bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive
      gastroesophageal reflux disease
    


Intervention name(s): JP-1366; JP-1366 placebo; Esomeprazole 40mg; Esomeprazole placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JP-1366, QD; JP-1366 placebo, QD; Esomeprazole 40mg, QD; Esomeprazole placebo, QD
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quantitative Study on HRCT Phenotype of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      To explore the HRCT phenotype of the combined COPD assessment staging system
    

Detailed description: 
      HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by
      facilitating and amplifying clinical phenotyping measurements, providing quantitative
      information, and detecting significant responses to therapy even in the absence of
      significant FEV1 improvements.

      We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:

        1. Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall
           thickness, area increasing and emphysema as the new GOLD classification Group A-D
           arising.

        2. The GOLD Combined assessment staging system helps doctors choose an individualized
           treatment for the COPD patients
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive outpatients
      
Keywords: Pulmonary disease; chronic obstructive; Phenotype
Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study)
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose now is to:

        1. identify brain connections related to proprioception to have a better understanding of
           differences between people with stroke and healthy persons

        2. evaluate how these brain connections will change in people with stroke when they are
           engaged in 6-week cognitive multisensory rehabilitation.
    


Intervention name(s): Cognitive multisensory rehabilitation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Exploratory Pharmacodynamic Study of Tenofovir-Based Products
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This single site study is designed to describe and measure the efficacy of oral versus
      vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil
      fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).
    

Detailed description: 
      This study will compare an investigational intravaginal ring containing tenofovir (TFV) with
      an FDA approved medication in tablet form called Truvada®. It will assess and compare the
      ability of the tablet and intravaginal ring to prevent HIV transmission (human
      immunodeficiency virus, the virus that causes AIDS).

      The study will enroll healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50,
      with regular menstrual cycles) who are not at risk of pregnancy.

      The enrollment goal is for 20 participants to complete the study.

      Participants will be assigned to use one of the study products: oral tablet or intravaginal
      ring. Participants will take the oral tablet each day for 14 days or wear the intravaginal
      ring all day and night for 14 days/nights. Blood, genital fluid samples and genital tissue
      samples (biopsies) will be taken at two visits. These sample collections will take place
      before and after use of the assigned study product. The samples will be tested to:

        1. Determine the levels of drug in the blood and genital tissue samples

        2. See if the samples taken from the vagina and cervix after use of study product, provides
           protection from HIV in the laboratory

        3. Ensure that the laboratory test used to measure HIV infection in the samples performs
           well when used repeatedly.

      In addition this study will also evaluate the returned TFV rings to see whether they were
      used as instructed.
    

Intervention name(s): Tenofovir intravaginal ring; Truvada
Intervention type(s): Drug; Drug
Intervention description(s): The participant will wear the intravaginal ring consecutively for 14 days and nights. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue); The participant will take the tablet for 14 days. taking one tablet each morning. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
Other intervention name(s): Tenofovir disoproxil fumarate intravaginal ring; TFV IVR; Emtricitabine/tenofovir disoproxil fumarate tablets
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Neuromuscular Training vs Strength Training
Condition: Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Chronic ankle instability is a complex condition. Limited mobility, perceived instability,
      and recurrent ankle sprains are common characteristics that reduce the quality of life in
      subjects who suffer chronic ankle instability. Neuromuscular training and strength training
      has been recommended in chronic ankle instability management interventions. However, there
      are contradictory findings on results when comparing neuromuscular training, strength
      training, and control group.
    

Detailed description: 
      Participants were randomly assigned to the neuromuscular training group, strength training
      group, and control group with no intervention if participants met the inclusion criteria.

      Neuromuscular training group. It consisted of a multi-station training with 6 exercises,
      increasing the difficulty progressively as the participants controlled the execution. The
      exercises were all performed barefoot and with the injured foot. These were a combination of
      standing and jumping exercises involving the injured ankle.

      A strength training group was performed with resistance bands. The band was fastened to the
      unaffected ankle, while the participant was told to perform front and back pulls, as well as
      adduction and abduction movements with the affected ankle. Participants were told to control
      the ankle movement and to make it slow.

      Control group received no intervention.
    

Intervention name(s): Strength training; Neuromuscular training
Intervention type(s): Other; Other
Intervention description(s): Strength training was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. They were told to control the ankle movement and to make it slow. Since the first day, they were told to perform the exercise pulling the band as if they wanted to make the resistance of 5 on a scale from 0 to 10.; consisted in a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle. The participants did not start the next progression until they perform a complete circuit in the level before.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blind randomized controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Lemborexant-Alcohol Interaction in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the effects on cognitive performance (Power of
      Attention domain) and postural stability of lemborexant in combination with alcohol versus
      lemborexant alone and versus alcohol alone in healthy participants. This study will also
      assess the safety and tolerability of a single oral dose of lemborexant when administered
      alone or in combination with alcohol in healthy participants.
    


Intervention name(s): Lemborexant; Alcohol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated oral tablet; 0.6 g/kg (female) or 0.7 g/kg (male) of 40% ethanol (volume per volume) vodka diluted in a low-calorie beverage (e.g., cranberry beverage), for a total volume of 300 mL (approximately 150 mL per aliquot).; Film-coated oral tablet
Other intervention name(s): E2006
Intervention MeSH terms: Lemborexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Drug-alcohol interaction; Lemborexant; E2006; Postural stability; Cognitive performance
Central Arterial Hemodynamics and Resistance Training
Condition: Hypertension; Cardiovascular Risk Factor
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Resistance exercise training is one of the popular exercise modes that has been drawn the
      public's attention. However, existing evidence showed high-intensity resistance exercise
      training-induced negative adaptation on vascular function and blood pressure responses.
      Upper-body resistance exercise training is more likely to induced arterial stiffening, which
      has been shown to be gender-dependent. It is still unknown whether age also plays a role. We
      like to test the hypothesis that high-intensity upper body resistance exercise may lead to a
      higher increase of arterial stiffness, central blood pressure, and hemodynamic parameters in
      younger adults than older adults. We also hypothesize high intensity resistance training
      could contribute to greater central hemodynamic responses and muscle stiffness than the
      control; the change of muscle stiffness correlates with the change of hemodynamic parameters.
      Collectively, study 1 in this project is aimed to recruit 40 apparently healthy young
      (20-35yrs) and middle-aged to older adults (50-75yrs) into this study followed by upper-body
      or lower-body high-intensity exercise (80% 1 repetition maximum, 10 reps, 4 sets) by a
      randomized order. Blood draw, central blood pressure, hemodynamics will be performed and
      obtained at pre-, immediately-post, 20min, 40mins, and 60 mins post-exercise. Study 2 is
      aimed to investigate the effects of 8-week whole-body resistance exercise training followed
      by a 4-week detraining on above-measured variables in order to determine the long-term
      effects on resistance training. We will employee state-of-art ultrafast ultrasound to obtain
      muscle stiffness and carotid local pulse wave velocity. Endothelin-1 and catecholamines will
      also be measured to discover its underlying mechanisms on such stiffening effects induced by
      high-intensity resistance exercise.
    


Intervention name(s): Resistance exercise training
Intervention type(s): Other
Intervention description(s): Eight weeks whole-body resistance exercise training (80%1 repetition maximal, 3 sessions per week) followed by a 4-week detraining intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Exercise; Ultrafast ultrasound
Dry Needling Effectiveness and Post-punction Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve
      Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from
      miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles
      were also mesured in order to determine how they change after each treatment.
    

Detailed description: 
      All patients suffered from mechanical neck pain and were randomized into three groups of
      treatment. A doible blinded control was carryed out. The main outcome messures were Visual
      Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and
      Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability
      Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.
    

Intervention name(s): Dry needling; Transcutaneous Nerve Stimulation.; Placebo needling
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.; Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.; No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Miofascial pain syndrom.; Trigger point.; Dry needling.; Transcotaneous Nerve Stimuilation.; Hipoalgesia
Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
Condition: Intrauterine Device
Study type: Observational

Summary: 
      We conducted a case-control study between December 2020-June 2021 at Istanbul Health Sciences
      University Kanuni Sultan Suleyman Training and Research Hospital family planning outpatient
      clinics. One hundred and forty-three patients who had copper intrauterine devices (T Cu 380
      A) inserted for contraception were evaluated between the 6th week to 5 years after insertion.
      Patients were divided into two groups according to their ultrasonographic examinations as
      "displaced" or "normal" positions. Uterocervical angles were measured of both groups by
      transvaginal ultrasonography and investigated whether the uterocervical angle had any effect
      in predicting the displacement of copper intrauterine devices.
    

Detailed description: 
      Family planning contains various protection methods, and copper intrauterine devices (IUD)
      are one of these. It has come forward among the contraception methods due to its long-acting
      effect, rapid return of fertility when discontinued, and ease of use. In worldwide usage,
      IUDs are the third most common method of contraception after tubal ligation and male condoms
      (1). When long-acting contraception methods were compared, the failure rate of the IUD was
      0.8% per 100 women within one year (2). Factors affecting failure were; the application time
      of IUDs (3), application technique (4), uterus dimensions (5), endometrial cavity length (6),
      parity (7), and mode of delivery (8).

      Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior
      uterine segment and the cervical canal (9). UCA has been evaluated to predict the threat of
      preterm birth in national and international studies (9,10). In the literature, UCA has not
      been used in any studies within the scope of family planning. Our study aimed to investigate
      the feasibility of uterocervical angle measurements in predicting the dislocation of IUDs.
    

Intervention name(s): uterocervical angle
Intervention type(s): Diagnostic Test
Intervention description(s): uterocervical angles were measured for both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The female patients between the ages of 21-45 who applied to either gynecology or family
        planning outpatient clinics and who had been using copper IUD (T Cu 380-A) as a
        contraception method for the last 6 weeks to 5 years were included in the study. Patients
        were included in the study on a voluntary basis.
      
Keywords: displacement; contraception; family planning; T-Cu 380A; uterocervical angle
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether a ketone ester drink will improve exercise in
      people with heart failure (HF) compared to a placebo. In HF, patients are limited in their
      ability to do all the things they want to do, and exercise as much as they would like, due to
      becoming tired and short of breath early. There may be several reasons why these symptoms
      occur.

      There is some evidence that in addition to problems with the heart, patients with HF also
      have problems with their arteries and muscles that affect their ability to exercise. Ketones
      have been shown to improve exercise capacity in healthy volunteers, which may be related to
      effects on the heart function or on muscles. An infusion of ketones through an intravenous
      (IV) line has also been shown to significantly improve heart function, but whether a drink
      can produce similar improvements in HF patients is not known. This drink has been given
      status by Food and Drug Administration as "generally regarded as safe".

      The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and
      Drug Administration (FDA) for the use being evaluated in this study.
    


Intervention name(s): Ketone ester; placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis; KE free placebo drink
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Overview: The overall study design will be a randomized, double-blind crossover comparison of ketone ester (KE) therapy vs. KE-free vehicle in 20 patients with established HF with preserved ejection fraction (HFpEF). The main outcomes will be measures of exercise performance (peak and submaximal exercise).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Previous studies on iron absorption have focused on the effects on the addition of iron
      absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic
      phytic acid removal through phytase. The investigators want here to investigate the effects
      of fat on iron absorption with and without the addition of exogenous phytase as a potential
      iron absorption enhancer in lipid nutrient supplements (LNS) products compared to
      micronutrient powder(MNP) products.

      Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to
      induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric
      density of a meal by increasing its fat content might enhance iron absorption by delaying
      gastric emptying, gastric acid secretion and increasing Fe stomach residence time.
    


Intervention name(s): micronutrient powder; micronutrient powder (containing FeSO4), phytase; Iron pyrophosphate (FePP); Iron sulphate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Iron; Trace Elements; Micronutrients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered
      to subjects from 2 to 17 years of age with increased risk of meningococcal disease because
      either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction.
      A group of healthy age-matched subjects will be enrolled to serve as a descriptive control
      for immunogenicity and safety.
    


Intervention name(s): rMenB+OMV; rMenB+OMV; rMenB+OMV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 doses of vaccine 2 months apart; 2 doses of vaccine 2 months apart; 2 doses of vaccine 2 months apart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; vaccination; complement deficiency; asplenia; splenic dysfunction
A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to
      evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.
    


Intervention name(s): Placebo; MSDC-0602 100 mg; MSDC-0602 250 mg; MSDC-0602 250 mg; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo Capsules; MSDC-0602 100 mg Capsules; MSDC-0602 250 mg Capsules; MSDC-0602 500 mg Capsules; Pioglitazone 45 mg Capsules
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2; Diabetes Mellitus; Diabetes; High blood sugar; Blood sugar; Blood glucose; Glucose