bioihbjkbjnl/mcl2 huggingface dataset:
Rectal Microbicide Acceptability, Tolerability and Adherence
Condition: HIV Prevention
Study type: Interventional

Summary: 
      MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that
      will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences
      of rectal microbicide placebo product application.
    

Detailed description: 
      MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that
      will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences
      of rectal microbicide placebo product application. At the start of each 4-week product use
      period, participants will receive either rectal inserts, rectal douches, or rectal
      suppositories and be instructed to use their assigned study product prior to each receptive
      anal intercourse (RAI) encounter during that period. Participants who do not have RAI in a
      given week will be asked to use the product without sex. There will be a 1-week washout
      period between each of the three product use periods. Participant follow-up will take
      approximately 3.5 months.
    

Intervention name(s): Placebo rectal insert; Placebo rectal suppository; Placebo rectal douche
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.; Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.; Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acceptability; Rectal microbicide
Trial to Evaluate Safety and Immunogenicity of a Vaccine Against HCMV
Condition: Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this first-in-human is to evaluate the safety and the immunogenicity of
      three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three
      different dose levels.
    

Detailed description: 
      Hookipa Biotech AG is developing a replication-deficient lymphocytic choriomeningitis virus
      (rLCMV) vector platform. HB-101 is a bivalent vaccine containing two recombinant,
      replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing the
      pp65 protein of the human cytomegalovirus (HCMV) and one expressing the gB protein of human
      cytomegalovirus (HCMV).

      This Phase 1 will enroll three successive cohorts of 18 healthy volunteers. Each cohort will
      receive either a low dose, a middle dose or a high dose of the vaccine (n=14 volunteers), or
      placebo (n=4). A DSMB will review the safety data for the low dose cohort, before progressing
      to the middle, and so before high dose. Eight DSMB meetings have been planned for the whole
      study.

      The subjects will be followed up to 12 months post first administration.
    

Intervention name(s): Low dose HB-101; Medium dose HB-101; High dose HB-101; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Three intra muscular administrations at Day 0, Month 1 and Month 3; Three intra muscular administrations at Day 0, Month 1 and Month 3; Three intra muscular administrations at Day 0, Month 1 and Month 3; Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention
Clinical Assessment of Barley and Oat Phytochemicals
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this placebo-controlled, 3-way crossover study is to determine the acute (24-h)
      bioavailability and pharmacokinetics of the major phytochemicals found whole barley and oats,
      as well as their effects on selected measures of antioxidation, inflammation, insulin
      sensitivity/glucose regulation, and vascular remodeling following challenge by an oral
      glucose tolerance test (OGTT).
    


Intervention name(s): Whole grain oats and barley
Intervention type(s): Other
Intervention description(s): One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oat; barley; whole grain; bioavailability; phytochemical
The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Walking Meditation training would yield more favorable adaptations than walking alone in
      improving glycemic control and vascular function in patients with type 2 diabetes.
    


Intervention name(s): Walking Meditation; Walking; No exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Walking Meditation training program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking on the treadmill while concentrated on foot stepping by voiced "Budd" and "Dha" with each foot step that contacted the floor to practice mindfulness while walking. Walking Meditation will be conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.; Walking training program will be based on aerobic walking exercise. The subjects will perform walking on the treadmill and conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.; Sedentary life style.
Other intervention name(s): Buddhist Walking Meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mind and body Exercise; Flow mediated dilation; Diabetes
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, randomized-controlled, dispensing clinical trial. A total of
      approximately 60 eligible hyperopic subjects will be targeted to complete this study.
    


Intervention name(s): senofilcon A Multifocal; senofilcon A Sphere; etafilcon A Multifocal; etafilcon A Sphere
Intervention type(s): Device; Device; Device; Device
Intervention description(s): TEST Lens; TEST Lens Sphere; CONTROL Lens; CONTROL Lens Sphere
Other intervention name(s): JJVC Investigational Multifocal Contact Lens; ACUVUE OASYS 2-WEEK with HYDRACLEAR PLUS; 1-Day Acuvue Moist Brand Multifocal Contact Lens; 1-Day Acuvue Moist Brand Contact Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Home-based Breathing Training on Menopausal Symptoms
Condition: Menopause; Menopause Related Conditions
Study type: Interventional

Summary: 
      This is a prospective, triple-blinded and randomized controlled trial examining the effects
      of a home-based breathing training assisted with biofeedback on menopausal symptoms and
      autonomic functions among community menopausal women. We also examines whether the changes in
      autonomic functions would be mediators between slow breathing and menopausal symptoms. This
      study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms.
      Participants will be randomly assigned to either an intervention group (n = 80) or a
      waiting-list control group (n = 80). The intervention group will undergo the home-based
      breathing training 20 minutes twice daily and participants in the control condition will
      participate the same breathing training after a four-week waiting list period. The primary
      outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms
      and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions
      expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV).
      Measurements will be taken at baseline, week 4, and week 8.
    

Detailed description: 
      Ditto
    

Intervention name(s): home-based breathing training
Intervention type(s): Behavioral
Intervention description(s): The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks. Participants in the control condition will participate the same breathing training after a four-week waiting list period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate and compare the single oral dose bioavailability of
      Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline
      México, S.A. de C.V. with that of PAXIL® (Paroxetine) of GlaxoSmithKline, México, S.A. de
      C.V. in healthy, adult, male and female participants under fasting conditions. Maximum 38
      participants will be randomized and dosed. The expected duration of this study will be 12
      days including 7 days of washout period in-between each dosing. PAXIL is a registered
      trademark of GSK group of companies.
    


Intervention name(s): Paroxetine hydrochloride; PAXIL (Paroxetine hydrochloride )
Intervention type(s): Drug; Drug
Intervention description(s): Paroxetine hydrochloride will be administered.; PAXIL will be administered.
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single-dose, randomized, balanced, open-label, two-sequence, two-treatment, two-period, crossover bioequivalence study under fasting condition.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety Disorders; Bioequivalence study; Paroxetine hydrochloride; PAXIL; Fasting condition
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomised, double-blind, active-controlled, parallel-group
      comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +
      hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+
      hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the
      end of the double-blind period in essential hypertensive patients who fail to respond
      adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

      Patients are assigned to one of the two groups after a 6-week open-label run-in period taking
      T80/H12.5 mg.

      In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide
      12.5 mg will be evaluated in a 52-week extension period.

      In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg
      group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5
      mg group change to the T80/A5/H12.5 mg therapy.
    


Intervention name(s): placebo; telmisartan + HCTZ; telmisartan + HCTZ; amlodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): placebo matching amlodipine capsule; FDC tablet; FDC tablet; capsule
Intervention MeSH terms: Amlodipine; Telmisartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence Study to Compare Two Formulations of Deanxit®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a
      new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®),
      administered single dose in fasted and fed condition
    


Intervention name(s): test treatment: flupentixol/melitracen; reference treatment: flupentixol/melitracen
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose; 0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
Other intervention name(s): Deanxit®
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU
      in patients with Diabetic Foot Ulcer, compared to standard therapy.
    

Detailed description: 
      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide a new option in
      treating a Diabetic Foot Ulcer.
    

Intervention name(s): ALLO-ASC-DFU; Standard therapy
Intervention type(s): Biological; Other
Intervention description(s): Application of ALLO-ASC-DFU sheet to diabetic foot ulcer; Standard therapy conducted for patients with diabetic foot ulcer
Other intervention name(s): Allogeneic mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
Condition: Hip; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The aim of the study will be to compare functional outcomes of the two surgical hip
      approaches in total hip arthroplasty: anterior, posterolateral and anterolateral. Surgical
      approach may have influence on patients functional outcome.
    

Detailed description: 
      Patients with primary hip osteoarthritis will be included in a randomized controlled trial
      and assigned to total hip arthroplasty using one the of hip approaches: anterior or
      anterolateral. Subjects will be assessed preoperative and 3 and 12 moths postoperative.

      Biomechanical gait parameters will be collected using tree-dimensional motion analysis system
      "BTS SMART".

      Evaluation of the function of the middle gluteal muscle with superficial EMG (sEMG)
      percutaneous surface electromyography. Fatigue assessment (mean frequency and amplitude) of
      the gluteus medius muscle during isometric muscle contraction.

      Balance and coordination as well as fall risk will be assessed with use of dynamometric
      Biodex Balance platform. The study will determine the values of individual indicators:
      general stability index (OWS), anterior-posterior stability index (APW), the median lateral
      stability index (MLW) and the fall risk index (RU).

      Subjective assessment will be conducted with use of Visual Analogue Scale, WOMAC Index,
      Oxford Hip Score, The Short Form-36 (SF-36) and Harris Hip Score
    

Intervention name(s): Direct Anterior Approach (DAA); Anterolateral approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Direct Anterior Approach surgery to replace the hip.; Anterolateral approach surgery to replace the hip.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: total; hip; arthroplasty; surgical; approach
Evaluation of the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)
Condition: Acupuncture; Healthy Volunteers
Study type: Interventional

Summary: 
      To be able to have data on brain activity during an acupuncture session, this pilot study is
      necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate
      the kinetics of the bispectral index in healthy volunteers during an acupuncture session,
      Sham acupuncture or resting in a lying position.
    


Intervention name(s): Acupuncture; A digital stress scale; a relaxation questionnaire; Bispectral Index
Intervention type(s): Procedure; Behavioral; Behavioral; Diagnostic Test
Intervention description(s): one session with precise acupunture points; The digital stress scale before and after the session: Oral digital scale. The doctor asks the participant to quantify their anxiety on a virtual scale ranging from 0 (absent anxiety) to 10 (maximum anxiety imaginable); The Global Relaxation Questionnaire after the session: Dovero Global Relaxation Scale; BIS is based on an EEG analysis algorithm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome) Study
Condition: A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Periprocedural treatment with high-dose statins is known to have cardioprotective and
      pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.

      -Objective: to determine whether preoperative rosuvastatin loading is independently
      associated with reduced myocardial ischemia and clinical outcomes in patients with stable
      angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary
      syndrome.

      Study design

        -  Prospective, double-blinded, single-center study of each 117 subjects enrolled

        -  Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will
           be enrolled preoperatively.

        -  Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B)
           Placebo (n=117).

        -  The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a
           total

        -  All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be
           compared at 30 days and 2 years postoperatively between two groups
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Patients will be randomized in a ratio of 1:1 to A) High-dose rosuvastatin vs. B) Placebo.
A) Rosuvastatin group : Administration of 40mg of rosuvastatin PO 12 hours before surgery and 20mg of rosuvastatin PO 2hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.
B) Placebo group : Administration of placebo at 12 hours and 2 hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome
Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
Condition: Chronic Respiratory Failure
MeSH terms: Respiratory Insufficiency; Neuromuscular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive
      mechanical ventilation in patient with hypercapnic respiratory failure secondary to
      neuromuscular diseases or alterations in thoracic cage in comparison with hospital
      adaptation.
    


Intervention name(s): Ambulatory adaptation to non- invasive mechanical ventilation for 7 days; Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Intervention type(s): Procedure; Procedure
Intervention description(s): Ambulatory adaptation to non- invasive mechanical ventilation for 7 days; Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Respiratory insufficiency; Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
OCTA in Epivascular Glia After Dex Implant
Condition: Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy
Study type: Observational

Summary: 
      The aim of this prospective study was for the first time, to analyze specific morphologic
      features in diabetic eyes with macular oedema, such as changes of the foveal avascular zone
      and the presence of epivascular glia, and see how they would change after dexamethasone
      intravitreal implant
    


Intervention name(s): Dexamethasone intravitreal implant
Intervention type(s): Drug
Intervention description(s): Dexamethasone intravitreal implant
Intervention MeSH terms: Dexamethasone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with diagnosis of inflammatory diabetic macular
        edema glaucoma..