bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Parasomnias; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This study seeks to characterize sleep physiology in adolescents with and without Attention
      deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and
      clinical outcomes within these groups.
    

Detailed description: 
      This project will involve recruitment of 30 adolescents with ADHD and a control group of 30
      healthy adolescents without psychiatric diagnoses. Participants will participate in 3 phases:
      Screening visit, Washout/In-Home Sleep Study, and Neurocognitive Assessment visit. To ensure
      consistency in sleep schedules, the three nights of the sleep study will occur on weeknights
      during the school year. The neurocognitive assessment will occur during the afternoon
      following the final night of sleep assessment.

      The 2-hour screening visit will be conducted at the Duke ADHD Clinic at 2608 Erwin Road,
      Pavilion East, Suite 300, Durham, NC 27705. During the screening visit, participants will
      undergo screening to evaluate eligibility for the study.

      Eligible participants will enter the 48-hour Washout from stimulant medication (if
      applicable) and/or a 7-day washout from melatonin (if applicable). Following this washout,
      subjects will enter a 3-night Sleep Study Phase (At Home). Subjects not taking stimulant
      medication or melatonin will initiate 3 consecutive nights of ambulatory (in-home) PSG
      recording, beginning on the a Monday evening within 4 weeks of the screening visit. Subjects
      will be instructed to maintain usual sleep routines/behaviors for all study nights. In
      addition, subjects will be asked to complete a "sleep diary" each morning.

      If subject is currently taking stimulant medication, they will be instructed to initiate a
      48-hour washout period. If subject is currently taking melatonin, they will be instructed to
      initiate a 7-day washout period. Subjects will be instructed to discuss this option with
      their prescribing physician prior to initiating the study.

      Subjects will be asked to return for a three hour neurocognitive assessment on the afternoon
      directly following the final night of the sleep study. In order to reduce interference with
      school attendance, this visit will be scheduled in the afternoon. Subjects will take breaks
      throughout the assessment.

      Subjects will restart their ADHD medications on the morning following the neurocognitive
      assessment (if applicable).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with ADHD and healthy control adolescents
      
Keywords: ADHD; Sleep; Adolescents; Neurocognition; Polysomnography
ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to test the protection of volunteers previously
      vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum
      and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an
      experimental dengue virus challenge. The Investigators will also include people that have not
      received the study vaccine. The Investigators are collecting information about how the
      vaccine protects against a dengue virus challenge as well as adding to knowledge about the
      safety of the challenge.
    

Detailed description: 
      The purpose of this research study is to test the protection of volunteers previously
      vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum
      and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an
      experimental dengue virus challenge. The Investigators will also include people that have not
      received the study vaccine. The Investigators are collecting information about how the
      vaccine protects against a dengue virus challenge as well as adding to knowledge about the
      safety of the challenge. The information will help Investigators develop vaccines to protect
      people from dengue. Participation is voluntary. The duration of participation will last for
      180 days (six months). After participants are exposed to the weakened dengue virus, the
      Investigators will follow them closely to measure their symptoms. Like the flu, participants
      might expect to have a headache, rash, body aches, fever and chills or they may experience no
      symptoms whatsoever. If a participant does develops symptoms, the Investigators will monitor
      him/her closely in a local hotel or a wing of our hospital to ensure safety and to treat
      symptoms if they occur. Participants will be compensated for their time.
    

Intervention name(s): Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)
Intervention type(s): Biological
Intervention description(s): one subcutaneous injection of Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at 0.5 mL of 6.5 x 10^3 PFU/mL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in
      adult participants with uncontrolled, moderate-to-severe, persistent asthma.
    

Detailed description: 
      The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous
      (SC) administration of MEDI-528 on asthma control in adults with uncontrolled,
      moderate-to-severe, persistent asthma.
    

Intervention name(s): MEDI528 30 mg; MEDI528 100 mg; MEDI528 300 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks; MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks; MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks; Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of High-frequency Deep Diathermy on Heart Rate Variability in Women With Primary Dysmenorrhea
Condition: Primary Dysmenorrhea; Dysmucorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Superficial heat therapy is mainly used to relieve menstrual pain, but it does not penetrate
      deeper than the skin tissue. In order to penetrate deep into the deep layers and promote
      tissue relaxation, deep heat therapy can be effective. The treatment time for deep heat
      treatment is controversial, and there is no study on deep heat treatment using radio
      frequency for dysmenorrhea. Therefore, in this study, by applying radiofrequency waves at
      different times to the lower abdomen for patients with primary dysmenorrhea, the pain and
      changes in the autonomic nervous system were compared with thermotherapy to suggest
      appropriate therapeutic interventions.
    


Intervention name(s): High frequency therapy (5 minutes); High frequency therapy (7 minutes); High frequency therapy (9 minutes); Superficial heat therapy
Intervention type(s): Device; Device; Device; Device
Intervention description(s): The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 5 minutes using a 500 kHz resistive electric transfer (RET).; The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 7 minutes using a 500 kHz resistive electric transfer (RET).; The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 9 minutes using a 500 kHz resistive electric transfer (RET).; In the physical therapy used in this study, it was applied for 20 minutes using conventionally used superficial heat therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Combined Intensive and Conventional Exercise on Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The prevalence of NAFLD is 50-70% in obese people. A decrease of calorie intake and increase
      of physical activity are recommended as an effective approach for the prevention and
      treatment of NAFLD. However, the exercise model for NAFLD intervention is understudied. In
      the present study we aim to compare the effect of intensive and conventional exercise
      interventions on NAFLD.
    


Intervention name(s): Intensive exercise; Conventional exercise
Intervention type(s): Other; Other
Intervention description(s): Subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption for 30 minutes each day, five days a week, totally for 6 months.Subsequently, moderate physical activity(3.0-6.0 MET s) at 150 min/wk for 6 months.; Subjects receive moderate physical activity(3.0-6.0 MET s) at 150 min/wk(30 min per day, five days a week) for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD; exercise; hepatic triglycerides
ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Experienced participants who had HCV GT4 infection were treated with
      Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
    

Detailed description: 
      Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA
      treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or
      SOF/RBV (4/92) were enrolled in the current study.

      In the present study, the regimen used was designed by the combination of triple DAAs with
      different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus
      RBV.
    

Intervention name(s): SOF/SMV/DCV/RBV
Intervention type(s): Drug
Intervention description(s): SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.
Other intervention name(s): Olysio is a trade name of simeprevir; Sovaldi is a trade name of sofosbuvir; Daklinza is a trade name of daclatasvir
Intervention MeSH terms: Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic HCV GT4; Sofosbuvir; Simeprevir; Daclatasvir; Ribavirin; Experienced
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics, safety and tolerability of a single dose of
      AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease
      with that in healthy matched control subjects.
    


Intervention name(s): AGO178C
Intervention type(s): Drug
Intervention MeSH terms: Agomelatine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AGO178C,; renal impairment,; ESRD,; pharmacokinetics
Taste Function and Eating Habits in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      This study evaluates taste function and eating habits in patients with PCOS compared to
      healthy women and before and after oral contraceptive use.
    

Detailed description: 
      The objective of this study is to investigate the taste function and eating habits in
      patients with PCOS in comparison with healthy women at baseline and after routine use of an
      oral contraceptive (2mg ethinylestradiol and 0.03mg dienogest) along with general lifestyle
      advice for three months.

      Patients with diagnosis of PCOS (Rotterdam criteria) will be recruited from Hacettepe
      University outpatient clinics. Along with clinical, hormonal and biochemical evaluation,
      taste function and eating habit tests will be performed at baseline both in patients and
      healthy volunteers. These tests will be repeated in women with PCOS after 3 months of oral
      contraceptive use.
    

Intervention name(s): Contraceptive
Intervention type(s): Drug
Intervention description(s): Oral contraceptive pill
Other intervention name(s): birth control pill
Intervention MeSH terms: Contraceptive Agents
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient clinic
      
Biospecimen description: 
      Serum
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in
      adults to monitor analgesia during general anesthesia. In adults, under general anesthesia,
      ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to
      the intensity of the stim. This study aims to investigate if NIPE index decreases in the same
      manner after stimulations in anesthetized children.
    


Intervention name(s): NIPE monitor; Tetanic stimulations
Intervention type(s): Device; Procedure
Intervention description(s): NIPE monitor connected to the anesthetic station. No part of the device in contact with the patient. No action on patient or anesthesia. Automatic recording of Heart rate and NIPE index during the study period.; Three tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision.
Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3.
Intervention model: Single Group Assignment
Intervention model description: The research does not involve the evaluation or comparison of medical strategies.The order of application of the stimuli will be randomized according to a Latin square of order 3.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Monitoring; General anesthesia; Analgesia; Pain; Pediatric
FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535
      compared to a placebo in patients with active Ulcerative Colitis.

      Depending on their response, participants will be offered the investigational medication for
      up to one year after the study's completion at select sites.
    


Intervention name(s): OPC-6535 Tablets (drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ulcerative Colitis
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The authors hypothesize that, in patients with low volume tumors identified according to
      anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by
      unilateral embolization of prostatic arteries will provide local control of the tumor via
      selective ischemia
    


Intervention name(s): Embolization
Intervention type(s): Procedure
Intervention description(s): Embolization by microparticles (300-500 microns)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of canagliflozin relative to placebo on
      glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and
      tolerability of canagliflozin.
    


Intervention name(s): Canagliflozin 100 mg; Canagliflozin 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.; Canagliflozin 300 mg tablet will be administered orally once-daily.; Matching placebo tablet will be administered orally once-daily.
Other intervention name(s): JNJ-28431754; JNJ-28431754
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Food on BIA 5-1058
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the effect of food on the pharmacokinetic (PK)
      profile of BIA 5-1058 after a single dose in healthy subjects.
    

Detailed description: 
      Single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in
      54 healthy subjects.

      Duration of treatment:

      The study comprised a screening evaluation between 2 and 28 days before the first IMP
      (Investigational Medicinal Product) administration and 3 treatment periods of approximately 4
      days, separated by wash-out periods of at least 7 days. A follow-up visit was performed
      approximately 7 days after discharge from the last period or early discontinuation. For each
      subject, the full duration of the participation in the study was approximately 9 weeks.
    

Intervention name(s): BIA 5-1058
Intervention type(s): Drug
Intervention description(s): BIA 5-1058 (tablets 100 mg) was administered orally with 240 mL (Part 1) or 270 mL (Part 2 and Part 3) of water, in one period in the morning under fasting conditions (after at least a 10-hour overnight fast), in one period in the morning after a moderate meal, and in the other period at lunch after a moderate meal.
Other intervention name(s): Zamicastat
Intervention MeSH terms: Zamicastat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: To evaluate the relative bioavailability of a new formulation containing a
      combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare
      this formulation with the branded formulation (R) to meet regulatory criteria for marketing
      the test product in Argentina.
    

Detailed description: 
      A randomized-sequence, open-label, two-period crossover study was conducted on 24 healthy
      Caucasian volunteers in a fasting state. A single oral dose of either T or R formulations was
      followed by a 7-day washout period. Blood samples were collected at baseline and 0.25, 0.50,
      0.75, 1, 1.25, 1.5 2, 2.5, 3, 4, 7, 12, 24 and 48 h after administration. Emtricitabine and
      tenofovir concentrations were determined using a validated LC (liquid chromatography) - MS
      (mass spectrometry) / MS method. Adverse events were monitored based on clinical parameters
      and volunteer reports.
    

Intervention name(s): Tenofovir disoproxil fumarate and emtricitabine
Intervention type(s): Drug
Intervention description(s): Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)