cyrilzakka/clinical-trials huggingface dataset:
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite

The goal of this project is to identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new therapeutic avenues to treat this eating disorder.


Eligibility Criteria:
Inclusion Criteria:

* Hyperphagic

Exclusion Criteria:

* Psychiatric disorders
* Pregnancy
Prospective Cohort of Immune Checkpoint Inhibitor-induced Hepatitis

Background and Study Rationale Immune checkpoint inhibitors (ICI) are a breakthrough cancer treatment that boosts the immune system to fight tumors. While effective, they can cause immune-related side effects, including liver inflammation (ICI-induced hepatitis or CHILI), which affects up to 25% of patients. Severe cases requiring treatment discontinuation are rare but challenging to manage.

Study Objective This multicenter prospective study aims to better understand CHILI, its clinical patterns, treatment response, and risk of recurrence. It will focus on different types of liver injury (cholestatic, hepatocellular, or mixed) to guide better treatment decisions.

Innovation and Approach Currently, there is no clear consensus on how to manage CHILI or when to safely restart immunotherapy. This study will collect real-world data from adult patients treated with ICIs, following international guidelines or a pragmatic approach when no consensus exists. Findings will help improve care strategies for patients experiencing ICI-related liver toxicity.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years

  * Patient willing to participate in the study
  * Patient with cancer receiving neoadjuvant, adjuvant, or maintenance treatment · Patient treated with ICI, either as monotherapy or in combination with another antitumor treatment (targeted therapy, chemotherapy, or radiotherapy), either de novo or after a first-line treatment including ICIs
  * Patient who has received at least one injection of an ICI ·
  * Onset of hepatitis following treatment initiation, defined by the following criteria:

    * ALT (alanine aminotransferase) ≥ 5 times the upper normal limit
    * ALP (alkaline phosphatase) ≥ 2 times the upper normal limit
    * ALT (alanine aminotransferase) ≥ 3 times the upper normal limit and bilirubin ≥ 2 times the upper normal limit ·
  * Patient with grade 3 or 4 hepatitis, according to the current CTCAE classification
  * Exclusion criteria:
* Patient with another cause of acute hepatitis, including viral, autoimmune, ischemic, acute alcoholic hepatitis, or Wilson's disease.
* Patient unable to express their non-opposition to participate in the study.
* Person deprived of liberty, under guardianship or curatorship, or in an emergency situation.
* Person not affiliated with a social security system or without entitlement to healthcare coverage.
Effects of L-carnitine on Hypothyroidism

L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypothyroidism with fatigue symptom
* Currently use of the same amount of levothyroxine over at least six months
* Normal serum free T4 level

Exclusion Criteria:

* Current smoker
* Serum hemoglobin level of under 12mg/dL
* Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5%
* History of significant heart failure
* History of large amount of alcohol consumption
* Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg
* pregnant, or planning to be pregnant, or breast feeding women
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit
* serum Cr level \> 2.0mg/dL
Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease

The elimination of the pathogenic microorganisms of the periodontal pocket is one of the main points for success in periodontal treatment. The objective of this study is to investigate the clinical and antimicrobial effect of papain-mediated photodynamic therapy in the clinical treatment of periodontal disease. Twenty patients with chronic periodontitis will be selected. Patients will be divided randomly into two groups (n = 10), and the control group will receive conventional periodontal treatment and group II will receive conventional treatment and antimicrobial photodynamic therapy (aPDT). Conventional treatment will consist of oral hygiene guidance, with brushing technique instructions and recommendation of daily flossing. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for scraping and root planing. The aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The PapaMblue® photosensitizer will be deposited in the periodontal pockets with a syringe and a pre-irradiation time of 1 min will be adopted. Then, the laser emitting wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 will be applied. Patients will undergo clinical evaluations before treatment (day 1) and 30, 60 and 90 days after the end of treatment. Microbiological evaluations will be made before and 30 days after treatment. The distribution of the data within each group and the homogeneity of the variances will be verified. With this information, the most appropriate statistical test for each evaluation will be used. The sample calculation is based on the literature and the significance level of 5% will be adopted.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have chronic periodontitis (AAP, 2001);
* At least 10 present teeth, with at least 3 sites with clinical depth of probing greater than 4 mm;
* The patient must be in periodontal treatment at the Dental Clinic of Universidade Nove de Julho, institution where this research will be carried out;

Exclusion Criteria:

* Smokers or former smokers who discontinued the habit less than 12 months prior to selection;
* Uncontrolled diabetes;
* Anemia;
* Cancer;
* Pregnant women;
* Use of antibiotics in the last 6 months;
* Use of anti-inflammatory in the last 3 months;
* Coagulation disorder (use of anti-coagulant, presence of liver diseases, thrombocytopenia and immunosuppression);
* Patients under orthodontic treatment;
* Patients who maintain a biofilm index greater than 25%.
Global Postural Reeducation in Chronic Low Back Pain

The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.

Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).

Eligibility Criteria:
Inclusion Criteria:

* between 18-65 years age,
* low back pain (more than 12 weeks) without legs irradiation,
* pain between 3-8 cm on a visual Analogue scale (0-10cm).

Exclusion Criteria:

* fibromyalgia,
* pregnancy,
* osteoporosis severe,
* disc herniation,
* patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.
The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers

Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.

This study investigates the following questions:

Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.

Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.

The study protocol includes the following steps:

Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
* Study population is composed of people who are exposed to environmental particles form industrial sources.
* Informed consent is requested from each subject.

Exclusion Criteria:

* Unemployed individuals.
* Individuals who are not working in industrial jobs, such as office workers and secretaries.
506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).

II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.

OUTLINE:

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
* Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8
* Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13
* Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
* No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy

PATIENT CHARACTERISTICS:

* Age: 16 and over
* Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
* Creatinine clearance at least 50 mL/min (unless due to leukemia)
* No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL
* No preexisting neuropathy of grade 2 or greater regardless of causality
* No history of seizure disorder
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No concurrent erythropoietin
* No other concurrent chemotherapy
* No concurrent dexamethasone or other steroidal antiemetics
* No concurrent hormone therapy, except for non-disease-related conditions
Cardiac Rehabilitation for the Patients With Acute Myocardial Infarction

The benefits of cardiac rehabilitation include improving exercise tolerance and quality of life. However the attending rate of the patients with acute myocardial infarction was low according to the previous studies. This is a retrospective chart review study collecting the basic characteristics of the patients diagnosed with acute myocardial infarction of Wang-Fang Hospital (from Jan 1, 2012 to June 30, 2021). The aims of the studies are to investigate the related issues of cardiac rehabilitation including (1) attending rate (2) the efficacy of exercise training (3) the factors that limit the participation of the training programs.


Eligibility Criteria:
Inclusion Criteria:

1. Cased diagnosed with acute myocardial infarction at emergent department and admitted
2. Age over 20 years old

Exclusion Criteria:

1. AAD cases after admission to ER or the general ward
2. Cases died within admission.
3. Cases refused the treatments.-
Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination

This randomized, controlled trial study was designed to examine the efficacy of Cognitive Behavioural Therapy (CBT) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in Tehran, Iran.

A total of 52 individuals with Social Anxiety Disorder (SAD) (68% female, mean age = 35.67) were allocated to a CBT group or to a control group. The intervention group was given one session of therapy per week over a duration of 8 weeks, while the control group did not receive any intervention and was placed on a waiting list. Self-reported social anxiety, perfectionism, and rumination were measured before the CBT intervention, after the intervention, and two months after the intervention for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants formally diagnosed with SAD by psychologists who determined the individual meet criteria outlined by the Diagnostic and Statistics Manual for Mental Disorders (DSM-5)

Exclusion Criteria:

* If participants report a history of psychiatric disorders within the past 12 months such as schizophrenia, dementia, depression, alcohol and other drug addiction.
* Participants could not partake if they were pregnant
* Participants enroll in another psychological treatment program.
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, incurable, locally advanced or metastatic breast cancer
* Evaluable or measurable HER2-positive disease
* History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
* Previous treatment with chemotherapy for MBC
* Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL
* Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST ≤ 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 60 mL/min based on a 24-hour urine collection
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment

Exclusion Criteria:

* History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication
* History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
* History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued
* Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment
* Require supplemental oxygen for daily activities
* Grade ≥ 2 peripheral neuropathy
* Bisphosphonate therapy for symptomatic hypercalcemia
* Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment
* Any experimental therapy within 4 weeks of first study treatment
* Any major surgical procedure within 4 weeks of first study treatment
* History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis
* Pregnancy or lactation
* Cardiac troponin I ≥ 0.2 ng/mL
* Ejection fraction \< 50% or below the lower limit of normal determined by echocardiogram or MUGA scan
* Prior cumulative doxorubicin dose of \> 360 mg/m2 or equivalent
CODE Registry - Cardiac Arrest Outcomes Data Evaluation

The purpose of this study is based on method Utstein, registering all recommended items of that model, in addition to adding more information, characterizing this way using a template Utstein modified for the epidemiology of PCR-hospital in Brazil.

Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to assess demographic and clinical variables such as morbidity, mortality and standard practice in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors associated with survival in several times and survival curves.

Bedding: Despite of ongoing advances and standardizing worldwide trumpeted by CPR guidelines, yet is little knowledge of the effectiveness of procedures for intra and extra-hospital CPR, so vast are the opportunities for documentation of these results in the field of clinical and epidemiological research. Utstein style emerged, then as a proposed methodology for the PCR during the Conference held at the former monastery Utstein, Norway. The "Utstein Style" was also the model for the construction of the National Registry of Cardiac Pulmonary Resuscitation (NRCPR), sponsored by the American Heart Association (AHA). The proposal of this study is based on method Utstein, registering all recommended items of that model, in addition to adding more information, characterizing this way using a template Utstein modified for the epidemiology of PCR-hospital in Brazil.

Objectives: establish a registry of patients suffering from respiratory (PCR)-hospital to assess demographic and clinical variables such as morbidity, mortality and standard practice in cardiopulmonary resuscitation (CPR). In addition, assess independent predictors associated with survival in several times and survival curves.

Methods: Observational Study of prospective registration type, to document the clinical practice of cardiopulmonary resuscitation in-hospital effect in 17 hospitals and institutes of public and private Brazilian specialties. Additionally the longitudinal follow-up will be conducted until discharged, and measurement of mortality at 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patient in cardiac arrest in-hospital
* Consent Form signed by subject's legally acceptable representative or by patient in case of survive

Exclusion Criteria:

* Patient in cardiac arrest out-hospital
* Cardiac arrest induced (e.g: for cardiac surgery)
The Effects on Growth of a Non-Routine Infant Formula

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Eligibility Criteria:
Inclusion Criteria:

* Term infant
* Solely formula fed
* 14 days of age

Exclusion Criteria:

* History of underlying disease
* Evidence of formula intolerance
* Current illness
A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia

Severe community acquired pneumonia is common and associated with high mortality. Conventional microbiological diagnostics identify pathogens in approximately half of cases, which is inadequate for both clinical and epidemiological purposes. This study applies next-generation sequencing based metagenomic techniques to patients with extremely severe community acquired pneumonia, to investigate the microbiome of severe community acquired pneumonia and evaluate metagenomic approaches as diagnostic tools.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or over
* Admitted to a participating severe respiratory failure centre or ICU
* Admitted due to community acquired pneumonia (CAP) according to clinical and radiological criteria
* Tracheal intubation, receiving mechanical ventilation +/- ECMO
* Requires bronchoscopy as part of routine diagnostic care plan
* Bronchoscopy takes place within 72 hours of first admission to hospital

Exclusion Criteria:

* Any current or previous condition/circumstance that, in the opinion of the investigator or study nurse, may put the individual at risk if participating
* Patients receiving end of life care
* Hospitalisation within the previous 28 days (not including pre-ECMO hospitalisation for ECMO patients)
* Consent or assent not given
Collection of Blood and Urine Specimens From Volunteers Utilizing Health Examination Services

In summary, the researchers want to construct a longitudinal data bank using voluntary health examination participants. Researchers in the National Taiwan University Hospital (NTUH) campus can utilize these data to clarify the effects of several genetic and environmental factors on various common diseases in Taiwan in the future.


Eligibility Criteria:
Inclusion Criteria:

* Persons who sign informed consent

Exclusion Criteria:

* Age below 18 years