bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Transcranial Direct Current Stimulation (tDCS)
Condition: Major Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Among antidepressant treatments, ECT stands as the most effective in treating acute
      depression. However, patient concerns with the cognitive side effects of ECT have encouraged
      the development of new and more focal forms of brain stimulation such as transcranial Direct
      Current Stimulation (tDCS). However, not all patients may respond to this treatment in the
      way that it is currently administered and this has raised interest in finding alternative,
      possibly more optimal ways of administering tDCS. This study will investigate whether tDCS
      stimulation using an alternative electrode montage has antidepressant effects. Further
      sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood,
      cognitive test performance and biomarkers will be measured periodically in the duration of
      the trial.
    


Intervention name(s): Eldith Company - direct current stimulator; Eldith Company - direct current stimulator
Intervention type(s): Device; Device
Intervention description(s): Direct current stimulation montage 1.; Direct current stimulation montage 2.
Other intervention name(s): Neuroconn - direct current stimulator; Neuroconn - direct current stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects
Condition: Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      Ceftaroline in a group of patients with renal disease and matching healthy subjects with
      normal renal function
    

Detailed description: 
      An Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline
      After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients
      with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of
      Ceftaroline Fosamil (600 mg)
    

Intervention name(s): 200 mg Ceftaroline fosamil; 600 mg Ceftaroline fosamil
Intervention type(s): Drug; Drug
Intervention description(s): 1 h infusion; 1 h infusion
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Patient Safety; Tolerability; Pharmacokinetics
A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand if ARV-471 affects how a BCRP substrate
      (rosuvastatin) gets into the body in healthy adults.

      All participants in this study will receive one dose of rosuvastatin alone by mouth in Period
      1. In Period 2, everyone will receive one dose of ARV-471 by mouth 90 min before one dose of
      rosuvastatin by mouth. The levels of rosuvastatin in Period 1 will be compared to the levels
      of rosuvastatin in Period 2 to determine if ARV-471 affects how rosuvastatin gets into the
      body differently in healthy adults.

      All participants will stay at the study clinic for 10 days and 9 nights.
    


Intervention name(s): ARV-471; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Experimental; Probe substrate
Other intervention name(s): PF-07850327; CRESTOR®
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safinamide Renal Impairment Trial
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the
      compound in the body) of safinamide in subjects with different degrees of renal impairment in
      comparison to matched subjects with normal renal function.
    


Intervention name(s): 50mg safinamide
Intervention type(s): Drug
Intervention description(s): 50 mg safinamide on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: safinamide; pharmacokinetics; renal impairment; Moderate and Severe Renal Impairment
Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.
Condition: Nevi
MeSH terms: Nevus
Study type: Interventional

Summary: 
      This project is a multicenter study in which we will investigate a dual concept of
      nevogenesis. Study location is the Department of Dermatology at the Medical University of
      Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena),
      Spain (Barcelona) and the United States (New York).

      The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic
      nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular
      pattern, belong to the same spectrum of genetically determined melanocytic proliferations
      that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi,
      dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as
      UV-exposure.
    

Detailed description: 
      The investigations to this study will verify whether small CMN, "early" AMN and dermal nevi,
      characterized by globular pattern differ in their genetic alterations compared to reticular
      typed nevi. It will be expected that globular typed nevi and eventually dermal nevi lack
      B-RAF mutations whereas reticular nevi show alterations in the B-RAF gene. Study location:
      Graz
    

Intervention name(s): To test the frequency of BRAF and NRAS mutations among nevi
Intervention type(s): Genetic
Intervention description(s): Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations
Other intervention name(s): NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dermoscopy; Histopathology; Genetics; Nevi; Nevogenesis
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children
Condition: Glycemic Control; Subjective Appetite
Study type: Interventional

Summary: 
      The purpose of the study is to understand the role chocolate milk compared to a fruit drink,
      with and without exercise, on glycaemic regulation and subjective appetite in children. The
      investigators hypothesize that chocolate milk in combination with exercise will have the
      greatest effect attenuating glycaemic response. Blood glucose will be measured by finger
      prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65
      minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.
    


Intervention name(s): Chocolate Milk; Fruit Drink; Exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Citron(Citrus
      Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.
    

Detailed description: 
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty
      subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a
      placebo group. Blood cholesterol profiles before and after the intervention.
    

Intervention name(s): Citron peel extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Citron peel extract for 12 weeks; Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Patient-Centered Implementation Trial for Single Embryo Transfer
Condition: Male Infertility; Female Infertility; Pregnancy
MeSH terms: Infertility; Infertility, Male; Infertility, Female
Study type: Interventional

Summary: 
      Background: The number of multiple pregnancies is considered to be the most important adverse
      effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or
      ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce
      this incidence remarkably. Unfortunately, former research has documented that cycles with SET
      maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of
      eSET will require a carefully chosen and thoroughly defined implementation strategy focussed
      on the couple undergoing the subfertility treatment. This trial will investigate the
      (cost)effectiveness of a combined patient centred implementation strategy.

      Objective: The main aim is to compare the effectiveness and costs of implementation of
      elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic
      sperm injection (ICSI), between usual care and a combined patient-centred strategy.

      Study design: A randomised controlled trial

      Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment
      in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

      Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The
      strategy consists of counselling through an evidence based decision aid and reimbursement of
      a 4th cycle if couples have chosen for eSET in the first 2 cycles.

      Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes
      and cost-effectiveness of the combined strategy.

      Secondary study parameters/outcome of the study:

        -  patient knowledge

        -  patient decisional conflict

        -  patient satisfaction

        -  IVF/ICSI treatment outcome.
    

Detailed description: 
      see above
    

Intervention name(s): evidence based decision aid; Possible reimbursement 4th IVF/ICSI cycle when necessary
Intervention type(s): Behavioral; Behavioral
Intervention description(s): evidence based decision aid; Potential reimbursement 4th IVF/ICSI cycle when necessary
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Implementation; Single embryo transfer; ICSI; IVF; prevention
Effects of WB-EMS and Protein Supplementation on LBM Maintenance During Intended Weight Loss
Condition: Overweight; Obesity; Abdominal Obesity
MeSH terms: Obesity; Overweight; Obesity, Abdominal; Weight Loss
Study type: Interventional

Summary: 
      The present study aimed to determine the effect of different interventions on lean body mass
      maintenance under weight loss conditions in overweight and obese premenopausal women. Three
      study groups were implemented: (1) Protein supplementation (only) group (2) Protein
      supplementation and walking intervention (3) Protein supplementation, walking and
      WB-EMS-application. All protocols were applied for 16 week of intervention.

      A energy deficit of 500 kcal/d was intended however while group (1) focus consistently on
      energy restriction (500 kcal/d), in group (2) and (3) a combined physical activity (i.e.
      walking with a volume representing 250 kcal/d) and energy restriction (250 kcal/d) protocol
      was applied. Total protein uptake including protein supplementation was calculated to average
      around 1.2 g/kg body mass per day in groups (1) and 1.5 g/kg body mass/d in group (2) and
      (3). WB-EMS was applied 1.5x 20 min/week (i.e. each Tuesday and every second Thursday).

      Primary study endpoint was LBM as determined by Dual Energy x-Ray Absorptiometry.
    


Intervention name(s): Protein; Walking; WB-EMS application
Intervention type(s): Dietary Supplement; Behavioral; Behavioral
Intervention description(s): Protein supplementation 1.2 or 1.5 g/kg body mass/d; Walking with a volume corresponding to 250 kcal/d; WB-EMS application 1.5x 20 min/week
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled parallel group design with 3 study arms
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; electromyostimulation; protein; weight reduction
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the peripheral balloon dilatation catheter
      (trade name: Iris) is safe an effective in PTA procedure.
    


Intervention name(s): percutaneous transluminal angioplasty balloon catheter
Intervention type(s): Device
Other intervention name(s): PTA catheter; trade name: Iris
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
Condition: Glomerulosclerosis, Focal Segmental
MeSH terms: Proteinuria; Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate
      the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21
      subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive
      proteinuria as indicated by a Urinary protein/creatinine Up/c ratio >=2 gram/gram (g/g) or 24
      hr urine protein >=2 g/day. Losmapimod will be orally administered twice daily over a 24-week
      treatment phase followed by a 12-week follow-up for safety and relapse assessments.
    


Intervention name(s): Losmapimod
Intervention type(s): Drug
Intervention description(s): Losmapimod (micronized GW856553X) will be supplied as a film coated white, 7 mm round, biconvex, plain faced, tablet. Oral doses of losmapimod, 7.5 mg (1 tablet) or 15 mg (2 tablets), will be taken twice daily (BID) with food and swallowed whole (not chewed or crushed)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GW856553; Focal segmental glomerulosclerosis (FSGS); p38 mitogen-activated protein kinase (MAPK) inhibitor; losmapimod; nephrotic syndrome
The Effects of Ellagic Acid From Pomegranate Juice vs. Pure Ellagic Acid on Healthy Male Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this research study is to compare the extent of polyphenol absorption in the
      body in normal healthy male volunteers when consuming either pomegranate juice or pure
      ellagic acid, an ellagitannin naturally present in pomegranates. Polyphenols are naturally
      occurring chemicals found in plant based food that serve to reduce inflammation and damage to
      cells. You will be asked to avoid foods rich in polyphenols including dark chocolate and
      cocoa products, dried herbs, berries, coffee, tea, flaxseeds, nuts (chestnut, hazelnut),
      olive and artichoke. Timed urine collections will be used to measure the metabolism of
      polyphenols through the presence and concentration of urolithin and ellagic acid metabolites.
      Additionally, it has been demonstrated in animal studies that fruits and vegetables, which
      are high in antioxidants and fiber, lead to improvement of gut health, inflammation and
      glucose tolerance. However, no information is available about the effect of ellagitanins on
      the gut microbiome (bacteria in the intestines).
    

Detailed description: 
      Based on the limited knowledge about the difference in bacterial metabolism of a mixture of
      ellagitannins, punicalin, punicalagin and EA in PJ compared to pure EA leading to intestinal
      formation of different urolithins (urolithin A, B and iso-urolithin A), the objective of this
      study is to perform a cross over acute bioavailability study of 1-day consumption of either
      PJ or EA. Primary endpoint will be the formation and bioavailability of EA and urolithins.
      Secondary endpoints will be A) effect on the fecal microbiome and B) correlation of urolithin
      formation to the lipid/cholesterol status of the study participants.
    

Intervention name(s): Pomegranate Juice; Ellagic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.; Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.
Other intervention name(s): PJ; EA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Glycemic Index of Table Grape Varietals
Condition: Healthy
Study type: Interventional

Summary: 
      Investigate the postprandial glycemic responses of healthy individuals when consuming
      commercially available table grape varietals or grape juice, compared to a standard amount of
      glucose.
    

Detailed description: 
      The study aims to investigate the postprandial glycemic responses of healthy individuals when
      consuming commercially available table grape varietals, compared to a standard amount of
      glucose. The study also aims to evaluate a new grape varietal, compared to other common table
      grapes, with regard to glycemic index and metabolic response related to inflammation.
    

Intervention name(s): Milano grapes; Table grapes; Grape juice; Glucose beverage
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Milano grapes to test post-prandial glycemic response; Table grapes to test post-prandial glycemic response; Grape juice to test post-prandial glycemic response; Standardized glucose beverage to test post-prandial glycemic response
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents
Condition: Obstructive Sleep Apnea Syndrome; Polycystic Ovary Syndrome; Sleep Apnea
MeSH terms: Polycystic Ovary Syndrome; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Insulin Resistance; Syndrome
Study type: Observational

Summary: 
      Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal
      imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent
      girls and women capable of having children. Polycystic ovary syndrome is associated with
      missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes.
      Girls with polycystic ovary syndrome may have a breathing problem known as "sleep apnea."
      Sleep apnea may cause a person to stop breathing for short periods of time while sleeping.
      People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea
      than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime
      sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The
      purpose of this study is to understand how insulin function is affected in presence of sleep
      apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls
      with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert
      food into energy. In people with increase weight body cannot use insulin properly. The
      investigators also want to see if insulin action is also affected by sleep apnea.
    

Detailed description: 
      See above.
    

Intervention name(s): Nasal Continuous positive airway pressure (CPAP)
Intervention type(s): Device
Intervention description(s): We will initiate treatment of OSA with CPAP for 3 months in PCOS adolescents with moderate to severe OSA. Compliance will be defined as the average number of hours for which CPAP was used per night over the 12-wk treatment period. Adherence with CPAP will be defined as CPAP use ≥4 hours daily. The primary outcome variable will be insulin sensitivity measured as change in GIR. Changes in cardio metabolic variables after CPAP treatment will be expressed as a percentage of the corresponding baseline values.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Girls with PCOS, with and without sleep apnea. Ages 13-21.
      
Biospecimen description: 
      Blood
    
Keywords: insulin function; sleep apnea; girls; PCOS; insulin action
Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      (-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired
      skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.
    

Detailed description: 
      This is a proof-of-concept phase 1/2a pilot and endpoint development study that is designed
      to provide initial evidence of biological activity of (-)-epicatechin. Primary endpoints
      include initial assessment of tissue-specific evidence of efficacy from muscle biopsy
      samples. Secondary endpoints include measures of strength and physical function, and safety
      and adverse event data. Pilot endpoints include assessment of mRNA and miRNA peripheral blood
      profiles and validation of non-invasive near-infrared spectroscopy (NIRS) muscle perfusion
      studies during exercise and a recumbent cycle exercise test that may be employed as endpoints
      in future clinical trials.

      This single center open-label pilot study will enroll 10 adults with genetically-confirmed
      Becker muscular dystrophy, who will receive the purified nutritional extract (-)-epicatechin
      100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the
      study if they meet all inclusion criteria. They will be evaluated at baseline and at
      screening, day 1, and weeks 1, 2, 4 and 8.
    

Intervention name(s): (-)-epicatechin
Intervention type(s): Drug
Intervention description(s): purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.
Other intervention name(s): dietary supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMD; Becker muscular dystrophy; epicatechin; clinical trial; neuromuscular disease