bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional

Summary: 
      Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.

      In this study we will test the effects of a liquid meal on the bone remodeling in
      participants with hypoparathyroidism. Furthermore, we will test the effects of the gut
      hormones GIP and GLP-2.
    


Intervention name(s): Liquid meal (Nutridrink); GIP; GLP-2; Placebo (saline)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Liquid meal ingested over 1 minute.; Subcutaneous injected GIP; Subcutaneous injected GLP-2; Subcutaneous injected Placebo (saline)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: hypoparathyroidism; Glucose-dependent insulinotropic polypeptide (GIP); Glucagon-like peptide-2 (GLP-2); Bone remodeling; Bone resorption; Bone formation; C-terminal telopeptide (CTX); N-terminal propeptide of type 1 procollagen (P1NP)
SkinPen Efficacy on Acne Scars on the Face and/or Back
Condition: Atrophic Acne Scar
MeSH terms: Acne Vulgaris; Atrophy
Study type: Interventional

Summary: 
      This single-center, clinical trial will take place over a 90 day course followed by 1-month
      and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen
      device when used on both men and women on the face and/or back.
    

Detailed description: 
      At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for
      treatment on their moderate to severe acne scars on the face and/or back. Implementation of
      needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their
      location. Each subject will undergo 3 treatments in 30 day increments and will take
      pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will
      be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic
      Improvement Scale, as well as a self-assessment.
    

Intervention name(s): Aesthetic Microneedling Treatment
Intervention type(s): Procedure
Intervention description(s): Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of gut microbial metabolism of flaxseed
      lignans on cardiovascular health. Enterolactone is the main gut microbial metabolite of
      lignans. The study population will be stratified in low and high enterolactone producers and
      will investigate whether high producers will have greater benefits than low producers, and
      whether low producers may become high producers after daily consumption of lignans over 8
      weeks. The investigators will evaluate changes in endothelial function, blood pressure,
      arterial stiffness, insulin resistance, lipid profile and gut microbiome composition after 8
      weeks daily consumption of flaxseed lignans.
    

Detailed description: 
      Epidemiological studies have shown inverse relation between enterolactone levels and
      cardiovascular mortality. Participants will be stratified from first phase (NCT03573414) and
      then randomly allocated to treatment or placebo. Outcomes are measured at baseline and after
      8 weeks post consumption.
    

Intervention name(s): lignan capsules contain 300 mg flaxseed (SDG) extract; Placebo treatment matching intervention
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): lignan capsules contain 300 mg flaxseed (SDG) extract; Placebo treatment matching intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular system Polyphenols
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will
      be given boceprevir. Blood samples will be taken at specified intervals to find out whether
      boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.
    


Intervention name(s): boceprevir; methadone; buprenorphine/naloxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7; methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8; buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8
Other intervention name(s): SCH 503034, Victrelis™
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
Condition: Compare Blood Age for Transfusion
MeSH terms: Acidosis; Acidosis, Lactic
Study type: Interventional

Summary: 
      In resolving lactic acidosis among children with severe malarial anemia, there is no
      difference between those transfused with blood of longer storage compared to shorter storage
      age
    

Detailed description: 
      Objective of the study is to evaluate the effect of blood storage age on resolution of lactic
      acidosis in children with severe malarial anemia.

      Methods:

      Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb <5g/dl) and
      Lactic Acidosis (blood lactate >5 mmol /l), will be randomly assigned to receive either blood
      of shorter storage age (<10 days) or longer storage age (21 -35 days) by gravity infusion as
      is the routine practice. 37 patients will be enrolled in each study arm. Physiological
      measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory
      rate and pulse rate will be taken at baseline, during and after transfusion. The two groups
      will be compared. The primary outcome variable will be the proportion of children whose
      lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary
      outcome.
    

Intervention name(s): Blood transfusion
Intervention type(s): Biological
Intervention description(s): The short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Blood; Storage; Age; Transfusion; Lactic acidosis
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Condition: Bioequivalence; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate and compare the bioavailability and therefore to
      assess the bioequivalence of two different formulations of sitagliptin/metformin extended
      release tablets after a single oral dose administration under fasting conditions.
    


Intervention name(s): Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test
Condition: Balance
Study type: Interventional

Summary: 
      This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate
      its validity in spanish population.
    

Detailed description: 
      To translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity
      in spanish. Check its metric properties in relation to other balance tests.
    

Intervention name(s): Case group
Intervention type(s): Behavioral
Intervention description(s): assessment of quality on posture, transfers and displacement
Intervention model: Single Group Assignment
Intervention model description: single group assignment. cross-sectional survey.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: balance, risk of falling
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to
      placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have
      inadequate glycemic control on maximally or near-maximally effective doses of metformin and
      sitagliptin.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (an inactive substance that is compared with a study drug, to test whether the study drug has
      a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in
      participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or
      near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day.
      Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1
      ratio for 26 weeks. During the study the participants will be also provided with diet and
      exercise counseling (standardized non-pharmacological therapy).
    

Intervention name(s): Canagliflozin, 100 mg; Canagliflozin, 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 100 mg capsule taken orally (by mouth) once daily.; One 300 mg capsule taken orally (by mouth) once daily.; One placebo capsule taken orally (by mouth) once daily.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Canagliflozin; Hemoglobin A1c; Metformin; Sitagliptin; T2DM; JNJ-28431754
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety and tolerability for
      pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the
      symptoms of neuropathic pain.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF)
      and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of
      SPR206 in healthy adult volunteers.
    


Intervention name(s): SPR206
Intervention type(s): Drug
Intervention description(s): Three 100 mg SPR206 intravenous doses administered every 8 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; alveolar macrophages (AM); epithelial lining fluid (ELF); intrapulmonary; bronchoalveolar lavage
A Placebo-Controlled Single-Dose Trial of Sildenafil in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of
      sildenafil 50 & 100 mg added to stable antipsychotic treatment in schizophrenia patients to
      assess whether this PDE5 inhibitor improves cognitive functioning (including verbal memory,
      fluency, attention, spatial memory, motor speed, and executive function) and clinical
      symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).
    

Detailed description: 
      Specific Aims:

        1. Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on
           cognitive functioning, including verbal memory, fluency, attention, spatial memory,
           motor speed, and executive function.

        2. Evaluate the effects of single doses of sildenafil 50 & 100 mg compared to placebo on
           psychotic, negative, and mood symptoms.

        3. Assess self-reports of side effects of sildenafil 50 & 100 mg.

      Location and Subjects:

      25 adult outpatients with schizophrenia will be recruited from the Massachusetts General
      Hospital outpatient clinic or the Freedom Trail Clinic of the Lindemann Center. All research
      procedures will be performed at the Psychopharmacology Clinic of the Massachusetts General
      Hospital. Subjects must be English speaking because the cognitive battery has only been
      validated in English.
    

Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): 1 capsule Sildenafil 50mg or Sildenafil 100mg or placebo taken at the time of study visit.
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Sildenafil; PDE5 Inhibitor
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of concomitant
      Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of
      the routine vaccination series in healthy infants
    


Intervention name(s): Prevenar and Meningitec; Prevenar; Meningitec
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 dose of Prevenar at 2,3.5,6 and 12 months and 1 dose of Meningitec at 2,6 and 12 months; 1 dose at 2,3.5,6 and 12 months; 1 dose at 2,6 and 12 months
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease; pneumococcal disease; meningitis
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A significant number of patients with high risk superficial bladder cancer has progression to
      invasive disease. No consensus exists regarding the optimal treatment to decrease the
      recurrence and progression rate. The aim of this research is to evaluate the safety,
      tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of
      high-risk superficial bladder cancer
    

Detailed description: 
      This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary
      urban teaching University Urological Department regarding sixty-four patients with high-risk
      superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions
      (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated
      weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at
      3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a
      weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36
      months.
    

Intervention name(s): BCG; gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): 6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.; 14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: BCG; Gemcitabine; Intravesical; Therapy; Superficial; Transitional; Cell carcinoma
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label Phase III extension study to evaluate the long-term safety of
      eltrombopag in pediatric patients with chronic ITP who previously participated in study
      TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each
      subject based upon platelet count. The starting dose was based on the subject's dose at the
      end of the TRA115450 study. The maximum dose was 75 mg daily.
    


Intervention name(s): Eltrombopag Tablets; Eltrombopag PfOS
Intervention type(s): Drug; Drug
Intervention description(s): Eltrombopag tablets will be white, round film coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg and 75 mg of eltrombopag. The 12.5 mg tablet will be smaller than the 25 mg, 50 mg and 75 mg tablets. Subjects will receive maximum dose of 75 mg once daily (QD).; Eltrombopag PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain eltrombopag olamine equivalent to 20 mg of eltrombopag per gram of powder. Subjects will receive maximum dose of 75 mg once daily (QD)
Intervention model description: AEs were graded using the common toxicity criteria for adverse events (CTCAE) Version 4.03. If a patient reported more than one AE with the same preferred term (PT), the AE with the greatest severity was presented. If a patient reported more than one AE within the same primary system organ class (SOC), the patient was counted only once with the greatest severity at the SOC level, where applicable. An AE with missing CTCAE grade was included in the 'All grades' column of the summary tables.
In AE summaries, the primary SOC was presented alphabetically and the PTs were sorted within the primary SOC in descending frequency.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic immune thrombocytopenic purpura, ITP, eltrombopag olamine, thrombopoietin receptor agonist, pediatrics
Controlling Hyperglycemia Among Minority Population
Condition: Diabetes
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of three approaches in diabetes
      management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual
      hospital-based care. The goal is to determine the most cost-effective method of diabetes
      management among an economically-disadvantaged, minority population.
    

Detailed description: 
      The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled
      hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes.
      Patients from a safety-net hospital will be randomized into three groups: 1) a control group,
      2) an intervention providing diabetes self-care text messages, or 3) an intervention using
      community health workers to provide diabetes education and linkage to care. Secondary
      objectives include increasing diabetes knowledge, improving diabetes self-management, and
      increasing use of primary care (i.e., make one visit to the physician in 6 months) among the
      intervention participants. A cost-effectiveness analysis will determine the most appropriate
      way to reduce the burden of uncontrolled diabetes.
    

Intervention name(s): Community health worker education; Cell phone text messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diabetes self-management education by community health workers; Diabetes self-management education through cell phone text messaging
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: A1C≥9%; minorities; economically disadvantaged
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy (how well the drug works), safety, and
      any side effects of olanzapine compared to placebo in the treatment of mania in bipolar
      disorder in adolescents. Both the potential benefits and side effects of olanzapine will be
      evaluated throughout this trial.
    


Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment