cyrilzakka/clinical-trials huggingface dataset:
Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .


Eligibility Criteria:
Inclusion Criteria:

* New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
* Recipient of an allogeneic hematopoietic stem cell transplantation
* Age \< 65 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

* Relapsed or refractory advanced MDS
* Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
* Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis

This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis.

Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments every 1-2 weeks on the abdomen or flanks.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female between the age of 18 - 55 years old.
* Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
* The subject has a cut, wound, or infected skin on the area to be treated.
* The subject is on local, oral, or systemic anesthetic agents.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
DAnalysis of the Distribution of Adrenal Steroids in a Control Population

This is a biomedical research study on the determination of adrenal steroids. It has been proposed in recent years as a tool for the diagnostic orientation of an adrenal pathology. The main objective is to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 controls. The secondary objective is to establish reference values for each of these parameters, if their distribution permits, and to study the possible link between the blood pressure level, the orthostatism state, the potassium level and these adrenal steroids.


Eligibility Criteria:
Inclusion Criteria:

* Negative blood pregnancy test
* Normosalt diet
* Men and women ≥ 18 years
* Being able and willing to give written informed consent

Exclusion Criteria:

* Personal history of diabetes, high blood pressure, adrenal pathologies.
* Family history of adrenal pathologies.
* Taking of the following drugs:

Antihypertensives drugs: ACE inhibitor, Angiotensin II receptor, beta-blocker, thiazide diuretic, loop diuretic, anti-aldosterone, dihydropyridine-type calcium antagonist.

* Hormone replacement therapy, cyproterone acetate
* NSAID (except occasional intake), corticosteroid
* Antidepressant: serotonin reuptake inhibitor (paroxetine, fluoxetine, sertraline, citalopram)
* Contraception or estrogen / progestin treatment (progestins only allowed)
* Not be able to keep standing position.
Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum

The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* prepregnant BMI 25-35
* non smoking, single term birth
* intention to breastfeed exclusively for 6 mo

Exclusion Criteria:

* Diseases or medication in mother or child
Prognosis Factors Associated With Convulsive Status Epilepticus in Adults

The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.

Status epilepticus is a neurologic and medical emergency associated with high mortality and morbidity rates. According to the operational definition Convulsive Status Epilepticus (CSE) is defined as a single clinical seizure lasting more than 10 min, or two or more repeated seizures over a period of more than 10 minutes without intervening recovery of consciousness.

There are a few to date in literature reporting prognosis factors associated with this condition and, at this time, there are no published data considering an operational definition of CSE.

In a retrospective study considering an operational definition we identified a seizure duration of 15 min associated with poor outcome (not yet published).

The principal goal of this study is to evaluate factors associated with outcome in CSE, in particular seizure duration of more than 15 minutes.

The secondary goals are to evaluate the epidemiology and management at every stage of CSE thus redefined.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Convulsive status epilepticus according to operational definition as any seizure lasting for 10 minutes or longer, or two or more intermittent seizures lasting for greater than 10 minutes from which the patient did not regain consciousness.
* Beginning of seizure less than 12 hours before intensive care unit admission
* Convulsive status epilepticus occurring during intensive care unit stay

Exclusion Criteria:

* Less than 18 years old
* Patients that seized up to 9 minutes
* Beginning of seizure more than 12 hours before intensive care unit admission
Secretin in Refeeding

Patients with restrictive-type anorexia nervosa who are admitted to the hospital for feeding often urinate excessive amounts. Others have changes in the way that they handle acid and base. These issues prolong hospitalizations. Current data suggest that one hormone--named secretin--may control both urine output and how the body handles acid and base. This study will evaluate whether secretin levels are different in anorexic patients who urinate an excessive amount compared to those who urinate normal amounts. For this study, patients will have one extra blood draw before and after one meal during their hospitalization. The blood draw before the meal coincides with a standard of care blood draw. Also after the meal, subjects will be asked to provide one extra urine sample. Information from subject's medical records will also be used.


Eligibility Criteria:
Inclusion Criteria:

* Group 1:

  * male and female patients
  * age 13-24 years
  * diagnosis of restrictive-type anorexia nervosa
  * hospitalization for nutritional support
  * \>4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5)
* Group 2:

  * male and female patients
  * age 13-24 years
  * diagnosis of restrictive-type anorexia nervosa
  * hospitalization for nutritional support
  * \<2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5)

Exclusion Criteria:

* 5150 hold
* Anti-depressant, anti-psychotic, or anticonvulsant medications
* Previous hospitalization within the past 6 months
* Underlying metabolic disorder not related to anorexia nervosa (including chronic kidney disease, renal tubular disorders, and underlying endocrine disorders)
* Pregnancy
* NG or G-tube feeds after day 2 of hospitalization
* \> 10% of nutritional needs from supplemental feeds
Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age included between 60 and 80 years

Exclusion Criteria:

* Age \< 60 or \> 80 years
* Pregnancy
* The allergy in used medicines (N-acétylcystéine, Diltiazem)
* Presence of a pathology valvulaire associated
* Urgency
* Unstable angor
* Bypass as a matter of urgency
* Recours peropératoire to a CEC
* FE \< 0,40
* BAV of the 2nd and 3rd not sailed degree
* fibrillation or flutter little finger.
Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
* Individuals who are able to comply with all study procedures and requirements;
* Healthy volunteers and volunteers specifically HIV positive, transplant recipients, cancer patients may be eligible;
* Please contact the site for additional eligibility criteria.

Exclusion Criteria:

* Individuals who are not able to follow all the required study procedures for the whole period of the study;
* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
* Please contact the site for additional eligibility criteria.
The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen

The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:

* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 15 years
* Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), myelofibrosis primary and/or post PV/ET myelofibrosis, aplastic anemia, lymphoma, or paroxysmal nocturnal hemoglobinuria
* Received HLA-matched related (MSD-HSCT) or unrelated allo-SCT (MUD-HSCT) or haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

* Insufficient data needed for analysis
Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model

This study may provide information that may serve as the foundation for a larger research study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the Down syndrome patient population.

Osteoporosis is responsible for more than 1.5 million fractures and $14 billion in medical care costs annually (U.S Dept of Health and Human Services data, 2006). Down syndrome is an independent risk factor for osteopenia/osteoporosis. Increases in life expectancy as well as costly morbidity following fracture are reasons for further investigation of osteoporosis and prevention in this population. Etiology for low bone density is presently unknown in this population but may be related to unique genes on chromosome 21 which alter the biochemistry of bone metabolism or change the gonadal, thyroid and parathyroid function to alter bone formation and/or resorption. There are no published data on the measurement of bone turnover markers in the Down syndrome population; therefore we will measure and accrue this information and compare to our Ts65Dn data, as described later in this protocol.

This pilot study will serve as the foundation for a larger translational research grant which will address multiple issues regarding the pathogenesis, diagnosis and treatment of osteoporosis in the Down syndrome patient population and the Down syndrome mouse model (Ts65Dn). The data has the potential to improve our fundamental understanding of osteoporosis pathogenesis and treatment in the Down syndrome patient with potential applications to treatment in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females of all races and ethnicities
* Age 18 or older and current clinical diagnosis of Down Syndrome

Exclusion Criteria:

* No legally authorized representative (if applicable) willing to provide informed consent. Any condition the investigator determines will put the subject at risk by participating in the study.
Common Canister Protocol for Inhaler Administration in Mechanically Ventilated Patients

Many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. Common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. Small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings.

Common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. Metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. However, the average length of stay for most inpatients is only several days. Therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted.

The common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). This study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit

Exclusion Criteria:

* lung transplant
* neutropenic
* contact isolation
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura

The purpose of this study is to determine if a dose dense administration of Rituximab in newly diagnosed acute immune thrombocytopenic purpura (ITP) and determine relapse rate following this treatment.

Correlative studies will be performed as outlined in the appendices.

Quality of Life will be measured using the KIT as outlined in the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Age: Subjects must be ≥ 1 year and ≤ 21 years of age.
* Diagnosis: Patients must have newly diagnosed ITP and a platelet count of ≤ 20 x 109 per Liter. Bone marrow aspirate and biopsy should be performed to rule out malignancy in the bone marrow.
* High-risk features : In addition, patients must have one of more of the following high-risk criteria:

  * Age ≥ 10 years
  * Grade II-IV bleeding at diagnosis
  * ANA positivity
  * No history of preceding infection within 2 weeks prior to ITP diagnosis
* Performance Status: Patients must have a performance status ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.
* Prior Therapy

  * Patients may not have received any treatment for ITP prior to start of therapy.
  * Patients may not receive systemic steroids ≥ 0.5 mg/kg prednisone (or equivalent) within 2 weeks prior to diagnosis.
* Concomitant Medications Restrictions:

  * Steroids are only warranted as premedication prior to rituximab.
  * Patients who receive thrombopoetic agonists, eltrombopag or romiplostim will be taken off protocol.
* Organ Function Requirements

  * Adequate Renal Function Defined As: estimated CrCl \> 60 mL/min or \>30% of GFR for age based on the Schwartz formula
  * Adequate Liver Function Defined As: AST and/or ALT less than 5 times the upper limit of normal, and/or direct bilirubin less than the 2 times of the upper limit of normal

Exclusion Criteria

* Patients with a history of Grade III-IV allergic reaction to rituximab
* Patients with bone marrow neoplastic infiltration
* Patients with a history of hepatitis B infection
* Pregnancy and Breast Feeding

  * Female patients who are pregnant are ineligible (insert the reason: "due to risks of fetal and teratogenic adverse events as seen in animal/human studies" or "since there is yet no available information regarding human fetal or teratogenic toxicities").
  * Lactating females are not eligible unless they have agreed not to breastfeed their infants.
  * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
Brain-Physical Optimization Conditioning

Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). The current study seeks to isolate neurocognitive mechanisms of performance, particularly under high stress (e.g., physical or cognitive load) conditions, and to develop corresponding cognitive optimization tools.

Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). B-POC uses an acute mentally fatiguing task during routine exercise with the aim of optimizing the effects of physical endurance (e.g., aerobic exercise). B-POC differs from other types of cognitive training by increasing the cognitive demands of a specific concurrent task rather than teaching a cognitive strategy and relying on task transfer effects. Similar to strengthening a muscle, cognitive trainings may be one means of increasing Soldier's cognitive capacity and improving performance (Walton et al., 2018).

Eligibility Criteria:
Inclusion Criteria:

* Healthy active duty Soldiers
* 18-40 years old
* Available for study duration

Exclusion Criteria:

* Failure of an Army Physical Fitness/Combat Test (APFT/ACFT) test
* On a physical profile that prevents them from 1) engaging in intense aerobic exercise, 2) running on a treadmill, 3) riding the stationary bike, and 4) performing a cognitive task on a computer screen.
* Medically non-deployable
* Impaired cognitive function due to medication, injury or illness,
* Have been advised by a medical professional not to engage in aerobic exercise
* Are a pregnant female
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. M/F patients 18 years of age or older
2. Diagnosis of ESRD (GFR ≤ 15 mL/min)
3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. DM (Type 1 and 2) on glycemic-control medication, for 90 days
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

1. Cardiovascular event within the last 90 days
2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)
3. Allergy to starch-based polymers
4. Glycogen storage disease
5. Glycogen storage disease
6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77) at Screening.
8. Serum urea \> 30 mmol/L
9. Receiving rosiglitazone maleate