bioihbjkbjnl/mcl2 huggingface dataset:
Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data
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 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 through 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): Glimepiride; Liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Glimepiride dispensing claim is used as the reference group.; Liraglutide dispensing claim is used as the exposure group.
Intervention MeSH terms: Liraglutide; Glimepiride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort design comparing injectable subcutaneous liraglutide (1.2 or 1.8 mg/day) to oral
        glimepiride (4 mg once daily). Treatments in both arms are administered in combination with
        metformin (up to 2,000 mg/day). Patients will be required to have continuous enrollment
        during a baseline period of 180 days before initiation of liraglutide or glimepiride. The
        analyses will be restricted to individuals with type 2 diabetes mellitus who have been
        previously treated with antidiabetic drugs. In the replication, previous anti-diabetic
        treatment was defined as the presence of at least 2 prescriptions for metformin within 6
        months before and including cohort entry.
NIV Application in the Treatment of Asthmatic Children
Condition: Asthma; Child; Bronchial Spasm
MeSH terms: Bronchial Spasm
Study type: Interventional

Summary: 
      Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness
      and chronic airway inflammation and pharmacological treatment for this condition is done with
      bronchodilators and anti-inflammatory.
    

Detailed description: 
      Pharmacologic therapy has clinical efficacy in the control, but the patient often does not
      adhere adequately.

      There is need for further research into non-pharmacological therapies for clinical asthma
      control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial
      effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that
      these therapies also have effects on the BIE.The aim of this study is to evaluate the effect
      of these non-pharmacological therapies in several variables and especially the BIE.
    

Intervention name(s): muscle training; Continue Positive Airway Pressure; bilevel positive airway pressure
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Condition: Post Laser Vision Correction Pain and Discomfort
Study type: Interventional

Summary: 
      The purpose of this research is to determine if an investigational thin shield can
      effectively reduce discomfort following Laser Vision Correction.
    


Intervention name(s): Eye Shield
Intervention type(s): Device
Intervention description(s): one application following refractive surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin
      (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT)
      administered intrapartum and to the newborn, on incidence of HIV infection in infants born to
      HIV-infected women who received AZT during pregnancy for medical indications.

      Vertical transmission of HIV from mother to child may occur before, during, or after
      parturition (via breast-feeding). It is believed that therapy administered both during
      pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive
      short-term antiretroviral therapy for the newborn, following the intensive viral exposure
      presumed to occur at birth, may be necessary.
    

Detailed description: 
      Vertical transmission of HIV from mother to child may occur before, during, or after
      parturition (via breast-feeding). It is believed that therapy administered both during
      pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive
      short-term antiretroviral therapy for the newborn, following the intensive viral exposure
      presumed to occur at birth, may be necessary.

      Pregnant women who are currently receiving AZT are randomized at 20-30 weeks of gestation to
      begin receiving either HIVIG or IVIG every 28 days up to delivery. Within 12 hours after
      birth, the infant receives an infusion of matching study drug. During labor, all women
      receive an intravenous loading dose of AZT administered over 1 hour, followed by continuous
      infusion during the intrapartum period until the umbilical cord is clamped. All infants
      receive AZT syrup every 6 hours, beginning as soon as oral fluids are tolerated but within
      8-12 hours after birth and continuing for 6 weeks. Women are followed until 26 weeks
      postpartum. Infants are followed at weeks 1, 2, 4, and then every 4 weeks through week 24,
      every 12 weeks through week 60, at week 78 (18 months), and at week 104 (24 months).
    

Intervention name(s): Anti-HIV Immune Serum Globulin (Human); Globulin, Immune; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zidovudine; Immune Sera; Immunoglobulins; Antibodies
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Pregnancy; Pregnancy Complications, Infectious; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Immunoglobulins, Intravenous; Immunization, Passive
The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
Condition: Surgical Performance
Study type: Interventional

Summary: 
      Music is commonly heard in operating room. The goal of this study is to measure the effect of
      music on surgical performance using a intraocular surgery simulator. The music chosen is
      Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the
      simulator, both with and without music, in a randomized sequence. The results will be
      subtracted from the simulator and analyzed.
    


Intervention name(s): Music - Mozart's sonata for 2 pianos in D-440
Intervention type(s): Behavioral
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Simulator; Music; Mozart Effect
Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
    


Intervention name(s): doxorubicin hydrochloride; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.; given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Intervention MeSH terms: Gemcitabine; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; recurrent adenoid cystic carcinoma of the oral cavity; recurrent basal cell carcinoma of the lip; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; recurrent metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx
An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone
Condition: Adhesive Capsulitis
MeSH terms: Bursitis; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to
      affect 25% of the general population. Many forms of treatment have been advocated for frozen
      shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid,
      manipulation under anesthetic and arthroscopic releases. There is no general agreement in
      favour of one form of treatment, and the response to a particular treatment varies in
      different series. A few randomized controlled trials appear in the literature. Most of these
      showed improvements with steroid use, but the results were not always statistically
      significant. One randomized control trial reported superior results in favor of arthrographic
      joint distension with steroid compared to a saline placebo. To our knowledge there have been
      no other similar randomized trials to support these results. The objective of this study is
      to determine if arthrographic distension of the shoulder joint with steriods is an effective
      treatment modality for adhesive capsulitis as compared to injection with local anesthetic and
      contrast alone. The study design is a placebo-controlled, double blind clinical trial where
      participants will undergo distension arthrogram of the shoulder and be randomized to receive
      either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and
      contrast alone.
    


Intervention name(s): Triamcinalone (steroid) and lidocaine; Lidocaine
Intervention type(s): Drug; Other
Intervention description(s): receive once; receive once
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: shoulder
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability, pharmacokinetics (the determination of the concentration of the
      administered medication in blood over time) and pharmacodynamics (the determination of the
      effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in
      growth hormone deficient children.
    


Intervention name(s): NNC126-0083; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): One single dose administered in four dose levels in an escalating order; A daily dose of Norditropin NordiFlex® for seven days. Dose will remain constant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an
      open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid,
      and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with
      nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic
      decompensation.
    


Intervention name(s): Obeticholic Acid; Atorvastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once a day (QD) by mouth (PO); Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).
Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.
Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.; Once a day (QD) by mouth (PO)
Other intervention name(s): OCA; 6alpha-ethylchenodeoxycholic acid (6-ECDCA); INT-747
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-alcoholic Fatty Liver Disease; NAFLD; Fatty Liver Disease; NASH
T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This dedicated T/QT study will investigate the effect of relacorilant on cardiac
      repolarization in healthy participants.
    

Detailed description: 
      This four-period crossover study with 12 treatment sequences includes relacorilant
      administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses,
      placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control.
      The positive control will serve to determine the sensitivity of the assay to detect small
      increases from baseline in the QTc interval. Each of the four treatment periods will last 5
      days with a washout of at least 10 days between periods. Relacorilant and placebo to
      relacorilant will be administered double-blind; moxifloxacin will be administered open label.
    

Intervention name(s): Relacorilant; Placebo to relacorilant; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily; Placebo to relacorilant capsule by mouth once daily; Moxifloxacin 400 mg tablet by mouth
Other intervention name(s): CORT125134
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
Condition: Obesity; Overweight; Dyslipidemia
MeSH terms: Obesity; Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight
      management and related conditions. This study set out to investigate if a combination of the
      two could have additional benefits to overweight and obese people.
    

Detailed description: 
      To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a
      Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting
      blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects.

      The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72
      obese or overweight participants. Participants were randomly divided into three groups (24
      participants/ group):

      Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and
      Irvingia gabonensis (CQ-IG).

      The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered
      twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8
      and 10 weeks.

      No major dietary changes or exercises were suggested during the study.
    

Intervention name(s): Irvingia/cissus combo
Intervention type(s): Dietary Supplement
Other intervention name(s): Irvingia cissus combo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Antiobesity; Weight loss
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-period,
      two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300
      mg/5mL oral suspension of OHM Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
      with Trileptal® 300 mg/5mL oral suspension (containing oxcarbazepine 300 mg/5mL) of Novartis
      Pharmaceutical Corporation in healthy, adult, male, human subjects under fasting conditions.
    

Detailed description: 
      Following an overnight fast of at least 10 hours, a single dose of 10 mL of oxcarbazepine 300
      mg/5 mL oral suspension (containing oxcarbazepine 300 mg/5rnL) was administered using a 10 mL
      graduated syringe, during each period of the study under the supervision of trained study
      personnel, along with 240 mL of drinking water at ambient temperature.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study.

      A total of forty (40) subjects were administered a single oral dose of the test or reference
      formulation of 10 mL of oxcarbazepine 300 mg/5 mL oral suspension (containing oxcarbazepine
      300 mg/5mL) according to a randomization schedule. Thirty-five (35) subjects completed both
      the periods of the study.
    

Intervention name(s): oxcarbazepine 300 mg/5mL oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Oxcarbazepine oral suspension fasting study
Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The objective of this study is to validate a social skills training program manual for
      adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately
      150 adolescents with autism spectrum disorders will participate in this study, in groups
      consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both
      group therapy and peer generalization sessions (in the form of a photography class) once a
      week over the course of twelve weeks. Participants and their parents will complete paper and
      pencil, online, or phone measures and video-recordings to assess the participant's social
      skills prior to the intervention, at completion of the intervention and three months later.
    

Detailed description: 
      This study is a pre-test, post-test single group design with post test measures at one week
      after completion of intervention and follow-up at three months. Approximately 300 adolescents
      will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort
      will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time
      sequential manner with up to four cohorts running at a time. Participants and their parents
      will complete pre-test measures including both paper and pencil, online, or phone measures
      and a video-recording to assess the participant's social interaction skills and fluency.
      These adolescents will participate in both group therapy and peer generalization sessions
      once a week over the course of twelve weeks. Upon completion of the intervention,
      participants and parents will complete paper and pencil, online, or phone measures and video
      post-test measures. Participants will be encouraged to participate in a follow-up session
      where the paper and pencil and video measures will be completed again.
    

Intervention name(s): Social Skills Intervention
Intervention type(s): Behavioral
Intervention description(s): Twelve week manual based social skills curriculum targeting social fluency and responsiveness.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspergers; Social Skills; Adolescents; High-functioning Autism
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
Condition: Mild and Moderate Hepatic Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and
      Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic
      Function
    


Intervention name(s): MT-7117
Intervention type(s): Drug
Intervention description(s): Single Dose of MT-7117
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment