cyrilzakka/clinical-trials huggingface dataset:
Sevelamer, Fetuin-A and Endothelial Dysfunction in CKD

Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified.

This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.

CKD stage 4 patients older than 18 years of age and willing to participate to the study were screened. Those who had serum phosphorus \> 5.5 mg/dl were evaluated for the study. Patients with diabetes mellitus, history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 62 screened patients 50 met the study criteria and were included in this study. Thirty-two healthy subjects were studied as controls. The ethical committee of Gulhane School of Medicine approved the study and written informed consent was obtained from all patients.

Study design:

This was a randomized study conducted from 2005 through 2006 in Gulhane School of Medicine. The Outpatient Clinic of Department of Nephrology is a tertiary referral center. At admission, most patients were untreated (including phosphate binders) or treated only with antihypertensive agents. After the first evaluation, patients receiving phosphate binders (n=9) underwent a 2-week washout period. Patients who developed a phosphate level \>5.5 mg/dl during this period were included in the study. Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet). The treatment phase was 8 weeks. During the study period serum calcium and phosphorus concentration were measured every 2 weeks and the dose of phosphate binders were titrated to achieve a serum phosphorus concentration \< 5.5 mg/dl. The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day and for calcium acetate (1000 mg) 1 tablet three times a day. The medications were given with meal and the doses were increased as needed. Patients were not given calcitriol during the study period.

Fasting blood samples were taken before and after the study to measure serum creatinine, serum albumin, hs-CRP, insulin, iPTH, lipid profile and serum fetuin-A concentration. Additionally, flow-mediated dilatation (FMD) was also evaluated before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 4 patients
* Older than 18 years of age
* Non-diabetic
* Serum phosphorus \> 5.5 mg/dl

Exclusion Criteria:

* Diabetes mellitus
* History of coronary artery disease
* Smokers
* Taking statins or renin-angiotensin blockers
Sleep Inertia and Functional Connectivity

The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.


Eligibility Criteria:
Inclusion Criteria:

* 65 \> age \> 18
* high or law dream recall frequency

Exclusion Criteria:

* history of psychiatric or neurologic or sleep pathologies
* counter indication for MRI
Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

The main purpose of this clinical trial is to examine the feasibility and effects of fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will evaluate changes in circulating hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers after the administration of fulvestrant. Changes in tricuspid annular plane systolic excursion, stroke volume index, right ventricular fractional area change, and other echo parameters after fulvestrant administration will be evaluated as well as changes in distance walked in six minutes.


Eligibility Criteria:
Inclusion Criteria:

* Previous documentation of mean pulmonary artery pressure \> 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \< 16 mm Hg and pulmonary vascular resistance \> 3 WU at any time before study entry.
* Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection.
* Most recent pulmonary function tests with FEV1/FVC \>50% AND either a) total lung capacity \> 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest.
* Female, post-menopausal state, defined as:
* \> 50 years old and a) have not menstruated during the preceding 12 months or b) have follicle-stimulating hormone (FSH) levels \> 40 IU/L or
* \< 50 years and FSH \> 40 IU/L or
* having had a bilateral oophorectomy.
* Informed consent.

Exclusion Criteria:

* Age \< 18.
* Treatment with estrogen or anti-hormone therapy (tamoxifen, anastrozole, etc.)
* WHO Class IV functional status.
* History of breast cancer.
* Clinically significant untreated sleep apnea.
* Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on echocardiography.
* Initiation of PAH therapy (prostacyclin analogues or receptor agonists, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within three months of enrollment; the dose must be stable for at least 3 months prior to Baseline Visit. PAH therapy which is stopped and then restarted or has dose changes which are not related to initiation and uptitration will be allowed within 3 months prior to the Baseline Visit.
* Hormone therapy.
* Use of warfarin or other anticoagulant (use of aspirin is permitted).
* Platelet count \<100,000.
* Renal failure (creatinine \>/= 2.0).
* Child-Pugh Class C cirrhosis.
* Current or recent (\< 6 months) chronic heavy alcohol consumption.
* Current use of another investigational drug (non-FDA approved) for PAH.
Antibiotic Therapy for Early Onset Neonatal Sepsis

Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Age: postnatal age ≤ 72h;
* Meets NICE guidelines for using antibiotics to treat EONS;
* Azlocillin used as part of antimicrobial treatment;
* Parental written consent.

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Major congenital malformations;
* Undergoing surgery within the first week of life;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.
The Role of Probiotics PS128 in Movement Disorders

Pediatric movement disorders comprise of a large number of different neurological diseases including Rett syndrome (RTT) and Tourette syndrome. Studies in the literature as well as our preliminary reports showed that Rett syndrome and Tourette syndrome/Tic disorders are associated with a dysbiosis of the gut microbiota compared to normal control. Probiotic Lactobacillus plantarum PS128 is a diet supplement that available for human consumption. Probiotic Lactobacillus plantarum PS128 had showed psychotropic effects such as ameliorate anxiety- and depression-like behaviors as well as altered the level of neurotransmitters such as dopamine in the brain in animal models, which might be through microbiota-gut-brain axis. Therefore, the purpose of this study is to access the possible neurobehavior effects of Probiotic Lactobacillus plantarum PS128 in Rett syndrome and Tic disorders/Tourette syndrome.

The study is a placebo-controlled double-blind randomized study, to determine the benefits of probiotic Lactobacillus plantarum PS128 vs placebo on symptoms for Tic disorders; and the symptoms, behavior, or cognition for Rett syndrome.

Patients with the Rett syndrome and Tic disorders/Tourette syndrome will be recruited into our study.The study period will last 4 months for Rett syndrome patients, age one year-50years; while 2 months for Tic disorders/Tourette syndrome patient, age 5 years-18 years.

The study will be performed in National Taiwan University Children Hospital. The patients will have neuropsychological and gut microbiota evaluation before and at the end of the study. There will also be interim follow up evaluations each month after the patient start taking the probiotic or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Rett syndrome:
* Males and females who have classic or atypical RTT diagnosed under consensus criteria
* Age: 1-50 years
* Tic disorders:
* males and females with clinical diagnosis
* Age: 8-18years
* Treatment naive 4 weeks prior to study
* Those with standard medications, dosage stable 4 weeks prior to study
* AADC syndrome:
* Males and females with AADC diagnosis
* Age: 1-50 years

Exclusion Criteria:

* Those who took probiotic or probiotic related product 4 weeks prior to the study or during the study
* Those who took antibiotic 4 weeks prior to the study
* Those showing poor compliance with any aspect of the study
* Those had adverse reactions to PS128
Examine the Psychosocial Impacts of COVID-19 Pandemic.

This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The data was obtained on standardised measures of wellbeing (WHO Well-Being Index), psychological distress (Kessler 10), post-traumatic stress (PTSD Checklist for DSM-5), post-traumatic growth (Posttraumatic Growth Inventory), and a novel pandemic-related stress (COVID Psychosocial Impacts Scale). Data was collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from participants (N=2574) aged 18 and above using a non-probability convenient sampling. The findings enabled us to examine the psychosocial impacts of COVID-19, validate the translations of the CPIS and standardized measures; and determine the trajectory of study variables with pandemic exposure.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and above
* Currently residing in the country of interest.
* Additional inclusion criterion applies to bilingual studies; which is having English as a second language.

Exclusion Criteria:

* Aged below 18 years.
* Not residing in the country of interest.
* Additional exclusion criterion applies to bilingual studies; which is not having English as a second language.
Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery

Our aim is to test whether short term perioperative administration of oral spironolactone could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical patients.

Adult patients (\>18 years old) were eligible for the study if they were undergoing elective or emergency cardiac surgery requiring CPB and aortic cross clamp. Exclusion criteria were patients with preoperative chronic renal insufficiency (Serum creatinine \>1.6 mg/dl) or on dialysis, hyperkalemia (\>5.0 mEq/L), AKI detected up to 24 hours before the procedure; patients receiving contrast agents 72 hours before surgery, planned off-pump cardiac surgery, hypersensitivity, allergy or known intolerance to spironolactone and pregnancy. Patients that died during the surgical procedure or 24 hours after surgery were eliminated from the analysis, as well as patients that did not receive spironolactone during the postoperative period. Criteria for stopping spironolactone were serum potassium \>5.5 mEq/L, a serum creatinine level ≥2.5 mg/dL and urine output of \<0.3 ml/k/hr during 8 hours.

One day prior to the procedure, patients that met the inclusion criteria were invited to participate in the trial, signing an informed consent. Spironolactone was administered orally by a study investigator (100 mg 12-24 hrs before surgery); subsequently three further doses of 25 mg were administered orally in postoperative days 1, 2 and 3. Thus, a total 1 x 100 mg and 3 x 25 mg doses of spironolactone in the intervention group were be given. If the patient had not been extubated, spironolactone was administered nasogastrically. Oral drugs were delayed by up to 4 hours if extubation had just occurred. The patients that decided not to receive spironolactone were followed during the study period and considered as controls. Preexisting ACE inhibitor, angiotensin receptor blocker, or MR antagonist were not suspended before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Elective and emergent cardiac surgery with cardiopulmonary bypass and aortic cross clamp

Exclusion Criteria:

* Patients with preoperative chronic renal insufficiency on dialysis
* Acute kidney injury detected up to 24 hours before the procedure a
* Patients receiving contrast agents 72 hours before surgery
* Planned off-pump cardiac surgery
* Hypersensitivity, allergy or known intolerance to spironolactone
* Pregnancy
* Hyperkalemia with potassium \>5.0 mEq/L

Criteria for stopping study medication:

- Serum potassium \>5.5 mEq/L
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 weeks through 12 weeks at Dose 1
* Parent able to understand study procedures and give consent

Exclusion Criteria:

* Clinical evidence of active gastrointestinal disease
* Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Routine Transcervical Thymectomy in MEN-1 Patients

A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.

Introduction and Importance Malignant thymic carcinoids are uncommon but important entities among patients with multiple endocrine neoplasia type 1 (MEN-1). Current treatment guidelines advise the performance of a routine transcervical thymectomy (TCT) during parathyroidectomy, to prevent its development, although data on the yield of this prophylactic TCT is scarce. We aimed to revisit available literature to investigate and summarize the efficacy of routine TCT during neck exploration for parathyroidectomy, for the prevention of thymic carcinoid tumours among MEN-1 patients.

Methods A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.

Eligibility Criteria:
Inclusion Criteria:

* Studies including MEN-1 patients who underwent a routine thymectomy during parathyoidectomy

  * We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.

Exclusion Criteria:

* We excluded reviews, letters, conference proceedings and non-English publications.
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism

The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent.
* Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).

Exclusion Criteria:

* Subject pregnant or nursing
Initial Specialist Telephone Consultation With New Patients in Secondary Care

Consultations with patients by hospital consultants are organised today in a manner which is barely dissimilar from that offered 30 or 40 years ago. Whilst some attempts to improve this process, such as Choose and Book, shorter waiting times and patients' receiving a copy of the correspondence sent to their general practitioner (GP) have improved the situation, there has been little radical change and little thought given to the patient experience.

The investigators wish to investigate whether patients' experience of attending respiratory outpatient clinics can be improved by a pre-clinic telephone call with a specialist thereby reducing the number of attendances at the hospital for appointments and investigations and improving overall patient satisfaction.

This study will investigate whether taking a new patient's history over the telephone permits better selection and arrangement of investigations prior to or synchronous with the first face to face consultation, with the potential to reduce the number of visits the patient has to make to the hospital.

Patients will be offered an initial telephone consultation by post and may opt-in or out of the study. Those having a telephone consultation would have this booked for a specific time and date and the patient would be sent an appropriate information leaflet regarding this. After the telephone consultation patients receive a summary of the consultation and details of any investigations and appointments booked by the research nurse. Patients who did not respond to the initial invitation letter within seven days or who declined to participate would be sent a routine appointment. All patients would asked to complete the MISS-21 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All new adult general respiratory referrals from primary care

Exclusion Criteria:

* Follow-up patients
Mediators of Kidney-Bone Communication in Childhood

An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23 (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves the body's overall needs. However, it is not clear as to whether this is true, particularly with growth. The contribution of dietary factors directly linked with the bone/kidney axis through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and urinary analysis) will be included in investigations. Findings will serve as a springboard for delineating more specific mechanisms by which these systems become disordered and are influenced by diet. It is expected that adequacy of nutrients known to have a central role in bone function will optimize the hormonal milieu through crosstalk with the kidney.

This effort will allow ongoing investigation in detecting and treating disturbances in mineral metabolism related to kidney disease, specifically in the pediatric population and broaden the understanding of kidney disease itself, as well as that of chronic diseases in which kidney health is of importance, such as diabetes and osteoporosis. Findings of this research may stress the importance of achieving dietary adequacy essential for establishing optimal body composition trajectories, particularly puberty.


Eligibility Criteria:
Inclusion Criteria:

* Male
* ages 7-11y
* Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner

Exclusion Criteria:

* History of Cushing's Syndrome, hyperprolactinemia, congenital (non-classic) adrenal hyperplasia, type 1 or 2 diabetes, disturbances in glucose or lipid metabolism
* use of tobacco or consumption of alcohol; thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
* eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease.
Benefits of ADHD Treatment in Detained People

Attention deficit hyperactivity disorder (ADHD) is characterized by difficulties paying attention, poor impulse control, and hyperactive behaviors. It is associated with several health and social detrimental outcomes and leads to increased risks of criminality and recidivism. However, to date, ADHD treatment has been neglected in prison. This project will test the efficacy of ADHD treatment using a randomized controlled trial.

This project aims to compare the efficacy of a three-month in-prison OROS-methylphenidate vs. placebo treatment on the severity of ADHD core symptoms. Secondary outcomes address additional important in-prison and outpatient (in-prison or post-prison) aspects: 1) reduction in acute events in prison (e.g., disciplinary sanctions, violence, misuse of ADHD treatment), 2) evaluation of the risk of recidivism upon release, 3) three-month side effects of treatment, 4) in- and post-prison adherence to medication, 5) in- and post-prison study retention, 6) in- and post-prison costs-benefits of treatment, and 8) one-year rule-breaking behaviour. The outpatient part of the project will highlight long-lasting benefits of a treatment provided during three months while people are detained.

These research questions will be answered using a randomized controlled trial. After randomization, the participants will undertake three months of treatment with OROS-MPH or placebo (1:1 ratio) while they are incarcerated. After three months, all participants will be offered the possibility to have the treatment, but they will remain blinded regarding their initial study group. All of them will benefit of a cognitive-behavioral psycho-education program during detention and a cognitive-behavioral therapy after release.

The RCT will provide empirical-based evidence of the benefits of in-prison ADHD treatment using different perspectives: Clinical, behavioral, rule-breaking-related, and economical. The investigators expect that early detection and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach, likely to decrease the vulnerability of people living in detention and to promote pathways out criminal involvement.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* good command of French
* stay in prison approx. 4 months at eligibility visit
* endorsing clinical diagnostic criteria for DSM-5 ADHD
* providing written informed consent

Exclusion Criteria:

* presence of an acute uncontrolled comorbid psychiatric disorder
* medical contraindication to stimulant prescription
* potential adverse interaction with another medication
* already receive ADHD treatment