bioihbjkbjnl/mcl2 huggingface dataset:
Fluid at Work Study
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool
      for use in the UK working population.

      From the results of a systematic review and a round table discussion a novel fluid
      measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

      The observational evaluation study will measure the relative validity and reliability of WBIQ
      for assessing fluid intake in a workplace population.
    

Detailed description: 
      The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool
      for use in the UK working population.

      From the results of a systematic review and a round table discussion a novel fluid
      measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

      WBIQ will be used to conduct a preliminary investigation of relative validity and
      reliability. Relative validity of the tool will be tested, rather than 'absolute validity',
      as there is no 'gold' standard measure for exact fluid intake in free living population
      groups.

      Individuals responding to local advertisements will complete an initial telephone or email
      questionnaire, and then eligible respondents will be asked to attend King's College London
      for a screening visit where they will be asked questions to confirm their inclusion criteria.
      Inclusion criteria: full-time disked based/ office workers. Following confirmation of
      eligibility and written consent participants will be asked to attend two study visits 7-days
      apart and complete three on-line fluid intake surveys.
    

Intervention name(s): Evaluation study - provision of an online questionnaire
Intervention type(s): Other
Intervention description(s): Evaluation study - provision of an online questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Desk based office employees
      
Biospecimen description: 
      If participants consent, a urine sample will bio banked for future analyses
    
Keywords: Workplace; Fluid; Assessment; Employee
RS-fMRI to Nutrient Shakes
Condition: Pleasure
Study type: Interventional

Summary: 
      Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure
      pleasantness after consumption of four different milkshakes with added sugars or sweeteners.
    

Detailed description: 
      The central role of the brain in regulating food intake and steering feeding behaviour is
      increasingly recognized. It is currently well accepted that the brain is the target organ to
      measure the effects of pleasantness and energy homeostasis in order to change feeding
      behaviour to reduce the rising prevalence of obesity. The effects of food on the brain are
      multiple and complex. In addition to primary aspects of food such as taste, texture, looks
      and smell, secondary aspects such as energy regulation are as much important in the entire
      "eating experience". Resting state functional connectivity in the brain can be assessed by
      the analysis of low-frequency fluctuations present in the blood-oxygenation-level-dependent
      (BOLD) signal in functional magnetic resonance imaging (fMRI). Investigators will use resting
      state functional magnetic resonance imaging (rsfMRl) to detect changes in connectivity in the
      default mode and salience network after consumption of four different milkshakes with added
      sugars or sweeteners.
    

Intervention name(s): Glucose; Fructose; Sucralose; Allulose
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Assessment of Body Composition and Physical Function
Condition: Body Composition; Physical Function
Study type: Observational

Summary: 
      Sarcopenia, which is the loss of muscle mass and strength or physical function, naturally
      occurs in aging. In sarcopenic obesity, growth of muscle mass and increments in strength do
      not parallel weight gain, and places older adults at increased risk of falls, fractures,
      physical disability, frailty, and mortality from too low muscle strength relative to body
      size. The goal of the study is to assess body composition and physical function in older
      adults with obesity.
    

Detailed description: 
      This is a cross-sectional study in 40 adults aged 60 to 80 years with obesity. Body
      composition, physical function, and insulin resistance will be measured. Subjects who satisfy
      the eligibility criteria and sign the informed consent will be enrolled. Subjects will
      complete an assessment of body composition by bioelectrical impedance analysis and tests of
      physical performance. Blood will be drawn for measurement of fasting glucose and insulin.
    

Intervention name(s): Body Composition Assessment; Modified Physical Performance Test; Hand grip strength; 6-minute walk test; Measurement of blood glucose and insulin
Intervention type(s): Other; Other; Other; Other; Procedure
Intervention description(s): Assessment of body composition using bioelectrical impedance analysis.; A test of physical functioning; A test of hand grip strength using a hand dynamometer.; Self-paced test of walking capacity.; Blood will be drawn for measurement of glucose and insulin.
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 60 - 80 years with obesity.
Safety and Effectiveness of Omega 3-Fatty Acids, EPA Versus DHA, for the Treatment of Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study examines the difference in the effectiveness of two natural compounds,
      eicosapentanoic (EPA) and docosahexanoic (DHA)omega-3 fatty acids, in treating major
      depressive disorder. Both types of omega-3 fatty acids are commonly found in fish oils. It is
      believed that a deficiency in these omega-3 fatty acids may lead to the development of major
      depression.
    

Detailed description: 
      The study lasts for eight weeks and involves four visits after the screen and baseline visits
      (biweekly). Participants will be randomized, or chosen by chance, to enter into one of three
      groups. People in the first group will take 1 g/day or EPA omega-3 fatty acid, those in the
      second group will take 1 g/day of DHA omega-3 fatty acid, and those in the third group will
      take a placebo. This study is double-blind, which means that neither the participant, nor the
      doctor, nor the research staff will know which group each person is in. At the end of the
      study the participant will be offered three months of follow-up care at the Depression
      Clinical and Research Program.
    

Intervention name(s): eicosapentaenoic acid; docosahexaenoic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 1 gram/day; 1 gram/day; 980 milligram/day
Other intervention name(s): EPA, Omega-3 Fatty Acid, ProEPAXtra; DHA, Omega-3 Fatty Acid, ProDHA; Placebo, Soybean oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Omega-3; Boston
Observing the Effect of Fascial Manipulation in Athletes With Shin Splits.Tibial Stress Syndrome.
Condition: Shin Splint; Fascial Manipulation; Running Kinematics
MeSH terms: Medial Tibial Stress Syndrome
Study type: Interventional

Summary: 
      Aims & objectives:

        1. The aim of the study is to find out the influence of fascial manipulation on running
           kinematics among athletes with medial tibial stress syndrome (MTSS).

        2. The objectives of our study are

      i. To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running
      kinematics before and after treatment intervention. iii. To compare pain perception before
      and after treatment intervention.
    

Detailed description: 
      The justification for study:

        1. MTSS is associated with altered lower extremity kinematics.

        2. There is an association between tibial fascia tightness and forces acting along the
           tibial crest due to alterations in the transfer of energy from foot proximally in the
           closed kinematic chain.

        3. Fascial manipulation is found to be effective in improving the pliability of connective
           tissues in the management of musculoskeletal conditions.

        4. Therefore there is a need to determine the influence of fascial manipulation on MTSS.
    

Intervention name(s): Fascial manipulation
Intervention type(s): Other
Intervention description(s): Deep frictional massage
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Feasibility of BabyGentleStick- Adult Pilot Study
Condition: Lack of Adverse Events; Reduced Pain Response
Study type: Interventional

Summary: 
      This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.
      BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain
      subject feedback, assess device performance; and ascertain potential harm in healthy adult
      volunteers.
    


Intervention name(s): BabyGentleStick™ ON; BabyGentleStick™ OFF
Intervention type(s): Device; Device
Intervention description(s): experimental intervention; active comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Bipolar Depression and Inflammation
Condition: Bipolar Depression
MeSH terms: Inflammation; Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This project will attempt to enhance and augment the antidepressant efficacy of a commonly
      used antidepressant in poorly responding bipolar depressed patients.
    

Detailed description: 
      This is a placebo-controlled study of patients with bipolar I disorder (BPD) utilizing a
      well-known antidepressant, escitalopram (ESC), in combination with the anti-inflammatory
      agent, celecoxib (CBX). The investigators hypothesize that combination treatment will lead to
      a qualitatively and quantitatively augmented response and will result in greater numbers of
      remitters compared to ESC monotherapy.
    

Intervention name(s): ESC + CBX; ESC + PBO.; ESC+CBX
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.; • Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.; • Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar depression; Celecoxib; Escitalopram; Inflammation
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in
      combination with escitalopram 10mg once daily compared to saredutant placebo in combination
      with escitalopram 10mg once daily in patients with major depressive disorder. This study also
      includes a double-placebo group (saredutant placebo in combination with escitalopram
      placebo).
    


Intervention name(s): saredutant (SR48968); escitalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration, capsules; oral administration, capsules; oral administration, capsules
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Episode; Antidepressant
Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Condition: Advanced Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to investigate the safety and efficacy of Toripalimab Combined With
      Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation
      Non-small Cell Lung Cancer.
    


Intervention name(s): Toripalimab combination with platinum-containing dual-drug chemotherapy
Intervention type(s): Drug
Intervention description(s): Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Toripalimab NSCLC
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when
      administered to healthy Japanese subjects once a day (QD) for 10 days.
    


Intervention name(s): 1 mg; 5 mg; 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg or placebo a material sparing tablet per day for 10 days; 5 mg or placebo as material sparing tablet per day for 10 days; 10 mg or placebo as a material sparing tablet per day for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PH-797804; Japanese; Phase 1; multiple dose study
Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the effect of manual based cognitive therapy in adjunct
      of three different pharmacotherapy.
    

Detailed description: 
      Context Alcoholism is common clinical problem and its treatment has no standard and is
      controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown
      to improve the drinking outcomes, but there is no randomized comparative studies on the
      effects of these three medications.

      Objectives The aim of this study was to compare the effect of manual based cognitive therapy
      in adjunct of three different pharmacotherapy.

      Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous
      medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary
      treatment seeking alcohol dependent outpatients.

      Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to
      receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per
      day. The patients were met weekly in first month, then after 3, 6 and 12 months.
    

Intervention name(s): Disulfiram; Acamprosate; Naltexone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Disulfiram; Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcoholism; Dependence; Randomization; Effect; Disulfiram; Naltrexone; Acamprosate
Cohort of Healthy People in Brain MRI, Together With a Language and Cognitive Assessment at the University Hospital of Nice
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The aim of this study is to constitute a cohort of healthy subjects in brain MRI, including
      functional and diffusion sequences, together with a language and cognitive assessment. This
      will make it possible to compare the data with those obtained in the same center and under
      the same examination conditions in brain tumor patients. The investigators seek to evidence
      general patterns of cerebral morphological and functional changes, correlated with
      behavioural scores, in brain-damaged patients.
    


Intervention name(s): Neurological assessments
Intervention type(s): Other
Intervention description(s): The participants will have a MRI, and language and cognitive assessments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Endocardial Stem Cells Approach Efficacy
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to test that endocardial stem cells implantation in
      patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and
      PCI or despite on previous revascularization improves long-term survival compared to MED
      alone
    


Intervention name(s): Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Intervention type(s): Procedure
Intervention description(s): Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor
Condition: Labor, Obstetric; Episiotomy
Study type: Interventional

Summary: 
      In order to determine the optimal angle to perform an episiotomy, the investigators assessed
      the angle of marked episiotomy lines at the first stage of labor and at the time of crowning
      of the head.

      Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°,
      and 60° angles from the midline, at the first stage of labor, in women with singleton
      pregnancies. The angles of the marked lines were measured again at crowning of the head.
      Mediolateral episiotomy was performed only for obstetric indications.
    


Intervention name(s): change of medilateral angle line during crowning of the head
Intervention type(s): Procedure
Intervention description(s): change of medilateral angle line during crowning of the head
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
Condition: Stem Cells
Study type: Interventional

Summary: 
      The goal of the study is to determine the acute and short-term supplementation effect of a
      commercially available theacrine-containing supplement (NAD3) on numbers of various
      circulating stem cell populations in older adults.
    

Detailed description: 
      This is a double-blind, placebo-controlled crossover study with 12 participants randomized to
      receive either NAD3® or a placebo for seven days. Blood samples are collected after an
      overnight fast, before and after the seven-day supplementation period, as well as one and two
      hours after the final supplement/placebo dose. Using flow cytometry, circulating stem cells,
      including lymphocytoid CD34+ stem cells (CD45dimCD34+), stem cells associated with vascular
      maintenance and repair (CD45dimCD34+CD309+), CD34+ stem cells linked to a progenitor
      phenotype (CD45dimCD34+CD309neg), circulating endothelial stem cells (CD45negCD31+CD309+),
      and mesenchymal stem cells (CD45negCD90+) are quantified.
    

Intervention name(s): NAD3
Intervention type(s): Dietary Supplement
Intervention description(s): NAD3 supplement (per capsule): 344 mg microcrystalline cellulose,156 mg of a proprietary blend of Wasabia japonica (freeze-dried rhizome) cultivar, standardized to NLT 12,000 ppm isothiocyanates, 97.0% Theacrine, Copper Nicotinic Acid chelated complex (17-20% Copper by ICP-Mass spectroscopy)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo controlled, double blind, crossover study with a two-week washout period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Coffee, Exercise, and Oxidative Stress
Condition: Healthy
Study type: Interventional

Summary: 
      Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic
      acids) and bioavailability of these bioactive compounds is now somewhat well understood. In
      addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence
      remains to be observed in vivo. The objective of this trial is to understand if regular (14d)
      coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and
      plasma after an acute stress caused by exercise.
    

Detailed description: 
      Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic
      acids) and bioavailability of these bioactive compounds is now somewhat well understood.
      However, even if chlorogenic acids are known to be antioxidants in the cup, reliable evidence
      remains to be observed in vivo.

      After medical examination and approval, subjects will undergo 2 periods of 21 days. The first
      7 days will consist of a dietary restriction to lower the polyphenols intake. Then subjects
      will drink at random one of the three treatments for 14 days (4 cups/day). Blood and urine
      samples will be collected throughout the study to evaluate in vivo effects on oxidative
      biomarkers. Furthermore, at day 21, subjects will undergo a physical regimen to increase
      acutely and transiently their oxidative damage. Blood and urine samples collected throughout
      this challenge will allow us to evaluate the effect of coffee intake in reducing oxidative
      damage created by exercise compared to placebo.
    

Intervention name(s): Coffee; Placebo comparator
Intervention type(s): Other; Other
Intervention description(s): coffee versus placebo; maltodextrine with caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)