bioihbjkbjnl/mcl2 huggingface dataset:
Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of
      chronic constipation.
    

Detailed description: 
      The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal
      University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It
      is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan
      area of the São Paulo and in Brazil. In general, the patients go to consultation after a
      referral from a primary care center.

      Study design and sample size The design was a randomized double-blind trial,
      placebo-controlled study. Sample size was calculated by the formula of comparison of two
      proportions, using clinical improvement as a primary outcome. It had been previously
      calculated that a minimum of 14 patients in each group will give a power of 80% to detect a
      effect size of 50% with significance at the level of 5% (one-sided).
    

Intervention name(s): Soy polysaccharide fiber
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.
The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.
Arms: Soy polysaccharide fiber, purified soy extract, with no fiber
Other Names:
Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)
Other intervention name(s): Soy polysaccharide fiber (Pró-fibra®); Purified soy extract, with no fiber (Soyac®)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: clinical trial; dietary fiber; constipation; children
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide a preliminary assessment of the safety and effectiveness of
      the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the
      treatment of chronic hepatitis C virus infection.
    


Intervention name(s): PPI-668; BI 207127 Dose 1; BI 207127 Dose 2; Faldaprevir; Ribavirin; BI 207127 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Liver diseases; Virus diseases; Ribavirin; protease inhibitor; NS5B polymerase inhibitor; NS5A inhibitor
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,
      crossover, oral bioequivalence study.
    

Detailed description: 
      The objective of this study was to determine the single-dose oral bioequivalence of
      Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited,
      India with REQUIP® XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of
      Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fed condition.
    

Intervention name(s): Ropinirole
Intervention type(s): Drug
Other intervention name(s): Requip
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ropinirole Hydrochloride; crossover
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix
      administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered
      according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6
      months in 9-14 years old healthy females.
    


Intervention name(s): Cervarix; Gardasil; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.; 2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.; 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human papillomavirus; Safety; HPV vaccine; Immune response
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and
      Metformin XR vs. uptitrated Metformin XR.
    


Intervention name(s): Saxagliptin; Metformin XR; Metformin XR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg oral tablet once daily; 500mg oral tablet once daily; 750mg, 2 tablets once daily
Other intervention name(s): Onglyza
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T2DM; Metformin; A1c
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Condition: Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to
      assist in real-time identification of anatomy during cholecystectomy (gallbladder removal).
      We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction
      during cholecystectomy.
    

Detailed description: 
      This study is designed to determine the clinical utility of intravenous indocyanine green
      (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the
      biliary tree with a near-infrared light source and camera. Testing will be done during an
      abdominal surgery which requires gallbladder removal. Subjects will be recruited during
      consult for their surgical procedure. The study itself will take an estimated 5 minutes
      during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before
      surgery, and following perfusion of the biliary tree, images will be recorded and visibility
      of the appropriate anatomy will be assessed using a near-infrared light source and camera. If
      fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be
      given. Following the completion of imaging, the standard procedure for cholecystectomy will
      be performed including intraoperative cholangiography (IOC), which is standard of care.
      Subject post-operative recovery will be monitored for the duration of their hospital stay.
      Adverse events will be monitored at the patient's routine follow up visit.
    

Intervention name(s): Injection of indocyanine green (ICG); Near Infrared Cholangiography Fluorescence (NIRF-C)
Intervention type(s): Drug; Device
Intervention description(s): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.; These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
Other intervention name(s): Stryker 1488 Camera System; Stryker L9000 Light Source; Stryker 1488 Coupler; Stryker 10mm Ideal Eyes Laparoscope (0 and 30 degree)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cholecystectomy; cholecystitis
Platelet Rich Plasma and Recurrent Implantation Failure
Condition: Recurrent Implantation Failure
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      This study is a randomized controlled clinical trial to compare the pregnancy outcomes of
      infertile women with recurrent implantation failure. The study population consisted of
      infertile women with a history of recurrent implantation failure who had failed to achieve a
      clinical pregnancy which at least four good quality embryos transfers and are now candidate
      for IVF-ICSI or freeze embryo transfer cycles with and without intra uterine infusion of
      platelet rich plasma in Reproductive Biomedicine Research Center, Royan institute, Tehran
      Iran.
    

Detailed description: 
      Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma
      fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its
      application in the field of regenerative medicine has widely been interested over the last
      three decades. According to the literature, PRP is an effective and safe treatment in the
      fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and
      connective tissue damage, but its application in the field of infertility is limited to a few
      pilot studies in which the effects of PRP on endometrium and recurrent implantation failure
      (RIF) were investigated. Given the importance of endometrial compliance and according to
      molecular studies, which indicate that endometrial growth factors in women with a history of
      RIF are lower than normal fertile women, PRP, along with other existing strategies, can be
      used to improve endometrial compliance in patients with a history of RIF. The present
      randomized, controlled clinical trial is proposed to determine the efficacy of PRP in the
      treatment of patients with RIF in the cycles of IVF-ICSI and frozen embryo transfer at Royan
      Institute.
    

Intervention name(s): Intra uterine infusion of platelet rich plasma
Intervention type(s): Other
Intervention description(s): Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet rich plasma; Recurrent implantation failure; Infertility; Assisted reproduction technology
Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a primary investigation to determine the usefulness and safety of a short
      course of a relatively high dose of letrozole (a medication used to decrease the female
      hormone estrogen which is produced locally inside the breast after menopause) in improving
      the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in
      the breast by letrozole might help better identifying of suspicious areas in the breast and
      could assist radiologists in distinguishing between benign breast areas and cancer tissue.
      This might help reducing the rate of call backs and unnecessary biopsies for patients. We
      expect to enroll 20 healthy postmenopausal women in this study.
    

Detailed description: 
      A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline.
      A second MRI will be performed within a month and following administration of letrozole 12.5
      mg daily for three days to reduce breast estrogen levels and in anticipation of lowering
      breast gadolinium dye uptake.
    

Intervention name(s): letrozole
Intervention type(s): Drug
Intervention description(s): Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
Other intervention name(s): Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC
Intervention MeSH terms: Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Letrozole; Breast MRI; Postmenopausal women
Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease
Condition: COPD; Internet Access
Study type: Interventional

Summary: 
      Higher levels of physical activity are associated with better functional status, fewer
      hospital admissions, and lower mortality. The investigators studied the feasibility and
      safety of a novel program that combines a pedometer with a website to increase walking. This
      is a pilot study.
    


Intervention name(s): website and pedometer
Intervention type(s): Behavioral
Intervention description(s): use of pedometer and website
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Embryo Culture at a Constant Temperature of 36.6°C or 37.1°C
Condition: Temperature; Extreme, Exposure
Study type: Interventional

Summary: 
      On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C
      or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.
    

Detailed description: 
      A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on
      sibling oocytes. The primary aim was to analyse possible differneces in embryo development
      (utilization rate) up to day 5/6. In this study, the investigators found a high difference in
      clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not
      powered to find differences in clincial pregnancy rates between both groups, this RCT was
      especially powered as a superiority trial to find differences in clincial pregnancy rates
      between both groups. On the day of oocyte retrieval, patients will be allocated to culture at
      one of both temperatures.
    

Intervention name(s): G210 incubator
Intervention type(s): Device
Intervention description(s): very stable culture temperature, up to 0.1°C, in both arms
Other intervention name(s): Ksystems
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: temperature
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the pharmacokinetic parameters and safety of topical
      MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use
      conditions.
    

Detailed description: 
      This is a multi-center, open-label study to assess the degree of systemic exposure and safety
      of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in
      pediatric subjects with atopic dermatitis.
    

Intervention name(s): MM36 topical ointment, 1%
Intervention type(s): Drug
Intervention description(s): Twice daily application for 28 consecutive days
Other intervention name(s): OPA-15406
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Gloved Medical Personnel Scratch Less Often?
Condition: Hygiene; Equipment Contamination; Health Education
Study type: Observational

Summary: 
      Unconscious touching of a person's own head or neck (for example by scratching) is a
      frequently observed and completely normal physiological movement pattern in humans, which
      when done by medical personnel attending a patient poses a high risk of unconscious
      self-contamination, even of an already disinfected hand, and of subsequent contamination of
      the patient. However, as compared to an ungloved hand, a gloved hand is felt to be "foreign,"
      which could reduce the frequency of self-contact and thus the contamination rate.

      Wearing protective gloves is highly recommended in medical practice. The purpose of this
      study is to explore how wearing, or not wearing, protective gloves affects

        -  the frequency of unconscious self-contact

        -  contamination of the gloved/ungloved hand
    


Intervention name(s): wearing gloves
Intervention type(s): Procedure
Time perspective: Prospective
Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates whether a platelet function testing guided approach with a short-term
      (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate
      responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and
      thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary
      syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).
    

Detailed description: 
      Patients suffering of heart attack have highly activated blood platelets. During and after
      invasive treatment of blocked coronary vessels (percutaneous coronary intervention = PCI) a
      potent platelet inhibition is needed to reduce the risk of thrombotic complications which is
      particularly high within the first week after PCI. On the other hand, the use of potent
      platelet inhibitors such as prasugrel is associated with higher bleeding risk particularly
      when used at long-term. A combination of a potent antiplatelet drug (prasugrel) within the
      first week with a less potent antiplatelet drug (clopidogrel) thereafter might lead to a
      higher net clinical benefit - means less bleeding and thrombotic complications. This
      hypothesis is being investigated in the current trial.
    

Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): see Arm description; see arm description
Other intervention name(s): Efient; Iscover; Plavix
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prasugrel; Clopidogrel
Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
Condition: Periodontal Disease
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an
      adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal
      disease.
    

Detailed description: 
      The study is a 9-month, randomized, double-blind, parallel-design study of subjects with
      existing moderate to severe periodontal disease randomly assigned to one of three groups. The
      primary endpoint of PD change will be evaluated following 9 months of treatment. Subjects
      will be followed for 9 months for safety and radiographic evaluations.

      Subjects who meet inclusion criteria will be randomized to one of three treatment groups.

      Randomization will be stratified by site and smoker status (never smoked or quit smoking more
      than two years ago vs. has smoked within the last two years). Randomization will be blocked
      such that assignment to treatment groups both within sites and within smoker status will be
      approximately even (1:1:1). Treatment will be initiated after SRP.

      All subjects will be evaluated at baseline and Days 1, 15, 30, 60, 90, 180, and 270.
    

Intervention name(s): ST266; Saline (0.9% NaCl)
Intervention type(s): Biological; Drug
Intervention description(s): 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).; Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain
      when given at tracer levels (microdose) in healthy young men.
    


Intervention name(s): [11C]-Lu AF88370
Intervention type(s): Drug
Intervention description(s): PET ligand in a single intravenous bolus injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment