bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The study aims to determine the effects of dynamic flex cast with neurodevelopmental
      treatment on gross motor functions and gait in children with cerebral palsy.
    

Detailed description: 
      The study aims to determine the effects of dynamic flex cast with neurodevelopmental
      treatment on gross motor functions and gait in children with cerebral palsy. Combination of
      Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to
      improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous
      studies. It will help in facilitating children to perform their activities, restoring normal
      ranges and treatment of spasticity in cerebral palsy.
    

Intervention name(s): Dynamic flex cast with neurodevelopmental treatment; Rigid Ankle foot Orthosis with neurodevelopmental treatment
Intervention type(s): Other; Other
Intervention description(s): Neurodevelopmental therapy in combination with dynamic flex cast to treat experimental group.
Three times a week, 1 hour session per day.
Dynamic flex casting is casting which manipulate bone alignment and maintains range of motion or sustained stretch. Casting will be changed weekly for 3 months.
Neuro developmental approach is individualized treatment which is attuned to each child's specific problems, aims and goals.
Key elements in NDT are: facilitation (using sensory inputs to improve motor performance), management of compensatory motor behavior, and an overall management strategy (a 24-hour interdisciplinary management approach) NDT involves task specific postures and movements.; Rigid ankle foot orthosis will be applied to ankle joint at the start of intervention.
Neurodevelopmental treatment will be applied to both groups with protocol; Three times a week, 1 hour session per day.
Assessment on 1st day,6th week and 12th week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankle joint; Cerebral Palsy; Spasticity; Dynamic cast
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Condition: Coronary Arteriosclerosis; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel
      75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of
      study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous
      coronary intervention (PCI) with placement of a stent, performed to treat acute coronary
      syndrome (ACS).
    


Intervention name(s): prasugrel 10 mg; clopidogrel; prasugrel placebo; prasugrel 60 mg; clopidogrel placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg tablet taken orally; 75 mg tablet taken orally; oral, as blinding mechanism.; 60 mg (six 10-mg tablets) taken orally; oral, as blinding mechanism
Other intervention name(s): LY640315; Effient; Efient; Plavix; Clopilet; Clavix; LY640315; Effient; Efient
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of NTX-101 in Korean Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blinded, placebo controlled, multiple dose, randomized, single site, phase 1
      clinical trial to evaluate safety, tolerability, and pharmacokinetics of NTX-101 topical eye
      drop in Korean healthy volunteers
    


Intervention name(s): NTX-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eye drops, topical administration; Placebo as eye drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ophthalmic Solutions; Eye Drops; Eye Diseases; Ischemic Optic Neuropathy; Glaucoma
Combining Varenicline and Naltrexone for Smoking Cessation
Condition: Nicotine Dependence; Alcohol Use Disorder
MeSH terms: Alcoholism; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, randomized clinical trial using a two group medication design
      consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1
      mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking
      daily smokers who want to quit smoking and reduce drinking.
    

Detailed description: 
      This study is a double-blind, randomized clinical trial using a two group medication design
      consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1
      mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking
      daily smokers who want to quit smoking and reduce drinking. All participants will be daily
      smokers (≥ 5 cig/day) who are also heavy drinkers according to the National Institute on
      Alcohol Abuse and Alcoholism (NIAAA) guidelines: for men, > 14 drinks per week or ≥ 5 drinks
      per occasion at least once per month over the past 12 months; for women, > 7 drinks per week
      or ≥ 4 drinks per occasion at least once per month over the past 12 months. A total of 274
      participants will be randomized, 137 to each medication group.
    

Intervention name(s): Varenicline; Varenicline plus Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline 1 mg twice daily; Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily
Other intervention name(s): Chantix; Chantix; Revia
Intervention MeSH terms: Naltrexone; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
Condition: Tobacco Use Disorder; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility of using e-cigarettes as a method for
      harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking
      outcomes. Participants will be randomized to receive either e-cigarettes with nicotine
      cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.
    

Detailed description: 
      This pilot study will be a two-arm, randomized controlled trial. The investigator will
      randomize 40 participants into each intervention arm. Participants will be randomized to one
      of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo
      cartridges (0mg). Participants and research assistants will be blind to the allocation of
      nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist
      emitted from the e-cigarettes with and without nicotine containing cartridges. Participants
      will be asked to track their nicotine use via text message. All participants will receive a
      20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors
      will review each participant's smoking pattern and offer tailored behavioral and
      environmental change strategies including specific smoking reduction strategy options.
      Participants will be given a supply of e-cigarettes and followed for 3 weeks
    

Intervention name(s): e-cigarettes
Intervention type(s): Device
Intervention description(s): Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: smoking; cigarettes
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this pilot study is to determine the safety and efficacy of risperidone for the
      treatment of anorexia nervosa.

      Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image
      distortion and Eating Disorder Inventory -2 scores than subjects on placebo.

      Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body
      weight sooner than controls.
    

Detailed description: 
      The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with
      early promising findings in case reports (Risperidone and Olanzapine) and one open study of
      olanzapine have led to increased use of these medications for individuals with AN. This
      double-blind placebo controlled study of risperidone will attempt to determine if risperidone
      is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of
      time required to reach and maintain at or about 90% Ideal body weight. The safety of
      risperidone in this population will also be examined through monitoring of Extrapyramidal
      Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes
      and other blood chemistry. Other possible variables which may mediate the recovery process or
      be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.
    

Intervention name(s): Risperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.; Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
Other intervention name(s): Risperdal; placebo - inactive pill
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Risperidone; Atypical Neuroleptics; Dopamine; Leptin; Body Image; Adolescents
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this research is to measure daytime open-eye response to wearing of narafilcon
      B lenses.
    


Intervention name(s): narafilcon B; Polymacon; Lotrafilcon A; Spectacles
Intervention type(s): Device; Device; Device; Other
Intervention description(s): test product; marketed product; marketed product; None - subject used own spectacles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Pyrazinamide Plus Allopurinol in Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bactericidal activity against Mycobacterium
      tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and whole
      blood bactericidal activity (WBA) will be measured in healthy volunteers following
      administration of pyrazinamide alone and in combination with allopurinol.
    

Detailed description: 
      The whole blood bactericidal activity (WBA) assay is an ex vivo model for measuring the
      combined effects of administered drugs, host factors and strain factors on mycobacterial
      sterilisation. If performed in parallel with PK measurements, the method can be used to
      evaluate the effect of drugs throughout the dosing cycle. The aim of this trial is to assess
      the WBA activity and PK data of pyrazinamide and its metabolites boosted with allopurinol in
      healthy volunteers.
    

Intervention name(s): Pyrazinamide; Allopurinol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pyrazinamide; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms
Condition: Gastrointestinal Symptoms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to investigate the dose response effect of Bifidobacterium
      lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.
    


Intervention name(s): Bifidobacterium lactis HN019; Bifidobacterium lactis HN019; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days; Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days; Placebo, once a day for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of the study is to determine if resistant starch reduces the 2 hour
      glycemic response as measured by positive incremental area under the blood glucose response
      curve (Positive iAUC- ignores area below fasting). Secondary endpoints include insulin iAUC,
      glucose and insulin net incremental AUC (net iAUC), time point of peak rise (T max) of
      glucose and insulin, and glucose and insulin concentrations at each time point (C max).
    

Detailed description: 
      This is a single-center randomized, single-blinded, cross-over design study to allow for
      three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing
      different amounts of resistant starch. The study will evaluate acute glucose and insulin
      response in healthy men and women aged 20-45 years.

      The trial will initiate with record collection to assess background general health (screening
      visit) and dietary intake followed by counseling to follow a relatively low polyphenolic
      beverages/foods diet, and high fiber containing food (particularly fermentable) which will
      commence at least 3 days before randomization (washout) and continue for the duration of the
      study. After 3-day washout period, subjects will be randomized to treatment order within
      Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the
      consumption of cereal bars will be determined by blood collections via venous catheter. Blood
      samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and
      15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and
      insulin concentrations in the plasma. The primary endpoint is glucose positive incremental
      area under the curve (positive iAUC- ignores area below fasting) among the three tests bars.
      Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin
      net incremental AUC (net iAUC). Adverse events also will be collected and frequency
      tabulated.
    

Intervention name(s): Cereal Bar no fiber; Cereal bar with 10 g fiber; Cereal bar with 20 g fiber
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Cereal Bar no fiber; Cereal bar with 10 g fiber; Cereal bar with 20 g fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Cereal bar; Fiber; Resistant Starch; Glycemic Response; Insulin Response
A Single Dose Study of LY3023703 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study of LY3023703 in healthy participants. The purposes of this study are
      to look at safety, how well the study drug is tolerated, how much of the study drug gets into
      the blood stream, and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Participants will
      remain in the study for approximately 3 months. This study is for research purposes only and
      is not intended to treat any medical condition.
    


Intervention name(s): LY3023703; Placebo; Celecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Strength Training Adaptations, Age and Genes
Condition: Healthy
Study type: Interventional

Summary: 
      The study investigates the effect of maximal strength training on muscular strength and power
      in different age groups from 20 to 80 year old. It also relates the training adaptations to
      different known genes such as angiotensin I-converting enzyme (ACE) and Alpha-actinin-3
      (ACTN3). Participants will complete an eight weeks, three times per week training
      intervention of maximal strength training with a pre-post design. In addition, blood samples
      will be collected for the analyses of genetic variances.
    

Detailed description: 
      Aim: The study aims to investigate the effect of age and genes on training adaptations to a
      maximal strength training intervention.

      Methods: Participants will be recruited through invitations at work places and other
      community arenas. The investigators aim to recruit 10-15 subjects in each of the following
      age groups: 20-29, 30-39, 40-49, 50-59, 60-69 and 70-80 years of age. Both genders will be
      included. All age groups will be matched for age-related baseline maximal strength and
      distribution between the two genders. All participants will be checked via a health
      registration scheme, and excluded if contra indications for hard physical training or testing
      should appear. When in doubt, the projects physician will decide on inclusion or exclusion
      due to a thorough examination. Subjects will give a blood sample to be analyzed for known
      genes such as ACE and ACTN3. The intervention has a pre- post design. Tests of maximal
      strength and power will be conducted in a leg-press machine, using the protocol assessing one
      repetition maximum (1RM) previously described. Force and Power will be measured by the Muscle
      Lab system from Ergotest Tech. (Langesund, Norway). The intervention is an eight week, three
      times per week protocol, each training session consisting of a standardized warm-up, and 4
      repetitions x 4 sets with an intensity of 4 repetition maximum (4RM) performed in the leg
      press machine.There will be a three minutes pause between sets. Participants will be given
      instructions and supervision.

      Hypothesis: Maximal strength training adaptations will be affected by age and baseline
      maximal strength but not by gender or genetic variations.
    

Intervention name(s): Strength training
Intervention type(s): Behavioral
Intervention description(s): see arm description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: health; muscle strength; exercise genomics
Evaluation of Carbohydrates Part 2
Condition: Gastro-Intestinal Tolerance
Study type: Interventional

Summary: 
      The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal
      tolerance of carbohydrate blends.
    


Intervention name(s): CHO Control 1 and 2 Glucose; CHO Experimental 1 Slowly Digested; CHO Experimental 2 Digestion Resistant; CHO Experimental 3 Low Sugar; CHO Experimental 4 Maltodextrin
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
Condition: Mood; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Psychological interventions for cancer patients have been tested and found to reduce stress
      and improve quality of life. These interventions have been tested at academic medical centers
      but have not been available for use by community mental health professionals. One such
      intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L.
      Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to
      train mental health professionals from across the country to deliver the BBI at their
      institution. Recently diagnosed cancer patients who are participating in the BBI group at
      these institutions may participate in a research study completing self report measures asking
      about psychological and behavioral outcomes (for example, mood, stress, diet and physical
      activity). The investigators hypothesize that individuals participating in the intervention
      will report improvements in outcomes, such as reduced stress and improved mood, reduced
      symptoms of the disease and treatment, etc., after completing the intervention and continue
      to report these improvements up to 6 months after the group ends. OSU will coordinate this
      data collection project but information about participating sites is listed in
      http://clinicaltrials.gov.
    


Intervention name(s): From Cancer to Health (C2H-D)
Intervention type(s): Behavioral
Intervention description(s): From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).
Other intervention name(s): C2H; Biobehavioral Intervention; BBI; Stress management
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stress management; Coping skills; Recently diagnosed cancer patients; Intervention, Psychological