bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants
Condition: Hypothyroidism; Thyroid Disease; Euthyroid; Thyroid Gland; Thyroid Hormones
MeSH terms: Thyroid Diseases; Hypothyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safe and effective dose conversion from levothyroxine (synthetic
      T4) therapy to Armour Thyroid therapy in participants who are on a stable dose of
      levothyroxine and have thyroid stimulating hormone (TSH) levels within the normal reference
      range.
    

Detailed description: 
      This study will include will include a Screening Period, double-blinded Titration Period (at
      least 18 weeks, up to 36 weeks), and a double-blinded Stabilization Period (12 weeks).

      Participants will be randomized to receive either their same dose of levothyroxine or an
      approximately, matching dose of Armour Thyroid, using a dose-conversion chart based on the
      United States Pharmacopeia (USP) Drug Information 2000, which states that 1 grain of Armour
      Thyroid is equivalent to 100 mcg of levothyroxine.

      During the Titration Period, Investigators will have the option to up-or down-titrate a
      participant's dose as needed based on the participant's TSH level (normal reference range
      0.45 - 4.12 mIU/L, inclusive). At Week 18, if a participant's TSH levels are not within the
      normal reference range, the Investigator may up-or down-titrate the dose by continuing the
      Titration Period beyond Week 18 for up to a maximum of 3 additional titrations at 6-week
      intervals. Participants whose TSH levels have not normalized after the maximum 3 additional
      titrations will not enter the Stabilization Period.

      At the end of the Titration Period, participants with TSH levels within normal reference
      range may enter the Stabilization Period. Depending on whether a participant requires
      additional dose titration after the Week 18 visit, the Stabilization Period may end at Week
      30, 36, 42, or 48.
    

Intervention name(s): Armour® Thyroid; Levothyroxine
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally once a day. the daily dose could range from 1/4 - 2 grains.; Administered orally once a day; the daily dose could range from 25- 200 µg.
Other intervention name(s): Desiccated thyroid extract; AGN-204771; Synthetic T4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
Condition: Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
MeSH terms: Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study were to determine the rate, extent, and routes of
      radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to
      measure radioactivity concentrations in whole blood and plasma over time.
    

Detailed description: 
      Six adult male or female patients with end stage renal disease requiring hemodialysis will be
      enrolled to receive 750 nCi of [¹⁴C]-labeled etelcalcetide formulated in 10 mg etelcalcetide
      administered as a single 2 mL intravenous dose at the end of hemodialysis.

      Participants will spend the first approximately 12 days in confinement at the clinic (day -1
      until completion of day 11 study procedures). Blood samples, and complete collections of
      dialysate, dialysis membrane (as necessary), urine (as available), and feces will be analyzed
      for radioactivity content by accelerator mass spectrometry (AMS). Following the confinement
      period, participants will return to the site on an outpatient basis in accordance to their
      routine dialysis sessions up to day 39. Blood and dialysate samples and dialysis membranes
      will be collected at specified times during the outpatient visit period.

      Participants may be asked to return so the site for the Extended Pharmacokinetic Collection
      Period. During the Extended Pharmacokinetic Collection Period, participants will return to
      the site for 3 consecutive hemodialysis sessions (Collection Period 1) and then again
      approximately one month later, for an additional 3 consecutive hemodialysis sessions
      (Collection Period 2).
    

Intervention name(s): [¹⁴C]Etelcalcetide
Intervention type(s): Drug
Intervention description(s): 750 nCi of [¹⁴C]etelcalcetide formulated as a single 10 mg dose of etelcaletide in 2 mL liquid solution for bolus intravenous (IV) administration at the end of hemodialysis.
Other intervention name(s): AMG 416; Parsabiv™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMG 416, ESRD, hemodialysis
Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of
      midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and
      with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the
      single-dose pharmacokinetics of BBT-877, in healthy adult subjects.
    


Intervention name(s): BBT-877; Midazolam; Itraconazole; Esomeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BBT-877 oral capsule.; Midazolam oral syrup.; Itraconazole oral capsule.; Esomeprazole oral capsule.
Intervention MeSH terms: Itraconazole; Midazolam; Esomeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Safety and PK Study of OLT1177 Capsules
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy
      volunteers after administration of single or multiple dose(s) of investigational drug
      (OLT1177 Caps or Placebo Caps). A total of 36 subjects will be enrolled across 6 cohorts, and
      subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.
    


Intervention name(s): OLT1177 Capsules; Placebo Capsules
Intervention type(s): Drug; Drug
Intervention description(s): OLT1177 Capsules are an experimental drug.; Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.
Intervention MeSH terms: Dapansutrile
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics; Dose escalation; Randomized; Healthy volunteers; OLT1177; Olatec
The Drug -Drug Interaction of SP2086 and Glyburide
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the potential interaction between SP2086 and
      Glyburide after the singe and multiple oral doses treatment in healthy adult volunteers
      respectively.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center and cross-over study of SP2086 and Glyburide in healthy adult volunteers. All
      subject were randomized into two groups, and the drugs will be administered according to the
      AB and BA sequences.The A sequence was that Glyburide was taken at 5mg qd dose on
      Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.The B
      sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8; Glyburide will be
      administered orally (by mouth) as 200mg on Days 8.
    

Intervention name(s): SP2086; Glyburide
Intervention type(s): Drug; Drug
Intervention description(s): In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.; In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SP2086; Glyburide; drug-drug interaction
NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy
      of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with
      long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess
      safety of NeuroAiD™ (MLC901) in these patients.
    


Intervention name(s): Traditional Chinese Medicine (NeuroAiD II™ (MLC901); Placebo
Intervention type(s): Combination Product; Other
Intervention description(s): NeuroAiD II™ (MLC901) contains the extracts of 9 botanical active ingredients blended with commonly used excipients. The 9 botanical active ingredients are traditional herbs well documented in the Pharmacopoeia of the People's Republic of China.; Placebo with same appearance as active intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Randomized Double-blind; Placebo-controlled; NeuroAiD II™; MLC901; Traditional Chinese Medicine; Cognitive Functioning
vNOTES in Elective Bilateral Salpingectomy for Sterilization
Condition: Sterility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      Objective: To compare the vNOTES approach versus conventional laparoscopic approach to be
      used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer
      prevention strategy.

      Study design: Prospective cohort, two-centred trial. Study population: All women aged over 18
      who are planned to undergo for definitive surgical sterilisation regardless of parity with a
      non-prolapsed uterus.

      Primary outcomes: (1) Patient satisfaction (at 1st week and 1st month of the surgery)
      measured by The Patient Global Imression of Improvement (PGI-I), (2) Postoperative early pain
      (Visual Analog Score (VAS) at 6th and 24th hours of the surgery).

      Secondary outcomes: (1) Conversion to laparoscopy or laparotomy, (2) duration of the
      procedure, (3)total amount of analgesics used, (4) New-onset dyspareunia at first coitus
      measured by the Pain subdomain of Female Sexual Function Index (FSFI), (5) intraoperative
      complications, (6) postoperative complications
    

Detailed description: 
      Women who are indicated or seek for surgical sterilisation are routinely offered
      salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol.
      Those patients will be offered for vNOTES approach after detailed patient counselling and
      will be enrolled to the study upon acceptation.
    

Intervention name(s): vNOTES salpingectomy; Laparoscopic salpingectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical removal of both salpinx by vNOTES with using a 3-cm of posterior colpotomy and either glove port or Gel point V path. Colpotomy will be closed with using 2.0 rapid vicryl.; Surgical removal of both salpinx by conventional laparoscopy in a standardised fashion: with using one 10-mm umbilical and two 5-mm lateral ports.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women seeking for definitive surgical sterilization who prefers salpingectomy over tubal
        ligation due to its possible cancer risk reduction effect.
      
Keywords: vNOTES; Scarless surgery; cancer prevention
Translation and Validation of Stroke Impact Scale 3.0 in Urdu for Pakistan
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      BACKGROUND Knowledge about the perceived impact of stroke on survivors' lives is still scarce
      in Pakistan due to the lack of translated and culturally adapted self-rating scales. The
      stroke impact scale is a comprehensive self-reported outcome measure designed to assess the
      quality of life following the stroke. Although the psychometric properties of SIS found to be
      superior to the conventional generic quality of life scales, it has not been translated and
      tested in Pakistan.

      OBJECTIVE To translate and cross-culturally validate the Urdu version of stroke impact scale
      3.0 for Pakistan MATERIAL AND METHODS Established guidelines were followed for translation
      and adaption of the Stroke impact scale 3.0. A prospective cohort of 116 patients with mild
      to moderate stroke self-reported their recovery on the Urdu version of SIS 3.0. The patients
      were concurrently evaluated on the established scales to assess the validity using the
      Spearman correlation coefficient. ANOVA was used to determine the discriminant validity.
      Ninety patients were consecutively re-evaluated to determine the test-retest reliability,
      precision, minimal detectable change (MCD) and clinically minimally important difference. The
      coefficients of ICC, Cronbach's alpha, and weighted kappa were calculated to establish the
      stability and consistency of the scale. The receiver operating curve was used to estimate the
      MCID of SIS-16 using global rating scale as an anchor.

      KEYWORDS: Stroke, Stroke Impact Scale, Outcome Measures, Quality of Life
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute, subacute or chronic stroke-hemorrhagic or ischemic or recurrent stroke
        attack, age of patients between 50-80 and the ability to read and write Urdu with minimum
        education to 5th grade. Patients were not enrolled in the study if they presented with
        severe neurological comorbidities and communication difficulties, such as patients with
        global aphasia or reduced consciousness.
A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, open-label, three-way crossover, single dose,
      pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.
    


Intervention name(s): OPL-002
Intervention type(s): Drug
Intervention description(s): Spray dried dispersion and tablet formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Whole Body Periodic Acceleration on Airway Endothelial Function
Condition: Healthy; Smokers; Asthma
Study type: Interventional

Summary: 
      In the present proposal the investigators wish to assess the effect of a single session with
      the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on
      baseline airway blood flow (Qaw) and in Qaw variation, in current smokers,
      glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation
      that the treatment will transiently increase the Qaw, and to a greater extent in the current
      smokers and patients with asthma who have endothelial dysfunction.
    

Detailed description: 
      Endothelial shear stress activates nitric oxide synthase (NOS), leading to
      endothelium-dependent vasodilation. This can be accomplished through exercise or with a
      device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) that is also
      called pGz. WBPA produces systemic vasodilation, by exerting shear stress on the vascular
      endothelium, activating endothelial NOS and releasing NO in animal models and human subjects.
      Cigarette smoking is associated with attenuated vascular relaxation responses in the systemic
      circulation. Patients with asthma also exhibit endothelial dysfunction in the airway. In this
      study the investigators wish to assess the effect of a single pGz session on baseline Qaw and
      delta Qaw in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy
      never-smokers to test if this treatment will increase the vascular relaxation responses.
    

Intervention name(s): Whole Body Periodic Acceleration (WBPA); Sham WBPA
Intervention type(s): Device; Device
Intervention description(s): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.; The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: airway blood flow; albuterol; Whole Body Periodic Acceleration (WBPA); Nitric Oxide; Endothelial Dysfunction
Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a 4-week, multicenter, randomized, double-blind, parallel group,
      placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and
      be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2
      diabetes ) or placebo. The drug is a "DPP4 inhibitor"
    


Intervention name(s): PHX1149
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
Condition: Schizophrenia; Schizo-Affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      The importance of stress as a possible deteriorating factor for schizophrenic patients is
      well documented. However, this notion is based on subjective experience and retrospective
      psychological analysis.

      A novel method of measuring cortisol using hair has a proven correlation to subjective stress
      in non-clinical as well as psychiatric clinical populations.

      This pilot study will attempt to assess the use of cortisol hair level, as a marker of
      stress, to predict clinical deterioration in schizophrenic patients.
    


Intervention name(s): Hair Sample
Intervention type(s): Biological
Intervention description(s): Analysis of hair cortisol levels
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Schizophrenia or Schizo-Affective Disorder
      
Biospecimen description: 
      10mg of posterior vertex hair
    
Keywords: Schizophrenia; Schizo-Affective Disorder; Stress; Cortisol; PANSS
Effect of Gefapixant (AF-219/MK-7264) on Cough Reflex Sensitivity (MK-7264-015)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this double-blind crossover study is to assess the effect of single
      doses of 50 mg and 300 mg gefapixant (AF-219/MK-7264) on cough reflex sensitivity to
      capsaicin in both healthy participants and participants with chronic cough. This study will
      also assess the effect of single doses of gefapixant on cough reflex sensitivity to adenosine
      triphosphate (ATP) in healthy participants and participants with chronic cough.
    

Detailed description: 
      Up to 30 participants (male and female) who meet all entry criteria will be randomly assigned
      to treatment with gefapixant or matching placebo.

      There will be a Screening Period, a Baseline Visit (cough participants only), and four
      Treatment Periods, with a washout period between treatments. Participants will return after
      their last Treatment Visit for a Follow-up Visit.

      At the Screening Visit and during the Treatment Periods, cough sensitivity will be measured
      by standard clinical methodology incorporating two cough challenges: 1) capsaicin; 2) ATP.
      The ATP challenge will only be performed during the study treatment period. The Baseline
      Visit (cough participants only) will occur prior to Treatment Period 1. Daytime cough
      monitoring will be performed at the Baseline Visit and during each of the four Treatment
      Periods (cough participants only).
    

Intervention name(s): Gefapixant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gefapixant tablets administered orally as a single dose of 50 mg (1 tablet) or 300 mg (6 tablets)
Other intervention name(s): AF-219; MK-7264
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy
      Japanese male volunteers.
    


Intervention name(s): BI 1744 CL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment