cyrilzakka/clinical-trials huggingface dataset:
Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)

The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Two groups will be identified according to the serum vitamin D levels on eFET transfer day and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared between those groups

In the last decade there have been growing evidence about Vitamin D receptors and their role in female genital tract. But these studies are yet not well designed and the results should be interpreted cautiously. Although some of these studies advocating the Vitamin D deficiency as an negative circumstance on pregnancy rates some of the others don't agree. According to contradictory results understanding the actual role of those receptors needs more observation.

Latest retrospective analyse postulated that, vitamin D deficiency in fresh single embryo transfer cycles may reduce pregnancy rates mediated by endometrium or ovarian reserve and stimulation characteristics.

For this reason the investigators aimed to explore the effect of serum Vitamin D levels on pregnancy rates in infertile population undergoing frozen embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years to 35 years age, a frozen ET with 1 Day 5 (blastocyst stage) embryo
* Infertile women undergoing ICSI (intracytoplasmic sperm injection) cycle
* Factors affecting fertility are Tubal
* Unexplained or ovulatory disturbances,

Exclusion Criteria:

* Need to do Preimplantation Genetic Diagnosis
* Presence of endometriosis and adenomyosis
* Severe male factor infertility
Efficacy of Combined Treatment for Young Bipolar I Disorder

The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:

Group I: lithium + valproic acid

Group II: lithium + carbamazepine

Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.

During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

Exclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Mental retardation
* Unstable clinical diseases
PDA Post NICU Discharge

The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.


Eligibility Criteria:
Inclusion Criteria:

* Documentation of informed consent and authorization for participation.
* Estimated gestational age of 32 weeks or less.
* Active diagnosis of a PDA at discharge.
* At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
* Parental agreement to provide follow-up information on their child.
* Cardiologist and/or Pediatrician willing to provide follow-up information on enrolled infants.

Exclusion Criteria:

* No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
* Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
* Parent(s) unwilling to participate in follow-up.
Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.

The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.

Eligibility Criteria:
Inclusion Criteria:

* patients of early colorectal lesions with capillary pattern(CP) type II\&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.

Exclusion Criteria:

* lesions with CP type I;
* CP type III lesions with an obvious appearance of advanced cancer;
* lesions that had underwent biopsy;
* patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
* patients with previous colorectal surgery;
* having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.
Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy (CIN)

Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents. Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of normal saline in prevention of RCIN.

Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents and is the third leading cause of acquired acute renal failure in hospitalized patients. Strategies for the prevention of radiocontrast nephropathy have focused on countering vasoconstriction (pre-hydration, fenoldopam, and theophylline), enhancing flow through the nephron (diuretics), or protection against oxygen-free-radical injury (urinary alkalinization and N-acetylcysteine).

Among all prophylactic measures that have been proposed, adequate preprocedural and postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast nephropathy. Thus, it remains the most frequently applied measure in clinical practice.

A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over normal saline as a prophylaxy.Since alkalizing renal tubular fluid with bicarbonate may reduce injury.

Comparisons: IV 154 mEq/L solution of NaCl 0.9% OR IV 154 mEq/ L sodium bicarbonate solved in 154 mEq/ L NaCl 0.9%. Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.

Eligibility Criteria:
Inclusion Criteria:

* individuals aged 18 years or older with stable serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography during the next 24 hours of hospitalization and were available until 5 days after the procedure for serum creatinine measurements.

Exclusion Criteria:

* serum creatinine levels of more than 8 mg/dl
* previous history of dialysis
* eGFR \< 20
* emergency catheterization
* recent exposure to radiographic contrast agents (within previous two days of the study)
* radiocontrast agent dosage needed more than 300 cc during the procedure
* allergy to radiocontrast agent
* pregnancy
* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
* need for continuous hydration therapy (e.g. sepsis )
* history of Multiple myeloma , Pulmonary edema , Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.) ,Severe heart failure (EF \< 30% or NYHA 3-4).
Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)

This study attempts to learn about the effectiveness of a modification to the Transversus Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the abdominal wall postoperatively using ultrasound guidance. The investigators want to see if regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread in the appropriate plane could reduce error and improve postoperative recovery.

This study is a prospective, randomized blinded study that investigates the efficacy of a transversus abdominis plane block under direct view. In this pilot study involving gynecologic patients undergoing open (abdominal wall incision either vertically or horizontally) hysterectomy or other related gynecologic surgery, the investigators will use ropivacaine versus saline for the placebo control group, which in both groups involves injection of agent directly into the appropriate fascial layers prior to abdominal wall closure. Efficacy is to be assessed via measurement of pain scores, nausea and vomiting, and opioid consumption in both participant groups. The number of dermatomes which are blocked in both participant groups during the first 24 hours following surgery will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old and not pregnant
* Must be able to provide informed consent - functional understanding of English
* Undergoes exploratory laparotomy with midline abdominal incision

Exclusion Criteria:

* History of substance abuse
* History of chronic pain syndrome
* Daily opioid use for more than 1 month
* Patients considered to have chorioamnionitis at the time of cesarean surgery as determined by the attending physician
* Prior abdominal surgery involving mesh or placement of an ostomy site as this may disrupt the plane in which the anesthetic may spread
* Allergy to local anesthetics
* History of cardiac arrhythmias or cardiac abnormalities
* History of seizure disorder
* Liver disease
Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 1

This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \>28 kg/m2;
* not currently pregnant or lactating;
* have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
* no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
* not using insulin injection;
* able to attend the 22 (1 hour) diet improvement sessions;
* willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
* keep weighing their weight for one and a half years;
* fluent in reading and writing English.

Exclusion Criteria:

* age \<18 or \>64 years;
* body mass index of \<28 kg/m2;
* currently pregnant;
* currently lactating;
* self-reported with severe metabolic, cardiovascular, or musculoskeletal disease;
* use insulin injection;
* not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
* failed to set up a Wi-Fi scale;
* failed to submit a FFQ.
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception

Exclusion Criteria:

* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped
Evolution of the Rate and Causes of Death in Geriatric SSR

In view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative


Eligibility Criteria:
Inclusion Criteria:

* Major patients (≥ 18 years)
* All patients who died during their stay in geriatric SSR between 01/01/2013 and 31/12/2017
* Patients who have not expressed their living refusal to reuse their medical data for research purposes

Exclusion Criteria:

- Refusal on the part of patients of their living to reuse their medical data for research purposes
Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy

Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin A1c (HbA1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting

This randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that BT-001 compared to a control application, both on top of usual care, will lower HbA1c in real world clinical practice. Approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to BT-001 or the control application. Most clinical data will be collected via the electronic medical records (EMR) system with limited additional contacts to ascertain adverse device effects (ADEs), adverse events (AEs) and clinical events which may have occurred outside the health system and were not recorded in the EMR. For primary efficacy endpoint assessment, a requisition form for HbA1c at a local laboratory will be provided if HbA1c is not available from the EMR within the 90- and 180-day time windows. During the extension phase, biomarker endpoint data will only be collected from the EMR. For all participants, clinical and healthcare utilization data will be extracted from their EMR for the period from 180 days prior to enrollment to 720 days after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years, inclusive at the time of signing the informed consent
* Type 2 diabetes on stable anti-diabetic regimen for at least three (3) months
* HbA1c 7.0% to 10.9% (within thirty \[30\] days of signing the informed consent form \[ICF\])
* Able to use BT-001 e.g., English fluent, smartphone is capable of running the study intervention.

Exclusion Criteria:

* Current use of outpatient prandial insulin
* In the opinion of the investigator, life expectancy \< one (1) year
* COVID-19 diagnosis within thirty (30) days prior to randomization.
Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the second and subsequent attack of recurrent pericarditis,
* Age≥ 18 years,
* Informed consent.

Exclusion Criteria:

* Suspected neoplastic, tuberculous, or purulent etiology,
* Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality,
* serum creatinine\>2.5 mg/dl,
* Serum CK over the upper limit of normality or Known myopathy,
* Known gastrointestinal or blood disease,
* Pregnant or lactating women or women not protected by a contraception method,
* Known hypersensibility to colchicine,
* Treatment with colchicine at the enrolment.
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, ≥18 and ≤60 years of age.
* Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
* Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history.
* Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

* Have received:

  1. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
  2. Janus kinase (JAK) inhibitors within 2 weeks, or
  3. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
  4. anti-TNF-α biologics within 9 weeks, or
  5. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
* Have received orally administered azathioprine or 6-mercaptopurine that has been stable for \<8 weeks.
* Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for \<5 weeks.
* Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half-lives, whichever is longer.
* Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis.
* Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
* Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
* Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure ≥ 125 mmHg
* Admitted for Acute Heart Failure (AHF)
* Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
* eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m\^2

Exclusion Criteria:

* Dyspnea (non-cardiac causes)
* T \> 38.5°C
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
* Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm\^2 or mean gradient \>50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
* AHF due to significant arrhythmias
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters

The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants.
* Subjects presenting some or several of these characteristics will be prioritized:

Fasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: \< 50 mg/dL men, \< 40 mg/dL women. Blood pressure: systolic \> 130 mm Hg; diastolic \> 85 mm Hg.

Exclusion Criteria:

* Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.
* Volunteers participating in other studies or weight loss plans.
* Pregnant or breastfeeding women.