cyrilzakka/clinical-trials huggingface dataset:
Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study

This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 and ≤ 75 years
* Patient expressing the HLA-A\*0201 subtype of the human leukocyte antigen (HLA -A2)
* Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases
* Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR
* Absence of cerebral metastases
* ECOG ≤ 1 or Karnofsky ≥ 80%
* Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL... )
* Disease measurable / evaluable within 28 days before the first administration of study treatment
* Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis)
* Results of analysis:

  * Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l
  * Leukocytes ≥ 4000/μl
  * Lymphocytes ≥ 1500/μl
  * Platelets ≥ 80.000/μl
  * Creatinine ≤ 2.5 N
  * Total bilirubin ≤ 3 N
  * AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases
* Negative pregnancy test for women of childbearing age
* Patient affiliated to a social security system
* Patient who has signed informed consent

Exclusion Criteria:

* Brain metastases
* Ocular primitive melanoma
* Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion
* Treatment with ipilimumab within 8 weeks before the inclusion
* Known allergy to albumin
* Contraindication to the use of vasopressors
* Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis
* Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline
* Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma)
* History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction)
* Uncontrolled thyroid dysfunction
* Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study)
* History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo
* History of uveitis and retinopathy associated with melanoma
* Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria: -

* Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria: -

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:
* 1.Schizophrenia spectrum or other psychotic disorder
* 2.Bipolar or related disorder
* 3.Major neurocognitive disorder
* 4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
* 5.Dissociative disorder
* 6.Posttraumatic stress disorder
* 7.MDD with psychotic features
* Significant suicide risk, as judged by the Investigator
BNP Therapy Observation Unit Outcomes STudy (BOOST)

The investigators hypothesize that patients admitted to an emergency department (ED) observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with nesiritide versus standard therapy. The investigators also hypothesize that decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit will predict improved patient outcomes.

Congestive heart failure (CHF) is a growing problem in the United States. The increasing number of decompensated heart failure patients presenting to emergency departments (ED) for treatment is worsening the burden on already strained and limited health care resources. In addition, many of these patients will return to the ED for treatment within three months of being treated for decompensated heart failure. The emergence of ED observation units has provided a viable and cost effective alternative to inpatient treatment for many diseases including CHF. It has been shown that intensive, directed therapy in ED observation units has decreased the revisit rates for CHF patients. In addition, the introduction of nesiritide has shown promising results in the treatment of decompensated congestive heart failure.

The primary aim of this study is to compare nesiritide versus standard heart failure therapy in an ED setting. A secondary aim is to determine if serial BNP levels during this observation unit stay will predict clinical outcomes.

The treatment of heart failure in the ED places a tremendous burden on already limited resources. The costs of treatment as well as the morbidity and mortality associated with the disease are worsening and are predicted to increase as the general population ages. The ability to safely treat and discharge patients from an ED observation unit while reducing return visits would be invaluable in managing the growing number of heart failure patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> 18 years of age
* Have a working diagnosis of HF, as determined by the emergency physician using the Boston Criteria. A score of 8-12 is required for inclusion in the study.
* Alert, oriented and able to provide informed consent.
* Able to be contacted by telephone for follow up after discharge, and have none of the study exclusion criteria.

Exclusion Criteria:

* Dialysis Dependent Renal Failure
* Temperature \> 38.5 degrees celsius
* Pneumonia (Infiltrates on Chest X-ray)
* Requiring IV vasoactive agents (Other than Nesiritide)
* Killip Class III/IV
* Systolic blood pressure \< 90 mmHg
* EKG diagnostic or suggestive of Acute myocardial infarction or ischemia
* Abnormal Cardiac Markers
* Lack of a telephone
* Inability to provide informed consent due to cognitive impairment or a severe psychiatric disorder
The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial

Will follow up umblical artery Doppler indices for pregnancies with iugr taking placebo and oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted fetuses

Patients meeting these criteria are to be randomized into one of the following two groups:

* Group A (n=23): The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet, AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks (according to xPharm: The Comprehensive Pharmacology Reference, 2007, Pages 1-4).
* Group B (n=23): The placebo group will receive (Osteocare®, tab, VITABIOTICS, Egypt) twice daily for 4-6 weeks Justification: Using PASS 11 program for sample size calculation, setting power at 80% and alpha error at 0.05 and according to "Trapani et al., 2015", the expected change in UTA-PI in isosorbide mononitrate group=21% compared to no change in placebo group. Sample size of 23 women per group will be needed to detect difference between two groups.

The study is to be double-blinded, where neither the researcher, nor the participants will know what type of medication each participant will receive, as a nurse will give each patient a closed envelope containing 21 tablets of one of the above two medications in a randomized fashion.

Eligibility Criteria:
Inclusion Criteria:

* age : 18-34 BMI: 18-30 Singleton pregnancy Gestational age between 28-30 Criteria of IUGR

Exclusion Criteria:

Had known or suspected chromosomal or structural anomaly Had a condition which will require delivery Multiple pregnancy

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WEAR (Wearability and Evaluation of Adjustable Refraction) III

Two-month randomized trial comparing three groups.

Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.

Eligibility Criteria:
Inclusion Criteria:

* 11-16 years old middle school students from two locations in Guangdong Province.
* With ≤ -1.00 Diopter of myopic refractive error in each eye.
* With uncorrected vision ≤ 6/12 in both eyes thought to be due to refractive error (that is, correctable to at least 6/7.5 with subjective refraction by an optometrist).
* With informed consents(There are two types of informed consents. One of them is whether the parents of the students agree their kids to participate in the project. The other informed consent is whether the parents agree their kids to have the cycloplegic refraction. If the students were admitted to participate in project but without being agreed to have cycloplegic refraction by their parents , they would have non cycloplegic retinoscopy.).

Exclusion Criteria:

* Those corrected VA can not up to 6/7.5 with subjective refraction by an optometrist.
* Those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded.
* Children developing acquired vision problems other than myopia.
Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine

Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.

The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes with age between 55-70 years.
* Body mass index less than 35.
* Subjects who have given written informed consent to participate in the study.

Exclusion Criteria:

* Consumption during the 6 months prior to the study of functional food enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
* Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
* Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, ischemic heart disease under treatment, arrhythmias, etc).
* Abuse in the ingestion of alcohol.
* Present hypersensitivity or intolerance to any of the components of the products under study.
* Inability to understand informed consent.
Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue

This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:

* Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET
* Reduction of fatigue and other neuropsychological symptoms after iron supplementation


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects, Age \> 18 years, premenopausal, regularly menstruating
* BMI 18-25 kg/m2
* Serum ferritin level \< 15 μg/ml, Hb \> 120 g/L
* Adequate contraception during the study period
* Fatigue determined as 2 or more points in the basic questionnaire for fatigue
* Informed consent

Exclusion Criteria:

* Day-night shift work
* 11 or more points in the BDI
* No psychiatric disease (as assessed by neuropsychiatric assessment)
* 15 or more points in the ISI
* Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
* Intake of iron preparations during the last 8 weeks before the start of the trial protocol
* Pregnancy or lactation
* Any cardiovascular or pulmonary disease
* Acute or chronic infection/inflammation or malignancy
* Other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g. depression)
* Chronic intake of concurrent medication (especially antipsychotic drugs), except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.
* CRP \> 10 mg/L
* TSH out of normal range
* Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
* Participation in any other therapeutic trial within the previous month
* Known History of HIV/HBV/HCV
Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection

Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Patients who have been seriously ill and have been admitted to the ward with high oxygen mixtures or have been admitted to the ICU will be selected primarily. The program includes supervised rehabilitation sessions 2 times a week for 2 months. Patients will be evaluated during recruitment and at the end of the program. Patients who can not attend the program due to logistical/transport issues will be re-evaluated in 2 months and constitute the control population. Investigators hypothesis is that post COVID-19 patients who have persistent symptoms, including fatigue following a supervised rehabilitation program will have fewer symptoms after the end of the program compared to similar patients who do not attend a rehabilitation program.


Eligibility Criteria:
Inclusion Criteria: Candidates for inclusion in the study are:

* Patients recovering from COVID-19 disease AND suffering from persistent limitations (\>=1 month) of their physical activity and reduction of their quality of life and associated symptoms including shortness of breath, fatigue, weakness of the upper and lower extremities, post-traumatic stress, pain, etc.
* Priority will be given to patients suffering from more symptoms and disabilities. Patients who might suffer more after COVID-19 disease are:

  1. Patients admitted to the ICU, especially those who were intubated.
  2. Patients who needed high oxygen mixtures (high-flow nasal cannula -HFNC, non-re-breathing mask) as well as those who were older and had prolonged hospitalization.

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     Exclusion Criteria:
* Patients who suffer from active disease will not be included until they stop being infectious.
* Patients treated with COVID-19 infection where the main reason for hospitalization was not the virus infection (e.g. due to coronary heart disease, surgery, etc.) will also be excluded.
* Patients suffering from dementia,
* patients with myocarditis
* patients with thromboembolic disease that receive anticoagulants for less than a month
* patients chronically paralyzed,
* patients with paraplegia,
* patients with multiple injuries
* patients with serious orthopedic problems that cause disability
* patients suffering from very serious underlying diseases such as end-stage cancer,
* patients with neurological diseases that cause disability, require rehabilitation clinics and special interventions (speech therapy, kinesiotherapy, patients with tracheostomy etc.).
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.

Eligibility Criteria:
Inclusion Criteria:

* direct bilirubin \> 2 mg/dl x2 consecutive
* parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
* patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

* other primary cause of liver disease not parenteral nutrition-associated
* weight \<3 kg
* infant or child enrolled in other clinical trial involving an investigational agent
Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?

Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Patient operated on at HUS between 01/01/2018 and 12/31/2020
* Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position.
* Patient not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Patient who has expressed opposition to the reuse of his or her data for scientific research purposes.
* Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis)
* Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position
Analysis Before and After COVID 19

In our study, we aimed to compare the average length of stay, death rates and costs of intensive care patients in October-November-December 2019 (before COVID 19) and October-November-December 2020 (during COVID 19).


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* All patients in intensive care unit in last three months of 2019
* All SARS-Cov2 patients in intensive care unit in last three months of 2020

Exclusion Criteria:

* Under 18 years old
Terumo Aortic Global Endovascular Registry

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* • Minimum age as per local regulations

  * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
  * Ability to provide informed consent

    o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment)
  * Willingness to comply with the registry protocol
  * Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.

Exclusion Criteria:

* • Patient is unable or unwilling to comply with the study follow-up regime.

  * Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure
  * Patient is eligible to be enrolled in or is currently actively participating in the Terumo Aortic Global FACT clinical study (FACT-001)
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy

As many researches have been conducted to see the effects of vestibular system activation on gross motor activities of children with cerebral palsy but there are limited researches on improvement of motor abilities of hemiplegic cerebral palsy child using UEU or BOSU ball or treadmill in a single study. There is lack of research on vestibular stimulation in hemiplegic cerebral palsy along with neurodevelopmental treatment.

This study will improve the gross motor activities of children with hemiplegic cerebral palsy. It will broaden up the ways for physical therapist to deal with this type of cerebral palsy (hemiplegic).

There are various therapeutic approaches that are used to improve motor activities and postural control in CP child. Among these approaches vestibular stimulation is used to improve neuromotor development by different sensory stimulation techniques. It has shown positive effects on motor control of CP child. It also influences all sensory experiences and is an exercise based approach.

Eligibility Criteria:
Inclusion Criteria:

* Age: 3 years to 12 years
* Gender: Both Male and female
* Children with Spastic Hemiplegic CP scoring 1,1+ and 2 on Modified Ashworth scale
* Level III and IV on GMFCS (Gross Motor Function Classification System)

Exclusion Criteria:

* Children with other types of Cerebral Palsy (diplegia, quadriplegia etc)
* Children with other Abnormalities and pathologies (delayed milestones, hydrocephalous, epilepsy etc)
* Children Undergone any kind of surgery (cardiac, shunt placement, orthopedic etc)
* Children with any other neurological deficits (spina bifida etc)
* Children with conditions in which vestibular stimulation is not allowed (paroxysmal positional vertigo or vestibular neuritis, Meniere's disease, migraine-associated vertigo, and childhood vertigo).