cyrilzakka/clinical-trials huggingface dataset:
Adherence to Exclusive Enteral Nutrition in Patients With Crohn's Disease

The study has not yet been completed


Eligibility Criteria:
Inclusion Criteria:

* The main inclusion criteria were as follows: had diagnosed CD more than 3 months; had EEN in the past 6 months; were at least 18 years old; agreed to participate in this study.

Exclusion Criteria:

* The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.
Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg for for 6 weeks. (Clinical Trial phase I)

Sample size Group 1 (100mg/meal) = 6 female, 6 male Group 2 (200mg/meal) = 6 female, 6 male

Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai 95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks. After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will be followed up in the third week, sixth week and eighth week to evaluate the safety of the medicines. The researcher will record data such as age, career, BMI, vital signs, signs and symptoms. Safety will be monitored by hematology tests such as liver function test, renal function test, lipid profile and blood sugar.

The first step in this research will be to study group 1 (100 mg). If it proves safe, the group 2 (200 mg) will be studied.

The data gathered will be evaluated using statistical software. The results are in the form of mean ± standard deviation. The study will be planned as repeated measured ANOVA or Friedman's test in order to evaluate differences between groups, accompanied by using paired t-test or Wilcoxon's test in order to evaluate differences within groups. A significance level of p \< 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age in range 20-60 years old.
* 2) Healthy, or don't have serious medical conditions such as congestive heart disease, liver and renal dysfunction, uncontrolled hypertension, severe asthma, tuberculosis, HIV in the previous month before being recruited in the study, using history taking and complete physical examination and laboratory result.
* 3) Do not taking a medicine constantly.
* 4) Female not pregnant or lactating (non menopause woman will have a pregnancy test. Time since first day of last menstruation 28-35 days).
* 5) Participant and agreement to follow the instructions for 8 weeks.
* 6) Not a participant in another study.

Exclusion Criteria:

* 1) Allergic reactions to Prasaprohyai medications.
Myocardial Ischaemia After Exposure to Diesel Exhaust

Exposure to particulate air pollution is associated with increases in cardiovascular mortality and morbidity. The pathophysiological mechanisms underlying this observation are emerging, and exposure to particulate air pollution has been shown to result in increases in blood pressure and arterial tone, impaired vascular function and an increased tendency for blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from panel studies and controlled exposure studies have suggested an increase in myocardial ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male patients with stable coronary disease and healthy male controls. We hypothesize that following exposure to dilute diesel exhaust:

1. Myocardial blood flow will be reduced
2. Coronary flow reserve will be impaired
3. The magnitude of impairment will be higher in patients with coronary disease as compared to healthy controls


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers will be taking no regular medication, have a normal electrocardiogram and exercise stress test
* Patients with a previous history of myocardial infarction or successful coronary revascularization (PTCA or coronary artery bypass grafting) but without symptoms of angina pectoris will be recruited

Exclusion Criteria:

* Healthy volunteers:
* Regular medication
* Abnormal 12-lead electrocardiogram
* Abnormal exercise stress test
* Patients with coronary disease
* Acute coronary syndrome within past 3 months
* Impaired left ventricular function
* Significant valvular heart disease
* Left ventricular hypertrophy
* Resting conduction defect
* Digoxin use
* Renal impairment (eGFR \<60 mL/min)
* Hepatic impairment
* Asthma
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.


Eligibility Criteria:
Inclusion Criteria:

1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.

2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.

3) Patients with acute pulmonary embolism within 5 days after the onset.

