cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Vitamin D and B Regulatory Cell in Pregnancy

During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.

During pregnancy , the maternal immune system is always confronted with fetal alloantigens. the immunological mechanisms that prevent the rejection of the fetus are still not under understood.the fetus is normally accepted by the maternal immune system despite despite the expression of paternal alloantigens. Normally, the fetus grows and develops very well with ongoing pregnancy.

B regulatory cells are increased in pregnant women compared to non-pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* healthy female according to the required groups

Exclusion Criteria:

* patient with infectious disease , tuberculosis ,tumor ,hematologic disease,metabolic bone disease or any other connective tissue diseases were excluded.
* Patient with viral hepatitis.
* serological evidence of HIV infection.
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50, inclusive.
* Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
* Females of child-bearing potential must be using an adequate and reliable method of contraception.
* Willing to eat all the food supplied during the study.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) (unless immunized), hepatitis C antibody (anti-HCV).
* Positive Naloxone hydrochloride (HCl) challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air

Primary objective:

- Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared to air.

Secondary objective:

* Assessment of fluid markers of central nervous system injury in blood post diving
* Assessment of fluid markers of inflammation and endothelial dysfunction in blood post diving

Tertiary objective:

- Assessment of DCS frequency

This is a prospective, double blinded, randomized, cross-over study in Sweden. The study was performed in two different sets, each containing standardized dives in a wet hyperbaric chamber. The dives included movement on depth.

In each study set 16-32 professional divers performed no-decompression dives to a depth of 42 metres of seawater (msw). The gas used during the dives was compressed air.

After surfacing the divers breathed either normobaric oxygen or normobaric air on a demand mask. Timing of oxygen/air-breathing differed between study sets. The content of breathing gas was unknown to both divers and examining personnel.

Immediately post dive the divers were assessed using either transthoracic doppler ultrasound (TTD) or transthoracic 2-D ultrasound (TTE) to determine VGE load, time to VGE detection and VGE duration.

Signs of DCS were actively sought.

TTD measurements were done every five minutes during the first 30 minutes, thereafter every 15 minutes during 90 minutes.

TTE was performed every 30 minutes, using an apical 4-chamber view.

Blood samples were obtained pre-dive, 30-45 minutes post-dive and 120 minutes post-dive.

Set 1: 16 divers, divided into two equal groups (A and B). Dive to 42 msw during 10 min with a safety stop at five msw during three min. Immediately post dive breathing of oxygen (group A) or air (group B) during 30 min. VGE load, time to VGE detection and VGE duration is recorded. Blood samples were obtained pre-dive and 30 and 120 minutes post-dive. After 48 hours, the dives were repeated with switched gases between the groups.

Set 2: 32 divers, divided into two equal groups (A and B). Dive to 42 msw during 10 min with a safety stop at five msw during three min. Fifteen minutes post dive breathing of oxygen (group A) or air (group B) during 30 min. VGE load, time to VGE detection and VGE duration is recorded. Blood samples were obtained pre-dive and 45 and 120 minutes post-dive, from the first 16 divers. After 48 hours, the dives were repeated with switched gases between the groups.

Two further planned sets with repeated diving and shorter duration of oxygen/air-breathing were never carried through.

AE including SAE will be recorded during the study. DCS may be considered either an AE or SAE depending on severity. Ongoing AE and SAE will be followed up.

Eligibility Criteria:
Inclusion Criteria:

* Professional diver
* Fit to dive according to Swedish Navy standards

Exclusion Criteria:

* NONE
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops

The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
* Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
Nurse-performed Lung Ultrasound Versus Chest Radiography for Detection of Pneumothorax.

This is a prospective, single-center, observational, cross-sectional cohort study, comparing nurse-performed bedside lung ultrasound to standard portable CXR, for the detection of pneumothorax in the cardiac surgery patient population, following chest tube removal. This study aims to be conducted at an academic, tertiary adult center cardio-vascular intensive care unit (CVICU at TGH).

