bioihbjkbjnl/mcl2 huggingface dataset:
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is
      handled by the body, i.e the absorption, distribution, metabolism and excretion, when
      administered in combination with AZD1305.
    


Intervention name(s): Ketoconazole; Verapamil; AZD1305
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, administered as repeated doses.; Extended Release tablet, administered as repeated doses.; Extended Release tablet, administered as a single dose.
Other intervention name(s): Fungoral; Isoptin Retard
Intervention MeSH terms: Ketoconazole; Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD1305; Verapamil; Ketoconazole; pharmacokinetics
Amino Acids, Serotonin, and Body Weight Regulation
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Body Weight; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the behavioral effects of an amino acid mixture thought to influence
      serotonin function in individuals who have recovered from anorexia nervosa.
    

Detailed description: 
      Anorexia nervosa is a serious psychiatric disorder resulting in psychosocial distress for
      patients and their families, potentially severe medical consequences, and substantial
      long-term mortality. A major emphasis in current therapeutic research in anorexia nervosa is
      exploration of new interventions to stabilize recovery and prevent relapse. Although the
      etiology of anorexia nervosa is unknown, altered regulation of the neurotransmitter serotonin
      in the central nervous system is thought to contribute to preoccupation with body shape and
      weight, dysregulated eating patterns, persistent anxiety, and frequent mood fluctuations. The
      goal of this exploratory project is to assess the behavioral effects of an amino acid mixture
      thought to influence serotonin function in individuals who have recovered from anorexia
      nervosa. It is hypothesized that this brief intervention will help diminish residual eating
      disorder symptoms.

      All participants in this crossover study will attend eight sessions over a 9-week period.
      Participants will spend approximately 2 weeks in each phase, during which they will receive
      an amino acid mixture and the control condition.
    

Intervention name(s): Branched-chain amino acids
Intervention type(s): Other
Intervention description(s): Participants will spend approximately 2 weeks in each phase over a 9-week period, during which they will receive an amino acid mixture and the placebo control condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Propofol Based Total Intravenous Anesthesia on Oxidative Stress and Nitric Oxide
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Robot assisted laparoscopic radical prostatectomy(Robot-LRP) requires pneumoperitoneum and
      trendelenburg position which result in oxidative stress and inflammatory response.

      Propofol is well known to reduce those responses during anesthesia. Therefore, we try to
      figure out the efficacy of propofol to reduce oxidative stress, inflammatory response and
      increase the nitric oxide activity during robot-LRP compared to that of desflurane.

      To investigate the oxidative stress, malondialdehyde will be measured. As inflammatory
      markers, interleukin-1β, interleukin-6, tumor necrosis factor-α will be measured. Nitric
      oxide will be measured as well.

      Secondarily, kidney protection effect of propofol over desflurane will be compared.
    


Intervention name(s): propofol; Desflurane
Intervention type(s): Drug; Drug
Other intervention name(s): fresofol, 2%
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the PK parameters of a single dose of a test
      tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet
      formulation, both treatments administered without food, and to compare the PK parameters of
      the test tablet formulation given under fed and fasted conditions.
    


Intervention name(s): AKB-6548 tablet, reference formulation given in the fasted state; AKB-6548 tablet, test formulation given in the fasted state.; AKB-6548 tablet, test formulation given in the fed state
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Anemia; Chronic kidney disease; CKD; Renal impairment; Chronic renal insufficiency; Ferrous sulfate; Iron; End stage renal disease; Dialysis; Oral anemia treatment; Bioavailability; Erythropoietin; Hypoxia-inducible factor; Volunteers
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-66_R84-088)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurophysiological Reserve With Caffeine Manipulation
Condition: Caffeine; Placebo
Study type: Interventional

Summary: 
      The objective of this study is to verify if there is a neurophysiologic reserve when caffeine
      and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises.
      Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and
      peripheral metabolism will be measured
    

Detailed description: 
      A neurophysiological reserve related to central mechanisms is supposed to be present, which
      should be observed when an increased central drive occurs. In theory, according to the
      central regulation model of effort, an increased performance could be due to the elevation on
      Central Nervous System excitability and activity, since exercise is not peripherally limited.
      Conversely, the absence of muscle performance improvement to the increased central drive
      promoted by caffeine would be an evidence for a peripherally localized neurophysiological
      limit and would indicate the absence of reserve. Therefore, if present, this reserve could be
      verified by using peripheral and central measures derived from electric-stimulation, evoked
      twitch and interpolated twitch techniques, associated to measures of EMG and peripheral
      metabolism, when caffeine is manipulated during closed- and opened-loop exercise.

      In addition, there should also be possible to access the reserve without stimulant substance
      manipulation (placebo effect). By teleological argument derived from the central regulation
      model of effort, a neurophysiological reserve would be a natural mechanism to protect the
      cellular integrity. Therefore, it would be reasonable to hypothesize that, if present, a
      reserve would be observed by an increase in performance promoted by an elevation in central
      drive when placebo is perceived as caffeine. Unfortunately, however, no study utilized this
      experimental approach, including measures of central and peripheral activity during closed-
      and opened-loop exercise, to consistently respond the reserve question.
    

Intervention name(s): Caffeine; Caffeine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): After ingestion of 6 mg.kg-1 of body mass of caffeine, subjects will perform the one exercise trial.; 6 mg/kg of body mass of caffeine will be ingested by subjects before exercise.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Exercise; Caffeine; Reserve
The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety of Gayo Arabica coffee pulp extract cream
      as an antioxidant for the skin that can increase skin moisture
    

Detailed description: 
      This study is a phase I clinical trial aimed to assess the safety of the cream to be
      performed on volunteers, women, aged 20-40 years, who have healthy and normal skin. Research
      subjects that included in the study were determined based on inclusion and exclusion
      criteria. Enumerators previously provided information to the public using print media about
      this research to obtain research subjects that matched the inclusion and exclusion criteria.
      After that, the enumerators will conduct interviews and the willingness of research subjects
      according to the inclusion criteria by filling in the informed consent. Then before
      intervention, there will be an examination of skin conditions which will be carried out by
      two dermatologists including the condition of research subjects' skin moisture with a
      corneometer.

      The cascara pulp cream of Gayo Arabica coffee works to improve skin structure and increase
      moisture in the skin. The safety test of the cream with the patch test method of cascara pulp
      cream of Gayo Arabica coffee was carried out by researchers and left for 48 hours. After 48
      hours, the patch test unit was opened and evaluated by 2 dermatologists, the changes that
      occurred were recorded. Then with a corneometer examination was done to determine skin
      moisture. The same thing will also be done at the research subjects visit after 72 hours and
      96 hours after the patch test is opened to reassess whether there are changes in the skin
      such as irritation/redness and skin moisture.

      Data analysis in this study used univariate, bivariate and multivariate data analysis.
      Univariate analysis was carried out by describing the characteristics of the basic data in
      the form of frequency distribution, average value, standard deviation and range that occurred
      from the variables studied, both dependent (dependent) and independent (independent)
      variables. Bivariate analysis in this study was carried out by collecting data on a numerical
      scale first and then assessing its distribution using the Kolmogorov Smirnov test.
      Furthermore, if the data is normally distributed, the comparison of the mean before and after
      the intervention in the group will be analyzed using the Paired sample t-test. If the data is
      not normally distributed, a non-parametric test in the form of the Wilcoxon Rank test will be
      used.
    

Intervention name(s): Cascara pulp arabica gayo coffee cream
Intervention type(s): Drug
Intervention description(s): extract of cascara pulp arabica gayo coffee
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
Condition: Pain
Study type: Interventional

Summary: 
      Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol
      and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested
      whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.
    


Intervention name(s): Lidocaine Spray; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Scores During IUD insertion.
Sport Without Injury ProgrammE Floorball
Condition: Athletic Injuries
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      This study evaluates the preventive effect of a neuromuscular training program on injuries in
      youth floorball players. Half of participants will receive the training program, and half act
      as control and perform their usual training practices.
    

Detailed description: 
      The study is a cluster-randomized controlled trial including male and female youth (12-17
      years) floorball players. Club is used as cluster unit.

      Coaches in the intervention group receive education of the preventive neuromuscular training
      program Knee Control (Knäkontroll) before the start of the season. Knee Control consists of 6
      different exercises, with 4 different variations and 1 pair-exercise, and takes about 10
      minutes to complete. In addition, coaches are instructed to perform a 5-minute running
      warm-up before the Knee Control exercises. Teams are to carry out the intervention at all
      training sessions, and the 5-minute warm-up also before all matches.

      Coaches in the control group carry on their normal training and warm-up routines with their
      clubs.

      Teams are followed for one full season: October 2017 - March 2018. Data registered for the
      study include exposure to floorball training and matches, and injuries that occur as a result
      of participation in floorball.
    

Intervention name(s): Knee Control training program
Intervention type(s): Other
Intervention description(s): 10-minute training program to be performed at all team training sessions during the season.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallell group cluster-randomized trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
Condition: Disaster; PTSD; Adolescent Behavior; Trauma; Anxiety; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In October, 2017, Northern California experienced devastating and historic wildfires. Sonoma
      Rises is an app designed for anyone who was impacted by this event and is intended to help
      survivors of disaster find their new normal. This study will assess the feasibility and
      efficacy of a self-help post-disaster mental health intervention delivered via a mobile app
      with a sample of teens who are experiencing post-disaster mental health symptoms.
    


Intervention name(s): Sonoma Rises
Intervention type(s): Behavioral
Intervention description(s): All participants will receive the intervention, Sonoma Rises, a mobile app designed by psychologists at the National Center for PTSD for wildfire survivors to facilitate recovery from disaster. Users can access evidence-informed tools to help cope with stress, heal from loss, prioritize self-care, connect with others, manage anger, and track their mood using validated assessments. There are also tools designed just for teens and users are linked to psychoeducation on disaster and health and other mental health resources and services.
Other intervention name(s): Mobile Mental Health App
Intervention model: Single Group Assignment
Intervention model description: The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile app; Disaster; Digital Medicine; Teens
Usability Evaluation of Menai CPAP Masks
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the subjective performance of the Menai
      mask systems (full face, nasal, and pillows variants), compared against Comparison mask
      systems.
    

Detailed description: 
      The study will evaluate the subjective seal, comfort, stability, usability, and
      humidification performance of the prototype mask systems in CPAP established patients. The
      performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will
      be subjectively assessed through user questionnaires based on an 11-point Likert scale, and
      will be compared against Comparison masks.

      The prototype masks share the same parts (cushion, frame, headgear), with the difference
      being that the Menai masks feature a novel vent and humidification system.
    

Intervention name(s): Menai mask (full face); Menai Standard mask (full face); Menai mask (nasal); Menai Standard mask (nasal); Menai mask (pillows); Menai Standard mask (pillows)
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Prototype mask system (full face variant) with novel vent and humidification system; Prototype mask system (full face variant) with conventional vent and humidification system; Prototype mask system (nasal variant) with novel vent and humidification system; Prototype mask system (nasal variant) with conventional vent and humidification system; Prototype mask system (pillows variant) with conventional vent and humidification system; Prototype mask system (pillows variant) with conventional vent and humidification system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: sleep; apnea; OSA; CPAP
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
Condition: Pain; Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Polyneuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients
      with painful diabetic neuropathy.
    


Intervention name(s): GRT6005; GRT6005; GRT6005; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25µg/day once daily; 75 µg/day once daily; 200 µg/day once daily; Once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: analgesia; analgesics; pain; chronic pain; neuropathic pain
Effectiveness of Telepractice by Smartphone App Technology in Preventing Voice Problems
Condition: Prevention of Voice Disorders in Student Teachers
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      Voice disorders in teachers have a significant impact on communication, quality of life, and
      economic costs to the healthcare system. We need to advance the prevention of voice disorders
      in teachers by testing an online telepractice model with synchronous (in real-time) and
      asynchronous (stored and accessed later) methods. The current study will investigate the
      effectiveness of the theoretically-driven Global Voice Prevention Model (GVPM) delivered by
      two methods; 1) online telepractice (synchronous and asynchronous) and 2) traditional,
      in-person for vocally healthy physical education and vocal music student teachers.
      Effectiveness of the model will be assessed by voice-related measures captured daily on a
      smartphone app during student teaching, matching the asynchronous aspects of the telepractice
      model and representing the effects of vocal loading from teaching.
    


Intervention name(s): Telepractice Global Voice Prevention Model; In-person Global Voice Prevention Model; Telepractice, Vocal Hygiene and Vocal Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy:

      To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT,
      Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.

      Major structural bone parameters which determine bone strength and predict fracture risk
      earlier and more precisely are measurable in vivo by 3DpQCT.

      Safety:

      To assess the tolerability and safety of ibandronate therapy
    


Intervention name(s): ibandronate, calcium and vitamin D; placebo,calcium and vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): 1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or; 2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Ibandronic Acid; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bone structure; ibandronate