Kornimate/medical-research-clean huggingface dataset:
once-daily highly active antiretroviral treatment regimen administration in hiv-1 infected children in burkina faso (anrs 12103 burkiname)

Conditions: HIV Infections; AIDS

Summary: the purpose of this study is to try a known antiretroviral combination in hiv- infected children with only one intake a day, in order to simplify the prescription and improve adherence to treatment. this is what is called a phase ii clinical trial, only recruiting and following a small number of children (50) during one year to evaluate the quantity of drug in the blood just before it is taken and one to three hours after it is taken. the other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

the data relating to pharmacology tolerance and efficacy of the once-daily combination of 3tc + ddi + efv have never been studied. this regimen may lead to a better treatment of the hiv-1 infected children in developing countries, as well as in europe. because of its simplicity it would facilitate observance that is one of the essential parameters of efficacy of treatments. the main objectives are those of a phase ii clinical trial: * assess the virological and immunological efficacy of a once daily haart regimen comprising lamivudine (3tc) + didanosine (ddi) + efavirenz (efv) \[pediatric reference\]; * analyse the pharmacological characteristics of this combination in children; * assess the tolerance; * study the appearance of resistance; * evaluate the observance to treatment. 50 hiv-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage b or c) requires antiretroviral treatment, will be included in the study. they should be naive of any arv treatment (except the treatment received in the framework of pmtct (prevention of mother to child transmission). data collection and development of the study: * monthly clinical examination; * rna hiv-1 and cd4 counts; * pharmacological dosages; * haematology and biochemistry surveillance; * genotypic resistance at inclusion; and, in case of unsuccess or failure, * assessment of observance according to alternate methods. laboratory examinations will be carried out at centre muraz except for genotyping and for pharmacological tests sent to montpellier teaching hospital (france).

Eligibility criteria:
inclusion criteria: * hiv-1 infected children * weight over 12 kgs * age over 30 months * clinical stage requiring haart * naive to antiretroviral treatment (except pmtct prophylaxis) * mother's or tutor's informed consent signed exclusion criteria: * hiv-2 or dual hiv infection * previous antiretroviral therapy * children unable to swallow pills * known resistance to non-nucleoside reverse transcriptase inhibitor (nnrti)

Keywords: haart once-daily child africa hiv aids treatment naive
efficacy and safety of fty720 in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study evaluated the safety, tolerability and effect on mri lesion parameters of fty720 in patients with relapsing multiple sclerosis.


Eligibility criteria:
core study inclusion criteria: * diagnosis of relapsing multiple sclerosis (ms) * patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year * patients with an expanded disability status scale (edss) score of 0-6 extension study * a positive gd-enhanced mri scan at screening (in case the first mri scan obtained at screening was negative, a second scan could have been obtained 1 month later) * neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the screening and baseline periods. * female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period. exclusion criteria: core study * patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc * pregnant or nursing women extension study * patients who had permanently discontinued study drug prior to the month 6 visit of the core study * patients with diabetes mellitus (to reduce the risk of me), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study) other protocol-defined inclusion/exclusion criteria may apply

Keywords: fty720 ms multiple sclerosis rrms
cerebril™ in patients with lobar hemorrhage related to cerebral amyloid angiopathy

Conditions: Stroke; Neurologic Diseases, General

Summary: the main objective of this study is to evaluate the safety, tolerability and pharmacokinetics of cerebril™ in cerebral amyloid angiopathy (caa) patients who have had lobar cerebral hemorrhage.

hemorrhagic stroke due to caa represents approximately 7% of all strokes. the current phase ii clinical study investigates the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of the drug candidate in patients who have suffered lobar hemorrhages. the initial phase of the study is also aimed at determining the optimal dosing regimens for subsequent drug candidate efficacy trials. the trial is also evaluating the appearance of new cerebral hemorrhages on gradient-echo mri scans, the amyloid ß (aß) protein levels in the plasma and cerebrospinal fluid and the neurological and cognitive functions.

Eligibility criteria:
inclusion criteria * patients must be 55 years of age or older. * males and females. females must be of non-childbearing potential (i.e. surgically sterilized or at least one year post-menopausal). * diagnosis of possible or probable caa based on the boston criteria for diagnosis of caa-related hemorrhage. * nonfatal lobar hemorrhage (defined as hemorrhage in the cerebral cortex and underlying white matter sparing the basal ganglia and thalamus) within previous five years diagnosed by ct or mri scan. * patient has no intent to donate blood for 4 weeks after completion of the study. * signed informed consent. exclusion criteria * other established causes of hemorrhage at the time of the index hemorrhage event. exclusion causes include excessive anticoagulation (inr \> 4.0), associated head trauma or ischemic stroke, cns tumor, vascular malformation, vasculitis, and blood dyscrasia. * patient with a clinically significant and uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, hematological condition or other significant medical disease. * presence of any condition that could interfere with the interpretation of study results or compromise patient safety. * debilitated neurological state or other known disease likely to result in early death. * disability characterized by a modified rankin score ≥ 4. * alt, alp, ast or total bilirubin ≥ 1.5 the upper limit of normal ranges. * contraindications to mri scan (e.g. cranial metallic implant, cardiac pacemaker, and severe claustrophobia). * allergy and/or hypersensitivity to analgesic agents used for the lumbar puncture (for patients undergoing lumbar puncture only). * allergy and/or hypersensitivity to any component of the study medication. * use of an investigational drug within 30 days prior to screening visit. * use of warfarin or warfarin containing compounds and heparin or heparin containing compounds within 7 days prior to baseline (week 0) visit. * diagnosis of cystatin c amyloid angiopathy. * active alcohol and/or drug abuse. * inability to provide legal consent

Keywords: neurologic diseases (general) hemorrhagic stroke cerebral amyloid angiopathy cerebrovascular accident
a study to assess the safety, tolerability, pharmacokinetics and efficacy of cs0159 in subjects with nash

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: a randomized, double-blind study to assess the safety, tolerability, pk and efficacy of cs0159 in subjects with non-alcoholic steatohepatitis (nash)

this will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, pks, and efficacy of cs0159 in the treatment of patients with nash over 12 weeks.

Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnosis of nash. 2. evidence of metabolic syndrome, except for those patients with biopsy-proven nash. 3. body mass index (bmi) \>25 kg/m2, note: for asian-americans bmi \>23 kg/m2. 4. stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization. exclusion criteria: 1. use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer. 2. previous exposure to farnesoid x receptor (fxr) agonists 3 months prior to the first dosing. 3. current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid. 4. prothrombin time international normalized ratio \>1.3, unless due to therapeutic anticoagulation. 5. total bilirubin \>upper limit of normal (uln; except for patients with gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count). platelet count \<140 000/mm³, absolute neutrophil count \<1500 cells/mm3, or total 6. white blood cells \<3000 cells/mm3. 7. alanine aminotransferase and aspartate aminotransferase (ast) \>5 × uln, or alkaline phosphatase (alp) \>1.5 × uln. 8. weight changes \>10% in 6 months prior to screening, or weight changes \>5% from the screening mri-pdff to randomization or from the time of the diagnostic liver biopsy to randomization, whichever is longer. 9. poorly controlled hypertension (systolic \>160 mm hg, or diastolic blood pressure \>100 mm hg - mean of 3 measurements). 10. uncontrolled diabetes mellitus (hemoglobin a1c \>10.0% during screening).
ultrasound elastography for prediction of postoperative pancreatic fistula

Conditions: Pancreatic Fistula

Summary: the purpose of this study is to assess the value of preoperative objective modalities such as endoscopic ultrasound elastography and magnet resonance imaging in predicting development of postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or malignant disease.

one of the most generally accepted causes of postoperative pancreatic fistula (popf) is soft texture of the pancreas. the stiffness of organs depends on histologic features such as content of fat, fibrotic tissue and micro vascular structures. yet, pancreatic stiffness was evaluated only subjectively. endoscopic ultrasonography (eus) and magnetic resonance imaging (mri) may allow objective quantification of pancreatic stiffness prior to surgery. endoscopic ultrasound elastography (eue) is based on real-time doppler technology. image colors are derived from vibration patterns which depend on the stiffness of a specific region of the investigated organ. the retrieved images could be converted into numeric matrix using a specially designed program. magnetic resonance imaging (mri) is a non-invasive method for quantitatively assessing the mechanical properties of tissues based on fat tissue content. in this trial the investigators will assess at first the value of eue and mri in predicting development of postoperative pancreatic fistula and in a next step the value eue and mri as an objective method in prediction of pancreatic stiffness.

Eligibility criteria:
inclusion criteria: * adult (more than 18 years) with resectable pancreatic lesion(s) exclusion criteria: * total pancreatectomy * unresectable pancreatic lesion(s) * pregnancy

Keywords: postoperative pancreatic fistula soft and hard pancreas
sifrol (pramipexole) onset of action and impact: a 12-weeks observational study in patients with primary restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the objectives of the post market surveillance (pms) study are to evaluate the treatment effect of pramipexole on restless legs syndrome (rls) severity as measured by international restless legs rating scale and global clinical impression - improvement, to evaluate the time to reaching maintenance dose of pramipexole


Eligibility criteria:
inclusion criteria: * primary restless legs syndrome (i.e. idiopathic rls) * indication for treatment with pramipexole * male or female patients older than 18 years exclusion criteria: * any contraindications according to the summary of product characteristics (spc): hypersensitivity to pramipexole or to any of the excipients * current treatment with pramipexole
topical adrenaline versus warm saline solution for minimizing intraperitoneal bleeding during caesarian delivery for placenta previa / accreta spectrum ( pas)

Conditions: Placenta Accreta; Placenta Previa

Summary: placenta accreta spectrum (pas), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage . currently, more than 90% of women diagnosed with pas also have a placenta praevia , and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases . adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low cost, low risk, powerful vasoconstrictor, and platelet aggregation. topical use of adrenaline is an effective and reasonable hemostatic agent in tonsillectomy.

* population of study: a total of 84 pregnant patients with placenta previa / accreta spectrum. * study location: obstetrics and gynecology kasr al-ainy hospital , faculty of medicine , cairo university. this is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (medcalc ®) . group a : topical adrenaline group (n=42) group b : warm saline group (control) (n=42) the aim of the study is to evaluate the efficacy of topical adrenaline for decreasing intraperitoneal bleeding during caesarian section for placenta previa/ accreta spectrum (pas).

Eligibility criteria:
inclusion criteria: * age from 18 to 40 years. * bmi \< 35. * pregnant patients with placenta previa . * placenta accrete spectrum. * vitally stable . exclusion criteria: * vitally unstable . * massive pre- or intra-operative bleeding. * medical disorders ( e.g. : hypertension , cardiac .... )
combined treatment of minocycline and lovastatin to treat individuals with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the purpose of this study is to determine whether lovastatin, minocycline and the combination lovastatin/minocycline are effective in treating behavioral symptoms in fragile x individuals.


Eligibility criteria:
inclusion criteria: * molecular diagnosis of fragile x syndrome * the participant must be accompanied his parent, legal tutor or legal representative. * identify a caregiver who spends at least six hours per day with the participant (may be the parent, legal tutor, legal representative or an other person). * iq \< 70 * abc-c score \> 20 * cgi-severity score ≥ 4 exclusion criteria: * pregnant or breastfeeding participants * previous intolerance/allergy to statins, minocycline or tetracyclines * participants who have taken lovastatin or minocycline in the last 12 weeks * personal history of myopathy, myalgia or high creatine kinase (ck) levels * renal disease / liver disease / disturbed hepatorenal tests * participants taking more than three psychoactive medications (except anticonvulsants) * untreated or uncontrolled hypothyroidism * any other active medical condition * modification of psychoactive treatment in the last 6 weeks prior to randomization * participants under the age of 13 years who have incomplete formation of the crown of their teeth (except possibly their 3rd molars) as shown by panorex * concomitant use of prohibited drugs * prohibited drugs include other hypolipemic including gemfibrozil (or other fibrates) and niacin (nicotinic acid), angiotensin converting enzyme (ace), cyclosporine, danazol, amiodarone, verapamil and inhibitors p450 (cyp3a4) (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, inhibitors of hiv protease and nefazodone).

