bioihbjkbjnl/mcl2 huggingface dataset:
Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
Condition: Healthy Humans
Study type: Interventional
Phase: Phase 4

Summary: 
      In this placebo controlled study the investigators aim to investigate the effect of a 3 month
      vitamin D supplementation on parameters of the immune, endocrine and metabolic system in
      healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of
      certain immune cells, which regulate immunotolerance, the investigators therefore try to
      confirm these results with a placebo group. Furthermore the investigators assess the effect
      of vitamin D on the glucose metabolism and hormone levels.
    

Detailed description: 
      This is a randomized double-blind placebo controlled trial, with the aim to investigate the
      effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic
      system in healthy humans without diabetes and obesity.

      The primary aim is to assess the effect of vitamin D supplementation of the number and
      function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs
      at baseline and monthly for 3 months. Furthermore the investigators assess additional immune
      cells from the adaptive immunosystem.

      Furthermore the investigators will perform a standard mixed meal tolerance test at baseline
      and 3 months following the supplementation in order to assess the insulin secretion in vivo.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): monthly dose of 140.000 IU of cholecalciferol orally, 3 times.; Matching Placebo
Other intervention name(s): Oleovit D3; Almondoil
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D Deficiency; Autoimmune disease; Diabetes
Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Abstract

      Background: Insulin resistance has an important role in the development of nonalcoholic fatty
      liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and
      atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a
      favorable effect towards hepatic steatosis and cardiovascular outcomes.

      Objectives: The present study investigated the effect of metformin on arterial properties,
      metabolic parameters and liver function in patients with NAFLD. Methods In randomized,
      placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1
      received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and
      augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney,
      Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and
      serum adiponectin levels were determined.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Keywords: nonalcoholic fatty liver disease; Pulse wave velocity; augmentation index; metformin
Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals
Condition: HDV Infection; HBV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis B; Virus Diseases; Hepatitis D; Hepatitis
Study type: Observational

Summary: 
      Globally, about 248 million people are chronic HBV surface antigen carriers, and about 5% of
      them also had hepatitis delta virus (HDV) infection as well. The prevalence of HBsAg in Egypt
      is intermediate (2-7%) .

      Hepatitis D virus (HDV) is an incomplete RNA virus that needs hepatitis B surface antigen
      (HBsAg) to help its replication. HDV is considered a subviral particle because it depends on
      HBV for its propagation. Combined HDV- HBV infection produces more severe liver affection
      than HBV alone.

      HDV infection leads to both of acute and chronic liver illnesses. Acute HDV infection can
      occur at the same time with acute HBV infection (coinfection) or can be superimposed on the
      top of chronic HBV infection. About 20% to 30% of coinfections of HDV and HBV in humans
      develop fatal fulminant hepatitis versus 2% of patients with acute hepatitis B
      mono-infection. Worldwide, Hepatitis D virus (HDV) infection present in more than 15 million
      people and it is endemic in the Middle East . In Upper Egypt, data about the prevalence,
      clinical, laboratory and virological characters of Hepatitis D virus-infected patients is
      rare.

      This study aims were:

        1. To estimate the prevalence of hepatitis D virus infection among HBsAg positive
           individuals.

        2. To determine the clinical, laboratory and virological characters of HDV infected
           patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was a hospital-based, prospective, cross-sectional analytic one. The study was
        carried out on 186 HBsAg positive cases who were recruited from Tropical Medicine and
        Gastroenterology Department, Al Rajhi Liver Hospital, Assiut University, and Sohag
        University Hospital during two years.The Participants accepted to participate in the study.
      
Keywords: HDV; HBsAg; prevalence; Upper Egypt
Effect of Dietary Protein Intake Distribution on Protein Metabolism and Skeletal Muscle
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The investigators determined effects of 8-week dietary protein intake in mixed meals with
      uneven or even consumption pattern on the metabolic outcomes of whole-body net protein
      synthesis and muscle protein synthesis in older participants.
    

