bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
Condition: Endothelial Function
Study type: Observational

Summary: 
      Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar,
      taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting
      studies examining their vascular effects in young adults. We evaluated microvascular
      reactivity (MR) before and after ED in young healthy male volunteers.

      Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast
      imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the
      consumption of one can of ED or the same volume of water (control), followed by postocclusive
      reactive hyperemia (PORH).
    

Detailed description: 
      Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and
      caffeine. These products are marketed as boosters of mental and physical performance and are
      increasingly used in Western societies. Case reports of adverse effects related to ED
      consumption have been described in healthy young individuals, including coronary artery
      vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf)
      plays a role in ED cardiovascular effects and have prompted studies with conflicting results.
      The present study evaluated the microvascular reactivity (MR) after ingestion of one can of
      ED compared to a control, in young healthy male volunteers.
    

Intervention name(s): Ingestion of the energy drink (Red Bull®); Ingestion of mineral water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of 250 ml of the energy drink (Red Bull®); Ingestion of 250 ml of mineral water (Minalba®)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy male volunteers with no relevant findings in the medical history
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
Condition: Sleep Quality; Sleep Health
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effects of a proprietary oral
      supplement on the sleep health and quality of people with sleep problems. It is a
      double-blinded placebo-controlled crossover clinical study.
    


Intervention name(s): Sleep Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.; Placebo product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Health; Sleep Quality; Melatonin; Lavender essential oil; GABA
The Efficacy and Safety of Trapezius MSAT on Acute Whiplash Injury
Condition: Whiplash Injury of Cervical Spine; Neck Pain, Posterior
MeSH terms: Neck Pain; Wounds and Injuries; Whiplash Injuries
Study type: Interventional

Summary: 
      This study is a double blind, randomized controlled trail. condition/disease: acute neck pain
      treatment/intervention: motion style acupuncture treatment
    

Detailed description: 
      Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle
      created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to
      move the part of their body actively during acupuncture treatment under physicians'
      observation. This treatment is known to relieve the pain and increase the range of
      motion(ROM). However, there has been no specific value for the effect of this treatment.

      So, we conducted a randomized controlled trials to verify the efficacy and safety of
      trapezuis MSAT. From July 2019 to September 2019, we collected 100 inpatients who were
      suffered from posterior nick pain with the numeric rating scale(NRS) over 4 after whiplash
      injury by acute traffic accident(TA). For experimental group(n=50), we conducted MSAT three
      times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For
      control group(n=50), just Korean medical treatment except MSAT was conducted. For these two
      groups, we compared NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Nthe amount of
      pain via NRS(Numeric Rating Scale), VAS(Visual Analogue Scale), ROM(Range Of Motion), Neck
      Disability Index (NDI), and EuroQol 5-Dimension (EQ-5D).
    

Intervention name(s): trapezuis motion style acupuncture treatment; other Korean medical treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation; acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is a phase 1 study which carried out to establish the pharmacokinetic
      equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar
      candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous
      injection in healthy volunteers.
    

Detailed description: 
      This is single center comparative double blind randomized clinical study of pharmacokinetics,
      tolerance and safety of single subcutaneous injection of BCD-057 (CJSC BIOCAD, Russia) and
      Humira in healthy volunteers. The purpose of the study is to demonstrate that BCD-057 is
      equivalent to Humira in terms of pharmacokinetics, tolerability and safety after single
      subcutaneous injection in healthy volunteers.

      The study will enroll 94 healthy volunteers, who will be randomized into 2 groups (1:1
      ratio): volunteers from the first group will receive BCD-057; volunteers from the second
      group will receive Humira. Both study and reference drug will be used at the standard dose of
      40 mg.
    

Intervention name(s): Adalimumab (BCD-057); Adalimumab (Humira)
Intervention type(s): Drug; Drug
Intervention description(s): Adalimumab is a monoclonal antibody against tumor necrosis factor alpha; Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
Other intervention name(s): BCD-057; Humira; Trudexa; Trudexa
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood
      sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh
      and arm.

      The study will be conducted in healthy people to investigate the effect of different
      injection sites on the amount of insulin lispro in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 10 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    


Intervention name(s): LY900014 (SC); LY900014 (IV)
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered IV
Other intervention name(s): Ultra-Rapid Lispro; Ultra-Rapid Lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate the relative bioavailability of the final tablet
      formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
    


Intervention name(s): BI 10773 XX (Trial Formulation 2); BI 10773 (Final Formulation)
Intervention type(s): Drug; Drug
Intervention description(s): one single dose tablet in the morning; one single film-coated tablet in the morning
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Food-Effect Study of AND017 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase I study is to evaluate the food effect on the PKs of AND017
      following oral single-dose administration in healthy non-elderly Chinese subjects.
    

Detailed description: 
      This is a single-center, randomized, open-label, two-sequence, two-period crossover study in
      healthy non-elderly Chinese subjects to evaluate the food effect on the pharmacokinetics, as
      well as PD and safety of AND017 following oral single-dose administration
    

Intervention name(s): AND017
Intervention type(s): Drug
Intervention description(s): AND017 oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Platelet-dependent Thrombosis: a Placebo-controlled Trial of Antiplatelet Therapy (Clopidogrel)
Condition: Type 2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Thrombosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with diabetes are more likely to develop furring of their coronary arteries and
      present with angina and heart attacks. Furthermore, after such an event, they have poorer
      outcomes (higher rates of death) and survivors are more likely to have recurring symptoms.
      Using a novel "clotting chamber" the investigators have shown that patients with diabetes are
      more likely to develop blood clots. This study will look at the role of different blood
      thinning medications in patients with diabetes. If successful, the investigators will provide
      evidence to conduct large clinical studies to look at the role of additional blood thinning
      medication in reducing heart attacks and strokes in patients with diabetes.
    

Detailed description: 
      The objective of this study is to compare the effect of Clopidogrel on platelet dependent
      thrombosis in patients with T2DM and CAD with placebo. The Badimon chamber, an ex vivo
      arterial injury model is used for this purpose. This model simulates the in vivo situation of
      high shear arterial wall damage and helps to quantify thrombus which is the sum endpoint of
      all haemostatic abnormalities seen in vitro.
    

Intervention name(s): clopidogrel; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.; Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
Other intervention name(s): Plavix, 75 milligrams; Sanofi Pharma Bristol-Myers Squibb SNC; 174 Avenue de France; F-75013 Paris - France; EU/1/98/069/005a
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes mellitus; Coronary artery disease; Platelet dependent thrombogenicity; Aspirin; Clopidogrel; Badimon Chamber
Measuring Self-Efficacy on Portuguese Respiratory Patients on Pulmonary Rehabilitation
Condition: Pulmonary Rehabilitation
Study type: Observational

Summary: 
      This study aimed to translate and adapt to portuguese an original british instrument useful
      to measure respiratory patients' self-efficacy specific to the context of Pulmonary
      Rehabilitation.
    

Detailed description: 
      Recent updates on Pulmonary Rehabilitation highlight the importance of patients'
      self-efficacy on long-term adherence to health-enhancing behaviors. The Pulmonary
      Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is an adaptation of the General
      Self-Efficacy Scale. This study aimed to translate, culturally adapt and evaluate reliability
      and validity of PRAISE on Portuguese respiratory patients.Forward-backward translation and
      pilot testing were performed. Content validity was assessed by a multidisciplinary panel of
      expert judges. To evaluate reliability and validity, 150 respiratory outpatients on Pulmonary
      Rehabilitation participated on a cross-sectional study. Descriptive and reliability analyses,
      and exploratory factorial analysis using principal axis factoring, followed by oblique
      oblimin factor rotation were conducted to identify construct validity. IBM® SPSS® version 22
      was used to perform statistical analysis.
    

Intervention name(s): Pulmonary Rehabilitation
Intervention type(s): Other
Intervention description(s): Respiratory Physiotherapy, Exercise Therapy, Patient Education
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        150 adults attending an outpatient Pulmonary Rehabilitation program based at Hospital
        Pulido Valente from Centro Hospitalar Universitário de Lisboa Norte, in Lisbon, Portugal.
      
Keywords: self-efficacy; instrument validity; PRAISE
Postural Stability, Pelvic Floor Dysfunction, Respiratory Muscle Strength in Post-partum Women With Diastasis Recti
Condition: Diastasis Recti; Post-partum; Postural Stability
MeSH terms: Diastasis, Muscle
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of inter-rectus distance on postural
      stability, pelvic floor dysfunction and respiratory muscle strength in women with diastasis
      recti abdominis.
    

Detailed description: 
      Diastasis of recti abdominis muscles (DRAM) is defined as a separation of the two rectus
      abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal
      changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may
      caused. It is very common during pregnancy and may continue for eight weeks in postnatal
      period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with
      DRAM. The abdominal wall is one of the key point for body posture, trunk and pelvic
      stability. However, in our best knowledge, there is no study in the literature that evaluates
      women with and without DRA in terms of components related to postural control systems.
    

Intervention name(s): Measurement of postural stability
Intervention type(s): Other
Intervention description(s): The postural stability will assess by using Biodex balance system.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The post-partum women with diastasis recti abdominis will be enrolled to the study.
Impact of Exercise on the Metabolic Consequences of Overeating
Condition: Healthy
MeSH terms: Hyperphagia
Study type: Interventional

Summary: 
      The primary purpose of this study is to examine the effects of 1-week of overeating on
      important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile,
      and blood pressure) and factors regulating the structure and metabolic function of fat
      tissue. This study will determine how regular exercise during this overeating period impacts
      these responses.
    

Detailed description: 
      If subjects are eligible and decide to participate, they will take part in two identical
      study trials. One is scheduled before and the other is scheduled after 1 week of overeating
      controlled by the study team. Subjects who exercise regularly will be instructed to exercise
      the day before their first study trial - and they will be required to exercise during 6 of
      the 7 days of the overeating period (including the day before their second study trial).
      Subjects who do not regularly exercise (no planned physical activity) will remain inactive
      until the completion of both study trials.

      Before each study trial If a subject is a regular exerciser, they will be asked to come to
      the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to
      exercise in the lab for 45 min at a moderate intensity. The evening before the study trial,
      all subjects will need to eat a standardized dinner meal and snack. They must eat the meal
      and snack at specific times as indicated by the research staff. After eating the snack,
      subjects will need to fast (no food or beverages - besides water) overnight.

      During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM
      and will rest quietly for approximately 30 min. After which, the study team will measure
      their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV)
      will then be placed in a vein of the subject's hand or forearm for blood sampling. The
      research team will then collect a small sample of fat tissue in the subject's abdomen with a
      needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test
      (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this
      3 hour test, the IV catheter will be removed and subjects will be provided breakfast and
      discharged.
    

Intervention name(s): Overeating Protocol
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      To prove if the success rate of curative treatment of atrial fibrillation in left atrial
      circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer
      giving access to the left atrium then by using a conventionally introducer with fixed curve.
    

Detailed description: 
      To prove if the success rate of curative treatment of atrial fibrillation in left atrial
      circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer
      giving access to the left atrium then by using a conventionally introducer with fixed curve;
      in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.

      Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
    

Intervention name(s): Left atrial catheter ablation guided by introducer using Agilis sheeth; Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Intervention type(s): Procedure; Procedure
Intervention description(s): Left atrial catheter ablation guided by introducer using Agilis sheeth; Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: atrial fibrillation; paroxysmal; persistent; symptomatic; ablation; catheter; introducer; Agilis NxT; sinus rhythm; paroxysmal atrial fibrillation; persistent atrial fibrillation; symptomatic atrial fibrillation
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Condition: Vestibular Nerve Diseases
MeSH terms: Vestibulocochlear Nerve Diseases; Nervous System Diseases
Study type: Interventional

Summary: 
      The sense of gravity is one of the important input of our balance system. The utricle is the
      key structure on this subject but the contribution of the proprioceptive receptors is also
      important. The aim of this study is to measure the effect of different angles of head tilt
      and soft surface on SVV in healthy subjects with a new automated system.
    

Detailed description: 
      Two different settings will be used. In the first experiment, healthy subjects will make 15,
      30, and 45-degree head tilt to the left and right side while they are standing. In every
      position, 3 measurements will be done. In the second experiment, 40 health subjects will make
      the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both
      head tilt and soft surface. All measurements will be done with a virtual SVV
      system(Interacoustics).
    

Intervention name(s): Subjective Visual Vertical with Virtual SVV instrument
Intervention type(s): Diagnostic Test
Intervention description(s): The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Effectiveness of Gamma Capsulotomy in Intractable OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      A research study of the effectiveness and safety of gamma knife ventral capsulotomy in
      patients with severe intractable obsessive-compulsive disorder (OCD).
    


Intervention name(s): Gamma Ventral Capsulotomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment