bioihbjkbjnl/mcl2 huggingface dataset:
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy people is to evaluate safety, toleration and time course
      of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity
      of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be
      investigated.
    


Intervention name(s): PF-06743649; Placebo; PF-06743649; Placebo; PF-06743649; Placebo; PF-06743649; Placebo; PF-06743649; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days; Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days; To be decided dose, tablet once daily dosing for 14 days; Placebo tablet once daily dosing for 14 days; To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days; Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days; To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days; Placebo tablet one time once without a meal, followed by once daily dosing for 14 days; Tablet, to be decided dose, once daily, 14 days; Tablet, once daily, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple dose; safety; tolerability; PK
Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when
      administered twice daily for 4 weeks using success rate in Investigator's Global Assessment
      (IGA) at Week 4 as the primary endpoint in adult patients with AD.
    


Intervention name(s): 1% OPA-15406; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily; Twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Hypoplastic Left Heart Syndrome
Study type: Observational

Summary: 
      There have been many improvements in the care of children with hypoplastic left heart
      syndrome (HLHS). This has helped these children survive longer. Because these children now
      live longer, researchers are recognizing developmental disabilities (the children are behind
      in their thinking or physical activity) in children with hypoplastic left heart syndrome. The
      purpose of this research study is to help the investigators learn more about developmental
      disabilities in children with hypoplastic left heart syndrome.

      During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor
      was placed on your child's forehead to measure the oxygen levels in the brain. This monitor
      is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to
      know if oxygen levels in the blood vessels of the brain have any effect on developmental
      disabilities later in life in children with hypoplastic left heart syndrome. The researchers
      plan to enroll 60 research subjects.
    

Detailed description: 
      Our study is a cross-sectional, descriptive study to evaluate the developmental outcome for
      school-age children with HLHS. The general approach of the proposed research is confirmatory
      study/hypothesis testing. The hypothesis (neurodevelopmental outcome of children with HLHS is
      inversely correlated with cerebral oximetry values as measured by NIRS in the 48 hours
      following the Norwood operation) was formulated based on a meticulous review of the
      literature, which clearly demonstrates a substantial prevalence of neurodevelopmental
      deficits in children with HLHS who have undergone surgical palliation. The methodologies for
      measuring developmental outcome are highly reproducible and have been validated in this
      population.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children ages 2.5 to 6 years old who have hypoplastic left heart syndrome with surgical
        palliation and near infrared spectrometry monitoring during the Stage I Norwood procedure.
      
Keywords: Single Ventricle; Hypoplastic Left Heart; Developmental
Effectiveness of Brief Counseling for Weight Management
Condition: 1. Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the effectiveness of three different methods for
      delivering weight management information. Two methods utilize an obesity drug and the third
      method utilizes brief behavioral counseling sessions only.
    

Detailed description: 
      There is a growing demand for effective obesity treatments that don't require much time to
      implement especially in a primary health-care setting where time is especially limited. Brief
      interventions that might provide benefits similar to those produced by more time-intensive
      and costly lifestyle interventions would be very useful. There is also increasing interest in
      the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and
      24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention
      alone or in combination with a drug already approved for the long-term management of obesity
      (orlisat)and compare both interventions to a drug alone condition.
    

Intervention name(s): orlistat; Brief cognitive behavioral counseling
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity Treatment; Effectiveness of weight management treatment; Counseling for weight management
Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively
Condition: Abdominal Cancer
MeSH terms: Abdominal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the analgesic efficacy of transversus abdominis-plane block with
      bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer
      surgery.
    

Detailed description: 
      This randomized study will be approved by the local ethics committee of South Egypt Cancer
      Institute, Assuit University, Egypt after written informed consent. This study will include
      approximately 60 ASA I-II cancer patients with age range (18-60) years, weight (50- 85) kg
      who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy,
      oophorectomy and radical cystectomy). Exclude from the study Patients with known drug allergy
      to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation
      disorders and those with psychiatric illnesses that would interfere with perception and
      assessment of pain. Preoperatively, patients will be taught how to evaluate their own pain
      intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and
      10=worst pain imaginable).

      Patients will be randomly assigned using an online research randomizer into two groups, 30
      patients in each group:

      Group 1:

      30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic
      20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses
      i.e. 20 ml is administered on each side of the abdominal wall.

      Group 2:

      30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic
      20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in
      two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

      Surgery will be performed under standard general anesthesia and ultrasound guided TAP block
      will be performed before induction of GA.
    

Intervention name(s): transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine
Intervention type(s): Drug
Intervention description(s): compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery.
Intervention MeSH terms: Morphine; Bupivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: major abdominal cancer
A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects and the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical
      study with the following main purposes: (1) To evaluate the effect of a single-dose oral
      administration of nemonoxacin malate capsule on QTc intervals and heart rhythms of healthy
      subjects. (2) To evaluate the influence of food intake on QTc intervals and pharmacokinetic
      characteristics.
    


Intervention name(s): Nemonoxacin 500Mg Capsule; Moxifloxacin 400Mg Tablet; Nemonoxacin 750Mg Capsule; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Receive a single dose in a fasting state; Receive a single dose in a fasting state; Receive a single dose in a fasting state; Receive a single dose in a fasting state
Other intervention name(s): TG-873870 500Mg; TG-873870 750Mg
Intervention MeSH terms: Moxifloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota
Condition: Obesity
Study type: Interventional

Summary: 
      In this study, the investigators will evaluate the prebiotic effect of a moderate intake of
      extra virgin olive oil or red wine on the modulation of gut microbiota composition and the
      improvement of cardiometabolic factors in obese and lean adults subjects.
    


Intervention name(s): Extra Virgin Olive Oil and Red Wine
Intervention type(s): Dietary Supplement
Intervention description(s): Phase I: Extra VIrgin Olive Oil 80 grams per day (1 month)
Washout Period: 15 days
Phase II: Red Wine (270 ml per day) (1 month)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Resistance; Extra Virgin Olive Oil; Red Wine; Diet; Microbiota
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety and toleration of multiple oral doses as
      well as the time course of PF-03893787 concentration in the blood following dosing by oral
      solution.
    


Intervention name(s): PF-03893787; PF-03893787; PF-03893787
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral solution, 5 mg, QD for 14 days; oral solution, 15 mg, QD for 14 days; oral solution, 50 mg, QD for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Lung HIV Microbiome Project (Michigan Site)
Condition: Healthy Participants; Tobacco Use Disorder; Human Microbiome
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      In its original phase, this cohort study recruited subjects who were either HIV-positive or
      HIV-negative healthy controls, to analyze the community structure of the lung microbiome.
      Original recruitment was planned to occur both at the University of Michigan Medical Center
      and clinics, and at VA Ann Arbor Healthcare System.

      Enrollment for the original cohort is completed, and all current activity of this project is
      occurring at VA Ann Arbor, where both Veteran subjects and non-Veteran subjects are eligible
      to participate. This study is currently recruiting only healthy HIV-negative subjects.
      Participation, described below, involves a research bronchoscopy procedure.
    

Detailed description: 
      This is a non-interventional cohort study with single time point cross-sectional comparisons
      and longitudinal analyses, with the primary study aims of: evaluating how the immune
      deficiency associated with HIV infection influences the lung microbiome and lung function,
      and evaluating changes in lung microbiota over time. The study also aims to characterize the
      microbiome of the lower respiratory tract, determine the relationship between the lower
      respiratory Microbiome and the upper respiratory and gastrointestinal tract microbiomes,
      evaluate the influence of smoking on the microbiome compared with the influence of smoking on
      pulmonary function and respiratory systems, and to evaluate how Pneumocystis infection
      influences HIV-infected and HIV-uninfected individuals.
    

Intervention name(s): Fiberoptic bronchoscopy
Intervention type(s): Other
Intervention description(s): All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals with no more than mild treated chronic diseases that would not preclude
        a research bronchoscopy under moderate conscious sedation. Both never-smokers and active
        smokers are welcome.
      
Biospecimen description: 
      Oral rinse Nasal swap Bronchoalveolar lavage
    
Keywords: lung
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Condition: Asthenopia; Myopia
MeSH terms: Asthenopia
Study type: Interventional

Summary: 
      Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the
      cornea/contact lens surface, the accommodative system, the convergence system, overall
      postural/muscle fatigue, or a combination of these or other causes. The current study aims to
      systematically investigate the incremental benefits in ameliorating eye fatigue.
    


Intervention name(s): Contact lens with Multifocal Optics; Contact lens with Single Vision Optics
Intervention type(s): Device; Device
Intervention description(s): This contact lens has optics to aid the accommodative and convergence systems; This contact lens has standard single vision optics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Eye Fatigue
The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis
Condition: Colonic Diverticulitis
MeSH terms: Diverticulitis; Diverticulitis, Colonic
Study type: Observational

Summary: 
      Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated
      diverticulitis has a very low risk (1.4%) of developing severe complications such as
      perforations or abscesses. The question is whether or not hospitalization is necessary, and
      if patients in that case could return home without antibiotics.

      The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic
      diverticulitis is possible without readmission or complications.
    

Detailed description: 
      At the emergency room all patients with computed tomography verified acute uncomplicated
      diverticulitis will be asked about participation in the study. If They accept the
      participation, They will be send home with pain relief medicine. Every morning a nurse from
      our colorectal unit call the patient asking about the condition. The patients will have a
      visit at the surgery unit within 10 days.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to
        underwent out-patients managment
      
Keywords: diverticulitis; Out-patient management; Antibiotics
Kinesio Taping and Calf Muscle Fatigue
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Muscle fatigue results in decreased ability in muscles to generate force. Kinesio Tape may
      reverse the adverse effects of fatigue. Thus this study will examine the acute effects of
      Kinesio tape on muscle fatigue.
    

Detailed description: 
      The participants will be divided into three groups; 1. Experimental group: Kinesio tape with
      50% tension will be applied; 2. Sham group: Kinesio tape without any tension will be applied;
      3. Placebo group: Rigid tape without any tension will be applied.
    

Intervention name(s): Kinesio Taping under tension.; Kinesio Tape without tension; Rigid Taping
Intervention type(s): Other; Other; Other
Intervention description(s): Kinesio tape will be applied to participants under tension.; Kinesio tape will be applied to participants without any tension.; Rigid Taping will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-arm parallel group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Calf Muscle; Kinesio tape; Muscle fatigue; Heel raises
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
Condition: Safety Issues
Study type: Interventional

Summary: 
      This study aimed to preliminarily determine safety and efficacy of longan and lingzhi
      mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8)
      aged 18-60 years were recruited into a prospective, single-group study. All participants were
      assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood
      concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate
      aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN
      (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and
      C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.
    


Intervention name(s): Longan and lingzhi mushroom syrup
Intervention type(s): Dietary Supplement
Intervention description(s): Fresh fruit pulps of longan were stewed in hot water until they softened. No sugar and additives were added. The pulps were removed by filtration in order to obtain concentrated longan juice. After that, spray-dried powder of lingzhi mushroom extract was dissolved in water in the ratio of 1:2. To make the finished product, 99 g of longan juice was mixed with 1 g of the lingzhi extract in water. The sugar content of the syrup was 77 degrees Brix.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Regulation of Lipoprotein Transport in Metabolic Syndrome
Condition: Obesity; Lipid Disorders; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable
      effect on lipoprotein metabolism.
    

Detailed description: 
      The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD).
      Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density
      lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts
      CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta
      agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However,
      the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have
      not yet fully been investigated. We therefore carried out a study to study the effect of
      GW5015156 on lipoprotein transport in subject with metabolic syndrome.
    

Intervention name(s): GW501516; placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): 2.5mg/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug treatment
Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia
Condition: Circumcision; Lower Abdominal Surgery
Study type: Interventional

Summary: 
      Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block
      method for postoperative pain control in sub-umbilical surgeries in children. However,
      peripheral nerve blocks have been reported to be preferred in recent years in the literature
      since they provide longer and safer analgesia. One of these blocks, the erector spina plane
      (ESP) block, has been shown to provide effective postoperative analgesia when administered
      from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in
      pediatric patients.
    

Detailed description: 
      Circumcision and any lower abdominal surgery in the pediatric population result in a very
      painful postoperative period, even when each procedure is evaluated separately. Caudal block
      (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for
      postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve
      blocks have been reported to be preferred in recent years in the literature since they
      provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block,
      has been shown to provide effective postoperative analgesia when administered from the lumbar
      level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric
      patients. As far as we know, there is no previous study in the literature comparing CB and
      ESP block in pediatric patients.
    

Intervention name(s): Regional anesthesia intervention
Intervention type(s): Procedure
Intervention description(s): Ultrasound-guided caudal and erector spinae blocks were administered
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ultrasound; Pain; Caudal block; Erector spinae block