Keywords: fragile x syndrome autism fmr1 fraxa
the post intensive care syndrome follow-up and management study: the icu recovery answers project

Conditions: Post Intensive Care Syndrome; ICU Survivors; ICU Families

Summary: critically ill survivors develop mental health, cognition, and mobility sequelae known as post-intensive care syndrome (pics). clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after icu, impacting quality of life of the survivors and their relatives. the main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (icura) specifically designed for following-up and managing the mental health sequelae related to pics in icu survivors and their relatives during the one-year recovery phase. methods: observational, prospective and multicenter study including two cohorts: 1) icu patients' cohort (icucohort), and 2) icu patients' family cohort (icu-f-cohort). after icu discharge, patients will be randomized to participate in a follow-up with icura vs. the standard follow-up. expected results: critically ill survivors in the appics program after icu will show better levels of functionality and quality of life than those participants in the usual follow-up. appics will contribute to enhancing the prognosis of emotional alterations during the 12 months after icu both, in icu survivors, and relatives. analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in icu survivors.


Eligibility criteria:
inclusion criteria: * adult (≥18 years old) critically ill patients admitted to the icu with or without need of invasive mechanical ventilation (imv). exclusion criteria: * non-authorization of the relatives and/or patient to inclusion in the study; neurocritical icu patients. * severe neurological pathology (including dementia or focal brain damage with functional and cognitive impairment) prior to admission to the icu. * severe psychiatric pathology (schizophrenia, bipolar disorder, major depressive disorder) * intellectual disability (iq \<80). * patients who develop secondary complications (infections, stroke, tbi or any non-transient acquired brain damage) after icu discharge, that may compromise the results of the emotional and neuropsychological evaluation during the recovery phase * moderate-severe cognitive impairment (short-iqcode \>85) that impair icu patients an independent participation in the telematic follow up and accompaniment program * readmission to icu within 12 months after discharge from icu * idiomatic barrier (non spanish and/or catalan speaker) * patients with life expectancy \<1 year or not subsidiaries of active treatment measures.

Keywords: post-intensive care syndrome icu survivors icu families cognition emotional state
clinical trial of vitamin e to treat muscular cramps in patients with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis (als). this clinical trial will compare the response of high dose vitamin e supplementation to placebo for treatment of muscular cramps in patients with als. we hypothesize that vitamin e will be more effective than placebo in treating cramps.

this will be a single centre randomized placebo controlled crossover design trial. participants will be randomized at study entry to protocol a (vitamin e first) or protocol b (placebo first). the first 2 weeks of the study will be a baseline assessment of the frequency, severity and duration of cramps. patients will be blinded for the remainder of the duration of the study. for weeks 3-6 of the study, group a will receive vitamin e 800 iu bid and group b will receive placebo. for weeks 7-10 of the study, group a will receive placebo and group b will receive vitamin e. participants will record cramp frequency and characteristics via a daily journal for the duration of the study, however the data analysis will focus on cramp frequency only during weeks 5-6 and 9-10. weeks 3-4 and 7-8 will be used as time periods to allow the new drug to come to steady state and allow for washout of the previous drug. data analysis will focus on the difference in cramp frequency in individual patients in each treatment period.

Eligibility criteria:
inclusion criteria: * adults (\> age 18 years) * probable or definite als by el escorial revised criteria * at least 2 painful muscle cramps in one or more of the limbs per week. * may have tried other medications for cramping in the past. * if participants are currently on treatment for cramps and are continuing to have at least 2 cramps per week, they can be included in the trial. in this situation, the individual's previous cramp medication can be continued during the trial. * ideally, patients should not have any medication alterations during the duration of the trial. * willing to discontinue supplementary vitamin e and multivitamins containing \> 400 iu of vitamin e during the trial. exclusion criteria: * patients who are unable to safely consume the trial capsules. individuals with significant dysphagia can be included into the study if they have a functioning peg tube or gj tube, through which the medication can be given. * patients who are unable to fill out the daily diary, either personally or via a proxy. * patients who have had medication changes within the last 4 weeks prior to the onset of the trial will be excluded.

Keywords: amyotrophic lateral sclerosis vitamin e muscle cramp
the association between unprotected standing, walking and wound healing in diabetes

Conditions: Diabetic Foot

Summary: the aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. since this was an exploratory study, there was no study hypothesis.

diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.

Eligibility criteria:
inclusion criteria: * age 18 or older with non-infected, non-ischemic foot ulcers * active neuropathic foot ulcer exclusion criteria: * major foot amputation * active charcot arthropathy * ankle brachial index of 0.5 or less * history of substance abuse within 6 months * inability to walk 20m

Keywords: diabetic foot ulcer