bioihbjkbjnl/mcl2 huggingface dataset:
Phototoxicity Potential of NatrOVA Creme Rinse - 1%
Condition: Head Lice
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in
      humans, after exposure to UV radiation.
    


Intervention name(s): Spinosad (the active ingredient in NatrOVA); placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Head Lice
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
Condition: Pediatric Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This study is a non-interventional, observational study of Humira® in the treatment of
      pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be
      conducted in institutions which provide a written agreement to AbbVie Korea, and where the
      use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric
      patients who are prescribed Humira® as per physician's medical judgment in accordance with
      the approved Korean local label will be enrolled in the study. As this is a post marketing
      surveillance, AbbVie is NOT involved in the product supply since the drug is being used
      according to the approved marketing label and is to be prescribed by the physician under
      usual and customary practice of physician prescription.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric CD patients who have been prescribed Humira® by the treating physician
      
Keywords: Korea; Humira; Pediatric Crohn's Disease
Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Condition: Colon Polyp
MeSH terms: Colorectal Neoplasms; Colonic Polyps
Study type: Interventional

Summary: 
      In a prospective, randomized, controlled study, two methods (water method vs. air method) of
      performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC
      screening. The investigators hypothesize that:

        1. Study method increases overall cecal intubation with comparable assessment of current
           experience and patient willingness to repeat future colonoscopy compared with
           conventional colonoscopy

        2. Study method improves bowel preparation and increases polyp pickup rate
    

Detailed description: 
      Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans
      Affairs (VA) patients is being promoted. Compliance with this Directive will result in an
      increased number of VA patients undergoing colonoscopy.

      The demand for colonoscopy far exceeds the capacity available to perform the procedure in the
      VA system. The conventional practice for colonoscopy at VA facilities across the country is
      to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed
      by the fact that sedated patients require time and space for recovery and these are major
      limiting factors in the current setting for the use of colonoscopy for CRC screening.

      In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy
      will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared
      the water infusion in lieu of air insufflation (water method) with the conventional air
      insufflation method. We hypothesize that the water method (Study method) increases overall
      cecal intubation with comparable assessment of current experience and patient willingness to
      repeat future colonoscopy compared with conventional colonoscopy. In addition, the water
      method improves bowel preparation and increases polyp pickup rate.
    

Intervention name(s): Water infusion in lieu of air insufflation; Air method
Intervention type(s): Procedure; Procedure
Intervention description(s): Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.; Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.
Other intervention name(s): Water method; Screening colonoscopy; Screening colonoscopy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: water method; air method; unsedated colonoscopy; adenoma detection
Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The study investigates the efficacy of aerobic exercise on cognitive performance and brain
      plasticity in schizophrenia.
    

Detailed description: 
      This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical
      trial investigates the efficacy of aerobic exercise on cognitive performance and brain
      plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks
      of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and
      tone program consisting of exercises for flexibility, core strength, balance and relaxation.
      Followed by a follow-up period of 26 weeks.
    

Intervention name(s): endurance training; balance and tone program
Intervention type(s): Other; Other
Intervention description(s): endurance training with stationary bicycles; flexibility, core strength, balance, relaxation
Other intervention name(s): aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: exercise
Effect of Autonomic Neuropathy on the Efficacy of a DPP-IV Inhibitor (Galvus) Therapy
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effect of a single administration of a DPP-IV
      inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic
      patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with
      diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize that
      the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic nervous
      system. This hypothesis will be validated if a lower glycemic response to DPP-IV inhibitor
      treatment is observed for the neuropathy group compared to control.
    

Detailed description: 
      Recently published work has demonstrated in animals that the control of pancreatic hormone
      secretion is due, at least in part, to the action of GLP-1 on the via the autonomic nervous
      system. Therefore, rhe investigators hypothesized that altered autonomic nervous system could
      explain, at least in part, the altered therapeutic efficacy of DPP-IV inhibitors observed in
      some patients. Our aim is to validate this concept in humans.

      The objective of this physiopathological, monocentric, comparative, open, parallel study is
      to compare the effect of a single administration of a DPP-IV (vildagliptin: Galvus ®) over
      two populations of type 1 diabetic patients: a control group of 12 patients without diabetic
      autonomic neuropathy (NA) and a group of 12 patients with NA.

      This proof of concept study will enrol type 1 diabetic patients to avoid confounding factors
      related to endogen insulin secretion and frequent polymedication of type 2 diabetic patients.
      The response will be evaluated for each patient by the relative difference between pre-and
      post-glucagon concentrations following a test meal, measured in the absence and presence of
      treatment with DPP4 inhibitor. Expected results: the DPP-4 inhibitor should lead to a
      reduction of about 20 to 30% of the glucagon level in patients without NA and a smaller or no
      decrease in patients with NA.
    

Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention description(s): one 50 mg tablet per os
Other intervention name(s): GALVUS
Intervention MeSH terms: Vildagliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus; DPP-IV protein; Glucagon-Like Peptide 1; autonomic neuropathy
Low Grade Inflammation in Type 1 Diabetes Children
Condition: Type 1 Diabetes; Inflammation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Inflammation
Study type: Observational

Summary: 
      The study propose to measure the inflammation level in type 1 diabetes children with the
      cytokine analysis compared to non diabetic children of the same sibling and to healthy
      children.
    

Detailed description: 
      The increase of type 1 diabetes incidence, particularly in young children leads to conduce
      new diagnostic and therapeutic strategies, notably for associated chronic
      morbidity.Measurement of chronic inflammation, with modification of the balance between
      pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients
      with high risk to diabetes chronic morbidity.

      After parental consent, blood sampling will be carried out by micromethod for cytokine (500
      µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be
      collected (50 ml) in the morning for further researches.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 children in type 1 diabetes group and 30 children in control group
      
Keywords: type 1 diabetes; children; low grade inflammation; cytokine; CRP
Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to prove safety and efficacy of aripiprazole.
    

Detailed description: 
      This study was designed to prove safety and efficacy of aripiprazole in the treatment of
      acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in
      Korea and to confirm the maintenance of efficacy and safety during maintenance period and the
      changes in emotional factors and social functions.

      After administering 15 mg/day of aripiprazole for two weeks, the test may change the dose
      within the range of 10 mg and 30 mg per day by clinical judgment. (Medication duration: 8
      weeks (acute phase) + 18 weeks (maintenance phase)] + 26 weeks (extension phase), *total 52
      weeks)
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorder; Aripiprazole
Efficacy of Audio-Visual-Perception-Enhancement (AVWF®) Method in Chronic Pain Patients
Condition: Pain; Stress
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      It is anticipated that Audio-Visual-Perception-Enhancement (AVWF®) method leads to pain
      reduction and a decrease of inflammatory markers in chronic pain patients. Also an
      improvement of quality of life, self-perceived disability and depression in chronic pain
      patients is expected.
    


Intervention name(s): AVWF device
Intervention type(s): Device
Intervention description(s): The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain; Stress; AVWF; Audio-Visual-Perception-Enhancement
Effects of Green Tea Extracts on Gastric Mucosal Protection
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled pilot study to
      investigate the effects of a combined extract of green tea seed (saponins) and green tea
      leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional
      dyspepsia for 8 weeks.
    

Detailed description: 
      A previous study has indicated that combined extract of green tea seed (saponins) and green
      tea leaves (epigallocatechin-3-gallate) may improve gastric mucosal status in rat with
      alcohol-induced gastritis.Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled pilot study to investigate the effects of a combined extract of green tea
      seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal
      protection in adults with functional dyspepsia for 8 weeks; the safety of the compound are
      also evaluated. The Investigators examine C-reactive protein, IFN-γ, TNF-α, gastrin,
      malondialdehyde, 8-hydroxy-2' -deoxyguanosine, and questionnaires (Gastrointestinal Symptom
      Rating Scale, Nepean dyspepsia index-Korean version, Nepean dyspepsia index-Korean version
      QOL questionnaire, Gastrointestinal symptom scale) at baseline and after 8 weeks of
      intervention. Twenty four adults were administered either 320 mg of combined extracts of
      green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) or a placebo each
      day for 8 weeks.
    

Intervention name(s): Green tea combined extracts group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks; Placebo 320 mg/day during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
Condition: HIV Infections; Protease Inhibitor
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100
      mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in
      Healthy Subjects
    


Intervention name(s): Atazanavir Sulphate + Ritonavir; Atazanavir Sulphate + Ritonavir + Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.; Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.
Other intervention name(s): Reyataz; Reyataz, Sustiva
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Efavirenz
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)
Condition: AML
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123
      Chimeric Antigen Receptor to Patients With CD123+ AML
    

Detailed description: 
      Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123
      Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage.
    

Intervention name(s): IM23
Intervention type(s): Drug
Intervention description(s): T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tracheal Intubation Coaching in NICUs
Condition: Failed or Difficult Intubation, Sequela; Intubation;Difficult; Intubation Complication
Study type: Interventional

Summary: 
      The purpose of the study is to determine the efficacy of video coaching training for
      neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.
    

Detailed description: 
      Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and
      stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs).Recently,
      video laryngoscopy (VL) has become available in neonatal clinical practice to allows trainees
      and frontline providers to perform standard direct airway visualization (i.e., traditional
      laryngoscopy) while the supervisor can simultaneously view a real-time video displaying what
      the laryngoscopist is seeing. However, VL associated coaching during TI has not been
      rigorously evaluated.The purpose of the study is to determine the efficacy of video coaching
      training for neonatology attending providers on tracheal intubation procedural outcomes in
      neonatal ICUs. The primary objective of this study is to determine whether the video coaching
      skill training for neonatology attendings reduces the occurrence of adverse tracheal
      intubation associated events among all tracheal intubations in neonatal ICUs over 2 years
      before and after intervention. The secondary objectives are to 1) determine if video coaching
      training is feasible to all neonatology attending physicians using train the trainer approach
      with a remote simulation and 2) determine if the video coaching skill competency among
      neonatology attending physicians who completed the training using a remote simulation
    

Intervention name(s): VL Coaching training using C-MAC video laryngoscope
Intervention type(s): Device
Intervention description(s): Each neonatology attending providers will receive a video laryngoscopy coaching training using a C-MAC video laryngoscope and an intubation training manikin available at each site by a site leader. During the training, site leader will act as a trainee confederate, and each neonatology attending provider will be trained to coach a trainee utilizing video images from C-MAC video laryngoscope and a cognitive aid with standardized language in a laminated card. This training part typically takes approximately 15-30 minutes including consenting process.
Each site leader will be trained by PI or PI's designee using remote simulation. In this remote simulation, each site leader will coach an actor at the Children's Hospital of Philadelphia (CHOP) using a profile video image and C-MAC video laryngoscopy image through CHOP approved video conferencing software. A standardized language will be taught to each site leader with a cognitive aid (laminated card).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intubation; Video Laryngoscope; Coaching/training
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging
      study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose
      regimens of ABP-671 compared with placebo. The study will consist of three sequential groups
      with escalating total daily ABP-671 doses. Each group is further divided into two dose
      cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening:
      Run-in, Dose Evaluation, and Follow-up.
    


Intervention name(s): ABP-671; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABP-671 Tablet; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Moxibustion for Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypothesis: Moxibustion is effective for managing primary dysmenorrhea. Aim: To attest the
      effectiveness and safety of moxibustion for primary dysmenorrhea. Design: A randomized
      controlled trial. 152 participants will be included. Two arms: moxibustion treatment group
      and ibuprofen control group.
    

Detailed description: 
      There is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due
      to low methodologic quality and small sample size. The investigators designed the random
      clinical trial to investigates the effectiveness of moxibustion in treating primary
      dysmenorrhea, the purpose of this study is to provide the research base of moxibustion
      efficacy. The investigators also examined the acceptability and any adverse effects
      associated with the use of moxibustion.
    

Intervention name(s): moxibustion; Ibuprofen Sustained Release Capsules
Intervention type(s): Device; Drug
Intervention description(s): apply moxibustion according to traditional Chinese medicine; apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle
Other intervention name(s): Fenbid
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: moxibustion; primary dysmenorrhea
The Effect of Neuromuscular Electrical Stimulation
Condition: Postoperative Coronary Artery Bypass Grafting (CABG); Chronic Obstructive Pulmonary Disease (COPD); Ventilatory Failure
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation
Study type: Interventional

Summary: 
      The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on
      intensive care was studied. The aim of this study was to explore if electrical stimulation
      could prevent muscle atrophy.
    

Detailed description: 
      Patients were included in the study one day after administration when prolonged sedation and
      ventilation were expected. They were divided into intervention (n=7) and control (n=14)
      groups. For the intervention group, an intermittent neuromuscular electrical stimulation was
      applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control.
      Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation
      were monitored before, during and after the electrostimulation. Perimeter of the right and
      left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the
      kneecap.
    

Intervention name(s): ELECTRICAL STIMULATION
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Functional electrical stimulation; muscular atrophy; intensive care