bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in
      the treatment of IBS-D.
    

Detailed description: 
      We have fulfilled our enrollment requirements for this study.

      This study has been designed as a multicenter, randomized, double-blind, placebo controlled
      parallel dose group trial. The study will be open to both women and men. At screening the
      patient will be assessed to see if they meet the Rome III criteria for IBS-D. After
      screening, patients will undergo a 14-day run-in period evaluation, during which eligibility
      to be randomized to drug or placebo will be determined. Patients will complete daily
      telephone diaries during the run-in and double-blind phases of the study. Patients will be
      evaluated at regularly scheduled clinic visits during double-blind phase of the study.

      Patients who complete the study may have the opportunity to rollover to the open-label
      one-year safety study (ARDIS-3).
    

Intervention name(s): Rezular 15mg; Placebo; Rezular; Rezular
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral Tablets; placebo; Rezular 37.5mg 3xday up to 12 weeks; Rezular 75mg 3xday up to 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS, IBS-D, R-verapamil, Arverpamil, Rezular
Glucose-dependent Insulinotropic Polypeptide (GIP) and Lipid Metabolism
Condition: Healthy Subjects
Study type: Observational

Summary: 
      The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in
      combination with insulin affect gastric emptying (GE), appetite, energy intake, energy
      expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol
      in man.
    


Intervention name(s): Incretin hormone - Glucose-dependent insulinotropic polypeptide (GIP)
Intervention type(s): Other
Intervention description(s): two different dosages:
0.8 pmol/kg/min
1.5 pmol/kg/min for 300 minutes
Intervention MeSH terms: Gastric Inhibitory Polypeptide; Hormones; Incretins
Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Glucose-dependent insulinotropic polypeptide; gastric emptying; appetite; energy intake; lipid metabolism
Follow Up of Severely Malnourished Children (FUSAM)
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      The overall objective of the research is to assess the long-term and cost-effectiveness of a
      combined nutrition psychosocial intervention to a stand-alone nutritional treatment of
      children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of
      Nepal.
    

Detailed description: 
      In Nepal, the majority of SAM children are treated with therapeutic food in
      community/home-based care, and little is known about the long-term sustainability of the
      nutritional and health benefits of treatment after rehabilitation. The two treatments will be
      compared in terms of costs of treatment and convened health benefits (child nutritional
      status and development, cured rate and relapse, maternal mental health, and family care
      practices) at both short and long-term periods after admission. The proposed complementary
      psychosocial intervention focuses directly on the key underlying determinants of acute
      malnutrition within children's early years, such as child care practices and stimulation,
      parent-child relationships and maternal mental health. It includes the mother/caregiver as
      patient of psychosocial support, but also empowers her as the key ally in the treatment of
      the undernourished child. Adding a brief psychosocial component to the standard
      medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health,
      and development outcomes of children.
    

Intervention name(s): NUTPSY treatment; NUT treatment
Intervention type(s): Other; Other
Intervention description(s): The psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting.; Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe acute malnutrition; Psychosocial intervention; Child; Stimulation; CMAM; Nepal
A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression
Condition: Depression; Mood Disorder; Bipolar
MeSH terms: Depression; Depressive Disorder; Mood Disorders
Study type: Interventional

Summary: 
      The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of
      depression utilizing platform algorithm products that can allow rapid identification of
      pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may
      have the potential to optimize treatment selection by improving response, minimizing
      unfavorable adverse events / side effects and increasing treatment adherence.
    

Detailed description: 
      Treatment seeking depressed patients (SCID confirmed major depressive disorder or bipolar
      I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this
      study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK
      and PD genetic variation that can potentially impact antidepressant, antipsychotic, and
      stimulant associated treatment outcomes for depression. This study will recruit treatment
      seeking patients with major depression with an index episode of moderate symptom severity
      that has been unresponsive or poorly tolerated to at least one prior antidepressant
      treatment. This will be an 8-week, double-blind trial where depressed patients are randomized
      to testing results of GeneSight® (tricolored clinical report) prior to treatment selection
      (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be
      made available after the 8-week trial.
    

Intervention name(s): AssureRx GeneSight genotyping results; Treatment as usual
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to either genotyping intervention or treatment as usual.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar; Unipolar; Genotyping; Pharmacokinetic; Pharmacodynamic
Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the long-term safety of teriflunomide in multiple
      sclerosis subjects. The secondary objective is to assess the long-term efficacy.
    

Detailed description: 
      Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch
      to teriflunomide for 528 weeks or until teriflunomide is commercially available in the
      country where patient lives;

        -  subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.

        -  subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.

      The total study period per subject is 532 weeks or until teriflunomide is commercially
      available in the country where patient lives, broken up as follows:

        -  Treatment: 528 weeks or until teriflunomide is commercially available in the country
           where patient lives,

        -  Post-washout follow-up: 4 weeks after last treatment intake.
    

Intervention name(s): teriflunomide (HMR1726)
Intervention type(s): Drug
Intervention description(s): tablet, oral administration once daily.
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis Relapsing Remitting; Secondary Progressive; Progressive Relapsing
Alternate Day Buprenorphine Administration, Phase X - 15
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine how subjects will make changes in the amount of
      medication received when given a monetary alternative to buprenorphine.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
A Trial to Evaluate the Efficacy of AB-Life Probiotic Product on LDL-Cholesterol Reduction in Moderate Hypercholesterolemia
Condition: Moderate Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic
      blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.
    


Intervention name(s): Probiotics bacterial strains; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): AB-Life; AB-life
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotics; AB-Life; LDL-cholesterol; Hypercholesterolemia
Thickness of Retinal Layers in Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Observational

Summary: 
      The purpose of this study is to examine retinal layer thickness in amblyopia.
    

Detailed description: 
      Amblyopia is a visual disorder characterized by a reduction of vision that cannot be
      immediately improved by refractive correction or accounted for by clinically determined
      anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes
      with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the
      postnatal maturation of the retina including the postnatal reduction of retinal ganglion
      cells. However, although some studies have found incrased retinal nerve fiber layer thickness
      in amblyopic eyes, others have found no significant differences. This sutdy will examine the
      retinal layer thickness in amblyopia and compare the retinal layer thickness between
      amblyopic eyes and nonamblyopic fellow eyes.
    

Intervention name(s): Optical coherence tomography
Intervention type(s): Other
Intervention description(s): Spectral domain optical coherence tomography will be conducted once when patients are enrolled.
Other intervention name(s): Spectralis Optical coherence tomography
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients in tertiary hospital
      
Keywords: Amblyopia; Retinal layer thickness
A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate
      (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after
      8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.
    

Detailed description: 
      This will be a single centre, eight week, randomized, examiner-blind, three treatment,
      parallel group, stratified study. It will be conducted in healthy participants, with at least
      two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits.
      DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.
    

Intervention name(s): Potassium oxalate; Sodium fluoride; Placebo
Intervention type(s): Device; Drug; Other
Intervention description(s): Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride; Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF); Oral rinse containing 0% KOX and 0 ppm fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Train-of-four Monitoring Using the Tetragraph
Condition: Surgery
Study type: Interventional

Summary: 
      This is a prospective study that will evaluate the feasibility of using the Tetragraph
      Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four
      assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
    


Intervention name(s): Tetragraph (TM) NMT Monitor
Intervention type(s): Device
Intervention description(s): TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effects of Ultrasound Guided Genicular Nerve Block for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Goal: Comparison of the effects of genicular nerve block with usg and physical therapy on
      pain, physical function for patients with knee osteoarthritis.

      Material and Methods:102 patients with osteoarthritis of the knee with Kellgren-Lawrence
      (K-L) class 2 or 3 were included in the study.Patients were randomized to two groups, first
      being injected a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate
      target sites: the superior lateral, superior medial, and inferior medial genicular nerves
      with exercise treatment and second being ten sessions of hotpack as a surface warmer, TENS as
      a analgezic current, ultrasound therapy as a deep warmer with exercise treatment.For the
      first group, the ultrasound we used: 12 MHz linear transducer. (Logic E9-GE, USA).The
      transducer was first placed parallel to the long bone shaft and moved up or down to identify
      the epicondyle of the long bone. The genicular arteries were identified near the periosteal
      areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and
      confirmed by color Doppler ultrasound.Accordingly, GNB target points should be next to each
      genicular artery because the superior lateral, superior medial, and inferior medial genicular
      artery traveled along each genicular nerve. , Visual Analogue Scale for pain(VAS) was primer
      outcome measurement, Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)
      and six minute walk tests were seconder outcome measurements of the study applied before,
      after (two weeks) and 12th weeks of treatment. Primer endpoint of the study is decrease at
      least 40% in VAS values at 2nd week, second endpoint is the improvement in the womac and
      6-minute walk test observed in the 2nd week continues until the 12th week.
    


Intervention name(s): Ultrasound guided genicular nerve block + exercise treatment; Physical therapy + exercise treatment
Intervention type(s): Other; Device
Intervention description(s): This method was used to inject a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves plus exercise treatment; Ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Decentralized Study on Dietary Influences on Cognitive Functions
Condition: Glucose Metabolism; Cognitive Function
Study type: Interventional

Summary: 
      The current study aims to investigate the cognitive effects of diet-induced blood glucose
      fluctuations on cognitive performance in healthy older adults over multiple days, taking
      advantage of the currently available techniques to continuously measure blood glucose levels
      and to assess cognitive performance in a real-life setting.

      In this fully decentralized study, subjects will undergo two times a three-day measurement
      period, where their blood glucose will be continuously measured by a minimally invasive
      sensor and where the cognitive performance is measured at multiple time points throughout a
      day using a short test battery administered on their mobile phone. In addition to receiving
      standardized breakfast and lunch meals, the subjects are administered a low-GI(Glycemic
      Index) or normal-GI(Glycemic Index) snack in the morning and afternoon.
    

Detailed description: 
      The study has two main scientific objectives. First, the investigators aim to investigate the
      acute effect of a low versus high-GI snack taken mid-morning or mid-afternoon on cognition,
      appetite, alertness and mood. To this end the investigators will compare the pre-snack and
      ~2-hour snack measurements of the two snacks. The investigators hypothesize that the
      low-GI(Glycemic Index) snack, due to a blunted and sustained PPGR, leads to better cognition,
      appetite and alertness ratings. Secondly, the investigators aim to explore how daily
      fluctuations in blood glucose are associated with cognition, mood, appetite and alertness in
      healthy older adults. To this end the investigators will conduct exploratory correlational
      analyses between blood glucose parameters, the behavioural outcomes, and subject
      characteristics.
    

Intervention name(s): Intervention; Control
Intervention type(s): Other; Other
Intervention description(s): The low GI snack is a biscuit with a Glycemic Index of 23.8 ± 3.3. The low GI snack contains plain flour, fibre, plant-based protein, vegetable oil and a low GI sweetener.
The interventional snacks (control, experimental) are matched for caloric content.; The normal GI snack is a biscuit with a Glycemic Index of 54.4 ± 6.3. The control snack is formulated using basic ingredients for a biscuit recipe consisting of all-purpose flour, butter, sugar, vanilla flavour, baking soda, egg and salt.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be carried out according to a decentralized, randomized, placebo controlled, double-blind, cross-over design.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of a Probiotic on LDL-cholesterol Levels
Condition: Cardiovascular Diseases; LDL-cholesterol
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in
      reducing LDL-cholesterol levels in healthy individuals.
    

Detailed description: 
      There is a strong correlation between LDL-cholesterol and cardiovascular diseases.

      Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote
      their absorption by the enterocytes. The disruption or alteration of these micelles may
      interfere with the absorption of cholesterol.

      Several intestinal bacteria strains are capable of carrying out numerous biotransformations
      of bile salts during their enterohepatic circulation, such as the hydrolysis of the
      conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the
      cholesterol-lowering activity of these probiotic strains is that, due to the greater bile
      salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore,
      the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may
      also increase the excretion of bile acids in the stool, possibly by binding or absorbing
      them. This increase in fecal secretion of bile acids would require an increase in the hepatic
      catabolism of cholesterol for the synthesis of bile acids. All these processes may help to
      reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal
      milk with QPS category that presents a high hydrolase activity that exceeds in more than 20%
      the activity of other reference strains.
    

Intervention name(s): Bifidobacterium BSL_PS404; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Each participant will consume 1 capsule daily at lunch for 8 weeks.; Each participant will consume 1 capsule daily at lunch for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: LDL-cholesterol; Probiotics
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
Condition: Evaluation of a Rotavirus Vaccine
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The
      study will examine the safety and immunogenicity of this vaccine first in healthy South
      African toddlers. If the safety profile is deemed appropriate, the study will continue to
      explore the safety and immunogenicity of the vaccine in healthy South African infants.

      The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and
      well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that
      the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an
      immune response in at least 80% of participants in at least one of the study groups.
    


Intervention name(s): P2-VP8 Subunit Vaccine 10mcg; P2-VP8 Subunit Vaccine 30 mcg; P2-VP8 Subunit Vaccine 60mcg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): 10 mcg; 30 mcg; 60 mcg
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention