bioihbjkbjnl/mcl2 huggingface dataset:
Replication of the EMPAREG Diabetes Trial in Healthcare Claims
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Empagliflozin; DPP-4 inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): Empagliflozin dispensing claim is exposure; DPP4 inhibitor dispensing claim is reference
Intervention MeSH terms: Empagliflozin; Dipeptidyl-Peptidase IV Inhibitors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, cohort study design comparing
        empagliflozin to the DPP-4 inhibitor (DPP4i) antidiabetic class. DPP4is serve as a proxy
        for placebo, since this class of antidiabetic drugs is not known to have an impact on the
        outcome of interest. The comparison against DPP4 inhibitors is the primary comparison. The
        patients will be required to have continuous enrollment during the baseline period of 180
        days before initiation of empagliflozin or a comparator drug (cohort entry date). Follow-up
        for the outcome (3P-MACE), begins the day after drug initiation. As in the trial, patients
        are allowed to take other antidiabetic medications during the study.
A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the
      pharmacoMRI Effects of AUT00206 in Healthy Male Participants
    


Intervention name(s): Low dose AUT00206 800mg; High dose AUT00206 2000 mg; Placebo; Ketamine; Saline
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this project is to see whether treatment with a thyroid hormone, called
      triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial
      fibrillation.
    


Intervention name(s): Triiodothyronine; triiodothyronine
Intervention type(s): Drug; Drug
Intervention description(s): 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.; IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to investigate the relative bioavailability of BIIL 284
      BS boli in comparison to the tablet C at a dose of 75 mg in fasted condition and after a
      standard breakfast in healthy male volunteers
    


Intervention name(s): BIIL 284 BS boli; BIIL 284 BS tablet C; standard breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
Condition: Type 2 Diabetes Mellitus; Pancreatic Beta Cell Function; Glucotoxicity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled prospective study aims to evaluate the efficacy of intensive
      insulin therapy for long term glycemic control and improvement or preservation of beta cell
      function in newly diagnosed type 2 diabetes patients.
    

Detailed description: 
      Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of
      diabetes. Although the relative importance of these two alterations is controversial, growing
      evidence is swinging to the concept that there is no hyperglycemia without β-cell
      dysfunction. Also there is agreement that deterioration of glucose tolerance over time is
      associated with a progressive decrease of beta cell function.

      Beside the role of genetic factor, the continuous decline in β-cell function is affected by
      glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious
      cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports
      have shown that early intensive glycemic control plays a role in the prevention of
      progressive ß-cell function and worsening of diabetes.

      Some studies have shown that early intensive insulin therapy(IIT) to achieve near
      normoglycemia in new onset type 2 diabetes gives short term and long term improvement in
      glycemic control after discontinuation of insulin. It is suggested that long term glycemic
      control is associated with improvement of β-cell function.

      In the unpublished previous pilot study, the investigators found that early intensive insulin
      therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type
      2 diabetes can significantly improve the beta cell function and facilitate further long term
      glycemic control. To establish the effectiveness of intensive insulin therapy for long term
      glycemic control and improvement of β-cell function, the investigators will perform a
      randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.
    

Intervention name(s): intensive insulin group; Oral AntiDiabetic Drug (glimepiride and metformin)
Intervention type(s): Drug; Drug
Intervention description(s): Once daily long acting insulin and preprandial rapid acting insulin injection; glimepiride and metformin combined therapy
Other intervention name(s): glimepiride(amaryl); metformin(diabex)
Intervention MeSH terms: Metformin; Glimepiride; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; intensive insulin therapy
Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      In patients at risk of increased intracranial pressure (ICP), ICP measurements require
      invasive transducers, usually with insertion of a catheter into the cranium, or through a
      spinal tap. These invasive modalities involve risks and pain and they can be done only in
      specialized care units, with a high associated cost.

      A novel method for detecting changes in ICP has developed recently. The auditory hair cells
      emit sounds and electric signals in response to sound, which can be easily detected and
      measured non-invasively with the help of a microphone probe placed in the external ear canal
      or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF)
      spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within
      seconds.

      A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination
      of causes: the inflammatory reaction around the tumor, the mass effect of the tumor,
      secondary vascular changes, a change in the flow of CSF.

      The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the
      monitoring of intracranial tumors. It is then detected by using routine clinical signs, in
      combination with a standard imaging method (MRI), but still subjective.

      The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate
      whether the increase in ICP precedes tumor clinical worsening and / or imaging.
    


Intervention name(s): noninvasive method of ICP measurements (Elios)
Intervention type(s): Device
Other intervention name(s): Elios device from ECHODIA company
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: intracranial pressure
Effects of the Elastic Taping on the Chronic Ankle Instability
Condition: Ankle Sprains; Chronic Ankle Instability; Athletes Foot
MeSH terms: Tinea Pedis; Ankle Injuries
Study type: Interventional

Summary: 
      This study will analyze the effects of an elastic taping application protocol in individuals
      with chronic ankle instability. One group will perform a protocol with increased tape tension
      for five weeks while the other group will receive the same tape without tension during the
      same period.
    

Detailed description: 
      Elastic taping is a method widely used in clinical practice for the treatment of ankle
      instability and shows increasing interest in research to verify its effectiveness. The
      literature presents several studies with short-term effects, largely in healthy individuals
      and with several application techniques, with the incremental tensioning of the proposed tape
      subjectively.

      The literature presents several studies with short-term effects, largely in healthy
      individuals and with several application techniques, with the incremental tensioning of the
      proposed tape subjectively.
    

Intervention name(s): Tape with tension; Tape without tension
Intervention type(s): Other; Other
Intervention description(s): The elastic bandage will be applied with a voltage increase controlled weekly, for five weeks. Each week, 5% of tension will be added to the application. In the first week the application will be tension-free.; Bandaging applications will be weekly, for five weeks, without tensioning the tape.
Other intervention name(s): Elastic tape; Kinesiotaping; Tape tensioned; Elastic bandage; elastic tape; elastic bandage; kinesiotaping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Athletic Tape; Ankle Sprains; Chronic Ankle Instability
Garcinia Mangostana L.Pericarp Gel as a Local Drug Delivery in Treatment of Chronic Periodontitis
Condition: Generalized Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      A single-center, randomized controlled clinical trial was done to assess the periodontal
      status of the individuals and the presence of red complex microorganisms (RCM) such as
      Treponema denticola, Porphyromonas.gingivalis and Tannerella.forsythia in the subgingival
      tissues of periodontal pockets at baseline followed by the application of mangostana gel as
      an adjunct to scaling and root planing. The periodontal parameters and RCM were again
      assessed at 3rd month and compared with the placebo group.
    

Detailed description: 
      Background: The study aim to assess the periodontal status of individuals and the presence of
      red complex microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis
      (P.g) and Tannerella forsythia (T.f) in the subgingival tissues of periodontitis subjects
      before and after the application of 4% mangostana gel (MGA) as an adjunct to scaling and root
      planing.

      Methods: 25 sextants (MGA group) were treated with scaling and root planing (SRP) and
      subgingival application of mangostana gel used as local drug delivery (LDD). 25 sextants
      (Placebo group) were treated with SRP and placebo gel. Clinical parameters were recorded and
      the presence of RCM were assessed at baseline and at 3rd month.

      Statistical Analysis: The mean probing pocket depth, clinical attachment level, bleeding
      index, plaque index were assessed at 0th day and 3rd month and compared between the groups
      using one way analysis of co-variance (ANCOVA). Intra-group comparison (MGA) for the presence
      of T.d, from baseline to 3rd month and inter-group comparison (MGA & Placebo) at 3rd month
      was done using Fischer exact test. In both MGA and placebo group, the presence of T.d in
      subgingival tissues was compared with the clinical parameters at 3rd month using student's
      t-test. The p ≤ 0.05 was chosen as a level of significance.
    

Intervention name(s): Garcinia mangostana; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties; The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
Other intervention name(s): Mangosteen; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-inflammatory agents, antimicrobials, Periodontitis
Autonomic Failure Patients for RNA Blood Sampling
Condition: Pure Autonomic Failure; Multiple System Atrophy; Parkinson's Plus Syndromes
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Pure Autonomic Failure; Atrophy
Study type: Observational

Summary: 
      The purpose of this study is to identify 15 patients with autonomic failure and obtain blood
      samples for RNA from those participants and 15 control subjects within the same age range.
      The stabilized blood samples, along with a limited data set, will be shipped to Western
      Michigan University where the actual laboratory analysis (a separate study) of the samples
      will take place.

      Unique genetic inscriptions, called gene expression signatures, are currently being
      identified for many diseases, including neurological diseases. The secondary goal of this
      study is to support the research being done at WMU and they try to look for MSA-specific
      signs are present in whole blood samples of MSA patients at late-stages of the disease. This
      is a pilot study that has a long term goal (through additional studies) a MSA-specific gene
      expression signature for the development of a diagnostic test for this disease that can be
      used in the future. Other patient groups with autonomic failure, characterized by significant
      drop in blood pressure on standing, will also be included in this study, to look for similar
      genetic inscriptions.

      This pilot study is expected to last for 2 years. The investigators at WMU will need some
      de-identified health Information about the subjects, including their age at diagnosis, age
      (when sample drawn) and list of their medications
    

Detailed description: 
      Patients with one of the following autonomic problems will be recruited to participate in
      this study: multiple systems atrophy (MSA), pure autonomic failure (PAF) or Parkinson's Plus.
      The study consists of drawing 15 ml of whole blood for RNA. The blood is drawn in special
      collection tubes to stabilize the RNA material in the blood. The samples will be frozen and
      shipped to WMU for analysis.

      The patients will also be asked to provide the current list of their medications, their age
      and the age when they were first diagnosed with their neurologic or autonomic disorder. This
      information will be de-identified and sent to the investigators at WMU as a limited data set.
    

Sampling method: Non-Probability Sample
Study population: 
        15 patients with diagnosis of autonomic disorder characterized by orthostatic hypotension,
        Pure Autonomic Failure, Multiple System Atrophy or Parkinson's Plus.

        15 controls without a neurological disorder
      
Keywords: Gene Expression Changes in Blood Cells; RNA; Pure Autonomic Failure; Multiply System Atrophy; Parkinson's Plus
A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)
Condition: Healthy Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is
      aspirated out to remove any remaining TI. It's performed twice at specific time points in 12
      healthy volunteers. BAL fluid will be analyzed for insulin and FDKP.
    

Detailed description: 
      Informed consent and eligibility occur at Screening. Dosing is at Visit 2. Blood glucose
      levels are monitored and adjusted using IV infusion of glucose. Bronchoalveolar lavage (BAL)
      is performed at 30 minutes and 6 hours for Cohort 1 and at 4 and 8 hours for Cohort 2, post
      TI dose. A series of blood samples are taken at specified timepoints. Cohort 3 will proceed
      with dosing if deemed necessary once analysis of BAL from Cohorts 1 & 2 is performed. Visit 3
      is the follow-up safety visit.
    

Intervention name(s): TI Inhalation Powder
Intervention type(s): Drug
Intervention description(s): 1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects; insulin; bronchoscope; serum insulin; serum C-Peptide; BAL fluid; FDKP
Study of Pain Following Removal of Wisdom Teeth With Acute Pulpitis
Condition: Pain
MeSH terms: Pulpitis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether pulp chamber opening and drainage on wisdom
      teeth with acute pulpitis before the extraction could reduce postoperative pain so beneficial
      to patient.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients requiring surgical removal of a single upper wisdom tooth with acute pulpitis were
        included in this prospective study
      
Keywords: wisdom teeth; acute pulpitis; extraction; pain; Pain Following Removal of Wisdom Teeth with Acute Pulpitis
Maternal and Infant Growth Study
Condition: Maternal Behavior; Body Weight; Infant Behavior
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later
      in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with
      early rapid growth, and include high maternal BMI prior to pregnancy and excessive
      gestational weight gain. This research focuses on aspects of early feeding as potentially
      modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized
      to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks
      postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads
      are also included. The hypothesis is that differences in feeding practices will be associated
      with differences in growth and that infants randomized to be fed from smaller bottles will
      grow more slowly that those randomized to larger bottles. Growth patterns of formula fed
      infants will also be compared to those of exclusively breastfed infants.
    

Detailed description: 
      Mothers complete feeding logs, questionnaires on health history, demographics, feeding
      attitudes and practices. Infant growth and body composition are measured via PEA POD, and
      maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8,
      and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.
    

Intervention name(s): Feeding and growth differences, 5oz vs 8oz bottle
Intervention type(s): Behavioral
Intervention description(s): Group A: 5oz bottle Group B: 8oz bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Infant Feeding; Infant Growth
Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.
Condition: 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 the study was to determine safety and efficacy of 48 weeks treatment with
      Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and
      ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and
      not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in
      comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and
      placebo.
    


Intervention name(s): Thymosin alpha 1; Ribavirin; PEGinterferon alfa2a; Placebo
Intervention type(s): Biological; Drug; Biological; Drug
Intervention description(s): Thymosin alpha 1 (Zadaxin) 1.6 mg/day, two times weekly in the morning, by subcutaneous injection for 48 weeks.; Ribavirin 1000 mg (<75 kg) or 1200 mg (>75 kg) daily with food divided in two doses orally for 48 weeks; 180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks; Placebo
Other intervention name(s): Zadaxin; Copegus; Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment