's entry into the open-label safety study.
- A negative urine pregnancy test was required immediately before entry into this study.
- Women must have been surgically sterile or, if of childbearing potential, must have
been in a monogamous relationship with a sterile partner or a partner of the same sex.
- Women must have used an acceptable barrier contraception method with spermicide for
the duration of the study or must have been using a copper intrauterine device (IUD).
- In the opinion of the investigator, the subject must be able to understand this study,
cooperate with all study procedures, be able to return to the study site for visits
within the required visit windows and be deemed likely to complete the study.
- Subject will provide voluntary, written consent to participate in the study by signing
and dating an institutional review board (IRB)-approved informed consent before any
procedures are performed or study drug is dispensed.
Exclusion Criteria:
- History or presence of clinically significant hepatic or renal disease or other
medical disease that might confound the study or be detrimental to the subject (e.g.,
clinically significant cardiac arrhythmia, uncontrolled diabetes or uncontrolled
hypertension) as determined by the investigator.
- Normal gynecological examination and breast examination.
- Clinically significant abnormalities on screening physical examination that might
confound the study or be detrimental to the subject as assessed by the investigator.
Abnormal clinically significant electrocardiograms (ECG) as determined by the
centralized cardiologist, or laboratory tests suggestive of a potential
pituitary-prolactin stimulating tumor (prolactin >=30 µg/L), thrombocytopenia
(platelet count <100,000/mm3), uncontrolled hypothyroidism (TSH >=10 mU/L) or severe
anemia (hemoglobin <8 g/dL]).
- Anovulatory dysfunctional uterine bleeding, metrorrhagia (irregular or frequent
noncyclic flow), menometrorrhagia (irregular or frequent excessive noncyclic flow) or
polymenorrhea (frequent flow, cycles of less than 21 days).
- History or presence of endometrial polyps, endometrial hyperplasia, endometrial
carcinoma or cervical carcinoma (includes cervical carcinoma in situ).
- History of bilateral oophorectomy or hysterectomy.
- Women who are pregnant, breastfeeding, planning to become pregnant during the study or
become pregnant during the study.
- History or active presence of myocardial infarction or ischemic disease. History or
active presence of cerebrovascular accident, stroke, or transient ischemic attack.
- History or presence of thrombosis, thromboembolic disease or coagulopathy including,
but not limited to, pulmonary embolism, deep venous thrombosis, phlebitis and any
intravascular clotting disorder.
- History or known presence of acquired or inherited thrombophilia, including, but not
limited to, antithrombin deficiency, Protein C and/or S deficiency, antiphospholipid
deficiency, Factor V Leiden mutation and prothrombin mutation. Thalassemia or sickle
cell disease (sickle cell trait individuals are not excluded).
- History or presence of subarachnoid hemorrhage.
- Use or anticipated use of medications taken to relieve β-Hydroxy β-methylbutyric acid
(HMB) including the use of vaginal [rings, creams, gels] and transdermal hormone
products; use of oral estrogen-, progestin- or SERM-containing drug products, or
intrauterine progestins containing drug products. Use or anticipated use of Lupron (1
or 3 month) depot injection or estrogen pellet or long-acting progestin injectables.
- Use or anticipated use of meclofenamate sodium, mefenamic acid, danazol, or
desmopressin acetate or herbal remedies. Herbal remedies include, but are not limited
to, Capsella bursa pastoris (i.e. Sheperd's Purse), Agnus castus (i.e. Chasteberry,
Vitex), Cimicifuga racemosa (i.e. Black Cohosh), Symphytum officionale (i.e. Comfrey),
and/or Angelica sinensis (i.e. Dong Quai).
- Use of or anticipated use of the following drugs: oral, transdermal, injectable and
vaginal ring (NuvaRing®) hormonal contraceptives; anticoagulants (warfarin
[Coumadin®], heparin, low-molecular-weight heparin (LMWH), etc.), aminocaproic acid
(Amicar®) or Plaquenil®.
- Current use of an intrauterine device (IUD) other than copper IUDs.
- History or presence of hypersensitivity or idiosyncratic reaction to antifibrinolytics
(tranexamic acid or aminocaproic acid).
- Use of any investigational drug except XP12B-MR during the current study.
- Presence of untreated malabsorption disorder or malnutrition including, but not
limited to, chronic diarrhea, celiac disease, short bowl syndrome, Whipple's disease
or history of gastric bypass procedure.
- Presence of defective color vision as determined by the optometrist or
ophthalmologist. Inability of the subject to correctly identify symbols on plate 7 of
the HRR eye test is not considered defective color vision provided the subject
correctly identifies the symbols on plates 11-20.
- History or presence of glaucoma, ocular hypertension, macular degeneration or
retinopathies.
- History or presence of alcoholism or drug abuse within the past year.
- Malignancy, or treatment for malignancy, within the previous 2 years, with the
exception of basal cell carcinomas of the skin or squamous cell carcinoma of the skin.
- Does not read or understand English.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 49 Years | A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding | NCT01280981 | Entailment |
65 | 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:
1. Agrees to written as well as audio-visual informed consent.
2. Ability to understand the risks/benefits of the protocol
3. Male between 35-65 years of age.
4. Diagnosed with Symptomatic hypogonadism
Exclusion Criteria:
1. Uncooperative Subjects
2. Impaired hepatic function indicated by SGOT/SGPT >2.5 times the upper limit of normal.
3. Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of
normal
4. elevated creatinine, males > 125 µmol/L or 1.4mg/dl, females > 110 µmol/L or1.2mg/dl)
5. Patients suffering from CAD
6. History of malignancy
7. History of hypersensitivity to any of the investigational drugs Receiving any other
testosterone booster therapy/medication/supplement within the last 2 months
8. History of coagulopathies
9. High alcohol intake (>2 standard drinks per day)
10. History of psychiatric disorder that may impair the ability of subjects to provide
written informed consent.
11. Any medical condition, where the investigator feels participation in the study could
be detrimental to the subjects overall well-being
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Evaluation of Furosap in Human Volunteers | NCT02748005 | Contradiction |
5,137 | 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:
- Women
- Age ≥ 60 years
- Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of
≤ - 2.0, or has a history of an osteoporotic fracture
Exclusion Criteria:
- Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and
of zoledronic acid at any time
- Previous treatment with teriparatide, alendronate or risedronate of more than 2 months
in the last 24 months
- Previous treatment with calcitonin within the previous year; previous treatment with
an estrogen or selective estrogen modulator will not exclude a potential subject
unless she has been taking it for < 1 year (a woman who discontinued estrogen or a
selective estrogen receptor within the previous year will also be excluded)
- Other diseases known to affect bone, such as Paget's disease, Cushing's disease,
hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin
D deficiency
- Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids
(20 mg/day or more > 2 weeks within the previous 6 months)
- Current alcohol use > 3 drinks/day
- Untreated or unstable cardiac, pulmonary, liver (SGOT > 2X upper limit of normal) or
renal disease (creatinine > 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C > 8.0)
- Prior radiation therapy to the skeleton
- Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips
- Claustrophobia
- Subjects whose initial MRI is of poor quality due to motion artifact will be asked to
repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the
subject will be excluded from the study
- Abnormalities of the which delay esophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 30 minutes
- Hypocalcemia
- Uric acid level >7.5ml/dl
- Subjects with metallic objects in their bodies
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis | NCT01153425 | Contradiction |
3,476 | 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:
1. Gender: men and women
2. Ethnicity: all ethnic groups
3. Age: ≥18, < 75 years
4. Diagnosis of T2D -A1C within the last 90 days must be >7.5%
5. Obesity, BMI ≥30
6. An Employee, or the significant other of an employee, that is covered by the Cleveland
Clinic Employee Health Plan
Exclusion Criteria:
1. Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)
2. Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney
Disease Epidemiology Collaboration Equation, CKD-EPI)
3. Current glucocorticoid therapy
4. Currently or within the past 3 months receiving an anti-obesity medication, or any
other medication used for the primary intent of weight loss
5. Any condition, unwillingness or inability, not covered by any of the other exclusion
criteria, which, in the study clinician's opinion, might jeopardize the subject's
safety or compliance with the protocol
6. Mental incapacity or language barrier
7. Pregnancy or plans to become pregnant within the next 2 years
8. Personal or family history of medullary thyroid carcinoma
9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
10. History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of
digestive tract
11. History of congestive heart failure
12. History of bariatric or metabolic surgery/procedure
13. Visit with an endocrinologist within the past 1 year
14. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight
Management Program
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 | EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial | NCT04531176 | Entailment |
6,007 | 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:
1. Experiencing heartburn at least 2 days per week over the past month.
2. Having heartburn that responds to heartburn medication.
3. Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion
in the study.
Exclusion Criteria:
1. Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by
a physician and confirmed by testing (endoscopy).
2. Be unwilling to take only the study medication, and antacid provided as a rescue
medication for relief of acute heartburn during the study.
Other protocol-defined inclusion or 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.
| Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn | NCT00390390 | Entailment |
3,256 | 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:
- Sexually active 18-40 year old heterosexual couple
- Subject willing to take Mircette birth control pills for at least one cycle (one pack)
- Willing to have intercourse at the defined times (at least weekly within a 3 week
interval, and draw blood within 10 hours of intercourse)
- IRB signed informed consent
Exclusion Criteria:
- Undiagnosed vaginal bleeding
- Contraindication to oral contraceptives
- Liver dysfunction or disease
- Known sensitivity to Crinone
- Known or suspected malignancy of the breast or genital organs
- History of or active thrombophlebitis or thromboembolic disorders
- Use of condoms during intercourse
- Male erectile or ejaculatory dysfunction
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Sexual Absorption of Vaginal Progesterone | NCT01959464 | Entailment |
792 | 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:
- Age 19-65
- Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at
least one of the following:
- Age > 50 years old
- Morning stiffness < 30 minutes
- Crepitus
- Meet at least 3 of 6 diagnostic criteria for osteoarthritis:
- Age > 50 years old
- Morning stiffness < 30 minutes
- Crepitus
- Bony tenderness
- Bony enlargement
- No palpable warmth
Exclusion Criteria:
- BMI > 30
- History of traumatic spine or lower extremity injury within the last 6 months
- Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
- Cardiac pacemaker
- Metal implants in head
- Current pregnancy
- Neurological disorders
- History of seizures
- Unable to give consent or understand the procedures of this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 65 Years | Corticospinal Excitability and Rehab in Knee Osteoarthritis | NCT02036866 | Entailment |
5,742 | 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:
- Of any gender, 18 years or older.
- With a diagnosis of oral lichen planus previously proven on biopsy.
- With at least one erosion at baseline (baseline IGA of 2 or greater).
- Signed written informed consent.
- Willingness and ability to comply with the study requirements.
- Negative blood pregnancy tests must be documented for all females of childbearing
potential prior to enrollment.
Exclusion Criteria:
- Who have received systemic immunosuppressants (e.g. corticosteroids), or oral
retinoids, or any other systemic therapies known or suspected to have an effect on
oral lichen planus within 4 weeks prior to participation in the study.
- Who have been treated with topical therapy (e.g., topical corticosteroids,
pimecrolimus, tacrolimus, or topical retinoids, etc) or any other topical therapies
known or suspected to have an effect on oral lichen planus within two weeks prior to
participation in the study.
- Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an
evidence of malignant disease.
- Who have systemic or generalized infections (bacterial, viral or fungal).
- Who have a clinically relevant liver disorder (transaminase enzymes >3 x ULN) or renal
disorder (serum creatinine > 10% above upper normal limit).
- Who have unstable or uncontrolled diabetes or hypertension.
- Who are currently receiving or are intended to be treated with any potent inhibitor of
the enzyme CYP450 3A4. Treatment with substrates or moderately potent inhibitors of
CYP450 3A4 is permitted during the study, under close monitoring for adverse events
during that period.
- Menstruating females of childbearing potential who are not using a medically accepted
method of contraception during the study. Medically approved contraception may, at the
discretion of the investigator, include abstinence.
- Women who are breastfeeding.
- Who had received an investigational drug within four weeks prior to the study or who
intended to use other investigational drugs during the course of this study.
- Who are hypersensitive to pimecrolimus or any of the components of the cream.
- Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study.
- Who have a history of substance abuse or any factor, which limits the subject's
ability to cooperate with the study procedures.
- Who are uncooperative, known to miss appointments (according to subjects' records) and
are unlikely to follow medical instructions or are not willing to attend regular
visits.
- History of Netherton's syndrome
- Patients with lymphadenopathy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Pimecrolimus Cream for Oral Lichen Planus | NCT00297037 | Contradiction |
1,183 | 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:
- Male or female, at least 18 years of age, inclusive
- Subject has a symptomatic malignant pleural effusion requiring intervention. For an
effusion to be defined as malignant, at least one of the following must be true
- There is cytological confirmation of pleural malignancy
- The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum
protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the
upper limit of normal) in the context of histocytologically proven malignancy
elsewhere, with no other clear cause for fluid identified
- Subject is able to provide informed consent
- Subject is willing and able to meet study requirements, including follow up visits
- Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled
pleural catheter as determined by the PI
- Subject is able to perform home drainage of the pleural effusion or has sufficient
resources (family member, caregiver, home health).
Exclusion Criteria:
- Patients who refuse to participate
- Are less than 18 years of age
- Are pregnant
- Are unable to provide informed consent
- Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural
infection
- Subjects with uncorrected coagulopathy
- All patients whom do not have malignant pleural effusions as outlined in the
"definitions" section
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.
| Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System | NCT03414905 | Entailment |
624 | 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:
Left ventricular ejection fraction <40% assessed by transthoracic echocardiography or
cardiac magnetic resonance with at least 3 months.
- Serum ferritin < 100µg/L or 100-299µg/L with transferrin saturation < 20%
- clinical stability during last 3 months
Exclusion Criteria:
- Use of intracardiac defibrillator or pacemaker.
- Severe to moderate valvar heart disease
- Clinical instability, acute coronary syndrome and cardiac surgery 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.
| Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure | NCT03871699 | Contradiction |
915 | 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. | No eligibility criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | HYPGENE-Genetics Fitness Obesity & Risk of Hypertension | NCT00083811 | Entailment |
2,135 | 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:
All participants who were allocated to the study all had a history of taking tolerable and
adequate dose of urate lowering therapy including febuxostat 40-80mg daily or allopurinol
200-300 mg daily for at least 4 weeks and were defined as difficult to treat or refractory
gout patients. All patients had a negative of rheumatoid factor and antinuclear antibody,
Hb>100g/L, total leukocyte count≥3.5×109, PLT≥80×109, serum creatinine<133umol/L,
transaminases<60U/L and fasting urate≥6.0mg/dL.
Inclusion criteria for the gouty patients were age≥18 years old, BMI(18-30kg/m2). All
participants enrolled in our study fulfilled American College of Rheumatology criteria for
primary gout.
Exclusion Criteria:
Exclusion criteria included secondary gout (because it is always associated with some
underlying renal disease), a history of congestive heart failure, serum
creatinine≥133umol/L (because the patients have underlying risks if NSAID needed) or the
use of glucocorticoid>15mg daily,colchicine, uricosuric drugs, chemotherapy or
immunosuppressive therapy in the past three months.
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 | Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels | NCT02060552 | Contradiction |
2,579 | 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:
- Bilateral congenital inguinal hernia Unilateral congenital inguinal hernia Hernia
defect siameter less than 1.5 mm
Exclusion Criteria:
- Recurrent hernia age less than 6 Month Contraindication to laparoscopy
Female
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 10 Years | Needlescopic Inversion and Snaring of Hernia in Girls | NCT04628455 | Contradiction |
5,413 | 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 aged 18-50.
- Heavy menstrual bleeding, defined as self-report of bothersome periods with
subjectively heavy flow or frequency greater than 7 bleeding days per month.
- Anemia with hgb <11.5 g/dL
Exclusion Criteria:
- Suspected/confirmed malignancy
- Severe anemia currently requiring transfusion or emergent operative intervention
- Allergy or contraindication to either study drug
- Known iron overload
- Known sickle cell disease
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding | NCT04205266 | Entailment |
3,215 | 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:
Clinical Diagnosis of pSS healthy females who presented to the gynecology outpatient clinic
for reasons other than sexual dysfunction -
Exclusion Criteria:
Pregnancy hepatic, renal, interstitial lung, gynecological oncological diseases,
psychiatric disorders communication impairment
-
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions | NCT04816370 | Entailment |
4,001 | 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:
- Adult > or = 55 years.
- Being monitored by a rheumatologist in private practice or in a hospital.
- Presenting nociceptive pain:
- chronic (for at least 3 months),
- secondary to knee osteoarthritis confirmed by x-ray: stage 2 and over according
to Kellgren and Lawrence.
- Of moderate to severe intensity equal to or above 4 on a numerical scale of 0-10.
- In a situation of analgesic therapy failure for level 1 analgesics:
- paracetamol and NSAIDS,
- Prescribed at therapeutic dose : 4 g/d of paracetamol and 1200 mg/d of ibuprofen
or equivalent (analgesic dose),
- For at least 2 weeks,
- Requiring a level 2 prescription.
- Affiliated to social security insurance.
- Informed of the concept and agreeing to use the TENS as a non-medicinal analgesic
treatment.
- Capable of understanding how to use the TENS and the level 2 analgesic treatments.
- Intellectually and physically able to participate in the study in the opinion of the
investigator.
- Owns a Smartphone to be able to download the actiTENS application.
Exclusion Criteria:
- Current or previous allergy to the actiTENS electrodes.
- On-going or planned pregnancy and absence of effective contraception (except for
menopausal women).
- Neuropathic pain with a DN4 result > 4/10 or with a positive response to one or more
questions in the DN4 clinical examination.
- Osteoarthritis flare.
- Surgery planned in the following 6 months.
- History of multiple operations on the knee concerned.
- Medicinal or non-medicinal treatments which could influence the pathology being
studied.
- Modification of medicinal or non-medicinal treatments planned in the following 6
months.
- Current participation in another study.
- Presence of another painful condition which could perturb the evaluation.
- Patient with an absolute contraindication to TENS or level 2 systemic analgesic
treatments recommended for the treatment of chronic pain of moderate or severe
intensity.
- Patient unable to express his/her consent or deprived of liberty.
- Patient with cognitive disorder or behaviour rendering him/her unsuitable to follow
the instructions for this study.
- Patient not affiliated to a social security system.
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 55 Years | Comparison of the Efficacy, Tolerability and Safety of actiTENS to Those of Level 2 Analgesic Treatments. | NCT03902340 | Entailment |
3,812 | 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. Willing and able to give full consent;
2. According with classification of "Clinical Image" of 1986 American college of
rheumatology criteria in osteoarthritis of the knee ;
3. Grade II-III of Kellgren-Lawrence (KL) grading system, revealing synovial inflammation
or synovial fluid by combining ultrasound and/or MRI
4. Knee pain for at least 1 Month and Pain VAS Score>4 during the last week;
5. Fertile women agreed to adopt effective contraceptive measures during the test.
Exclusion Criteria:
1. Allergic to pharmaceutical ingredients;
2. Received Tumor Necrosis Factor inhibitor (TNFI) or other biologics preparation within
3 months;
3. Received physical therapy or articular injection, taking antidepressants or
antispasmodic, opioids within 3 months ;
4. Patients with history of knee surgery or upcoming surgery within 10 years;
5. Patients accompanied by other complications or joint disease (such as septic
arthritis, osteonecrosis,haemochromatosis, ochronosis, etc.);
6. Patients with serious joint deformation or joint deformities;
7. Patients with active or a history of recurrent infections;
8. Patients existing active tuberculosis (TB) or has a history of active TB;
9. Patients with positive on hepatitis b surface antigen or hepatitis c antibody;
10. Patients with a history of severe lung disease, tumor;
11. Patients with severely abnormal function on liver and kidney (liver enzyme > = 2 times
normal, creatinine > = normal);
12. Patients with pregnancy, ready for pregnancy or lactation;
13. Patients with other conditions which not suitable for use of Etanercept.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Efficacy of Intra-Articular Injection of Etanercept for Moderate and Severe Knee Osteoarthritis | NCT02722772 | Entailment |
4,187 | 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:
- Men with azoospermia (Group 1) and proven fertile men undergoing vasectomy (Group 2)
Exclusion Criteria:
- Men with testicular abnormalities (Group 2)
- Men who do not understand the purpose and possible consequences of the study (both
groups)
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| HPV as a Possible Cause of Azoospermia | NCT02329275 | Contradiction |
5,801 | 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:
- Healthy adults
- Age: 18-65 years
- Dutch-speaking
- Caucasian
Exclusion Criteria:
- Pregnancy or lactating
- Using ointment, crème, or gels based on corticoids
- Suffering from skin diseases (psoriasis, burning wounds)
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 | Echographic Measurement of Skin Thickness | NCT02363465 | Entailment |
6,983 | 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: Cohort 1: Older adults with memory impairment: must have a physician or
primary caregiver report of memory loss and must be between 50 and 100 years old.
cohort 2: Older adults who test normally on neuropsychologic testing and have no history of
neurologic disorders.
Exclusion Criteria: Lack of reported memory loss by physician or primary caregiver who does
not meet 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 50 Years old.
Subject must be at most 100 Years | Diagnosis of Alzheimer's Disease Using Event Related Potentials | NCT02957227 | Entailment |
4,832 | 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:Children aged 4-16 years. Healthy population from selected kindergarten
and Schools, and patients refered to the obesity clinic Haukeland University Hospital, for
examination and optionally treatment.
-
Exclusion Criteria:Use of any kind of steroids ( oral, liniments, inhalations etc)
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 16 Years | Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children. | NCT02646553 | Contradiction |
3,346 | 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:
- Singleton uncomplicated pregnancy
- Reside in Darwin, the Tiwi Islands, or other remote community where consent has been
obtained
- Intends to deliver child at the Royal Darwin Hospital or other designated hospital
where consent has been obtained
- Has given informed consent to participate
Exclusion Criteria:
- Had 23vPPV within the previous three years
- Had a previous dose of dTpa
- Intends to leave the study area during the follow-up period
- HIV positive
- History of severe allergy, uncontrolled asthma or splenectomy
Female
Accepts Healthy Volunteers
Subject must be at least 17 Years old.
Subject must be at most 39 Years | PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers | NCT00714064 | Contradiction |
5,557 | 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:
- Female
- Bone age <12 years
- Karyotype: 45, X; 45, X / 46, XXqi; 45, X / 46, XXr; 45, X / 46, XX; 46, XXqi; 46,
XXpi; 45, X / 47, XXX; 46, XXp-; 45, X / 46, XXp-; 46, XXq-; 45X / 46, XXq-; 45, X /
46, XX / 47, XXX, etc. (count 50 or more cells);
- Facial appearance and abnormalities: Patients with at least one of the following
signs, which include but are not limited to facial pigmented nevus, short neck, webbed
neck, low posterior hairline, low-set ears, micrognathia, high-voulted arch,
shield-like chest, cubitus valgus, genu valgum, short 4th and 5th metacarpals, nail
dysplasia, scoliosis, ptosis and strabismus, cardiovascular abnormalities (such as
aortic stenosis, bicuspid aortic valve and hypertension), reproductive abnormalities
(such as primary gonadal dysfunction), renal abnormalities, thyroid hypofunction,
middle ear lesion, etc.
- Short stature: height below -2.5SD of the mean height of the same age and gender.
- Pre-pubertal (Tanner Stage I ) patients
- No history of growth hormone treatment
- The subject and his/her guardian sign the informed consent (if the subject is
incapable to sign the informed consent, his/her legal guardian shall sign the name of
the subject instead)
Exclusion Criteria:
- Subjects with abnormal liver and kidney functions (ALT > upper limit of normal value;
Cr > upper limit of normal value)
- Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
- Subjects with highly allergic constitution or allergy to proteins or investigational
product or its excipient
- Subjects with systemic chronic disease and immune deficiency
- Patients diagnosed with tumor
- For patients whose tumor markers exceeding normal range in combination with other
information, considering as potential high risks of tumor, they may be excluded from
the treatment.
- Patients with mental disease
- Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose
(IFG) and/or impaired glucose tolerance (IGT) ) or diabetes
- Subjects who took part in other clinical trials within 3 months
- Subjects who received medicines which may interfere GH secretion or GH function, or
other hormones within 3 months (such as sex steroids, glucocorticoids, etc.)
- Other conditions which are unsuitable for this study in the opinion of the
investigator.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 18 Years | A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome | NCT03189160 | Contradiction |
2,923 | 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:
- A diagnosis of familial or sporadic ALS (defined as meeting the possible,
laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
according to the World Federation of Neurology El Escorial criteria) ≤ 24 months prior
to screening
- Upright SVC ≥ 70 % of predicted for age, height and sex
- Able to swallow tablets without crushing, and in the opinion of the Investigator, is
expected to continue to be able to do so during the trial
- A caregiver if one is needed
- Clinical laboratory findings within the normal range or, if outside the normal range,
deemed not clinically significant by the Investigator
- Male patients must agree for the duration of the study and 10 weeks after the end of
the study to use a condom during sexual intercourse with female partners who are of
childbearing potential (i.e., following menarche until post-menopausal if not
anatomically and physiologically incapable of becoming pregnant) and to have female
partners use an additional effective means of contraception (e.g., diaphragm plus
spermicide, or oral contraceptives) or the male patient must agree to abstain from
sexual intercourse during and for 10 weeks after the end of the study, unless the male
patient has had a vasectomy and confirmed sperm count is zero
- Female patients must be post-menopausal (≥ 1 year) or sterilized, or, if of
childbearing potential, not be breastfeeding, have a negative pregnancy test, have no
intention to become pregnant during the course of the study, and use effective
contraceptive drugs or devices while requiring male partner to use a condom for the
duration of the study and for 10 weeks after the end of the study
- Patients must be either on a stable dose of riluzole 50 mg twice daily for at least 30
days prior to screening or have not taken riluzole for at least 30 days prior to
screening and are willing not to begin riluzole use until they complete study drug
dosing
Exclusion Criteria:
- At the time of screening, any use of non-invasive positive pressure ventilation
(NIPPV, e.g. continuous positive airway pressure [CPAP] or bi-level positive airway
pressure [BiPAP]) for any portion of the day, or mechanical ventilation via
tracheostomy, or on any form of oxygen supplementation
- Patients with a diaphragm pacing system (DPS) at study entry or who anticipate DPS
placement during the course of the study
- BMI of 20.0 kg/m2 or lower
- Unwilling or unable to discontinue tizanidine and theophylline-containing medications
during study participation
- Serum chloride outside the normal reference range
- Neurological impairment due to a condition other than ALS, including history of
transient ischemic attack within the past year
- Presence at screening of any medically significant cardiac, pulmonary, GI,
musculoskeletal, or psychiatric illness that might interfere with the patient's
ability to comply with study procedures or that might confound the interpretation of
clinical safety or efficacy data, including, but not limited to:
1. Poorly controlled hypertension
2. NYHA Class II or greater congestive heart failure
3. Chronic obstructive pulmonary disease or asthma requiring daily use
bronchodilator medications
4. GI disorder that might impair absorption of study drug
5. History of significant liver disease defined by bilirubin > 2 times the upper
limit of normal (ULN) or ALT or AST > 3 times the ULN on repeat testing
6. Poorly controlled diabetes mellitus
7. History of vertigo within three months of study entry
8. History of syncope without an explainable or treated cause
9. History of untreated intracranial aneurysm or poorly controlled seizure disorder
10. Amputation of a limb
11. Cognitive impairment, related to ALS or otherwise, sufficient to impair the
patient's ability to give informed consent and to understand and/or comply with
study procedures
12. Cancer with metastatic potential (other than basal cell carcinoma, carcinoma in
situ of the cervix, or squamous cell carcinoma of the skin excised with clean
margins) diagnosed and treated within the last two years
13. Any other condition, impairment or social circumstance that, in the opinion of
the Investigator, would render the patient not suitable to participate in the
study
14. Patient judged to be actively suicidal or a suicide risk by the Investigator
- Has taken any investigational study drug within 30 days or five half-lives of the
prior agent, whichever is greater, prior to dosing
- Prior participation in any form of stem cell therapy for the treatment of ALS
- Previously received tirasemtiv in any previous clinical trial
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.
| Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year | NCT02496767 | Entailment |
4,813 | 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:
- Age: 18≤ years ≤85
- Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder.
- Stable symptoms for more than one month and less than a year.
- Ability to perform all tests (including computerized test) and interviews.
- Gave informed consent for participation in the study.
Exclusion Criteria:
- Dizziness disease with fluctuating symptoms such as in active Meniere's disease or
Benign Paroxysmal Positional Vertigo
- CNS disease or injuries
- Dizziness caused as a result of previous whiplash
- Any active or non-controlled disease that might cause dizziness (e.g. non-controlled
diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological
disorder etc.)
- Pregnant women
- Participation currently in another clinical study or enrolled in another clinical
study within 30 days prior to this 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.
Subject must be at most 85 Years | Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness | NCT01460121 | Entailment |
4,148 | 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:
- age > 40 years; smoking history of 30 pack-years or more; normal organ function;
sputum atypia
Exclusion Criteria:
- general debility that would prevent completion of 6 month follow-up; existing cancer
diagnosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide) | NCT00175747 | Contradiction |
5,595 | 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. | Patients with extreme short stature will qualify for inclusion under this protocol if they
meet the following criteria:
Age 9 through 15.99 years at the start of treatment.
Tanner II-V pubertal development.
Height at least 2.25 S.D. below the median for chronologic age at the time of pubertal
onset, or a predicted adult height at least 2.25 S.D. below median adult height.
The height criterion must be met before study entry, but not necessarily on the actual date
the patient starts to take the protocol injections because advancing puberty may cause an
increase in height velocity that temporarily increases height standard deviation score.
Unfused carpal and phalangeal epiphyses by bone age x-ray.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients With Extreme Short Stature | NCT00001190 | Contradiction |
2,543 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | - INCLUSION CRITERIA:
Males and females, age 3 months to 19 years old, (less than 18 years old).
Individuals referred to the NIH with a diagnosis of asthma, rhinitis, anaphylaxis,
urticaria, atopic dermatitis, food allergy, stinging insect allergy or other
allergic/inflammatory diseases.
Subjects must maintain a primary physician for protocol related and non-related long-term
follow-up and for any emergency medical treatment required.
INCLUSION CRITERIA FOR PARENTS:
Must be biological Parent
Must have a child with a diagnosis of allergic disease
EXCLUSION CRITERIA:
Inability to provide informed consent or assent. In the case of minors, unavailability of a
parent or guardian.
EXCLUSION CRITERIA FOR PARENTS:
Non-biological parent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 19 Years | Clinical and Immunological Evaluation of Children With Allergies | NCT00102570 | Entailment |
4,077 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Male and female subjects 18 to 65 years of age included.
- Confirmed diagnosis of SWD according to ICSD-3 criteria at Screening.
- Subjects who are at least moderately ill with respect to sleepiness on work nights,
including commute to and from work, as assessed by the Clinical Global
Impression-Severity scale (CGI-S, score ≥4) at Screening.
- Subjects must work 5 or more night shifts per month, and 2 or more shifts must occur
on consecutive nights, with 6 or more hours worked between 10 pm and 8 am, as
confirmed by subject at Screening.
- Subjects must have mean sleep latency ≤8 minutes on nighttime MSLT at Screening.
- Subjects must weigh at least 50 kg at Screening to participate in the study, and must
have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg)
/ [Height (m)]2
Exclusion Criteria:
- Women of child-bearing potential (defined as all women physiologically capable of
becoming pregnant) unless they are using highly effective methods of contraception
from start of taking the study medication in the first period until stopping the
medication in the second treatment period and for 3 additional days after AND an
additional barrier method of contraception will be used while taking the study
medication and for 3 additional days in both treatment periods.
- Sexually active males unwilling to use a condom during intercourse while taking
investigational drug and for 3 days after stopping investigational drug. A condom is
required for all sexually active male participants to prevent them from fathering a
child AND to prevent delivery of the investigational drug via seminal fluid to their
partner.
- Heavy smokers who smoke more than 10 cigarettes a day and occasional or light smokers
(not more than 10 cigarettes per day) who are not willing to, or in their own or the
investigators opinion are not able to refrain from tobacco/nicotine use for at least
12 hours without nicotine craving or other withdrawal symptoms
- Subjects for whom it is not safe to discontinue or who are unwilling to discontinue
use of modafinil, hypnotics, and antihistamines for the periods specified in the
prohibited medication section.
- Heavy caffeine consumers, i.e. subjects who consume greater than 850 mg of caffeine
per day (approximate equivalent of three tall cups of Starbucks coffee) in coffee,
tea, or other caffeine-containing drinks.
- Subjects who have high risk of obstructive sleep apnea, indicated by score of 5 or
more on the STOP-BANG questionnaire.
- Presence of any sleep disorder other than SWD, as confirmed by PSG at 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 65 Years | A Study to Assess the Wakefulness Promoting Effect, Safety, Tolerability, and Pharmacokinetics (PK) of LML134 in Shift Work Disorder | NCT03141086 | Contradiction |
5,647 | 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:
- Have a chronological age > 4.0 years and < 8.0 years for girls and < 10.0 years for
boys.
- Have a minimum body weight of 17 kg at the time of screening.
- Have a bone age examination at screening or within the 6 months prior to screening
that, in the interpretation of the PI, is delayed with respect to chronological age.
- Have a HT-SDS < -2.0
- Have a maximal GH response < 10 ng/mL from at least one prior GH stimulation test
within the past 6 months
- Have prepubertal status as evidenced by Tanner Stage I breast development in girls and
testicular volume < 4.0 mL in boys.
- Have height minus arm span difference < 4.5 cm.
- In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic
testing results are available, they need to be negative.
- Have normal thyroid function. Subjects diagnosed with hypothyroidism must have
documented successful treatment for at least 30 days prior to the Baseline visit.
Exclusion Criteria:
- Any medical or genetic condition which, in the opinion of the PI or Medical Monitor
(MM), can be an independent cause of short stature and/or limit the response to
exogenous growth factor treatment (e.g., diabetes).
- A medical or genetic condition that, in the opinion of the PI and/or MM, adds
unwarranted risk to use of LUM-201 (e.g., scoliosis).
- Use of any medication that, in the opinion of the PI and/or MM, can independently
cause short stature or limit the response to exogenous growth factors (e.g.,
glucocorticoids).
- Evidence or history of an intracranial mass (e.g., pituitary tumor,
craniopharyngioma).
- Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH
secretagogues. (These may be used for limited times as a diagnostic test.)
- Suspicion of absence of pituitary function as evidenced by a maximal stimulated GH ≤ 3
ng/mL or pituitary hormone deficiencies beyond GH and thyroid function.
- Gestational age-adjusted birth weight < 5th percentile (small for gestational age).
- At birth, gestational age < 36.0 weeks.
- Participation in any trial of investigational drug(s) within the prior 6 months.
- History of spinal or total body irradiation.
- A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and/or use of
medication to treat ADHD.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 9 Years | PK and PD Study of LUM-201 in Children With Growth Hormone Deficiency | NCT04806854 | Contradiction |
6,524 | 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:
- Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain
Exclusion Criteria:
- None
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.
| Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia | NCT00972296 | Contradiction |
6,085 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
Anyone 6 months to 89 years old who:
1. has Down syndrome (any type)
2. does not have Down syndrome
Exclusion Criteria:
1. Prisoners
2. Wards of the state
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
Subject must be at most 89 Years | The Crnic Institute Human Trisome Project Biobank | NCT02864108 | Contradiction |
1,920 | 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, resectable adenocarcinoma of the gastroesophageal junction
(AEG/GEJ-type II-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+
M0 patient, with the following specifications:
1. Medical and technical operability, according to the techniques described in
Chapter 12 Surgical Therapy that are subtotal, total or transhiatal extended
gastrectomy (patients planned to receive transthoracic esophagectomy are not
eligible for the study)
2. Participating sites in PETRARCA study: Negative HER-2 detection (score IHC HER-2
0 or IHC HER-2 1+ ); IHC HER-2 2+ and negative by FISH, SISH or CISH1
2. No preceding cytotoxic or targeted therapy
3. No prior partial or complete tumor resection
4. Female and male patients ≥ 18 and ≤ 70 years. Patients in reproductive age must be
willing to use adequate contraception during the study and for 7 months after the end
of ramucirumab treatment (Appropriate contraception is defined as surgical
sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception
(implantable, patch, oral), and double-barrier methods (any double combination of:
IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)).
Female patients with childbearing potential need to have a negative pregnancy test
within 7 days before study start.
5. ECOG ≤ 1
6. Exclusion of distant metastasis by CT or MRI of abdomen, pelvis, and thorax, bone scan
or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the
infiltration of any adjacent organs or structures by CT or MRI.
7. Laparoscopic exclusion of peritoneal carcinomatosis, in case of ascites, peritoneal
masses, or if otherwise suspected clinically
8. Adequate hematological, hepatic and renal function parameters:
1. Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL,
hemoglobin ≥9 g/dL (5.58 mmol/L),
2. Adequate coagulation function as defined by International Normalized Ratio (INR)
≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless
receiving anticoagulation therapy). Patients receiving warfarin/phenprocoumon
must be switched to low molecular weight heparin and have achieved stable
coagulation profile prior to randomization.
3. Serum creatinine ≤ 1.5 x upper limit of normal
4. Urinary protein ≤1+ on dipstick or routine urinalysis (UA; if urine dipstick or
routine analysis is ≥2+, a 24-hour urine collection for protein must demonstrate
<1000 mg of protein in 24 hours to allow participation in this protocol).
5. Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of
normal, alkaline phosphatase ≤ 6 x upper limit of normal
9. Patient able and willing to provide written informed consent and to comply with the
study protocol and with the planned surgical procedures
Exclusion Criteria:
1. Known hypersensitivity against ramucirumab, 5-FU, leucovorin, oxaliplatin, or
docetaxel
2. Other known contraindications against ramucirumab, 5-FU, leucovorin, oxaliplatin, or
docetaxel
3. Patients with esophageal cancer and those with adenocarcinoma of GEJ type I and all
patients who are planned to have transthoracic esophagectomy.
4. Clinically significant active coronary heart disease, cardiomyopathy or congestive
heart failure, peripheral artery occlusive disease (PAOD, German pAVK), or any history
of aortic aneurysm
5. Any arterial thromboembolic events, including but not limited to myocardial
infarction, transient ischemic attack, cerebrovascular accident, or unstable angina.
6. Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg
diastolic for >4 weeks) despite standard medical management.
7. Clinically significant valvular defect
8. Past or current history of other malignancies not curatively treated and without
evidence of disease for more than 5 years, except for curatively treated basal cell
carcinoma of the skin and in situ carcinoma of the cervix
9. Criteria of unresectability, e.g.:
- Radiologically documented evidence of major blood vessel invasion or encasement
by cancer.
- Patients with involved retroperitoneal (e.g. para-aortal, paracaval or
interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!)
10. Known brain metastases
11. Other severe internal disease or acute infection
12. Peripheral polyneuropathy ≥ NCI Grade II
13. Chronic inflammatory bowel disease
14. Grade 3-4 GI bleeding within 3 months prior to enrollment.
15. History of gastric perforation or fistulae in past 6 months
16. Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to
enrollment.
17. The patient has undergone major surgery within 28 days prior to enrollment except
staging laparoscopy.
18. Receiving chronic antiplatelet therapy, including aspirin (Once-daily aspirin use
(maximum dose 325 mg/day) is permitted), nonsteroidal anti-inflammatory drugs
(including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar
agents.
19. History of deep vein thrombosis, pulmonary embolism, or any other significant
thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis
are not considered "significant") during the 3 months prior to randomization.
20. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a
history of hepatic encephalopathy or ascites.
21. On-treatment participation in another clinical study in the period 30 days prior to
inclusion and during the study
22. Subject pregnant or breast feeding, or planning to become pregnant within 7 months
after the end of treatment.
23. Patients in a closed institution according to an authority or court decision (AMG §
40, Abs. 1 No. 4)
24. Any other concurrent antineoplastic treatment including irradiation
25. Current chronic alcohol, nicotine or drug abuse or history of chronic alcohol abuse
during last 12 months. Nicotine abuse is defined as ≥ 25 pack-years (Willigendael et
al., 2004).
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 | FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES) | NCT02661971 | Entailment |
6,096 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Down syndrome with psychological test results
Exclusion Criteria:
- Comorbidity of severe Autism or visual/auditory impairment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 40 Years | Trends in Intellectual Development in Down Syndrome | NCT00954382 | Entailment |
3,104 | 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:
Ocular foreign body sensation, burning or stinging, complaints more pronounced in winter,
windy conditions, during computer work, being bilateral, of the duration longer than three
months, visual acuity fluctuations depending on blinking after longer reading or computer
work, and tearing in cold weather, in the morning, after longer reading or computer work.
Patients were also asked whether the symptoms were more pronounced in the morning or
evening. The main enrollment criterion was the score of the above listed symptoms 15 or
higher.
Exclusion Criteria:
Pregnant women, children, chronic eye patients on continuous topical therapy during
previous month (i.e.glaucoma) and patients suffering from any acute eye disease and
therefore on topical or systemic therapy in the previous month were excluded from 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.
| The Effect of Ocular Lubricant Eyedrops on Lid Parallel Conjunctival Folds and Other Signs and Symptoms of Dry Eye | NCT01268735 | Contradiction |
2,088 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
1. Clinical symptoms consistent with idiopathic pulmonary fibrosis (IPF) of > 3 months
duration (insidious onset of otherwise unexplained dyspnea on exertion and bibasilar
inspiratory crackles)
2. Age 20 through 79, inclusive. Patients ages 20-34 must have diagnosis by either open
or video-assisted thoracoscopic (VATS) lung biopsy to be eligible.
3. Diagnosis must be made by high-resolution (HRCT) chest CT showing definite or probable
IPF AND within 30 months prior to screening either of the following):
- Open or VATS lung biopsy showing definite or probable usual interstitial
pneumonia (UIP), required for subjects ages 20-34 due to the rarity of IPF in
this age group OR
- Non-diagnostic transbronchial biopsy to exclude other conditions (including
granulomatous disease, sarcoidosis, hypersensitivity pneumonitis) AND
- abnormal pulmonary function tests (reduced FVC or decreased DLCO or impaired gas
exchange at rest or during exercise)
AND 2 of the following:
1. Age > 50 years
2. Insidious onset of otherwise unexplained dyspnea on exertion
3. Bibasilar, inspiratory crackles (dry or Velcro type in character)
4. Currently on low dose (< 0.3 mg/kg LBW) prednisone plus azathioprine or
cyclophosphamide per ATS Consensus for at least 28 days prior to study treatment and
intending to continue the same therapy until the end of study treatment. This therapy
may be preceded by a course of higher-dose prednisone at the discretion of the
treating physician.
5. FVC > 40% and < 90% of predicted (Hankinson/NHANES2) value at screening.
6. DLCO > 20% of predicted (Neas/NHANES3) value at screening.
7. PaO2 > 50 mmHg at rest after 20 minutes on room air at baseline.
8. Able to understand and sign a written informed consent form and comply with the
requirements of the study.
Exclusion criteria
Patients with any of the following will be excluded from the study:
1. History of clinically significant environmental exposure known to cause pulmonary
fibrosis (drugs, asbestos, beryllium, radiation, domestic birds, etc).
2. Known explanation for interstitial lung disease, other than IPF, including but not
limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis
obliterans organizing pneumonia (BOOP), and cancer.
3. Diagnosis of any connective tissue disease (scleroderma, SLE, rheumatoid arthritis,
etc.) according to the American College of Rheumatology criteria. Antinuclear antibody
(UCLA test # 0737, $39) ≥1:160, rheumatoid factor (UCLA test #0881, $29) >25, Scl-70
positive (UCLA test #1977, $12), anticentromere antibodies positive (UCLA test #16232,
$15) at baseline. These lab tests are considered minimum standard of care. Additional
criteria, if evaluated (preferred standard of care) ENA (SM & RNP) (UCLA test number
16393, $36) positive and double strand DNA (UCLA test number 0797, $67) positive.
4. Any condition other than IPF, which in the opinion of the investigator, is likely to
result in the death of the patient within the next year.
5. Evidence of active infection including bronchitis, sinusitis, UTI, cellulitis within 1
week prior to treatment.
6. History of unstable or deteriorating cardiac or neurologic disease, including but not
limited to:
1. Myocardial infarction, coronary artery bypass surgery or angioplasty within the
past 6 months
2. Congestive heart failure requiring hospitalization within the past 6 months
3. Uncontrolled arrhythmia
4. Stroke or TIAs within 18 months
7. Pregnant or lactating females. Females of child bearing potential are required to have
a negative serum or urine pregnancy test prior to enrollment and agree to practice
abstinence or prevent pregnancy by a medically acceptable method of birth control
(e.g. barrier methods, IUD, Norplant, Provera injection or oral birth control pills).
8. Liver function above specific limits. Total bilirubin > 1.5 X ULN, transaminases (AST,
SGOT) or (ALT, SGPT) > 3 ULN, alkaline phosphatase > 3 ULN.
9. Hematology outside of specified limits, WBC <2,500/mm3, hematocrit <30 or >59,
platelets <100,000/mm3 at screening.
10. TSH outside the normal range (with or without thyroid supplementation at a stable dose
for 3 months).
11. Investigational therapy for any indication within 28 days prior to treatment.
12. Investigational or clinical therapy including tetracycline (or derivatives),
cyclosporin, methotrexate, chlorambucil, colchicine, d-penicillamine, pirfenidone,
interferon-beta or interferon-gamma or other drugs (other than corticosteroids and
azathioprine or cyclophosphamide) potentially affecting IPF within 6 months prior to
treatment
13. Lung transplantation
14. Patients who would not be able to comply with the requirements for the trial.
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 79 Years | Minocycline Therapy for Lung Scarring in Patients With Idiopathic Pulmonary Fibrosis - a Pilot Study | NCT00203697 | Entailment |
675 | 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:
- Age over 18
- Signed written informed consent
- Ferritin ≥ 450 µg/L and ≤ 1500 µg/L
- Hepatic iron overload proved by MRI or histological biochemical measurement (Iron
hepatic concentration ≥ 50 μmol/g)
- At least one of the following criteria :
- Body mass index > 25 kg/m²
- Systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90 mmHg or
antihypertensive treatment
- Abdominal obesity (waist measurement ≥ 94 cm for men and ≥ 80 cm for women)
- Fasting triglyceridemia ≥ 1.7 mmol/L or triglyceride-lowering treatment
- Fasting HDL cholesterol < 1.03 mmol/L for men and < 1.29 mmol/L for women or HDL
cholesterol-elevating treatment
- Fasting blood glycemia ≥ 5.6 mmol/L
Exclusion Criteria:
- Subjects deprived of their liberty by judicial or administrative decision
- Pregnant women
- Other causes of increased serum ferritin levels:
- Inflammatory syndrome (CRP >10 mg/L) or inflammatory, immune or malignant
diseases
- Hyper-hemolysis
- Alcohol consumption more than 210 g for men and 140 g for women per week within
the year before inclusion
- Haemochromatosis established by the C282Y homozygous genotype
- Chronic hepatic cytolysis due to : viral infection (HBV, HCV), alcohol,
hyperthyroid disease, celiac disease, drug or immune hepatitis
- Increased serum ferritin levels - cataract syndrome (familial cataract or
personal history of cataract before 50 years of age)
- Low ceruloplasmin level
- Porphyria (cutaneous signs)
- Contraindication of phlebotomy
- Haemoglobin <13 g/dL for men and <12g/dL for women (threshold established by the
French Blood Agency)
- Congestive heart failure or coronary heart disease
- Hepatic failure (TP<60%), renal failure (GFR <50mL/min) or respiratory
insufficiency (chronic dyspnea)
- Poor venous system
- Fasting blood glycemia > 7 mmol/L or type 1 or type 2 diabetes, treated or not
- Use of drugs known to have anti-steatotic effects : metformin, thiazolidinedione
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.
| Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis | NCT01045525 | Contradiction |
1,392 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs
disease may be diagnosed or ruled out
Exclusion Criteria:
None
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 18 Years | Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease | NCT02342457 | Entailment |
6,719 | 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:
- 5-17 years of age, has a diagnosis of Hemophilia A or B.
Exclusion Criteria:
- Muscle or joint bleed within 4 weeks of study.
- Pre-existing co-morbidities that would affect physical activity participation.
- Unable to cooperate with study protocol.
- Unable to speak, read, or understand English.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 17 Years | An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia | NCT02199717 | Contradiction |
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