bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators intend to conduct a triple blind randomized clinical trial to investigate
      the effect of a biscuit containing herbal extract, available in the market on the fasting
      blood sugar control in patients with diabetes mellitus and also to find out whether there are
      any side effects on other vital organs such as kidneys and liver.
    

Detailed description: 
      The effect of a biscuit containing the extract of Salacia reticulata (Kothala Himbutu) on the
      reduction of blood glucose levels in patients with Type 2 Diabetes Mellitus. A single center
      randomized triple blind placebo controlled two period two sequence crossover clinical trial.
    

Intervention name(s): Kothala Himbutu Biscuit; Placebo Biscuit
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.; Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)
Other intervention name(s): Biscuit contining Salacia reticulata extract; Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd; Munchee Kothala Himbutu biscuit; Biscuit; Munchee biscuit
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients with diabetes were screened and Type I Diabetes was excluded. The minimum run-in period was eight weeks and if the variability of HbA1c is more than 20%, excluded, to exclude patients with fluctuating glycaemia. As this is a crossover trial some degree of stability of the glycemic control is necessary to prevent excessive variation of HbA1c interfering with the study outcome. Participants were randomized to receive the KH or placebo biscuit. Oral hypoglycemic was continued and adjusted. Participants consumed KH or placebo biscuit for a period of 3 months as mid-morning and afternoon snack. Subsequently in the washout period of 1 month the participants did not consumed any biscuits. After, crossing over they continued biscuits for another 3 months. HbA1c was done at recruitment, after run-in period, at 3 months and on completion of the study. When there was deterioration of the glycaemic control patient was prescribed insulin, and withdrawn from the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: biscuit containing Salacia reticulate; randomised controlled trial
Beetroot Juice Ingestion Effects on Field Hockey Performance.
Condition: Nitrates; Hockey
Study type: Interventional

Summary: 
      Scientific evidence supports that only a few dietary supplements have reported good evidence
      for improving sports performance, between we can mention beetroot juice supplementation with
      doses > 5 mmol of NO3-. In this randomized placebo-controlled study, we investigated the
      effects of BJ acute supplementation in improving neuromuscular performance and match-play
      demands in female field hockey players.
    

Detailed description: 
      Beetroot juice supplementation has demonstrated good evidence for improving sports
      performance, however, benefits in team sports, especially in female athletes, are
      underrepresented. In this randomized placebo-controlled study, we investigated the effects of
      beetroot juice acute supplementation in improving neuromuscular performance and match-play
      demands.Testing sessions will comprise a neuromuscular test battery consisting of a
      countermovement jump (CMJ), isometric handgrip strength, 20-m sprint and repeated sprint
      ability test, followed by a 20-minute simulated field hockey Physical match activity
      (distances, speeds, accelerations and decelerations) will be monitored in real-time using an
      inertial tracking system
    

Intervention name(s): Beetroot juice; Beetroot juice placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One serving 70 mL of beetroot juice (6.4 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) 3 h before initiating the testing session.; One serving 70 mL of beetroot juice placebo (0.04 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) 3 h before initiating the testing session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary supplements; sports nutrition; field hockey; female
Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia
Condition: Collapsed Lung
MeSH terms: Pulmonary Atelectasis; Pneumothorax
Study type: Interventional

Summary: 
      Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of
      pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts
      with anesthesia induction but can persist for hours or even days after surgery.

      Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing
      pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to
      collapse. While airway pressure is homogeneously distributed within all lung units, Pleural
      pressure increases along the vertical gravitational vector because of the lung's weight. As a
      consequence, the decreased Ptp in the dependent zones promotes collapse. This means that
      patients in the supine position suffer from increasing closing pressures in the ventral to
      dorsal direction.

      Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve
      arterial oxygenation.

      The investigators hypothesized that in children with anesthesia-induced atelectasis, postural
      changes have recruiting effects and improve lung aeration assessed by lung ultrasound.
    

Detailed description: 
      Compare lung aeration between two different lung recruitment strategies (recruitment
      maneuvers in supine position and recruitment maneuvers with postural changes of lateral
      decubitus with 10 cmH2O level of positive-end expiratory pressure (PEEP) during 180 seconds;
      in pediatric patients scheduled for surgery under general anesthesia using ultrasound imaging
      and a four-point-aeration score to assess the lung aeration.
    

Intervention name(s): Lung ultrasound
Intervention type(s): Device
Intervention description(s): Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lung ultrasound; recruitment maneuver; atelectasis; children
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of glimepiride on the PK of dapagliflozin and the effect of
      dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A)
      and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of
      dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)
    


Intervention name(s): Dapagliflozin; Glimepiride; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 20 mg, Single Dose; Tablets, Oral, 4 mg, Single Dose; Tablets, Oral, 100 mg, Single Dose
Other intervention name(s): BMS-512148; Amaryl; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Interaction of BI 691751 With Itraconazole
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the relative bioavailability of a single dose of BI 691751 when given alone
      and together with itraconazole; safety and tolerability
    


Intervention name(s): itraconazole; BI 691751; BI 691751
Intervention type(s): Drug; Drug; Drug
Intervention description(s): multiple doses of itraconazole given as capsules; single dose BI 691751 given as tablet; single dose BI 691751 given as tablet
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      To compare the persistence in using two different medications from the same drug class
      (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI)
      and Soft Mist Inhalers (SMI).
    


Intervention name(s): Olodaterol/Tiotropium Bromide; Umeclidinium/ Vilanterol
Intervention type(s): Drug; Drug
Intervention description(s): (Stiolto®) delivered via Respimat inhaler; (Anoro®) delivered via Ellipta Inhaler
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients initiating Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol up to 2.5
        years
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model
Condition: Motor Coordination or Function; Developmental Disorder
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      The investigators hypothesize that children completing 30 sessions of occupational therapy
      using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome
      measures related to motor coordination, functional performance and sensory processing
      (changes pre-post test).
    


Intervention name(s): OT-SI
Intervention type(s): Other
Intervention description(s): Occupational therapy using a sensory integration approach (OT-SI) 3x per week for 10 weeks. A typical session will be 1 hour (total of 3 hours per week).
Intervention model: Single Group Assignment
Intervention model description: This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control
Masking: None (Open Label)
Primary purpose: Treatment
A Study of RO5190591 (Danoprevir) in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This non-randomized, open-label study will evaluate the interaction of
      RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability
      in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole
      alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time
      on study treatment is 25 days.
    


Intervention name(s): danoprevir; ketoconazole; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Repeated daily doses; Repeated daily doses; Repeated daily doses
Intervention MeSH terms: Ritonavir; Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk of Celiac Disease and Age at Gluten Introduction
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether age at introduction of gluten-containing
      cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (CD) development
      in infants with a first-degree relative affected by CD.
    

Detailed description: 
      We undertook a prospective study to establish the incidence of CD autoimmunity related to the
      timing of gluten exposure in at-risk infants. Infants at family risk for CD (at least one
      first-degree relative affected) are enrolled in this prospective, multicentre, intervention
      study conducted in Italy. Infants are randomly assigned to introduce gluten at either 4-6 or
      12 months (groups A and B, respectively) and then enter a follow-up period of 5 years.
      Duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of
      gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9,
      and 12 months of age. HLA (Human Leucocyte Antigene) status and CD serology
      (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of
      age.
    

Intervention name(s): gluten-free, normocaloric diet from 6 to 12 months
Intervention type(s): Dietary Supplement
Intervention description(s): Gluten-containing cereals (wheat, rye and barley) will be replaced by gluten-free starchy food (rice, corn, tapioca-based, etc) in a normocaloric diet
Other intervention name(s): gluten-free products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Transversus Abdominis Plane Block for Laparoscopic Hysterectomy
Condition: Hysterectomy; Laparoscopic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose To evaluate whether adding a transversus abdominis plane block in patients undergoing
      elective laparoscopic hysterectomy reduces Patient-controlled analgesia (PCA) morphine
      requirements during the first 24 hours postoperatively.

      Forty-six patients undergoing laparoscopic hysterectomy will be randomized into two groups:

        1. Group treatment TAP (n=23) will receive the following analgesia:

             -  US guided transversus abdominis plane block performed with 40ml of 0.375%
                levobupivacaine (20 ml per side) after general anaesthesia induction, before
                surgical start

             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at
                rest

        2. Group control will receive:

             -  Morphine PCA with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at
                rest

      Primary Outcome Measures:

      Morphine consumption (mg) (Time Frame: 24 hours) in Groups TAP and Control

      Secondary Outcome Measures:

        -  Pain at rest and during movement quantified as Numerical Rating Scores (0-10) for pain
           when resting in bed and during cough during the first 24 hours postoperatively

        -  Time to PACU dimission, evaluated as patient's achievement of a White's score > or =
           12/14

        -  Time to home discharge, evaluated as patient's achievement of a PADDS score > or = 9

        -  Functional patient capacity as measured before surgery and whenever a White's score > or
           = 12 will be reached (2minute walking test)

        -  Eventual side effects such as nausea/vomiting
    

Detailed description: 
      After the start of the study, we had a higher drop out size than expected. We therefore added
      a 13% of patient to initial power calculation to compensate for drop outs.

      Total number of patients enrolled = 52 (46 + 6) Total number of patients who completed the
      study = 44
    

Intervention name(s): USguided bilateral TAP block; Morphine Patient Controlled Analgesia; Morphine Patient Controlled Analgesia
Intervention type(s): Other; Drug; Drug
Intervention description(s): 23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start; Morphine PCA i.v. (bolus 2mg, lockout 8 min); Morphine PCA i.v. (bolus 2mg, lockout 8min)
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Condition: Genotype 1 Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness, safety and tolerability of
      telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated
      interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced
      Russian participants with genotype 1 chronic hepatitis C.
    

Detailed description: 
      This is an open-label (all persons know the study drug assignment), multicenter study in
      treatment-naïve (participant did not receive any previous treatment for the treatment of
      hepatitis C) and treatment-experienced (participant did receive previous treatment for
      hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening
      period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir
      750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks
      of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status,
      response to previous treatment and individual virologic response during treatment in this
      study. After the treatment period, there is a follow-up phase of at least 12 weeks.
    

Intervention name(s): Telaprevir; Pegylated-interferon-alfa-2a; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks; Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks; Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is < 75kg) or 1200mg (if participant's weight is >= 75kg) per day for 24 or 48 weeks.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1 chronic Hepatitis C; VX-950HPC3007; VX-950; Hepatitis C; Telaprevir; HCV
Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
Condition: Fibrosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      with the introduction of Direct-acting antiviral agents in the management of HCV, the scope
      of inclusion criteria had been widened to include patients with compensated cirrhosis and
      even in special situations patients with decompensated liver disease; a chance that was not
      offered by the limited and strict inclusion criteria needed for treatment by pegylated
      interferon-based regimen. this made the number of patients with progressive liver fibrosis of
      cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR
      on halting fibrosis progression had risen; some studies postulated that patients benefit from
      an SVR through reduction of mortality, morbidity, and improved quality of life ; however,
      some patients may maintain their level of fibrosis or even progress to cirrhosis despite
      achieving SVR and the risk for HCC remains even after virologic eradication.
    


Intervention name(s): silymarin; Ursodeoxycholic Acid; Antioxidants; Colchicine; FOLLOW UP
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): silymarin 140 three times daily; Ursodeoxycholic Acid 500; Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg; Colchicine 0.6; follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
Other intervention name(s): silymarin 140; ursofalk; antox; ultrasound and fibroscan
Intervention MeSH terms: Colchicine; Ursodeoxycholic Acid; Antioxidants; Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 200 patients will receive silymarin 420 mg + antioxidants + colchicine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibrosis; HCV; Reversal; sustained virological response
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
Condition: Major Depressive Disorder; Recurrent
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This research proposal is intended to elucidate the efficacy and mechanisms underlying
      Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major
      Depressive Disorder (MDD). The first objective of the study is to replicate previous studies'
      findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates.
      However, this proposal aims to make a novel contribution to the literature by using a
      randomized, controlled design, and comparing the effects of MBCT to an active control
      condition (ACC). The use of a well-designed ACC will enable us to control for confounding
      variables such as social support and expected outcomes, thus allowing us to determine whether
      elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have
      largely relied on self-report measurement methodologies, limiting valid conclusions about the
      nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT
      on depressive symptoms and relapse. Theoretical considerations and preliminary empirical
      evidence suggest emotional, physiological, and cognitive functioning to be promising
      mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential
      mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim
      2). Collectively, these aims are expected to strengthen the evidence base for MBCT while
      cultivating a scientific model for its effects and mechanisms on decreasing depressive
      symptoms and depression relapse rates.
    


Intervention name(s): Mindfulness Based Cognitive Therapy; Health Enhancement Program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mindfulness; clinical trial; intervention; prevention