id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
1,255 | 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:
- Malignant pleural effusion diagnosed by pleural fluid cytology and / or pleural
biopsy;
- Recurrent pleural effusion (new accumulation of fluid after puncture) and symptoms
(dyspnea and / or chest pain);
- Complete lung expansion (> 90%) after puncture emptying confirmed by chest
radiography;
- Karnofsky index (KPS - Karnofsky Performance Status) > 30;
- Agreed to participate in the study and sign an informed consent.
Exclusion Criteria:
- Thrombocytopenia or coagulation disorders (prothrombin activity <50% and platelet
count <80,000 mm3);
- Endobronchial obstruction by the neoplasm;
- Major pulmonary fibrosis or lymphangitis carcinomatosis ipsilateral to the effusion;
- Volume drained <800 mL;
- No contact between the pleural surfaces after draining;
- Pleural or active systemic infection;
- Massive neoplastic infiltration of the skin;
- Inability to understand the quality of life questionnaire;
- Age less than 18 years;
- Previous pleural procedures (except punctures and needle biopsies).
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.
| Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion | NCT01819363 | Entailment |
6,591 | 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:
Each patient must meet the following criteria to be enrolled in this study:
1. be male with a diagnosis of congenital hemophilia A or B of any severity
2. have one of the following:
1. a positive inhibitor test Bethesda Unit (BU) ≥5 (as confirmed at screening by the
institutional lab), OR
2. a BU <5 but expected to have a high anamnestic response to FVIII or FIX, as
demonstrated from the patient's medical history, precluding the use of FVIII or
FIX products to treat or prevent bleeding, OR
3. a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as
demonstrated from the patient's medical history, precluding the use of FVIII or
FIX products to treat or prevent bleeding episodes
3. be ≥6 months to ≤75 years of age; different age restrictions may apply per local
regulation and ethical considerations (enrollment of children <12 years of age will
not begin until after review of data from the PERSEPT 2 study by the DMC)
4. be scheduled for an elective surgical or other invasive procedure
5. be capable of understanding and willing to comply with the conditions of the protocol
OR in the case of a patient <18 years of age, parent(s)/legal guardian(s) must be
capable of understanding and willing to comply with the conditions of the protocol
6. have read, understood, and provided written Informed Consent (patient and/or
parent(s)/legal guardian(s) if the patient is <18 years of age) or Assent, if
applicable
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study:
1. have any coagulation disorder other than hemophilia A or B
2. be immunosuppressed (ie, the patient should not be receiving systemic
immunosuppressive medication; cluster of differentiation 4 (CD4) counts at screening
should be >200/µL)
3. known intolerance to LR769 or any of its excipients
4. currently receiving immune tolerance induction (ITI) therapy
5. have a known allergy or hypersensitivity to rabbits
6. have a platelet count<100,000/µL
7. have received an investigational drug within 30 days of the planned first LR769
administration , or is expected to receive such drug during participation in this
study (with the exception of patients who are or were participating in another LR769
study, eg, a study assessing the treatment of bleeding episodes with LR769)
8. have a clinically relevant hepatic (aspartate aminotransferase (AST) and/or alanine
aminotransferase (ALT) >3 times the upper limit of normal (ULN)) and/or renal
impairment (creatinine >2 times the ULN)
9. have a history of arterial and/or venous thromboembolic events (such as myocardial
infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis (DVT)
or pulmonary embolism (PE)) within 2 years prior to the planned first dose of LR769,
uncontrolled arrhythmia, or current New York Heart Association (NYHA) functional
classification score of stages II - IV
10. have an active malignancy (those with non-melanoma skin cancer are allowed)
11. have any life-threatening disease or other disease or condition which, according to
the investigator's judgment, could imply a potential hazard to the patient, or
interfere with the trial participation or trial outcome (eg, a history of
non-responsiveness to bypassing products)
12. be using aspirin, NSAIDS, herbs, natural medications, or other drugs with platelet
inhibitory properties within one week prior to surgery and for the duration of
treatment with LR769
13. have active gastric or duodenal ulcer disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 75 Years | LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures | NCT02548143 | Contradiction |
2,810 | 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:
- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed within the 3 years
prior to participation as having possible, probable, or definite ALS, either sporadic
or familial according to modified El Escorial criteria
- Age 18-80, able to provide informed consent, and comply with study procedures
- Participants must not have started riluzole for at least 30 days, or be on a stable
dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants
are permitted in the study)
- Slow VC test equal to or greater than 50% of the predicted value
Exclusion Criteria:
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the participant to provide informed consent
- Exposure to any experimental agent within 30 days of entry or at any time during the
trial or enrollment in another research study within 30 days of or during this trial
- Women who are breastfeeding, who are pregnant or are planning to become pregnant
- Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of
normal
- Hepatic insufficiency or abnormal liver function (AST and/or ALT greater than 3 times
the upper limit of the normal range)
- Slow VC test less than 50% of the predicted value
- ECG finding of QTc prolongation > 450 ms
- Patients who had already undergone tracheostomy
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 | Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients | NCT03377309 | Contradiction |
4,494 | 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. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of
signing the informed consent
2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by
high-resolution MRI at screening
4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of
endometrium and presence of at least one ovary with no clinically significant
abnormalities at screening. Note that presence of uterine fibroids are not
exclusionary but presence of any submucosal fibroids or polyps are exclusionary
5. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for
contraception from the start of screening to the end-of-treatment. This is not
required if adequate contraception is achieved by vasectomy of the male sexual
partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as
ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse
with men requiring condom use)
6. Willing to avoid the use of vaginal douches or any other intravaginally administered
medications or devices (except for tampons) from randomisation to the end of treatment
Exclusion Criteria:
1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening
visit.
2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists
within 6 months prior to the screening visit.
3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase
inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or
levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the
screening visit.
4. Use of hormonal contraceptives (including combined oral contraceptive pill,
transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the
screening visit.
5. Contraindications to MRI such as having internal/external metallic devices and/or
accessories (e.g. cardiac pacemakers and leg braces)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis | NCT03749109 | Contradiction |
5,391 | 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:
- Two lowest VWF levels (VWF Antigen and/or VWF Ristocetin cofactor activity and/or VWF
Collagen Binding) >30 IU/dL <50 IU/dL.
Exclusion Criteria:
- Pregnant patients
- Hospitalised patients/acutely unwell patients
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.
| Low Von Willebrand in Ireland Cohort Study | NCT03167320 | Entailment |
2,370 | 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:
- Older than(including) 7 years old
- A definite diagnosis of DMD with muscle pathology confirming the expression of
dystrophin lower than 5% and/or confirmed mutations in the DMD gene using a clinical
accepted technique that completely defines the mutation.
- Using ACEI or ARB for more than 1 month
- Confirmed myocardial damage in one or more left ventricular segments evident by late
gadolinium enhancement and preserved left ventricular systolic function(>45%) by cine
cardiac MR in 45 days
- Normal renal function
- Holter and blood pressure shows no contraindication of using bisoprolol
Exclusion Criteria:
- Having metal implanted in body
- Having claustrophobia
- Allergic to gadolinium
- Complicated with other cardiovascular diseases
- Medical history or Holter show bradyarrhythmia like II/III degree atrioventricular
block, sick sinus syndrome etc.
- Systolic blood pressure lower than 90mmHg or rest heart rate lower than 75bpm
- Having COPD or asthma history
- Having other complications: tumor, endocrine diseases
- Having beta blockers therapy
- Planned operation in the future 12 months
- Allergic to bisoprolol
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| Bisoprolol in DMD Early Cardiomyopathy | NCT03779646 | Entailment |
3,867 | 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:
- Individuals of either sex, aged 40 years and more
- Subjects presenting primary OA of the knee according to ACR criteria with signs of
synovitis (warmth, swelling or effusion
- OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing
knee X-ray
- VAS of pain while walking ≥ 40 mm
Exclusion Criteria:
- Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated
allergic-type reactions to sulphonamides, experienced asthma, urticaria or
allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid
[ASA]), lactose or NSAIDs
- Active malignancy of any type or history of a malignancy within the last five years
other than basal cell carcinoma
- Increased risk for prostate cancer, with prostate cancer, or with a history of
prostate cancer within the last five years
- Subjects with other bone and articular diseases (antecedents and/or current signs)
such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee,
rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis,
acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative
spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease,
psoriasis, inflammatory bowel disease
- Isolated knee lateral compartment OA defined by joint space loss in the lateral
compartment only
- Class IV functional capacity using the American Rheumatism Association criteria
- Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower
limb joint within 180 days of the Baseline Visit
- History of heart attack or stroke, or experienced serious chest pain related to heart
disease, or who have had serious diseases of the heart such as congestive heart
failure
- High risk of CV events, according to the AHA assessment of CV risk tables
- History of recurrent UGI ulceration or active inflammatory bowel disease (e.g.,
Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other
condition, which in the investigator's opinion might preclude the chronic use of
CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids
daily as required
- Have been diagnosed as having or have been treated for oesophageal, gastric, pyloric
channel, or duodenal ulceration within 30 days prior to receiving the first dose of
study medication
- Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft
tissue injection at the exclusion of the target knee), indomethacin, tramadol,
codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the
12 weeks preceding inclusion
- Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding
inclusion
- Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and
analgesic gels (e.g. camphor and alcohol based gels) during one week preceding
baseline;
- Using Natural Health Products susceptible to increase the risk of bleeding (e.g.
garlic, dong quai, etc.) during one week preceding baseline;
- Receiving radioactive synovectomy (target knee) during the 12 weeks preceding
inclusion;
- Subjects who are receiving NSAID and do not want to stop during the study
- If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have
to be continued, unmodified, for the entire duration of the study
- Have used medications with MMP-inhibitory properties (e.g. tetracycline or
structurally related compounds) within 28 days prior to the Baseline Visit
- Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA
up to a maximum daily dose of 325 mg)
- Have received chondrocyte transplants in any lower extremity joint
- Use oral or topical COXIBs, calcitonin or immunosuppressive drugs
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.
| Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI | NCT01354145 | Entailment |
3,565 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- Diagnosis from GP confirming Lyme disease and/or
- Blood test confirming Lyme disease and/or
- Symptoms that correlate to Lyme disease without diagnosis from GP. This is called
"self diagnosis" and because 80% of the trial is focused on treating symptoms and not
the spirochetes, bacteria or small cysts of Lyme disease, the results are expected to
be largely the same
Exclusion Criteria:
- Persons currently undergoing antibiotic treatment for Lyme or other conditions
- Persons who were prescribed antibiotics but did not or could not take them
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
| PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics | NCT04577053 | Entailment |
955 | 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. Men or women of at least 18 years of age.
2. Osteoarthritis (OA) of knee or hip diagnosed since at least 6 months.
3. Affiliated with national welfare.
4. Reliable and willing to make themselves available for the duration of the study and
are willing to follow study procedures.
5. Have given written informed consent approved by the relevant Ethics Committee
governing the study sites.
6. Pain scores reported during the baseline period preceding randomization with a mean
APS on the last 14 reported values before Visit 2 between 3.6 and 8.4 inclusive and to
have completed at least 2/3 of each pain score in their diary between Visit 1 and
Visit 2.
7. Patient with a unilateral or bilateral OA of the knee or hip diagnosed according to
the American College of Rheumatology (ACR) criteria based on clinical and radiographic
evidence (Altman et al., 1986) (in case of bilateral OA or OA of both knee and hip,
the joint to consider should be the most affected one). The clinical diagnosis of OA
will be confirmed by the ACR clinical criteria and medical imaging criteria for
classification of OA of the knee or hip based upon the following criteria:
1. Knee or hip pain as an average at least half of the time for the last 3 months
before screening visit.
2. OA of the knee, at least 1 of the following 3 conditions:
i. age > 50, ii. morning stiffness <30 minutes, iii. crepitus on active motion and
osteophytes.
OA of the hip, at least 2 of the following 3 conditions:
i. erythrocyte sedimentation rate < 20mm/hour, ii. femoral and/or acetabular
osteophytes, iii. joint space narrowing (superior, axial, and/or medial). c. Kellgren
and Lawrence grade > 1 as assessed by a recent medical imaging of the referred joint
to confirm the diagnosis. If no imaging available, a new anterior- posterior view will
be obtained and reviewed by Investigator or his/her delegate(s) to verify that the
patient meets the disease diagnostic criteria.
Exclusion Criteria:
8. Change in the " regular analgesic therapy " or introduction of a " regular analgesic
therapy " (if none beforehand) for OA in the last 4 weeks prior to Visit 1 or during
the study.
9. Invariable pain scores reported between Visit 1 and Visit 2 (systematically the same
minimum score reported all along, the same mean score reported all along and the same
maximum score reported all along).
10. Have initiated (or plan to initiate) a program (or modify an existing program in
frequency and/or intensity) of physiotherapy or behavioral therapy such as pain
self-management, hypnosis, sophrology, meditation program within 2 weeks prior to
Visit 1 or during the study.
11. Pregnant, breastfeeding, or willing to be pregnant during the study.
12. Patients with a current or recent history, as determined by the Investigator, of
severe, progressive, and/or uncontrolled renal, hepatic, hematological,
gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease
which would interfere with the patient's participation in the study.
13. Uncontrolled epilepsy.
14. Any current primary psychiatric condition, including depression or personality
disorders (such as Axe II of Diagnostic and Statistical Manual of Mental Disorders
(DSM-V); personality disorders and mental retardation).
15. Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines,
barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and
phencyclidine).
16. Any other relevant medical disorder/acute disease state/pain condition like
fibromyalgia, lumbalgia, generalized OA judged by the Investigator as likely to
interfere with the trial or represent a risk for the patient.
17. Any close relationship with the Investigators or the Sponsor (i.e. belonging to
immediate family or subordination link).
18. Under legal protection, according to the national law.
19. Having completed or withdrawn from this study or any study investigating T4P1001.
20. Patient currently enrolled in a clinical trial involving use of an investigational
drug or device, or concurrently enrolled in any other type of medical research judged
not to be scientifically or medically compatible with this study, or in an exclusion
period according to the national law.
