bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Carbohydrate Drink in Adults
Condition: Glycemic Response
Study type: Interventional

Summary: 
      The objective of this study is to determine the postprandial glycemic response and rates of
      gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes
      following oral ingestion of carbohydrate.
    


Intervention name(s): Nutritional Supplement
Intervention type(s): Other
Intervention description(s): 50 g Carbohydrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigated the effect of exercise and high-dose salbutamol on the maximum heart
      rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic
      doses of indacaterol, salmeterol and placebo.
    


Intervention name(s): Indacaterol; Placebo; Salmeterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).; Single dose indacaterol matching placebo via Concept 1 device; Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; cycle ergometry; exercise testing; spirometry; cardiovascular; salbutamol; indacaterol; chronic obstructive pulmonary disease
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
Condition: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      It is normal for red blood cells to die, even in newborn babies. The waste from that is
      called bilirubin. The liver clears bilirubin out of the body.

      Some babies are born with illness that makes red blood cells die too fast, so the liver is
      not strong enough to keep up with it.

      The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be
      dangerous if a baby's bilirubin gets too high.

      Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of
      bilirubin.

      This study tests an experimental drug to see if it can help the liver even more, by safely
      cutting down the amount of bilirubin the body is making in the first place.
    

Detailed description: 
      Participants randomized (1:1:1) to treatment groups will be term or near-term infants with
      isoimmune hemolytic disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
    

Intervention name(s): Phototherapy; Stannsoporfin; Placebo
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Phototherapy starts within 30 minutes before or after injection; Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle); Matching placebo administered by IM injection
Other intervention name(s): Light therapy; Experimental drug; Matching placebo; Saline
Intervention MeSH terms: Tin mesoporphyrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: G6PD deficiency; Antibody (ABO) incompatibility; Coombs positive ABO/ rhesus factor (RH) incompatibility; Intensive phototherapy in neonates
A Study to Assess the Effects of GSK573719/VI Combination and GSK573719 Monotherapy in Subjects With Moderate Hepatic Impairment and Matched Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol
      combination in healthy subjects and subjects with moderate hepatic impairment. The results of
      this study will provide guidance on the use of the product in patients with hepatic
      impairment.
    

Detailed description: 
      GSK573719 is being developed as a monotherapy and in combination with vilanterol for the
      treatment of Chronic Obstructive Pulmonary Disease (COPD). This study will assess the
      pharmacokinetics and safety of inhaled GSK573719/ vilanterol (VI) and GSK573719 in healthy
      subjects and in subjects with moderate hepatic impairment. Nine subjects with moderate
      hepatic impairment will be recruited, together with nine matched healthy volunteers.

      There is a possibility that when used by patients with impaired hepatic function the
      pharmacokinetics of inhaled GSK573719 or GSK572719/VI may be altered. The results of this
      study will therefore provide guidance on the use of GSK573719 and GSK573719/VI in moderate
      hepatically impaired patients.
    

Intervention name(s): Inhaled GSK573719/vilanterol; Inhaled GSK573719
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive a single dose of GSK573719/VI (125mcg/25mcg) in Treatment Period 1; All subjects will receive GSK573719 (125mcg) once daily for seven days in Treatment Period 2
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy subjects; pharmacokinetics; vilanterol; tolerability; safety; hepatic impairment; GW642444; GSK573719
Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment
Condition: Dialysis; Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction
      of anemia in participants with end-stage renal disease who recently started dialysis.
    

Detailed description: 
      Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in
      a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron
      supplementation, respectively, in addition to roxadustat. At the same time, participants on
      peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD
      participants, and is an optional, confirmatory/supplemental treatment arm with flexible
      dosing and flexible iron supplementation based on the evaluation of data from the previous 4
      treatment arms.

      Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight [40
      to 60 kilograms {kg}], medium weight [>60 to 90 kg], and heavy weight [>90 to 140 kg]
      participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose
      adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for
      low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on
      the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.
    

Intervention name(s): Roxadustat; Oral Iron; IV Iron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tiered, weight-based dosing per schedule specified in the arm.; Administered per oral dose and schedule specified in the arm.; Administered per IV dose and schedule specified in the arm.
Other intervention name(s): FG-4592
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney; ESRD; Renal; End-Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of
      BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
    


Intervention name(s): BMS-394136; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Solution, Oral, 100 mg, Single dose, 1 day.; Oral Solution, Oral, 0 mg, Single dose, 1 day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Patients requiring dual-chamber pacemakers or defibrillators
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth
      hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
    

Detailed description: 
      Syntropin will be administered by subcutaneous injection. Eligible patients will receive a
      subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12
      hours before, immediately prior to, and 12 hours after the scheduled injection of growth
      hormone.
    

Intervention name(s): Syntropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human growth hormone; idiopathic short stature; short stature
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect of repaglinide plus metformin as initial treatment compared to
      repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated
      haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The
      associated unfavourable events including low blood sugar episodes between the two treatments
      are also compared.
    


Intervention name(s): repaglinide; metformin; repaglinide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily; The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily; The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Treatment Adherence and Compliance
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The investigators aimed to present the efficacy and safety data for patients with RA who
      received tofacitinib therapy in outpatient clinics.
    

Detailed description: 
      This retrospective cohort study included 35 patients with rheumatoid arthritis who received
      tofacitinib therapy in rheumatology outpatient clinic between June 2015 and December 2019.
      Patients who received tofacitinib due to unresponsiveness to ≥2 conventional synthetic
      disease-modifying anti-rheumatic drugs (csDMARDs) and/or ≥1 biological disease-modifying
      anti-rheumatic drugs (bDMARDs) were retrospectively evaluated. Demographic characteristics of
      the patients, the disease activity score-28 for rheumatoid arthritis with erythrocyte
      sedimentation rate (DAS 28-4 (ESR)), change in DAS-28, health assessment questionnaire score,
      visual analogue scale score, and laboratory parameters such as erythrocyte sedimentation rate
      (ESR), C-reactive protein (CRP) level, hemogram, lipid parameters, and uric acid were
      recorded. The data at six months of treatment were compared with baseline data. The effects
      related to the treatment as well as the undesired consequences were evaluated.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Retrospective cohort study
      
Keywords: Rheumatoid Arthritis; tofacitinib; disease activity
A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
Condition: Adverse Anesthesia Outcome
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,
      fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the
      LMA SupremeTM in paralyzed, anesthetized patients.
    

Detailed description: 
      The GuardianTM is a new extraglottic airway device which brings together features of both the
      LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation,
      airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use -
      prevention of disease transmission). In the following randomized, non-crossover study, the
      investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure,
      fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the
      LMA SupremeTM in paralyzed, anesthetized patients.
    

Intervention name(s): Guardian Laryngeal Mask; Supreme Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion; ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
Other intervention name(s): Guardian Laryngeal Mask, Umedaes; Supreme Laryngeal Mask Airway, LMA Deutschland GmbH
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
CCTA to Optimize the Diagnostic Yield of Invasive Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      This study aims to reduce patient risk and costs to the healthcare system by improving the
      diagnostic yield of invasive coronary angiography through existing triage processes to
      improve risk stratification using Coronary Computed Tomographic Angiography (CCTA) as a first
      step in low risk patients. All low-risk patients referred for invasive coronary angiography
      will be potentially eligible for CCTA instead of invasive angiography as a first-line
      diagnostic test. All CCTAs will be read by both a level 3-trained cardiologist and a
      radiologist. The results of the CCTA, coupled with evidence-based management recommendations
      will be sent to the referring physician and an invasive angiogram will be arranged by the HIU
      triage, only when clearly indicated
    


Intervention name(s): Coronary Computed Tomographic Angiography
Intervention type(s): Diagnostic Test
Intervention description(s): All low-risk patients referred for invasive coronary angiography will be potentially eligible to receive the intervention over a 12-month period. The intervention will include risk stratification using Coronary Computed Tomographic Angiography (CCTA) at HHS and NHS as an alternative to upfront invasive angiography. All CCTAs will be read by both a level 3-trained cardiologist and a radiologist. The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged only when indicated as per these management recommendations
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All eligible low-risk patients referred for invasive angiography will be recruited from the
        two interventional sites (approximately 240) via centralized triage process. Patients
        treated before the intervention implementation will be the control group (approximately
        480).
      
Keywords: Angiogram, Coronary Computed Tomographic Angiography
Allopregnanolone for the Treatment of Traumatic Brain Injury
Condition: Traumatic Brain Injury; Posttraumatic Epilepsy
MeSH terms: Brain Injuries; Epilepsy; Brain Injuries, Traumatic; Epilepsy, Post-Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will provide initial data on the safety and effectiveness of allopregnanolone in
      improving neurobehavioral outcome and reducing mortality in adults with moderate and severe
      traumatic brain injury.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive,
      clinical trial study comparing allopregnanolone to placebo when administered intravenously
      for 5 days beginning within 8 hours after injury. Test products to be administered are low
      and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P)
      intravenous solutions. The products are administered during a 4-day treatment period followed
      by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm
      that dosing with Products L and H achieve the target steady-state plasma concentrations set
      for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will
      initially allocate subjects equally to Products L, H and P but will then use adaptive
      randomization to allocate subjects between Products L and H to optimized the probability of
      yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.
    

Intervention name(s): Allopregnanolone injection; Placebo injection
Intervention type(s): Drug; Drug
Intervention description(s): Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium; Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Other intervention name(s): 3α,5α-tetrahydroprogesterone; 3α-hydroxy-5α-pregnan-20-one; Product L (allopregnanolone intravenous solution, low dose); Product H (allopregnanolone intravenous solution, high dose); Product P (placebo)
Intervention MeSH terms: Pregnanolone; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Injuries; Pregnanolone; Epilepsy
UVA Protection Factors of SPF 50 and 50+ Face Sunscreens
Condition: Ultraviolet-Induced Change in Normal Skin
Study type: Observational

Summary: 
      The goal of this observational study is to use the International Organization for
      Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A
      Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question
      it aims to answer is to determine the degree of UVA-protection against UVA radiation.

      An area of each subject's skin is exposed to UVA light without any protection and another
      (different) area is exposed after application of the sunscreen product under test. One
      further area is exposed after application of a reference UVA sunscreen formulation (S2),
      which is used to validate the procedure.
    

Detailed description: 
      The objective of the study conducted in accordance with the Declaration of Helsinki and
      national regulations regarding human studies is to evaluate the UVA protection factor of the
      investigational products against UVA, according to the ISO 24442:2011 methodology
      comparatively to a standard product (Standard S2) in healthy adult subjects.

      Standard reference S2 sunscreen formula is used in a study if any test sample has an expected
      UVAPF of 12 or above. The mean UVAPF for the reference sample S2 is 12,7. The test result of
      the reference S2 UVAPF must be between 10,7 and 14,7 or the test is invalid and shall be
      repeated. The reference S2 may be used to validate any product test.

      In order to determine the number of subjects, the 95 % confidence interval (CI) shall be
      taken into account. The 95 % confidence interval should lie within ±17 % of the mean UVAPF,
      and a minimum of 10 subjects is required.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adults meeting the inclusion and exclusion criteria and willing to adhere to the protocol
        and study procedures
      
Keywords: sunscreen; UVA protection; ISO 24442:2011; photoprotection