cyrilzakka/clinical-trials huggingface dataset:
Specimen Collection Study for H. Pylori Testing

The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.

This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 and to 75 years.
* Able to read, speak, and understand English or have access to a translator in subject's native language.
* Patients without prior H. pylori eradication treatment.
* Currently not on proton pump inhibitors, antibiotics or bismuth

  * Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
* Present with signs and symptoms of dyspepsia \[e.g. upper abdominal discomfort or pain\]
* Undergo gastric biopsies as part of routine care
* Physician able to provide histology and rapid urease result on biopsy specimens.

Exclusion Criteria:

* Aged less than 21 years old or older than 75 years
* Unable to provide consent.
* Patients with a history of prior H. pylori eradication therapy.
* Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
* Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
* Any unstable or poorly-controlled medical or psychiatric condition.
Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans

Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate.

The investigators evaluated, in healthy individuals, the impact of shifting from their usual food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut microbiota, gastro-intestinal symptoms and food-related behaviour.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 25 kg/m²
* Caucasian ethnicity
* Hydrogen producers (assessed by hydrogen breath test)

Exclusion Criteria:

* Smokers
* Laxative consumption (\<4 weeks)
* Severe intestinal problems
* Psychiatric problems or use of antipsychotic
* Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (\<6 weeks)
* Specific dietary practise (vegetarian, vegan,...)
* Specific dietary treatment (\<6 weeks) (e.g. high protein diet)
* Excessive alcohol consumption (\>3 glasses/day)
* Consumption of the following drugs: proton pump inhibitor, antidiabetic drugs, cholesterol lowering drugs
* Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)
Aetiology of TemporaL Arteritis Study

Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with high-dose steroids, and despite this there is a risk of flare during the treatment. Little is known about the initial triggers for the inflammatory process, and there are no good markers of response or relapse. We will study patients referred with suspected GCA to identify important components of the immune response in GCA, and follow them over time to collect evidence of how best to monitor their condition.

Objectives and Study Plan:

Study Purpose:

The purpose of the study is to investigate the underlying immunological processes in GCA and to study the pattern of expression of immune response over time to give us information about how best to monitor GCA.

End Point:

The end point will be the final visit of the final patient.

Milestones:

The project is in 3 phases. In phase 1 (0-2 years) patients will be recruited to fulfil the specified primary and secondary objectives. In phase 2 (0-4 years), these patients will be followed up for a total of 2 years each, or until they are discharged from clinic. In phase 3 (1-5 years), further studies will be defined and tissue and data collected under amended ethics.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or over
2. A clinical suspicion of a new diagnosis of GCA e.g. patients with a new onset of headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue claudication with or without visual loss
3. Participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by GCA (this will be made clear in the ethics approval application)

Exclusion Criteria:

1. Previous diagnosis of GCA
2. Long term (\>1 month) high dose (\>20mg per day at any time) steroids for conditions other than PMR, within three months prior to study entry
3. Inability to give informed consent (either written consent or verbal assent from a relative or carer)
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions

The purpose of this study is to assess the bioequivalence between Amoxicillin/Clavulanate Potassium Oral Suspension 600/42.9 mg/5 mL and Augmentin ES-600 Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of age and over.
* Body weight within ±15% of the appropriate weight range published in 1993 by Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less than 30.
* Negative for:

  * HIV
  * Hepatitis B and C
  * Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  * Cotinine (urine test)
  * Breath alcohol (Breathalyzer)
  * HCG (females only)
* No significant diseases or clinically significant abnormal laboratory values.
* No clinically significant findings in the physical examination.
* No clinically significant findings in vital sign measurements and 12-lead electrocardiogram (ECG).
* Informed of the nature of the study and give written consent prior to receiving any study medication.
* Female subjects: surgically steril, post-menopausal or practicing a recognized safe method of contraception (abstention, oral or implanted contraceptives, intra-uterine device or consistent condom plus spermicide use).

Exclusion Criteria:

* Known history or presence of any disease or condition which might compromise the following body systems: immunologic, endocrine, renal, cardiovascular, respiratory, hematologic, gastrointestinal, neurologic, hepatic, psychiatric or dermatologic
* More specifically: history or presence of significant: sensitivity to multiple allergens, diarrhea, stomach or intestinal disease, mononucleosis, renal or hepatic dysfunction and asthma.
* Known or suspected carcinoma.
* Known history or presence of:

  * Hypersensitivity or idiosyncratic reaction to amoxicillin, clavulanic acid, penicillin, cephalosporins and/or any other β-lactamase inhibitors.
  * Clavulin-associated jaundice/hepatic dysfunction.
  * Alcoholism within last 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine-containing products, within last 12 months.
* On a special diet within 4 weeks prior to drug administration (i.e. a deliberate change in diet for any reason).
* Participation in another clinical trial or received an investigational product in the previous 30 days prior to drug administration.
* Donation up to 250 mK of blood in the previous 30 days, 251-500 mKL in the previous 45 days, 501-750 mL in the previous 60 days or above 750 mL in the previous 90 days prior to study start.
* Requirement of any medication, (prescription and/or over-the-counter) or dietary supplements on a routine basis, with the exception of occasional use of acetaminophen and oral or implanted contraceptives.
* Difficulty fasting or consuming the standard prescribed meals.
Efficacy Study of the Use of Sequential DFP-DFO Versus DFP

Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with deferoxamine (DFO), using different schedules of treatment, in the majority of the 13 clinical trials published between 1990 and 2008.No statistically significant difference was shown between these two interventions during, at most, 18 months of treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone reported controversial results but this could be due to small sample sizes and short treatment duration. In fact, no trial with treatment duration longer than 18 months15, which reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so far been published.

This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to assess the impacts of these chelation treatments on serum ferritin concentrations, mortality, adverse events, and costs in thalassemia major patients.

The trial was designed as a multicentre randomised open-label trial with blinded data management and data analyses, to assess whether either treatment was superior to the other. The trial was performed on behalf of the Italian Society for the study of Thalassemia and Haemoglobinopathies (SoSTE). The investigators initiated, carried out, and controlled the trial, which was conducted without influence of the non-commercial sponsor.16

Eligibility Criteria:
Inclusion Criteria:

* Thalassemia major patients with serum ferritin concentration between 800 to 3,000 ng/ml and were over 13 years of age

Exclusion Criteria:

* Known intolerance to one of the trial treatments
* Platelet count \< 100,000/mm3 or or leukocyte count \< 3,000/mm3
* Severe liver damage indicated by ascites
* Heart failure
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39D in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.

Response to prior therapy is consistent with one of the following:

1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:

   * Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
   * Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;

     7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

   Exclusion Criteria:

   Subject eligible for this study must not meet any of the following criteria:

   1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).

   6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.

   7. Pregnant or lactating women;
Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette

The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.

Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains limited.

The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.

Eligibility Criteria:
Inclusion Criteria:

* Understanding and accepting the study procedures and signing the informed consent.
* Male adults volunteers (18-45 years old).
* Clinical history and physical examination demonstrating no organic or psychiatric disorders.
* The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
* Present use of nicotine without serious adverse reactions.
* Smokers ≥ 3 cigarettes/day.

Exclusion Criteria:

* Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start.
* History of drug dependence (except for nicotine dependence).
* Daily consumption \>4 standard units of ethanol.
* Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
* Having suffered any organic disease or major surgery in the three months prior to the study start.
* Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
* History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
* Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
* Use of any drug or substance inhibitor of cytochrome P-450-1A6 (CYP1A6) (p.e. raloxifene, coumarins, etc)
Effectiveness of Cognitive Behavioral Therapy of Reduction of Test Anxiety

This study will evaluate the role of Group Cognitive Behavioral Therapy in test anxiety. The study participants will be psychology undergraduates with social work and psychology majors. The students will be selected among those who score three or more in Westside Test Anxiety Scale will participate in the study. Westside Test Anxiety will be used two weeks after completion of the group Cognitive Behavioral Therapy protocol (Flaxman, Bond \& Keogh. 2004). The result will be analyzed using the t-test and Cohen's d.


Eligibility Criteria:
Inclusion Criteria:

* Those Studying Social work and Psychology as Major subjects, Those who have scored 3 and above in Westside Test Anxiety scale

Exclusion Criteria:

* Those scoring below 3 in Westside Test Anxiety Scale
The Effects of Ultrasonic Noise Exposure on Human Hearing

The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. A cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A subgroup of 10 subjects will be used as a control group. The resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (TTS).


Eligibility Criteria:
Inclusion Criteria:

* Adult, audiometrically healthy

Exclusion Criteria:

* Underlying/pre-existing hearing impairment
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.

The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 to 80 years old, including both male and female subjects.
2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).

Exclusion Criteria:

1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
3. Subject has active infection at the site of device application.
4. Subject has recurrent syncope symptoms within the past three months.
5. Subject is pregnant.
6. Subject has had VNS treatment within the past two months.

   .
IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome

The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 70 years old undergoing coronary drug-eluting stent (DES) implantation.


Eligibility Criteria:
Inclusion Criteria:

* Age over 70 years old
* Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
* Treated with at least 1 DES implanted in the coronary lesion
* Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
* Agree to attend the trial

Exclusion Criteria:

* Elective surgical procedure planned within 12 months
* Life expectancy ≤1 year
* Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
* History of cerebral hemorrhage
* History of stroke in six months
* Active bleeding
* Known relevant hematological deviations
* Known, clinically important thrombocytopenia (i.e., \<100\*10\^9/L) or anemia (i.e., \<90g/L)
* Active cancer
* Concomitant use of oral anticoagulants
* Active participation in another clinical study
* Other situations in which the investigator considers unsuitable to attend the study
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have failed treatment on Protocol PGN-1300X

Exclusion Criteria:

-