bioihbjkbjnl/mcl2 huggingface dataset:
Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women
Condition: Nervous System Effects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate possible effects of radio frequency
      electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in
      the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive
      performance measures in test of selective attention, divided attention and working memory in
      healthy elderly females (60 - 80 years).
    

Detailed description: 
      To investigate possible effects of radio frequency electromagnetic fields on EEG activity
      during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG
      potentials, auditory evoked potentials) and cognitive performance measures in test of
      selective attention, divided attention and working memory in healthy elderly females (60 - 80
      years).

      Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h
      during the night and for the whole duration of the test session during the day. Exposures
      will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure
      three times in addition to an adaptation/screening night and day to learn the test.

      The results have to be discussed in the context of possible health risks resulting from RF
    

Intervention name(s): Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: non-ionizing radiation
A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety and tolerability of sitagliptin 100
      mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus
      with inadequate glycemic control on metformin.
    


Intervention name(s): Sitagliptin 100 mg/simvastatin 40 mg FDC; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks; Participants will continue pre-study dose of metformin tablet(s) >=1000 per day
Other intervention name(s): MK-0431D; Fortamet®; Glucophage®; Glucophage® XR; Glumetza®; Riomet®; Metgluco®; Glycoran®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
Condition: Endothelial Dysfunction; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The importance of Aldosterone for endothelial function and Insulin resistance observed within
      patients with type 2 diabetes
    


Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention MeSH terms: Eplerenone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endothelial dysfunction; Insulin resistance; Type 2 diabetes; Mineralocorticoid blocker
Healthy Infant Development Project - Sucrose Component
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain
      threshold. The opioid system is involved in sucrose's ability to reduce pain and distress
      during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and
      sucrose analgesia. In order to compare response to pain and sucrose during heel stick in
      neonates with and without iron deficiency, healthy full-term Chinese infants were randomized
      to receive sucrose or water by syringe beforehand, in conjunction with heel stick for
      metabolic screening.
    


Intervention name(s): Water; Sucrose
Intervention type(s): Other; Other
Intervention description(s): 2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick; 2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will
      be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat
      meal.
    

Detailed description: 
      The pharmacokinetics and safety of single oral dose of DWN12088 in healthy adults will be
      compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat
      meal.
    

Intervention name(s): Diet A group; Diet B group; Diet C group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fasting + DWN12088 200 mg; 30 minutes after a high-fat meal + DWN12088 200 mg; 2 hours after a high-fat meal + DWN12088 200 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modulation of Immunity by Hormonal Contraceptives
Condition: Contraception
Study type: Observational

Summary: 
      Clinical study to determine if hormonal contraceptive use effects cells that fight infection
      (i.e., immune cells).
    

Detailed description: 
      Feminization of the HIV pandemic is impetus for better understanding of the risk factors
      promoting male to female sexual transmission. One putative risk factor is hormonal
      contraceptive use. Our laboratory recently reported that dendritic cell activation,
      virus-specific T cell expansion, and memory T cell development were impaired among female
      mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of
      mucosal tissue, and we now are enrolling women into a clinical investigation exploring the
      immunomodulatory effects of several common hormonal contraceptive forms. Completion of this
      research will provide important comparative evaluation of the capacity of these drugs to
      modulate host defenses combating genital tract infection, eventually supplying healthcare
      providers more informed recommendations regarding appropriate hormonal contraceptive choices
      among women at risk for acquisition of HIV.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women seeking to initiate use of an oral contraceptive, depot-medroxyprogesterone acetate,
        or Mirena.
The Food Phone Project
Condition: Comparison of Energy Intake Methods
Study type: Observational

Summary: 
      The Primary Aim of the project is to modify the RFPM for adolescents and to address the
      concerns identified by the reviewers of the first grant application. We will then test the
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.
    

Detailed description: 
      The Primary Aim of the project is to modify the RFPM for adolescents and to address the
      concerns identified by the reviewers of the first grant application. We will then test the
      RFPM's validity (accuracy) compared to the validity of pen-and-paper food records. Our
      experience and the literature indicate that the RFPM is acceptable and feasible in school
      settings. Following modification of the RFPM and pilot testing with 4 adolescents, we will
      test the reliability and validity of both the RFPM and food records when used by 60
      adolescents (12 to 18 years of age). During one week, participants will use the RFPM and
      during another week they will use food records (the order will be balanced across
      participants). The accuracy of each method will be examined by comparing energy and nutrient
      intake (collectively referred to as food intake or FI) to three gold standards: 1) doubly
      labeled water or DLW (energy intake only, or EIDLW), 2) a laboratory-based test meal
      (FILaboratory), and 3) food intake during lunch in a school cafeteria (FISchool).
      User-satisfaction and participant burden will also be compared between methods, and a
      cost-effectiveness analysis will determine if and under what conditions one method is more
      cost-effective than the other.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        50 adolescents will be recruited.
      
Biospecimen description: 
      Urine collection as part DLW procedure.
    
Keywords: Energy Intake
Efficacy of IARULIL® in the Treatment of Recurrent Cystitis Refractory to Escherichia Coli Extract
Condition: Recurrent Cystitis
MeSH terms: Escherichia coli Infections; Cystitis; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of Combined Intravesical Therapy With
      Hyaluronic Acid and Chondroitin Sulphate in the Treatment of Recurrent Cystitis Refractory to
      Escherichia Coli Extract
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of combined intravesical therapy with
      hyaluronic acid and chondroitin sulphate(IARULIL®) in the treatment of recurrent cystitis
      refractory to oral Escherichia Coli extract(Uro-Vaxom®) and the change of urinary tract
      infection symptoms after intravesical instillation treatment with IARULIL®.
    

Intervention name(s): hyaluronic acid and chondroitin sulphate
Intervention type(s): Drug
Intervention description(s): IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd~5th month:once a month)
Other intervention name(s): IALURIL®
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recurrent cystitis; hyaluronic acid; chondroitin sulphate
Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the influence of pantoprazole on the pharmacokinetic
      profile of cladribine, especially in terms of extent of absorption of cladribine since
      pH-modifying drug may potentially affect the stability of cladribine and thereby its
      bioavailability
    


Intervention name(s): Cladribine; Pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive two single doses of 10 mg cladribine orally in either first or second intervention period followed by a washout period of 10-25 days.; Subjects will receive a pantoprazole 40 mg orally for 2 consecutive days either in first or second intervention period.
Intervention MeSH terms: Cladribine; Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess the degree of artemisinin resistance in adult and pediatric
      subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study
      treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).
    

Detailed description: 
      Data generated by this study will provide a snapshot of the current situation regarding P.
      falciparum sensitivity to ACTs in Western Kenya. By having subjects in one of the study arms
      receive artesunate and then the partner drug after completion of the artemisinin phase will
      enable the accurate evaluation of the artemisinin derivative without the confounding
      influence of the partner drug. Sequential administration of the components of an ACT drug is
      recognized by the WHO as one of the ways in which ACTs can be administered. There will be
      close follow-up of the subjects throughout the duration of the study, and as such, subjects
      who fail to respond adequately will receive prompt rescue treatment. Since it is largely
      expected that most subjects in Western Kenya will have satisfactory responses to ACTs, data
      from this study will provide baseline information regarding parasite characteristics when
      compared to data from Thailand, an area that has reported resistance to ACTs. This, in turn,
      will potentially enable the identification of key markers, both in the host and the parasite,
      that may assist in the early detection of resistance, and also to better understand the
      development of resistance to ACTs. As such, the data generated from this study, both on its
      own and when compared to and pooled with data from similar studies that will be conducted in
      Peru and Thailand, will potentially inform both local and international policy regarding ACT
      use for the treatment of uncomplicated P. falciparum malaria.
    

Intervention name(s): Artesunate; Artemether Lumefantrine; Mefloquine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): AS; AL; MQ
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Mefloquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; P. falciparum mono infection; Early Treatment Failure; Late Treatment Failure
Body Fat Distribution and Fat Metabolism
Condition: Obesity; Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The primary purpose of the study is to examine the effect of body fat distribution on the
      physiological response to a dietary fat intervention. Physiological response will be
      evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).

      Secondary objectives are targeted protein production (apoB and adiponectin). Examination of
      the effect of chain length of the dietary fatty acids on fat tissue characteristics and the
      effect of chain length on satiety, will be studied as well.
    

Detailed description: 
      Rationale: The increased prevalence of obesity and the related risk for metabolic diseases
      have resulted in increased interest in prevention of obesity through life-style
      interventions. The site of fat storage (visceral or subcutaneous) is considered to be
      relevant in terms of risk for metabolic disorders. The type of fat consumed may determine
      storage in either fat storage site and hence be related to metabolic disorders. Long-chain
      fatty acids have been suggested to be preferentially targeted to subcutaneous fat, whereas
      medium chain fatty acids may preferably be targeted to the visceral fat depot.

      Objective: The primary objective is to examine the effect of body fat distribution on the
      physiological response to a dietary fat intervention. Physiological response will be
      evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance), targeted protein
      production (apoB and adiponectin) and satiety.

      Study design: The study is designed as a randomized, double-blind, cross-over trial. Two
      treatments will be supplied for three weeks, with a wash-out period of at least 3 weeks
      in-between.

      Study population: Twelve apparently healthy overweight/obese men (30-60 years of age) with a
      BMI of 27-35 kg.m-2 (6 upper body obese (high WHR) en 6 lower body obese (low WHR)).

      Intervention: Three weeks intervention with a fat replacement containing long chain fatty
      acids and three weeks intervention with a fat replacement containing medium chain fatty
      acids. The margarines will replace the normally consumed margarine. Consumption will take
      place with breakfast, lunch and dinner.

      Main study parameters/endpoints: On the last day of each treatment period subjects will come
      to TNO for evaluation of the effect of the dietary intervention on fat metabolism and fat
      tissue. This will be examined with stable isotope techniques and fat biopsies of subcutaneous
      fat. At baseline subjects will have a total body scan in the MRI to characterize body fat.
    

Intervention name(s): Long-chain (C18:2) and medium chain fatty acid (C8 and C10).
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Basic Science
Oral Androgens in Man-4: (Short Title: Oral T-4)
Condition: Contraception
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The protocol was designed to address the hypothesis that oral testosterone enanthate plus
      dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In
      addition, we will compare the gonadotropin suppression mediated by a dose of testosterone
      enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in
      the normal range throughout the day, with the same dose (800 mg once daily) administered once
      daily. This larger once-daily dose is expected to result in a higher peak and lower trough by
      the end of the dosing interval
    

Detailed description: 
      This study will be carried out in a double-blinded fashion, so neither the subject nor the
      investigator will be aware of treatment assignment during the study. This protocol is
      designed to address the hypothesis that oral testosterone enanthate plus dutasteride can
      suppress the secretion of LH and FSH after four weeks of administration. In addition, we will
      compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg
      twice daily) that would be expected to maintain the serum testosterone in the normal range
      throughout the day, with the same dose (800 mg once daily) administered once daily. This
      larger once-daily dose is expected to result in a higher peak and lower trough by the end of
      the dosing interval. Secondary endpoints in this study include the ability of oral
      testosterone enanthate plus dutasteride to maintain short-term androgen-mediated endpoints
      such as mood and sexual function over the 4-week treatment period as well as weekly measures
      of safety, including blood counts, PSA and liver and kidney function.
    

Intervention name(s): Testosterone Enanthate; Testosterone Enanthate; Dutasteride; placebo sesame oil; Dutasteride
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): Oral Testosterone 400 mg orally for 28 days; Oral Testosterone 800 mg orally for 28 days; dutasteride 0.5 mg orally, once daily for 28 days; placebo sesame oil; 24.5 mg po once (Day 0)
Other intervention name(s): Delatestryl; Delatestryl; Avodart; Avodart
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oral Contraception for Men; Contraceptive agent
Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders
Condition: Infertility; Premature Ovarian Failure
MeSH terms: Infertility; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist
      protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian
      stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes
      compared to the flare up protocol in this group of patients.
    

Detailed description: 
      Poor responders are women who fail to respond effectively to the usual gonadotropin
      stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is
      the principal factor of poor ovarian response. Several strategies have been proposed for the
      management of poor responders, including flare up GnRH agonist regimens and the GnRH
      antagonist, which presents a new hope in this group of patients.

      Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment
      cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or
      flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy
      rates in the two treatment groups.
    

Intervention name(s): Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands); Arvekap 0.1mg (Triptorelin, Ipsen, France)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Triptorelin Pamoate; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: poor responders; GnRH antagonist; GnRH agonist; flare up; short protocol