21. Have planned total knee or hip replacement intervention of the referred joint.
22. Reduced mobility due to OA (use of lower extremity assistive devices other than a cane
or a knee sleeve such as crutches or walker or a knee brace or a "shoe lift" in
relation to OA is not allowed).
23. Use or plan to use systemic corticosteroids 4 weeks prior to Visit 1 or during the
study; Intra-muscular corticosteroid injections or Intra-articular injection of
steroids into the referred knee/hip within 3 months before Visit 1 or during the
study; Intra-articular injection of corticosteroids into any other sites than the
referred knee/hip within 4 weeks prior to Visit 1 or during the study (corticosteroids
in topical use are allowed).
24. Have used viscosupplementation or intra articular injection of hyaluronic acid in the
referred joint within 3 months prior to Visit 1 or plan to use during 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.
| Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain | NCT03174145 | Entailment |
3,865 | 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:
- moderate or severe knee osteoarthritis
Exclusion Criteria:
- another disease than knee osteoarthritis
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Strategies for Management of Knee Osteoarthritis : Innovation and Medico-economic Study | NCT04158557 | Entailment |
2,038 | 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:
- Pathologically confirmed gastric adenocarcinoma;
- Bone marrow metastasis confirmed by biopsy;
- PLT < 50*10E9/L;
- Sufficient liver and renal functions;
Exclusion Criteria:
- treated by cytotoxic or target or I-O drugs;
- insufficient cardiac or pulmonary function;
- active infection;
- no contraceptive measures;
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 | LD-FUD for Highly Aggressive Gastric Cancer | NCT04547153 | Entailment |
6,089 | 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:
- Infants aged between 3 and 5 months in both groups
- Infants without any neurological, genetic or metabolic disorder diagnosis in the
control group
Exclusion Criteria:
- Infants whose parents did not want to participate study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 9 Weeks old.
Subject must be at most 19 Weeks | Infants With Down Syndrome on a Different Surface | NCT04539535 | Entailment |
5,476 | 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:
- Patients diagnosed congenital hemophilia A, Christmas disease, and VWD
Exclusion Criteria
- Patients diagnosed with acquired hemophilia
- Patients below 18 years
- Patients with other bleeding tendencies
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 | A Study of Factor Inhibitors in Adult Patients With Hemophilia and Von Willebrand's Disease in Upper Egypt | NCT04106323 | Entailment |
2,192 | 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:
- Hyperuricemic or gout patients
- Serum urate level:
>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension,
diabetes or metabolic syndrome, or >= 9.0mg/dL
Exclusion Criteria:
- Gouty arthritis within two weeks before start of study treatment
- Secondary hyperuricemia
- HbA1c: >= 8.4%
- Uric acid-overproduction type in the classification of hyperuricemia
- History of, clinically significant cardiac, hematologic and hepatic disease
- Kidney calculi or clinically significant urinary calculi
- eGFR: < 30mL/min/1.73m^2
- Systolic blood pressure: >= 180 mmHg
- Diastolic blood pressure: >= 110 mmHg
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.
| Study of FYU-981 in Hyperuricemia With or Without Gout | NCT02416167 | Contradiction |
374 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women aged 20-49;
- Having a regular menstrual cycle of which the menstrual period is between day 3-7, and
the period between day 25-35;
- Excluding internal and surgical disease (after having variety of physical examination
such as electrocardiogram/hepatic and renal function/blood routine and urine routine).
Exclusion Criteria:
- Having experienced severe allergies, trauma history and/or operation history within 3
months;
- With a history of mental illness and/or family history of mental illness;
- Limb disabled;
- Taking medicine within one month;
- Suffering major events or having mood swings.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 49 Years | Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age | NCT02951832 | Contradiction |
4,608 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Premenopausal women who are referred to the department
- benign condition requiring hysterectomy
- Dysmenorrohea/cyclic pelvic pain
- Informed consent
Exclusion Criteria:
- Women who are unable to communicate in Norwegian language.
- Women with a previous history of cervical dysplasia, with cellular changes suggestive
of dysplasia in preoperative cervical smear.
- Women with atypical hyperplasia or malignancy in preoperative endometrial biopsy.
- Women with a substantially enlarged uterus requiring abdominal hysterectomy or not
suitable for TLH (> 12 week amenorrhea).
- Women with a concomitant condition requiring uni- or bilateral oophorectomy.
- Postmenopausal women.
- Women with no dysmenorrohea/cyclic pelvic pain (<1 on a 10-point visual analogue
scale).
- Women with deep infiltrating endometriosis.
Female
No healthy subjects accepted to join the trial.
| Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy | NCT01289314 | Entailment |
4,862 | 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:
- hypothalamic-pituitary-adrenal disorders
Exclusion Criteria:
- under 18 or older than 65 years of age
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 | Value of 25 mcg Cortrosyn Stimulation Test | NCT01428336 | Entailment |
6,638 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as
evidenced by medical history, at the time of signing the informed consent.
2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior
to study entry.
3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure
days (EDs).
4. No previous documented history of a detectable FVIII inhibitor, and results from a
Bethesda assay or Bethesda assay with Nijmegen modification of less than 0.6 Bethesda
Units (BU) on 2 consecutive occasions at least one week apart within the past 12
months.
Exclusion Criteria:
1. Detectable pre-existing antibodies to the AAV5 capsid.
2. Any evidence of active infection or any immunosuppressive disorder, including HIV
infection.
3. Significant liver dysfunction.
4. Prior liver biopsy showing significant fibrosis.
5. Evidence of any bleeding disorder not related to hemophilia A.
6. Platelet count of < 100 x 10^9/L.
7. Creatinine ≥ 1.5 mg/dL.
8. Liver cirrhosis of any etiology as assessed by liver ultrasound.
9. Chronic or active hepatitis B.
10. Active Hepatitis C.
11. Active malignancy, except non-melanoma skin cancer.
12. History of hepatic malignancy.
13. History of arterial or venous thromboembolic events.
14. Known inherited or acquired thrombophilia, including conditions associated with
increased thromboembolic risk, such as atrial fibrillation.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients | NCT03370913 | Contradiction |
2,405 | 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:
- Boys aged 7 to 18, with genomic Duchenne muscular dystrophy whose parents (mother and
/ or father) or direct grandparents do not oppose.
Exclusion Criteria:
- Inability for the child to understand the issues
- Absence of direct parents or grandparents
- Child receiving antidepressant treatment
- Non French speaking child
- Duchenne Muscular Dystrophy girls
Male
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 18 Years | The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM. | NCT03513367 | Entailment |
4,259 | 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:
- at least three semen evaluations performed on separate occasions, when the seminal
specimen after centrifugation showed no sperm under the microscope and was then
diagnosed according to several clinical parameters；
Exclusion Criteria:
-
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Azoospermia Patients | NCT03991663 | Entailment |
2,874 | 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. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS,
according to a modified El Escorial criteria, by the study investigator (Appendix IV).
2. 21 to 80 years of age inclusive.
3. VC greater or equal to 75% of predicted at screening and baseline.
4. Onset of weakness within 2 years prior to enrollment.
5. If patients are taking riluzole for ALS, they must be on a stable dose for at least
thirty days prior to the baseline visit.
6. Women of childbearing age must be non-lactating and surgically sterile or using an
effective method of birth control and have a negative pregnancy test.
7. Willing and able to give signed informed consent that has been approved by the
Institutional Review Board (IRB).
Exclusion criteria
1. Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per
day.
2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine,
phenylpropanolamine, and ephedrine.
3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol,
methadone and propoxyphene, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d,
citalopram > 20 mg/d or paroxetine > 30 mg/d.
6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease,
etc).
7. Clinically significant history of unstable medical illness (unstable angina, advanced
cancer, etc) over the last 30 days.
8. Has a diaphragm pacing device or plan on obtaining a diaphragm pacing device during
the course of the study.
9. History of renal disease.
10. History of liver disease.
11. Current pregnancy or lactation.
12. Limited mental capacity such that the patient cannot provide written informed consent
or comply with evaluation procedures.
13. History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.
14. Vital Capacity (VC) < 75% of predicted.
15. Receipt of any investigational drug within the past 30 days.
16. Women with the potential to become pregnant who are not practicing effective birth
control.
17. Poorly controlled hypertensive subjects or resting systolic blood pressure (SBP) > 160
mmHg and/or diastolic (DBP) > 95 mmHg.
18. Use of BiPAP 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 21 Years old.
Subject must be at most 80 Years | Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) | NCT01786603 | Entailment |
5,453 | 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:
- Signed informed consent
- Reports subjectively heavy menses for most menses when not using hormonal
contraception or a copper IUD
- Healthy females 18-50 years old, inclusive, at the time of enrollment
- Able to read and write, as determined by study personnel
- FSH value ≤30 mIU/mL at screening
- Typical menstrual cycle length of 21-35 days with variation from cycle to cycle of
typically 5 days or less
- Has menstrual blood loss in 2 of the 3 cycles during the Screening Phase with ≥ 80 mL
per cycle as measured by the AH method
- Uterine sound depth of ≥5.5 cm
- Willing to comply with study visit schedule and assessments, including sanitary
product collection and diary completion requirements
- Documented (i.e., printed report) Pap testing, regardless of subject's age, and any
indicated evaluation/treatment that demonstrates no need for further evaluation during
the course of study participation (i.e., within 10 months after consent)
- Planning to reside within a reasonable driving distance of a research site
(approximately 150 miles) for duration of study participation
- Willing to use a medication other than a NSAID as first-line treatment for any pain
condition during the duration of study participation
- Willing to abstain from heterosexual intercourse or use acceptable contraception
during the screening phase; acceptable contraception includes male or female permanent
contraception, withdrawal (if has been using as current method prior to screening) or
a barrier method
- If previously pregnant, at least one subjectively heavy menses prior to screening
Exclusion Criteria:
- Currently pregnant
- Planning to attempt to become pregnant during the screening and treatment phases of
study participation (i.e., up to approximately 11 months after consent)
- Currently lactating or not having a subjectively heavy menses since discontinuation of
lactation prior to screening
- Clinical diagnosis of perimenopause (in the opinion of the investigator) based on one
or more of the following: changes in menstrual regularity (e.g., shorter, longer,
absent, irregular), hot flashes, sleeping disorder, or changes in mood (e.g.,
depression, nervous tension, and irritability) within 3 months prior to or during the
screening period
- Screening blood laboratory value outside of the normal range that, in the opinion of
the investigator, requires treatment or further work-up (i.e., are considered
clinically significant)
- Has poor venous access or significant history of inability to have blood samples drawn
- Body habitus or history of lower genital tract abnormalities or prior surgeries which
may prohibit proper visualization of the cervix or not allow the uterus to be
appropriately instrumented
- History of bicornuate uterus or any other abnormality of the uterus resulting in
distortion of the uterine cavity or cervical canal incompatible with insertion
- Prior (documented within 6 months) or baseline study ultrasound examination
demonstrating:
- A congenital or acquired uterine anomaly that distorts the uterine cavity or
cervical canal incompatible with insertion;
- Endometrial polyps (unless previously removed),
- Fibroids meeting any of the following criteria: Distort the uterine cavity or
cervical canal incompatible with insertion; Submucosal location; Exceeding 2 cm
in the greatest dimension for any individual fibroid; More than three fibroids of
at least 1.5 cm in greatest diameter
- Clear evidence of adenomyosis consisting of any of the following: Subendometrial
cysts; Diffuse adenomyosis based on a heterogeneous myometrial echotexture
consisting of Hyperechoic findings (islands of endometrial glands), hypoechoic
findings (associated muscle hypertrophy), or "Venetian blind" appearance due to
subendometrial echogenic linear striations and acoustic shadowing where
endometrial tissues cause a hyperplastic reaction.
- Recently diagnosed or clinically evident cervicitis or upper genital tract infection
at the time of IUS insertion (unless successfully treated and considered clinically
cured for at least 7 days prior to enrollment)
- History of pelvic actinomycosis infection (i.e., received antibiotic treatment;
criterion does not include solely a history of Pap test with actinomyces)
- Postpartum or post-abortion endometritis unless symptoms resolved at least 4 weeks
prior to screening
- Chronic endometritis on endometrial biopsy at screening (an endometrial biopsy
performed within 6 months of Visit 1 could be used if a report is available with a
tissue diagnosis)
- Has any of the following premalignant or malignant diseases:
- Malignant melanoma
- Acute malignancies affecting blood or leukemias
- Gestational trophoblastic disease (unless at least one year with undetectable
beta-hCG)
- Known or suspected cervical, ovarian, vaginal or vulvar cancer
- Uterine cancer or evidence of uterine malignancy, endometrial intraepithelial
neoplasia (EIN) or hyperplasia on an endometrial biopsy at screening (an
endometrial biopsy performed within 6 months of Visit 1 could be used if a report
is available with a tissue diagnosis)
- History of breast cancer, or suspicion of breast cancer until proven otherwise
- Has any of the following medical conditions:
- Bleeding diathesis (inherited or acquired)
- History of von Willebrand's disease or other known coagulopathy
- Uncontrolled significant hypertension defined as a sitting systolic blood
pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg at any screening or
enrollment visit unless treated and controlled within two weeks of discovery
- Presence or history of venous thromboembolic diseases (deep vein thrombosis,
pulmonary embolism), presence or history of arterial thromboembolic diseases
(e.g., myocardial infarction, stroke)
- Uncontrolled thyroid disorder
- Sickle cell anemia
- Diabetes mellitus that is poorly controlled or with end-organ/vascular
complications
- Hyperprolactinemia at screening
- Acute or severe liver disease or liver tumor
- Poorly controlled bipolar disorder, schizophrenia, psychosis, major depressive
disorder or other major psychiatric disorder according the criteria of the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-5)
- History of a positive HIV test or having a partner who is known to be HIV
positive
- Current or history of alcohol, illicit drug or prescription drug abuse within 12
months prior to screening
- Use of antifibrinolytics, platelet aggregation inhibitors, anticoagulants or other
similar medications that can increase or decrease bleeding within 30 days prior to and
during the screening (EXCEPTION: NSAIDs can be used as second-line treatment for pain
management)
- Use of intrauterine or implantable contraception, progestin-only pills, combined
hormonal contraceptives or oral progestin therapy within 30 days before screening
- Depomedroxyprogesterone acetate (DMPA) injection within the past 9 months prior to
screening (this exclusionary time period can be shortened to 6 months if the subject
has also had two spontaneous menstrual cycles [requires minimum of 3 heavy menses]
that meet criteria for normal menstrual cycle pattern)
- Use of non-contraceptive estrogen, progesterone, progestin, testosterone, androgen or
other gonadotropins (e.g. hCG) within 30 days before screening
- Prior total or partial endometrial ablation or resection
- History of a uterine aspiration or curettage procedure for any indication (other than
an office biopsy) within 4 weeks of screening
- Known or suspected allergy to levonorgestrel or hypersensitivity to any component of
the product
- Use of an experimental medication or receipt of an experimental treatment for any
condition within 30 days of screening
- Study staff or a member of the immediate family of a study staff
- Any condition or circumstance that, in the opinion of the Investigator, would
constitute contraindications to participation in the study or would compromise ability
to comply with the study protocol, such as any concurrent medical condition that is
not stable and well-controlled, that is likely to worsen, or that may require
recurrent hospitalizations during study participation
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding | NCT03642210 | Entailment |
5,964 | 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:
- Age > 18
- Affiliation to French Social Security
- Informed written consent
- RDQ score > 3
- Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to
normal values published by Zerbib et al (CGH 2013)
Exclusion Criteria:
- Pregnancy or breast feeding
- Women of childbearing potential without an effective method of contraception
- Person under guardianship
- History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)
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.
| FODMAPs and Refractory GERD | NCT02471989 | Contradiction |
2,957 | 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. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS,
according to a modified El Escorial criteria, by the study investigator (Appendix IV).
2. 21 to 80 years of age inclusive.
3. VC greater or equal to 75% of predicted at screening and baseline.
4. Onset of weakness within 3 years prior to enrollment.
5. If patients are taking riluzole for ALS, they must be on a stable dose for at least
thirty days prior to the baseline visit.
6. Women of childbearing age must be non-lactating and surgically sterile or using an
effective method of birth control and have a negative pregnancy test.
7. Willing and able to give signed informed consent that has been approved by the
Institutional Review Board (IRB).
Exclusion criteria
1. Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per
day.
2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine,
phenylpropanolamine, and ephedrine.
3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol,
methadone and propoxyphen, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d,
citalogram > 20 mg/d or paroxetine > 30 mg/d.
6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease,
etc).
7. Clinically significant history of unstable medical illness (unstable angina, advanced
cancer, etc) over the last 30 days.
8. History of renal disease.
9. History of liver disease.
10. Current pregnancy or lactation.
11. Limited mental capacity such that the patient cannot provide written informed consent
or comply with evaluation procedures.
12. History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.
13. VC < 75% of predicted.
14. Receipt of any investigational drug within the past 30 days.
15. Women with the potential to become pregnant who are not practicing effective birth
control.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT01232738 | Entailment |
6,754 | 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:
- Males with mild/moderate hemophilia A (fVIII activity 1-40%)
- Planned surgical intervention which is anticipated to require 5 consecutive days of
fVIII replacement therapy (These can be outpatient or inpatient treatment days.)
- Weight >22.5 kg (To assure that volumes of blood to be drawn for study purposes are
safe.)
Exclusion Criteria:
- Past history of an inhibitor (inhibitor titer >0.4 BU/ml)
- HIV infection with CD4 count <400/ul
- Currently receiving immunosuppressive medication(s)
- Unable to tolerate quantity of blood to be drawn
- Current or past diagnosis autoimmune disorder
- Current or past diagnosis of immune deficiency disorder other than HIV
Male
No healthy subjects accepted to join the trial.
| Inhibitor Development in Patients With Hemophilia A Undergoing Surgery | NCT01571934 | Entailment |
1,404 | 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:
- Health volunteers 18 years and above; equal numbers of males and females to address
Sex As a Biological Variable (SABV); and in sinus rhythm.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedures being performed (all
subjects should be able to understand the informed consent form and any other
documents that subjects are required to read).
Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Any other condition that would increase the risk of participation in the study in the
opinion of the site Investigator.
- A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
- Upper extremity arteriovenous hemodialysis shunt.
- Wrist distortion or pain from arthritis.
- Prior trauma or surgery at the radial artery monitoring site.
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 | Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices | NCT04835857 | Contradiction |
6,405 | 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:
- Adults (age > 18 years) seeking care for an acute respiratory illness (duration < 10
days) in which cough is a chief complaint.
- Eligible patients will be required to have at least 1 symptom of acute respiratory
tract infection (fever, night sweats, rhinorrhea, sinus congestion, myalgias).
Exclusion Criteria:
- Previous (within 21 days) antibiotic treatment;
- immunodeficiency;
- cystic fibrosis;
- patient requiring immediate evaluation/management;
- inability to provide informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough | NCT00221351 | Entailment |
6,966 | 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. | Core study
Inclusion Criteria:
- Diagnosis of probable Alzheimer's disease (AD) according to National Institute of
Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders
Association (NINCDS/ADRDA) criteria.
- A Mini-Mental State Examination (MMSE) score of ≥ 3 and ≤ 12.
- Be able to complete at least 1 item on the Severe Impairment Battery (SIB).
- Residing with someone in the community or in regular contact with the primary
caregiver.
- Be ambulatory or ambulatory with aid.
Exclusion Criteria:
- An advanced, severe, progressive, or unstable disease of any type that may interfere
with efficacy and safety assessments or put the patient at special risk.
- Patients currently residing in a nursing home.
- Any current medical or neurological condition other than AD that could explain the
patient's dementia.
- A current diagnosis of probable or possible vascular dementia.
- A current diagnosis of severe or unstable cardiovascular disease.
- A current diagnosis of bradycardia (< 50 beats per minute [bpm]), sick-sinus syndrome,
or conduction defects.
- Clinically significant urinary obstruction.
- History of malignancy of any organ system within the past 5 years unless patient is
verified to be in stable condition with no active metastasis.
- Current diagnosis of an active skin lesion/disorder that would prevent the patient
from using a transdermal patch every day.
- A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar
to rivastigmine, or to other cholinergic compounds.
- Taken any of the following substances (at the time of the Baseline Visit [Visit 2]).
- Succinylcholine-type muscle relaxants during the previous 2 weeks.
- Lithium during the previous 2 weeks.
- An investigational drug during the previous 4 weeks.
- A drug or treatment known to cause major organ system toxicity during the previous 4
weeks.
- Rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase
inhibitors (eg, tacrine, physostigmine, or pyridostigmine), or other approved
treatments for Alzheimer's disease during the previous 2 weeks, with exception of
stable treatment with memantine for at least 3 months before study entry (Visit 1).
- Centrally acting anticholinergic drugs including tricyclic and tetracyclic
antidepressants during the previous 4 weeks.
- Selegiline unless taken at a stable dose during the previous 4 weeks.
- Peripheral anticholinergics not taken at a stable dose during the previous 4 weeks.
Extension study
Inclusion Criteria:
- Complete the double-blind phase (Week 24) of the core study.
- Provide, if mentally competent, a separate written informed consent prior to
participation in the extension study. In addition, the patient's caregiver, will
provide written informed consent prior to the patient's participation in the
open-label extension study. If the patient is not able to provide written informed
consent, written informed consent must be obtained from the legally authorized
representative on the patient's behalf.
- Continue to reside with someone in the community or in regular contact with the
primary caregiver; patients who reside in an assisted living facility are eligible to
participate.
- Continue to have a primary caregiver willing to accept responsibility for supervising
treatment (eg, application and removal of the patch daily at approximately the same
time of day), assessing the condition of the patient throughout the extension study.
- Must be medically stable and tolerating the current dose of rivastigmine patch as
determined by the investigator.
Exclusion Criteria:
Refer to the core study protocol for full details of the exclusion criteria.
- Patients who discontinued the core study due to any reason are excluded.
- No additional exclusions may be applied by the investigator, in order to ensure that
the study population will be representative of all eligible patients.
Other protocol-defined inclusion/exclusion criteria applied to 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 50 Years old.
| Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 | NCT00948766 | Entailment |
6,786 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
1. Able and willing to provide written informed consent.
2. Males ≥18 years of age.
3. Clinically severe hemophilia A
4. Previous exposure to FVIII therapy
5. No prior history of hypersensitivity or anaphylaxis associated with an FVIII or
intravenous immunoglobulin administration.
6. No measurable inhibitor against FVIII
7. Willing to participate and receive treatment in a future Spark hemophilia A gene
therapy study.
Exclusion Criteria:
1. Documented active hepatitis B or C within the past 12 months of Screening
2. Currently on antiviral therapy to treat hepatitis B or C;
3. Documented significant liver disease within the past 6 months of Screening
4. Have serological evidence of HIV-1 or HIV-2
5. Anti-AAV-Spark 200 neutralizing titers ≥1:1
6. Previously received SPK-8011;
7. Previously dosed with any investigational or approved gene therapy product at any time
or treated with an investigational drug within the last 12 weeks;
8. Planned surgical procedure in the next 12 months requiring FVIII prophylactic
treatment.
9. Any history of chronic infection or other chronic disease, concurrent clinically
significant major disease (such as liver abnormalities or type I diabetes) including
active malignancy, except for non-melanoma skin cancer, any other condition or any
other unspecified reasons that, in opinion of the Investigator or Sponsor, makes the
participant unsuitable for participation and dosing in a future clinical study for
Spark's hemophilia A gene therapy.
10. Unable or unwilling to comply with the schedule of visits and/or study assessments
described in the protocol.
Male
Subject must be at least 18 Years old.
| Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants | NCT03876301 | Entailment |
2,760 | 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:
- Elective inguinal hernia repair in a portuguese hospital
- Willing and able to consent and comply with the follow up protocol
Exclusion Criteria:
- Urgent/emergent inguinal hernia repair
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.
| Portuguese Inguinal Hernia Cohort (PINE) Study | NCT04328597 | Entailment |
4,388 | 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:
- The entire population of Manitoba is considered for inclusion.
Exclusion Criteria:
- Individuals less than or equal to 6 months of age;
- Having less than one year of insurance coverage before the enrolment period;
- Not registered with MH during the enrolment period;
- Physician or hospitalization records indicating a diagnosis of any demyelinating
condition between 1971 (earliest year for which information is available) and the
index date.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Months old.
| A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada | NCT02367222 | Entailment |
3,138 | 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:
- 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or
primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
- A group: Patients using glaucoma eye drops longer than 6 months, and in accordance
with the diagnostic criteria of dry eye:
1. Subjective symptoms (required): dryness, foreign body sensation, fatigue and
discomfort;
2. The instability of tear film (required): tear break up time (TBUT);
3. Lacrimal secretion: Schirmer I test;
4. The ocular surface damage (strengthen diagnosis): fluorescein staining (FL); in
the mentioned in ①+②（TBUT≤5s) or ①+②（TBUT≤10s)+③（<10mm）/④（FL+）。
- The choice of study eyes: Choose the eye of the patient with low basical intraocular
pressure, and if the basal intraocular pressure is the same, choose the right eye for
the study.
- Voluntary participation in this clinical study, and signed informed consent.
Exclusion Criteria:
- With metabolic diseases, autoimmune diseases, connective tissue diseases, such as
diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus,
Sjogren's syndrome eat;
- Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease,
atumor diseases and psychosis.
- Using any artificial tears and except any clinical trials of dry eyes within two
weeks.
- With drug therapy, embolization and surgical treatment of dry eyes.
- With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic
dacryocystitis, trichiasis, corneal lesions.
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 80 Years | Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops | NCT03515187 | Contradiction |
2,993 | 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:
- Genetically confirmed diagnosis of FXS
- At Screening and first baseline, vital signs, body weight and body mass index (BMI)
must be age-specific within normal ranges.
Exclusion Criteria:
- Use of any other investigational drug within 30 days or 5 half-lives (whichever is
longer) of the investigational drug prior to screening until end of study visit.
- History of hypersensitivity to AFQ056 or any mGluR antagonist.
- Female patients who are confirmed or suspected to be sexually active.
- History or presence of any clinically significant disease of any major system organ
class, within the past 2 years prior to screening including but not limited to
psychiatric, neurological, cardiovascular, endocrine, metabolic, renal, or
gastrointestinal disorders (except for typical features of FXS).
- Smokers.
- Loss of ≥10% of total blood volume within 8 weeks (or less if required for this age
group and/or by local regulation) prior to dosing or longer if required for this age
group and/or by local regulation.
- Significant illness that did not completely resolve at least four weeks prior to the
first baseline visit.
- Any abnormal laboratory values at screening or first baseline that are in the opinion
of the investigator clinically significant and may jeopardize the safety of the study
subject.
- Use of (or use within at least 5 half lives before dosing) concomitant medications
that are strong/moderate inhibitors or inducers of CYP1A1/2, CYP2C9/19 or CYP3A4
- History or presence of Hepatitis B/C or HIV 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 3 Years old.
Subject must be at most 11 Years | Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS) | NCT01482143 | Contradiction |
3,976 | 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 ≥ 21 years
2. Able to understand and personally sign and date the informed consent form
3. Able to complete outcome measures
4. Chronic knee pain for longer than 6 months that interferes with functional activities
(for example, ambulation, prolonged standing, etc.)
5. Continued pain in the target knee despite at least 3 months of conservative
treatments, including activity modification, home exercise, protective weight bearing,
and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs
[NSAIDs])
6. Positive response (defined as a decrease in numeric pain scores of at least 50%) to a
single genicular nerve block of the index knee
7. Pain on NRS ≥ 6 on an 11-point scale for the index knee
8. Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3 (moderate)
or 4 (severe) noted within 6 months for the index knee
9. Analgesics including membrane stabilizers such as Neurontin (gabapentin) and
antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable
(defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not
change during the course of the study without approval of the investigator
10. Agree to see one physician (study physician) for knee pain during the study period
11. Subjects of child bearing potential must be willing to utilize double barrier
contraceptive method
12. Willingness to comply with the requirements of this protocol for the full duration of
the study (24 months regardless of effect of initial therapy)
Exclusion Criteria:
1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic
inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause
knee pain
2. Evidence of neuropathic pain affecting the index knee
3. Previous or pending lower limb amputation
4. Intra-articular steroid injection into the index knee within 90 days from
randomization
5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic
debridement/lavage injection into the index knee within 180 days from randomization
6. Prior radiofrequency ablation of the genicular nerves of the index knee
7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual
hardware)
8. Clinically significant ligamentous laxity of the index knee
9. Clinically significant valgus/varus deformities or evidence of pathology (other than
osteoarthritis of knee) that materially affects gait or function of the knee or is the
underlying cause of the knee pain and/or functional limitations
10. Body mass index (BMI) > 40 kg/m2
11. Extremely thin patients and those with minimal subcutaneous tissue thickness that
would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the
risk of skin burns
12. Pending or active compensation claim, litigation, or disability remuneration
(secondary gain)
13. Pregnant, nursing or intent of becoming pregnant during the study period
14. Chronic pain associated with significant psychosocial dysfunction
15. Poorly controlled severe psychiatric illness or ongoing psychological barriers to
recovery, as determined by the investigator
16. Allergies to any of the medications to be used during the procedures
17. Active joint infection or systemic or localized infection at needle entry sites
(subject may be considered for inclusion once infection is resolved)
18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be
safely interrupted for procedure, or unexplained or uncontrollable bleeding that is
uncorrectable
19. Identifiable anatomical variability that would materially alter the procedure as
described in the protocol
20. Within the preceding 2 years, subject has suffered from active narcotic addiction,
substance, or alcohol abuse
21. Current prescribed opioid medications greater than 60 mg morphine equivalent daily
opioid dose
22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
23. Subject currently implanted with pacemaker, stimulator or defibrillator
24. Participating in another clinical trial/investigation which included therapeutic
treatment within 30 days prior to signing informed consent
25. Subject unwilling or unable to comply with follow up schedule, protocol requirements
or procedures
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain | NCT04145011 | Entailment |
3,034 | 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:
- Patients with developmental disabilities
- No etiologic diagnosis but suspected genetic cause
- Fragile X syndrome research negative
Exclusion Criteria:
- Children born to consanguineous couples
- Diagnosis already established or suspected
- Identification of an independent etiology
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 75 Years | Various Type of Genetic Events in Patients With Intellectual Disability | NCT02881333 | Entailment |
5,796 | 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:
- Patients presenting to the UCSF oral medicine clinic with oral lichen planus confirmed
by biopsy. Patients with either the atrophic or the erosive form of oral lichen planus
were eligible.
- Study subjects had to have a symptom score between 3 to 8 at the time of entry into
the study. (Range of scale: zero to ten, with zero being no symptoms and ten being the
worst imaginable symptoms.)
- Eligible subjects had to have discontinued systemic and/or topical corticosteroids for
at least two weeks before entry into the study.
Exclusion Criteria:
- Pregnancy, lactation or unwillingness to use an effective method of contraception. An
attempt was to be made to ascertain the date of the last menstrual period among
eligible pre-menopausal women. If pregnancy could not be ruled out, a pregnancy test
was to be provided to the women before enrollment into the study.
- Patients younger than 21 years of age.
- Patients who could not return for follow-up visits at one week, 4 weeks and 7 weeks
after enrollment.
- Patients with a medical contraindication or refusal to take prednisone and
or/fluconazole.
- Patients who had a medical contraindication to discontinuation of systemic
corticosteroids (eg. those on long term corticosteroid therapy).
- Patients with a history of gastric / duodenal ulcers or gallstones.
- Patients with a history of liver disease.
- Patients on anticoagulants or antiplatelet medications.
- Patients undergoing orthodontic treatment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus | NCT00226174 | Contradiction |
4,251 | 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:
- Consent to participate in study
Exclusion Criteria:
- Systemic uncontrolled disease
Male
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Association Study Between Periodontal Disease and Male Infertility | NCT01140945 | Entailment |
5,946 | 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. Able and willing to provide written informed consent
2. Able and willing to comply with required study procedures and follow-up schedule
3. 22 - 75 years of age at the time of informed consent
4. Documented symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months
(regurgitation and/or heartburn which is defined as burning epigastric or substernal
pain which responds to acid neutralization or suppression) which requires daily use of
proton pump inhibitors (PPIs) or other anti-reflux drug therapy, who continue to have
symptoms despite maximum medical therapy or are "intolerant" -severe side-effects
(e.g. anaphylaxis or severe allergic reaction, recurrent C. difficile, severe
hypomagnesaemia) to one PPI or mild/moderate side effect (e.g. nausea, vomiting,
diarrhea or abdominal pain) to at least 2 PPIs of different chemical classes.
5. Symptomatic improvement on PPI therapy demonstrated by a composite GERD-health-related
quality of life (HRQL) score of ≥20 off PPI, and a ≥10 point improvement on PPI
compared to the off PPI composite GERD-HRQL score. Patients who meet the definition
above of PPI intolerant are not required to have ≥10 point improvement. The on-PPI
score to satisfy this criterion will be the score from the GERD-HRQL assessment
completed after resuming PPIs following the Baseline visit.
6. Excessive lower esophageal acid exposure during pH monitoring (defined as distal
esophageal pH < 4 for > 6.0% of the monitoring time) performed after at least 5 days
off of PPIs and at least 2 days off of H2 blockers. At least 18 hour of esophageal pH
recording will be considered adequate and inclusion will be based on the day (at least
18 hours of valid data) with the highest acid exposure percentage time.
7. Esophagitis ≤ Grade B (Los Angeles (LA) classification) as measured by upper endoscopy
off PPI and H2 blockers for 10-14 days
8. Esophageal body contraction amplitude > 30 mmHg for > 30% of swallows and > 30%
peristaltic contractions on HRM or ≥ 30% peristaltic contractions with DCI >450.
9. Suitable surgical candidate able to undergo general anesthesia and laparoscopic
surgery
Exclusion Criteria:
1. Previous EndoStim LES System implant and/or implant attempt
2. Previous surgery involving the gastroesophageal junction or the lead implant site,
such as a Nissen fundoplication
3. Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
4. Hiatal hernia larger than 3 cm as determined by endoscopy
5. History of gastroparesis
6. Any non-GERD esophageal motility disorders that in the opinion of investigator
precludes an anti-reflux procedure
7. History of or known esophageal stricture or significant esophageal anatomic
abnormalities (obstructive lesions, etc.)
8. Barrett's esophagus or any grade of dysplasia
9. Documented history of esophagitis Grade C or D (LA Classification)
10. History of suspected or confirmed esophageal or gastric cancer
11. Esophageal or gastric varices
12. Symptoms of dysphagia more than once per week every week within the last 3 months
13. Unable to tolerate withdrawal from H2 Blockers or PPI medications
14. Suspected or known allergies to titanium, platinum, iridium, stainless steel,
silicone, epoxy, or nylon
15. Body mass index (BMI) > 35 kg/m2
16. Any significant multisystem diseases
17. Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis,
Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome,
Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years
18. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as
HbA1c > 9.5 in the previous 6 months or at screening/baseline
19. Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e.
unstable angina pectoris, hemodynamically significant valvular disease, severe
congestive heart failure), or any cardiac therapeutic intervention within the last 6
months.
20. Significant cerebrovascular event within the last 6 months
21. Existing implanted electrical stimulator (pacemaker, implantable cardioverter
defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators,
drug pumps, etc.)
22. Female subject of child-bearing potential and is pregnant or nursing, or intends to
become pregnant during the trial period, who is not using a reliable form of birth
control
23. Currently enrolled in other potentially confounding research
24. Active infection as determined by the investigator
25. History of any malignancy, other than basal cell carcinoma, in the last 2 years
26. Life expectancy less than 3 years aa. Diagnosed major psychiatric disorder (bipolar,
schizophrenia, etc.) bb. Any condition that, at the discretion of the investigator or
sponsor, would interfere with accurate interpretation of the study endpoints or
preclude participation in 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 22 Years old.
Subject must be at most 75 Years | An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux | NCT02749071 | Contradiction |
4,820 | 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:
- Subject, male or female over 18
- Subject presenting a hypercortisolism in remission or controlled by a drug treatment
for more than one year.
- Subject with a good understanding of the French language
- Non-institutionalized subject
- Subject whose informed consent could be obtained
Exclusion Criteria:
- Minor subject or over 80 years
- Subject presenting hypercortisolism in remission for more than 20 years
- Major cognitive impairment that does not allow answering a questionnaire
- Genetic syndrome responsible for hypercortisolism
- Mixed adenoma whose corticotropic share is responsible for hypercortisolism
- Pituitary carcinoma
- Subject refusing to participate in the study
- Subject having no close
- Subject whose relative refuses to answer the questionnaires
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 80 Years | Patient and Partner Perception After Remission of Cushing's Syndrome | NCT03607474 | Contradiction |
6,249 | 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:
- Cases aged 18 years and over. Cases diagnosed as COVID-19 by radiology or with positive
PCR. Cases admitted to Assiut University Hospitals.
Exclusion Criteria:
- Cases less than 18 years old. Cases diagnosed as COVID-19 and discharged from
emergency department for Home Isolation. Cases express a dissent from the use of their
data in 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 120 Years | Risks and Outcomes Among COVID-19 Patients Admitted to Assiut University Hospitals. | NCT04860245 | Contradiction |
3,741 | 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 osteoarthritis patients
- Medial knee pain
Exclusion Criteria:
- Unable to walk independently
- Ambulation with device
- Any neurologic disease
- Rheumatoid arthritis, gouty arthritis
- History of lower limbs fracture
- History of operation for lower limbs
- Any infectious disease
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.
| The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed | NCT04629040 | Contradiction |
5,029 | 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:
- Age 18 or older
- Subject diagnosed with essential tremor affecting both upper extremities.
- Subject has been diagnosed for at least one year with tremor that is troublesome, so
that improvement of tremor would improve the quality of life.
- Subject has tremor with a tremor rating scale severity of 2 to 4 in one or both upper
extremities in the tremor rating scale during posture and/or kinesis.
- Subject has not had satisfactory tremor response to at least one anti-tremor
medication.
- Subject is able to comply with all testing and follow-up visit requirements.
- Subject is able to abstain from alcohol for at least 12 hours prior to each Study
Visit and from caffeinated beverages on the day of the Visit.
- Subject has voluntarily signed an informed consent in accordance with institutional
policies.
- Subject is either
- Not taking medication for Essential Tremor and has not done so for at least 28
days prior to Visit 1.
- Taking medication for Essential Tremor and has been taking a stable dose so for
at least 28 days prior to Visit 1.
Exclusion Criteria:
- Subject has progressive neurological disease other than Essential Tremor.
- Subject has history of alcoholism or drug abuse within the past year.
- Subject has history of mania, bipolar depressive disorder, schizophrenia, or other
major psychiatric disorder.
- Subject drinks more than 2 glasses of wine or equivalent per day in last 30 days.
- Subject has received botulinum injection of the upper extremities in the past 6
months.
- Subject is currently using investigational device.
- Subject has taken an investigational drug within a clearance duration of 5 times the
half-life of the investigational drug.
- Subject is pregnant or a female of childbearing potential not using adequate
contraception.
- Subject has a medical condition likely to result in hospitalization.
- Known allergy to memantine or amantadine.
- Taking medication that alkalinizes the urine, such as carbonic anhydrase inhibitor or
sodium bicarbonate.
- Any disorder or condition that may interfere with the absorption, the distribution, or
excretion of drugs.
- Taking medication known to cause postural tremor, that in the clinical judgement of
the investigator is contributing to the subject's tremor.
- Receiving deep brain stimulation within two weeks prior to Visit 1 or has potential
need for deep brain stimulation during the study.
- Has received ablative thalamotomy or gamma knife thalamotomy within six months of
study onset.
- Tremor potentially due to head trauma, hyperthyroidism, cerebrovascular disease,
multiple sclerosis, polyneuropathy, or family history of Fragile X syndrome.
- Known renal disease with creatinine level outside normal range.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Pilot Clinical Trial Of Memantine for Essential Tremor | NCT00439699 | Entailment |
3,972 | 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 40 years or older, presence of a primary knee OA with knee pain for at least 6
months despite conservative treatment (rest, physical therapy, orthoses or pain
medications etc.); (2) had average pain on knee movement of at least 3 cm on a 10-cm
VAS; (3) had a current Lequesne index score (described below) >7 (possible range,
0-24); (4) were willing to discontinue all nonsteroidal anti-inflammatory drugs
(NSAIDs) or other analgesic medication (except for rescue medication) for the duration
of the study; and (5) were willing to not receive physical therapy or trial of shoe
modifications or orthoses during the study period.
Exclusion Criteria:Exclusion criteria included previous orthopedic surgery on the spine or
lower limbs, knee instability or marked deformity on examination, clinically apparent tense
effusion of the knee, intra-articular steroid or HA injection in any joint within the past
6 months, and concomitant inflammatory arthropathy or other rheumatologic, neurological,
cardiovascular or psychiatric disorders that would interfere with the clinical assessment
during the study period.
-
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 | Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA) | NCT01185444 | Entailment |
2,036 | 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:
- Schedule for video endoscopy at UVHS
- Ability to speak, read and write English
- Age >18
- Able to provide consent
Exclusion Criteria:
- Prisoner
- Woman who is currently pregnant or breastfeeding
- Allergy to linaclotide
- Patients with known or suspected mechanical gastrointestinal obstruction
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.
| Single-dose Linaclotide for Capsule Endoscopy Preparation | NCT02465385 | Entailment |
463 | 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:
- English or Spanish speaking
- Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound
dating on the day of enrollment
- Ultrasound used for dating purposes must be within the last two weeks.
- Women 18-50 years of age undergoing surgical termination of pregnancy
Exclusion Criteria:
- Spontaneous fetal demise
- Ruptured membranes or intrauterine infection
- Fibroids that significantly distort the uterine shape
- Uterine abnormality such as unicornuate uterus
- Prior transmural myomectomy
- Severe oligohydramnios
- Morbid obesity with BMI>45
- Inability to place osmotic dilators
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion | NCT01436266 | Contradiction |
5,613 | 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:
- Attendance from first to sixth grade
- Ages 6-12 years
- BMI ≥ 85th percentile for age and sex
- Hispanic origin
- Both parents Hispanic
- Low socioeconomic status
- Signed consent from both parents/care givers and active assent from children
Exclusion Criteria:
- Disapproval by the children's physician due to any at-risk medical condition known by
the parents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 12 Years | Individualized Dietetic Intervention-eating Habits in Obese Hispanic Children of Low Socioeconomic Status | NCT01925976 | Contradiction |
4,569 | 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. Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis.
2. Planning for birth spacing for at least 2 years.
3. Patient aged between 20-45 years old.
4. Ultrasonographic and Doppler examination suggestive of adenomyosis.
5. Living in a nearby area to make follow-up reasonably possible.
Exclusion Criteria:
1. Pregnancy
2. Evidence of defective coagulation.
3. History or evidence of malignancy.
4. Hyperplasia in the endometrial biopsy.
5. Incidental adnexal abnormality on ultrasound.
6. Contraindications to COCs.
7. Absolute contraindication of LNG-IUS insertion.
8. Previous endometrial ablation or resection
9. Uninvestigated postcoital bleeding
10. Untreated abnormal cervical cytology
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | LNG-IUS for Treatment of Dysmenorrhea | NCT01601366 | Contradiction |
348 | 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:
- Hemodynamic stability
- Initial β-hCG <2000 mIU / mL
- Titers of β-hCG in decline in 48 hours before treatment
- Adnexal mass <5.0 cm
- Desire for future pregnancy
Exclusion Criteria:
- Alive embryo
- Ectopic pregnancy other than in tubal location
- Pregnancy of unknown location
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy | NCT01876004 | Contradiction |
2,164 | 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:
- Hyperuricemia (serum uric acid ≥8.0 mg/dL).
- Must meet American College of Rheumatology criteria for gout.
- Must have adequate renal function (serum creatinine <1.5 mg/dL).
- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant nor lactating from Screening throughout the
duration of the study.
Exclusion Criteria:
- History of xanthinuria
- Alcohol consumption >14/week
- Has a history of significant concomitant illness.
- Has active liver disease.
- Has a body mass index greater than 50 kilogram per meter² (kg/m²)
- Any other significant medical condition that would interfere with the treatment,
safety or compliance with the protocol, as defined by the investigator.
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 | Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout | NCT00174967 | Contradiction |
3,140 | 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. Male or female patients, ≥ 18 years old;
2. Required use of artificial tears for the treatment of Dry Eye within the 3 months
prior to study enrolment;
3. Current use or recommended use of artificial tears for the treatment of Dry Eye;
4. Average VAS score for typical symptoms of Dry Eye (foreign body sensation,
burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25
mm;
5. Corneal staining score with lissamine green > 3 using the NEI corneal grading system
in the worse eye (study eye);
6. Conjunctival staining score > 3 using the NEI conjunctival grading system in the worse
eye (study eye);
7. Schirmer test without anaesthesia ≤ 10 mm/5 minutes in the worse eye (study eye);
8. Tear film break-up time (TBUT) ≤ 10 seconds in the worse eye (study eye);
9. A negative urine pregnancy test if female of childbearing potential and must use
adequate birth control throughout the study period
Exclusion Criteria:
1. Patient not suitable to participate in the study in the opinion of the investigator;
2. Patient with a mild or moderate Dry Eye condition (severity level less than 3
according to the Report of the International Dry Eye Workshop -DEWS, 2007) if fourteen
(14) patients with mild or moderate dry eye condition have been already enrolled in
the current treatment group (Group 1 and Group 2 separately);
3. Patient has had a serious adverse reaction or significant hypersensitivity to any drug
or chemically related compounds or has a clinically significant allergy to drugs,
foods, amide local anaesthetics or other materials including commercial artificial
tears containing Hypromellose (in the opinion of the investigator);
4. Use of topical cyclosporine, topical corticosteroids or any other topical medication
for the treatment of dry eye in either eye within 30 days of study enrolment. Use of
own artificial tears is allowed until Visit 2;
5. Any ocular disease other than Dry Eye requiring treatment with topical medications in
either eye within 30 days of study enrolment;
6. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye;
7. Presence or history of any systemic or ocular disorder, condition or disease that
could possibly interfere with the conduct of the required study procedures or the
interpretation of the study results;
8. Use of therapeutic or Refractive Contact lenses in either eye within 30 days of study
enrolment;
9. History of ocular surgery in the study eye, including corneal refractive procedures,
within 90 days of study enrolment;
10. Participation in another clinical study at the same time as the present and within 30
days of study enrolment;
11. History of drug, medication or alcohol abuse or addiction.
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.
| Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye | NCT02101281 | Contradiction |
4,910 | 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:
- Male and female patients ages 18-100 who have been diagnosed with essential tremor of
the voice (EVT) Diagnosis Code 478.75 Laryngeal Spasm.
Exclusion Criteria:
- WCMC subjects under age 18
- Pregnant patients
- Patients with laryngeal pathology besides tremor, including but not limited to polyps
and other benign lesions, precancerous or cancerous changes, vocal fold paralysis, or
other laryngeal disorders of mobility
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation | NCT02711995 | Contradiction |
1,312 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Polyarticular or systemic juvenile idiopathic arthritis,
- Growth velocity below the 25th percentile and or short stature ,
- Treatment with glucocorticoids for at least the previous 6 months before inclusion,
- Prepubertal stage,
- Bone age below 10 in girls and 12 in boys,
- Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml
Exclusion Criteria:
- Previous treatment with growth hormone,
- Endocrinopathy,
- Additional chronic disease beside juvenile idiopathic arthritis,
- Malignant disase,
- Chromosomal aberration or othe syndromal disease,
- Previous treatment with Oxandrolone,
- Small for gestational age,
- Elevated fasting glucose level
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 14 Years | Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis | NCT00420251 | Contradiction |
5,205 | 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:
- Vitamin D insufficiency, defined as a serum 25(OH)D 16 to 25 ng/mL by high performance
liquid chromotography assay
- Women ≥ 5 years past the date of last menses or bilateral oophorectomy, or ≥ 60 years
old if they had prior hysterectomy without bilateral oophorectomy
- Total dietary and supplemental calcium intake < 600 mg daily but ≤ 1,400 mg daily,
based on a food frequency questionnaire
Exclusion Criteria:
- Women > 75 years old
- Hypercalcemia (serum calcium corrected for albumin > 10.4 mg/dL)
- Nephrolithiasis by medical record or patient report
- Inflammatory bowel disease, malabsorption or chronic diarrhea
- Stage 3, 4 or 5 Chronic Kidney Disease based on the Modification of Renal Diet (MDRD)
formula
- Use of bone-active medications within the past 6 months including bisphosphonates,
estrogen compounds, calcitonin, teriparatide, oral corticosteroids and anticonvulsants
- Allergy or intolerance to orange juice
- Allergy or intolerance to sunscreen
- Prior adult clinical fragility fracture of the hip, spine or wrist or a T-score below
-2.5 at the lumbar spine or femur
Female
Accepts Healthy Volunteers
Subject must be at most 75 Years | Treatment of Vitamin D Insufficiency | NCT00933244 | Entailment |
3,054 | 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:
- receive psychiatric services through the adult or young adult treatment team at the
West Haven Mental Health Clinic
- have a child receiving psychiatric services through the child treatment team at the
West Haven Mental Health Clinic
- express interest in receiving a parent intervention at the West Haven Mental Health
Clinic
Exclusion Criteria:
- severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
- severely cognitively impaired
- have psychiatric or substance-related symptoms requiring inpatient hospitalization or
ambulatory detoxification
- are not fluent in English
- child has a serious illness or significant developmental delay (e.g., cognitive,
language, or motor)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Program for Caregivers Involved With Mental Health Services | NCT01872585 | Entailment |
4,661 | 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. Hysterectomy or myomectomy planned for a benign gynecologic reason. (This means that
there is no evidence of, or concern for, malignancy in the cervix, uterus, tubes or
ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal
uterine bleeding, endometriosis, and pelvic pain. Benign reason for myomectomy would
be fibroids)
2. Patient is scheduled to have surgery with one of the minimally invasive gynecologic
surgeons at George Washington University Hospital (GWUH)
3. Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or
a total laparoscopic hysterectomy (TLH) or robotic assisted or laparoscopic
myomectomy.
4. Patient is capable of informed consent.
5. The patient has no baseline urinary disease.
Exclusion Criteria:
1. Hysterectomy or myomectomy is indicated for malignancy
2. Hysterectomy or myomectomy is not being performed via robotic or laparoscopic method
3. Patient is not capable of providing informed consent
4. Patient has urinary disease
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 | The Effect of Partial Bladder Filling on Post-operative Time to Void in Minimally Invasive Gynecologic Procedures | NCT02741531 | Entailment |
4,623 | 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:
- Pre- and Peri-menopausal woman patient age 18-65 years
- Women with fibroids, adenomyosis, and endometrial hyperplasia and indication for
laparoscopic hysterectomy.
- Normal Pap smear result within one year
- The uterus is larger than 12 weeks of gestation
- The body mass index of the patients is 18.5-27.9kg/m2
- Signed informed consent form
Exclusion Criteria:
- Women with Known or suspected malignancy
- patients during pregnancy and lactation
- Known blood diseases, bleeding coagulation disease, any part of the active bleeding or
bleeding tendency of the constitution of the patient
- Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2
times of normal upper limit, or renal function (Cr) ≥ normal upper limit
- Patients who are known to have participated in any other clinical trial within 3
months
- Patients who cannot sign informed consent
- Patients with acute stage infection of the reproductive system or other sites
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Safety, Efficacy and Operability of Using the New Tissue Containment System During Laprascopic Hysterectomy | NCT04423172 | Entailment |
6,513 | 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 suffering from constitutional von Willebrand disease for whom Desmopressin
treatment is deemed ineffective or contraindicated
- Patients suffering from von Willebrand disease and being treated or having been
treated with Voncento® for the treatment of surgical and non-surgical bleeding
episodes, the prophylaxis of surgical and non-surgical bleedings
- Patients with no history or suspicion of inhibitors (judged on previous efficacy)
Exclusion Criteria:
- Refusal of the patient or the patient's legal representative to take part in the
study;
- Existence of a contraindication to the use of Voncento® treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Registry of Patients With Von WilLEbrand Disease Treated With Voncento® | NCT04657887 | Contradiction |
4,984 | 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:
- Men and women, age 22 years and older
- Subjects who are able and willing to give informed consent and able to attend all
study visits
- Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and
examination by a neurologist or neurosurgeon specialized in movement disorder
- Subject exhibits a significant disability from their ET despite medical treatment
- Subjects should be on a stable dose of all ET medications for 30 days prior to study
entry
- Subject is able to communicate sensations during the ExAblate Transcranial procedure
Exclusion Criteria:
- Subjects with unstable cardiac status
- Severe hypertension
- Subjects with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent including advanced kidney
disease or severely impaired renal function
- Significant claustrophobia that cannot be managed with mild medication
- Current medical condition resulting in abnormal bleeding and/or coagulopathy
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within
one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
- History of intracranial hemorrhage
- History of multiple strokes, or a stroke within past 6 months
- Subjects who are not able or willing to tolerate the required prolonged stationary
supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Subjects unable to communicate with the investigator and staff
- Subjects with a history of seizures within the past year
- Subjects with brain tumors
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
| Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors | NCT02289560 | Entailment |
4,192 | 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:
- BMI 28-35
Exclusion Criteria:
- Severe disease
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 | Dietary Advice on Prescription in Kungsbacka | NCT01385930 | Contradiction |
835 | 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. Knee pain in at least one knee for more than half the days in the month prior to
screening
2. X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or
three, with definite osteophytes and possible or definite joint space narrowing,
consistent with mild to moderate knee osteoarthritis. If both knees are affected,
patients would choose the more severe knee for outcomes assessments.
3. Willingness to maintain stable analgesic regimen throughout the study period
Exclusion Criteria:
1. Diagnosis of fibromyalgia
2. Presence of an underlying inflammatory disease in the affected knee, including
Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory
disease.
3. Patients who cannot give consent will be excluded, as will patients who cannot speak,
read and understand English, as we will not have translated documents, consent forms,
and surveys for them.
4. While this supplement is considered very safe and low risk, patients with underlying
significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10,
or platelets less than 100), or with impaired renal function (glomerular filtration
rate less than 60) or elevated liver enzymes will be excluded as well.
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 | Blocking Extracellular Galectin-3 in Patients With Osteoarthritis | NCT02800629 | Entailment |
3,339 | 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:
- Aged 45 years and above.
- Bilateral moderate to severe symmetrical sensorineural hearing loss, defined as PTA
thresholds from 0.5- 4kHz falling between 40dB and 85dB.
- Normal otoscopic examination and normal middle ear function.
- Currently wears bilateral hearing aids.
- Good hearing aid user >5 hours a day bilaterally, assessed by data logging.
- English as a first language, due to the speech testing material
Exclusion Criteria:
- Under 45 years old
- Asymmetrical, mixed or conductive hearing loss,
- Recent history (<1 year) of otalgia, otitis externa, otitis media with effusion.
- Current or recent (<12 months ago) exposure to ototoxic medication e.g. cisplatin (or
other platinum-containing chemotherapy drugs) or amikacin (or other aminoglycoside
antibiotics), as stable hearing thresholds are required for the duration of the study.
- Poor hearing aid user with data logging <5 hours a day.
- English as a foreign language, illiterate or unable to read due to poor eyesight.
- Diagnosis of conditions such as muscular dystrophies or chronic fatigue syndrome that
may cause tiring during testing.
- Diagnosis of dementia or a neurological condition that would suggest poor cognitive
function.
- Identification of a significant cochlear dead region (< 3kHz) in one ear only.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 44 Years old.
| Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. | NCT04145661 | Contradiction |
2,039 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | - INCLUSION CRITERIA:
- Patients 18 years of age and older
- Patients with a diagnosis of cancer
- Patients must be able to understand and willing to sign a written informed consent
document
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 18 Years old.
| Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer | NCT01313442 | Entailment |
3,453 | 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:
- 18 years old or older
Exclusion Criteria:
- having aphasia, or severe mental disability, or other conditions which can not
accommodate audiometry.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Thai-version Five Minute Hearing Test | NCT01408992 | Entailment |
4,467 | 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:
- Traumatic distal segment injuries (elbow and wrist)
- Patients in their subacute stage.
Exclusion Criteria:
- Multiple joint problems
- Bilateral extremity problems
- Reflex sympathetic dystrophy
- Trunk and lower extremity problems
- Non-union fractures
- Malignant ans systemic diseases
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 50 Years | Effects of Core Stabilization Approach on Patients With Upper Extremity Injuries | NCT01659112 | Entailment |
3,101 | 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:
- We included all patients with moderate to severe dry eye disease (grade 3 or grade 4)
with the following criteria: The tear film break up time ≤5 seconds for grade 3 and
immediate for grade 4, schirmer test with anesthetic is ≤5 millimeters for grade 3 and
≤2 millimeters for grade 4, corneal or conjunctival staining pattern with fluorescein
is abnormal and consistent with an abnormal tear film. Oxford grade II or more,
meibomian gland dysfunction is documented (inspissation of the meibomian gland
orifices, pitting and neovascularization of the eyelid margins) and one or more
moderate (≥2+) dry eye related symptoms; including itching, burning, blurred vision,
foreign body sensation, photophobia, veiling, and soreness or pain
Exclusion Criteria:
- Exclusion criteria included Post LASIK patients, Post radiation fibrosis of lacrimal
gland, Vitamin A deficiency, Conjunctival scarring (advanced trachoma, chemical burn,
OCP), Drugs (anti-histaminics, anti-cholinergic, anti-psychotics, selective serotonin
uptake inhibitors), Patients with familial dysautonomia (Riley-Day syndrome), Use of
systemic or topical CsA in the previous 90 days.
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 | Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study | NCT04714099 | Contradiction |
5,655 | 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:
- short stature
- Physical healthy
- Mental healthy
- Capable to perform fitness test
Exclusion Criteria:
- Cardiac disease that interfere or risk the child during physical activity
- Respiratory disease that interfere or risk the child during physical activity
- Musculoskeletal disease interfering physical preformance.
- Family history of death for unknown reasons at an early age.
- Uncontroled thyroid diseae
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 17 Years | Fitness Level in Short Stature Children and After Growth Hormone Treatment | NCT02977091 | Contradiction |
5,124 | 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. | - Osteoporosis: To be included the candidate must: be >65 years with osteoporosis
objectively verified by Dual energy X-ray absorptiometry (DXA) in the hip and lumbar
back,be an independent ambulator, have experienced at least one fall in the last 12
months and have an adequate medical treatment for their osteoporosis.
- Parkinson's disease: All PD subjects will have a clinical diagnosis of -idiopathic‖ PD
(Hoehn &Yahr scores 2-3), > 60 years of age and no other existing neuromuscular
disorders, including severely flexed posture. In addition, the subjects will have no
history suggesting -atypical‖ PD symptoms.
Exclusion criteria's for all subjects are:
- moderate-severe dementia (Mini-Mental score <24)
- respiratory, cardiovascular, musculoskeletal or neurological (except PD) disorders
that may interfere with participation in the exercise program
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity | NCT01417598 | Contradiction |
4,473 | 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:
- Pain: pain will be assessed as the physician touches lateral epicondyle or passively
flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger
against resistance. Individuals who fulfill two or more of above will be considered to
have lateral epicondylitis.
- Symptom duration: should be at least 6 months.
- Previous trial of complete course of physiotherapy and corticosteroid injection.
Exclusion Criteria:
- Rheumatoid arthritis
- Generalized polyarthritis
- Local elbow arthritis
- Simultaneous medial epicondylalgia
- Bilateral lateral epicondylitis
- Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality,
radicular pain, radial nerve entrapment, signs of nerve root compression, decreased
muscle force, multiple sclerosis, seizures)
- The use of corticosteroid in last 30 days
- Simultaneous use of drugs other than acetaminophen or physical therapy in the course
of study
- Pregnancy
- Breast-feeding
- Previous hand surgery
- Having a hobby or job that needs finger extension
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 | Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis | NCT00497913 | Entailment |
4,110 | 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:
- Cough arm 1.Children age 16 years old and below with cough at presentation- Patients
presenting with active or chronic or residual cough
Well arm
1.Children age 16 years old and below and Well with no cough presentation.
Exclusion Criteria:
1. Children with severe behavioral
2. Droplet isloated cases as determined by protocol of hospital
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 16 Years | Acoustic Analytic Apps for Smart Telehealth Screening - Creating a Big Data | NCT03169699 | Contradiction |
3,733 | 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:
- Presence of osteoarthritis of the knee. Traditional American College of Rheumatology
criteria, which are based on the presence of pain (gonalgia) plus at least three of
the following characteristics, will be used for the diagnosis of osteoarthritis of the
knee:
- Age > 50 years
- Stiffness in the morning < 30 minutes
- Presence of articular rusting
- Painfulness of the bones
- Tumefaction of the bones
- Absence of palpable heat
Exclusion Criteria:
- - pregnancy and breastfeeding (if the potential participant does not declare to be in
a menopausal state)
- other specific contraindications/intolerances to the compounds contained in the
supplement (e.g. celiac disease, allergy)
- simultaneous intake of other supplements
- to be at the time of enrolment for treatment with anti-inflammatory or pain-relieving
treatment for other clinical conditions
- Participation in other clinical studies
- State of inability to understand or desire
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 | Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis | NCT04207021 | Contradiction |
816 | 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 :
Diagnosis of primary knee osteoarthritis, based upon the following:
- X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint
space narrowing and osteophyte formation
- Patients will be Kellgren and Lawrence classification II/III, and total Western
Ontario McMaster (WOMAC) score 24 -72.
- Patients fulfilling the American College of Rheumatology Clinical and Radiographic
criteria for Osteoarthritis.
Exclusion criteria:
- Patients younger than 40 years
- Women of child bearing potential.
- Women either sterilized for more than 3 months, or post-menopausal for more than 12
months. Menopause is defined as over age of 60 years or being amenorrheic for at least
2 years with plasma FSH level >30 IU/L.
- Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic
osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease,
Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium
pyrophosphate deposition disease, or neuropathic arthropathy.
- Presence of local skin abnormality at the affected knee joint.
- Intra-articular injection within 3 months.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a 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 40 Years old.
| Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II | NCT01598415 | Entailment |
1,106 | 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:
- Wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by
loading conditions.
- LVOT gradient > 30 mmHg at rest and/or > 50 mmHg at Valsalva's maneuver or exercise
- New York Heart Association Functional class (NYHA) ≥ II
Exclusion Criteria:
- Age < 18 years
- Known allergy to trial medicine
- Contraindications to beta-blocker treatment
- Contraindications to Magnetic resonans scan, including contraindication to the
contrast agent gadolinium.
- Female patients who are pregnant (positive plasma-HCG), breastfeeding or of
child-bearing potential while not practicing effective chemical contraceptive
hormones.
- In case of patients having a pacemaker, they may not be pace-dependent.
- Treatment with Amiodarone
- Atrial fibrillation/flutter at the time of examination
- Bradycardia < 49 beats/min
- Systolic blood pressure < 100 mmHg
- Trifascicular block
- Previous transcoronary ablation of septum hypertrophy (TASH) or myectomy
- Current abuse of alcohol and/or drugs
- Significant co-morbidity or issues that makes the patient unsuitable for
participation, judged by the investigator
- Patients who cannot give valid consent (e.g. mental illness or dementia)
- Patients who do not understand danish
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 Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy. | NCT03532802 | Entailment |
1,149 | 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. | 1. Physician: physicians involved in ED syncope care
2. Patients:
- Inclusion Criteria: adult (aged > 18 years) patients who present within 24 hours
of syncope
- Exclusion Criteria:
- non-syncope (prolonged LOC >5 minutes, change in the mental status from
baseline, patients with witnessed obvious seizure, or head trauma preceding
the LOC),
- those unable to provide proper details - e.g., intoxication, and those with
significant trauma requiring admission as per international consensus.
- patients who had a serious underlying condition identified during the index
ED evaluation.
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.
| Implementation of CSRS Based Practice Recommendations for Emergency Department Syncope Management | NCT04790058 | Entailment |
2,292 | 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:
- Patient is a male or female aged 18 to 65 years, inclusive.
- Patient has an established, genetically-confirmed, diagnosis of facioscapulohumeral
dystrophy with clinical findings meeting existing criteria.
- Patient has provided written informed consent after the nature of the study has been
explained and prior to the performance of any research-related procedures.
- Patient is, in the Investigator's opinion, willing and able to comply with all study
procedures.
- Cohorts ≥2 only: Patient has imaging findings meeting defined criteria for muscle
inflammation in at least 1 skeletal muscle
Exclusion Criteria:
- Patient is currently receiving treatment with an immunomodulatory agent or has a
history of such treatment, including targeted biological therapies (e.g., etanercept,
omalizumab) within the 3 months before Baseline; corticosteroids within 4 weeks before
Baseline; or high-dose non-steroidal anti-inflammatory agents (NSAIDs) within 2 weeks
before Baseline.
- Patient is currently receiving curcumin or albuterol or requires such treatment during
study participation.
- Patient has evidence of an alternative diagnosis other than FSHD, based on prior
muscle biopsy or genetic test findings.
- Patient has a presumptive diagnosis of FSHD, based on clinical assessment, but does
not yet have genetic confirmation of the diagnosis.
- Patient has a severe retinopathy.
- Patient has a history of obstructive or restrictive lung disease (including
interstitial lung disease, pulmonary fibrosis, or asthma), or evidence for
interstitial lung disease on Screening chest radiograph.
- Patient has a history of anti-synthetase syndrome, prior Jo-1 antibody
(Ab)-positivity, or has a positive or equivocally positive Jo-1 Ab test result during
Screening.
- Patient has acute or clinically relevant Epstein-Barr virus or cytomegalovirus
infection or re-activation.
- Patient has a chronic infection such as hepatitis B virus, hepatitis C virus, or human
immunodeficiency virus or a history of tuberculosis.
- Patient has received a vaccination within 8 weeks before Baseline or vaccination is
planned during study participation.
- Patient has symptomatic cardiomyopathy or severe cardiac arrhythmia that may, in the
Investigator's opinion, limit the patient's ability to complete the study protocol.
- Patient has anemia (as defined for patient's age and gender by local laboratory
range).
- Patient has gamma-glutamyl transferase (GGT) or serum creatinine levels >2 × the upper
limit of normal (ULN).
- Patient has abnormal baseline findings, medical condition(s), or laboratory findings
that, in the Investigator's opinion, might jeopardize patient's safety or decrease the
chance of obtaining satisfactory data needed to achieve the objectives of the study.
- Patient has evidence of clinically significant cardiovascular, pulmonary, hepatic,
renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a
condition that requires immediate surgical intervention or other treatment or may not
allow safe participation.
- Patient has used any investigational product or device (other than a mobility
assistance device) within 30 days before Baseline.
- Patient has received a product intended to enhance muscle growth within 30 days before
Baseline.
- Patient underwent muscle biopsy within 30 days before Baseline.
- Patient initiated treatment with a statin or had a significant adjustment to their
statin regimen within 3 months before Baseline. (Stable, chronic statin use is
permissible.)
- Patient has received a product that putatively enhances muscle growth (e.g.,
insulin-like growth factor, growth hormone) or activity (e.g., Coenzyme A) on a
chronic basis within 4 weeks before Baseline.
- Patient is unwilling to abstain from strenuous physical activity for 24 hours prior to
each study center visit.
- Patient previously received ATYR1940.
- If female and of childbearing potential (premenopausal and not surgically sterile),
patient has a positive pregnancy test at Screening or is unwilling to use
contraception from the time of Screening through 1 -month after the last Study Drug
dose. Acceptable methods of birth control include abstinence, barrier methods,
hormones, or intra-uterine device.
- If male, patient is unwilling to use a condom plus spermicide during sexual
intercourse from the time of Screening through 1 -month after the last Study Drug
dose.
- Cohorts ≥2 only: Patient has a known contraindication for MRI assessments (e.g., metal
prosthesis or pacemaker) as per local site MRI protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATYR1940 in Adult Patients With Muscular Dystrophy | NCT02239224 | Contradiction |
2,627 | 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:
- 18 month to 12 years old children undergoing elective unilateral inguinal hernia
repair surgery
Exclusion Criteria:
- neurological disease, developmental delay
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Months old.
Subject must be at most 12 Years | Does Oral Intake Decreases Postoperative Pain Score in Children | NCT01949987 | Contradiction |
3,940 | 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:
- Patient is at least 40 years of age
- Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on
clinical and radiographic criteria
- Female patients of childbearing potential must have a negative pregnancy test prior to
study enrollment and must agree to remain abstinent, and use barrier, intramuscular,
or implanted contraceptives from Visit 1 until 28 days after the last dose of study
medication.
- Patient is of American Rheumatism Association (ARA) functional Class I, II, or III
- Patient is willing to limit alcohol intake to 2 or less drinks per day during study
and the follow-up period
- Patient is willing to avoid unaccustomed physical activity for the duration of the
study and follow-up period
- With the exception of osteoarthritis, the patient is judged to be in good general
health based on medical history, physical exam, and routine laboratory tests
- Patient is able to read, understand and complete study questionnaires, including
questions requiring a visual analog scale (VAS) response
- Patient provides written informed consent for the trial
- For prior non-steroidal anti-inflammatory drug (NSAID) users only, the patient has a
history of positive therapeutic benefit with NSAIDs and has taken an NSAID prior to
study enrollment and at a therapeutic dose level prior to study enrollment (Visit 1)
- For prior NSAID users only, the patient assessment of Pain Walking on a Flat Surface
(WOMAC Section A, Question1) at Visit 1 (prestudy) is less than 80 mm (100 mm VAS)
- For prior NSAID users only, prior to randomization, and following discontinuation of
NSAIDs during the washout period specified patients must satisfy the following 3 flare
criteria: Minimum of 40 mm on patient reported Pain Walking on a Flat Surface (WOMAC
Section A, Question 1); Increase of 15 mm on patient reported Pain Walking on a Flat
Surface (WOMAC Section A, Question 1) compared to prestudy baseline recorded at Visit
1; and A worsening in Investigator Global Assessment of Disease Status of at least 1
category on a 5 category scale compared to Visit 1 recording
- For prior acetaminophen/paracetamol users only, patient has taken
acetaminophen/paracetamol on a regular basis prior to study enrollment (Visit 1) and
does not use NSAIDs for the treatment of osteoarthritis of the knee
- For prior acetominophen/paracetamol users only, at both Visits 1 and 2, patients must
satisfy all of the following 3 criteria: Minimum of 40 mm on patient reported Pain
Walking on a Flat Surface (WOMAC Section A, Question 1); Investigator Global
Assessment of Disease Status as fair, poor, or very poor; and Minimum of 40 mm on
Patient Global Assessment of Disease Status (100 mm
VAS)
Exclusion Criteria:
- Patient has a concurrent medical/arthritic disease that could confound or interfere
with evaluation of efficacy
- Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has
active psychosis, or significant emotional problems at the time of the study which in
the view of the investigator are sufficient to interfere with the conduct of the study
- Patient has a history of gastric or biliary surgery (including gastric bypass
surgery), or small intestine surgery that causes clinical malabsorption
- Patient is allergic to, or has a history of a significant clinical or laboratory
adverse experience associated with etoricoxib or celecoxib or any of their
constituents
- Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g.,
bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs
- Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min
- Patient has Class II-IV congestive heart failure
- Patient has established ischemic heart disease, cerebrovascular disease, or peripheral
vascular disease
- Patient has uncontrolled hypertension with an diastolic exclusionary limit of > 90 mm
Hg and a systolic exclusionary limit of > 140 mm Hg
- Patient has moderate or severe hepatic insufficiency defined as Child Pugh score > 6
- Patient has a history of neoplastic disease
- Patient has a history of any illness, which in the opinion of the investigator, might
confound the results of the study or pose additional risk to the patient
- Patient is, at the time of signing informed consent, a user of recreational or illicit
drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse
or dependence
- Patients considered morbidly obese with a body mass index (BMI) ≥ 35 kg/m^2
- Patient has new use (within 2 weeks of Visit 1 and during the entire duration of the
study and follow-up period) of physical medicine modalities involving the study joint,
including but not limited to: physical therapy, chiropractic interventions,
acupuncture, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound
- Patient is expected to undergo surgery involving the study joint during the course of
the study
- Patients taking oral contraceptives
- Patients using intra-articular steroids or hyaluronic acid injections to the study
knee or other immunosuppressant medication within 3 months of Visit 1
- Patients using intravenous, intramuscular, or oral corticosteroids, intra-articular
steroids or hyaluronic acid injections to any joint other than the study joint within
1 month of Visit 1
- Patients using topical or systemic analgesic medications within 3 days of Visit 1 and
throughout the duration of the study
- Patients using non-study NSAID or cyclooxygenase 2 (COX-2) specific inhibitor during
the study treatment period, with the exception of low-dose aspirin (≤ 325 mg/day)
- Patients receiving a Chinese traditional arthritis treatment within 1 week of Visit 1
- Patients with clinically significant abnormalities on Visit 1 clinical examination or
laboratory safety tests. Serum transaminases should be ≤ 150% of the upper limit of
normal
- Patients currently participating in or has participated in a study with an
investigational drug or device within 4 weeks of signing informed consent
- Patients with an active peptic ulcer or a history of inflammatory bowel disease
- Patients with a personal or family history of an inherited or acquired bleeding
- Patients that are pregnant or breast-feeding, or expecting to conceive within the
projected duration of 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 40 Years old.
| Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis | NCT01554163 | Entailment |
1,152 | 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 - HCM Patients:
HCM defined as maximal LV wall thickness by echocardiography greater than 13mm in the
absence of other causes of LVH or greater than 15mm asymmetrical LV wall thickness if there
is a history of mild hypertension (defined as systolic less than 160mmHg and diastolic less
than 100mHg) controlled for greater than 6 months
Non-obstructive HCM
Age greater than or equal to 21 years.
Patients with LV obstruction treated by LV myotomy and myectomy or percutaneous septal
alcohol ablation that meet inclusion criteria are eligible for this study.
EXCLUSION CRITERIA - HCM Patients:
LV outflow obstruction noted during Doppler echocardiography at rest or with Valsalva
maneuver defined as instantaneous peak gradient greater than 30 mmHg
Hemodynamically significant valvular disorders, history of significant coronary obstruction
(greater than 50% in any single artery), angina symptoms, myocardial ischemia on an imaging
stress test or evidence of prior myocardial infarction. Patients older than 40 years of age
with effort induced anginal symptoms typical of coronary insufficiency and a coronary
distribution of myocardial ischemia on an imaging stress test will be considered for the
study if coronary angiography rules out significant obstructive coronary disease.
Chronic atrial fibrillation
Cardiac pacemaker or other metallic implant unsafe for MRI
Uncontrolled hypertension
Dependence on a beta blocker that cannot be withdrawn
Dependence on a calcium blocker that cannot be withdrawn
Current use of digoxin
History of digitalis intolerance
Renal failure
Diabetes mellitus
Pregnancy or lactation
Failure to indicate effective method of birth control measures if female patient is of
childbearing age.
Inability to exercise or disease states likely to result in impaired exercise capacity
(such as pulmonary, hematological and musculoskeletal disorders)
Echocardiographic images of insufficient quality, even after administration of contrast
agent, for volumetric analysis.
Inability to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy | NCT00074880 | Entailment |
4,445 | 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:
- Patients who present with elbow pain and are diagnosed with unilateral LE due to the
presence of pain by pressing on the epicondyle in physical examination, wrist
extension against resistance and during stretching of the wrist extensors, who have
elbow pain for at least 3 months and between the ages of 18-65 will be accepted to the
study.
Exclusion Criteria
- Those with communication problems
- A history of cervical and shoulder problems
- History of injection, surgery, physical therapy in the elbow area in the last 6 months
- Having had ESWT treatment in the elbow area before
- History of elbow problems other than LE
- Elbow osteoarthritis, previous elbow fracture history
- A history of polyneuropathy,
- Those with a history of uncontrolled systemic disease (cardiovascular, pulmonary,
hepatic, renal, hematologic ..),
- Those with a history of systemic endocrine disease (DM, hyperthyroidism ..),
- Major psychiatric illness
- History of rheumatic diseases such as fibromyalgia, polymyalgiaromatica, ankylosing
spondylitis, rheumatoid arthritis
- Those who use bleeding disorders and anticoagulants
- Neurological deficit
- Malignancy
- Those with a history of pacemakers were not included in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis | NCT04748406 | Contradiction |
6,191 | 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:
- Age over 18
- A person diagnosed with COVID-19
- Asymptomatic at the time of admission
Exclusion Criteria:
- Patients over 75 years
- Taking antibiotics or antiretroviral for any reason
- Mild to Moderate symptoms at the time of hospital admission
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients | NCT04480398 | Contradiction |
5,208 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related
vertebral fracture. Chronic back pain.
Exclusion Criteria:
- Previous/current treatment and medical history.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM) | NCT00713258 | Entailment |
3,229 | 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 Sjogren's Syndrome.
- Self-reported complaints of ocular dryness for a period of at least 3 months
- Best-corrected distance visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
- Use of cyclosporine within the last 3 months.
- Use of ocular steroid within the 3 months.
- Previous history of treatment failure with cyclosporine.
- Known hypersensitivity or contraindication to the study medication or any of its
ingredients.
- Use of any systemic or topical ocular medication that is known to cause or exacerbate
dry eye.
- Any active ocular infection.
- Severe or serious ocular condition in either eye or any other unstable medical
condition that may preclude study treatment or follow-up.
- History or presence of chronic generalized systemic disease that might increase the
risk to the subject or confound the results of the study.
- Currently pregnant or lactating.
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 | CEQUA for Sjogren's Syndrome Dry Eye | NCT04835623 | Entailment |
4,360 | 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:
- Healthy male or female subjects in good health as determined by past medical history
- physical examination, vital signs and safety lab at screening
- between 18 to 45 years of age
Exclusion Criteria:
- Significant illness
- pregnant or lactating women
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 45 Years | Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat | NCT04644705 | Entailment |
2,187 | 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:
- Age 30 years or older and able to provide informed consent
- Diagnosis of gout according to the American College of Rheumatology (ACR) / European
League Against Rheumatism (EULAR) classification criteria
- Radiographic foot bone erosion attributable to gout and confirmed by a radiologist
- Serum urate of ≤ 5 mg/dL (300 µmol/L) or less*
Exclusion Criteria:
- Treatment with bisphosphonates in the preceding 2 years
- Any prior treatment with denosumab
- Women of childbearing potential, who are not currently using birth control, are
pregnant, planning to become pregnant, or are breast-feeding
- Men planning to conceive in the next 12 months
- Unstable systemic medical condition
- Uncontrolled hyperthyroidism
- Uncontrolled hypothyroidism
- History of Addison disease
- History of osteomalacia
- History of osteonecrosis of the jaw (ONJ)
- History of atypical femur fracture
- History of tooth extraction, jaw surgery, dental implants, or other dental surgery
within the prior 6 months
- History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition.
- Invasive dental work planned in the next 2 years
- History of Paget's disease of bone
- Other bone diseases which affect bone metabolism
- Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]†
- Hypercalcemia
- Elevated transaminases ≥ 2.0 x upper limit of normal (ULN)
- Elevated total bilirubin > 1.5x ULN
- History of any solid organ or bone marrow transplant
- Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell
carcinoma)
- Hypocalcemia
- Poorly tolerant of ULT including allopurinol, febuxostat, or probenecid
- Estimated glomerular filtration rate < 30 mL/minute/1.73 m^2
- Current use of any biological therapy (eg. infliximab, etanercept, adalimumab, etc.)
- Treatment history with pegloticase or another recombinant uricase
- Recipient of an investigational drug within 4 weeks prior to study drug administration
or plans to take an investigational agent during 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 30 Years old.
| Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions | NCT02903446 | Contradiction |
5,021 | 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:
1. Subjects must provide written informed consent prior to the initiation of any study
related procedures;
2. Subjects ≥ 40 years of age;
3. Subjects with upper extremity tremor for < 2 years duration.
Exclusion Criteria:
1. Any clinically significant acute or unstable physical or psychological illness based
on medical history or physical examination at Visit 1, as determined by the Principal
Investigator;
2. Any unexpected clinically significant abnormal laboratory or ECG results obtained at
Visit 1 and as determined by the Principal Investigator;
3. Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of
informed consent, as defined by the Diagnostic and Statistical Manual of the American
Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994
#2});
4. Positive urine drug screen at Visit 1;
5. Participation in an investigational drug or device clinical trial within 30 days prior
to the date of informed consent;
6. Previous participation in any 123I-ALTROPANE® trial;
7. Any exposure to radiopharmaceuticals within 30 days prior to the date of informed
consent;
8. Positive (+) pregnancy test at Visit 1 and/or Visit 2;
9. Breast-feeding;
10. Inability to lie supine for 1 hour;
11. Any significant active thyroid disease;
12. Known sensitivity or allergy to Iodine or Iodine containing products;
13. A history of repeated head injury or sustained severe head injury in year prior to
onset of tremor;
14. A definitive diagnosis of encephalitis;
15. Any uncontrolled hypertension or diabetes;
16. Any history of cerebrovascular disease;
17. Previous evaluation by a Movement Disorder Specialist (MDS);
18. Treatment within the previous six (6) months prior to informed consent with bupropion,
metoclopramide, cinnarizine, flunarizine, methylphenidate, reserpine, modafinil, alpha
methyldopa, amphetamine, or any anti-psychotic medication;
19. Any treatment with anti-Parkinson's drugs or anti-tremor medications within three (3)
months prior to the date of the subject signing the informed consent;
20. Any new prescription or change in dose of medications for chronic conditions within
four (4) weeks of Visit 2.
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.
| 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor | NCT00596908 | Entailment |
5,116 | 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:
- Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with
osteoporosis
- BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total
neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites
Exclusion criteria:
- Have been treated with other bisphosphonates or using chronic steroids within the past
6 months
- Have a history of major upper gastrointestinal (GI) diseases or have severe kidney
dysfunction
- Have a spine fracture (identified on X-ray)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 80 Years | A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo | NCT00148915 | Contradiction |
1,355 | 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:
- Newborn with a diagnosis of Hirschsprung's disease the 2 first months of life,
- Born at or after 35 weeks of gestation (37 weeks of amenorrhea),
- With a short-segment Hirschsprung's disease limited to the rectum and/or sigmoid colon
diagnosed on rectal biopsy with established pathological criteria (absence of
ganglionic cells +/- hypertrophic extrinsic nerve fibres) (Kapur, Sem Ped Surg 2009),
- Managed successfully with colonic decompressions/irrigations before curative surgery
(usually performed 2-3 times a day),
- Uncomplicated form (without enterocolitis and/or diverting colostomy),
- Curative surgery and follow-up in one of the included centres,
- With consent of the 2 parents or legal(s) representative(s),
- Absence of severe or lethal associated malformations,
- Affiliation with the French social security system.
Exclusion Criteria:
- - Long segment Hirschsprung's disease prior to the junction between the left colon and
the sigmoid colon,
- Hirschsprung's disease not managed successfully with colonic
decompressions/irrigations and requiring a diverting colostomy before the curative
surgery,
- Hirschsprung-associated enterocolitis occurring before the randomization,
- Severe or lethal associated malformation, including Down syndrome,
- Intestinal associated malformations (intestinal atresia, gastroschisis, omphalocele,
intestinal malrotation and volvulus),
- Any pathological condition that can modify intestinal motility or intestinal transit
time (cystic fibrosis, hypothyroidism),
- Refusal of parent(s) or legal representative(s).
- Patients under curatorship or tutorship
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's Disease | NCT03660176 | Contradiction |
6,226 | 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:
- Age > 18 years old
- Patient COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 for less than 10 days, or by
thorax CT-scan suggesting specificdiagnostic aspects of COVID-19 requiring abdominal
or gynecological surgery by emergency laparoscopy
OR
- Patient COVID-19 suspected requiring abdominal or gynecological surgery by emergency
laparoscopy. Suspicion will be defined by the presence of at least one of the
following symptoms:
- Cough for less than 15 days
- Fever which appeared recently and which excluded another etiology
- Anosmia without obstructive rhinitis
- Contact with a COVID-19 + case person less than 21 days ago
- Patient requiring abdominal or gynecological surgery by emergency laparoscopy and who
should be tested by RT-PCR SARS-CoV-2
- Written and signed consent of the patient or guardian or family or, if this is not
possible, emergency inclusion procedure
- Patients with affiliation to French social security system
Exclusion Criteria:
- Patient already participating in research involving the human person
- Negative RT-PCR SARS-CoV-2
- Withdrawal of patient or guardian or family; or refusal to sign the required inform
consent form to continue to participate 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 18 Years old.
| Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum of COVID-19 Patients | NCT04361396 | Contradiction |
4,078 | 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:
- Age 65 or above;
- No history of cerebral vascular disease, Parkinson's disease or other neurological
deficit;
- Chinese version of the Mini-Mental State Examination (MMSE-C) total score of equal or
more than 24;
- Able to walk independently indoor for at least 40 meters continuously with comfortable
pace;
- Older adults with moderate to high risk of falling, as indicated by the score of less
than 24 out of 28 in the Tinetti Balance Assessment Tool.
Exclusion Criteria:
- Any potential participant who cannot meet the inclusion criteria.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| The Role of Attention Focus Walking Training in Older Adults. | NCT04419753 | Contradiction |
2,791 | 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:
- All consecutive ASA grade I-II- III patients undergoing elective unilateral
laparoscopic total extra peritoneal (TEP) Inguinal hernia repair
- Age 18 - 80 yrs, including those who are having recurrent inguinal hernia repair.
Exclusion Criteria:
- ASA grade IV, V
- Bilateral inguinal hernia repair
- BMI > 40 kg/m2
- Converted to open procedures.
- Conversion to Transabdominal preperitoneal (TAPP) repair
- Coagulopathy.
- Allergy to Bupivacaine.
- Diagnosis of "chronic pain syndrome".
- Known alcohol or substance abuse within the last 6 months.
- Daily Opioid intake.
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 | Lap TAP Block for Laparoscopic TEP Inguinal Hernia Repair: a Prospective, Double-blinded, Randomized, Clinical Trial | NCT02632136 | Entailment |
1,971 | 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:
- Pathologically confirmed adenocarcinoma of the esophagus, GEJ or stomach.
- Stage IV disease or locally advanced/unresectable tumors
- Prior progression on only 1 line of chemotherapy in the advanced/metastatic setting
containing a fluoropyrimidine and/or platinum compound
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Exclusion Criteria:
- Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients
in the dose escalation component may have received a taxane in the peri-operative
setting, provided they developed disease recurrence >6 months after the completion of
this therapy
- Known pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C,
nonalcoholic steatohepatitis, sclerosing cholangitis)
- Patients with any clinically apparent ascites or who have undergone a paracentesis
within 7 days of enrollment
- Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm
Hg on repeated measurement) despite optimal medical management
- Active or clinically significant cardiac disease
- Patients with arterial thrombotic events, such as cerebrovascular accident or
myocardial infarction, within 6 months of enrollment
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.
| Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma | NCT03193918 | Entailment |
226 | 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:
- General good health (by volunteer history and per investigator judgment) without any
clinically significant systemic disease (including, but not limited to significant
liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract,
uterus and cervix
- Currently have regular menstrual cycles of 21-35 days by participant record
- Willing to abstain from vaginal intercourse and any other vaginal activity including
use of vaginal products (tampons, spermicides, lubricants, and douches) other than
study products:
- 48 hours before Visit 2 until six days after Visit 2
- 48 hours before Visit 3 until six days after Visit 4
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Estimated calculated creatinine clearance (eCcr) of at least 60 mL/min
- History of Pap smears and follow-up consistent with standard clinical practice as
outlined in the study manual or willing to undergo a Pap smear at Visit 1
- Protected from pregnancy by one of the following:
- sterilization of either partner
- abstinence
- same sex relationship
- condoms
- combined contraceptives (including oral, patch)
- copper IUD
- Willing and able to comply with protocol requirements including swallowing tablets
- Willing to give voluntary consent and sign an informed consent form
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within two calendar months from the last pregnancy outcome.
Note: if recently pregnant must have had at least two spontaneous menses since
pregnancy outcome
- Injection of Depo-Provera in the last 10 months or use of other progestin-only based
contraceptive (including hormonal IUD)
- Currently breastfeeding or planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study products, topical
anesthetic, or to both silver nitrate and Monsel's solution
- In the last three months, diagnosed with or treated for any STI, by self report
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
HIV, or Hepatitis B surface antigen (HBsAg) Note: Women with a history of genital
herpes who have been asymptomatic for at least three months may be considered for
eligibility
- Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding,
discharge, etc.)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, anticoagulants or other drugs known to
prolong bleeding and/or clotting, antifungals, or antivirals (e.g., acyclovir,
valacyclovir, Viread®, Atripla®, Emtriva®, or Complera®)
- Current or anticipated chronic use of NSAIDS, or Tylenol for the duration of the study
- Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS,
National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the
Severity of Adverse Events, or clinically significant laboratory abnormality as
determined by the clinician
- Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or which, in the opinion of the investigator, would
make participation in the study unsafe or would complicate interpretation of data
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Exploratory Pharmacodynamic Study of Tenofovir-Based Products | NCT02722343 | Contradiction |
6,850 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Diagnosis of Polymyositis or Dermatomyositis.
Baseline muscle weakness score of less than or equal to 139 out of 160 on manual testing
(MMT).
Baseline functional assessment score of less than or equal to 82 out of 91.
Ability to provide informed consent to all aspects of the study after full information is
provided.
Age equal to or older than 18.
A diagnosis of classic or definite polymyositis or dermatomyositis (Critieria A and B plus
at least one of the three other criteria):
1. Symmetrical proximal muscle weakness;
2. Muscle biopsy abnormalities at some time during their disease:
i. degeneration and regeneration of muscle fibers
ii. necrosis
iii. phagocytosis
iv. interstitial mononuclear infiltration;
c. Elevation of serum creatinine phosphokinase (CPK), transaminases, lactic dehydrogenase
(LDH) or aldolase activity;
d. Electromyography (EMG) triad of changes
i. small amplitude, short duration polyphasic motor unit potentials
ii. fibrillations, positive sharp waves, increased insertional irritability
iii. spontaneous bizarre high frequency discharges;
e. Typical skin rash of DM.
Willingness to undergo 2 muscle biopsies.
Evidence of active disease as measured by weakness, and an elevated CK or an active MRI.
Must be tapered to a stable dose of steroid equal to or less than 0.50 mg/kg/day equivalent
of prednisone for one month prior to the study.
If on additional immunosuppressive drugs, the drugs must be maintained at a stable dose for
1 month prior to the initiation of therapy and will be maintained throughout the trial.
Women of childbearing potential and men whose partners are of childbearing potential must
practice an acceptable form of contraception. No pregnant females or nursing mothers.
No history of hepatitis or abnormal liver function tests.
No history of prior thyroid disease.
No active acute or chronic infections requiring antimicrobial therapy, or serious viral or
fungal infections.
No preexisting or coexisting malignancy other than basal cell and localized squamous cell
carcinoma of the skin.
No history of cerebrovascular accidents, seizure disorder, aseptic meningitis, transverse
myelitis or central nervous system disease.
No history of documented coronary artery disease, cardiomyopathy, greater than first-degree
heart block, or dysrhythmia requiring therapy.
No confounding medical illness that in the judgement of the investigators would pose added
risk for study participants.
No anemia requiring maintenance blood transfusions; leukoplakia with WBC less than 3,000
micrograms or absolute neutrophil count less than 2,000 micrograms; and platelet count less
than 100,000 micrograms on at least two different occasions.
No history of (or current) autoimmune hemolytic anemia.
No current anticoagulant therapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Methimazole to Treat Polymyositis and Dermatomyositis | NCT00001421 | Entailment |
4,292 | 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:
- Patient and/or parents/guardian signed informed consent
- Patients with cough or shortness of breath
Exclusion Criteria:
- Chest tubes
- Skin lesions precluding attachment of sensors
- Respiratory distress
- Pregnant women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 45 Years | Assessment of Cough and Wheeze With Breath Sound Documenting Device | NCT00711399 | Entailment |
4,802 | 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. Age between 20 and 79 years, of either sex
2. Dizziness originating from Ménière disease, psychogenic cause, or unknown cause
3. Recurring symptom of dizziness for more than 1 month
4. Dizziness Handicap Inventory (DHI) score ≥ 24 at baseline
5. Liver-deficiency pattern/syndrome identified by Traditional Korean Medicine doctors
6. Willingness to provide written informed consent
Exclusion Criteria:
1. Dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional
vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others)
2. Dizziness attributable to central nervous system (CNS) disorders (e.g., cerebellar
ataxia, stroke, demyelination, vertebrobasilar insufficiency, seizure, increased
intracranial pressure, Parkinson's disease, migraines, and others)
3. Cervicogenic dizziness
4. Dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular
disease, anemia, orthostatic hypotension, coronary artery disease, and others)
5. Any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled
diabetes mellitus, hypertension, respiratory or endocrinological disorders, and
others)
6. Dizziness attributable to medication side effects
7. Severe chronic or terminal diseases (malignant cancer, tuberculosis, and others)
8. Intake of other antivertiginous drugs that cannot be discontinued
9. Following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or
cognitive behavioral therapy for the treatment of dizziness
10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen
(BUN), or creatinine > 3 × upper limit of normal range at baseline
11. Women of (suspected) pregnancy or breast-feeding
12. Allergic reactions to the study medications
13. Suspicion of alcohol and/or drug abuse
14. Enrollment in another clinical study presently or within 30 days prior to the initial
administration of the study medications
15. Difficulty in reliably communicating with the investigators or likelihood of inability
to follow instructions
16. Other reason for ineligibility of participation
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 | Herbal Medication (Gongjin-dan) for Chronic Dizziness | NCT03219515 | Entailment |
6,683 | 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:
- Severe hemophilia A (FVIII:C <= 1%)
- Male subjects between 12 and 65 years of age
- Body weight 25 kg to 110 kg
- Previously treated with FVIII concentrate for at least 150 EDs
Exclusion Criteria:
- Other coagulation disorder than hemophilia A
- Present or past FVIII inhibitor activity
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A | NCT00989196 | Contradiction |
850 | 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. HOA with fulfillment of the ACR criteria:
a. Hand pain, aching or stiffness on most days the previous 4 weeks
And at least 3 of the following features:
- Hard tissue enlargement of ≥2 of the 10 selected joints*
- Hard tissue enlargement of ≥2 of the 10 DIP joints
- Fewer than 3 swollen metacarpophalangeal (MCP) joints
- Deformity of at least 1 of 10 selected joints* *The 10 selected joints are the
second and third DIP, the second and third PIP, and the first carpometacarpal
joints of both hands.
2. AUSCAN Function ≥ 40 aggregated points (0-100 scale)
3. Willing and able to participate in all study visits
4. Able to understand and read Danish.
Exclusion Criteria:
1. Other diseases affecting the joints of the hand (Rheumatoid arthritis, Psoriatic
arthritis, ect.)
2. Widespread or generalized pain syndrome (e.g. fibromyalgia)
3. Steroid injections in the finger joints within the last month
4. Other condition that in the opinion of the investigator makes the participant
unsuitable for participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Heated Mittens for Patients With Hand Osteoarthritis | NCT04576403 | Entailment |
2,864 | 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. | Early ALS Inclusion Criteria:
- Sporadic or familial ALS (as defined by revised El Escorial criteria)
- Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline
Visit.
- Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age
Early ALS Exclusion Criteria:
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of active
substance abuse within the prior year.
ALS Disease Mimics Inclusion Criteria:
- Diagnosis of one of the following:
a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii.
Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness
involving more than one extremity or more than a single myotome if restricted to one
extremity.
iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth
Disease vi. Any condition that produces generalized or localized weakness without
concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating
physician deems mimics ALS.
b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple
sclerosis iii. Hereditary spastic paraparesis
ALS Disease Mimics Exclusion Criteria:
- Diagnosis of possible, probable, probable-laboratory supported, or definite ALS
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.
Healthy Volunteer Inclusion Criteria:
- Absence of a known neurological disorder.
Healthy Volunteer Exclusion Criteria:
- History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative
disease.
- Presence of positive family history of ALS.
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.
*Please note that this is not a complete listing on all eligibility criteria.*
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 80 Years | Study of Electrical Impedance Myography (EIM) in ALS | NCT02011204 | Entailment |
5,708 | 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:
- Turner Syndrome
- Not previously treated with growth hormone or androgen
- Well-documented height over the previous 12 months
- Informed consent of parents (and child if appropriate)
Exclusion Criteria:
- Growth hormone (GH) deficiency based on a GH stimulation test
Female
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 11 Years | Use of Somatropin in Turner Syndrome | NCT01518036 | Entailment |
5,243 | 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:
- Being in the postmenopausal period
- Having body mass index equal to or greater than 18,5 kg/m²
- A lack of regular exercise
- Having been diagnosed with osteoporosis
- Having the ability to walk independently
Exclusion Criteria:
- Having a cardiopulmonary problem that may prevent participating in exercise programs
- Having kidney stones
- Being diagnosed with diabetes
- Presence of epilepsy
- Having cardiological problems such as arrhythmia, using a pacemaker, hypertension
- Having neurological disorders such as Parkinson, stroke, multiple sclerosis,
neuropathy
- Having surgery in the last 6 months
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Effects of Clinical Pilates and Whole Body Vibration Exercises in Postmenopausal Osteoporotic Women | NCT04259697 | Entailment |
4,690 | 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 submitted to total laparoscopic hysterectomy
Exclusion Criteria:
- Women <18 years
- Women no able to understand the study or not native in Danish
- Women with uterine malignancy
- Women with suspicion of pelvic mass
- Women with abnormal coagulation
- Women receiving glucocorticoid treatment
- Women receiving anticoagulant treatment or have not followed prescription in relation
to surgery
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy | NCT02709460 | Entailment |
Subsets and Splits
No saved queries yet
Save your SQL queries to embed, download, and access them later. Queries will appear here once saved.