cyrilzakka/clinical-trials huggingface dataset:
(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis

This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosed with 1 of the following diagnoses according to the 2016 World Health Organization (WHO) classification for systemic mastocytosis (SM):

   * Indolent systemic mastocytosis (ISM),
   * Bone marrow mastocytosis (BMM)
   * Smoldering systemic mastocytosis (SSM)
2. Moderate-to-severe symptoms based on a minimum total symptom scoew (TSS) of the Mastocytosis Activity Score (MAS) and after establishing a stable regimen of at least 2 antimediator therapies over a 14-day eligibility period
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
4. For patients receiving corticosteroids, the dose must be ≤10 mg/day of prednisone or equivalent

Key Exclusion Criteria:

1. Persistent toxicity from previous therapy for NonAdvSM that has not resolved to ≤ Grade 1
2. Diagnosed with any of the following WHO SM classifications: bone marrow mastocytosis, advanced systemic mastocytosis including SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia; or mast cell sarcoma
3. Diagnosed with mastocytosis of the skin without systemic involvement
4. Received prior treatment with any targeted KIT inhibitor with the exception of approved agents for the treatment of SM
5. Received prior cytoreductive therapy or investigational agent for \<14 days or 5 half- lives of the drug and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \<28 days or 5 half-lives of the drug (whichever is longer), before starting screening assessments
6. Received radiotherapy or psoralen and ultraviolet A therapy \<14 days before starting screening assessments
7. Received any hematopoietic growth factor support \<14 days or 5 half lives of the drug before starting screening assessments
8. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
9. Need for treatment of corticosteroids at \>10 mg/day of prednisone or equivalent
10. Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives before the first dose of study drug
Immunological Consequences of CARD15/NOD2 Mutations in Crohn's Disease

The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Crohn's Disease (CD) affects about 60.000 to 80.000 people in France. It is characterised by a chronic or relapsing inflammation of the gut. Its aetiology is largely unknown, limiting the development of preventive and curative therapeutic options. In 2001, we have identified the first CD susceptibility gene: CARD15/NOD2. This gene is involved in the innate immune response but we do not know today how gene mutations may induce the disease lesions. However, many data suggest that the intestinal inflammation may be related with an abnormal function of the lymphoid tissue present in the gut.

The aim of the present proposal is to better understand the role of CARD15/NOD2 mutations (R702W, G908R and 1007fs) in the development and the function of the intestinal lymphoid tissue. 250 patients and controls will be enrolled at Robert Debré and Saint Louis Hospital (Paris, France) within a 2 years period.

For participant, 4 to 5 ileal biopsies will be taken during a routine colonoscopy. Patients will be classed in three groups according to their number of CARD15/NOD2 mutations (1) wild-type, 2) mutated heterozygotes and 3) mutated homozygotes or compound heterozygotes). A comparison between groups and with non inflammatory (colonoscopy performed for other reasons) or inflammatory (ulcerative colitis patients) controls will be done. For each group, cell phenotype, cytokine profile, permeability and bacterial translocation will be analysed on Peyer's patches.

The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Children and adults ≥ 5 ans and ≤ 65 ans with a programmed routine colonoscopy for Crohn's disease, ulcerative colitis, or another benign gastroenterological disorder

Exclusion Criteria:

* Patients \< 5 ans or \> 65 ans
* Patients with contra-indications for multiple biopsies
* Patients with an undeterminate colitis
Pilot Study of LED for PIE and PIH

The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH.

Evidence regarding the efficacy of LEDs for post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) is limited.

The aim of this study was to evaluate the efficacy of 830 nm and 590 nm LED phototherapies on PIE and PIH.

Design of the study:

308 nm LED light (1.5 MED) induced an in vivo PIE/PIH model on the thigh of ten healthy subjects. 830 nm (60 J/cm2) and 590 nm LED (20 J/cm2) were irradiated respectively. For therapeutic irradiation, PIE/PIH model was induced on D1, and LEDs were irradiated on D0, 1, 3, 6 and 8. For preventive irradiation, LEDs were irradiated on D0, 1, 3, 6 and 8 and PIE/PIH model was induced on D9. Erythema index (EI), melanin index (MI), transdermal water loss (TEWL) and C-Cube photography were measured during 10-day follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Asians;
2. 20-65 years old;
3. Fitzpatrick classification III-IV;
4. Sign the informed consent form.

Exclusion Criteria:

1. Have abnormal skin manifestations, such as pigment diseases, photosensitivity diseases and other allergic diseases;
2. Those with a history of abnormal systemic diseases, such as heart disease, liver disease, kidney disease, tumors, and mental illness;
3. Women who are preparing for pregnancy, pregnant or breastfeeding;
4. Have used photosensitizing drugs within two weeks before inclusion in this study;
5. Topical or systemic drugs may be used during this study;
6. bad habits, such as smoking, drinking, etc.;
7. Volunteers who have recently participated in other clinical trials;
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Colectomy for Non metastatic colon cancer

Exclusion Criteria:

* Tumor T4
* No medical insurance
* Pregnant woman
* Psychiatric disorders
Remote Ischemic Preconditioning for Subcortical Vascular Dementia

The purpose of this study is to determine whether the remote ischemic preconditioning are effective in the treatment of mild to moderate vascular dementia.

In this randomized, double-blind, placebo-controlled trial, the investigators enrolled 52 participants aged 50-80 years. The participants had a diagnosis of subcortical vascular dementia at the neurology department of Tianjin medical university general hospital. Inclusion criteria included a clinical dementia rating 1-2; a mini-mental state examination score 15-26; and brain magnetic resonance imaging consistent with subcortical ischemic small vessel disease. All participants received standard medical management.Participants in the remote ischemic preconditioning group underwent 5 brief cycles consisting of bilateral upper limb ischemia followed by reperfusion. The remote ischemic precondition procedure was performed once daily over 180 consecutive days. Cognitive impairment assessment scale ( Hopkins Verbal Learning Test,HVLT;Symbol digital modalities tes,SDMT;judgement line orientation, JLO;trail making test A and B,TMT-A/B;chinese word fluency test;Activity of Daily Living Scale,ADL;Neuropsychiatric Inventory,NPI), serological inflammatory markers:hypersensitive C-reactive protein（hs-CRP）、plasma tumor necrosis factor-α(TNF-α)、interleukin-1β(IL-1β)、interleukin-6 (IL-6)、α1-antichymotrypsin),and MRI diffusion tensor imaging, DTI were compared with the untreated control group.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of vascular dementia
2. In three months without cerebral infarction
3. MMSE 15 to 26 points;CDR 1-2 points;MoCA \< 26 points
4. MRI showed subcortical ischemic cerebrovascular disease.

Exclusion Criteria:

1. AD 、 FTD, DLB and other causes of dementia.
2. Cortical/subcortical infarction
3. Cortex watershed infarction
4. Cerebral hemorrhage
5. Hydrocephalus
6. Other special causes of white matter lesions such as multiple sclerosis, sarcoidosis, radiation encephalopathy, etc.
7. Cannot complete aphasia neuropsychological assessment.
8. Genetic or inflammatory small vascular disease.
9. Serious cardiovascular, lung, liver, kidney, endocrine, such as infection disease.
10. Alcohol poisoning;
11. Cancer
12. Hypothyroidism
13. Schizophrenia;Hamilton depression rating scale \> 17 points.
14. Can not complete MRI.
Homeopathic Remedy for the Third Stage of Delivery

The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. The purpose of this study is to repeat the previous methodology, this time on a larger population.

210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo (n=70).


Eligibility Criteria:
Inclusion Criteria:

* healthy women in 3rd stage of labor
* age 20-35
* second to fifth gestation
* spontaneous PV delivery
* term delivery (37-42nd weeks)

Exclusion Criteria:

* scarred uterus
* multifetal pregnancy
* history of bleeding problems
* caesarian section delivery
* chorioamnionitis
* pregnancy-induced hypertension
* gestational diabetes mellitus
* polyhydramnios, premature rupture of membrane
* suspected macrosomy/SGA
ICCAC-ToNF & Tinnitus

Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol.

Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness).

Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied.

Based on this multifocal (Insula, dorsal anterior cingulate cortex \& auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.


Eligibility Criteria:
Inclusion Criteria:

* chronic tinnitus (\>6 months)
* Age 40 to 80
* Informed Consent
* Fluent in German language
* mentally \& physically fit

Exclusion Criteria:

* ferromagnetic implants
* cochlear implants
* average hearing loss over 50 dB
* claustrophoby
* addiction to alcohol or drugs
* intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
* acute suicidal
Anthropometric Characteristics, Level of Physical Fitness, and Muscle Strength in Youngsters Attending School

It has long been believed that evaluating a child's development is essential to determining population health trends and creating effective interventions. Assessing school-age children's overall health and well-being in the 7-14 age range requires careful observation of their anthropometric metrics, physical fitness, and muscle strength. These assessments can provide insight into several physical health-related concerns during this crucial period of childhood development. Anthropometric parameters include height (in centimeters or centimeters), body mass index (BMI), skin fold measurements (which provide estimates of body fat), circumference measurements, and body weight (kg), which is typically measured in kilograms (kg).

A cross-sectional descriptive study design will be used. The goal of this research is to determine how anthropometric characteristics, physical

The participants' anthropometric parameters will be assessed both subjectively and objectively to calculate the data. Weight will be measured in kilograms using a weight machine, and height will be measured in inches using a measuring tape and converted into meters, respectively, to determine BMI. Using a measuring tape, the chest, abdomen, thigh, triceps, and supraillium are measured to determine the skin fold measurement, which determines the body fat percentage. Circumference measurements, such as those taken of the midthigh, biceps, waist, hips, and conicity index. The body mass index, conicity index, weight scale, and inch tape will be used for these measurements.

A common tool is the International Physical Activity Questionnaire (IPAQ). The seven-day IPAQ-SF is a self-administered, scientifically validated recall questionnaire for children ages 7 to 14. The quantity of time a child spends exercising during the

Eligibility Criteria:
Inclusion Criteria:

* The age of participants will be 7-14 years.
* Males and females will be included.
* Healthy and physically fit participants will be taken.
* Regular and enrolled students of public and private schools.

Exclusion Criteria:

* Students with any significant past medical or surgical history will be not included in this study.
* Chronic disease or injury to the lower extremity or were on continuous medication
Validation of the Facial and Cephalic Pain Inventory

This study proposes to develop and validate a new instrument designed to measure facial and nasal discomfort related to chronic sinusitis. The second phase of the study will be to use this instrument to measure correlation with sinus computed tomography (CT) scans.

The following specific aims will be addressed:

* to create a user-friendly, self-explanatory instrument (FACE PAIN questionnaire) with pain severity visual analog scales associated with the common locations of facial pain in chronic sinusitis.
* to evaluate the clinimetric reliability and validity of the FACE PAIN questionnaire
* to evaluate the ability of th FACE PAIN questionnaire to detect change in symptoms following medical or surgical treatment
* to quantify a minimally important difference in the FACE PAIN instrument by correlating disease-specific quality of life change (Transition Scale) with FACE PAIN rating changes following treatment.
* to evaluate the correlation between facial pain symptoms described on the FACE PAIN questionnaire with CT scan and endoscopic findings.

The measurements used for the study are: demographics (age, gender and race), contact information (to facilitate mailing of future instruments), Sinonasal Outcome Test-20 (SNOT-20 - a well validated, 20-item measure of rhinosinusitis specific QOL), FAcial and CEphalic PAin INventory (instrument under study) and Translational Quality of Life Form (this transition scale provides a subjective quantification of the degree of change in quality of life from sinusitis); CT scans and nasal endoscopy findings.

Control subjects will complete the SNOT-20 (validated QOL form) and the FACE PAIN a single time.

Case subjects will complete the SNOT-20 and the FACE PAIN questionnaire at the visit during which they review their CT results with the MD. Thereafter, they will complete the FACE PAIN questionaire twice more; at weeks 12 and 14 post that visit. They will also complete the Transition Scale at week 12. These forms will be mailed to the subjects and returned by mail.

We hypothesize that facial pain ratings will correlate moderately with SNOT-20 scores and a transition scale. Higher values are not expected because QOL instruments encompass many symptoms of chronic sinusitis, but the FACE PAIN instrument addresses location and severity of pain.

We will also test the hypothesis that facial pain ratings will be much lower in non-sinusitis patients.

Eligibility Criteria:
Inclusion Criteria:

* Case subjects from the Rhinology Clinic must have CT evidence of chronic sinusitis
* Control subject from the Otology Clinic who have not had sinus surgery in the past 2 months

Exclusion Criteria:

* any subject unable to give informed consent of complete self-administered questionnaires written in English
* Control subjects with a history of sinusitis in the last 6 months
The Effect of Education on Vaginal Effects of Menopausal Women

The aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress. It is a pretest-posttest randomized controlled experimental study. The universe of the research; It consisted of menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep. The sample of the research consisted of 102 people determined by the GPower method and determined by simple random method among all women who volunteered to participate in the study. Introductory Information Form, Daily Effect of Vaginal Aging Scale, Sexuality Avoidance Decision Balance Scale and Sexuality Avoidance Self-Efficacy Scale, Female Sexual Distress Scale were used to collect the research data. . The data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.

Menopause is an inevitable event in every woman's life. This is a period in which women adapt to physical, emotional, mental and hormonal changes in their lives. During this process, the woman's menstrual cycle is permanently interrupted. The aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress. It is a pretest-posttest randomized controlled experimental study. This research was conducted between October 2023 and December 2023 with menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep. The universe of the research; It consisted of menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep. The sample of the research consisted of 102 people determined by the GPower method and determined by simple random method among all women who volunteered to participate in the study. Introductory Information Form, Daily Effect of Vaginal Aging Scale, Sexuality Avoidance Decision Balance Scale and Sexual Avoidance Self-Efficacy Scale, Female Sexual Distress Scale were used to collect the research data. . The data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.

Eligibility Criteria:
Inclusion Criteria:

* Being able to understand what you read
* being in menopause
* continue throughout education
* Being 45 years or older

Exclusion Criteria:

* being under 45
* having a mental problem
* not being in menopause
* not attending one of the training sessions
Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption

In this study, the investigators will be developing and testing a mobile phone text message intervention to reduce alcohol use for people at risk of alcohol dependence. The investigators hypothesize that this intervention will be acceptable to participants, and that they will stay in the intervention until it's one week completion.


Eligibility Criteria:
Inclusion Criteria:

* AUDIT score 15-20
* have a mobile phone capable of receiving text messages

Exclusion Criteria:

* age \<18
* unable to consent
* language other than English or Spanish
Frequency of Female Athlete Triad Among Elite Female Athlete of Iran in Different Sport in 2007

Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female athletes are potentially at risk, but it is not clear to what extent those exercising at different levels are at risk of this syndrome/triad. Since the manifestation of this triad is often denied, or under-reported, appropriate screening methods are required to identify the symptoms. There is still no clear-cut information available on the incidence of this triad in Iran. And there are religious and cultural differences between Iran's elite female athletes and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the investigators decided to determine the frequency of the female athlete triad in Iran.


Eligibility Criteria:
Inclusion Criteria:

* All Elite Female athletes who play in international teams in sport federation or champion Team in Tehran between 13-45 years old.

Exclusion Criteria:

* The 13-15 year old female athletes who are not manarch with secondary sex charactristics.