bioihbjkbjnl/mcl2 huggingface dataset:
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
Condition: Presbycusis; Hearing Loss, Sensorineural; Noise Induced Hearing Loss; Sudden Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Presbycusis; Hearing Loss, Noise-Induced; Hearing Loss, Sudden
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose,
      multicenter, safety study of FX-322, administered by intratympanic injection, in adults with
      age-related sensorineural hearing loss.
    

Detailed description: 
      This is a Phase 1b placebo-controlled, double-blind, randomized, single-dose safety study of
      intratympanic FX-322 dosed in subjects with age-related sensorineural hearing loss.

      Approximately 30 subjects are planned to be enrolled in this study. The subjects will be
      randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety,
      otologic, and audiologic assessments at Days 30 and 90 after the study injection.
    

Intervention name(s): FX-322; placebo
Intervention type(s): Drug; Other
Intervention description(s): active comparator; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive FX-322 or placebo randomized 4:1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intratympanic administration; Restoration of hearing loss
Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM
Condition: HIV CDC Category A1
Study type: Interventional

Summary: 
      B-ME is a research intervention study designed to address the needs of African American men
      who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is
      to decrease HIV risk behaviors among African American MSM using an intervention developed by
      and for African American MSM.

      The hypothesis guiding this study is: that participants who complete B-ME intervention will
      report greater reductions in sexual risk behaviors than the standard of care comparison
      group.
    

Detailed description: 
      The Specific Aims of this study are 1) to further explicate and develop the intervention, 2)
      to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of
      research on HIV prevention/risk reduction practices for African American men who have sex
      with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving
      B-ME intervention to receiving basic men's health and wellness messaging (standard of care),
      hypothesizing: hypothesizing: that participants who complete B-ME intervention will report
      greater reductions in sexual risk behaviors than the standard of care comparison group. The
      study will utilize a pre-test/post-test design with participants randomized to intervention
      and comparison groups; have a strategy to retain at least 80% of participants through study
      completion; collect data at baseline, at 3 months post-intervention, and at 6 months
      post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will
      be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes
      that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex
      events; (2) number of unprotected sex events with persons of unknown HIV status; (3)
      frequency of HIV testing, and (4) increased communication between partners about sex and
      strategies for reducing the risk of HIV infection.
    

Intervention name(s): B-ME Intervention
Intervention type(s): Behavioral
Intervention description(s): B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment to behavioral intervention or comparison group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Black MSM; HIV Prevention
The Relationship Between the Tumor Markers and Interstitial Lung Disease
Condition: the Relationship Between the Tumor Markers and Interstitial Lung Disease Patients
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125
      are often increased in interstitial lung disease patients.

      This study was undertaken to investigate the source of these serum tumor markers.
    

Detailed description: 
      The serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), CA125
      are often increased in interstitial lung disease patients.

      This study was undertaken to investigate the source of these serum tumor markers.We
      hypothesis that these tumor markers are released from the lung.

      The broncholveolr lvge fluid levels of carcinoembryonic antigen (CEA), carbohydrate antigen
      19-9 (CA19-9), CA125 were measured in the interstitial lung disease patients before lung
      transplantation. The immunohistochemical test was performed in the specimen lung after lung
      transplantation.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        lung disease patients for lung transplantation
      
Biospecimen description: 
      lung specimen after lung transplantation
    
Keywords: carcinoembryonic antigen; carbohydrate antigen 19-9; carbohydrate antigen 125
Flax Lignans and Heart Health
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower
      serum cholesterol levels.

      Background: Flaxseed has been studied for various health benefits in humans, including
      prostate health, glucose control, and cardiovascular health. Cholesterol levels and high
      blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has
      had variable effects on serum lipid levels, perhaps a consequence of variations in the
      amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making
      the study of this bioactive compound difficult.

      Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL
      cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.
    


Intervention name(s): secoisolariciresinol diglucoside-containing extract of flaxseed
Intervention type(s): Dietary Supplement
Intervention description(s): 0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet
Other intervention name(s): Beneflax
Intervention MeSH terms: Secoisolariciresinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: hypercholesterolemia; postmenopause; secoisolariciresinol diglucoside; flaxseed; lignans; enterolactone; enterodiol; serum cholesterol; LDL cholesterol
A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
Condition: Epilepsy; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of
      orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and
      Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary
      generalization.
    


Intervention name(s): Lacosamide 50 mg; Lacosamide 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use; Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use; Matching oral Placebo tablets twice daily for 16 weeks.
Other intervention name(s): Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lacosamide; Epilepsy; Partial Onset Seizures
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of
      Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered
      intramuscularly as single dose and as 2-dose schedules in healthy adults.
    


Intervention name(s): Ad26.ZIKV.001 5*10^10 vp; Ad26.ZIKV.001 1*10^11 vp; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.; Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.; Participants will receive placebo via IM route.
Other intervention name(s): JNJ-66684657; JNJ-66684657
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of High-intensity Interval Training in Combination With Side-alternating Whole-body Vibration
Condition: Health Behavior
Study type: Interventional

Summary: 
      Investigation of the training effects following 8 weeks of high-intensity interval training
      (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT
      or side-alternating whole-body vibration. The adaptations are investigated on a molecular
      (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping mechanography,
      dynamometry) level. In addition, the acute effects of the first and last training session
      will be investigated on a molecular (e.g. satellite cell activation, mRNA abundance) and
      systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived exertion) level.
    


Intervention name(s): 4x4 min HIT; 4x4 min HIT + WBV (18 Hz); 4x4 min HIT + (30 Hz); whole-body vibration at 30 Hz
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Conventional 4x4 min high-intensity interval training; 4x4 min high-intensity interval training in combination with whole-body vibration at 18 Hz during the active rest; 4x4 min high-intensity interval training in combination with whole-body vibration at 30 Hz during the active rest; 4x3 min whole-body vibration at 30 Hz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Balance and Leg Function After Hip Replacement
Condition: Hip Injuries; Coxarthrosis; Hip Replacement
MeSH terms: Osteoarthritis, Hip; Hip Injuries
Study type: Interventional

Summary: 
      Task-oriented leg exercise are commonly used after joint surgeries in various hip
      pathologies. Based on this theory, it was hypothesized that task-oriented exercise without
      conventional physiotherapy can have better result in recovery of balance and leg function
      than with a conventional post-hip physiotherapy program after hip replacement surgery. The
      aim of the study was to determine the effect of task-oriented exercise on balance and leg
      function after total hip replacement.
    

Detailed description: 
      Study included 40 subjects. All subjects were randomly divided into control and intervention
      groups. VAS scale was used to assess the pain, hip range of motion were measured using a
      goniometer, strength of the muscles was assessed on the Oxford 5 point scale, leg function
      was evaluated with modified Harris hip scale, Abili balance analyzer was used to assess
      static balance and Berg balance scale was used to measure dynamic balance. Intervention
      duration was 18 days.
    

Intervention name(s): Task-oriented exercise; Control
Intervention type(s): Other; Other
Intervention description(s): Task-oriented exercise program for patients after total hip replacement.; Control intervention: conventional physiotherapy after hip replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: balance; hip function; hip replacement; elderly; physical functioning
The Effects of Kinesiotaping on Balance in Children With Down Syndrome.
Condition: Down Syndrome; Balance
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to explore the effects of Kinesio tape applied to plantar soles on balance
      in children with Down Syndrome (DS). Two groups including children with DS and a group with
      their typically developing peers evaluated. Half of the children with DS took Kinesio tape
      application to the plantar soles and the other half took sham taping application. All
      children evaluated with dynamic and static balance measurements and DS children evaluated
      immediately after taping and 45 minutes after taping again with the same measurements.
    

Detailed description: 
      Balance is one of the most problematic issues in children with DS. Mechanoreceptors of
      plantar region of the foot helps to regulate human erect posture and balance. Studies shows
      that inputs from foot sole give a positive effect in improving balance both in healthy and
      neurologically demaged subjects. Kinesio tape is a supportive method in physiotherapy with
      it's proprioceptive input giving effects. It is aimed to show the acute effects of Kinesio
      tape on balance parameters in children with DS.
    

Intervention name(s): Kinesio taping; Sham taping
Intervention type(s): Other; Other
Intervention description(s): For the fascia technique, one part of the band which were divided by 4 fans is adhered on Achilles tendon to the heel with a 0% stretch. Then the plantar fascia was stretched by the examiner and the toes were extended (ankle dorsiflexion, toe extension) and the divided part of the band was applied toward the metatarsal heads with paper-off technique (5-15%).; ''I'' bant were cut from the middle point of the Achilles tendon to the metatarsal heads. The band was applied from the Achilles tendon to the metatarsal heads without any stretching of plantar fascia and band.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was carried out with the participation of 3 groups as kinesio taping application group with Down Sydnrome children (KT) (n=12, DS), sham taping application group with Down Syndrome children (ST) (n=12, DS) and healthy control with healty children (HC) (n=12). Healty children took no taping applications. KT group took Kinesio tape, ST group took sham taping evaluated 2 times after the tapings (immediately and 45 minutes later).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Down Syndrome; Postural Balance; Kinesio Taping
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      "The purpose of this investigator-initiated study is to see if giving dextrose fluid in the
      veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic,
      gynecologic and breast outpatient surgery patients and at what blood surgery level. The
      reason for this study is that IV dextrose has been shown to decrease the incidence of PONV
      and the use of medications to treat PONV, while leading to sooner discharge after surgery.
      This can decrease overall healthcare cost and improving patient satisfaction."
    


Intervention name(s): Intravenous fluid; D5LR or lactated ringers
Intervention type(s): Other; Other
Intervention description(s): The treatment group will receive a 250cc bolus over 2 hrs of D5LR prior to the end of surgery and continued in the PACU. Blood glucose will be checked 3 different times using an Accu-chek monitor along with the type and number of rescue medications given at 30, 60, and 120 minutes after anesthesia and the post-op morning.
The control group will receive a 250cc bolus over 2 hours of LR. Blood glucose will be monitored 3 times along with the type and how much of rescue medications are given at 30, 60 and 120 minutes post-op and the morning after surgery.; The purpose of the study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood sugar level.
The reason for this study is that IV dextrose may decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of Antipsychotics on Appetite Regulation
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate changes in appetite-regulating hormones, body
      composition (weight, body fat%), and hunger ratings in persons early in treatment with one of
      four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).
    

Detailed description: 
      Severe weight gain and glucose dysregulation are serious problems in patients treated with
      second-generation ('atypical') antipsychotics (SGA). These side effects frequently interfere
      with medication compliance and necessitate discontinuation of treatment. Although the causal
      mechanisms for weight and glucose dysregulation are not well understood, one promising area
      of investigation targets SGA-induced disturbances in appetite and in appetite-regulating
      hormones. Findings from our group (and others) demonstrate SGA treatment-related increases in
      fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in
      self-report hunger. This novel study will examine prospective changes in ghrelin and in the
      'satiety-signaling' peptide YY (PYY) as measured before and after participants consume a
      standard mixed-macronutrient meal. Data are obtained at baseline (within 4 weeks of beginning
      medication), and again 2 months and 4 months later.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients ages 18 to 40 years of age who are early in treatment (i.e., started treatment in
        the past month) with 1 of 4 antipsychotic medications (olanzapine, risperidone,
        ziprasidone, aripiprazole)
      
Biospecimen description: 
      whole blood, serum, plasma
    
Keywords: antipsychotic; ghrelin; PYY; appetite; weight gain
Anxiety, Mood, and Health Behaviors in Young Adults
Condition: Anxiety Sensitivity
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This is a randomized control trial to test the effect of an anxiety sensitivity intervention
      on health behaviors among 18-35 year-olds.
    

Detailed description: 
      This is a 2-arm randomized control trial to test the effect of an anxiety sensitivity
      intervention on health behaviors among 18-35 year-olds. Participants will be 18-35 year-olds
      with high anxiety sensitivity randomized to 1)Exercise Exposure Intervention or 2)Assessment
      Only Control Condition. Participants in both groups will be followed for 8 weeks.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Behavioral
Intervention description(s): At each of the six exposure sessions, participants will be invited to engage in 2-minute warm-up on the treadmill. Following this warm-up period, participants will be asked to briskly walk or jog on the treadmill at a speed that maintains their heart rate at 60-80% of maximum age-predicted heart rate for 20 minutes using the formula: (220-age) x (0.60 [lower bound] or 0.80 [upper bound]). Participants will be fitted with a heart rate monitor, which will be checked by a research assistant at 5-minute intervals in order to ensure adherence to this prescription; participants will be asked to adjust treadmill speed in order to remain in this range. Following each 20-minute exposure, participants will complete 5 minutes of cool down walking on the treadmill. Assessments will take place at baseline, week 2 (post-intervention), week 4, and week 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; Young Adults; Health Behaviors
Non-surgical Peridontal Treatment on Cardiovascular Risk Markers
Condition: Cardiovascular Risk Markers; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The study evaluates the influence of non-surgical mechanical periodontal treatment in
      patients with severe chronic periodontitis on inflammatory markers related to risk for
      cardiovascular diseases
    

Detailed description: 
      A total of 80 non-smokers with systemically healthy, including 40 patients with severe
      chronic periodontitis and 40 periodontally health subjects were included into the present
      study. The probing depth, clinical attachment level, plaque index, gingival index and blood
      samples were collected at baseline and at the 3rd months after treatment and the serum levels
      of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine
      (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked
      immunosorbent assay (ELISA).
    

Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asymmetric dimethylarginine; endothelial nitric oxide synthase; homocysteine; monocyte chemoattractant protein-1