bioihbjkbjnl/mcl2 huggingface dataset:
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance
      (IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
      glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
      agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
      recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
      exciting development, representing a novel mechanism for improving IR. BCQR has not been
      studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
      support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
      and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
      in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
      is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
      will include fasting and postprandial glucose, glycemic variability, insulin dosing,
      hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.
    


Intervention name(s): Bromocriptine; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Bromocriptine Quick Release (BCQR)
Intervention MeSH terms: Bromocriptine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioequivalence and compare the safety profiles following
      inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.

      Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra
      nebulizer solution compared to TOBI nebulizer solution.
    


Intervention name(s): Vantobra (tobramycin); TOBI (tobramycin)
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation; Inhalation
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; AUC; Cmax
Investigating the Effects of Evening Light Exposure on Melatonin Suppression, Alertness and Nocturnal Sleep
Condition: Non-visual Photoreception
Study type: Interventional

Summary: 
      The timing and quality of sleep is governed by environmental and physiologic factors.
      Environmental factors, especially ambient lighting can impact the circadian system and alter
      the timing and structure of sleep. Light exposure can also acutely alter neural activation
      state and impair sleep. These effects all demonstrate marked sensitivity to short-wavelength
      blue light with maximal sensitivity in the 460-480 nm range. The alerting effects of blue
      light in the evening persist for at least 3-4 hours after the lights are turned off, and can
      disturb subsequent sleep. Avoiding these deleterious effects of light exposure prior to sleep
      on subsequent sleep would be beneficial to sleep quality and potentially health.

      The investigators will compare the effects of two light sources, equated for visual stimulus
      (lux), on multiple non-visual responses to light. The investigators will compare a 90 lux
      exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white
      light source that is depleted in the short-wavelength visible range (Biological Illumination
      LCC, FL). In a within-subject design, the investigators will test the hypotheses that
      exposure to a blue-depleted LED as compared to a CFL exposure at (1) 90 lux or (2) 50 lux
      will cause significantly:

        1. Less melatonin suppression between melatonin onset and bedtime;

        2. Less subjective and objective alerting responses before bedtime;

        3. Less disruption of nocturnal sleep structure and quality.
    


Intervention name(s): Visible light
Intervention type(s): Device
Intervention description(s): We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Stratified randomized crossover trial. Participants randomized between CFL and LED conditions stratified by light intensity (50 lux and 90 lux).
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Melatonin; Sleep; Light; Alertness; Circadian Rhythms
Dichotic Listening as a Predictor of Medication Response in Depression
Condition: Major Depression; Dysthymia; Depressive Disorder Not Otherwise Specified
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Depressed patients will have hearing tests and then be treated with up to three treatments
      (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific
      outcomes.
    

Detailed description: 
      100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then
      treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere
      for auditory processing will be correlated with treatment outcome.
    

Intervention name(s): Fluoxetine; Imipramine
Intervention type(s): Drug; Drug
Intervention description(s): Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day *All increases only if tolerated.; Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. *All increases only if tolerated.
Other intervention name(s): Prozac; Tofranil
Intervention MeSH terms: Fluoxetine; Imipramine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Dysthymia; Depression Not Otherwise Specified; Dichotic Listening; Fluoxetine; Imipramine; Predictors
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of increased stomach pH on how much
      evacetrapib is found in the blood stream and how long the body takes to get rid of it when
      given to healthy participants. Information about any side effects that may occur will also be
      collected.

      There are two parts to the study. Participation in both parts will be required.

      The study will last approximately 30 days, not including screening.
    


Intervention name(s): Evacetrapib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Omeprazole; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication
      zonisamide for the treatment of heavy drinking alcoholic civilians.
    

Detailed description: 
      This is a 16-week randomized, double blind, placebo-controlled trial designed to determine
      the effectiveness of zonisamide treatment for reducing heavy drinking and overall drinking in
      160 treatment-seeking, regularly heavy drinking, alcohol-dependent civilians who want to quit
      drinking or reduce consumption to non-hazardous levels. The investigators will use
      state-of-the-art methodology and outcome assessments, including medical management (MM)
      therapy (a minimal behavioral intervention aimed at reinforcing treatment goals and adherence
      to medication), which is simple and easily implemented in primary care settings. The use of
      MM in the study will increase the generalizability of results, allowing a more accurate
      assessment of zonisamide's effectiveness than if a more intensive behavioral intervention
      were to be used. To demonstrate zonisamide's effectiveness in a representative civilian
      sample, the investigators will include civilians with co-morbid mood and anxiety disorders.
    

Intervention name(s): Zonisamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose; Placebo
Other intervention name(s): Brand name: Zonegran; Brand name: Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Use Disorder; Alcoholism; Alcohol Dependence; Zonisamide; Alcohol Intoxication; Drinking Behaviors; Anticonvulsants
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
Condition: Hepatic Impairment; NASH - Nonalcoholic Steatohepatitis; Cirrhosis, Liver
MeSH terms: Fatty Liver; Liver Diseases; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of
      MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses
      (QD x 6 days) in subjects with varying degrees of hepatic impairment (HI) compared to healthy
      matched control subjects with normal hepatic function, including a subset of NASH subjects.
    


Intervention name(s): MGL-3196
Intervention type(s): Drug
Intervention description(s): Once daily oral dose for 6 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for
      cognitive impairments in 120 chronic schizophrenia patients
    

Detailed description: 
      OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive
      transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the
      treatment of cognitive impairments in 120 chronic patients with schizophrenia.

