bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline
Condition: Mild Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Purpose: The purpose of this study is to examine the effect of blueberry consumption on
      cognitive decline and body composition in humans.

      Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an
      improvement in cognitive abilities as measured by a standardized battery of tests, relative
      to those who consume a placebo.

      Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an
      increase in processing speed and an improvement in memory abilities as measured in an
      electrophysiological paradigm and compared to those who consume a placebo.

      Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition
      (fat mass vs. lean mass).

      Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress
      and inflammatory markers.
    


Intervention name(s): Freeze-dried blueberries; Dextrose Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Wild blueberries, freeze-dried and pulverized; Placebo developed to closely match blueberry powder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Spread and Course of COVID-19 Infections
Condition: Covid-19; Virus Disease
MeSH terms: COVID-19; Virus Diseases
Study type: Observational

Summary: 
      The overall goal is to study the immune response to SARS-CoV-2 infection over the period of
      one year in the blood of a representative cohort of ETH students/employees.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The cohort consists of initially healthy volunteers, all employees or students of ETH.
        Inclusion into the longitudinal study will be carried out in strict response to the STOP
        safety concept of the Safety, Security, Health and Environment administrative department of
        ETH.
      
Biospecimen description: 
      CTG tubes
Status Asthmaticus on the Intensive Care Prospective - STATIC PRO
Condition: Childhood Asthma With Status Asthmaticus
MeSH terms: Asthma; Status Asthmaticus
Study type: Observational

Summary: 
      This study will prospectively assess the impact and relevance of several risk factors for
      children with severe acute asthma (SAA) or acute wheeze that have been identified in
      retrospective studies. Secondary we will assess short-term medical and psychosocial
      functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control
      group admitted to a MC for SAA/acute wheeze.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 2-18 years admitted to a Medium Care or Paediatric Intensive Care Unit in the
        Netherlands, with a diagnosis of acute wheeze or SAA.
      
Keywords: Short-term medical and psychosocial functioning
Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      BACKGROUND:

      Molluscum contagiosum is a non-serious children viral infection. Because of its natural
      history, being highly contagious and the aesthetic and psychotherapeutic effects of its
      treatment, the investigators intend to test the use of different concentrations of potassium
      hydroxide solution in the primary care setting.

      METHODS:

      A double blind, randomized clinical trial, in three groups of topic treatment is designed.
      The intended treatment consists on a daily application of potassium hydroxide in aqueous
      solution at 10% and 15% concentration, versus a placebo administered to the control group. 4
      follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and
      tolerance.

      The main target of the trial is to determine the healing rate, defined as lesion
      disappearance in the affected zones after the topic application of the treatment. Secondary
      targets are the main characteristics and evolution of the affected zone (surface, number of
      lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching,
      burning, pain), recurrence rate estimation and natural evolution of lesions in the control
      group.
    


Intervention name(s): Hydroxide Potassium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment will consist of the application of topical 10% or 15% KOH in an aqueous solution for the two treatment groups, compared to a placebo-treated control group. Topical Application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Potassium hydroxide.; Molluscum Contagiosum
Influence of Hydration and Functional Aerobic Capacity on the Nonlinear Dynamics of Heart Rate in Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to analyze the influence of hydration and functional aerobic
      capacity in young and healthy individuals on non-linear heart rate dynamics as a technique
      that favor faster and more efficient recovery cardiac autonomic modulation.
    


Intervention name(s): water; aerobic activity
Intervention type(s): Other; Other
Intervention description(s): hydration with mineral water in 10 equal portions, administered at regular intervals from the 15th minute of exercise until the end of the recovery period.; aerobic activity
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; hydration; non-linear dynamic; Autonomic nervous system
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary trial objective is to determine the clinically effective dose of orally
      administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with
      acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa.
      Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA
      and to explore possible ethnic differences in safety or efficacy.
    

Detailed description: 
      This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the
      efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1
      weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum
      malaria. Patients will be recruited from 5 to 7 study sites in endemic regions of South East
      Asia and Africa and will be randomized to 1 of 3 treatment groups differing in dosage, with
      160 patients per group (n-480). Randomization will be balanced within each study site across
      all 3 study groups in pre-assigned treatment blocks.

      The first dose will be administered on Day 0 and patients will remain hospitalized for at
      least 4 days whilst undertaking the 3-day regimen. Patients will remain near the study site
      for a minimum of 7 days or once fever and parasite clearance is confirmed (assessed by 3
      negative readings of fever and/or slide).

      The primary efficacy end point is the cure rate on Day 28 - the proportion of patients with
      PCR-corrected adequate clinical and parasitological response (ACPR). Despite this Day 28 end
      point, the relatively long half-life of pyronaridine necessitates follow-up until Day 42. In
      the case of adverse events reported and unresolved at Day 42, patients will be followed up
      for a further 30 days, or until resolution of the event.
    

Intervention name(s): pyronaridine/artesunate
Intervention type(s): Drug
Intervention description(s): Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.
Other intervention name(s): Pyramax
Intervention MeSH terms: Artesunate; Pyronaridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: malaria; antimalarial; artemisinin based combination therapy (ACT); pyronaridine artesunate (Pyramax)
Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study
      in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl
      peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate
      the safety of GI148512 when applied topically once daily for 12 weeks.
    

Detailed description: 
      Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global
      Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial
      inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions
      (open and closed comedones), including nasal lesions. The primary objective is to demonstrate
      the superiority of GI148512 to vehicle gel in total lesion counts. The secondary objectives
      are to demonstrate the superiority of GI148512 to vehicle gel in inflammatory lesion counts,
      and to evaluate the efficacy of GI148512 compared with vehicle gel at each visit. A total of
      360 subjects will be enrolled and randomly assigned to one of the groups.
    

Intervention name(s): GI148512; vehicle gel
Intervention type(s): Drug; Drug
Intervention description(s): GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg; Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)
Other intervention name(s): Benzoyl Peroxide 3% Gel
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inflammatory lesion; Benzoyl peroxide (BPO); once daily; acne vulgaris; vehicle gel; clindamycin (CLDM) 1%-BPO 3% gel; non-inflammatory lesion
N-Acetyl Cysteine After Cervical Cerclage
Condition: Cervical Cerclage
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy
      outcome in women undergoing cervical cerclage for cervical insufficiency.
    

Detailed description: 
      A randomized controlled clinical trial to be carried out in a university-affiliated tertiary
      center.Participating women will be randomized into two groups: Group A will be given an oral
      daily dose of 0.6 g of NAC in effervescent form; group B, serving as controls, will not
      receive NAC.The two groups will then be compared according to pregnancy outcome.
    

Intervention name(s): N-Acetyl Cysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
Other intervention name(s): placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: N-acetyl cysteine (NAC); Cervical cerclage; cervical cerclage for cervical insufficiency
Stimulating the Brain to Improve Self-Awareness
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study investigates whether Introspective Accuracy (IA) can be improved in individuals
      with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation
      (tDCS).
    

Detailed description: 
      Self-awareness is markedly impaired in severe mental illness including schizophrenia and
      schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in
      the estimation of abilities and capabilities, which we refer to as introspective accuracy
      (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders,
      specifically in the abilities to retrospectively judge everyday functioning and
      neurocognitive impairment, as well as the ability to make correct real-time judgments of
      performance on neurocognitive tests.

      Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation
      which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in
      healthy adults has been demonstrated to improve cognitive and memory performance, and in
      schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears
      to be a promising therapeutic technique that may be useful for improving IA. This study will
      compare IA performance in individuals with schizophrenia across two conditions: active anodal
      tDCS and sham tDCS.
    

Intervention name(s): active anodal tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): active anodal tDCS with behavioral tasks to assess IA; sham tDCS with behavioral tasks to assess IA
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Oxytocin and Emotion Processing
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether oxytocin influences emotional processing
      and learning of emotional and social stimuli.
    

Detailed description: 
      An effect of OXT on emotion processing and anxiety has been broadly investigated in animal
      studies. However, in humans, effects seem more complex.

      The rationale of the study is to examine direct effects of OXT to processing and learning of
      emotional and social values in humans.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries
Condition: Wound Healing; Cell Proliferation; Gene Expression
Study type: Interventional
Phase: Phase 4

Summary: 
      In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the
      gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a
      role during cell proliferating processes.The aim of this study is to investigate the
      molecular effect of Dexpanthenol on human living skin, during wound healing.
    


Intervention name(s): Dexpanthenol (BAY81-2996); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.; Test product and the respective placebo will be applied to previously wounded test areas and the surrounding skin (approx. 3 cm2). After a certain time the second skin biopsy will be taken from the treated test areas. The skin biopsies will be analysed via micro array.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Wound healing; Cell proliferation; Gene expression
Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a
      single oral drug. The purpose of this study is to assess the safety and effectiveness of two
      doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when
      added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a
      sulfonylurea alone.
    


Intervention name(s): vildagliptin; Glimepiride; LAF237 placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glimepiride 4 mg qd
Intervention MeSH terms: Glimepiride; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Sleep, Fatigue, and Dexamethosone in Children With Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the relationship between dexamethosone (steroid)
      and children's sleep and fatigue.
    

Detailed description: 
      Approximately 134 children and adolescents will be enrolled. All children and adolescents
      will wear a wrist actigraph for two consecutive 5-day study periods. Children and adolescents
      will have blood drawn 2 times on Day 1 when they are on dexamethosone. Their parents will
      complete a sleep diary and fatigue questionnaire by telephone on Days 2 and 5 of both study
      periods.
    

Intervention name(s): Dexamethosone
Intervention type(s): Drug
Intervention description(s): 10 day study cycle: 5 day observation pre-steroid,5 day observation post-steroid
Other intervention name(s): Mestinon
Intervention MeSH terms: Pyridostigmine Bromide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Adverse Effect; Pediatric Cancer
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of various degrees of renal function on the
      pharmacokinetics and safety of ALKS 5461.
    


Intervention name(s): ALKS 5461
Intervention type(s): Drug
Intervention description(s): Single dose, given orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALKS 5461; Alkermes; Samidorphan; Renal Impairment; Pharmacokinetics; Buprenorphine
A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®)
      listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided
      by Dongguan Dongyang Sunshine Biopharmaceutical R&D Co., Ltd. (RD15003) pharmacokinetics and
      pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence
      of test drugs and control drugs.
    


Intervention name(s): Insulin degludec injection, RD15003; Insulin degludec, Tresiba
Intervention type(s): Biological; Biological
Intervention description(s): single dose, s.c. injection; single dose, s.c. injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation
Condition: Smokers
Study type: Interventional

Summary: 
      Background: Pharmacological strategies to improve smoking cessation have been largely
      studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in
      tobacco cessation has not yet been demonstrated.

      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine
      replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52
      weeks.

      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334
      patients. Analysis will follow intention-to-treat principle.

      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year
      before randomization will be included.

      All of them will receive nicotine replacement therapy with patches and gum. They will be
      randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first
      six weeks of the treatment. Every two weeks all of the patients will be evaluated by a
      physician in order to access any adverse effects from the nicotine replacement.

      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.
      Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco
      cessation, relapses episodes and abstinence maintenance.
    


Intervention name(s): Cognitive behavioral therapy in group; Nicotine replacement
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: behavior cognitive therapy; Smokers; randomized clinical trial