cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal bacterial overgrowth (SIBO).

Approximately 180 study subjects with SIBO identified by positive glucose hydrogen breath (GHB) testing who meet inclusive and exclusive criteria will be randomized to receive either ciprofloxacin 500mg by mouth twice daily, metronidazole 500mg by mouth twice daily, or placebo by mouth twice daily. Subjects will complete a baseline symptom questionnaire and be treated for 14 days. Response will be assessed at end of treatment. The Gastrointestinal Symptom Rating Scale (GSRS) and GHB testing will be performed at the end of treatment. Subjects with a negative GHB at the end of treatment are considered as cured, or treatment success. Patients with treatment success will be reassessed for long-term response to treatment or disease recurrence at 30 days, 4 months, and 9 months using GHB. Symptoms will also be re-assessed at the 30 day, 4 month, and 9 month intervals with GSRS-IBS symptom questionnaire done prior to GHB testing.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients age greater than 18 who have been diagnosed with SIBO after a clinically indicated hydrogen breath test.
* Patients with liver disease or liver cirrhosis will be included, as this particular group is at higher risk for developing SIBO, would potentially benefit from inclusion, and do not require dose adjustments with either study medication.
* Patients on warfarin are not excluded, but INR will be uniformly recommended to be checked within 1 week of therapy initiation, as standard practice through the Coumadin clinic, for the potential effect on INR and increased risk of bleeding while on any antibiotic

Exclusion Criteria:

* Patient age less than 18
* Hypersensitivity to the antibiotics
* Pregnancy or breast feeding
* Patients who cannot consent for themselves
* End stage renal disease defined as creatinine clearance \<30 mL/min or on hemodialysis.
* Patients who have taken antibiotics in the past 30 days
* Laxatives, stool softeners, or bulk fiber in the last 7 days
* Enemas or suppositories in the last 3 daysⱡ
UR+AIMS Gout Wearable Skin Uric Acid Monitor Study

15 patients with gout \[10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)\] will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.

First Visit at the UCLA Human Nutrition Center:

* Patients will sign the informed consent, then answer some study questionnaires.
* The Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch and the study mobile device will be provided.
* Study nurse will start an IV for pre and post blood draws.
* Patients will be provided a standardized high-purine meal within 15 minutes. Pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours).
* Then patients will be sent home with the skin patch and study mobile device.

Community 7-day observation period:

* Patients will be asked to apply a study patch each morning before their first meal of the day. The patch should be removed at the end of the day and put under water.
* The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep. Patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 with diagnosis of gout (screening positive ACR/EULAR Gout Classification Criteria - see screening survey) and eGFR \> 60 (within the last 12-months).
2. For the 10 patients with gout off urate-lowering therapy (ULT) \[no Allopurinol, febuxostat, or probenecid prescription within the last 6-months\] and serum urate (SU) \> 7 mg/dL (within the last 12-months).
3. For the 5 patients with gout on urate-lowering therapy (ULT) \[no dose change within the last 30 days\].

Exclusion Criteria:

1. Contraindications to miosis, which include acute iritis, narrow-angle glaucoma
2. Known Hypersensitivity to pilocarpine hydrochloride
3. Pupillary block glaucoma (ophthalmic solution)
4. Subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and Sprite).
Insecure Attachment and Psychosocial Functioning in Autistic Adults Are Mediated by Depression and Paranoid Ideation

The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults.

The present study examines if depressive symptoms, paranoid ideation, and emotion regulation strategies mediate the relationship between attachment and psychosocial functioning in autistic adults. Within a cross-sectional design, we used mediation analysis to clarify the roles of co-occurring mental conditions as depressive symptoms, paranoid ideation, and (mal)adaptive emotion regulation strategies in mediating the pathway from insecure attachment to psychosocial functioning in autistic adults. Questionaires about attachment, psychosocial functioning, depressive symptoms, paranoid ideation, and emotion regulation were administered to 83 autistic adults (50 males, 33 females).

Eligibility Criteria:
Inclusion Criteria:

* a primary clinical diagnosis of DSM-5 ASD (APA, 2013)
* age ≥ 18 years
* at least eight years of education.

Exclusion Criteria:

* intellectual disability (IQ ≤ 80)
* presence of current suicidal ideation.
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of HR+/HER2- mBC
2. Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
3. Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes

Exclusion Criteria:

1. Enrollment in an interventional clinical trial during the study period
2. Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
3. Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants 18 to 75 years of age.
* Clinical diagnosis of PN for at least 3 months prior to Screening visit.
* Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
* Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
* Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
* Diagnosis of PN secondary to medications.
* Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
* Women who are pregnant (or are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy - proven rectal cancer
* Transmural rectal wall invasion
* Karnofsky performance status \>70
* Normal bone marrow, liver and kidney function

Exclusion Criteria:

* Distant metastases
* Prior pelvic radiation
* Inflammatory bowel disease
* Severe ischemic heart disease
* Anticoagulant therapy
* Pregnancy
RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres

Retro-prospective survey on specific and overall prevalence and incidence of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta) in patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014-April 30, 2017 - retrospective data) and annually (from May 1, 2017 - prospective data).

We planned to collect data from May 1, 2014 and afterwards, by means of both retrospective and prospective approaches.

All patients who have received or will receive a diagnosis of rare primary headache will be asked to participate and, to this aim, to give their informed consent. Each participating Centre should have received the approval of the competent Ethics Committee before commencing any study procedures.

The registry will contain anagraphic information and data about diagnosis, treatment, comorbidity, and clinical features of the headache. Patients' data will be coded through the Italian Health System unique identifier, in order to avoid duplications of patients referring to more than one Centre and also to monitor multiple referrals.

A web-based open source platform (SurveyMonkey.org) will be used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
* signed informed consent

Exclusion Criteria:

* none
Primary Care Treatment Integrating Motivation and Exposure

This project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and PTSD severity in veterans receiving Veterans Affairs Primary Care. Standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and PTSD are too long to be delivered in Primary Care. Therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring PTSD. This study aims to incorporate two evidenced-based interventions: Brief Motivational Interviewing (BMI) with Prolonged Exposure for Primary Care (PE-PC). This newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.


Eligibility Criteria:
Inclusion Criteria:

* A score of 8-25 for men, 6-25 for women on the AUDIT and have past month drinking (i.e., have not quit drinking over the last month)
* Score ≥30 on the PTSD Checklist-5 (PCL-5) and report a traumatic event on the Criterion A screener

Exclusion Criteria:

* Score of a 26 or higher on the AUDIT
* gross cognitive impairment as assessed by the Mini Mental Status Exam
* current symptoms of mania or psychosis
* currently in need of detox services
* Have had a suicide attempt in the last two months or a current intent to commit suicide as assessed on the P4 Screener. (Patients with recent suicide attempts or intent may be enrolled following receipt of suicide prevention services)
* Are currently receiving psychotherapy for heavy drinking or PTSD outside of PC within the last 2 months
* Have started or changed the dose of a psychotropic medication for heavy drinking or PTSD in the last two months that was prescribed outside of VA PC
* Have a preference to be directly referred to VA specialty care for heavy drinking or PTSD.
Healthy Buddies Manitoba

School-based interventions are generally ineffective for preventing weight gain in children. In 2007, a group from the University of British Columbia, developed a program called Healthy Buddies, that relied on peer mentors to help young children adopt healthy living behaviours. Pilot studies revealed that the program effectively prevented weight gain in children. This trial had never been tested on a large scale using a more scientifically sound study design. We developed a large school-based randomized trial to overcome that limitation and test the hypothesis that that a school-based peer-led healthy living program would reduce adiposity and increase physical activity among children 6-12yrs old.


Eligibility Criteria:
Inclusion Criteria:

* Participating schools need to meet the following eligibility criteria: (1) were within provincial jurisdiction, (2) had a minimum of 200 students per school, (3) offered grades 1 through 6.

Exclusion Criteria:

* Children will be excluded if consent was not received from parents or if they had a condition that limited participation in physical activity.
Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR

The recent years, the use of bronchoscopic lung volume reduction in emphysema patients instead of surgical operations has become widespread. Before this procedure, the implementation of Pulmonary Rehabilitation became a necessity. The inadequacy of the number of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number of mentioned operations have increased the need for different exercise program applications. Prior to valve and coil applications in our study, changes in clinical conditions of patients will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.

The records of emphysema patients referred to the Pulmonary Rehabilitation Unit for prophylactic pulmonary rehabilitation prior to bronchoscopic lung volume reduction will be recorded prospectively. Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation (Group 2). The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program and will be reevaluated after 8 weeks. The differences in the parameters of initial and rehabilitation end-tracing and the differences between the groups will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with emphysema and bronchoscopic lung volume reduction procedures decided by chest physician
* Acceptance of participation in a 2-month Pulmonary Rehabilitation program.

Exclusion Criteria:

-Possible orthopedic, cardiovascular or psychological disturbance that may prevent exercising.
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance.

This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.


Eligibility Criteria:
Key Inclusion Criteria:

* Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity \< 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR
* Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL)

Key Exclusion Criteria:

* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus or use of insulin
* History of pancreatitis within 3 month of Screening
Optimizing Analgesia for Endometrial Biopsy

Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia


Eligibility Criteria:
Inclusion Criteria:

* women aged 18-75 needs endometrial biopsy

Exclusion Criteria:

* women with allergies to prilocaine, lidocaine or dexketoprofen trometamol
* women with a history of severe uncontrolled cardiovascular disease, diabetes mellitus, pregnancy, vaginal, cervical, or pelvic infection, cervical cancer, or severe cervical stenosis
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
2. Nerve diameter at injury site ≤3mm.
3. Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
6. Repair must take place within 3 months from injury
7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

Exclusion Criteria:

1. Previous history of nerve repair attempt at the treated nerve.
2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
4. Pregnancy or planning to become pregnant
Evaluation of Surgical Positioning in Arthroscopic Shoulder Stabilization

The purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability.


Eligibility Criteria:
Inclusion Criteria:

-Any patient undergoing arthroscopic labral repair due to shoulder instability, with or without concomitant debridement.

Exclusion Criteria:

* Revision stabilization surgery
* No previous Bankart repairs, labral repairs, capsulorrhaphy, or Latarjet
* Multidirectional shoulder instability
* Concomitant rotator cuff repair, biceps tenodesis/tenotomy, HAGL repair
* Isolated SLAP repair/labral repair in association with mechanism other than -instability (eg: overhead athletes) open procedures for instability
Study Evaluating the Benefit of Music Therapy on Pruritus in Patients With Pruritic Dermatitis

Many clinical studies have shown the benefit of music therapy in various pathologies, including pain, and it is now established that the latter has a complementary therapeutic interest. Its most frequently identified indications are the fight against acute or chronic pains, the reduction of anxiety, depression and stress, as well as memory disorders such as Alzheimer's disease.

The main modes of action of music therapy involve sensory, cognitive, psychological and behavioral processes that are also found in pruritus.

Pruritus is defined as "an uncomfortable sensation causing the need to scratch. It has similarities with pain but also differences: relief by heat / cold, scratching / withdrawal behavior, localization on the skin, semi-mucous / ubiquitous ... etc.

The pathophysiology also has similarities, pruritus is born at the dermal-epidermal junction at the level of specific cutaneous receptors then follows the classical pathways through a 1st neuron, then the dorsal horn of the spinal cord and a second neuron. At the cerebral level, there is no single center of pruritus but several motor and sensory areas involved.

The similarities suggest that music therapy may have an interest in the management of chronic pruritus, especially since classical treatments (antihistamines, topical corticosteroids) have only partial efficacy in some dermatoses


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Patient with pruritic dermatosis whatever the etiology (psoriasis, atopic dermatitis, toxiderma, cutaneous lymphoma, chronic urticaria ...)
* Hospitalized in continuous hospitalization in the Dermatology Department
* Age of dermatosis ≥ 1 month
* Pruritus score ≥ 3/10 by numerical evaluation
* Patient having signed a consent form

Exclusion Criteria:

* Patient under the age of 18
* Major impairment of hearing function
* Presence of major cognitive disorders
* Refusal to participate
* Pregnant or lactating women
* Institutionalized or emergency patients
* Patient under legal protection regime
* Patient not affiliated to the social security system