      METHODS:

        1. Clinical Trial: The study consists of 8 weeks of treatment.

        2. Assessment Procedures:

      2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by
      three clinical trained staff, who were blind to treatment protocols, using the Positive and
      Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2
      weeks, 4 weeks, 6 weeks and 8 weeks.

      2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists,
      which is comprised of a total score and 5 age-adjusted index scores for attention, language,
      delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese
      version of RBANS has been evaluated for the test-retest reliability and clinical validity
      between schizophrenia patients and control subjects. Cognitive performance was measured at
      baseline and at 8-weeks.

      2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks.

      2.5 Weight gain measurement: weight gain every week
    

Intervention name(s): 10 Hz treatment group; 20 Hz treatment group; Control Group
Intervention type(s): Device; Device; Device
Intervention description(s): 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.; 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.; all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: schizophrenia; rTMS
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
Condition: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of
      PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects
      with moderate to severe active Ulcerative Colitis (UC).
    

Detailed description: 
      The study consists of a 12-week double-blind, placebo-controlled treatment period.
      Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or
      matching placebo BID.

      Participants who successfully complete the double-blind period may be eligible for an
      extended treatment period of 40 weeks duration.
    

Intervention name(s): PN-943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by the oral route BID for the duration of the study.; Administered by the oral route BID for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 12-week randomized, double-blind, placebo-controlled, parallel design study in patients with moderate to severe active UC. It will be followed by 40 weeks of Extended Active Treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease (IBD)
A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking
      insulin for Type 2 Diabetes.
    


Intervention name(s): MK-0941; Placebo; Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.; Placebo tablets, taken 3 times daily.; Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Other intervention name(s): LANTUS®
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cervix Image Sharing Protocol (CISP)
Condition: Cervical Cancer; Cervical Abnormalities
MeSH terms: Uterine Cervical Neoplasms; Congenital Abnormalities
Study type: Observational

Summary: 
      The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer
      Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for
      all kinds of settings, including lowresource ones that rely on development of robust,
      low-cost screening and triage tools. Therefore, to support development of algorithms for
      cervical image recognition software, NCI seeks to share digital cervical images and
      accompanying clinical data from our large epidemiological studies on HPV and cervical cancer
      screening with interested and qualified image analysis researchers. To accommodate the many
      researchers that are interested, we have created this standard protocol to describe a unified
      process for sharing deidentified cervical images and accompanying de-identified clinical data
      from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical
      Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .
    

Detailed description: 
      The Clinical Epidemiology Unit in the Clinical Genetics Branch of the Division of Cancer
      Epidemiology, NCI has a strong interest in fostering cervical cancer prevention solutions for
      all kinds of settings, including lowresource ones that rely on development of robust,
      low-cost screening and triage tools. Therefore, to support development of algorithms for
      cervical image recognition software, NCI seeks to share digital cervical images and
      accompanying clinical data from our large epidemiological studies on HPV and cervical cancer

      screening with interested and qualified image analysis researchers. To accommodate the many
      researchers that are interested, we have created this standard protocol to describe a unified
      process for sharing deidentified cervical images and accompanying de-identified clinical data
      from the following NCI studies: Costa Rican Natural History Study of HPV and Cervical
      Neoplasia , ASCUS LSIL Triage Study-- ALTS , SUCCEED and Costa Rica Vaccine Trial .
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        collection of images and data from other NCI studies
      
Keywords: Cervix; HPV; Imaging; Costa Rica
Accuracy of Mobile-Based Vision Charts.
Condition: Visual Spatial Processing
Study type: Observational

Summary: 
      Analyzing the accuracy of mobile-based distant vision charts in clinical practice as an
      economic alternative for standard vision charts.
    

Detailed description: 
      Accuracy of mobile-based visual acuity testing in clinical practice is still debatable. The
      aim of this study was to analyze the accuracy of mobile-based distant vision chart in
      comparison to standard chart projector.
    

Intervention name(s): Distant best corrected visual acuity assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Measuring distant visual acuity on snellen's chart using two methods and results were converted to equivalent logarithm of minimum angle of resolution to compare accuracy of mobile based chart to the standard vision chart.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects aimed to asses their best corrected visual acuity or seek spectacles prescription
        at ophthalmology clinic at Al-Nil Hospital, Banha, EGYPT.
      
Keywords: Visual acuity; Mobile-based chart; Snellen's chart
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of photoirritation and
      photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).
    


Intervention name(s): Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Intervention type(s): Drug
Intervention description(s): Lactic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an intervention to breast cancer patients
      including psycho-education and group psychotherapy can enhance quality of life and survival.
    

Detailed description: 
      PURPOSE: This randomized study included patients diagnosed with breast cancer who
      participated in an intervention including education and group psychotherapy lasting 10 weeks
      after surgery. The purpose of the study was to enhance Quality of Life, coping and social
      relations and to support the women when going through treatment. PATIENTS AND METHODS: We
      randomly assigned 210 patients with primary breast cancer to a control or an intervention
      group. Patients in the intervention group were offered 2 weekly 6-hour sessions of
      psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and
      nonparticipants were followed up for QoL, coping and social relations after one, six and
      twelve months post intervention and on vital status 5 years after surgical treatment.
    

Intervention name(s): Psychosocial support
Intervention type(s): Behavioral
Intervention description(s): Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks
Other intervention name(s): Patient-education and group therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Quality of life; Coping; Social relations; Survival; Psychotherapy