cyrilzakka/clinical-trials huggingface dataset:
Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study

This pilot study will investigate the clinical and neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) followed by comprehensive behavioral intervention for tics (CBIT) in adult patients with Tourette's Syndrome (TS). Two groups of moderate disease severity will be randomized to receive active or sham rTMS targeted to the supplementary motor area (SMA) followed by eight CBIT sessions. The change in tic frequency and severity (primary outcome) and neurophysiological changes (secondary outcome) will be compared between the two groups. The central hypothesis is that low frequency rTMS will augment the effects of CBIT through favorable priming of the SMA network.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of Tourette Syndrome
* Moderate Tic Severity at baseline

Exclusion Criteria:

* Presence of metallic objects or neurostimulators in the brain
* Pregnancy
* History of active seizures or epilepsy
* Contraindications to receiving fMRI
* Inability to participate in CBIT due to other underlying cognitive or medical condition
Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

The LEAP-SE study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.

The LEAP-SE study is an 8-week, multicenter, randomized, blinded study to evaluate the performance of EEG-based biomarkers in predicting treatment outcome. Study participants will be randomized in a 1:1 ratio to receive either sertraline or escitalopram and followed for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 22 or older at the time of informed consent.
* Diagnosis of Major Depressive Disorder (MDD) based on the Structured Clinical Interview for DSM-5 for depression.
* Moderate or severe depression on DSM-5 depression criteria items, as assessed by a score of 10 or more on the Patient Health Questionnaire (PHQ-9)
* Has not taken either study medications (sertraline, escitalopram) in the current episode
* Has not received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or esketamine treatment in the current episode
* Provision of personally signed and dated written informed consent prior to any study procedures
* Agrees to, and is eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing)
* Fluent in English
* Ability to complete all assessments independently
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Diagnosis of bipolar disorder or a psychotic disorder based on the Structured Clinical Interview for DSM-5.
* Concurrent use of antidepressants, antipsychotics or mood stabilizers
* Use of hypnotics, anxiolytics or opiate pain medications greater than three days per week and unable to reduce use to three or fewer days per week on an as needed basis
* Pregnant or breastfeeding
* Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
* Active substance use that interferes with ability to consent and/or complete assessments
* Any contraindication to EEG (e.g. requiring high concentration oxygen)
* Employees/family of employees of clinic site
* Participation in another research study within 2 months prior to the first study visit
Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis

1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
3. The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.

* All patients signed informed consents for the procedure, and the participation in the study.
* Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
* Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
* A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
* Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:

  1. the total time of the procedure,
  2. the number of attempts at cannulation,
  3. the number of pancreatic duct cannulation,
  4. the final diagnosis by ERCP,
  5. whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.
* Serum amylase was determined 12 hours after ERCP.

  * If the 12-hours serum amylase level was \> 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
  * Acute pancreatitis was defined as serum amylase \> 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
* Statistical analysis:

  1. Randomization was done by the GI nurse, concealed envelop
  2. Data were summarized by descriptive statistics.
  3. The Chi square was used to compare categorical patient data.
  4. The Student's t test was used to compare continuous variables.
  5. Two-tailed P \< 0.05 was considered to indicate significance.

Eligibility Criteria:
Inclusion Criteria:

* any patient above the age of 16, referred for ERCP

Exclusion Criteria:

* 1.could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula 2. ERCP done recently 3. Stent replacement 4. Congestive Heart Failure(CHF) 5. Asthma
Addressing Racial Disparities in Opioid Overdose Using Peer Recovery Coach Training and MHealth Platform

The study aims to adapt an existing Cultural Structural Humility (CSH) training into a video format for peer recovery coaches (PRCs) and refine an AI-driven texting tool to reinforce the training. After refining these tools using user-centered design, a pilot test will be conducted to assess their impact on the uptake of opioid treatment and social services. The study will also evaluate the feasibility and effectiveness of the intervention to inform future large-scale trials.

The purpose of this study is to adapt an evidence-supported, currently staff-led Cultural Structural Humility (CSH) training to an interactive video format (7 brief video modules) for PRCs (Aim 1) while concurrently, refining a validated AI-driven texting tool that will newly reinforce core CSH training principles (Aim 2) that focus upon cultural and structural determinants of health (CSDH). After completing iterative refinement per user-centered design strategies based on the Technology Acceptance Model (TAM) for Aim 1 and 2, the investigators will pilot test CSH-trained PRCs delivering telephone based care/services coordination combined with refined AI-driven texting to enhance uptake of MOUD services, and social services (Aim 3). Aim 3 is sized for feasibility testing, final 'de-bugging' of the platform, and informing study conceptualization for a future large-scale efficacy trial. In this R34, the intervention effects will be assessed on the primary clinical outcome (i.e., receipt of buprenorphine), secondary outcome (i.e., uptake of social services), and implementation of the proposed multimodal intervention platform per the RE-AIM framework.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* fluent in English
* self-reported non-prescription opioid use \<30 days prior to consent
* provision of informed consent
* planned stay in NYC ≥3 months
* Black and/or Latinx race/ethnicity
* positive urine toxicology for opioids per EMR records or study staff administered random saliva drug testing
* diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
* self-reported interest in initiating buprenorphine in primary care, or elsewhere.

Exclusion Criteria:

* inability to comprehend text content written at a 3rd grade reading level
* physical or visual disability preventing mobile phone use
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis

The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender, any race and between the ages of 18 and 70 inclusive
* Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety

Exclusion Criteria:

* Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution
* Subjects who are currently participating or have recently participated in another investigational medication or device study
MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

The purpose of this study is to target lesions of the prostate in the bone and to biopsy these lesions using MRI to identify the areas.

* This study involves a one-time, MRI-guided bone marrow biopsy. Prior to this procedure, patients will need to have a bone scan performed within the last three months and a PSA blood test drawn within one month of registration to the study.
* Patients are also required to participate in the DFCI research study "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer".

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of prostate cancer
* Bone scan consistent with or suspicious of metastatic prostate cancer within last three months
* Platelet count \> 50,000/ul
* PT and aPTT \< 1.5 x control
* At least one week removed from taking aspirin or coumadin
* Currently participating in protocol "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer"

Exclusion Criteria:

* Devices incompatible to MR studies (e.g. pacemakers, ear implants, etc.)
The Health-Promoting Behavior and Related Factors Among Home Care Attendants

Background: With the trend of aging population and increasing demand for long-term care, Taiwan's long-term care 2.0 policy places special emphasis on home care services to achieve the goal of local aging. This study focused on the health-promoting behaviors home care attendants and applied Pender's health promotion model theory to investigate the impact of home care attendants' self-perceived health and health literacy on health-promoting behaviors.

Objective: To investigate the current status of home care attendants' health-promoting behaviors and the correlation between self-perceived health and health literacy.

Methodology: A structured questionnaire was used to collect data from 150 eligible home care attendants in the northern region using self-perceived health, health literacy, and health-promoting behaviors scales. Multiple regression analysis was used to analyze the correlation between the independent variables and the dependent variables.

Expected contribution: The results of this study will help to understand the current status of health-promoting behaviors of home care attendants and the correlation with their self-perceived health and health literacy. It will also help to understand whether home care attendants have sufficient health literacy to maintain or improve their health status, and to understand the areas in which home care attendants' health-promoting behaviors are still inadequate, so as to suggest effective methods or strategies to improve health-promoting behaviors in the future.


Eligibility Criteria:
Inclusion Criteria:

1. have license or have received training and a certificate of completion.
2. have been working in home care for at least three months
3. agree to participate in the study.

Exclusion Criteria:

1. under 20 years of age.
2. non-national.
Delayed Surgery in Inflammatory Bowel Disease

The timing of elective surgery in inflammatory bowel disease (IBD) may be crucial according to progression of the disease. In most cases, medical treatment has failed when surgery is discussed. If treatment with surgery then is delayed, complications may arise, such as fistula, severe inflammation with risk of perforation or stenosis, nutrition problems i.e. This may affect quality of life, and also make the surgery more complicated, with higher risk of per- and postoperative complications.

The COVID-19 pandemic led to a shift in resources where elective surgery has been postponed. The waiting time for elective surgery for IBD-patients at Sahlgrenska University Hospital/Östra is still affected which might have impact on patient health outcomes as well as health economics, due to the risk of complications and need of emergency and planned care while waiting for surgery.

The primary object is to evaluate how long an IBD patient can wait for surgery before affecting health economy and quality of life. In the operation program Orbit, we identify all patients with ulcerative colitits (UC) and Crohn´s disease (CD) that stands in line for elective surgery (not including dysplasia/cancer). The date when operation was decided is registered including time of delay. Patient characteristics are registered in CRF, including diagnosis, age and reason for scheduled surgery. Number of hospital visits (planned/emergency visits) are registered during time of waiting for surgery. Days of sick leave is registered from the Swedish Social Insurance Agency. Questionnaires are sent to the patients for quality of life and bowel function (EQ5D and Short Health Scale).

