bioihbjkbjnl/mcl2 huggingface dataset:
Measurement of Pulse Wave Velocity
Condition: Healthy
Study type: Observational

Summary: 
      Optically-based data will be compared to tonometry to determine correlation of pulse wave
      velocity measurement.
    


Intervention name(s): Pulse wave velocity measurement Photoplethysmogram; tonometer
Intervention type(s): Device; Device
Intervention description(s): Correlation of pulse wave velocity measurement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy normotensive and hypertensive subjects.
      
Keywords: Correlation; pulse wave velocity measurement; tonometry
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another
      drug called pregabalin in people with fibromyalgia.
    


Intervention name(s): No Treatment Added; Milnacipran Added
Intervention type(s): Drug; Drug
Intervention description(s): No added treatment; Milnacipran 100 mg/d added
Other intervention name(s): Lyrica (r)
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; milnacipran; pregabalin; treatment; Forest Research Institute
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
Condition: Primary Immunodeficiency Disease (PIDD)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment
      naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients
      using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and
      disability assessments using CareExchange in the home setting.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and Females between 15-85 years of age with any form of PIDD who are considered 5%
        IVIg treatment naïve and whose physician has decided to prescribe Gammaplex® IVIg therapy.
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, two-way crossover, randomised, open-label study in 20 healthy female
      volunteers.The volunteers received an oral single-dose of a combined contraceptive containing
      with an oral once daily dose of 1200 mg of BIA 2-093
    

Detailed description: 
      Single centre, two-way crossover, randomised, open-label study in 20 healthy female
      volunteers.The volunteers received an oral single-dose of a combined contraceptive containing
      30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once
      after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days
      separated by a washout period of at least 3 weeks.
    

Intervention name(s): BIA 2-093; Contraceptives, Oral, Combined
Intervention type(s): Drug; Drug
Intervention MeSH terms: Eslicarbazepine acetate; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis
Condition: Anaphylaxis
MeSH terms: Anaphylaxis; Shock
Study type: Observational

Summary: 
      This is an open-label, single-center study of whether oral penicillin desensitization of
      healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin
      testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be
      PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints
      will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence
      intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium
      ionophore.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Clinical and community recruitment
      
Keywords: Penicillin; Allergy; Prevention; Anaphylaxis; Clinically proven history of penicillin allergy; preventing anaphylaxis
Fatty Acid Biomarkers of Carbohydrate Intake
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The overall aim is to investigate if circulating fatty acids and lipids are influenced by
      alterations in carbohydrate amount and quality.
    

Detailed description: 
      In this isocaloric clinical cross-over trial, the investigators aim to investigate if
      circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and
      quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality
      (including sugar) influence circulating even-chain saturated fatty acids or if fatty
      acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of
      carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to
      search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators
      also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake
      on lipoproteins, insulin sensitivity, inflammatory proteins.
    

Intervention name(s): Low carbohydrate diet; High carbohydrate, high sugar diet; High carbohydrate, low sugar diet
Intervention type(s): Other; Other; Other
Intervention description(s): Diet low in carbohydrates (38%E), but higher in total and saturated fat.; Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.; Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fatty acids; biomarker; carbohydrate; lipogenesis
Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States
Condition: Healthy
MeSH terms: Thrombophilia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a
      single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase.
      Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with
      evidence of antiphospholipid antibodies
    

Detailed description: 
      To compare the absorption and activity of quercetin or isoquercetin with or without ascorbic
      acid in healthy adults. Oral chews containing quercetin (500mg) or isoquercetin(500 mg total)
      with or without ascorbic acid will be given. Pharmacokinetic parameters (AUC, Cmax, Tmax,
      elimination half-life) will be determined over 24 hours (8 time points). Pharmacodynamic
      inhibition of protein disulfide isomerase activity will also be assessed.

      In addition to healthy subjects, a cohort of 10 individuals with antiphospholipid antibodies
      will participate. These participants will receive isoquercetin 1000 mg and have
      pharmacodynamics studies performed at time 0 and 4 hours.

      All study drugs will be provided by Quercegen Pharma.
    

Intervention name(s): isoquercetin or quercetin
Intervention type(s): Drug
Intervention description(s): Single dose PK/PD study
Intervention MeSH terms: Quercetin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: quercetin; isoquercetin; pharmacokinetic; pharmacodynamic
Tracking Response in Advance of Investigational Trials, Borderline Study
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic
      criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical
      trial of a novel compound to treat BPD. The current study seeks to determine if there are
      therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.
    


Intervention name(s): Supportive psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Participants will receive monthly 30-45 minute supportive psychotherapy sessions. Supportive psychotherapy is an integrative and eclectic psychotherapeutic approach, based upon the individual's needs and symptoms. It draws from elements of a variety of psychotherapeutic disciplines, including cognitive-behavior, psychodynamic, and interpersonal therapies.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 18 to 65 years old, who meet criteria for BPD, and who have expressed interest
        in participating in a clinical trial of an investigational product for treatment of BPD.
Ciprofloxacin in Drug-resistant Epilepsy
Condition: Epilepsy Intractable
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      This study aims to investigate the effect of a short-term prescription of ciprofloxacin on
      intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.
    


Intervention name(s): Ciprofloxacin Oral Product
Intervention type(s): Drug
Intervention description(s): The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.
Intervention MeSH terms: Ciprofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Serious Games for Shoulder Rehabilitation
Condition: Serious Game; Rotator Cuff Tears; Rehabilitation
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of Serious-Game Exercise (SGE) platform on
      pain, range of motion (ROM), joint position sense, shoulder functions, and approximation
      force in patients with rotator cuff rupture. In addition, another objective is to evaluate
      the usage of balance board as a measurement tool for measuring the approximation force in the
      rotator cuff rupture.
    

Detailed description: 
      Purpose: To examine the effect of Serious-Game Exercise (SGE) platform on pain, range of
      motion (ROM), joint position sense, shoulder functions, and approximation force in patients
      with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance
      board as a measurement tool for measuring the approximation force in the rotator cuff
      rupture.

      Method: Twenty patients with rotator cuff rupture will be included in the study. They will be
      divided into two groups as a serious game group (SGG) and a conventional exercise group (CEG)
      with a randomization method. The Serious game exercise program developed for shoulder
      rehabilitation will be applied to the SG group and conventional exercise training will be
      applied to the CEG. Pain severity, flexion, abduction and external rotation ROM,
      functionality, joint position sense, and approximation force of all individuals will be
      evaluated pre and post-treatment. SGG and CEG underwent serious games and conventional
      therapy twice a week for 6 weeks, respectively.
    

Intervention name(s): ConventioanalExercises; Serious games
Intervention type(s): Other; Other
Intervention description(s): Wand exercises and shoulder wheel exercises to increase the range of motion of the shoulder joint with 10 repetitions will be applied in CEG. Finger ladder exercises will be performed in the abduction and flexion position with 5 repetitions, holding the endpoint for 5 seconds. Stretching exercises with 5 repetitions will be applied in all directions for the limitation of movement, holding it for 20 seconds at the endpoint. Individuals performed conventional exercises twice a week for 6 weeks.; A Serious game program will be applied to the individuals twice a week for 6 weeks in this group. Armrotate, Uball, Balance Surf and Balance Adventure games will be developed by Becure company for shoulder rehabilitation. These games developed for shoulder rehabilitation will be applied to individuals under the supervision of a physiotherapist. Each game will be played for 10 minutes, for a total of 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Serious game; Rotator cuff rupture; Shoulder Rehabilitation
Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole
Condition: Idiopathic Macula Hole
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      The purpose of this study is to observe the technologic application of no-touch fluid-air
      exchange in Surgery of Idiopathic Macula Hole.
    


Intervention name(s): no-touch fluid-air exchange; vitrectomy metrectomy and internal membrane peeling and gas tamponed
Intervention type(s): Procedure; Procedure
Other intervention name(s): vitrectomy metrectomy and internal membrane peeling and gas tamponed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study the investigators aimed to determine the effect of the herbal porridge containing
      the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone
      formation markers of menopausal women. Forty-five participants were randomly assigned to
      receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.
    

Detailed description: 
      At present, the novel cheap and effective intervention against menopause related symptoms
      such as memory impairment and osteoporosis is still required due to the increased breast
      cancer risk induced by hormone replacement therapy. Based on the role of oxidative stress on
      cognitive deficit in menopause and the synergistic effect of herbs in traditional folklore,
      the cognitive enhancing effects and anti-osteoporosis effects of the functional food
      containing the combined extract of herbs possessing antioxidant effect has gained attention.
      Therefore, we aimed to determine the effect of the herbal porridge containing the combined
      extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation
      markers of menopausal women. Forty-five participants were randomly assigned to receive a
      placebo or MP (50, 1500 mg) treatments once daily for 8 weeks. The cognitive function and
      working memory were assessed via the auditory oddball paradigm of event-related potentials
      and computerized battery tests respectively prior to the intervention, 1 month, 2 month, and
      at delay 1 month. Bone formation markers including serum calcium, alkaline phosphatase, and
      osteocalcin were determine prior to the intervention and at the end of study.
    

Intervention name(s): Placebo; MP 50 mg/day; MP 1500 mg/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects are received placebo treatments once daily for 8 weeks; Subjects are received MP 50 mg/day treatments once daily for 8 weeks; Subjects are received MP 1500 mg/day treatments once daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Menopause; Cognitive impairment; Working memory; Bone formation markers; Osteoporosis
Investigation of the Effectiveness of Resistance Exercise Program Given With Diet in Obese Individuals.
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of diet and combined resistance exercise
      training on physical activity and sleep patterns compared to diet program alone.
    

Detailed description: 
      The study was planned as a randomized controlled trial. The groups will be divided into two
      as control group and exercise group by simple randomization method.While the normal diet
      program will be applied to the obese individuals in the control group, the individuals in the
      exercise group will be given resistance exercise training together with the diet
      program.Before and after the treatment, fatigue severity scale pittsburgh sleep quality scale
      international physical activity index questionnaires will be applied to the participants.In
      addition, sociodemographic characteristics and waist circumference measurement will be
      recorded. After the 12-week diet program, the data of the participants will be compared by
      making statistical analysis.
    

Intervention name(s): Diet program; Exercise training protocols
Intervention type(s): Other; Other
Intervention description(s): A diet program will be prepared with the help of a dietitian at the beginning of 12 weeks for all participants who agree to participate in the study, and this program will be controlled by a dietitian once a month and completed at the end of 12 weeks.; calisthenic exercises exercises with lower and upper extremity theraband exercises with light dumbbells
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: resistance training (RT), (3 days/wk, 3 sets/day, 8-12 repetitions/set)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: resistant exercise; diet
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and
      self-reported pain scored. Machine learning was used to analyze the EEG data and derive a
      chronic pain biomarker.
    


Intervention name(s): IRIS System
Intervention type(s): Device
Intervention description(s): A QEEG based pain biomarker that scales with the patient reported NRS
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty (50) male and female pain patients with symptoms in excess of 3 months duration (per
        the IASP definition of Chronic Pain) between the ages of 18-85 years were enrolled.
        Subjects who met the inclusion/exclusion criteria were asked to volunteer for the study.
Neurophysiological Study of tDCS Effects in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Transcranial direct current stimulation is a tool to modulate cortical excitability.
    

Detailed description: 
      Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the
      thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial
      direct current stimulation has the opposite effect, it decreases VEP amplitude and
      habituation. This neuromodulation technique is probably a tool in the prevention in episodic
      and chronic migraine.

      The aim of the study is to study short and long term effect of tDCS over pain treshold,
      contact heat evoked potentials, blink reflex and visual evoked potentials in healthy
      volunteers.
    

Intervention name(s): Cefaly tDCS
Intervention type(s): Device
Intervention description(s): Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this observer-blind study is to gather key efficacy, safety, and
      immunogenicity information on GSK's candidate malaria vaccine in infants and children.
    

Detailed description: 
      The protocol posting document has been updated due to a protocol amendment dated 23 January
      2012. An analysis time point has been added at Month 20. No changes have been made to the
      protocol endpoints or statistical methods but protocol endpoints will be analysed on data
      collected up to Month 20 once these data are available. The rationale is to have the full
      scope of protocol defined efficacy and safety endpoints related to a primary schedule without
      booster in both age categories followed up for 20 months earlier than at the initially
      planned study end time point (Visit 34 or Month 32 time point).

      The protocol posting document was updated due to a protocol amendment dated 10 December 2010
      to extend the study until December 2013 for all enrolled subjects (interval: Nov 2013-Jan
      2014). Including the extension, the mean follow-up time for subjects from 5-17 months will be
      during 49 months post dose 1 (range: 41-55), while for subjects from 6-12 weeks, it will be
      during 41 months post dose 1 (range: 32-48). This study is double-blind during the first part
      and single-blind during the extension part. An analysis will be conducted at the end of the
      extension including an evaluation of safety and efficacy against clinical malaria, severe
      malaria and prevalent parasitemia.

      The protocol posting document has been updated following the posting of results of the study
      (January 2015): The study remained double-blind until the end of the extension phase, and the
      analyses of Month 32 (initial end of study now becoming end of the first part of the study or
      primary study phase) and of the extension phase were conducted together.
    

Intervention name(s): Malaria Vaccine 257049; Meningococcal C Conjugate Vaccine; Cell-culture rabies vaccine; TritanrixHepB/Hib; Polio Sabin Oral Polio Vaccine (GSK)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered intramuscularly into the left deltoid.; administered orally.
Other intervention name(s): Menjugate; VeroRab
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention