cyrilzakka/clinical-trials huggingface dataset:
Study of Immune Thrombocytopenia Pathogenesis:

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ITP, defined as thrombocytopenia \< 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
* persons who have provided written informed consent

Exclusion Criteria:

* persons without national health insurance
* persons under 18 years old
* patients under guardianship
* pregnancy
* subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
A Study to Assess the Safety and Tolerability of Lucerastat in Subjects With Fabry Disease

The primary purpose of this study was to assess the safety and tolerability of lucerastat in adults with Fabry Disease receiving Enzyme Replacement Therapy (ERT).

The secondary objectives were to investigate the effects of lucerastat on plasma and urine levels of biomarkers, to assess its effects on renal and cardiac functions and to determine the pharmacokinetic profile of lucerastat at steady-state.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Male and female adult subjects with a diagnosis of Fabry Disease (FD) based on historical assessments (residual α-GAL A activity level below lower limit of normal for males and presence of a galactosidase alpha mutation for females) and a history of clinical symptoms of FD
* On ERT for at least 24 months without any change in dose within the last 6 months prior to screening

Exclusion Criteria:

* Severe renal function impairment
* Severe residual neurologic deficit
* Clinically significant unstable cardiac disease
* Any circumstances or conditions, which, in the opinion of the investigator, may have affected full participation in the study or compliance with the protocol
Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM

Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.

Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD and type 2 DM

Exclusion Criteria:

* Viral hepatitis.
* Child score more than 6.
* renal impairment.
Mechanical Posture Changes in Adolescent Female at Public Schools Compared to International Schools

The aim of this study is to determine different mechanical posture changes in adolescent females at public schools compared to international schools.

Two hundred adolescent female subjects at public schools and in this study. All subjects will be recruited from different schools. 1-Group A: it will be consists of 200 adolescent female from public schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS)and Depression Anxiety Stress Scales-21(DASS-21).

2- Group B: it will be consists of 200 adolescent female from international schools, will be evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS) and Depression Anxiety Stress Scales-21(DASS-21).

Eligibility Criteria:
Inclusion Criteria:

1. Adolescent female at schools.
2. Their age will be ranged from 13 to 17 years.
3. BMI more than 20.
4. Initiated menstrual cycle.

Exclusion Criteria:

1. Asthma and chronic respiratory disease.
2. History of upper and lower limb injury.
3. Under weight subjects.
4. Females with congenital spinal deformities.
5. Diabetes, cardiopulmonary diseases and any physical impairment that prevent following the study program.
Hot Water Immersion Therapy for Mental Health

In 2016, it was estimated that nearly 1 billion people worldwide were affected by a mental or addictive disorder, and were associated with considerable excess mortality. Acute heat therapy sessions (e.g. whole-body heating or foot immersions) have been shown to improve symptoms in individuals diagnosed with common mental health illness such as major depressive disorders and reduce anxiety.

This study will assess the impact of an at-home 8-week lower-limb immersion in hot water on symptom severity in patients diagnosed with major depressive disorder, generalized anxiety disorder, and PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with depression, anxiety, or post-traumatic stress disorder
* Internet access (e.g. via smartphone, computer)
* Currently engaging in mental health treatment

Exclusion Criteria:

* Free of any mental health disorder
* Not engaging in regular mental health treatment
* Diagnosed with other psychiatric disorders (e.g. schizophrenia, bipolar disorder, panic disorder)
Optic Nerve Sheath Diameter Difference Between Different Injection Volume

Valid method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. Different volume of injection is known to affect the degree of increase of intracranial pressure.

This study is desinged to measure the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter.

This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer
* gallbladder cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain lesion causing increased intracranial pressure
Feasibility of Modified Mindfulness Training on Antenatal Depression and Perceived Stress in Pregnant Women With Male Child Preference

This study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. The findings aim to support mental health interventions in maternity care.

Utilizing the ADAPT-ITT framework, this study will tailor mindfulness-based interventions to address unique cultural stressors, particularly those affecting maternal mental health due to male child preference.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the first and second trimester
* Score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS)

Exclusion Criteria:

* Psychiatric illness history, use of psychiatric medication
0.05 mg Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy

This study aims to compare the effect of spinal morphine between the dose 0.05 mg and 0.1 mg on the amount of morphine during the first 24 hours postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Female ASA 1-3
* Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
* Can operate PCA device

Exclusion Criteria:

* History of allergy to the study drugs
* History of bleeding tendency
* History of infection at the back
* Patient refuse to have spinal anesthesia
* History of CAD or CVD
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.

The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (greater than or equal to 18 years old)
* Patient with acromegaly, diagnosed for less than 5 years

Exclusion Criteria:

* Patient who have objected to the collection of his/her data
FoodSteps for Binge Eating & Food Insecurity

The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Type 2 diabetes mellitus
* Food insecure status (e.g. difficulty accessing food)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Not pregnant
* English-speaking

Exclusion Criteria:

* Diagnosis for which the study/intervention is not clinically indicated
* Currently receiving clinical services for weight management or binge eating
* Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes
Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial

During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.


Eligibility Criteria:
Inclusion Criteria:

1. Above 18

Exclusion Criteria:

1. Bad bowel preparation
2. Failure of cecum intubation
3. Inflammatory bowel disease
4. Colectomy story
Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic

Type 2DM is present in the populations of almost all the countries in the world and is a significant disease burden in most countries .Evidences suggest that population in India develop Type 2 DM at an increasing rate as they reject their traditional life styles.

Awareness and knowledge regarding Diabetes and role of physical inactivity in producing complications is still grossly inadequate( Mohan. D, Raj.D Awareness and knowledge of Diabetes in Chennai.The Chennai urban Rural Epidemiology study(CURES-9)J Assoc. Physicians India 2005 April;53:283-7).Exercise is a low cost , non pharmacological intervention that has been shown to be effective in metabolic control. Exercise is still vastly under-utilized in the management of Type 2 DM.

Most proximal behavioral cause of insulin resistance is physical inactivity.(Michael J. LaMonte, Steven N. Blair et al.( Physical activity and Diabetes prevention J Appl Physiol. 99: 1205-1213,2005)

This study was designed to promote physical activity among type 2 DM female subjects aged 35-65 yrs attending Diabetic clinic of a tertiary care hospital in Kerala.

The BCC model consisted of 1.an audio visual module imparting knowledge about DM, its complications, advantages of PA in Diabetes control, how to include more PA in routine life style 2. pamphlets.All these were standardised. Physical activity was measured using international physical activity questionnaire validated(responsiveness\& reliability) for our cultural activity.IPAQ covers four domains of physical activity: work-related,transportation, housework/gardening and leisure-time activity. PA data from the questionnaire were transformed into energy expenditure estimates as MET using published values. To calculate the weekly physical activity (MET-h /week), the number of hours dedicated to each activity class was multiplied by the specific MET score for that activity.

follow up once in a month (4 times) measure incremental physical activity and reinforcement in each visit. Students t test was used to compare the experimental and control groups with respect to the incremental physical activity measured in calorie expenditure. It was found that the incremental physical activity(final-basal) measured in METS is significantly higher in intervention group.

Eligibility Criteria:
Inclusion Criteria:

* females 30to 65yrs. with type-2 Diabetes Mellitus.
* Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram)
* on oral hypoglycemics

Exclusion Criteria:

* only one patient from one family
* H/o myocardial infarction
* nephropathy
* autonomic neuropathy
* severe limiting osteo arthritis
* pregnancy
* Mental incompetence
Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.

Exclusion Criteria:

* None
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Eligibility Criteria:
Inclusion Criteria:

1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
2. The participant is a premenopausal woman.
3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
4. The participant has experienced regular menstrual cycles
5. The participant is diagnosed as menorrhagia

Exclusion Criteria:

1. Participants with a screening Hb \<8 g/dL
2. Participants with a previous or current history of blood disorders
3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
4. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
5. Participants with a previous or current history of thyroid dysfunction
6. Participants with a previous or current history of pelvic inflammatory disease
7. Participants with a positive PAP smear test result
8. Participants with a history of panhysterectomy or bilateral oophorectomy
9. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
10. Participants with a previous or current history of a malignant tumor
11. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
12. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
13. Participants who have been treated with a bisphosphonate preparation
14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
15. Participants with non-diagnosable abnormal genital bleeding
16. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
18. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
19. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \> 1.5 times the upper limit of normal (ULN)
Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy

The purpose of this study is to obtain preliminary data in advance of a larger clinical trial aimed to test whether a single session of green light exposure can lead to a clinically significant reduction in epileptic spikes in patients with medically-refractory epilepsy. As this is a potentially fragile patient population, the study will test safety and tolerability as well as efficacy.

The trial is designed to detect (1) change in spike frequency on EEG before and after exposure to low intensity green light, and (2) presence or absence of neurologic/systemic symptoms referable to exposure of the pre-selected duration, intensity, and band of green light.

Our primary aim is to determine whether prolonged exposure (120 minutes) to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) alters the pattern of electrical activity in the cortex of epilepsy patients.

The primary outcome measure for this aim will be the fraction of patients in which the number of epileptiform discharges (spikes or sharp waves) decrease, per recording, in response to green light exposure, as determined by spike frequency detected via scalp EEG before and after green light exposure.

The investigators anticipate that the primary outcome measures of safety and tolerability will not differ from the previously established measures of green light exposure for migraine (Noseda et al. 2016). The investigators will use only low intensities (1-10 cd/m2) of green light which is well tolerated in adults and children (Main et al. 2000). In addition, given limited experience with conventional green light exposure in epilepsy, the investigators predict that post-exposure to green light, patients will have an improvement on the post-exposure EEG (decreased spike frequency).

Eligibility Criteria:
Inclusion Criteria:

* 6 months-30 years of age
* Epileptic spike frequency ≥1 epileptic spike per minute at baseline, as determined by scalp EEG recording
* Admitted to the Boston Children's Hospital Epilepsy Long Term Monitoring Unit at the time of enrollment

Exclusion Criteria:

* Cataracts
* Retinol disease
* Any history of or currently not well controlled ophthalmic disease that prevents transmission from the retina to the optic nerve
* Clinical seizure 4 hours or less before anticipated green light exposure
The Efficacy of Sentimag in Detection of Sentinel Node Biopsy

The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hypothesis behind this evaluation is that Sentimag is as efficient as conventional sentinel node mapping.

The programme will compare the Sentimag® with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB.

Sentinel lymph node biopsy (SLNB) is now the standard technique used in breast cancer patients with a clinically and radiologically negative axilla. SLNB for breast cancer was introduced in the 1990s3 and it significantly reduces the morbidity associated with axillary node dissection (ALND) including lymphedema, seroma, numbness, wound infection, reduced shoulder motility, and chronic pain.2 The gold standard for sentinel node detection is the 'combined technique'; using both blue dye and radioisotope injection. After allowing both radioisotope and blue dye to localize in the lymphatic system, the clinician uses a 'gamma probe' (a handheld scintillation counter) to locate the SLNs. The blue dye assists in localisation post-incision, with lymph nodes that are blue and/or radioactive are judged as 'SLNs' and excised. Some centres use either radioisotope or blue dye alone. Although detection rates are lower, they can still reach satisfying values in experienced centres.

The use of radioisotope exposes patients and healthcare workers to radiation, is heavily controlled by legislation (both on the specific training for operators and subsequent disposal of surgical waste), and provides poor pre-operative imaging. As a result, many centres have stopped undertaking routine pre-operative lymphoscintigraphy. There is thus a clinical need to develop new techniques for detecting sentinel nodes without these drawbacks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary breast cancer scheduled for Sentinel node biopsy;
* Patients who are clinically and radiologically node negative;.
* Patients aged ≥18 years at time of consent
* Patients are able and willing to give informed consent
* Ability and willingness to undertake all scheduled visits and assessments

Exclusion Criteria:

* Patients who are currently Pregnantcy or lactatingon;
* Patients with metastatic cancer;
* Subject has a known hypersensitivity to blue dye;
* Patients with intolerance or hypersensitivity to iron oxide or dextran compounds;, or to Sienna+
* Patients who have iron overload disease;
* Patients who has a pacemaker or other implantable device in the chest wall or shoulder;
* Previous axilla surgery, or impaired lymphatic function
* Subject is deprived of liberty or under guardianship
* Subject is indicated or scheduled for post-operative MRI investigation of the breast
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.

Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
* Participants must be starting a new regimen of bioidentical hormone replacement therapy.
* Participants must be expected to receive therapy for at least 12 weeks.
* Participants must be between 30 and 65 years of age.
* Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion Criteria:

* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
* Participants must not be pregnant or breastfeeding women.
* Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
* Participants must not be using another bioidentical hormone at the time of enrollment.