bioihbjkbjnl/mcl2 huggingface dataset:
Effect of NO Precursors on Physiological Responses to Exercise
Condition: Physiology
Study type: Interventional

Summary: 
      NO is an ubiquitous molecule contributing to many physiological functions such as
      vasodilation, immune and oxidative stress responses. NO production can be supplemented either
      by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing
      nitrate which can lead to NO. In the present project the investigators evaluate the effect of
      various acute and chronic oral NO precursors supplementation on exercise performance and
      responses in healthy young and older subjects.
    


Intervention name(s): Nitrate; Nitrate and L-Arginine; Nitrate and L-Citrulline; Placebo; Evaluation of post-ischemic vascular reactivity; Neuromuscular evaluations
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Biological; Biological
Intervention description(s): Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.; Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.; Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.; Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with a placebo.; After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.; After the intake of the supplement. Measure the stretching force in the ankle (N)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
Condition: Hemophilia; Elbow Joint Contracture
MeSH terms: Contracture; Hemophilia A
Study type: Interventional

Summary: 
      This is a research study of adults with hemophilia that have limitations in elbow joint
      motion that is the result of bleeding into the joint.

      People with hemophilia who have bleeding into their elbow joint may have limitations in elbow
      joint movement and pain in the joint. This research is being done to determine the effect a
      strength training program has on the amount of movement people with hemophilia and elbow
      joint disease have.
    


Intervention name(s): Strength training
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mixed Reality Gaming for Chronic Low Back Pain
Condition: Recurrent Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Mixed Reality Gaming for Chronic Low Back Pain
    

Detailed description: 
      The company, From the Future and University of Alabama at Birmingham (UAB) team aimed to
      develop a virtual reality (VR) game that integrated with the features of a specialized
      self-driven treadmill to provide accessible and progressive walking challenges for
      individuals with chronic low back pain (LBP). The game was designed to go beyond typical VR
      research efforts and provide a truly immersive and engaging experience that would motivate
      individuals with high pain-related fear to keep moving.
    

Intervention name(s): Exergaming
Intervention type(s): Device
Intervention description(s): Mixed Reality Gaming for Chronic Low Back Pain
Other intervention name(s): Mixed Reality
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Walking; Exercise; Exergaming
Canadian Biomarker Integration Network for Depression Study
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a pilot to assess feasibility of the protocol in patients and controls across
      six participating sites. The goal is to identify biological markers (biomarkers)that can be
      measured at baseline or early in treatment to predict treatment outcome in individual
      patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using
      interview and self-report measures), molecular (from blood samples) and neurobiological
      (using neuroimaging and EEG).
    

Detailed description: 
      This is a study to collect clinical and biomarker data which will be used to build models to
      predict treatment response. This is not a study to evaluate efficacy of medications, as
      medications in this study have been approved by Health Canada and are widely used for the
      treatment of MDD.

      This is an open label study involving MDD patients and healthy controls.Patients with a
      diagnosis of MDD and a current major depressive episode (MDE) will receive open-label
      standard of care treatment with escitalopram (10-20mg). Healthy controls will not receive
      medication; however, they will go through clinical assessments, blood collection and
      neuroimaging procedures.

      At week 8, patients will be assessed for medication response (response is defined as ≥ 50%
      reduction in MADRS scores from baseline). Responders will continue medication at their
      effective dose until study endpoint while non-responders will receive open label add-on
      treatment with aripiprazole (2-10mg).

      There are approximately 7 clinic visits over a 16 week period during which patients and
      healthy controls will undergo clinician administered scales and self reports, provide blood
      and urine samples (which will undergo proteomic and genomic analyses) as well as neuroimaging
      (fMRI and EEG).

      At the end of the study, mathematical modeling methods will be used to integrate the data
      from the various modalities to see which features best predict treatment outcome.
    

Intervention name(s): escitalopram; aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.; At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
Other intervention name(s): Cipralex; Abilify
Intervention MeSH terms: Aripiprazole; Escitalopram
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: major depression; major depressive disorder; biomarkers; escitalopram; aripiprazole; MDD; neuroimaging; proteomic; genomics
A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104
      on brain circuitry associated with emotional processing in healthy participants.

      The secondary objectives of the study are to evaluate the safety and tolerability of BIIB104
      in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry
      associated with emotional processing in healthy participants; To explore the PD effects of
      BIIB104 on brain circuitry associated with working memory in healthy participants using the
      N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy
      participants; To explore the PD effects of BIIB104 on brain circuitry during resting state in
      healthy participants.
    


Intervention name(s): Placebo; BIIB104
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of Zinc-biofortified Rice in Bangladeshi Children
Condition: Zinc Deficiency; Growth; Stunting, Nutritional
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants
      from a rural area of Bangladesh.
    

