cyrilzakka/clinical-trials huggingface dataset:
Genetic Analysis of Gray Platelet Syndrome

This study will identify and characterize the gene or genes responsible for Gray Platelet syndrome (GPS). Platelets are small blood cells that stick on injured blood vessels to form a plug and stop bleeding. When a blood vessel is injured (like a cut on a finger), platelets release the proteins stored in their sacs to help form a blood clot. Patients with GPS bleed longer than other people because their platelets lack some of these protein-carrying sacs. Platelets without sacs look pale gray under the microscope rather than pink, giving the syndrome its name. Except for rare patients with severe hemorrhage, the bleeding tendency in GPS is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and, in women, excessive menstrual bleeding.

Patients with GPS and members of their family with GPS may be eligible for this study. Participants will provide a personal and family medical history and will have blood drawn. About 1 to 2 tablespoons of blood will be drawn in adults, and about 1 teaspoon in children. The blood will be analyzed for genes that cause GPS

Patients with Gray Platelet Syndrome (GPS) and their unaffected family members will be studied to identify the gene(s) involved in GPS using linkage analysis and gene mapping strategies. Up to 200 individual members of GPS families will be investigated to identify candidate regions of the human genome, which will be further studied using fine mapping and sequence analysis. Characterization of gene(s) involved in GPS could provide important insight into the mechanisms of vesicle formation and protein sorting in human cells.

Eligibility Criteria:
* INCLUSION CRITERIA:

Enrollment in this study will be limited to patients diagnosed with GPS and their unaffected relatives. The diagnosis will be based upon absence or marked reduction of platelet Alpha-granules on electron microscopy.

EXCLUSION CRITERIA:

Patients with reduction in both Alpha and Beta granules will be excluded, since this is probably a separate disease.
CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2). The treatments that the investigators are studying try to improve the immune system by changing some of your T cells so they can find and destroy HIV infected cells (HIV is usually able to hide from your T cells). In this study, the investigators are also trying to find out if giving you more IL-2 at the same time as gene changed T cells will help the T cells to live longer or fight HIV better.

Eligibility Criteria:
Inclusion Criteria:

* DOD beneficiary with HIV-1 infection
* Greater than or equal to 200 CD4 cells/mm3
* Undetectable viral load, for at least the previous 8 weeks
* Stable anti-retroviral regimen for greater than or equal to 8 weeks
* Venous access sufficient for apheresis
* Karnofsky performance \> 80%

Exclusion Criteria:

* Inadequate organ function
* Lifetime history of CD4 count less than 200 cells/mm3 on 2 consecutive measurements over at least an 8 week period
* Any previous history of gene therapy
* Recent IL-2 therapy or other treatment with an investigational agent
* Pregnancy
* some medications (hydroxyurea, corticosteroids and other immunosuppressants, chemotherapy, etc.)
Is There Room for Butter in a Healthy Diet?

The aim of this study is to examine the effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols).

The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.


Eligibility Criteria:
Inclusion Criteria:

* Sign written consent
* Age: 20-70 y
* BMI: 18.5 - 32 kg/m2
* Healthy men and women (with no known diseases)

Exclusion criteria

* Current or previously cardiovascular disease, high blood pressure
* Diabetes Mellitus or other severe chronic disease, including severe allergies
* Use of dietary supplements and blood donations prior to, and during the study
* Known or suspected abuse of alcohol, drugs or medication
* Pregnant or are planning pregnancy during the study period
* Extreme physical activity level (more than 10 hours tough physical activity pr. week)
* Participation in other research studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.


Eligibility Criteria:
Inclusion Criteria:

* male
* acute watery diarrhoea defined as at least 3 watery stools per 24 hours
* duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours
* dehydration signs requiring oral rehydration according to current WHO guidelines

Exclusion Criteria:

* severe dehydration that needs IV therapy
* presence of gross blood in stools
* fever \>39 degrees Celsius
D-serine and Cognitive Remediation in Schizophrenia

The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm

We will enroll 8 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR.

5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session.

3 subjects received no intervention

Eligibility Criteria:
Inclusion criteria:

* 18 to 64 years old,
* IQ≥85 and
* estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry.

Exclusion criteria:

* history of neurological visual or hearing impairment,
* active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),
* current alcohol or drug abuse (\<1 month) or substance dependence (\<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.
Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection

This research project will study whether the drug telmisartan administered in conjunction with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The investigators are studying the effect of this treatment in people who have contracted HIV infection within the past three weeks, and thus have a form of HIV called acute HIV infection. The investigators will measure biological markers of immune activation in the blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs in affected patients.

Note regarding the primary purpose of the study: In the Study Design section, this protocol is classified as "Other", since it is specifically designed to examine the effect of telmisartan administered in conjunction with ART on the size of HIV reservoirs in the central nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Have protocol-defined acute HIV-1 infection
* Be part of the SEARCH 010/RV 254 study in Bangkok, Thailand
* Ability and willingness to start ART immediately after diagnosis
* Availability for follow-up for the duration of the planned study
* Systolic blood pressure ≥ 110 mmHg
* Agree to undergo lumbar puncture at weeks 0, 48 and 72
* Ability and willingness to provide informed consent. Subjects must understand the study and sign the consent form. Persons who cannot read will have the consent form read to them by a member of the study staff and may then give informed consent by using making a thumb print.

Exclusion Criteria:

* Pregnancy (current or within the last 6 months) or breastfeeding
* Uncontrolled hypertension
* Use of thiazolidinediones or other angiotensin receptor blockers class \[losartan, irbesartan, olmesartan, valsartan, candesartan (washout permitted)\]
* Screening laboratory values: absolute neutrophil count \< 750 cells/mm3, hemoglobin \<10 gm/dL creatinine clearance \<30 mL/min (estimated by the Cockcroft-Gault equation using ideal body weight)
* Known renal artery stenosis
* Known cirrhosis or severe liver disease
* Unstable coronary artery disease/angina or decompensated congestive heart failure
* Any history of intolerance to any angiotensin receptor blocker
* Need for ongoing potassium supplementation
* Any contraindication to lumbar puncture such as history of bleeding diathesis or cerebral mass lesion
Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome

The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease.

Renal Doppler will be done for all children in supine and lateral positions using Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and 6months, in which these values will be obtained by the ultrasound machine based on the computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical thickness and echogenicity.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years

Exclusion Criteria:

* - Patients with congenital nephrotic syndrome.
* Patients with secondary causes of nephrotic syndrome.
Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma

International retrospective observational cohort study aimed to describe a molecular classification for NMZL.

Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned to a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. The coded biological material will be transferred to the coordinating center at the Oncology Institute of Southern Switzerland and Institute of Oncology Research in Bellinzona. Health-related data will be collected in the eCRF (OpenClinica). Data quality will be insured by query generation.

Annotated baseline features will include date of diagnosis, date of lymph node biopsy, age, gender, ECOG PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, number of nodal sites, B symptoms, lymph nodes larger than 7 cm, Hb, platelets, lymphocytes, beta-2-microglobulin, albumin, HCV infection, serum paraprotein and type.

Annotated follow-up features included date of progression to a disease requiring treatment, type of first line treatment, date of start of first line treatment, date of progression after first line treatment, date of second line treatment, type of second line treatment, date of transformation, date of death, cause of death, date of last follow-up.

Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis and DNA methylation profile will be performed by next generation sequencing of genomic DNA extracted from the lymph node biopsy. Gene expression will be assessed by next generation sequencing of RNA extracted from the lymph node biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults 18 years or older
2. Diagnosis of NMZL on lymph node histology after Jan 1st, 2000
3. Availability of tumor material from lymph node (either frozen or FFPE) collected when the patient was treatment naïve
4. Availability of the baseline and follow-up annotations

Exclusion Criteria:

1. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by carefully evaluating the extranodal tissues draining to the involved lymph nodes by imaging or endoscopy)
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:

- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.

Secondary Objective:

- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM

The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:

* Screening: 3 to 27 days;
* Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
* Wash-out between doses: 7 to 10 days;
* End of Study visit: 7 to 10 days after last dose.
* Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.

Eligibility Criteria:
Inclusion criteria:

* Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of \<1.2 U/kg/day
* Fasting negative serum C-peptide (\<0.3 nmol/L)
* Glycated hemoglobin (HbA1c) \< or = 9%
* Stable insulin regimen for at least 2 months before the study
* Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
* Certified as healthy for T1DM by a comprehensive clinical assessment

Exclusion criteria:

* Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
* Blood donation, any volume, within 1 month before inclusion.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
* Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
* Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.

This is a Phase 1/2 open-label study to evaluate the safety of autologous genetically engineered TC-110 T cells in patients with aggressive NHL (DLBCL, PMBCL, TFL), high-risk indolent NHL (including MCL), or adult ALL.


Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years of age at the time the Informed Consent is signed
* Patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and LTFU
* Histologically confirmed NHL or ALL
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
* Patient must be fit for leukapheresis and have adequate venous access for cell collection
* Patient must have evidence of CD19 expression
* Prior CD19-directed CAR T therapy is allowed
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to exemestane or any comparable or similar product.
Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus

The purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent Type 2 Diabetes mellitus.

In this clinical trial 50 patients with insulin dependent type 2 diabetes will be randomised in two study arms: monitoring of blood glucose and blood pressure using a telemedical device or in an arm with treatment as usual. Patients will the following measurement devices: blood glucose, blood pressure. Both devices can communicate with a mobile phone, which will also be provided to the patients. The mobile phone will transfer the data to a central, safe server. Patients will receive automated reminder/feedback. Caregivers can evaluate the transferred data whenever necessary via a web-based access. Data will be presented in tables as well as trend figures.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2, age 18-70 years, able to use a mobile phone

Exclusion Criteria:

* Pacemaker, intracardial defibrillator, no cure planned within the active study period.
The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients

The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation

The Acceptance and Commitment Therapy is a mindfulness-based intervention which efficacy has been proven in the treatment of depression and anxiety, in stress reduction and in the modification of health- related behaviors in patients with several physical conditions. The application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour.

The purpose of the trial is to evaluate the efficacy of a brief group-administered program based on Acceptance and Commitment Therapy in improving patients' ability to address modifiable multiple cardiovascular risk factors and overall psychological well-being, compared with the usual care.

Eligibility Criteria:
Inclusion Criteria:

* having a current diagnosis of ischemic heart disease (IHD)
* being affected by major modifiable cardiovascular risk factors that will be assessed through the INTERHEART Modifiable Risk Score.

Only subjects with a full score \>9 will be included in the study.

* between the ages of 18 and 70 years
* fluency in spoken and written Italian language
* expression of written informed consent.

Exclusion Criteria:

* cognitive impairment
* severe psychiatric disorders according to Diagnostic and Statistical Manual-IV TR criteria (APA, 2000).
Prevalence of Post Traumatic Stress Disorder Related to Diabetes Diagnosis or Severe Hypoglycaemia in Adult With Type 1 Diabetes

In France, the adult population living with diabetes in 2016 is estimated at more than 3.3 million patients treated. Type 1 diabetes (T1DM) represents 5.6% of diabetic patients (approximately 185,000 patients).

Numerous studies show that patients fear hypoglycemia, with an impact on their quality of life, sleep disorders and depressive symptoms. In addition, there is a metabolic impact with a problem of therapeutic compliance and an alteration of glycemic control.

This study examine the relation between Post Traumatic Stress disorder (PTSD) and diabetes diagnosis or severe hypoglycaemia in adults with Type 1 Diabetes.

The aim of this study is to evaluate the prevalence of PTSD in this population.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* With type 1 diabetes,
* Willing and able to complete all the questionnaires in French,
* Who have given oral consent,
* being affiliated to a social security scheme or being a beneficiary of such a scheme.

Exclusion Criteria:

* Non-diabetic type 1,
* With an unstable psychiatric pathology,
* Pregnant or breastfeeding women,
* Subject to a measure for the protection of justice,
* Having opposed the research.
Investigation of Arm Swings Characteristics in Patient With Chronic Obstructive Pulmonary Disease

The former aim of this study is to determine whether the arm swings change in patients with Chronic Obstructive Pulmonary Disease (COPD) according to healthy subjects. The latter purposes to investigate the correlation between balance parameters and arm swing, how to change arm swing according to severity of the disease, and to determine the relationship between balance and the severity of disease, the relationship of posture both arm swing and severity of disease in patients with COPD. In accordance with this purposes, 20 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3 and 20 healthy controls will be included between the ages of 40 and 65, respectively. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Berg Balance Scale, Time Up and Go Test, 6 Minute Pegboard and Ring Test, 6 Minute Walk Test and gait analysis will be performed. It is expected that by determining the parameters that can be affected by severity of COPD. It is estimate to have information about severity of the disease by means of observational analysis. It will guide professional working in the field.


Eligibility Criteria:
Inclusion Criteria:

* Who has been clinically stable for the last 4 weeks,
* who will be able to walk independently for 6 minutes,
* According to the Classification of Airflow Limitation in COPD (GOLD) system, the Stage is 1-2-3,
* who declares that he has not taken part in any other research

Exclusion Criteria:

* walking assistive devices,
* receiving chronic oxygen therapy,
* with central and peripheral vestibular disease,
* with orthopedic, neuromuscular, neurological and cardiac diseases that may affect gait and balance,
* with a history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery,
* who has communication problems,
* with mental and cognitive problems