cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology

The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) \>15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol


Eligibility Criteria:
Inclusion criteria:

* Patient signed inform consent.
* Males and Females.
* Age ≥50 years.
* Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) ≥15mm in Echocardiogram.
* Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.

Exclusion criteria:

* Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
* Severe aortic stenosis defined as aortic valve area (AVA) \< 1.0 cm2
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).

This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms:

* Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks
* Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks
* Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
3. Has NYHA functional class II- III heart failure.
4. Has 6MWT distance from 100 to 450m.
5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
6. Is able to understand and provide documented consent for participation.

Exclusion Criteria:

1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
2. Current or recent hospitalization prior to screening.
3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.
7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
8. Has any of the following clinical laboratory values during screening:

   1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN;
   2. eGFR \<30 mL/min/1.73 m2;
   3. HbA1c (glycosylated hemoglobin) \>9%;
   4. Platelet count \<50,000/millimeter cube;
   5. Hemoglobin \<10.0g/dL;
9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
10. Is pregnant or breastfeeding.
11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
12. Has a history of drug or alcohol abuse.
13. Was recently dosed in any clinical research study.
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the hip, knee, or spine for 1 year or longer.
* taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

Exclusion Criteria:

* taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
* requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.
Cardiac Rehabilitation With and Without Delorme Technique of Progressive Resisted Exercises in Patients of Post PCI.

To find the effect of cardiac rehabilitation program with and without progressive resisted exercises on patients after acute stage of PCI with at least 8 weeks history. It is a randomized clinical trial using convenient sampling technique. Randomly assign participants into two groups: An intervention group receiving Delorme progressive resisted exercise along with cardiac rehab and a control group undergoing standard cardiac rehabilitation alone. In Group A, Delorme technique will involve a 10-repetition max of aerobic and resistance exercises along with cardiac rehab. Seven different exercises will be performed in 3 sets of 10-repetition max. The control group will not be performing any type of training but will undergo cardiac rehab alone. Data will be analyzed using t test and SPSS 21 will be used for data collection. Age group will be from ≥70 years with patient undergoing dyspnea along with recent history of primary diseases. Data will be collected from Bethania Hospital, Sialkot through tools like the 6-minute walk test, Rose Angina questionnaire or settle angina questionnaire, quality of life scale (QOLFS), and Modified Borg dyspnea scale.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 70 years"
* "Recent history of PCI due to primary diseases (coronary heart disease, acute myocardial infarction, acute coronary syndrome, acute angina)"
* "Presence of dyspnea"
* "First-time PCI

Exclusion Criteria:

* "Renal failure"
* Chronic liver disease
* Chest disease
* Patient who could not fulfill the questionnaire or cooperate through the performed procedures
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

This study is a phase I\& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged ≥3 years;
* Proven legal identity;
* Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

Exclusion Criteria:

* Prior vaccination with influenza vaccine of the current year;
* History of influenza within 6 months prior to study entry;
* Axillary temperature \> 37.0 °C;
* History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
* Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
* History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
* No spleen, or functional no spleen, or splenectomy.
Mifepristone and Misoprostol for Fetal Demise

This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.


Eligibility Criteria:
Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy

-

Exclusion Criteria:

* orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism

OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.

II. Identify intake measures that predict differences in outcome between subjects in the experimental group.

PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.

A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.

Eligibility Criteria:
INCLUSION CRITERIA:

--Disease Characteristics--

Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria

Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development

--Patient Characteristics--

Other:

Must reside within 60 km (37.5 miles) of a treatment site

EXCLUSION CRITERIA:

Severe medically induced limitations defined as:

* Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
* Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
* Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
* Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation

Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC

Inclusion criteria:

1. Primary hepatocellular
2. No other treatments ware performed before microwave ablation
3. Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
4. No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi

Exclusion Criteria:

* Exclusion criteria:

  1. Non-primary hepatocellular carcinoma or hepatic metastases
  2. Accept other treatment before microwave ablation
  3. Extrahepatic metastasis, vessel invasion or bile duct thrombi
Point of Care Ultrasound for the Detection of Esophageal Food Bolus

This will be a prospective, observational, case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department (YHED) with signs and symptoms of esophageal food or foreign body impaction. Point of care ultrasound (POCUS) will then be performed by a trained emergency physician to collect ultrasound data, including the presence or absence of direct visualization food bolus/foreign body, as well as secondary markers of dilatation, such as maximal esophageal area. Investigators will also enroll an age/sex-matched control group of asymptomatic individuals to establish baseline esophageal measurements.

Patients will otherwise receive medical treatment per standard of care. Subsequent interventions will also be documented, including glucagon, carbonated beverages, and esophagogastroduodenoscopy (EGD). If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound. Chart review at 1 month will be performed to establish results of EGD including improvement, recurrence, or presence of pathologic abnormalities. The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management.


Eligibility Criteria:
Eligibility (CASES)

* Inclusion criteria:

  1. Age ≥18 years
  2. Signs and symptoms of esophageal food bolus or foreign body
* Exclusion criteria:

  1. Prior esophageal surgery
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise

Eligibility (CONTROLS)

* Inclusion criteria:

  1. Age ≥18 years
  2. NO signs or symptoms of esophageal food bolus or foreign body
  3. Age/Sex match to previously enrolled case subject
* Exclusion criteria:

  1. Prior esophageal surgery/dilation/pathology
  2. History of head/neck cancer
  3. Incarcerated individuals
  4. Individuals unable to provide consent
  5. Clinical instability or airway compromise
  6. Presentation involving any of the following symptoms:
* Nausea/vomiting
* Diarrhea
* Abdominal pain
* Chest pain
* Shortness of breath
* Dysphagia/odynophagia
* Cough
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

The purpose of this study is to asses the efficacy of the Gammacore device reducing the need for mechanical ventilation in patients diagnosed of Covid-19


Eligibility Criteria:
Inclusion Criteria:

1. Has been tested positive or suspected/presumed positive for CoViD-19
2. Patients with cough, shortness of breath or respiratory compromise (RR\>24/min, increased work of breathing.)
3. O2 Saturation less than or equal to 96% on room air or sensation
4. Agrees to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data
5. Patient is able to provide signed and witnessed Informed Consent

Exclusion Criteria:

1. On home/therapy oxygen (i.e. for COPD patients) at baseline prior to development of CoViD-19
2. Is already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-19
3. Already gammaCore for other medical conditions
4. A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma
5. Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction
6. Uncontrolled high blood pressure (\>140/90)
7. Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
8. Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site
9. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner)
10. Compromised access to peripheral veinous for blood)
11. Pregnant women
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C levels (measured by a direct method at baseline) that meet the following criteria. (Participant categories are based on the definition in Japan Atherosclerosis Society 2012 guidelines.)

  * Category I: 160 mg/deciliter (dL)≤LDL-C\<200 mg/dL
  * Category II: 140 mg/dL≤LDL-C\<175 mg/dL
  * Category III: 120 mg/dL≤LDL-C\<150 mg/dL
* Have triglycerides (TG) ≤400 mg/dL.
* Have HDL-C \<100 mg/dL.

Exclusion Criteria:

* Participants on LDL apheresis or plasma apheresis.
* Participants with secondary hypercholesterolemia or familial hypercholesterolemia.
* Any planned angiography. If angiography is planned, participants may be screened and enrolled after all such planned procedures are completed.
* History of any of the following any conditions:

  * Stable angina or acute coronary syndrome (unstable angina, myocardial infarction), old myocardial infarction or a coronary revascularization procedure including stent placement, or symptomatic carotid artery disease
  * peripheral arterial disease
  * ischemic stroke or transient ischemic attack (TIA)
  * intracranial hemorrhage
  * abdominal aortic aneurysm
* Have systolic blood pressure (SBP) \>160 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) \>100 mm Hg.
* Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).
* During the study period, participants who plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription, over the counter medication, supplements or health foods with the intent to treat serum lipids (LDL-C, HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic agents within 8 weeks before screening are excluded from the study.
* Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib or dalcetrapib).
A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients
2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged 20 to 70 at the time of writing an informed consent.
2. Subjects who were diagnosed with Erosive Reflux Esophagitis (ERE) using Los Angeles (LA) classification grade A\~D, confirmed by endoscopy.
3. The subjects regardless of presence of ERE symptom (i.e., symptomatic ERE or asymptomatic ERE).

   For symptomatic ERE, the subject must have one or more symptoms of the followings: acid regurgitation, heartburn, epigastric pain, cough, hoarseness, globus pharyngis, atypical chest pain.
4. Subjects who have consented to participate in this clinical study by signing an informed consent form.

Exclusion Criteria:

1. Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations.
2. Other concurrent organic upper gastroesophageal disease in endoscopy (i.e., drug-induced esophagitis, viral esophagitis, Mallory-Weiss syndrome, peptic ulcer disease, malignancies) and patients who was diagnosed with Barrett's esophagus.
3. History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy).
4. History of upper gastrointestinal bleeding or obstruction.
5. Patients administrated with any drugs that can affect the efficacy of study regimen (proton pump inhibitors, revaprazan, prokinetics, H2-blockers, etc.) within 2 weeks (however, 4 weeks for PPIs) prior to enrollment and/or those who are required of NSAIDs, anti-coagulants, anti-cholinergics, prostaglandin E, corticosteroids, and anti-depressants treatment during the study period.
6. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
7. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence.
8. History of psychological disorder, alcoholics, and drug abuser.
9. Blood test results of hemoglobin (Hb) ≤ 10.0 g/dL, platelets ≤ 50,000 /µL, total WBCs ≤ 4,000/µL or ≥ 10,000/µL, and with serum test results showing the levels of AST, ALT, ALP, BUN, and creatinine exceeding twice the normal range of respective institution.
10. Patients who previously underwent another clinical survey within 4 weeks.
11. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.
Multicenter Trial for Adults With Partial Seizures

To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.

A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.

Eligibility Criteria:
Inclusion Criteria:

* must weigh greater than or equal to 40kg
* Patients must have diagnosis of partial seizures
* At least 3 observable partial seizures a month
* Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.

Exclusion:

* Patients on Valproic acid, and Felbamate