Detailed description: 
      Rationale: Around the world and estimated 30% of the population is at risk of Zinc
      deficiency, mainly due to monotonous plant base diets and the poor bioavailability of this
      sources. One staple food crop which is low in zinc content is rice. Therefore, zinc
      deficiency is highly common in Asia. Zinc plays a major role in child growth and
      neurobehavioral development. Furthermore, it is linked to infection control and normal immune
      response. One way to add extra zinc to someone's diet is zinc bio fortification of staple
      crops, which can be a cost saving sustainable approach to improve zinc nutrition. However,
      data on long-term intake of biofortified crops with zinc is scarce and efficacy of newly
      developed rice crops high in zinc are not well known.

      Objective: The objective is to assess the efficacy of a newly developed zinc biofortified
      rice variety on plasma zinc concentrations in children in a rural area of Bangladesh when
      compared to their controls in a 9 month randomized controlled trial (RCT).

      Study design: A double randomized control trial. Study population: Stunted children whom are
      zinc deficient at start of the study intervention determined by plasma zinc levels <9.9
      µmol/L.

      Main study parameters/endpoints: The difference in zinc status between the intervention and
      control group expressed in blood plasma zinc levels. Plasma zinc will be measured 4 times
      during the intervention period. Besides plasma zinc other zinc biomarkers will be tested for
      their usefulness.
    

Intervention name(s): Intervention-group; Control-group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Biofortified Rice is grown by foliar Zn application; Control Rice with normal zinc levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc Biofortification; Zinc Status; Zinc Biomarker
Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to look at how the body handles the drug maraviroc. It will
      measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is
      to understand how much of the drug (taken by mouth) reaches the oral, reproductive and
      intestinal tracts. It is believed that the presence of this drug in these areas may be
      beneficial in preventing the AIDS virus (HIV) from being passed from one person to another.
      The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug
      levels. This study will also collect information on side effects.
    


Intervention name(s): Maraviroc
Intervention type(s): Drug
Intervention description(s): Healthy male volunteers will take maraviroc 300 mg orally twice daily for 15 doses (8 days)
Other intervention name(s): Selzentry
Intervention MeSH terms: Maraviroc
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Trial of Different Dietary Fats on Blood Lipids and Metabolic Measures in Healthy Participants
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from
      the general community are randomized into one of three arms: participants will be provided
      with 50 gm extra virgin coconut oil,or 50 grams butter or 50 extra virgin olive oil to be
      eaten daily for a month. The key outcome is blood low density lipoprotein cholesterol
      concentrations and secondary outcomes blood lipid profile (total cholesterol, high density
      lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist
      circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol
      difference between the trial arms.
    

Detailed description: 
      This is a randomized trial in which healthy volunteers from the general community are
      randomized into one of three arms: consumption of 50 gm of extra virgin coconut oil daily OR
      50gm of butter daily OR 50gm of extra virgin olive oil daily (50gm is about 2 ounces, or 2
      table spoons), to be consumed over a one month period.

      The research participants will be recruited from the general community through advertising
      (BBC).

      After full informed consent, participants will attend an assessment visit and have a baseline
      measures of weight, height, waist circumference, blood pressure, a blood sample for
      assessment of blood lipids and other metabolic markers, and fill in a health questionnaire
      and dietary questionnaire. Participants will be randomly allocated to one of three arms:
      coconut oil, butter or olive oil and will be given supplies of these (portioned, or with
      measuring spoons) with information about daily consumption of 50 gram of one of these fats.

      After one month, participants will return for follow up assessment which will include a
      repeat blood sample, anthropometric measures and blood pressure, and questionnaire.

      Blood samples collected by venepuncture will be stored at the University of Cambridge and
      analysed at the Department of Clinical Biochemistry, Cambridge University Addenbrooke's
      Hospital.

      At the end of the study, all participants will be given the individual participant results of
      the anthropometric measures and lipid profiles at baseline and follow up as well as the
      overall findings of the trial.
    

Intervention name(s): Coconut oil; Butter; Olive oil
Intervention type(s): Other; Other; Other
Intervention description(s): 50g extravirgin coconut oil daily for four weeks; 50g butter daily for four weeks; 50g extra virgin olive oil daily for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial of different dietary fats
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: lipids; dietary fats
An Evaluation of Outcomes Following Wavefront Optimized or Wavefront Guided Lasik Procedure in Low to Moderate Myopic Patients
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare post-surgical outcomes in patients who have undergone Wavefront Guided LASIK
      (iLASIK platform) compared with patients who have undergone Wavefront Optimized LASIK
      (Wavelight Allegretto 400 Hz platform).
    


Intervention name(s): WAVEFRONT Optimized LASIK; WAVEFRONT GUIDED LASIK
Intervention type(s): Device; Device
Intervention description(s): 30 patients; 30 patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: LOW TO MODERATE MYOPIC PATIENTS
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the
      pancreas are destroyed such that the patient is reliant on injection of insulin to adequately
      control blood glucose levels for the remainder of his/her life. The autoimmune process
      targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a
      novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and
      tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is
      a mixture of peptides from islet auto antigens. The mixture has been designed to induce or
      restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to
      protect beta-cells
    

Detailed description: 
      Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each
      group will receive 6 injections of either placebo, low, medium or high dose of IMP; each
      injection is intradermal and spaced 1 month apart.
    

Intervention name(s): MultiPepT1De injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A mix of peptides; Water for injection
Other intervention name(s): Multipeptide injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Condition: Brain Tumor; Cerebrovascular Disorders
MeSH terms: Cerebrovascular Disorders
Study type: Interventional

Summary: 
      Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In
      brain tumor resection craniotomy, it is proven to be effective in improving postoperative
      hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives
      postoperative pain. In addition, many animal experiments show that DEX inhibits the
      proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also
      reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral
      focal ischemic region (penumbra). However, the neuroprotective effects were never
      investigated clinically in patients undergoing brain tumor resection surgery.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Intraoperative dexmedetomidine infusion
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Functions in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their
      cognitive function. Long-term memory is one of the most frequently affected functions in MS
      patients. Many factors play a role in the deterioration of cognitive functions because of
      many symptoms of MS.

      The aim of this study is to investigate the relationship of cognitive function with physical
      factors such as balance, functional exercise capacity and personal factors such as fatigue
      level, mood, sleep quality in patients with MS.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will
      be evaluated once.

      Investigators will use descriptive statistics and t-tests to compare variables between
      groups. Investigators will examine the correlations between variables using Pearson bivariate
      correlations. The significance level is set at p<0,05.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of
        Health Sciences will be invited to this study.
      
Keywords: Multiple sclerosis; Balance; Cognition; Functional exercise capacity; Fatigue; Sleep quality
The Efficacy of Chlorella Supplementation on Health and Performance Following a 12-week Training Programme
Condition: Sedentary; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Algae are an emerging functional food source that are gaining traction and popularity in
      biopharmaceutical, nutraceutical, and biotechnology industries. They are a diverse and
      complex species that comprise an abundant breadth of micronutrients (multiple vitamins,
      minerals, fatty acids, and amino acids) that can possibly promote human health. One such
      popular algae is chlorella, a unicellular dark green organism, which can be readily bought in
      health stores worldwide. Although there is some promising data to suggest chlorella
      supplementation can alleviate cardiovascular risk factors and improve VO2max from
      supplementation alone, an area which has particularly limited existing literature is the
      possible ergogenic and health influence of chlorella supplementation combined with a
      controlled training programme in sedentary and overweight populations. Given that such
      populations are susceptible to increased risk of developing associated diseases
      (cardiovascular disease, diabetes, hypertension) and possess poor diets, there is a need to
      investigate the possible synergistic effect of a training programme and supplementation of
      algae further. Furthermore, there is growing evidence to suggest that supplementation with
      algae may have a beneficial effect on cognitive function, primarily owed to antioxidant and
      anti-inflammatory mechanisms. Therefore, the purpose of this study aims to assess the
      efficacy of chlorella supplementation on VO2max, blood lipid profiles, cognitive function and
      body composition following a 12-week training programme. Briefly, in a double blind,
      randomised, placebo-controlled trial, participants will be randomly allocated into 1 of 4
      groups (A. Exercise + Chlorella, B. Exercise + Placebo, C. Control + Chlorella, D. Control +
      Placebo).
    


Intervention name(s): Chlorella supplementation; 12 week cardiovascular training programme; Placebo Supplementation
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Supplementation with Chlorella (1.5 g/d) in 3 capsules for 12 weeks.; Participants will be asked to complete a 12 week cycling training programme. This will consist of 4 X 50 min sessions per week. Each exercise session will include a warm-up phase (~ 5 min), a main physical conditioning phase (~ 40 min), and a cool-down phase (~ 5 min).; Supplementation with Placebo - microcrystalline cellulose (1.5 g/d) in 3 capsules for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CKD-828(80/2.5mg) Pharmacokinetic Study_2nd
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed
      Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
    


Intervention name(s): CKD-828(FDC); Combination Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily; Drug: Telmisatan 80mg Tablet, Oral, Once Daily
Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-828; Hypertension; Primary Hypertension; Healthy Volunteer; S-Amlodipine; Telmisartan; Amlodipine; Pharmacokinetic; Phase 1