bioihbjkbjnl/mcl2 huggingface dataset:
Diet Treatment of Patients With Ulcerative Colitis in Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The study examines the effect of a low FODMAP diet in patients with UC in remission but still
      having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be
      on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
    

Detailed description: 
      Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet.
      Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded
      food supplement with low FODMAP content and the other arm is assigned a blinded food
      supplement containing FODMAP. A control group is "watchful waiting".

      Symptom reports, blood, and fecal samples are collected.
    

Intervention name(s): Low FODMAP; Standardized FODMAP
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Blinded food supplements containing only items with a low content of FODMAPs; Blinded food supplements containing FODMAPs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Diet; low FODMAP; UC; IBS
Asparagus Capsule Consumption and Blood Sugar and Lipids and Oxidative Stress
Condition: Asparagus Capsule Consumption
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants were 44 overweight and obese persons, male and female, age 18-59 years.
      Participants were divided into 2 groups consisting of 23 asparagus capsules and 21 placebo
      capsules groups. They received health screenings including history taking, mental health
      questionnaire, and vital signs, height and body weight, body composition, fat distribution
      measurements and oral glucose tolerance test. Then, a venipuncture was conducted to determine
      blood glucose, insulin, lipids malondialdehyde and protein carbonyl levels.
    

Detailed description: 
      The study design was cross-sectional. Participants were 44 overweight and obese persons, male
      and female, age 18-59 years. Participants were divided into 2 groups consisting of 23
      asparagus capsules and 21 placebo capsules groups. They received health screenings including
      history taking, mental health questionnaire, and vital signs, height and body weight, body
      composition, fat distribution measurements and oral glucose tolerance test. Then, a
      venipuncture was conducted to determine blood glucose, insulin, lipids malondialdehyde and
      protein carbonyl levels. Analysis of covariance was used to analyze parameters between groups
      and paired t-test was used to analyze parameters intra-group.
    

Intervention name(s): Asparagus capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Asparagus capsule is categorized as dietary supplement.; Placebo capsule is categorized as other.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly divided into 2 groups consisting of 23 asparagus capsules and 21 placebo capsules groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Symptomatic Treatment of Common Cold Symptoms
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel
      groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C)
      in adult patients with a common cold during a two hour in patient phase; and a follow-up
      period of five days of home treatment as required.
    


Intervention name(s): Aspirin (Acetylsalicylic acid, BAYE4465); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days; 1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic treatment of Common Cold symptoms
Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether perioperative glutamine administration
      possess protective properties on internal organs (heart and gut) in patients with coronary
      atherosclerosis, operated under cardiopulmonary bypass.
    


Intervention name(s): N(2)-L-Alanine L-Glutamine dipeptide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of glutamine in total dose of 2 g/kg/day (rate=2*weight/24 ml/h). Infusion starts in operating room and ends next day after the surgery.; Intravenous infusion of 0,9% solution of NaCl, rate=2*weight/24. Infusion starts in operating room and ends next day after the surgery.
Other intervention name(s): Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Condition: Central Neuropathic Pain; Allodynia; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Hyperalgesia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a
      larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of
      chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain
      following spinal cord injury.
    

Detailed description: 
      This trial has several objectives:

      Primary Objective To determine which combination (dose-ratio) of dextromethorphan and
      lidocaine provides the best balance of pain reduction and toxicity.

      Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and
      lidocaine in attenuating pain related to central nervous system sensitization, specifically
      spontaneous pain, mechanical allodynia, and hyperalgesia.
    

Intervention name(s): Dextromethorphan; Lidocaine; Placebo (Dextromethorphan); Placebo (Lidocaine)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD); 0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose); 0mg Dextromethorphan; 0mg/kg LBM Lidocaine
Intervention MeSH terms: Lidocaine; Dextromethorphan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia
Physical Activity in Pediatric Cancer (PAPEC)
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC)
      is to assess the impact of an exercise program intervention in pediatric cancer patients
      undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention
      will have a beneficial effect on the study outcomes.
    

Detailed description: 
      Sixty patients, of both sexes, children will be recruited for this trial with an age range
      between 4 to 16 years old, undergoing treatment for primary tumors (excluding central nervous
      system tumors). Each participant will be assigned randomly (with blocking on sex) to either
      intervention or control (usual care) group.

      The intervention group will participate in combined inpatient physical training (aerobic +
      strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise
      sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym
      specifically enabled on the aforementioned hospital, depending on the children's health
      status.

      Primary outcomes [cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg
      and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test', and
      '3 m and 10m Time Up and Go tests'), physical activity levels (determined by accelerometry)
      and quality of life "Child Report Form of the Child's Health and Illness Profile-Child
      Edition", Adolescent Edition and Parents Report Form )] and secondary outcomes [immune
      function (immune cell subpopulations, natural killer cells' cytotoxicity), inflammatory
      profile (blood levels of 47 cytokines) and leukocyte telomere length] will be measured in
      both groups in the following time points:

      (i) before the exercise intervention (immediately after diagnosis and before the start of
      treatment); (ii) after the exercise intervention (upon termination of neoadjuvant
      chemotherapy); and iii) after a detraining period (2 months after the intervention).
    

Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
Other intervention name(s): physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: randomized controlled trial; in-hospital exercise; children; cancer
One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children
Condition: Cross-bite
MeSH terms: Malocclusion
Study type: Observational

Summary: 
      Many author have exposed the rapid and slow expansion, the diversity of activation and
      containment protocols and the follow-up time, justify the need for more studies to evaluate
      the effects to the ERM for the long-term.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Rapid maxillary expansion; Cross bite; Haas appliance; Lateral cephalograms
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
Condition: Choroidal Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients
      with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help
      reduce the number of laser treatments that might be needed to control the tumor.
    


Intervention name(s): Ranibizumab 2 mg; 0.5 mg Ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): intravitreal injections of ranibizumab once a month, times 3.; 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Choroidal melanoma; Ranibizumab; Transpupillary Thermotherapy; CSTIP; Indocyanine Green
Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      This research is being conducted to examine the effects of nasal insufflation of warm and
      humidified air through a small nasal cannula on sleep, breathing pulmonary function, and
      daytime exercise capability.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity
      including substantial daytime fatigue exertional intolerance and ventilatory impairment,
      which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common
      in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown.
      The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a
      substantial source of morbidity in this disorder.

      Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including
      nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study
      promises to significantly alter our approach to the diagnosis and management of sleep
      disordered breathing in COPD.
    

Intervention name(s): Oxygen; High flow of room air
Intervention type(s): Other; Other
Intervention description(s): oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.; Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
Other intervention name(s): supplemental oxygen; nocturnal oxygen; TNI: Transnasal insufflation; Open CPAP; Optiflow
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Sleep; Supplemental oxygen; Breathing mechanics; nasal insufflation
Physical Activity, Dietary Intake and Bone Status in 6-12 Years Children
Condition: Bone Status
Study type: Observational

Summary: 
      Peak bone mass acquisition through childhood and adolescence has been associated with lower
      risk of osteopenia and osteoporosis in the elderly. The main factors that influence bone mass
      are the non-modifiable, such as genetics, ethnicity and sex, and the modifiable ones which
      are nutrition and physical activity or exercise. In the literature are references that
      demonstrates positive effects of high physical activity, adequate intakes of macro- and
      micronutrients on bone mass both in adults and in children. Bone mineralization is more
      adaptive in childrens' growing bones and this is an opportunity for stronger effects by
      mechanical stimuli during physical activity. The presence of a diet complete of nutrient
      intakes seems to strengthen the effects of mechanical loads on bone growth and
      mineralization. The present trial aimed to evaluate the effects of physical activity and
      nutrition intakes on bone mass in pre-pubertal children.
    

Detailed description: 
      The sample of this study was healthy pre-pubertal boys and girls (N=210) who had training age
      0-1 years. Data collection included anthropometric measurements, blood sampling, body
      composition, bone measurements and physical performance measurements. Nutritional intake was
      recorded for seven consecutive days in order to evaluate nutrient intakes using an
      appropriate software and habitual physical activity was measured for the same days using
      accelerometers. Pubertal stage determined by Tanner scale. All measurements were made only
      once at the beginning of school year.
    

Intervention name(s): physical activity level; Dietary Intake
Intervention type(s): Behavioral; Behavioral
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary schoolchildren (boys and girls) aged 6-12 years and were at pre-pubertal stage.
Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women
Condition: Anti Aging
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Determine the effects of 8 week Investigational Supplement on cellular detoxification and
      gene expression profiles
    


Intervention name(s): Vitality product AM + Vitality product PM; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days; Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Ginseng; Cordyceps; Pomegranate; Red Orange; Grape Seed; Broccoli Seed
Buspirone in Reducing Shortness of Breath in Patients With Cancer
Condition: Dyspnea; Pulmonary Complications; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Dyspnea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients
      with cancer who are undergoing chemotherapy.

      PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing
      shortness of breath in patients who are undergoing chemotherapy for cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the degree to which buspirone can decrease the sensation of dyspnea in patients
           with malignant disease.

        -  Estimate the incidence of dyspnea in patients seen in community oncology practice
           settings.

        -  Investigate interrelationships of fatigue, depression, anxiety, and patient report of
           dyspnea.

        -  Assess the quality of life of patients treated with this drug.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center (CCOP site). Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I: Beginning on day 7 of chemotherapy, patients receive oral buspirone once a day
           for 3 days and then twice daily for up to 28 days.

        -  Arm II: Patients receive oral placebo as in arm I. Dyspnea is assessed at baseline.
           Dyspnea, mood, fatigue, depression, anxiety, and quality of life are assessed within 5-7
           days before chemotherapy and immediately following therapy.

      PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): buspirone hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period; Placebo
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: dyspnea; pulmonary complications; unspecified adult solid tumor, protocol specific
Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue.
Condition: Asymptomatic Condition
MeSH terms: Fatigue; Asymptomatic Diseases
Study type: Interventional

Summary: 
      The aim of this study will be to determine the effects of active tDCS on rotator cuff
      fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical
      trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active
      asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be
      recruited via social networks, WhatsApp and emails and must be currently engaged in moderate
      physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of
      assessment. In addition, participants will be asked not to perform any type of strenuous
      exercise and do not drink alcoholic or caffeinated beverages during the time the work is
      performed. The study will consist of three sessions, with an interval of 72 hours between
      them.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Other
Intervention description(s): The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Brain stimulation; tDCS; Fatigue; Rotator cuff
Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women
Condition: Vulvovaginal Candidiasis; Bacterial Vaginosis
MeSH terms: Candidiasis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall objective of this clinical pilot study is to determine at a random sampling time,
      the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial
      vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects
      could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins
      will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and
      infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the
      ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a
      healthy state and lower environmental toxins will be completed.
    


Intervention name(s): Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules; Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science