bioihbjkbjnl/mcl2 huggingface dataset:
Cooling Vest May Reduce Heat Stress During Surgery
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      The investigators will propose a randomized cross-over trial using a uniform and strongly
      balanced 4-period design in which will include four operations for each surgeon. Surgeons
      will be randomized to 1 of 4 sequences: ABBA, BAAB, AABB or BBAA. The design is "uniform" in
      that each treatment appears the same number of times within each sequence (uniform within
      sequence) and if each treatment appears the same number of times within each period (uniform
      within each period). It is strongly balanced with respect to first-order carryover effects
      because each treatment precedes every other treatment, including itself, the same number of
      times
    

Detailed description: 
      The subjects will be randomly assigned to use either the CoolSource™ cooling vest (worn
      between scrubs) and a conventional surgical gown for each of 4 surgeries. Sequence of
      treatments within the subjects will be randomized (ABBA, BAAB, AABB or BBAA), and determined
      using the PLAN procedure in SAS, such that each surgeon will wear vest and non-vest twice.
      The sequencing will not be shared with any study personnel. Allocation for each case will be
      concealed with a web-based system that will be accessed only shortly before surgery.

      The investigators will target an ambient temperature of 21°C ± 1°C, and try to maintain the
      same temperature of each of the four study cases for each surgeon. The CoolSource vest holds
      six reusable cooling packs located bilaterally on the shoulders, angled flank along the base
      of the rib cage, and along each side of the spine, mid-back. The vest will be donned over
      hospital-issued scrubs after all temperature sensing devices have been applied and before
      surgical hand scrubbing. The subjects will wear the vest throughout surgery, and for a few
      additional minutes while postoperative assessments are made (details below).

      The weight of the disposable cooling vest is 1 kg which is evenly distributed over both
      shoulders. The cooling packs have an insulated cover to reduce condensation or sweating while
      seated inside the vest pocket. The flexible frozen reusable cooling packs will be inserted
      into each of the six pockets and the vest belt will be tied to hold the cooling packs
      securely. The disposable cooling vests will be discarded after each case, and the cooling
      packs returned to a freezer.
    

Intervention name(s): Cooling Vest; Without cooling vest
Intervention type(s): Device; Device
Intervention description(s): Evaluate that wearing a cooling vest during surgery reduces surgeons' mean-body temperature and preserves their cognitive performance.; Evaluate surgeons' mean-body temperature and cognitive performance without cooling vest.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ramelteon for a Nap Prior to a Night Shift
Condition: Healthy
Study type: Interventional

Summary: 
      Night shift-workers are often advised to take a prophylactic nap prior to starting the shift
      in order to improve alertness and performance. However, individuals often report difficulty
      initiating and maintaining sleep at that time of the day secondary to the alerting influence
      of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may
      improve the quality of an evening nap and subsequent alertness and performance during a night
      shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order
      to test the following hypotheses:

        1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a
           2-hour nap;

        2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective
           sleepiness assessments will not be significantly increased after ramelteon treatment
           compared with placebo treatment; and

        3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood
           during a simulated 8-hour night shift will be significantly improved when ramelteon is
           given prior to a prophylactic nap compared to a prophylactic nap with placebo.
    


Intervention name(s): Ramelteon; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ramelteon 8 mg tablet by mouth x 1 dose; placebo identical in appearance to active experimental drug x 1 dose
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sleep; performance; night shift; Ramelteon; Healthy Individuals
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate
      Lowering Effect of URC102 in gout patients.
    


Intervention name(s): URC102; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Body Image in Middle Schoolers
Condition: Healthy; Body Image
Study type: Interventional
Phase: Phase 1

Summary: 
      The focus of this study is the development of a school-based multimedia product for the
      prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The
      program is being designed for early adolescents, age 12-14, and will include information on
      maturation, healthy eating and exercise, skill building modules and media literacy awareness.
    


Intervention name(s): Education and awareness about body image issues.
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Are Static and Dynamic Balance Tests A Criteria Showing Cognitive Impairments In the Elderly?
Condition: Geriatric Population; Balance Problems
MeSH terms: Cognitive Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study is to reveal whether static and dynamic balance tests can be an
      indicator of deterioration in cognitive impairments in geriatric individuals.
    

Detailed description: 
      the static and dynamic balance test will be used to predict cognitive impairments in older
      adults.
    

Intervention name(s): Four Square Step Test
Intervention type(s): Diagnostic Test
Intervention description(s): These are standardized test which will be applied to subjects with pencil, paper and time recorder.
Other intervention name(s): Timed Get Up and Go Test; One Leg Standing Test (Eyes Open and Eyes Closed); Standardized Mini Mental Test; Functional Reach Test
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Relative healthy nursing home residents aged 65-85 living in the nursing home will be
        included in the study.
      
Keywords: geriatria; cognitive status; balance test
A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have symptoms caused by hormonal
      changes, such as hot flashes. Before a treatment can be approved for patients to take,
      researchers do clinical studies to better understand its safety and what happens to the
      treatment in the body.

      In this study researchers want to learn more about a new substance called elinzanetant.

      Elinzanetant, the study treatment, was developed to treat symptoms caused by hormonal
      changes, such as hot flashes. Carbamazepine is a drug that is already available for doctors
      to prescribe, for example against seizures. Midazolam is a treatment that is already
      available for doctors to prescribe as a sedative (calming treatment) or to help people sleep.

      In this study, the researchers will learn how much elinzanetant gets into the participants'
      blood when taken with or without carbamazepine. They will also get to know if taking
      elinzanetant will affect the amount of midazolam in the blood.

      The participants will all take elinzanetant as capsules, carbamazepine as tablets and
      midazolam as a liquid by mouth. On some days, they will take only 1 treatment of midazolam or
      carbamazepine or only elinzanetant. On other days, they will take two study treatments. On 3
      different days during the study, the participants will take elinzanetant with midazolam,
      elinzanetant with carbamazepine and midazolam with carbamazepine.

      Each participant will be in the study for up to 10 weeks. But, the entire study will last
      about 4 months.

      During the study, all of the participants will stay at the study site for 2 periods, period 1
      with 9 overnight stays and period 2 with 22 overnight stays at the study site. In addition,
      there will be two ambulatory visits, one before joining the study and one at the end of the
      study.

      Blood and urine samples will be collected. The doctors will also check the participants'
      heart health using an electrocardiogram (ECG). The participants will answer questions about
      how they are feeling and about any medications they are taking.
    


Intervention name(s): Elinzanetant (BAY3427080); Midazolam; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Elinzanetant given orally as a single dose in Period 1 and in Period 2.; Midazolam given orally as single dose in Period 1 and in Period 2.; Carbamazepine given orally twice daily in Period 2 .
Other intervention name(s): NT-814
Intervention MeSH terms: Carbamazepine; Midazolam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vasomotor symptoms,; Menopause,; Healthy volunteers.
Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly
Condition: HIV; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg
      thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients
    

Detailed description: 
      The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for
      the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative
      to rifampicin for HIV infected patients as its half-life is longer and the enzymatic
      induction effect appears to be less important on the associated ART drugs. This phase II
      trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination
      with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that
      will be further tested in a larger phase III trial comparing safety, tolerability and
      efficacy of rifabutin and rifampicin regimens.
    

Intervention name(s): Lopinavir/r will be supplied by NHSO/GPO; Rifabutin
Intervention type(s): Drug; Drug
Intervention description(s): 200/50 mg tablet LPV/rtv
Other intervention name(s): LPV/rtv
Intervention MeSH terms: Lopinavir; Rifabutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics of rifabutin; HIV/TB co-infection; resource limited setting; AUC; Cmax; Cmin; Ctrough
Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to
      65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study
      will be randomized, double-blind and stratified by gender. Each cohort will contain 36
      subjects (including at least four females), 30 who will receive ETI-204 and six who will
      receive placebo.
    

Detailed description: 
      Protocol AH-105 is a single center, randomized, double-blind, placebo-controlled, sequential,
      dose escalation study. It will evaluate the safety and PK of single IV doses of ETI-204
      administered to approximately 108 healthy male and female subjects. At each dose level, 30
      healthy subjects, including at least 4 females, will be randomly assigned to active drug, and
      at least 6 healthy subjects of both genders will be randomly assigned to matching placebo.

      Description of Agent: ETI-204 is a monoclonal antibody (mAb) to protective antigen (PA) from
      Bacillus anthracis.

      The study will consist of 3 phases: Screening, Inpatient, and Outpatient Follow-up.
      Enrollment criteria will be determined during the 21-day Screening Phase (Visit 1), following
      by a 3 night inpatient phase where eligible subjects will receive a single dose of IV ETI-204
      or matching placebo as described above and undergo routine safety monitoring, dermatologic
      assessments, and blood draws at pre-specified time points. Subjects will be discharged from
      the center after collection of the 48-hour PK sample. During the subsequent 70-day outpatient
      follow-up phase, subjects will return to the center on Days 8, 15, 29, 43 and 71 for clinical
      laboratory testing (hematology and clinical chemistry), physical examinations and vital signs
      measurements, and routine safety monitoring. Blood samples for PK and anti-drug antibodies
      (ADA)will also be collected. The 70 day post-dosing follow-up in this study was selected to
      allow characterization for the PK profile of ETI-204 and the potential development of ADA.
    

Intervention name(s): ETI-204, "Anthim"; placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenously, single dose; intravenously, single dose
Other intervention name(s): ETI-204
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics in Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study pharmacokinetics in adolescents.
    

Detailed description: 
      An open, single centre, phase I study in male adolescents with asthma, aged 12 to 17 years,
      to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 61/2
      days.
    

Intervention name(s): AZD1981 100 mg twice daily for 61/2 days
Intervention type(s): Drug
Intervention description(s): 100 mg tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics AZD1981; Asthma
Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
Condition: Coronary Artery Disease; Heart Valve Diseases
MeSH terms: Coronary Artery Disease; Heart Valve Diseases
Study type: Observational

Summary: 
      This traditional feasibility study aims to capture preliminary safety and effectiveness
      information on a near-final Investigational Device design to adequately plan the forthcoming
      pivotal study.
    

Detailed description: 
      The study design is based on measuring the depth of ischemia during the operation, which is
      compared to the intraoperative and postoperative morbidity of the patient, especially to the
      dysfunction of the heart.

      A qualified and experienced Monitor is assigned for the study to oversee and document the
      progress of the trial. The Monitor ensures the trial performance in accordance with the
      Protocol and Good Clinical Practice (GCP).

      The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included
      in the monitoring activities are documented in the quality management system. Below are
      described the summaries of all these activities.

      Source data will be collected and transferred into the electronic CRFs by site staff, and the
      collected data quality and the conformity to the Good Clinical Practice will be assessed by
      monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be
      established.

      Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness
      of Case Report Form (CRF) entries, source documents, and other investigation-related records
      against each other. Other responsibilities of CRA, including detailed Source Data
      Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical
      research (HCR)(both are sponsor's representatives). SDVs will be performed and documented
      during monitoring visits.

      Monitoring planning, reporting, and visits are pre-defined and documented with pre-made
      templates per the sponsor's quality management system. Monitoring visits will be performed to
      cover data from all study participants, and according to QMS and the Standard Operation
      Procedures.

      The monitoring shall ensure that all source documentation is precise and document control is
      exercised in all relevant documentation. The monitoring ensures, that the Adverse events are
      always reported and appropriate authorities or stakeholders are informed.
    

Intervention name(s): Spectrocor device
Intervention type(s): Device
Intervention description(s): This feasibility study is intended to document the feasibility, safety, and usability of the Investigational device.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for open-heart operation
      
Keywords: Monitoring, Intraoperative; Heart Surgery
Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split
      vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III
      clinical trials.
    


Intervention name(s): 0.5ml Quadrivalent influenza vaccine; 0.25ml Quadrivalent influenza vaccine; 0.25ml Trivalent influenza vaccine(B/V); 0.25ml Trivalent influenza vaccine(B/Y)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains; The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains; The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains; The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
Condition: Male Factor Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select
      sperm for ICSI will result in increased pregnancies especially with men that have a low
      hyaluronan binding score (HBA).
    


Intervention name(s): PICSI dish
Intervention type(s): Device
Intervention description(s): Sperm are added to the PICSI dish. Only those that bind to the hyaluronan microdots are selected for ICSI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: infertility; ICSI; hyaluronan binding; sperm; sperm selection; male factor; hyaluronan; sperm maturity; clinical pregnancy rates; hyaluronan binding assay; HBA; PICSI
Safety and Efficacy of Drug Combinations Against Trichuris Trichiura
Condition: Parasitic Diseases
MeSH terms: Parasitic Diseases
Study type: Interventional

Summary: 
      This randomised, controlled, double-blinded clinical study investigates the safety and
      efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and
      MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged
      5-14 years.
    


Intervention name(s): albendazole; mebendazole; ivermectin; albendazole + ivermectin; mebendazole + ivermectin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): albendazole (400 mg on dose); mebendazole (500 mg one dose); ivermectin (200 microgram/kg body weight); albendazole (400 mg one dose) + ivermectin (200 mg microgram/kg body weight); mebendazole (500 mg one dose) + ivermectin (200 microgram/kg body weight)
Intervention MeSH terms: Ivermectin; Albendazole; Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment