bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
Condition: Sensory Processing Disorder; Special Education; Autism
Study type: Interventional

Summary: 
      This study investigated the effects of a sensory diet intervention program on five children
      with a sensory processing disorder. The effect was investigated on children's sensory
      processing skills, psychosocial skills, and classroom engagement.
    

Detailed description: 
      Sensory diets are one of the interventions occupational therapists use in school-based
      settings to manage manifestations of sensory processing disorder. However, very few studies
      have investigated the effectiveness of sensory diets, and the results of these studies were
      mixed. Past studies also had methodological limitations. Therefore, this study investigated
      the effect of sensory diets on children's sensory processing skills, psychosocial skills, and
      engagement in classroom activities. This study used a single-subject ABCA design. Five
      children between the ages of five and eleven years participated in the study. The study
      consisted of an initial baseline phase A1, the control intervention phase B, sensory diets
      intervention phase C, and the second baseline phase A2. Each phase lasted for seven days. The
      PI videotaped each participant for fifteen minutes each school day during all phases to
      collect the data. The participants were videotaped during classroom group activities. Visual
      analysis of the data showed that sensory diets had a positive effect on participants' sensory
      processing, psychosocial skills, and classroom engagement.
    

Intervention name(s): Sensory diet
Intervention type(s): Other
Intervention description(s): Sensory diets are one of the interventions occupational therapists use in school-based settings to manage manifestations of sensory processing disorder. Sensory diets are composed of exercises and multisensory activities that are tailored for children and provide them sensorimotor experiences to facilitate their participation in daily activities.
Other intervention name(s): Non-therapeutic activities or activities without a therapeutic goal (Placebo)
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Supplemental Protein And Resistance Training Adaptations
Condition: Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Chronic resistance training has been shown to increase muscle cross-sectional area, volume
      and strength. Individuals participating in a resistance training program may wish to consume
      protein supplements to aid recovery and maximise adaptation. Furthermore, antioxidants have
      been shown to aid recovery from acute bouts of exercise. However, the effect of antioxidants
      combined with protein on long term-training adaptation is not fully understood.

      This study will combine measures of muscle size, muscle strength and function, and the
      underlying changes in muscle metabolism in order to assess the effect of consuming a combined
      protein-antioxidant supplement during a 30 session resistance training program.
    

Detailed description: 
      Supplemental protein ingestion is an established method for augmenting gains in fat free
      mass, muscle strength and muscle cross sectional area following a period of resistance
      exercise training. In addition to protein, supplements high in polyphenols such as berry and
      pomegranate extract are believed to be an effective method of reducing soreness and
      facilitating recovery following a single bout of resistance exercise.

      However, whilst polyphenols are shown to facilitate recovery from a single session of
      resistance exercise, their effect on adaptations to repeated bouts of resistance exercise are
      unknown. Asking this question will allow a detailed investigation of the mechanisms by which
      protein-polyphenol ingestion may affect adaptations to resistance exercise training when
      compared to a non protein or polyphenol containing placebo, which is an important yet
      underexplored area
    

Intervention name(s): Placebo beverage; Protein-polyphenol beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A placebo beverage will be consumed both post-exercise and pre-bed; A protein-polyphenol beverage will be consumed both post-exercise and pre-bed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bone Health Management for Women Diagnosed With Breast Cancer
Condition: Osteoporosis; Breast Cancer
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to test the feasibility of the study protocol. The study
      protocol was designed to evaluate questions - "Do educational materials improve dual x-ray
      absorptiometry (DXA) screening rates for women diagnosed with breast cancer" and "Does
      educational materials delivered by the participant's selected choice change DXA screening
      rates compared to the conventional mail method?".
    

Detailed description: 
      "Bone health management" for osteoporosis is important for women diagnosed with breast
      cancer. Osteoporosis can lead to bones breaking easily. Broken bones may make living
      independently challenging. Effective bone health management can reduce the risk of broken
      bones. This study will examine whether providing "osteoporosis information" to women
      diagnosed with breast cancer will promote their bone health management. With the current
      advance in technology, people are more interested in receiving information by email or
      smartphone text messaging. This study will also examine whether delivering osteoporosis
      information in different ways will change bone health management.
    

Intervention name(s): Educational materials/mail; Educational materials/participant choice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this group will receive any educational materials by mail during hte follow-up period.; Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Osteoporosis; DXA Screening; Women; Breast Cancer; Survivors; Educational materials; Personal choices on delivery methods
Mechanisms of Insulin Resistance in Humans
Condition: Inflammation; Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Study type: Observational

Summary: 
      The Objectives of the study are to: (1)compare the inflammatory response and insulin
      resistance in skeletal muscles during a systemic infusion of lipid with that during a local
      infusion of lipid into the femoral artery. which would cause minimal or no systemic
      hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during
      the systemic lipid infusion, and (2) determine the inflammatory response and insulin
      resistance in skeletal muscle during an infusion of lipid into the femoral artery as
      described above after NF-KB inhibition by high dose salicylate treatment in humans.
    

Detailed description: 
      Insulin resistance in skeletal muscle is a characteristic abnormality in obesity and the
      metabolic syndrome and a major factor responsible for the development of type 2 diabetes.
      Although the mechanisms responsible for muscle insulin resistance are largely unclear, lipid
      oversupply is an important factor. Among numerous potential mechanisms whereby lipid
      oversupply may cause muscle insulin resistance, current evidence points towards inflammation
      as being critical. Recent studies in animals, however, indicate that the inflammatory
      response in skeletal muscles may require the presence of circulating pro-inflammatory factors
      suggesting that the inflammation induced insulin resistance in skeletal muscles may be a
      secondary event. More specifically, activation of Nuclear Factor-Kappa B(NF-kB), and
      inflammatory master switch that drives the production of numerous pro-inflammatory cytokines
      in fat and liver, has been implicated in causing insulin resistance in skeletal muscles by
      increasing circulating pro-inflammatory cytokines. In contrast, animal studies have found
      that activation of NF-KB directly in skeletal muscles has no or little effect on its insulin
      sensitivity but does produce other abnormalities such as increased proteasome activity. The
      study shall therefore be undertaken to determine to what extent lipid-induced inflammation
      and insulin resistance in skeletal muscles requires the presence of circulating
      proinflammatory factors in humans.
    

Intervention name(s): 20% Intralipid
Intervention type(s): Drug
Intervention description(s): lipid infusion
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
      
Biospecimen description: 
      Blood samples, muscle biopsies
    
Keywords: Fat Emulsions, Intravenous; Free Fatty Acids; Glucose Clamp Technique; Inflammation; Insulin Resistance; Muscle, Skeletal; NF-Kappa B
Use of Perforated Barrier Membranes and IPRF Nano- Micro Sticky Bone
Condition: Bone Augmentation
Study type: Interventional

Summary: 
      Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using
      IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier
      membrane by :

        1. clinical and Radiographic analysis .

        2. Histomorphometric analysis .
    


Intervention name(s): Perforated collagen membrane; Occlusive collagen membrane
Intervention type(s): Procedure; Procedure
Intervention description(s): Horizontal Bone Augmentation using Perforated Collagen Membrane; Occlusive collagen membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5,
      CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo
      probes. In order to avoid a potential pharmacokinetic interaction between the probes,
      midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together
      as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time
      period between the 2 assessments.

      The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2
      weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg,
      150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady
      state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day
      of cenobamate for all CYP probes.

      The results of this DDI study will provide a basis to make appropriate dose recommendation
      for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic
      pathway.
    


Intervention name(s): Cenobamate; midazolam; Warfarin Pill; Omeprazole Pill; Bupropion Pill
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 12.5 mg q.d.(Days 13-26), 25 mg q.d. (Days 27-40), 50 mg q.d. (Days 41-54), 100 mg q.d. (Days 55-70), 150 mg q.d. (Days 71-84), 200 mg q.d. (Days 85-110); 2 mg midazolam syrup (Days 7, 69, 105); 5 mg (Days 7 and 105); 20 mg (Days 7 and 105); 150 mg (Days 1 and 99)
Intervention MeSH terms: Midazolam; Cenobamate; Bupropion; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Vitamin D Fortification of Milk and Oil
Condition: Healthy Individuals
Study type: Observational

Summary: 
      It is a two-year longitudinal effectiveness study. A comparative study with a case-control
      design. Study will be conducted in Pune city. A total of up to 100 families (50 families per
      group) will be recruited. The test group will consist of families consuming fortified milk
      and oil and the control group will consist of families consuming non fortified milk and oil.
      Individuals between the age 5-18 years, 18-50 years and more than 50 years will be enrolled.
      Families which intend to stay in the city for the next 2 years, willing to continue with the
      same brand of milk and oil for the next 2 years, children living with their biological
      parents and families willing to sign consent form, will be enrolled in the study. Individuals
      having chronic illnesses likely to affect vitamin D concentrations and those allergic to milk
      will be excluded.
    

Detailed description: 
      Study design: A two-year longitudinal effectiveness study Sample selection: Hundred families
      will be selected for this study, 50 in each group.

      For the test group, people/families buying the standardized milk habitually will be
      identified and offered the study, an ethics approval would be obtained before commencing the
      study. After a consent is signed, a home visit will be made and family will be given
      information about the study.

      Individuals from families who consume standardized fortified milk + fortified oil will be
      offered the study. The control group will consist of families consuming unfortified milk and
      oil. Thus, families habitually consuming unfortified milk and oil (from 'ghanas') will be
      offered the study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals between the age 5 - 80 years will be enrolled.
Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery
Condition: Nociceptive Pain; Goal-directed Therapy; Hemodynamic Instability; Nol-Index; Remifentanil; Cardiac Surgery; Vascular Surgery; General Anesthesia
MeSH terms: Nociceptive Pain
Study type: Interventional

Summary: 
      This study will investigate the potential of guiding remifentanil analgesia during cardiac
      and vascular surgery in moderate to high risk patients requiring general anesthesia.
    

Detailed description: 
      Justification:

      Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and
      mortality. These patients undergo general anesthesia and often require tight blood pressure
      control (e.g., using norepinephrine titration) to avoid the complications associated with
      hypotension and reduced cardiac output. Standard analgesia opioid titration to control
      nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the
      anesthesiologist's experience and variations in the patient's heart rate and blood pressure.
      This causes anesthesiologists to often give too much analgesic, which can lead to inhibition
      of the sympathetic autonomic nervous system, hypotension, and associated side effects. A
      recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of
      measuring the patient's level of nociception-antinociception balance and can guide opioid
      administration. This monitor may allow anesthesiologists to administer only the required
      amount of opioid, which may lead to better hemodynamic stability and better postoperative
      outcome.

      Objectives:

      The goal of this study is to determine if titrating analgesia using the Nol-Index, when
      compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine,
      increased cardiac output, more stable blood pressure control, and decreased postoperative
      complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.
    

Intervention name(s): Nol-Index guided analgesia; Standard Analgesia
Intervention type(s): Device; Other
Intervention description(s): Monitor that indicates the level of nociception-antinociception balance; Administration of remifentanil based guided by heart rate, blood pressure, and experience
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
    

Detailed description: 
      Secondary Objective:

      To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose +
      Ribavirin 800-1400 mg PO daily.
    

Intervention name(s): P1101 + Ribavirin
Intervention type(s): Drug
Intervention description(s): P1101 400 µg SC
Other intervention name(s): Ropeginterferon alfa-2b
Intervention MeSH terms: Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: P1101; HCV genotype 2; Pharmacokinetics; PK; Hepatitis C, Chronic
Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women
Condition: Postpartum Hemorrhage; High Risk Pregnancy; Tranexamic Acid; Third-Stage Postpartum Hemorrhage, With Delivery
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage and its complications are very well known causes for maternal mortality
      .Uterine atony is the most common cause for postpartum hemorrhage
    

Detailed description: 
      Postpartum hemorrhage and its complications are very well known causes for maternal mortality
      and morbidity especially in developing countries. World Health Organization Recommendations
      for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of
      uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor
      for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in
      surgery and health conditions associated with increased bleeding.

      A Cochrane Systematic Review from the best available evidence to determine whether TA is
      effective and safe for preventing PPH in comparison to placebo or no treatment the review
      concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and
      prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women
      at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw
      conclusions about serious side effects and the effects of TA on venous thromboembolic events
      and mortality beside its use in high-risk women was not investigated on
    

Intervention name(s): Tranexamic acid injection; Glucose water 5%
Intervention type(s): Drug; Other
Intervention description(s): Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus; Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
Other intervention name(s): TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India; Glucose B.Braun 50 mg/mL
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Probiotics and Multi-Drug Resistant Urinary Tract Infection
Condition: Urinary Tract Infections; Recurrent UTI; Antibiotic Resistant Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      This pilot study is a single-site randomized, double blinded placebo-controlled in females
      with recurrent multi-drug resistant (MDR) urinary tract infections(UTI). Our study
      hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these
      former MDR UTIs.
    

Detailed description: 
      The aims of this study are (1) to evaluate the effects of six months of probiotic therapy in
      addition to standard of care in changing sensitivity patterns of MDR bacteria causing
      recurrent UTI, (2) analyze the genetic composition of MDR bacterial isolates causing
      recurrent UTI before and after administration of probiotic vs. placebo, with standard of care
      antibiotics.

      Study subjects will be asked to take a either a probiotic supplement or placebo at a dose of
      1 caplet per day for 24 weeks in addition to antibiotic regimen. Subjects will be followed
      for 12 months. The outcome measure is the percent of probiotic ingestors vs placebo ingestors
      who experience a change in antibiotic susceptibility over this time period. The secondary
      outcome measure is the evaluation of genetic composition of bacteria recurring after
      probiotic vs. placebo administration.
    

Intervention name(s): Bifidobacterium infantis; Placebo; Antibiotics
Intervention type(s): Dietary Supplement; Other; Drug
Intervention description(s): Probiotics; Sugar pill manufactured to mimic probiotic tablet; Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
Other intervention name(s): Align; Placebo (for Probiotic)
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; multi-drug resistant UTI; recurrent UTI