Detailed description: 
      The demonstrated benefits of increased protein intake on sarcopenia and many physiological
      functions is becoming increasingly evident. For this reason, there is growing importance to
      ensuring that Americans consume the recommended amount of protein, calculated to be 17-21% of
      caloric intake. As it relates to the prevention of sarcopenia, adequate protein consumption
      inherently assumes that sufficient protein is ingested to stimulate protein anabolism.
      Specifically, adequate essential amino acid precursors, and anabolic triggers such as
      leucine, must be present for protein anabolism to occur. Population data from the NHANES
      study suggests that American protein intake pattern is skewed towards the evening meal. The
      NHANES data also suggests that the average protein consumption of both men and women over the
      age of 50 yrs is approximately 1.1 g/kg/d. Thus, the prevalent consumption pattern ensures
      that many individuals consume adequate protein, or amino acid precursors sufficient to
      stimulate protein synthesis, only with the larger, or dinner meal. The investigators have
      demonstrated that frequent stimulation of protein synthesis with amino acids preserves
      strength and function. Others have demonstrated that adequate protein intake stimulates
      muscle protein synthesis and increases lean mass. Given these data, The investigators studied
      the effects of two different protein intake patterns on metabolic and functional outcomes in
      older individuals after 8 wks of dietary control. The mean protein intake for this group of
      1.1 g/kg/d was consumed in two distinct meal patterns. Participants consumed high quality
      protein in the ratio of 15/20/65% of total protein intake for breakfast/lunch/dinner,
      respectively (Uneven protein intake pattern), or protein consumption was distributed equally
      among each meal (33% of total protein)(Even protein intake pattern). The investigators
      determined the longitudinal effects of this consumption pattern on the metabolic outcomes of
      whole-body net protein synthesis and muscle protein synthesis in older participants.
    

Intervention name(s): Uneven Protein intake pattern; Even Protein Intake Pattern
Intervention type(s): Other; Other
Intervention description(s): Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)] on net protein synthesis over 8 weeks.; Each participant will consume 33% of total protein consumed each meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neutrino Regimen for Treatment-experienced HCV GT1 Patients
Condition: Chronic Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV
      genotype 1b treatment-experienced patients.
    


Intervention name(s): SOF+PEG+RBV
Intervention type(s): Drug
Intervention description(s): Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other intervention name(s): GS-7977; PSI-7977; Sovaldi®; Pegasys®; Copegus®
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Condition: Children's Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Pharmacological interventions to aid behavior management's techniques are commonly used in
      pediatric dentistry. The aim of the medicaments is to control behavior and allow safe
      completion of a dental procedure. Homeopathic remedy is safe and can be effective to control
      behavior and decrease anxiety in children during dental treatment.

      Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety
      before dental treatment.

      2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for
      anxious children.

      Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will
      receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be
      measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS),
      and Houpt behavior scale.

      Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation
      during dental treatment.
    


Intervention name(s): Homeopathic remedy; Placebo
Intervention type(s): Other; Other
Intervention description(s): drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.; drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of extended-release (ER)
      paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having
      symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of
      emotional instability, detachment from reality, often with delusions and hallucinations
      [imagining things], and withdrawal into the self) .
    

Detailed description: 
      This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor
      participant knows the name of the assigned drug), randomized (study drug is assigned by
      chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a
      medical research study comparing the response in 2 or more groups of participants receiving
      different treatments), flexible-dose (the physician has the freedom to give different doses
      to the participant depending on how they respond to treatment) study designed to determine
      the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age)
      with schizophrenia. The total duration of the study will be approximately 29 weeks. The study
      consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout
      period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18
      weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER
      or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits.
      Efficacy of the participants will primarily be evaluated through Positive and Negative
      Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone extended release (ER); Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.; Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Aripiprazole
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether addition of memantine to bipolar
      depression patients who have had an incomplete response to lamotrigine (Lamictal) which is
      frequently used to treat bipolar depression in the clinical setting. At present, memantine is
      approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the
      treatment of bipolar depression. Subjects will be asked to participate because they are
      suffering from bipolar depression associated and have had an inadequate response to
      lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.
    

Detailed description: 
      Hypothesis/Objectives:

      H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have
      significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical
      Global Improvement (CGI) scale compared to patients augmented with placebo.

      H2: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have
      significantly greater improvement of scores on the Selective Reminding Test (SRT), the Digit
      Span Test, the Stroop Test, and Trail Making Test (TMT) than patients augmented with placebo.

      Study Population:

      We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from
      the outpatient Mood Disorders Clinic and by advertisement.
    

Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.; No active medication, only placebo
Other intervention name(s): Memantine or Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar; Depression; Incomplete Response
Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience
Condition: Neurodevelopmental Abnormality
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      Thanks to the evolution in knowledge and technical advances in premature newborn intensive
      care, the survival of very premature infants is now possible. However, prognosis remain
      sometimes uncertain.

      In 2011, the Epipage 2 study showed a significant improvement as compared with the 1997
      Epipage1 study with a decrease in mortality and an increase of the survival rate without
      severe morbidity of 14% for preterm babies born between 25 and 29 weeks and 6% for babies
      born between 30 and 31 weeks.

      However, surviving babies without initial major deficiencies, may later show problems in
      terms of growth, sensory - motor and/or neuro-psychologic development. This untoward
      evolution lead to social and family interaction disorders and school difficulties.

      In this context, a perinatal care network was created for each Region in France, making it
      possible to take care of these vulnerable children early on and all along their development.
      A retrospective study will evaluate 97 pre-term babies born before 33 weeks in 2012 and who
      are taken care of at Nancy as part of the Lorraine regional network program "Rafael" until
      they are 7 years old.

      The objective is to evaluate objectively the neurocognitive and school abilities of these
      children at the age of 7.

      At 8 years of age, a secondary measure of outcome will be the impact of the eventual
      neurocognitive consequences on the quality of their family life, on the behavior of the child
      and the parents' feelings. This way more options to improve the way they are taken care of
      will be available.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children born prematurely (< 33SA) in 2012 and followed up in the RAFAEL network 7 years of
        age
Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele
Condition: Neurogenic Bladder
MeSH terms: Urinary Bladder, Neurogenic; Meningomyelocele; Spina Bifida Cystica
Study type: Interventional

Summary: 
      This study was conducted to assess the efficacy of pulsed electromagnetic field therapy on
      neurogenic bladder in children with myelomeningocele .Intervention: A pretest-post test
      controlled study was conducted in out-patient clinic in faculty of physical therapy Cairo
      university.
    

Detailed description: 
      Myelomeningocele is the most common cause of neurogenic bladder in children. Bladder function
      in these children is affected by disordered innervation of detrusor muscle and external
      urethral sphincter that may lead to hydronephrosis. Thirty myelomeningocele children with
      neurogenic bladder were enrolled in this study and were assessed for eligibility. Their aged
      between 4 and 12 years. They were divided randomly into two groups. Group (A) which is the
      control group received medical care and standard urotherapy only. And Group (B) which is the
      study group received medical care and standard urotherapy in addition to pulsed
      electromagnetic field therapy for three successful months. All children were assisted using
      urodynamic studies before and after three months of intervention.
    

Intervention name(s): pulsed electromagnetic field therapy device
Intervention type(s): Device
Intervention description(s): magnetic field stimulation (MFS) is a novel technique for stimulating the nervous system non-invasively, which can activate deep neural structures via induced electric currents, without pain and discomfort. Also, several clinical trials including placebo-controlled studies have shown that MFS of the pelvic floor and sacral roots is effective for overactive bladder (OAB). MFS induces inhibitory effects on detrusor overactivity in a similar manner to electrical stimulation, with significant clinical advantages. MFS of the sacral nerve roots could be a promising alternative treatment for OAB.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided randomly into two groups. Group (A) which is the control group received medical care and standard urotherapy only. And Group (B) which is the study group received medical care and standard urotherapy in addition to pulsed electromagnetic field therapy for three successful months. All children were assisted using urodynamic studies before and after three months of intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myelomeningocele; Pulsed electromagnetic field therapy
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the safety and effectiveness of coronary stenting
      with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic
      patients.
    

Detailed description: 
      Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in
      Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by
      visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for
      stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b)
      Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up
      at 9-months is routinely recommended.
    

Intervention name(s): Xience Prime; Cilotax stent
Intervention type(s): Device; Device
Intervention description(s): everolimus-eluting stent implantation; paclitaxel with cilostazol dual drug eluting stent implantation
Other intervention name(s): everolimus-eluting stent; paclitaxel with cilostazol dual drug eluting stent
Intervention MeSH terms: Paclitaxel; Everolimus; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: requiring drug eluting stents