The primary endpoint in the first manuscript is how health economics is affected by the delay of elective care in IBD-patients, due to complications and extensive need of hospital visits while waiting for surgery, costs of medical material (stoma bandage i.e), costs of medical treatment and sick leave rates, including quality of life. Patients who have been operated for IBD will form the control group and comparison will be made in terms of complications, hospital visits, costs of medical material and medical treatment and sick leave rates, as well as quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel Disease
* Minimum 18 years old
* Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital

Exclusion Criteria:

* cancer surgery
Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers

OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and non-childbearing potential female volunteers of between 18 and 55 years of age
* Female volunteers must have a negative serum pregnancy test at screening
* Females must be of non-childbearing potential
* Male volunteers and their partner(s) must agree to use a double barrier method of contraception for at least 14 days prior to first dose of study drug through 90 days after the last dose.
* Body mass Index between 18 and 30kg/m2, inclusive; and a total body weight \>50 kg
* Laboratory tests at screening within normal ranges or not clinically significant as judged by the Investigator.

Exclusion Criteria:

* Received an investigational drug or participated in another research study within 30 days of the first dose of study drug or at any time through the study
* Evidence of current or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, gastrointestinal, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or clinically significant current infection.
* Any condition that could possibly affect drug absorption, such as gastrectomy, diarrhea and lactose intolerance
* Use of any medications, vitamins, herbal supplements, dietary supplements or vaccinations within 14 days of the first dose of study drug or at any time through the study, unless prior approval is granted. This includes any drugs that are substrates, inhibitors or inducers of CYP3A4. Intermittent use of acetaminophen at doses of up to 2g/day is permitted
* History of drug or alcohol abuse within 2 years of Screening
* History of alcohol consumption within 24 hours of any study visit
* Tobacco users
* Consumption of fruit juices within 7 days prior to dosing
* Participation in unaccustomed strenuous exercise within 7 days prior to
* Positive urine drug screen
* Positive test for HIV-1, HBsAg or HCV
* Known hypersensitivity to MQ or artemisinins
* QTcF greater than 450msec
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART

30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age;
* Voluntarily signed informed consent;
* Patient is male, or female with negative pregnancy test prior to enrolment;
* Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA);
* Patient must be on stable treatment with HAART for at least 6 months (HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents\*);
* Mean of all measured CD4+ cell counts during the 6 months prior to the start of HAART must be above or equal to 200 cells/ mm3
* Current CD4+ cell count must be at least 450 cells/ mm3;
* HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted);
* Patient is one of the following: not sexually active, or a heterosexually active female, agreeing to use condoms with her partner from 14 days prior to the first vaccination until 4 months after the last, even though using another method of contraception, and willing to undergo pregnancy tests during screening and prior to each vaccination, or a male, agreeing to use condoms with his partner from the day of the first vaccination until 4 months after the last vaccination.

Exclusion Criteria:

* Treatment with a non-HAART regimen of antiretroviral agents prior to the start of HAART;
* History of a CDC class C event (see Appendix);
* Interruption of HAART during the course of the study which is expected at the time of inclusion;
* History of exposure \<20 years ago to any poxvirus based vaccine;
* Patient is female and has a positive pregnancy test or the wish of pregnancy:
* Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
* Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
* History of allergy to any vaccine component;
* Use of anti-coagulant medication;
* Use of any investigational drug during the 90 days prior to study entry;
* Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy
* Any other condition which, in the opinion
Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 40 years or over.
* Body mass index (BMI) of 35 or less.
* History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
* X-Ray of the target knee.
* Willing and able to complete the study procedures.

Exclusion Criteria:

* Female patients who are pregnant or lactating or who plan to get pregnant.
* Clinically significant form of joint disease other than OA.
* Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
* Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
* Arthroscopic surgery on the target knee within 6 months.
Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)

An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis).

It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety.

Effectiveness and Treatment adherence during real-life use will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Signed informed consent
* Indication for Velphoro treatment in accordance with the SmPC
* Prevalent dialysis patients with a dialysis vintage of at least 6 months (HD or PD)
* Treatment-naïve or pre-treated with anti-hyperphosphataemic therapy

Exclusion Criteria:

* Prior participation in this NIS (Non-Interventional Study)
* Parallel participation in an interventional study
* Enrolment in a prior clinical trial with Velphoro