4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items:

1. Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography.
2. Confirmed to have any of the following right ventricular overloads by echocardiography:

   i) Dilation of right ventricular cavity or hypokinesis in ventricular wall

   ii) Floating thrombi in pulmonary artery and right heart

   iii) Paradoxical motion in the interventricular septum

   iv) Disparity of tricuspid regurgitation pressure

   v) Enlargement of pulmonary artery
3. Mean pulmonary arterial pressure (PAP) is 20 mmHg or above
4. PaO2 is 65 mmHg or below (confirmed by blood gas analysis)

Exclusion Criteria:

1. Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).
2. Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment.
3. Patients with intracranial tumor, arteriovenous malformation, or aneurysm
4. Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia)
5. Patients with hypertension of systolic blood pressure \>=180 mmHg or diastolic pressure \>= 110 mmHg.
6. Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage).
7. Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure).
8. Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment.
9. Patients with pulmonary cardiac arrest (CPA).
10. Patients with a history of hypersensitivity to monteplase or protein preparations.
11. Pregnant women, women suspected of being pregnant, women who desire to become pregnant during a period between obtaining informed consent to the final observation, or lactating women.
12. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
Near Infrared Spectroscopy and Testicular Torsion in Children

NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child


Eligibility Criteria:
Inclusion Criteria:

* Step 1: healthy boys between 0 and 16 years old
* Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

Exclusion Criteria:

* cutaneous scrotal lesion,
* fever (for the control group),
* hypertension
Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors

The investigators propose to compare the effects of a 12-week, supervised, site-based group yoga intervention on cognitive function, functional fitness, and well-being in middle-aged cancer survivors. Subjects will be randomly assigned to one of three exercise conditions: a yoga group, an aerobic walking group or a strength training group. All sessions (2-3 times per week) will be led by a trained exercise leader for a total of 150 minutes of exercise each week for the 12-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* 30-70 years of age
* Cancer diagnosis
* 1 year since last cancer treatment (surgery, chemotherapy, and/or radiation)
* Not planning to receive treatment during study period
* Completion of Physical Activity Readiness Questionnaire (PAR-Q)
* Ambulatory and absence of health conditions that may be exacerbated by yoga, walking, or strength training
* Physician consent (if deemed necessary)
* Low-active, i.e. less than 150 minutes/week of moderate to vigorous exercise, no current yoga practice (including within last six months)
* Intention to remain in the Champaign-Urbana area over the study duration
* Willingness to be randomly assigned to one of the three groups (yoga, aerobic walking, strength training)
* Comfortable with reading, writing, and speaking English

Exclusion Criteria:

* Below 30 or above 70 years of age
* Cancer diagnosis of the brain
* Less than 1 year since last treatment (surgery, chemotherapy, and/or radiation) or plans to receive treatment during study
* Determined ambulatory or 'high risk' based on responses to PAR-Q
* High-active (exercising more than 150 minutes/week in the last six months)
* No consent from physician
* Intent to be away from the Champaign-Urbana area for an extended period of time during the study
* Inability to communicate effectively in English
Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome

OBJECTIVES:

I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due to DiGeorge syndrome or velocardiofacial syndrome.

II. Determine any correlation between immunologic function in these patients and chromosome 22 deletion breakpoints.

III. Determine presence of sustained immunologic compromise in older patients.

PROTOCOL OUTLINE:

Blood samples are collected at diagnosis of chromosome 22q11 deletion and assessed for lymphocyte proliferation in response to mitogens phytohemagglutinin, pokeweed mitogen, and concanavalin A (mitogen stimulation analyses). These analyses are repeated at 4 months along with a quantitative analysis of immunoglobulin.

At 8 months, patients are tested for their lymphocytes' ability to respond to antigens (candida, tetanus, and diphtheria). At 1 year, patients have lymphocyte subset, IgG, IgA, and IgM analyses performed. Quantitative evaluations of antibody titers to diphtheria, tetanus, Haemophilus influenza, and hepatitis B are also performed.

Over 1 year of age, all studies are performed if the patient is seen for a single visit.

Eligibility Criteria:
* Conotruncal cardiac lesion to be repaired by surgery AND Chromosome 22q11 deletion by FISH
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants

The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be Chinese (both biological parents are ethnically Chinese).
* Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
* Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height \[m\])2.
* Body weight ≥ 50 kg

Exclusion Criteria:

* Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome)
* Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable)
* Women who are of childbearing potential
* Women who are breastfeeding
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate \< 90 mL/min/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine

Other protocol-defined inclusion/exclusion criteria apply.
The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver.

To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease


Eligibility Criteria:
Inclusion Criteria:

1. All patients of COVID-19 positive
2. Age 18-70 years

Exclusion Criteria:

1. No Valid consent
High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study

Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.

Incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. Diagnosis and treatment are major public health issues. High Instensity Focused Ultrasound (HIFU) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. This technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (MRI).

The main objective is to evaluate the efficacy of HIFU for the treatment of breast tumors, based on histological criteria.

Indication :

Histologically invasive ductal carcinoma, T0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical N0.

Course of the study :

* Signature of consent,
* Clinical and radiological assessment at Baseline,
* Realization of the HIFU procedure under local anesthesia and sedation (J0),
* Total or partial mastectomy depending on the lesion (between D2 and D8),
* Consultation with surgeon (J30),

Number of patients :

15 patients will be included in this pilot study. If no success is observed, the study will be stopped and the technique considered inefficient. If there are one or more successes, an Independant Data Monitoring Committee (IDMC) will meet to propose an additional trial if necessary with the data from this trial.

Eligibility Criteria:
Inclusion Criteria :

1. Histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, Her-2 expression.
2. T0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound.
3. Clinical N0.
4. Bra cup size greater than or equal to B.
5. Markable and identifiable lesion in MRI.
6. Indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery.
7. Breast assessment performed by a referent radiologist: Mammography, ultrasound, clinical examination.
8. No contraindication to MRI.

Exclusion Criteria :

1. Infiltrating lobular carcinoma and Pure ductal carcinoma in situ.
2. Bilateral lesion.
3. Non-detectable MRI lesions, within 10 mm of the skin, greater than 15 mm on ultrasound.
4. Unifocal palpable tumor.
5. Cup size bra equal to A.
6. Cutaneous lesion on the breast to be treated by HIFU.
7. Impossibility of ventral decubitus immobility, extended arm, during 1 hour.
8. Pregnant or postpartum patient.
9. Patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.
Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.

This is a prospective, observational clinical trial investigating the morphological and volumetric changes in the brain following cranial Radiation Therapy in pediatric patients with brain or skull base tumors.

Brain injury is a known complication of cranial RT, but little is known about the factors that predispose patients to such injury. The brain is a highly interconnected organ linked through neuronal connections, cellular migration, and vascular supply and is endowed with exquisitely radiosensitive stem cell niches responsible for neuro-regeneration. To date, the effects of brain radiation have been quantified in few brain substructures. The majority of publications on this topic have focused on regions receiving higher doses. Even low dose radiation exposure, however has global implications on brain development and function, and its effects are less well studied. It is increasingly recognized that radiation damage to one brain region can potentially affect brain development more broadly. This has important implications on RT planning and the potential for understanding its long-term effects.

In this protocol, the investigators aim to measure serum inflammatory cytokine levels and other molecular biomarkers at baseline and post-exposure in an exploratory manner to investigate potential associations with the risk of developing volumetric changes in the brain and radiation-induced toxicities.

This study will observe sixty (60) patients under the age of 21 with brain or base of skull tumor. The study team will observe the effect of radiation therapy per the study protocol versus standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patient (parent) must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Written assent will be obtained as per Institutional guidelines.
* Patients (Age equal to or less than 35 years old) that are planned to receive photon or proton RT to the brain according to standard of care are eligible to participate.
* Patients that are planned to receive fractionated RT at 1.2-2.0 Gy RBE dose per fraction per standard of care are eligible to participate. If patients are planned to receive an alternative dose/fractionation regimen, then they should be treated according to standard of care and should not be enrolled.
* Zubrod/Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1

Exclusion Criteria:

* Patient cannot undergo MRI without contrast as per standard of care
* Patient and family do not speak English or Spanish
* Patient receiving treatment with non-curative intent
* Patients with an expected 3-year overall survival less than 50%
Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect.

In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent/assent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female athletes, aged 13-17 inclusive

Exclusion Criteria:

1. Individuals who have suffered a known concussion within the 6 months prior to enrollment
2. Individuals who suffer from an acute neurological disorder
3. Known pregnancy