bioihbjkbjnl/mcl2 huggingface dataset:
Dyad Oxytocin Study (DOS)
Condition: Schizophrenia; Autism Spectrum Disorder
MeSH terms: Schizophrenia; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the investigators proposed study is twofold: 1) To investigate the role of the
      affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with
      schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate
      whether manipulation of this oxytocinergic system positively influences these family
      interactions.
    


Intervention name(s): Oxytocin; Placebo Comparator
Intervention type(s): Drug; Other
Other intervention name(s): Syntocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: oxytocin; schizophrenia; autism spectrum disorder
Micropulse Laser Trabeculoplasty (532nm) Versus Conventional Laser Trabeculoplasty (532nm)
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      This study will investigate if micropulse laser trabeculoplasty (532nm) is as effecttive as
      or better than the conventional laser trabeculoplasty (532nm), it might be a new treatment
      strategy for glaucoma patients. It is done with a laser device that can also be used for many
      other ophthalmic applications, thus reducing the economic burden of treatment.
    


Intervention name(s): lasertrabeculoplasty
Intervention type(s): Procedure
Other intervention name(s): Conventional (532nm)
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: laser trabeculoplasty; glaucoma
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the efficacy of lumacaftor in combination
      with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)
      who are homozygous for the F508del mutation on the CF transmembrane conductance regulator
      (CFTR) gene.
    

Detailed description: 
      This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter
      study of orally administered lumacaftor in combination with ivacaftor in participants aged 12
      years and older with CF who are homozygous for the F508del-CFTR mutation.

      The study included a Screening Period (Day -28 through Day -1), a Treatment Period (Day 1
      [first dose of study drug] to Week 24 ± 5 days), and a Safety Follow-up Visit (4 weeks ± 7
      days after the Week 24 Visit).
    

Intervention name(s): Placebo; Lumacaftor Plus Ivacaftor Combination; Ivacaftor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching placebo tablet; Fixed dose combination tablet; Film-coated tablet
Other intervention name(s): VX-809+VX-770, LUM+IVA; VX-770, IVA
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI
      therapies in forthcoming randomised controlled multi-centre clinical trials following
      international standards and guidelines.
    

Detailed description: 
      This is a multicentre, observational, registry study of outcome data on SCI patients in
      Mainland China and Hong Kong. The target population consists of patients who have a SCI,
      where acute SCI is defined as <7 days post-injury and chronic SCI is defined as >12 months
      post-initial SCI surgery.

      A total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in
      Mainland China (namely: Beijing, Shanghai, Guangzhou, NingBo, Xi'an and Kunming) and Hong
      Kong. The duration of the study will be one year, with a total of 4 visits.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Each study enrolled Hospital in China and Hong Kong is expected to recruit 20 chronic
        spinal cord injury patients, who have never had any cell therapy treatment for spinal cord
        injur before.
A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of
      PF-05175157 in a dose-dependent fashion in healthy volunteers
    


Intervention name(s): PF-05175157; PF-05175157; PF-05175157; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.; One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.; One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.; One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Single Doses; Pharmacodynamics; Healthy Volunteers
Topical Estriol for Vaginal Health
Condition: Vaginal Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I study is to investigate and document the effects of local
      treatment with a topical estriol cream on the vaginal environment of pre-menopausal women.
    

Detailed description: 
      There is evidence from human studies that estrogen can give rise to health-promoting changes
      in the vaginal environment in addition to affecting the thickness of the vaginal epithelium.
      The purpose of the proposed study is to take the first steps in testing the effects of local
      estrogen treatment on vaginal health parameters in humans. We have chosen an estriol product
      because, in comparison with estrone (E1) and estradiol (E2), estriol (E3) is generally
      considered to be a weak estrogen. The duration of estriol's interaction with the estrogen
      receptor is quick and exhibits rapid metabolic clearance. We have chosen a topical route of
      administration because it appears to result in fewer systemic effects than oral
      administration, while allowing us to concentrate treatment locally in the areas we wish to
      affect.

      Our primary goal is to test whether or not topically applied estrogen results in significant
      thickening and maturation of the vaginal epithelium. Our secondary goal is to measure the
      treatment's effects on other parameters of the vagina, such as Lactobacillus colonization and
      vaginal pH. If estrogen cream does indeed affect the vaginal environment in pre-menopausal
      women as it does in post-menopausal women, further study would be indicated to determine
      whether estrogen cream in the vagina decreases risk of infection in pre-menopausal women.
    

Intervention name(s): estriol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 ml vaginal cream (1.0 mg estriol/1 ml cream), 3 days/week for approximately 2 months.; Placebo cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: estrogen; estriol; cream; vagina; infection prevention
A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a
      combination with a myeloablative dose of busulfan. This is an initial step in developing a
      novel myeloablative preparative regimen for allogeneic hematopoietic stem cell
      transplantation (HSCT). While this phase I trial will initially develop the regimen in
      patients with refractory disease, it is expected that it will find its best application in
      patients with less advanced disease
    

Detailed description: 
      All patients will receive the same dose of busulfan. The dose of clofarabine will be
      escalated in successive cohorts of patients. Using a standard dose escalation design,
      successive cohorts of 3 patients will be treated with escalating doses of clofarabine. At the
      MTD (or highest dose-level if the MTD is not reached), the cohort will be expanded to 10
      patients to better investigate correlative studies and give some preliminary idea of
      efficacy.
    

Intervention name(s): clofarabine
Intervention type(s): Drug
Intervention description(s): Cohort- n- Clofarabine (mg/m2/day)
-1 3-10 20
3-6 30
3-6 40
3-6 50
3-6 60
6-10 70
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clofarabine; allogeneic HSCT; refractory malignancies
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Condition: Hypoglycemia; Diabetes Mellitus; Drug-Specific Antibodies
MeSH terms: Diabetes Mellitus; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years
      will be selected for inclusion in the study. The target is to obtain treatment response and
      user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of
      hypoglycemia. The population will be enriched to include participants who suffer from
      impaired hypoglycemia awareness.
    

Detailed description: 
      This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered
      under clinical use conditions in treating episodes of hypoglycemia in persons with T1D.

      This study also aims to assess the ease with which caregivers can administer the experimental
      medication in treatment of hypoglycemic events.

      The study will also generate data on the participants' assessment of local tolerability and
      provide information on immunogenicity of nasal glucagon with regards to the potential
      development of anti-glucagon antibodies.
    

Intervention name(s): Nasal Glucagon
Intervention type(s): Drug
Intervention description(s): 3 mg nasal glucagon powder
Other intervention name(s): Dry-Mist Nasal Glucagon; AMG504-1; LY900018
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Hypoglycemia; Glucagon; Anti-glucagon Antibody; Immunogenicity
Assessing the Effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis
Condition: Sepsis; Immune Deficiency; Hemoperfusion; Blood Purification
MeSH terms: Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomized, open-label study, the investigators will assess whether CytoSorb
      hemoperfusion will prevent or attenuate the development of immunoparalysis in healthy
      volunteers undergoing repeated experimental endotoxemia.
    

Detailed description: 
      Sepsis is an inflammatory syndrome with high mortality rates and increasing incidence.
      Sepsis-induced immunoparalysis, increasingly recognized as the overriding immune disorder in
      sepsis patients, attributes significantly to late mortality in sepsis patients.

      The investigators hypothesize that 'blood purification' techniques targeted at the removal of
      excess circulating cytokines, such as the CytoSorb hemoperfusion device, might prevent or
      attenuate the development of immunoparalysis.

      The objective of this trial is to determine the effects of CytoSorb hemoperfusion on the
      development of immunoparalysis in a repeated experimental endotoxemia model in healthy male
      volunteers.

      To this end, 24 healthy male volunteers subjects will be randomized in a 1:1 fashion into one
      of two treatment groups (active or control). Both study groups will undergo two endotoxin
      challenges, separated by seven days. To this end, endotoxin (LPS) will be administered as a
      bolus of 1 ng/kg, followed by continuous infusion of 0.5 ng/kg/hr for three hours. The active
      group will be treated with CytoSorb hemoperfusion during the first endotoxin challenge,
      whereas the control group will receive no additional treatment. During both endotoxin
      challenges, blood samples will be obtained serially to measure levels of circulating
      cytokines and other inflammatory mediators.
    

Intervention name(s): CytoSorb hemoperfusion
Intervention type(s): Device
Intervention description(s): Subjects will be treated with CytoSorb hemoperfusion (in stand-alone setup) for 6 hours at a flow rate of 250 ml/min during endotoxemia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Metformin During Nicotine Withdrawal
Condition: Smoking; HIV-1-infection
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effects of a medication called metformin
      (Glucophage®) on smoking behavior. This medication is FDA-approved for treatment of type-2
      diabetes. It is being used for research purposes in this study. Participants will be
      randomized to one of 3 treatment groups: low dose of metformin, high dose of metformin, or
      placebo.
    

Detailed description: 
      There is a need for novel approaches to optimize smoking cessation treatment to help more
      smokers quit. Mood disturbance and cognitive deficits during nicotine withdrawal may be
      important treatment targets given their association with smoking relapse. In addition,
      factors such as HIV-1 infection may exacerbate abstinence effects on mood and cognitive
      deficits and thus should be measured and controlled for. The investigators hypothesize that
      the FDA-approved medication, metformin, will attenuate withdrawal-related mood disturbance
      and cognitive deficits, controlling for HIV status. Using a well-validated abstinence
      challenge paradigm, the investigators propose a placebo-controlled double-blind parallel arm
      study with one between-subjects factor of medication (low dose: 500 mg, high dose: 1500 mg,
      and placebo). Non-treatment seeking smokers (HIV-: n=54; 18 per group) will complete this 23
      day study.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin capsule; Sucrose filler in gel capsules
Other intervention name(s): Glucophage; Placebo (for Metformin)
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TAK-935 Multiple Rising Dose Study in Healthy Participants
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      multiple rising doses of TAK-935 in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-935. This study will look at the
      pharmacokinetics, safety and tolerability of TAK-935 in healthy participants. The study will
      enroll approximately 56 participants. Participants will be randomly assigned (by chance, like
      flipping a coin) to 1 of the 5 cohorts in Part 1, which will remain undisclosed to the
      participant and study doctor during the study (unless there is an urgent medical need):

        -  Part 1, Cohort 1: TAK-935 100 mg QD

        -  Part 1, Cohort 2: TAK-935 300 mg QD

        -  Part 1, Cohort 3: TAK-935 300 mg BID

        -  Part 1, Cohort 4: TAK-935 600 mg QD

        -  Part 1, Cohort 5: TAK-935 400 mg QD Participants will be asked to take the oral solution
           once or twice a day at the same time for 14 days. An optional Part 2 may be conducted
           for collecting data to assess the engagement by TAK-935 of the central molecular target
           cholesterol 24S-hydroxylase (CH24H) by measuring the changes of levels of the metabolite
           24S-hydroxycholesterol (24HC). In Part 2, participants will be assigned to up to 2
           treatment groups at doses based on the data from other ongoing TAK-935 trials, combined
           with the safety and tolerability data from Cohorts 1-4 of Part 1.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study will be approximately 30 days. Participants will be admitted in the
      clinic for the first 14 days, and will be contacted by telephone on Day 28 for a follow-up
      assessment.
    

Intervention name(s): TAK-935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 oral solution; TAK-935 placebo-matching oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug therapy
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study was to evaluate the efficacy, safety, tolerability and
      pharmacokinetics of mirabegron after multiple-dose administration in the pediatric
      population.
    

Detailed description: 
      This was a phase 3, open-label, baseline-controlled, multicenter study. The study consisted
      of 3 periods: Pretreatment period: for a maximum of 28 days before baseline, including
      screening, washout (if applicable) and baseline.

      Efficacy treatment period: beginning the day after baseline and continuing to week 24.
      Long-term safety period: beginning after week 24 and continuing to week 52 (end of study
      [EOS]), or to the end of treatment (EOT).
    

Intervention name(s): Mirabegron
Intervention type(s): Drug
Intervention description(s): Participants received initial dose of 25 mg of mirabegron PED25 orally once daily. At weeks 2, 4 or 8, participants were up-titrated to PED50 based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT. Participants with a body weight >=35 kg received mirabegron tablets or body weight <35 kg received mirabegron oral suspension. At week 24, participants on mirabegron oral suspension could switch to tablets if the body weight became >=35 kg or participants on mirabegron tablets could switch to oral suspension if the body weight became <35 Kg or participants could switch to either of the dosage form for acceptability reasons after sponsor's prior approval and on a case-by-case basis. Mirabegron extended-release granules were reconstituted with water to prepare a mirabegron oral suspension of 8 mg/mL. Administration was via an oral syringe with a sip of water afterwards.
Other intervention name(s): YM178; Myrbetriq; Betanis; Betmiga
Intervention MeSH terms: Mirabegron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics; Urodynamics; Mirabegron; Phase 3; Neurogenic Detrusor Overactivity
A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20
      μg/ml concentration administered two or three times daily for 4 weeks in patients with
      moderate to severe dry eye.
    

Detailed description: 
      This is a 4 weeks, Phase II, multicenter, randomized, double-masked, vehicle-controlled,
      parallel group study with 12 weeks of follow-up, designed to perform dose-ranging and to
      evaluate safety and efficacy of recombinant human Nerve Growth Factor (rhNGF) eye drops
      solution versus vehicle, in patients with moderate to severe dry eye (DE).

      Test product is rhNGF 20 μg/ml; reference product is vehicle. Test and reference will be
      instilled in both eyes according to the following scheme:

      Group 1: one drop of rhNGF 20 μg/ml is instilled in both eyes three times daily (every 6-8
      hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

      Group 2: one drop of rhNGF 20 μg/ml is instilled in both eyes two times daily (in the morning
      and in the evening) plus one drop (40 μL) of vehicle (placebo) is instilled in both eyes once
      daily in the afternoon.

      Group 3: one drop (40 μL) of vehicle (placebo) is instilled in both eyes three times daily
      (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

      Approximate randomization 1:1:1 of 261 patients to rhNGF eye drops solution 20 μg/ml TID (87
      patients) or rhNGF eye drops solution 20 μg/ml BID + vehicle eye drop SID (86 patients) or
      vehicle eye drops solution (88 patients) TID for 4 weeks was applied.
    

Intervention name(s): rhNGF 20 μg/ml; rhNGF 20 μg/ml + vehicle; Vehicle
Intervention type(s): Drug; Drug; Other
Intervention description(s): one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours); one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).
rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.; one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)
Other intervention name(s): cenegermin; cenegermin + placebo; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment