bioihbjkbjnl/mcl2 huggingface dataset:
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study
      to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in
      subjects 18 to 80 years of age with HFrEF ≤40%.

      Initially 5 cohorts are planned with the option to expand the study to a total of 7 cohorts.
      The size of the cohorts will range from 5 to 9 subjects. Each cohort will include one single
      active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized
      single dose administration of JK07 or placebo [3:1] in the remainder of the cohort.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study
      to assess the safety, tolerability, immunogenicity, PK, and exploratory efficacy of JK07 in
      HF subjects 18 to 80 years of age with LVEF ≤40%. Subjects must have been maintained on an
      optimal HF medical regimen for at least 2 months prior to enrollment and remain on the same
      treatment regimen throughout the course of the study, per the 2017 ACC/AHA/HFSA) treatment
      guidelines.

      At screening, eligible subjects will undergo a physical examination, 2-dimensional
      transthoracic echocardiography (2D-TTE), ECG assessment, blood sampling for laboratory
      parameters, and urine testing. Safety assessments at screening will include hematology,
      biochemistry, coagulation, liver, and thyroid function.

      Subjects will be observed in the hospital on continuous telemetry from the time of hospital
      admission until shortly before discharge approximately 48 hours later. During this time, they
      will additionally have safety labs, vital signs, PK and biomarker samples collected, and ECGs
      and 2D-TTEs performed.

      Only a single dose of the investigational product will be administered and only a single
      hospital admission is planned per subject during the study. Subjects will complete follow-up
      visits through 180 days after administration of the investigational product.
    

Intervention name(s): JK07; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1; Vehicle control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, single-ascending dose with single active sentinel subject per cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; HFrEF; neuregulin 1; NRG-1; heregulin; HER3; HER4; ErbB3; ErbB4; reduced ejection fraction
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.
    


Intervention name(s): AK106-001616; AK106-001616; Active comparator
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coherence Imaging of the Cervical Epithelium
Condition: Cervical Epithelia
Study type: Interventional

Summary: 
      The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI)
      endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will
      obtain optical measurements from the cervix. These measurements can be used to create a map
      of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and
      the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most
      likely to occur.
    


Intervention name(s): mLCI Device
Intervention type(s): Device
Intervention description(s): imaging of cervical epithelium using mLCI device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Determinants of Functional Capacity in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      The primary aim of this study is to compare the respiratory function, respiratory muscle
      strength, functional capacity, and lower extremity strength of children with asthma and
      healthy children in the same age group. The secondary aim of our study is to determine the
      determinants of functional capacity in children with asthma.
    


Intervention name(s): 6-minute walk test; Pulmonary function test; Respiratory muscle strength test; Lower extremity muscle strength test
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.; Pulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.; Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.; The 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with asthma aged between 6-17 years and healthy children aged between 6-17 years
        will be included in the study. Informed consent forms for the study prepared for both the
        asthma group and the control group will be carefully explained and the participants will be
        included in the study after they and their parents have read, understood, and accepted.
Efficacy of a Supervised Intervention Protocol on Rounded Shoulder Posture and Shoulder ROM Among Saudi Young Females
Condition: Postural; Defect
Study type: Interventional

Summary: 
      Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in
      limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of
      Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to
      increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded
      shoulder posture.
    

Detailed description: 
      Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in
      limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of
      Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to
      increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded
      shoulder posture.

      Randomized sixty female subjects with rounded shoulder posture into two groups: Group A
      performed active Stretching of PMi along with the strengthening of LTR muscle(n=30); group B
      performed dynamic Stretching of PMi muscle only. Scores of outcome measures were recorded
      before and post interventions on day 0, day10th, and day21st, respectively.
    

Intervention name(s): Active Stretching or Self-stretching exercises; Active strengthening Or Self-Strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): Pectoralis minor muscle was actively stretched under the supervision of a physiotherapist as follows: - 2 sets of 3-stretches/session/day, for 5 consecutive days a week, for 3 weeks; Lower trapezius muscle was strengthened under the supervision of a physiotherapist as follows: -2 sets of 5-rep./session/day, for 5 consecutive days in 1st week, progressed to 10 and 20 reps./session/day for 2 weeks and 3 weeks respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel groups randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Round shoulder posture; Active Stretching; Pectoralis Muscles; Strength Training; Trapezius Muscle
Prenatal Yoga for Pregnancy Related Back Pain
Condition: Pregnancy Related
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This is a pilot feasibility study investigating prenatal yoga for pregnancy related back
      pain.
    


Intervention name(s): yoga; support group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): once weekly group yoga class for 12 weeks; once weekly group support class for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen
Condition: Bronchial Hyperreactivity; Hypersensitivity; Allergy; Bronchial Asthma
MeSH terms: Asthma; Bronchial Hyperreactivity; Hypersensitivity
Study type: Interventional

Summary: 
      The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in
      patients with allergy on grass pollen after specific bronchial provocation. Therefore, the
      investigators will record the patients' nutrition habits and measure the blood level of long
      chained polyunsaturated fatty-acids.
    


Intervention name(s): inhalative specific bronchial provocation with grass-pollen
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: grass-pollen; allergy; bronchial hyperreactivity; asthma
Corneal Biomechanical Properties in Pregnancy
Condition: Corneal Biomechanics; Pregnancy
Study type: Interventional

Summary: 
      57 eyes of 57 healthy pregnant women who were visiting Obstetrics and Gynecology department
      for routine examination and 26 eyes of 26 non pregnant control subjects who were at the first
      week of the menstrual cycle were enrolled in the study. All subjects had a detailed
      ophthalmologic examination including the best corrected visual acuity with a Snellen chart,
      slit- lamp biomicroscopic evaluation, and indirect fundoscopy. The biomechanical properties
      Corneal Hysteresis, Corneal resistance factor, corneal compensated intraocular pressure and
      Goldmann-correlated intraocular pressure values were measured with ORA (Ocular Response
      Analyzer, software version 1.02, Reichert, Inc.) Central corneal thickness was measured with
      a built-in ultrasonic pachymeter attached to the ORA device.Axial length , Anterior chamber
      depth , and keratometry readings were acquired with an ocular biometer (IOLMaster; Carl-Zeiss
      Meditec, Inc.) before CCT determinations had been taken. Results of these parameters were
      compared between pregnant group and healthy control group.
    


Intervention name(s): corneal biomechanical properties
Intervention type(s): Diagnostic Test
Intervention description(s): We want to investigate changes of corneal biomechanical properties during pregnancy. The Ocular Response Analyzer (ORA) evaluate the in vivo corneal biomechanical properties in form of corneal hysteresis (CH) and corneal resistance factor (CRF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about
      6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present
      together with hyperinsulinaemia and insulin resistance
    


Intervention name(s): Clomiphene Citrate 50mg; L-carnitine; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral 50 mg tablets; 1000 mg oral tablet; oral tablets identical to L-carnitine
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents
Condition: Oral Health Behavior Change
Study type: Interventional
Phase: Phase 2

Summary: 
      the present study had two main aims. First, due to the current underconsumption of dental
      brush adolescents, the investigators should apply a volitional intervention to increase oral
      health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness
      of action planning intervention and implementation intention will improve oral health
      behavior in adolescents.
    

Detailed description: 
      This is a study to explore the impact of two volitional interventions on brushing intentions
      , behaviors and clinical characteristics among a sample of adolescent students.
    

Intervention name(s): Implementation intention; Action planning; active control group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth!; It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).
I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).; Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Action planning, Implementation intention
Esomeprazole/Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional

Summary: 
      This study intends to collect the clinical data of patients with Helicobacter pylori
      infection in the outpatient department of the Department of Gastroenterology of the Third
      Xiangya Hospital of Central South University, and to observe and count the high-dose double
      therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin
      double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal
      bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose
      double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The
      eradication rate of Helicobacter pylori was compared between the two different regimens
      respectively, and the efficacy, safety and compliance of different regimens were compared. It
      provides a new reference for clinical treatment of Helicobacter pylori, and has great
      clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan,
      increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy
      suitable for the Chinese population.
    


Intervention name(s): esomeprazole + amoxicillin; esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent; Vonoprazan + amoxicillin; Vonoprazan + amoxicillin + clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): esomeprazole enteric-coated tablets (AstraZeneca Pharmaceuticals) 20mg four times daily and amoxicillin capsules 750mg four times daily; 20mg twice daily of esomeprazole enteric-coated tablets, 1000 mg twice daily of amoxicillin capsules, 500 mg twice daily of clarithromycin sustained-release tablets and 165 mg four times daily of colloidal bismuth tartrate capsules; 20 mg twice daily of fumaric acid vonoprazan tablets (Takeda Pharmaceutical Company Limited) and 1000 mg three times daily of amoxicillin capsules; 20 mg twice daily of fumaric acid vonoprazan tablets, 1000 mg twice daily of amoxicillin capsules and 500 mg twice daily of clarithromycin sustained-release tablets
Intervention MeSH terms: Amoxicillin; Clarithromycin; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety
      and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2
      after failure of standard of care.
    

Detailed description: 
      This study is an open-label and dose escalation study aimed at exploring the safety and MTD
      of HLX22.

      three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3
      mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign
      doses to the patients, and thereby determine the MTD of HLX22.
    

Intervention name(s): HLX22
Intervention type(s): Drug
Intervention description(s): Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody
Other intervention name(s): HER2 Monoclonal Antibody
Intervention MeSH terms: Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overexpressing HER2
Long-Term Safety Study of Tafenoquine
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo controlled study will involve 600 healthy
      (Glucose-6-Phosphate Dehydrogenase [G6PD] normal) volunteers. Participants who meet the
      eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either
      tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed
      by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety
      follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at
      Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit
      will continue to be assessed for up to 3 more times at approximately 12-week intervals or
      until resolution or stabilization of the AE whichever is earlier.
    


Intervention name(s): Tafenoquine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tafenoquine 200mg; Placebo
Intervention MeSH terms: Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tafenoquine; australia
Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is the comparison between the effects of supplementation with omega 3
      or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with
      cardiovascular disease.
    

Detailed description: 
      The aim of this study is the comparison between the effects of supplementation with omega 3
      or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with
      cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled,
      single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are
      enrolled in the study from Tehran Heart Center. After signing informed consent all
      individuals complete a general information form , 24-hour food recall for 3 days will be
      taken from the participants at the beginning and the end of the study,. Selected samples are
      randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement
      group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also
      receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and
      size). Patients are recommended to sustain their diets and medication dose (s) during the
      study and also advised to maintain a constant level of physical activity. Blood samples will
      be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters
      and physical activity before and after the trial will be measured.
    

Intervention name(s): Omega-3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 cap 1 g Omega-3 per day for 2 months; 4 cap 1 g Placebo(paraffin) per day for 2 months
Other intervention name(s): n-3 fatty acids; n-3 PUFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atherosclerotic; BDNF; Follistatin; Irisin