bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Beetroot Juice Supplements on Lower-limb Strength in Females
Condition: Muscular Endurance
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of beetroot juice supplements on lower-limb strength
      and muscular endurance in physically active women, due to the presence of NO3- in beetroot
      juice.
    

Detailed description: 
      Beetroot juice (BJR) is used as an ergogenic aid, but no study has analyzed its' effects on
      explosive force production in physically active women. It has been proposed that females
      could blunt reduction of NO2- to NO based on a higher oxidative skeletal muscle phenotype
      than males. However, it has been observed a higher increase on plasma NO2- levels after
      supplementation compared to and a greater enhancement on muscle contractile function.

      Based on the absence of any study that has analyzed the effect of NO3- supplements on jump
      ability and power production on weightlifting on female population; the purpose of this study
      will be to investigate the possible ergogenic effect of BJR on physically active women on
      explosive force production and muscular endurance in a lower-limb body weightlifting
      protocol, due to the presence of NO3- in BJR and its effects.
    

Intervention name(s): Beetroot juice; Capri-Sun
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subjects will drink juice 120 minutes before each visit; 70 mL of blackcurrant beverage, which is depleted of NO3- will be taken 120 min before each visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The experimental procedure will consist of three visits, separate from each other by one week, to achieve the total elimination of any effects caused by BJR as well as the optimal recovery of the participants.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Explosive force production; Beetroot juice; Beetroot; muscular endurance
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants
      with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX)
      compared with adalimumab.
    

Detailed description: 
      This study consists of a 12-week double-blind active-controlled phase and a 12 week
      double-blind extension period.

      In the active-controlled period of the first 12 weeks of treatment, participants are
      randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or
      adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.

      At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the
      observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to
      receive placebo injections, whereas participants randomized into the adalimumab arm were to
      continue their 80 mg dosing.
    

Intervention name(s): ABBV-3373; Placebo for ABBV-3373; Adalimumab; Placebo for adalimumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABBV-3373 is administered as intravenous (IV) infusion; Placebo for ABBV-3373 is administered as IV infusion; Adalimumab is administered as subcutaneous (SC) injection; Placebo for adalimumab is administered as subcutaneous (SC) injection
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis (RA); ABBV-3373; Adalimumab
Two Warming Methods in Knee Arthroplasty
Condition: Hypothermia, Accidental
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      In this study two warming methods will be compared in knee arthroplasty surgery. Barrier
      EasyWarm will be used in the study group and BairHugger upper body warming blanket in the
      control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the
      operating room warming will be continued with the same warming method. Primary end point is
      core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier
      EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.

      Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is
      used in this study. During the study we will test the accuracy of the 3M BairHugger
      Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head.
      After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M
      BairHugger Temperature Monitoring System. So the patients (n=30) have both these different
      core temperature monitoring systems on their foreheads. This observational monitoring study
      is performed from the patient number 80 until the end.
    


Intervention name(s): EasyWarm; BairHugger
Intervention type(s): Device; Device
Intervention description(s): Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia; Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: inadvertent, intraoperative hypothermia, prewarming; core temperature monitoring
A Relative Bioavailability Study of 60 mg Nifedipine ER Tablets Under Non-fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the relative bioavailability of Nifedipine ER tablets 60
      mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by
      Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg
      tablet) in healthy adult volunteers under non-fasting conditions
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study
      under non-fasting conditions

      Official Title: A Relative Bioavailability Study of 60 mg Nifedipine Extended Release tablets
      Under Non-Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Nifedipine Extended Release tablets 60 mg, single dose; ADALAT® CC Extended Release Tablets 60 mg
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under non-fasting conditions; B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under non-fasting conditions
Other intervention name(s): Nifedipine; Nifedipine
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Nifedipine; Healthy subjects
Endometrial Receptivity After GnRH Agonist Triggering
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in
      women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides
      adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS)
      still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are
      used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.

      By testing different luteal support protocols on women undergoing GnRHa triggering, the
      investigators aim to find out which protocol resembles the most the gene expression profile
      observed after hCG triggering and conventional luteal phase support, in order to choose it as
      the most adequate in terms of endometrium receptivity and safety (OHSS incidence).
    


Intervention name(s): hCG; triptorelin; Triptorelin, estradiol valerate, micronized vaginal progesterone; triptorelin, hCG; triptorelin, hCG; triptorelin, recombinant LH
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single shot of 6500 IU hCG s.c. at the time of triggering; single shot of 0.2mg triptorelin s.c. at the time of triggering; 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU; single shot of 1500 IU hCG s.c. the day of OPU plus 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU; Multiple doses of 500 IU hCG (OPU, +4 and +7) and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU; 300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
Intervention MeSH terms: Triptorelin Pamoate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: endometrial receptivity; gene arrays; agonist triggering; Endometrial gene expression; OHSS
Effect of a Female Strength & Conditioning Specialist on High School Girls' Health
Condition: Physical Inactivity; Low Physical Fitness
Study type: Interventional

Summary: 
      The majority of today's youth do not engage in enough physical activity (PA) to maintain good
      health. Low PA levels are associated with poor health (e.g. diabetes, high blood pressure)
      and early mortality. Girls are less likely than boys to be active, and their rates of
      participation drop off more steeply during adolescence. Girls report many barriers to
      exercise, including transportation issues and feeling self-conscious about their appearance
      and abilities. School-based PA programs that try to improve health, mainly through aerobic
      exercise and education, have had a small effect to date. However, the few programs that
      included resistance training as the focus showed strong improvements in health related
      measures. In this project, we will examine the effect of a female strength and conditioning
      specialist on decreasing barriers and increasing the overall health of high school girls,
      with the delivery of in-school, girls-only resistance training programs. We will see if
      physical and mental health changes with the training, and how the presence of the S & C
      specialist affects the girls' social interactions within the school. The results will help
      individuals in the education sector plan programs and services to improve overall youth and
      school health.
    


Intervention name(s): Girls-only resistance training
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resistance Training; Muscle Strength
Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.
Condition: Rotavirus Infections; Rotavirus Vaccines
MeSH terms: Infections; Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the presented study was to evaluate the safety and immunological efficacy in
      preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45
      years old) by using the pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral,
      freeze-dried).
    

Detailed description: 
      The clinical study named "Prospective, randomized, double-blind, placebo-controlled study of
      safety and immunological efficacy for preventing a rotavirus infection pentavalent vaccine,
      live attenuated at the healthy subjects at the age of 18-45 years" was conducted in the
      Russian Federation. The mentioned study was performed as per Protocol of clinical trial No.
      RTB 001/18 (given by MOH RF exp June 7, 2018). All relevant requirements of the National
      Legislative system and the international rules of conduct of clinical trials (ICH GCP).

      The study objective was to assess the safety and immunological efficacy for preventing a
      rotavirus infection pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral,
      freeze-dried) at healthy adults aged 18 to 45 years for the subsequent vaccination of the
      children's contingent.

      For the achievement of a goal, it was necessary to solve the following problems:

        1. Assessment of the vaccine's safety for preventing a rotavirus infection pentavalent live
           compared to placebo at a single oral introduction to volunteers at the age of 18-45
           years.

        2. Immunological efficacy assessment for prevention of a rotavirus infection pentavalent
           live in comparison with placebo at a single oral introduction to volunteers at the age
           of 18-45 years
    

Intervention name(s): The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).; Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).
Other intervention name(s): Rota-V-Aid™; Diluent is a sterile solution (Citrate Bicarbonate Buffer)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized double-blind placebo-controllable.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Transcranial Magnetic Stimulation and Bulimic Craving
Condition: Bulimia
MeSH terms: Bulimia
Study type: Interventional

Summary: 
      Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a
      sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may
      be considered appropriately by using paradigms developed in the framework of embodied
      cognition theories.

      In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for
      food in these patients, as measured by reaction time.

      Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated
      transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to
      the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among
      bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more
      than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms
      have not yet been explored.
    

Detailed description: 
      The exams / treatments of the study include:

        -  a 20 minute session of rTMS at a frequency of 10 Hz.

        -  cognitive testing and attention, which will be made on the computer before and 24 hours
           after the session of rTMS.

      Cognitive test consist in , on a computer screen:

        -  Is first displayed, food and non-food words. The patient must pull a lever to it if the
           letter A is present in the word and push the lever if the letter A is missing the word.

        -  Then presents a series of food and non-food words. The patient must pull a lever to it
           if it deems that the word has a positive meaning and push the lever if it determines
           that the word has a negative meaning
    

Intervention name(s): rTMS session; rTMS Placebo (SHAM)
Intervention type(s): Device; Device
Intervention description(s): One session of rTMS at a frequency of 10 Hz during 20 minutes; One session of placebo (SHAM) rTMS during 20 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: bulimia; repetitive transcranial magnetic stimulation (rTMS)
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Condition: Diabetic Retinopathy
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This project aims to validate a predictive model of diabetic retinopathy progression to
      clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The
      Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and
      LDL levels, established on a set of 52 diabetic patients, will be tested on a population of
      400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at
      6-month interval (V0 and V6) to classify each patient into one of the 3 previously
      established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of
      end-points, achieved by the patients, are expected to validate our predictive model.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetic patients with Mild non-prolipherative retinopathy fulfilling the inclusion
        criterion.
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Condition: High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 1

Summary: 
      Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute
      mountain sickness such as headache and malaise. However, the blunting of inflammation by
      ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of
      inflammation for adjustments in breathing.

      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to
      altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue
      oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that
      subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at
      altitude than will placebo subjects.
    

Detailed description: 
      The study will begin with 2 days of studies in San Francisco (sea level baseline).
      Measurements will include non-invasive measurements of blood and tissue oxygen and venous
      blood draws for cytokine levels.

      The altitude part of the study involves ascent to the University of California's White
      Mountain Research Center Barcroft Laboratory, at 12,500 feet elevation. The subjects will
      remain at that altitude for at least 48 hours for measurements of oxygenation and blood
      cytokines.
    

Intervention name(s): Ibuprofen; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Other intervention name(s): motrin
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: altitude; mountain sickness; ibuprofen; hypoxia
The Validity and Reliability Study of the Chelsea Critical Care Physical Assesment Tool
Condition: ICU Patients; ICU Acquired Weakness
MeSH terms: Asthenia
Study type: Observational

Summary: 
      This study is aimed at providing an translation and cross-cultural adaptation of Chelsea
      Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity.
    

Detailed description: 
      Survival has increased in the ICU due to technological developments , but physical disability
      after discharge has become an important problem. İntensive Care Unit Acquired
      Weakness(ICU-AW) is seen in most of the patients admitted in this unit. The biggest reasons
      for ICU-AW are; sepsis, multiple organ failure and prolonged mechanical ventilation. The use
      of measurement tools to evaluate disabilities during stay and after discharge in intensive
      care unit, is a subject that has been researched all over the world.. These measurement tools
      provide; monitoring and evaluation during the ICU admission and assessment efficacy of
      treatment in the unit. The Chelsea Critical Care Physical Assessment Tool(CPAX) has been
      shown to valid, reliable and to exhibited strong clinimetric properties. CPAx is a numerical
      measurement tool, rated according to the 6-point Guttman Scale, from complete dependence to
      independence and consist of ten physical function parameters. This study is aimed at
      providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical
      Assesment Tool (CPAx) and tested its reliability and validity. The protocol includes a
      pre-test of the Turkish version on 10 patients, a final revision, and a validation on a
      sample of 40 İCU patients.
    

Intervention name(s): Validation of the Chelsea Critical Care Physical Assesment Tools
Intervention type(s): Other
Intervention description(s): The validation of the CPAX tools will focus on the validity of constructs, internal consistency reliability and test-retest reliability. PFIT used for criterion validity.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ICU patients
      
Keywords: Physical Function; Critical İll; ICU Acquired Weakness
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Condition: Healthy; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of
      cabozantinib in adult subjects with impaired renal function compared with healthy adult
      subjects. Another objective is to assess the safety and tolerability of cabozantinib in these
      adult subjects.
    


Intervention name(s): cabozantinib
Intervention type(s): Drug
Intervention description(s): 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.
Other intervention name(s): XL184
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment