cyrilzakka/clinical-trials huggingface dataset:
Modulating Anxious Coping

This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to the Medical University of South Carolina. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS, which works by rapidly turning a focused magnetic field on and off repeatedly over the head in a way that passes directly through the hair, scalp, and skull and onto the brain and can temporarily increase brain activity under the magnetic field. After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head.

Each visit in this study is expected to last between 2 - 4 hours. This is not a treatment study, but the study is being conducted with the hope that it will help improve treatment in the future.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 y.o.
* Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety
* Is currently seeking mental health treatment
* Is able to read consent document and provide informed consent.
* English is a first or primary fluent language.

Exclusion Criteria:

* Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)
* Lifetime diagnosis of psychotic disorder or bipolar mania
* Presence of neurological disorder that contraindicates TMS or neurophysiological recording: Seizure disorder Lifetime history of traumatic brain injury with loss of consciousness Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
* Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods
* Presence of standard contraindications for MRI or rTMS Metal in the body Currently pregnant Claustrophobia Significant sensitivity to noise Medical conditions or treatments that lower seizure threshold History of severe brain injury History of seizures/ epilepsy
* Currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication Note: SSRI, cholinesterase inhibitors or NMDA receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment
* Currently taking chronic opiate medications or substances
* Currently taking naltrexone
Pain Sensitivity Evaluation in Respiratory Patients

Previous studies have reported that asthmatic or chronic pulmonary obstructive disease patients have an increased response to pain stimulus. However, this aspect has not been evaluated in allergic patients. Additionally, the difference in pain sensitivity between asymptomatic period crisis have not been evaluated yet.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age.
* Accepted to sign the informed consent.
* Diagnosis of asthma or allergy.

Exclusion Criteria:

* Cognitive impairment.
* Orthopedic pathologies limiting test performance.
* Active smokers.
* Neurologic pathologies limiting voluntary mobility.
Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules

The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial identification test after administration of itraconazole (ICZ) capsule, to identify the change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the relationship between the change of SCIO score and mycological cure rate and clinical improvement.

This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) study of ICZ in participants with onychomycosis. The present study consists of 2 periods: Screening period (up to Week minus 2) and Treatment period (up to Week 49). The ICZ will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally, twice daily, continuously for 1 week. Total duration of treatment will be of 49 weeks. Efficacy will primarily be evaluated by percentage of participants showing 10 percent or higher response in SCIO Score. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Onychomycosis participants whose etiologic agent is identified by potassium hydroxide (KOH) smear and bacterial identification test
* Participants with Scoring Clinical Index for Onychomycosis (SCIO) greater than or equal to 9
* Participants who are healthy in general in following items: medical and medication history, physical examination before administration time, vital signs (blood pressure and pulse) and clinical laboratory tests (clinical test results \[liver function and renal function\] are within 2 times the normal range)
* Female participants of child-bearing age who use acceptable contraceptives
* Participants who can understand features of clinical study and signed informed consent form

Exclusion Criteria:

* Participants with psoriasis (scaly skin rash)
* Diabetic participants who take an anti-diabetic drug
* Pregnant or breast feeding female participants
* Participants with clinical evidence of arterial insufficiency or peripheral vascular disease and medical history of decreased ventricular function like congestive heart failure (heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body)
* Participants who applied a topical antifungal agent (nail lacquer) on target nail within 1 month before the study medication administration and who took an oral antifungal agent within 3 month before the study medication administration
Eluxadoline Bile Acid Malabsorption (BAM) Study

This study will evaluate the possibility of a differential effect of eluxadoline on altered bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) participants with and without evidence of Bile Acid Malabsorption (BAM).


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
* Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) \> 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.
* Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA \< 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.
* Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
* Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
* Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
* Has not used loperamide rescue medication on \> 3 of the 14 days prior to Day 1.

Exclusion Criteria:

* Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
* Does not have a gallbladder.
* Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
* Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
* Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
* Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
* Has Celiac disease or a positive serological test for celiac disease.
* Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
* Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
* Has known allergies or hypersensitivity to opioids.
Lens Wearing Experience and Biocompatibility of a Multi-Purpose Disinfecting Solution (MPDS)

The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
* Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
* Read, sign, and date IRB-approved informed consent and privacy document;
* Be generally healthy and have normal ocular health;
* Willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

* Wear lenses on an extended wear basis during the study;
* Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
* Monocular subject;
* Requirestoric or multifocal contact lenses;
* Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
* Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
* Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;
* Ocular surgery within the 12 months prior to Visit 1;
* Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;
* Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;
* Participation in any clinical study within 30 days of Visit 1;
* Other protocol-defined exclusion criteria may apply.
Zilver PTX Post-Market Study in Japan

Japanese post market clinical study of the Zilver PTX device.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.

This study is to determine the safety of ceralasertib when given as monotherapy (discontinued) and in combination with acalabrutinib in subjects with R/R CLL and in subjects who have few therapeutic options available to them. As such, this study includes a formal DLT assessment of the first 6-12 subjects dosed in Part 1 of the study. In addition, routine and regular safety monitoring will be undertaken during this study to fully assess safety of ceralasertib given as monotherapy and in combination with acalabrutinib, with toxicity assessment and dose reduction guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed or refractory CLL that meets published diagnostic criteria (International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] Hallek 2008) and supported/documented by medical records
* Subjects must be Relapse/Refractory high risk CLL and have exhausted other therapeutic options according to local/regional standard of care
* Must have received ≥1 prior therapy for treatment of their disease.

Exclusion Criteria:

* A diagnosis of ataxia telangiectasia
* Any prior exposure to an ATR inhibitor or known hypersensitivity to an excipient of the product.
* Known history of infection with human immunodeficiency virus (HIV).
* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib) and/or Ceralasertib
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Requirement of treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
* Breast feeding or pregnant
Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery

This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.


Eligibility Criteria:
Inclusion Criteria:

* English speaking, able to understand informed consent
* Vaginal hysterectomy with vaginal vault suspension
* with or without anterior and posterior repairs
* with or without removal of fallopian tubes or ovaries
* with or without procedures for stress urinary incontinence

Exclusion Criteria:

* Use of mesh for prolapse repair
* Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
* Concomitant procedure done by an additional surgeon
* Concomitant anal sphincteroplasty or rectovaginal fistula repair
* History of chronic pelvic pain receiving medical care
* Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
* Pregnancy
Novel Treatment for Rotator Cuff Tears

The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (\<50%) of the supraspinatus tendon of the rotator cuff.


Eligibility Criteria:
Inclusion Criteria:

- Evidence of partial tear (\< 50%) of the supraspinatus tendon on MRI.

Exclusion Criteria:

* A tear of the supraspinatus tendon greater \> 50% and any areas of full thickness tearing, concomitant tears \> 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum.
* Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period.
* Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder.
* Previous corticosteroid injection within three months.
* Those individuals less than 25 and greater than 75 years of age will be excluded.
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg.
2. Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented
3. Treatment-naïve or off-antiviral therapy for ≥24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis

Exclusion Criteria:

1. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma
5. Current or prior treatment for cHBV
The Experience of the Child With Cancer When Port à Cath Needle : Child's Speech

This qualitative research refers to the descriptive phenomenological method of Hurssel which allows an analysis of the experience and an understanding of the phenomenon. Semi-structured interviews are carried out with 10 children followed for cancer in 3 pediatric hemato-oncology departments. The children interviewed are aged 6 to 12 and can be with their parents. A thematic analysis approach is used to analyze the data of this research.


Eligibility Criteria:
Inclusion Criteria:

* Child followed in pediatric oncology for cancer or hematological disease
* Child wearing a Port-a-cath needle placement and minimum use once a week

Exclusion Criteria:

* Child no speaking the French language
Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC

TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.

Furthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved \>90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Confirmed diagnosis of triple negative breast cancer (non-metastatic)
* Planned for neo-adjuvant systemic therapy
* Written consent to generic Tissue for Research donation

Exclusion Criteria:

* Patients declined consent for generic Tissue for Research donation
HBsAg Related Response Guided Therapy

Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)

Secondary objective :

* The changes of HBsAg titer

  * The rate of combined HBeAg seroconversion and HBV DNA \< 300 copies/mL

    * The rate of serum HBV DNA \< 300 copies/mL ⅳ. The rate of ALT normalization

      * The rate of HBsAg loss ⅵ. The rate of serum HBV DNA \< 10,000 copies/mL

After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.

* HBsAg \>20,000 : study termination
* Group A :1,500\<HBsAg≤ 20,000
* Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have \> 100,000 copies/ml as measured by PCR) and anti-HBs negative
3. Elevated serum ALT \> 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.

Exclusion Criteria:

1. Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
2. Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
3. Diagnosed hepatic cellular carcinoma
4. Any evidence of decompensated liver disease (Childs B-C)
The MI-HEART Project

The purpose of the study is to examine ways in which a clinical information system can help patients better recognize the signs and symptoms of an acute myocardial infarction (heart attack) and to take actions to decrease morbidity and mortality that may be related to delay in seeking treatment. The software-based intervention will use the best scientific evidence to create tailored strategies using a patient's specific health data. This approach is based on well-established cognitive and behavioral educational models.


Eligibility Criteria:
Inclusion Criteria

* Patients at high-risk for an acute myocardial infarction, including any 2 of these risk factors: males age \> 45; females age \>55; family history of premature coronary heart disease (CHD); current cigarette smoker; hypertension; or elevated total cholesterol with low HDL and/or high LDL.

OR have:

* Active angina (chest pain due to coronary heart disease)
* History of coronary heart disease according to the treating physician
* Past history of myocardial infarction documented by electrocardiogram or arteriography
* Diabetes Mellitus
* Renal dialysis

Exclusion Criteria

* Hospitalization within previous 4 weeks
* Persons living in a home with previously enrolled patients
* Patients disoriented to person, place, or time at onset of study