To avoid the accumulation of blood and fluids in the mediastinum or pleural cavities after cardiac surgery, mediastinal and pleural drains are routinely used. The rate of pneumothorax following chest drain removal is approximately 1.5-13%, resulting in increased patient morbidity and hospital stay. The standard method for the determination of pneumothorax (PNX) in most institutions is to obtain a chest radiography (CXR) following chest tube removal, but the reliability of the supine anteroposterior chest radiography is not utter, with up to 30% of pneumothoraxes misdiagnosis. The delay of ordering, performing and interpreting a CXR post mediastinal tube removal, results in potential delay in patients transfers, with an estimated cost savings of omitting an additional chest radiography, of approximately $10 000 per year.

Lung ultrasound (LUS) is recommended for detection of pneumothorax as per evidence-based guidelines and expert consensus. Lung ultrasound is a safe technique due to minimal radiation, with the potential for immediate results when compared with the standard CXR. LUS has high accuracy for PNX detection, with better pooled sensitivities (78.6%) when compared to CXR (39.8%) and equal specificity (98.4 vs 99.3%). In intensive care units, those results have been reproducible, with LUS having greater sensitivity than CXR for PNX diagnosis (0.87 vs 0.46) and equal specificity, 0.99 vs 1.00. LUS is more accurate and faster than chest radiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years in the cardiovascular intensive care unit post cardiac surgery, with a chest tube removed within the past 2 hours.

Exclusion Criteria:

* Patients who were mechanically ventilated or with subcutaneous emphysema due to impaired pleural line visualization.
Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy

This study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore Integrated Research Database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates used to select the propensity matched patients will include: age; gender; health plan type and region; DCI score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period.

Claims information about patients selected for the study will be followed longitudinally to the end of data availability. This data stream will be used to determine treatment patterns for Metanx®, healthcare resource utilization, and cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have pharmacy claims for \>120 continuous days of Metanx®. This will be defined as at least a 90-day supply dispensed within the first 120 days post-index. The first pharmacy claim for Metanx® will be the index date.
* Patients must have a diagnosis of diabetes prior to or including the index date.
* Patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder.
* Patients must have a diagnosis of lower limb ulcer.

Exclusion Criteria:

* Patients will be excluded if they have \<18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility.
* Patients will be excluded if they have taken other L-methylfolate containing products (Deplin®, Cerefolin®, Cerefolin NAC®,Neevo®) or other prescription folic acid combination products with \>1mg folic acid.
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms


Eligibility Criteria:
Inclusion criteria:

* Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
* Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.
* Recipients who are at least 4 weeks post renal transplantation with stable renal function.

Exclusion criteria:

* Multi organ transplant or previous transplant with organ other than kidney
* History of GI disorder prior to transplant
* Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF
* Modification of GI med or MMF dose within one week
* Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit

Other protocol-defined inclusion/exclusion criteria may apply
Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers

The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.

The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* English fluency and literacy
* Patient with an informal caregiver available and willing to participate
* Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
* Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores \> 7)

Exclusion Criteria:

* Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
* Short form of Mini-Mental State Exam (SMMSE) score \<4 (If SMMSE \<4, nursing team decides whether or not the patient can meaningfully participate)
* Glasgow Coma Scale (GCS) score \<10
* Terminal diagnosis
* Lack of access to internet and/or a device with a camera
* Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Scape Room With High Fidelity Simulators

The objective of the present study is assess the efficcacy in the acquisition of knowledge and practical skills of a scape room with high definition simulators.

An experimental trial will be carried out in which the students of the intervention group will receive practical training on newborn care in the delivery room through the development of a scape room with high-fidelity simulators. The control group students will receive practical training only with the use of high-fidelity simulators. The participants of both groups will previously receive a theoretical training of 10 hours. Knowledge acquisition and student satisfaction with both methodologies will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Nursing degree students of University of Extremadura

Exclusion Criteria:

* 1st year nursing degree students
* Nursing degree students of other universities
Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia.

Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Hospitalized in ICU
* Presence of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms:
* PaO2/FiO2 \<300 mmHg with positive end-expiratory pressure (PEEP) ≥5 cmH2O
* Bilateral opacities not fully explained by cardiac failure or fluid overload
* Intubated and sedated for mechanical protective ventilation
* Affiliation to the French Sociale security
* Beta HCG negative for women

For Covid-19 subgroup:

- Covid-19 infection (RT-PCR \< 7 days and/or another approved diagnostic technique and/or typical CT appearance of COVID-19 pneumonia

Exclusion Criteria:

* Allergy to amide local anesthetics
* Acute porphyria
* Disorders of atrioventricular conduction requiring a non-done permanent electrosystolic pacing
* Uncontrolled epilepsy
* Fluvoxamine treatment
* Class III antiarrythmic agent treatments (amiodarone, dronedarone)
* Class I antiarythmic agent (quinidine, disopyramide, hydroquinidine, flecainid, propafenone)
* Hepatocellular insufficiency defined by PT\<15% in the absence of anti-vitamin K
* Patient under a tutelage measure or placed under judicial protection
* Known pregnancy
* Breastfeeding
The Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts

The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.

The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.

The secondary objectives are:

* Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act.
* Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months.
* Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months.
* Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a "neutral" person (health manager) once every 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Child virgin with experience for targeted acts during the 1st painful act or child undergoing follow-up provided that he is virgin with experience of the presence of clowns during these acts.
* Child with cancer
* Child requiring a painful act among the following 3 acts: lumbar puncture, myelogram, needle placement in an implantable chamber
* Parental authority holder (s) who have received full information on the organization of the research and who have given their written consent for the participation of their child
* Personal adhesion of the child with a view to his participation
* Presence of at least one of the two parents during act 1
* Availability of the duo of clowns for the realization of act n ° 1 if the group assigned is the group Clowns-Sans Clowns

Exclusion Criteria:

* Parents / child's refusal of clowns to intervene
Austrian Left Atrial Appendage Closure Registry

Left atrial appendage (LAA) occlusion (LAAC) has been introduced to treat patients with indication of oral anticoagulation (OAC) for atrial fibrillation (AF) with contraindication to OAC. This registry aims to document all LAAC procedures in Austria.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received LAAC in Austria

Exclusion Criteria:

* Absence of informed consent
A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.


Eligibility Criteria:
Role of ARNi in Ventricular Remodeling in Hypertensive LVH

In Singapore, hypertension is very common in the adult population. Hypertensive heart disease is a leading cause of heart failure and cardiovascular death. Current management relies primarily on achieving blood pressure targets. However, the optimal blood pressure goals are controversial and there are inherent difficulties in measuring blood pressure using external devices applied to peripheral arteries. As a result of (usually longstanding) hypertension, the heart thickens (i.e. hypertrophies) to maintain function. Ultimately, HF may occur due to long standing energy deficits, muscle injury/death and diffuse interstitial fibrosis (heart muscle scarring). In an ongoing study (REMODEL, ClinicalTrial.gov Identifier NCT02670031), we have been able to undertake preliminary analyses with respect to factors associated with the development of fibrosis. In this randomize controlled trial, we will be examining a novel therapy that has the potential to induce regression cardiac hypertrophy and fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Increased left ventricular mass on cardiovascular magnetic resonance (based on established local age- and sex-specific CMR ranges)
* Essential hypertension

Exclusion Criteria:

* Known secondary causes of hypertension
* Previous intolerance to angiotensin receptor blockers
* History of heart failure
* Stage IV/V chronic renal disease (eGFR \< 30ml/min/1.73m2)
* Patients with serum potassium \> 5.2 mmol/L (mEg/L) at Visit 1
* History of cardiovascular events (myocardial infarction, strokes and transient ischemic attacks)
* Known atrial fibrillation
* Being unable to understand or comply with study procedures (including CMR)
* History or presence of any other disease with a life expectancy of \< 3 years
* Pregnant or nursing (lactating) women