bioihbjkbjnl/mcl2 huggingface dataset:
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation(AF) is the most common sustained arrhythmia in humans. The loss of
      rate-dependent action potential duration(APD) adaptation is one of the characteristics of
      atrial fibrillation, but detailed understanding of mechanism is limited. Thus, we propose to
      utilize the monophasic action potential recording data from human patients in three groups,
      control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method
      to quantify the extent of electrical remodeling of ionic channel parameters using a
      mathematical model of atrial cell. Our approach will be useful in developing drug targets for
      ion channels in atrial fibrillation patients.
    


Intervention name(s): Monophasic action potential(MAP) catheter
Intervention type(s): Device
Intervention description(s): After ordinary procedure for electrophysiologic study or catheter ablation, the investigators will replace conventional catheter to monophasic action potential (MAP) recording catheter through right femoral sheath. MAP recording catheter is introduced to endocardial surface of atrium, and we record atrial MAP at variable pacing cycle lengths: steady state cycle lengths of 600, 400, 300, 240, 220, 240, 260, 300, 400 and 600 ms. At each cycle length, pacing was applied for 20 sec. It takes less than 5 min to acquire MAP recordings.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Condition: Performance; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day
      intervention on aerobic exercise performance and fatigue.

      The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and
      reduce subjective measures of fatigue.
    

Detailed description: 
      Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day
      intervention on aerobic exercise performance and fatigue.

      The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and
      reduce subjective measures of fatigue.

      The basic protocol includes baseline assessment of fitness and participation in a vigorous
      session of exercise immediately before and 30 days after consumption of the experimental
      supplement or placebo.

      The exercise task is intended to be fatiguing and demanding but is not expected to create
      failure.

      The supplement makes claims related to boosting exercise performance and reducing fatigue.

      The study design will determine if these outcomes are in fact present in a group of healthy,
      young, and active adults.

      The primary dependent measures are perceived exertion during exercise and levels of fatigue
      measured on multiple non-exercise days.
    

Intervention name(s): NutraStem Active; NutraStem Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Supplement impact; Performance; Fatigue
A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
Condition: Influenza
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the safety and descriptive immunogenicity of the
      H1N1 influenza vaccine in healthy children.
    

Detailed description: 
      The primary objective of this study was to assess the safety and descriptive immunogenicity
      of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in
      healthy children.
    

Intervention name(s): MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL: (intranasal sprayer); Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: randomized, double-blind, placebo-controlled
Exercise as an Adjunctive Treatment for Cocaine Dependent Patients
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if exercise added to usual treatment improves
      cocaine dependence treatment. The primary objective of this study is to investigate if
      exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if
      exercise can reduce negative mood states, improve quality of life and facilitate abstinence
      of cocaine.
    

Detailed description: 
      This study is designed as two-groups, randomized controlled trial to evaluate the
      effectiveness of an 8-week exercise program added to usual treatment compared with a health
      education program in 20 cocaine dependent patients. These participants will be randomized to
      one of the following two groups: a) exercise group: supervised moderate-vigorous exercise in
      group based on strength and calisthenics exercises, b) control group: supervised health
      education in group. All participants must have DSM-IV diagnosis of cocaine dependence as the
      primary disorder and must be in treatment.
    

Intervention name(s): Exercise; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.; Supervised groups 2 times per week during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Cocaine dependence
Dose-dependent Effects of Second-hand Smoke on Vascular Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the vascular effects of brief second-hand smoke
      exposure on normal healthy individuals.
    

Detailed description: 
      Second-hand smoke remains a significant public health threat. Despite evidence to suggest
      that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about
      the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly
      encountered in the community. This study will investigate the acute vascular effects and
      dose-dependent biological mechanisms of secondhand smoke on endothelial function and
      oxidative stress.
    

Intervention name(s): Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
Intervention type(s): Other
Intervention description(s): acute one time exposure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Tobacco smoke; Oxidative stress; Endothelial Function; Atherosclerosis; Arterial Stiffness; Microvascular Function
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
Condition: Atopic Dermatitis; Ichthyosis; Psoriasis
MeSH terms: Dermatitis, Atopic; Ichthyosis; Psoriasis; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This is designated to validate patient-reported outcomes (PRO) measures in itch-specific
      pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified
      stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis
      and other potentially stigmatizing conditions.
    

Detailed description: 
      This study involves a series of research and development projects targeted at two of the most
      common chronic diseases affecting children: asthma and atopic dermatitis (AD, or eczema). The
      Investigators propose to directly validate patient-reported outcomes (PRO) measures in a
      large cohort of itch-specific pediatric skin conditions, with a primary focus on AD. The
      Investigators propose to examine the ability of PROMIS (Patient-Reported Outcomes Measurement
      Information Systems) instruments to detect meaningful and clinically significant change in
      disease status, as well as to create a pediatric itch item pool and PRO model for signs and
      symptoms of skin disease. The Investigators will also examine the ability of a modified
      Neuro-QOL stigma instrument to assess the severity and type of stigma experienced in AD and
      across various dermatologic or other potentially stigmatizing conditions. Lurie Children's
      Hospital will only be involved in the AD and stigma portions of this project
    

Intervention name(s): Itch Questionnaire and Interview; Stigma Questionnaire and Interview; Cognitive Interview and PROMIS Itch Questionnaire
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether aripiprazole augmentation is safe and
      effective in the treatment of clozapine-treated patients with refractory schizophrenia.
    

Detailed description: 
      Clozapine is renowned for its efficacy in treating schizophrenia refractory to typical or
      atypical antipsychotics. Though the effectiveness of clozapine has been established, a
      considerable number of patients with schizophrenia are partially responsive or unresponsive
      to clozapine. In addition, long-term use of clozapine is associated with the development of
      obsessive-compulsive symptoms and metabolic syndrome. In order to overcome these
      short-comings and to increase efficacy, aripiprazole augmentation was implemented.
      Quantitative electroencephalogram will be used to monitor the occurrence of abnormal findings
      and to analyze the changes in electroencephalographic pattern with linear and non-linear
      methodology.

      Comparisons: Design of double-blind randomized placebo controlled study of patients at
      Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National
      University Hospital.
    

Intervention name(s): aripiprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): aripiprazole augmentation of clozapine; placebo
Other intervention name(s): abilify; OPC-14597
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; aripiprazole; clozapine
Effect of Food on BIA 6-512 (Trans-resveratrol)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to investigate the effect of food on the pharmacokinetics of a
      single 400 mg dose of BIA 6-512 (trans-resveratrol) in healthy volunteers
    

Detailed description: 
      Single-centre, open-label, randomised, two-way crossover study in 24 healthy male and female
      subjects. The study consisted of 2 single-dose periods separated by a washout of 7 days or
      more.

      Eligible subjects were admitted to the UFH on the day (Day 0) prior to receiving the dose of
      study medication (Day 1). On the morning of the next day (Day 1), a BIA 6-512 400 mg dose was
      administered following either a standard breakfast (Test) or at least 8 hours of fasting
      (Reference). Subjects remained confined in the UFH from admission (Day 0) until at least 24 h
      post dose (Day 2); then, they were discharged and returned for the second treatment period or
      a follow-up visit.
    

Intervention name(s): BIA 6-512 400 mg
Intervention type(s): Drug
Intervention description(s): 4 capsules of BIA 6-512 100 mg / oral administration with 240 mL of potable water .Subjects were administered a 400 mg BIA 6-512 single-dose on two different occasions. In one treatment period subjects were dosed with a single oral dose of 400 mg after a fasting of at least 8 hours, and in the other treatment period subjects were dosed with a single oral dose of 400 mg after a standard meal. Subjects were requested to fast overnight for at least 8 hours before product administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioinformation Therapy for Liver Cancer
Condition: Liver, Cancer of, Non-Resectable
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable liver cancer.
    

Detailed description: 
      By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study
      will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoablation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT
Condition: Obstetric Pain; Obstetric Anesthesia Problems
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Adequate pain control after cesarean delivery is a significant concern both for parturients
      and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound
      infiltration with anesthetics are alternatives for reducing the severity of pain, total
      analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are
      superior to placebo; however, it is unknown which provides better analgesia after cesarean
      delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the
      TAP block would decrease postoperative pain and postoperative cumulative opioid consumption
      at 24 hours
    


Intervention name(s): Transversus Abdominis Plane Block; Local anesthetic wound infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.; 40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: transversus abdominis plane; VAS; visual analogue score; wound infiltration; cesarean section; postoperative pain; analgesia
Confounding Factors of Impedance Pneumography
Condition: Healthy; Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the association of signals recorded and analysed
      with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the
      whole night sleep with the gold standard for sleep recording events, polysomnography, in
      order to better understand the confounding factors for momentary changes in the impedance
      pneumography-derived tidal breathing flow-volume (TBFV) curves.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects referred to sleep laboratory at the investigational site or healthy volunteers
        from Zagreb and surroundings
Axitinib Pharmacokinetics in Chinese Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      As part of the global clinical development program for AG-013736, studies are ongoing (and
      planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese
      subjects, as required by the Chinese Health Authorities, is therefore warranted.

      In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3
      doses (5 mg, 7 mg and 10 mg).
    


Intervention name(s): AG-013736 (axitinib)
Intervention type(s): Drug
Intervention description(s): Three single oral-doses of AG-013736 (5-mg, 7-mg and 10-mg) will be successively administered (each separated by a washout period of at least 7 days) to healthy Chinese volunteers in the fed state.
Intervention MeSH terms: Axitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: AG-013736, axitinib, pharmacokinetics, healthy, Chinese
Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation
      under fed conditions in healthy volunteers.
    


Intervention name(s): Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions; One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dose proportionality; oxycodone
MacTel Laser Study
Condition: Macular Telangiectasia
MeSH terms: Telangiectasis
Study type: Interventional

Summary: 
      This is a two armed Single Masked Pilot Study enrolling participants with Macular
      Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal
      treatment or a sham procedure to one eye. The participants will be followed for one year with
      visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to
      the small number of participants enrolled in this study the data will be analyzed by
      descriptive statistics and exploratory figures. Summary statistics will be produced for study
      and fellow eyes.
    


Intervention name(s): 577-nm PASCAL laser
Intervention type(s): Device
Intervention description(s): The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MacTel
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,
      02 sequences, and 02 periods, in which the volunteers receive, in each period, the test
      formulation or the reference formulation, under fed conditions.
    

Detailed description: 
      It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,
      02 sequences, and 02 periods, in which the volunteers receive, in each period, the test
      formulation or the reference formulation, under fed conditions.

      The treatment's sequence attributed to each volunteer on the study period is determined by a
      randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system.

      The formulations will be administered as a single oral dose followed by blood collections
      between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of
      7 half lives between them (period for drug's whole elimination by the organism).
    

Intervention name(s): Reference formulation; Test formulation
Intervention type(s): Drug; Drug
Intervention description(s): SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim); tamsulosin hydrochloride 0,4 mg (Synthon BV)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Healthy volunteers; tamsulosin hydrochloride; Fed administration
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of
      Osteoarthritic Pain - Dose escalation
    

Detailed description: 
      Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of
      Osteoarthritic Pain.

      Subjects for whom replacement knee surgery is recommended will be enrolled in the study. A
      single injection of a DNA plasmid with a variant Interleukin-10 (IL-10) transgene will be
      injected into the synovial capsule of the knee.

      This is a first in human, dose-range, safety and efficacy study.
    

Intervention name(s): XT-150
Intervention type(s): Biological
Intervention description(s): IL-10 transgene DNA plasmid injected into the knee synovial capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Inflammation and pain due to osteoarthritis in the knee
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inflammation; cytokine; anti-inflammatory; pain
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to
      standard-of-care
    

Detailed description: 
      This is a multi-centre study conducted in four countries. A total of 60 subjects with
      Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active
      HTL0018318 or placebo for a period of four weeks
    

Intervention name(s): HTL0018318; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HTL0018318; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease