bioihbjkbjnl/mcl2 huggingface dataset:
Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors
Condition: Pregnancy; Smoking
Study type: Observational

Summary: 
      This study assessed the relationship between pregnant women, partner support, and cigarette
      and alcohol use in pregnancy.
    

Detailed description: 
      Paternal support is related to positive pregnancy outcomes. We explored the relationship
      between paternal involvement and maternal smoking and alcohol consumption during pregnancy.
      This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44
      years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas
      Jefferson University. Women who identified their partner as their main support were included.
      Demographic and health information was collected. A composite support score for each woman
      was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a
      scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking
      status using ANOVA and Student's t-test.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Norbeck Social Support Questionnaire (NSSQ)
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Paternal support is related to positive pregnancy outcomes. We explored the relationship
        between paternal involvement and maternal smoking and alcohol consumption during pregnancy.
        This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44
        years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas
        Jefferson University. Women who identified their partner as their main support were
        included.
Validation of Next Generation Cerebral and Tissue Oximeter
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure
      the cerebral tissue oxygen saturation.
    


Intervention name(s): Desaturation
Intervention type(s): Device
Intervention description(s): The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
Other intervention name(s): Cerebral and Tissue Oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
Condition: Type-1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
      insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would
      regulate glucose levels through the infusion of two hormones: insulin and glucagon.

      The main goal of this project is to assess whether a dual-hormone closed-loop strategy would
      alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D)
      without a significant degradation in post-meal glucose control.

      Each patient will be admitted twice to a clinical research facility. In one visit, patients
      will eat a morning meal accompanied with a matching insulin bolus (depending on the
      carbohydrate content of the meal) and glucose levels will be subsequently regulated using
      dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will
      inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and
      the remaining needed insulin will be delivered based on glucose sensor excursions as part of
      closed-loop operation. If post-meal glucose levels were indifferent between the two visits,
      then this would suggest that carbohydrate counting may not be necessary during closed-loop
      operation as the closed-loop system will give any remaining insulin needed to cover the
      glucose absorbed from the meal. Twelve subjects will be enrolled in this study.
    


Intervention name(s): Dual Hormone closed-loop system
Intervention type(s): Device
Intervention description(s): The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study examined the 12-month effectiveness of continuous therapeutic assertive community
      treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment
      area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with
      quetiapine IR.
    

Detailed description: 
      Two catchment areas in Hamburg, Germany with similar population size and health care
      structures were assigned to offer 12-month ACT (& IC; Department of Psychiatry and
      Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital,
      Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected
      multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement.
      Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning,
      quality of life, satisfaction with care from patients and relatives perspectives, and service
      use data.
    

Intervention name(s): Assertive Community Treatment (ACT)
Intervention type(s): Behavioral
Intervention description(s): ACT was structured and implemented according to guidelines of the Assertive Community Treatment Association (ACTA). Team members were highly educated psychosis experts consisting of a consultant psychiatrist, a psychiatrist, two psychologists, and a nurse, all of which received training in cognitive behavioral (CBT), dynamic, and/or family psychotherapy. Study participants could use all treatment options within the integrated care program such as psychoeducation groups, social skills training, family groups, motivational addiction therapy, meta-cognitive training etc.
Other intervention name(s): Assertive Community Treatment, Schizophrenia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, assertive community treatment, quetiapine
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia
Condition: Torticollis (Spasmodic)
MeSH terms: Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of
      daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).
    


Intervention name(s): DaxibotulinumtoxinA
Intervention type(s): Biological
Intervention description(s): Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical dystonia; Spasmodic torticollis
Results of Peripheral Blood Stem Cells According to Stimulatory Molecule,: Zarzio Versus Granocytes
Condition: Hematology, Graft, Mobilization
Study type: Observational

Summary: 
      Investigator therefore propose a retrospective mono-centric study, to compare the results
      obtained in patients with myeloma or lymphoma, mobilized with Zarzio® in order to obtain a
      graft, with the results obtained in our study. retrospective cohort of mobilization by
      Granocyte®.
    

Detailed description: 
      Autologous cell therapy remains the standard treatment in lymphomas (Hodgkin or non Hodgkin)
      and myelomas in the first line if they have bad prognostic factors or second-line cases of
      relapsed or relapsed patients. The essential condition for performing an autograft is the
      existence of a graft sufficient for this procedure. The European Society of Marrow
      Transplantation (EBMT) recommends to inject a minimum of 2 × 10 6 CD34 + cells / kg.

      Although in terms of conventional products (Neupogen® and Granocyte®), the literature is very
      rich, there is no data on the use of biosimilars in this indication. A PUBMED search using
      the terms "peripheral blood stem cell harvest, OR Zarzio® biosimilars" did not produce any
      results.

      Zarzio® has a tolerance and efficacy profile equivalent to "classical" products when used in
      post-chemotherapy, primary or secondary prophylaxis.

      It therefore seems important to compare its efficacy and tolerance in mobilization situations
      for peripheral stem cell sampling.The Investigator therefore propose a retrospective
      mono-centric study, to compare the results obtained in patients with myeloma or lymphoma,
      mobilized with Zarzio® to obtain a graft, with the results obtained in our study.
      retrospective cohort of mobilization by Granocyte®.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Lymphoma or myeloma patients for whom autologous stem cell tansplatation is a therapeutical
        option
The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA (
      adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related
      differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation
      in this patient population.

      Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has
      resulted in increased bioavailability in adult patients in clinical trials. However, the
      safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and
      the direction of the variation is not predictable. This study will assess these parameters of
      bis-POM PMEA in children.
    

Detailed description: 
      Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has
      resulted in increased bioavailability in adult patients in clinical trials. However, the
      safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and
      the direction of the variation is not predictable. This study will assess these parameters of
      bis-POM PMEA in children.

      Patients are stratified by age, and separate cohorts from each age group receive 1 of 2
      single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17
      years; if toxicity is acceptable, the other cohort in this age range receives the higher
      dose. At this point, accrual of infants < 3 months old may begin at the lower dose, followed
      by accrual of this age group at the higher dose if toxicity is acceptable. Serum drug
      concentrations are monitored up to 8 hours post dose.

      AS PER AMENDMENT 5/2/97: Based on data from both the low- and high-dose cohorts of the older
      age group (>= 3 months to < 18 years), the younger age group (<3 months) will be started at
      the high-dose.
    

Intervention name(s): Adefovir dipivoxil
Intervention type(s): Drug
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiviral Agents; Adenine
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble
      in patients diagnosed with Pathological Gambling.
    

Detailed description: 
      The purpose of this study is to determine if ecopipam is able to stop urges to gamble in
      patients diagnosed with Pathological Gambling. Nerves communicate with each other by
      releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain
      is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by
      interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that
      selectively blocks one family of dopamine receptors. Some scientists believe that the urge to
      gamble is related to having too much dopamine in the brain. By blocking the receptors that
      dopamine uses, ecopipam may be able to relieve the urge to gamble.
    

Intervention name(s): Ecopipam
Intervention type(s): Drug
Intervention description(s): 50mg tablets
Other intervention name(s): PSYRX101; SCH 39166
Intervention MeSH terms: Ecopipam
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pathological Gambling; ecopipam; Dopamine
Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered
      alone and when both are administered together.
    


Intervention name(s): K-877; CSG452
Intervention type(s): Drug; Drug
Intervention description(s): K-877 tablets; CSG452 tablets
Intervention MeSH terms: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ANX-188 Thorough QT/QTc Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the
      effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac
      repolarization, specifically, Fridericia's QT-Interval (QTcF)
    


Intervention name(s): ANX-188 Therapeutic Dose; ANX-188 Supratherapeutic dose; Saline; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): vepoloxamer; vepoloxamer; Placebo Comparator; Active Comparator
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Vitamin D Status and Muscle Function
Condition: Vitamin D Status; Muscle Function
Study type: Observational

Summary: 
      People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due
      to low sun exposure and the risk may be even more pronounced among elite swimmers since
      indoor training further reduces sun exposure. In light of this, the investigators want to
      examine vitamin D status in young elite swimmers and if there is an association between
      vitamin D status and muscle strength.
    

Detailed description: 
      To examine vitamin D status in young elite swimmers and if there is an association between
      vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24
      years) residing at latitude 55-56°N were included to the trial conducted in March-April.
      Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength
      was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were
      assessed by food frequency questionnaire and sun exposure and training status by
      questionnaires.
    

Intervention name(s): Screening
Intervention type(s): Other
Intervention description(s): Screening of elite swimmers
Observational model: Cohort
Time perspective: Prospective
Efficacy and Safety of GTR in Comparison to Copaxone®
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer
      acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple
      sclerosis
    

Detailed description: 
      GTR is being developed by Synthon as a similar version of Copaxone®. GTR has a similar
      quantitative and qualitative composition as Copaxone®, with regard to active substance and
      excipients and is presented in the same dosage form (pre-filled syringe containing a solution
      for injection). Introduction of GTR is anticipated to have a price lowering effect and will
      give doctors and patients more choice in the pharmaceutical armamentarium for MS.

      This trial consists of two parts:

      Part 1 is a multi-country, multi-centre, randomized, double-blind, active and
      placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of
      GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to
      receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9
      months.

      In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and
      safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period
      will be treated with open-label 20 mg daily GTR for another 15 months.
    

Intervention name(s): Glatiramer Acetate (GTR); Glatiramer Acetate (Copaxone®); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2); Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2); Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis,; Relapsing-Remitting Multiple Sclerosis,; glatiramer acetate,; MRI,; lesions,; MS relapse rate,; Copaxone
Staccato Loxapine Multidose PK
Condition: Volunteers on Chronic, Stable Antipsychotic Regimens
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of
      multiple inhaled doses of Staccato Loxapine.
    

Detailed description: 
      The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety
      and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time
      period. The study will be conducted in schizophrenic patients who are on chronic, stable
      antipsychotic medication. Patients meeting entry criteria will be randomized to one of three
      dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of
      medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial
      time points.
    

Intervention name(s): A - 10 mg loxapine q 4 h x 3 (30 mg total); B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total); C - 5 mg loxapine q 4 h x 3 (15 mg total); D - inhaled placebo q 4 h x 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): loxapine aerosol inhalation high dose regimen (30 mg total); loxapine aerosol inhalation middle dose regimen (20 mg total); loxapine aerosol inhalation low dose regimen (15 mg total); placebo aerosol inhalation (0 mg total)
Other intervention name(s): Staccato Loxapine 10 mg; Staccato Loxapine 5 and 10 mg; Staccato Loxapine 5 mg; Staccato Placebo
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pharmacokinetic; multidose; Staccato Loxapine
Increasing Childhood Sleep Duration in the Primary Care Setting
Condition: Sleep
Study type: Interventional

Summary: 
      Investigators seek to determine if a mobile health based intervention can be developed to
      target increases in childhood sleep duration.
    

Detailed description: 
      Investigators seek to determine if an online based intervention can be developed to target
      increases in childhood sleep. The primary objectives of this study are to determine if
      different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep
      about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep
      patterns. Participants will have a sleep goal to meet each night. Participants will be
      randomized to one of thirty-two study conditions and receive text and/or email messaging.
      Some study arms receive additional messaging with different content and frequency of
      delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).
    

Intervention name(s): Sleep Extension
Intervention type(s): Behavioral
Intervention description(s): The intervention is designed to test if sleep tips delivered by text messages can aid with reaching sleep targets. And if additional motivational text messages can further aide with reaching sleep targets.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Childhood sleep promotion; Sleep promotion; Sleep