bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)
Condition: Fertilization
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to investigate the dose -response relationship of a
      single injection of Org 38286 to initiate multifollicular growth for the first seven days in
      a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
    


Intervention name(s): corifollitropin alfa; Follitropin beta injection
Intervention type(s): Drug; Drug
Intervention description(s): On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.; Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.
Other intervention name(s): Org 36286; Follistim®; Puregon®
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In-vitro fertilization
Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients
Condition: COVID19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the
      efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia
      patients
    


Intervention name(s): NuSepin® 0.1 mg; NuSepin® 0.2 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NuSepin® 0.1 mg; NuSepin® 0.2 mg; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Sleep
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this project is to look at how sleep affects glucose values in children with
      Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to
      the body's own internal rhythm also known as the circadian rhythm.
    

Detailed description: 
      Diabetes Mellitus (DM) is one of the most prevalent chronic pediatric diseases, affecting
      2.80 cases per 1000 youth between the ages of 10 and 19. Since the crux of diabetes
      management is glucose regulation, any further challenges such as stress and/or poor sleep may
      make glucose regulation even more difficult. Mounting evidence supports the association
      between inadequate sleep and obesity as well as metabolic syndrome. Despite emerging findings
      supporting that total sleep time (TST) may contribute to the risk of obesity and/or metabolic
      complications, less research has been focused on Type 1 Diabetes Mellitus (T1DM) and on other
      sleep parameters.

      Participants will have a Continuous Glucose Monitor (CGM) and actigraph placed which they
      will wear for 5 days. At the end of the 5 days, they will return the glucose meter, CGM, and
      actigraph to a clinic staff or research team member to download their data. They will provide
      us with a glucose log that contains the glucose levels obtained from a fingerstick capillary
      glucose meter. In this log, participants will also record their activities, meals, and
      insulin administered. They will also provide us with a sleep diary. In addition, participants
      will have the option for the child to undergo polysomnography (sleep study) for one night in
      their home or two nights in the sleep lab.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pariticipants will be recruited from the Angel Clinic for Children with Diabetes and
        Endocrine Disorders which is part of University Medical Center in Tucson, Arizona
      
Keywords: Pediatrics; Sleep; Glucose regulation; Type 1 Diabetes Mellitus
ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS
Condition: Acute Hepatitis
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional

Summary: 
      A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis
      (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum
      cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of
      decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol
      (SalivCort) in SAH.

      Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were
      measured
    

Detailed description: 
      We prospectively and consecutively enrolled 75 patients suffering from a SAH (n=44) or a NSAH
      (n=31). Inclusion criteria were patients aged between 18 and 75 years with an acute hepatitis
      defined by an abrupt rise in serum aminotransaminase levels during the 15 previous days (AST
      or ALT greater than 500 IU/L or greater than 10 times the upper normal value); the acute
      hepatitis was considered as severe if the prothrombin index was lower than 50% and as
      non-severe if it was greater than 50%. We excluded patients with the following conditions: a
      history of hypothalamic-pituitary or adrenal disease, corticosteroids treatment within the
      previous 6 months, ketoconazole intake, oral candida infection, any visible bleeding in the
      oral cavity, liver transplanted patients, acute alcoholic hepatitis and night workers.
      Twenty-nine healthy controls (HC) were thereafter enrolled and similarly distributed with the
      SAH group on age, sex and estrogen pill intake, estrogen therapy being the most common cause
      for changes in CBG levels. HC were without any known illnesses and were not receiving any
      medications. To evaluate the range of the SFC concentrations, eight patients with a known AD
      caused by impairment of hypothalamic-pituitary-adrenal axis (n=5) and adrenal gland (n=3) and
      followed at the Endocrinology Department of Besancon were also studied.

      STC, SFC and salivary cortisol concentrations were measured blindly before (T0 between 8am
      and 9am) and 60 minutes after (T60) an intravenous injection of 250 µg tetracosactrin
      (synacthenÒ, Sigma-Tau laboratory, France). Serum CBG, albumin and ACTH were also measured
    

Intervention name(s): Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
Intervention type(s): Biological
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Acute hepatitis; acute liver failure; adrenal dysfunction; salivary cortisol; serum free cortisol
Effects of PSAPs on Speech Processing
Condition: Hearing Loss, Age-Related
MeSH terms: Hearing Loss; Deafness; Presbycusis
Study type: Interventional

Summary: 
      Mild to moderate hearing loss remains undertreated, largely because of the high cost of
      hearing aids. A promising and much less expensive alternative is the use of personal sound
      amplification products (PSAPs), which are electronic, portable, over-the-counter devices that
      amplify sound. Studies have shown that the use of PSAPs provides significant hearing benefits
      and improves the quality of life for older adults with mild to moderate hearing loss.
      However, there is insufficient data to determine the impact of PSAPs use on speech processing
      in the brain.

      The purpose of this study is to use electroencephalography (EEG) measurements to assess the
      neurobiological and behavioral effects of PSAPs on speech perception in noise in individuals
      with mild to moderate hearing loss.

      The investigators expect that the PSAPs use will result in an immediate improvement in the
      ability to perceive speech-in-noise, supporting that these hearing devices may be a means of
      restoring communication skills in people with mild to moderate hearing loss. Behavioral
      benefits will be associated with increased brain activity in auditory regions and
      connectivity between auditory and speech regions in the brain.
    

Detailed description: 
      This study will consist of two sessions of 3 hours each. On one session, participants will
      perform the speech-in-noise task without hearing devices and on the other session,
      participants will perform the speech-in-noise task while wearing personal sound amplification
      products. The order of the sessions will be counterbalanced across participants. The
      speech-in-noise task consists in a word discrimination task in babble noise at three
      signal-to-noise ratios. On each trial, the task is to determine whether two words are
      identical or different.
    

Intervention name(s): Personal sound amplification products
Intervention type(s): Device
Intervention description(s): Participants will be tested with bilateral personal sound amplification products.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hearing loss; Speech processing; Speech-in-noise; Aging
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and
      tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe
      pruritus (itching), following a 28-day regimen of twice-daily topical application.
    

Detailed description: 
      (none provided)
    

Intervention name(s): TS022; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Lotion; Lotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Pruritus
A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of laquinimod as treatment in
      participants with HD after 52 weeks using the Unified Huntington's Disease Rating Scale Total
      Motor Score (UHDRS-TMS or TMS).
    


Intervention name(s): Laquinimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Laquinimod capsules will be administered as per the dose and schedule specified in the respective arms.; Matching laquinimod placebo will be administered as per the schedule specified in the respective arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
Condition: Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to
      quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR
      (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping
      schizophrenic individuals quit smoking. In addition, this study will evaluate how the
      combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.
    

Detailed description: 
      Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic
      individuals to aid in smoking cessation has been encouraging. The purpose of this study is to
      compare bupropion SR to a placebo to determine its effectiveness when used in combination
      with an NTP to help schizophrenic individuals quit smoking.

      Participants in this double-blind, placebo-controlled study will be randomly assigned to
      receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day).
      Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at
      the start of the second week of the study. After three days, the dose of bupropion SR or
      placebo will increase to 2 pills each day. Participants will continue this dosing regimen
      until the end of Week 10. Throughout the 10-week study, participants will receive weekly
      group therapy.
    

Intervention name(s): Bupropion; nicotine transdermal patch
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nicotine dependence
Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by
      administering sodium nitrite intravenously in healthy volunteers. The accuracy of a
      noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison
      to blood measurements from a laboratory analyzer.
    


Intervention name(s): DCI pulse oximeter sensor
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and
      pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple
      combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF
      genotypes.
    


Intervention name(s): ELX/TEZ/IVA; IVA
Intervention type(s): Drug; Drug
Intervention description(s): Fixed-dose combination tablet orally once daily in the morning.; IVA tablet orally once daily in the evening.
Other intervention name(s): VX-445/VX-661/VX-770; elexacaftor/tezacaftor/ivacaftor; VX-770; ivacaftor
Intervention MeSH terms: Ivacaftor; Elexacaftor
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in
      patients with chronic schizophrenia that are not responding adequately to their current
      antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose
      range of 15 to 25 mg, BID in a 1:1 ratio.
    

Detailed description: 
      This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed
      to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of
      NW-3509A of 30 to 50 mg/day (15 to 25 mg, BID) in patients with chronic schizophrenia on a
      stable dose of an antipsychotic (aripiprazole or risperidone). A minimum of 90 patients will
      be randomized in a 1:1 ratio to receive either NW-3509A (n=45) or placebo (n=45). Dose
      increases will be performed only during in-patient setting.

      Safety and efficacy assessments will be done on a weekly basis during the randomized
      treatment period. The assessment of safety will be based on laboratory tests (biochemistry,
      hematology, and urinalysis), 12-lead standard ECG, vital signs, physical examinations,
      neurological examinations, C-SSRS, ESRS-A, subjective reporting of any AE by the subject,
      objective observation of any AE by the Investigator. Pharmacokinetic samples will be taken at
      various time-points. Efficacy assessments will include the PANSS, CGI-C, CGI-S and the
      Strauss-Carpenter Level of Functioning (LOF) scale.
    

Intervention name(s): NW-3509A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A; Patients will be given oral dose of matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO)
      dosed once daily for 5 days is a safe treatment for patients who have suffered an acute
      ischemic stroke.
    

Detailed description: 
      Acute ischemic stroke is a major cause of death and severe disability. The naturally
      occurring hormone, erythropoietin (EPO), is able to protect various neuronal tissues from
      ischemic injury and is beneficial in animal models of acute ischemic stroke. Lu AA24493 is a
      modified (carbamylated) version of EPO, neuroprotective but without the haematopoietic side
      effects. Lu AA24493 is developed for treatment of patients with acute ischemic stroke.
    

Intervention name(s): Lu AA24493 (CEPO); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset; Vials with solution for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; Erythropoietin; Carbamylated; Neuroprotection
A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate effect of single and repeated doses of darunavir
      (DRV) in combination with cobicistat (DRV/COBI) and with ritonavir (DRV+rtv) on the
      pharmacokinetics of single dose dabigatran etexilate (measured in plasma as free and total
      dabigatran) when co-administered in healthy participants.
    


Intervention name(s): Dabigatran Etexilate; DRV/COBI; Ritonavir; Darunavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive single dose of dabigatran etexilate orally.; Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).; Participants will receive ritonavir orally.; Participants will receive Darunavir orally.
Other intervention name(s): REZOLSTA
Intervention MeSH terms: Ritonavir; Darunavir; Dabigatran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Early Parenting Intervention Comparison
Condition: Behavior Problems, Child
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two parenting programs in a
      mental health clinic serving young children with behavior problems.
    


Intervention name(s): Chicago Parent Program; Parent-Child Interaction Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems; Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preschool children behavior problems; child between 2 and 5 years old
Pain in Diagnostic Hysteroscopy
Condition: Pain in Diagnostic Hysteroscopy
Study type: Interventional

Summary: 
      The objective of this study is to assess which factors influence the pain perceived during
      diagnostic anesthesia-free hysteroscopy.
    


Intervention name(s): Diagnostic hysteroscopy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Diagnostic hysteroscopy; Pain; VAS; Multivariate analysis; Normal saline; Carbon dioxide
Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
Condition: Meningitis; Meningococcemia
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study will evaluate the persistence of antibodies approximately three years after an initial
      dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and
      age-matched Menactra naive participants.

      Objectives:

        -  To assess the persistence of antibody responses three years after one or two doses of
           Menactra® vaccine in subjects who participated in study MTA26.

        -  To describe the antibody responses to a single dose of Menactra® vaccine in subjects who
           had previously received one or two doses of Menactra® vaccine and in Menactra®
           vaccine-naïve subjects.

        -  To describe the safety profile of a single dose of Menactra® vaccine in subjects.
    

Detailed description: 
      Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched
      Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be
      evaluated for immunogenicity and safety post-vaccination.
    

Intervention name(s): Meningococcal polysaccharide diphtheria toxoid conjugate; Meningococcal polysaccharide diphtheria toxoid conjugate; Meningococcal polysaccharide diphtheria toxoid conjugate
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): Menactra®; Menactra®; Menactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis; Menactra®