bioihbjkbjnl/mcl2 huggingface dataset:
Energy Homeostasis in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to investigate the potential biological predispositions that
      contribute to the difficulty patients with anorexia nervosa have in maintaining normal
      weight.
    

Detailed description: 
      Anorexia Nervosa (AN) is a psychiatric illness that is characterized by extreme weight loss
      and severe body image distortions. In this study, we are examining changes in body
      composition, metabolic rate, and reproductive function before and after treatment for AN.
      More specifically, we are testing the hypotheses that 1)Weight-restored patients with AN have
      elevated resting energy expenditure (REE) compared to controls, 2) Weight-restored patients
      with AN have a central disposition of body fat compared to controls, 3) Weight-restored
      patients with AN who gain the most fat centrally will have the least improvement on
      psychological measures, 4) Weight-restored patients with AN will have leptin levels out of
      proportion to body fat mass. It will also investigate the relationship between REE and leptin
      with respect to the return of menses.
    

Time perspective: Prospective
Keywords: Anorexia Nervosa; Body Composition; Metabolic Rate
Effect of Mass Deworming on Child Growth
Condition: Low Weight for Age in Preschool Children
Study type: Interventional

Summary: 
      The purpose of the study was to determine whether periodical mass deworming improves growth
      in children below six years of age.
    

Detailed description: 
      Many children in developing countries get slowed growth because of heavy loads of intestinal
      helminths. Quite often treatment is not sought because there may not be any obvious symptoms.
      Slowed growth may manifest as low weight for age or low height for age.

      The objective of the study was to estimate the effectiveness of the delivery of an
      anthelmintic drug through a community child health program on the weight gain of preschool
      aged children.

      Design: This was a cluster randomized controlled trial in 48 parishes in Eastern Uganda. All
      48 parishes were participating in a new program for child health; 24 were randomly assigned
      to offer to children an additional service of anthelmintic treatment. The intervention was
      400 mg of albendazole added to the standard services at child days over a 3 years period. All
      children were offered the drug and the main outcome measure was weight gain.

      Results: A total of 27,995 children were recruited into the 2 arms of the study with 14,940
      in the treatment arm and 13,055 in the control arm. The intervention arm got an increase in
      weight gain of about 10% (166 grams per child per year (CI: 16-316) above expected weight
      gain when treatment was taken twice a year and an increase of 5% when treatment was received
      approximately annually.

      Conclusion: The inclusion of deworming in regularly scheduled health services appears
      practical and capable of increasing child growth.
    

Intervention name(s): Albendazole 400 mg, given 6 monthly
Intervention type(s): Drug
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: underweight; preschool; mass deworming
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized
      anxiety disorder (GAD).
    

Detailed description: 
      This is a multicenter, randomized, double blind, placebo controlled study of the safety and
      efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of
      generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8
      weeks of treatment, and a 7 day follow-up period. This study was previously posted by
      Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and
      in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): eszopiclone; eszopiclone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-225441 (eszopiclone) total daily dose of 1.5 mg; SEP-225441 (eszopiclone) total daily dose of 0.9 mg; Placebo total daily dose 0.9 mg
Other intervention name(s): SEP-225441; SEP-225441
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia
Condition: Spinal Anesthesia; Analgesia; Hip Fractures
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional

Summary: 
      The purpose of the study is to compare the analgesic efficacy of femoral nerve block and
      peri-capsular nerve group block administered before spinal anesthesia for positioning to
      spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the
      efficacy for postoperative analgesia
    

Detailed description: 
      Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the
      procedure of patient positioning to perform a spinal block is painful and may require the
      administration of IV analgesics or some regional anesthesia techniques such as femoral nerve
      block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the
      investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular
      nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia
      in patients undergoing surgery for hip fracture and to evaluate the efficacy for
      postoperative analgesia.
    

Intervention name(s): femoral nerve block; peri-capsular nerve group block
Intervention type(s): Other; Other
Intervention description(s): Patients will be performed a femoral nerve block using bupivacaine thirty minutes before the performing of spinal block.; Patients will be performed a peri-capsular nerve group block using bupivacaine thirty minutes before the performing of spinal block.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to
      non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft
      contact lenses and experiencing symptoms of dryness.
    


Intervention name(s): Opti-Free® PureMoist® contact lens solution; Habitual Multi-Purpose Contact Lens Solution; Habitual Contact Lenses
Intervention type(s): Device; Device; Device
Intervention description(s): Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
Other intervention name(s): OPTI-FREE® PureMoist®
Intervention MeSH terms: Contact Lens Solutions; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Contact lens induced dryness
Hot Flash as a Marker of Cardiovascular Risk in Recent Postmenopause: Effects of Non-hormonal Treatments
Condition: Postmenopausal Flushing; Cardiovascular Risk Factor; Endothelial Dysfunction
MeSH terms: Hot Flashes; Flushing
Study type: Interventional
Phase: Phase 4

Summary: 
      Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with
      cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with
      progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial
      function of postmenopausal women with hot flushes, even those with cardiovascular risk
      factors, such as hypertension. It is not known whether hot flushes are a cause for the
      development of endothelial dysfunction or are markers of this dysfunction, evidenced by
      estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was
      approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this
      double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5
      mg / day, compared to placebo, during 12 weeks are evaluated.
    

Detailed description: 
      Paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and
      pressure components of vascular function are evaluated.

      Non invasive venous occlusion plethysmography is used to study endothelial function;
      ambulatory blood pressure monitoring is used to study blood pressure variations during
      daytime and nocturnal descent; autonomic function is studied following sympathetic and
      parasympathetic parameters through heart rate variability.

      The effects of paroxetine and placebo are also evaluated on:

        -  daytime sleepiness (through Epworth Sleepiness Scale ),

        -  sleep quality (through Pittsburgh Sleep Quality Index),

        -  perceived stress (through Perceived Scale Stress).

      Biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin,
      estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH); inflammatory and
      oxidative stress markers are also studied.
    

Intervention name(s): Paroxetine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postmenopause; paroxetine; endothelial dysfunction; blood pressure; heart rate variability; sleep quality; perceived stress; sleepiness
A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic
      profile of HB002.1M, a human immunoglobulin Fc fusion protein containing domain 2 and
      flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with
      age-related macular degeneration (AMD).
    


Intervention name(s): HB002.1M
Intervention type(s): Drug
Intervention description(s): HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
Other intervention name(s): Recombinant Human Vascular Endothelial Growth Factor Receptor-Immunoglobulin(IgG) Fc Fusion Protein Ophthalmic Injection
Intervention MeSH terms: Immunoglobulins; Endothelial Growth Factors
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
Condition: Giardiasis
MeSH terms: Giardiasis
Study type: Interventional

Summary: 
      This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic
      treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.
    

Detailed description: 
      A randomised double-blind controlled intervention of 36 weeks duration was conducted in a
      rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged
      between 3 and 11 months were randomly assigned to either receiving anti-Giardia and
      antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving
      placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal
      permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein,
      immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three
      common geohelminths and Giardia intestinalis cysts were determined.
    

Intervention name(s): Anti-Giardia and antihelmintic treatment (secnidazole or albendazole); Anti-Giardia treatment only (secnidazole or albendazole); Control group (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg); Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole; Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo
Intervention MeSH terms: Albendazole; Anthelmintics; Secnidazole; Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate the effect on intestinal permeability of a
      supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from
      irritable bowel syndrome (IBS) with diarrhea predominance.

      Secondary objectives of the study are to evaluate the effects of supplementation with
      Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea
      predominance on intestinal permeability, inflammation of the digestive tract, symptoms and
      comfort.

      Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel
      Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and
      non-inclusion listed below.
    

Detailed description: 
      single-center pilot study in single open arm:

        -  2 to 6 weeks before enrollment: a screening visit (visit 0 [V0]) is carried out for
           verification of eligibility. time between V0 and V1 is a wash-out period with a duration
           decided by the physician (max 8 weeks).

        -  The experimental phase is composed of 2 visits (Visit 1 [V1] and Visit 2 [V2]) separated
           by 28 days (± 2 days) : from V1 to V2 patients are taking the product Lactibiane
           Tolérance®.

        -  V1 and V2 each include collection of stools, a blood sample, questionnaires on abdominal
           symptoms and quality of life, dynamic test of absorption of lactulose / mannitol to
           evaluate the intestinal permeability, recto-sigmoidoscopy with confocal endomicroscopy
           for in-vivo study of fluorescein leakage in the lamina propria and biopsies for ex-vivo
           measurements.

        -  "carmine red" test for the evaluation of intestinal transit speed is carried out the
           week before V1 and V2 (at least 72 hours before the visit). Questionnaires on abdominal
           symptoms as well as the frequency and consistency of stools are filled during the 7 days
           before V1 and V2 before.
    

Intervention name(s): Lactibiane Tolerance
Intervention type(s): Dietary Supplement
Intervention description(s): probiotics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgical Patient Education in Pediatric Urology
Condition: Health Care Utilization
Study type: Interventional

Summary: 
      Randomized study to assess the impact of supplemental educational YouTube videos on
      postoperative healthcare utilization following ambulatory pediatric urologic surgery
    


Intervention name(s): YouTube videos on care after urologic surgery
Intervention type(s): Behavioral
Intervention description(s): Supplemental educational videos regarding care following pediatric urologic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Families randomized by urologic surgery type to receive access to YouTube video link
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Outcomes of Stem Cells for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in patients with cerebral palsy.
    

Detailed description: 
      The aim of this study is to assess the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital,
      Hanoi, Vietnam.
    

Intervention name(s): Autologous Bone Marrow Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Stem Cells
Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of
      fixed-dose combination of bromopride and simethicone versus isolated bromopride on research
      participants diagnosed with functional dyspepsia.
    

Detailed description: 
      Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of
      fixed-dose combination of bromopride and simethicone versus isolated bromopride in the relief
      os dyspepsia symptoms on research participants diagnosed with functional dyspepsia.
    

Intervention name(s): FDC Bromopride 10 mg and Simethicone 80 mg; Bromopride 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg; Bromopride 10 mg
Other intervention name(s): Bromopride 10 mg and Simethicone 80 mg; Digesan®
Intervention MeSH terms: Bromopride; Metoclopramide; Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: functional dyspepsia
Measurement of Glycaemic Responses of Bakery and Confectionery Products
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to determine the glycemic index, glycemic load and insulin index of eleven
      Fazer bakery and confectionary products.
    


Intervention name(s): Bakery and confectionary products
Intervention type(s): Other
Intervention description(s): Control product: Glucose solution, Test products: 11 bakery and confectionary products
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effect of Meal Composition and Timing on Evobrutinib Bioavailability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of
      Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour
      prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.
    


Intervention name(s): Evobrutinib
Intervention type(s): Drug
Intervention description(s): Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).
Other intervention name(s): M2951
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Evobrutinib; Pharmacokinetics
Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety
Condition: Social Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The current study aims to explore the efficacy of a text message based Safety Behavior Fading
      Intervention compared to an active control intervention.
    

Detailed description: 
      Safety behavior fading may be a viable standalone intervention for social anxiety. In the
      present trial, participants high in social anxiety will be randomized to either receive a
      daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy
      behaviors. Individuals randomly assigned to the safety behavior fading condition will receive
      instructions to decrease or eliminate their four most habitual social anxiety safety
      behaviors. In addition, they will receive daily reminders via text message to decrease these
      behaviors, along with a safety behavior monitoring checklist in which the participant
      indicates the extent to which they decreased and/or eliminated each safety behavior over the
      previous day. Individuals randomly assigned to the control condition will receive similar
      text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants
      in both conditions will complete checklists for 28 days. After day 14 of treatment,
      participants will re-select their target safety behaviors or unhealthy behaviors, and will
      then be prompted to reduce these new behaviors for another 14 days.
    

Intervention name(s): Safety Behavior Fading for Social Anxiety; Unhealthy Behavior Fading
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are asked to reduce or eliminate safety behaviors via text message reminders and checklists to monitor progress; Participants are asked to reduce or eliminate unhealthy behaviors via text message reminders and checklists to monitor progress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized in to one of two conditions
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Social Anxiety; Safety Behaviors; Intervention; Text-message