bioihbjkbjnl/mcl2 huggingface dataset:
Heart Obesity Prevention Education
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Study to collect data on weight management on a male population of retired NFL athletes.
    

Detailed description: 
      Up to ten retired NFL players will receive a comprehensive and monitored weight loss program
      using a protocol that has been established at the TGH+USF Bariatric Center. A low calorie
      diet with meal replacements will be used and over the course of the study the participants
      will be taught to eat low calorie nutritious foods. The sessions will teach proper eating
      habits, stress control, and skills to maintain a healthy weight.

      The length of the study is 6 months. Treatment will last 24 weeks, the participants will
      attend group sessions (60-90 mins.) on a weekly basis for weeks 1-12 and then every other
      week for weeks 14-24, for a total of 18 treatments. Treatment will include meal replacement,
      education on nutrition and proper eating habits as well as behavior modification and skills
      which is known to be effective.

      Participants will be scheduled to come to the Bariatric Center for the first
      assessment/screening and for the consenting process. TGH+USF Bariatric Center has dedicated
      clinical space in their suite with private exam rooms, an education classroom, and private
      testing room.
    

Intervention name(s): Ketogenic diet
Intervention type(s): Other
Other intervention name(s): High protein; Low carbohydrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Resistant Starch, Antioxidant Status and Insulin Resistance
Condition: Overweight; Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      The aim of this study is to evaluate whether supplementation with resistant starch improves
      biomarkers associated with antioxidant status and insulin resistance in subjects with
      overweight and obesity.
    


Intervention name(s): Hi-maize resistant starch; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 13.5 g/day; 13.5 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Resistant Starch; Antioxidant Status; Insulin Resistance; Overweight; Obesity
Safety, Tolerability and PK of SHR1314 in axSpA
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics
      (PK) of SHR1314 with axial spondyloarthritis.
    

Detailed description: 
      This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The
      study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
    

Intervention name(s): SHR-1314
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SHR1314
Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
Condition: Infantile Esotropia
MeSH terms: Esotropia
Study type: Interventional

Summary: 
      Strabismus (or squint) is defined as the presence of misalignment between the visual axes of
      the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into
      comitant (if the amount of misalignment between the 2 eyes remained equal in all directions
      of gaze) and incomitant (if the amount of misalignment varied in different directions of
      gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or
      esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or
      exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a
      well-defined entity with an onset prior to 6 months of age, characterised by a large stable
      angle, cross fixation, and a limited potential for binocular single vision. Acquired
      childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type,
      which is neither congenital nor secondary to ocular pathology, can be divided into three main
      groups: (1) Accommodative esotropia, which may be fully accommodative, partially
      accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3)
      Esotropia associated with neurological dysfunction, in particular cerebral palsy and
      hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric
      strabismus must be treated early to maximize the potential for binocular vision and decrease
      the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and
      straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a
      third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired
      stereopsis, diplopia, and negative psychological effect.
    


Intervention name(s): bilateral medial rectus recession
Intervention type(s): Procedure
Intervention description(s): release muuscle from its original insertion and backword inserted in sclera
Other intervention name(s): Monocular medial rectus (MR) recession and lateral rectus (LR) resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smoking Tobacco and Drinking Study
Condition: Smoking; Heavy Episodic Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use
      and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use.
      Both groups will be offered a nicotine patch starter kit. The primary outcome is verified
      7-day point prevalence abstinence from smoking at 3, 6, and 12 months.
    

Detailed description: 
      Participants will be randomized to one of two conditions: (1) a Facebook-delivered
      intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to
      quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both
      interventions will include 12 weeks of Facebook-based messages and activities tailored to
      participants' readiness to quit smoking.

      Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include
      measures on smoking and drinking patterns and thoughts about abstinence. All participants who
      report no past 7-day smoking will be asked to give biochemical verification of smoking status
      with saliva cotinine test kits that will be mailed to participants.
    

Intervention name(s): Tobacco Status Project Intervention; Tobacco Status Project + Alcohol Intervention; nicotine patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): 90 days of Facebook messaging, weekly live sessions targeting tobacco use; 90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use; 14-day supply of nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco; Cigarettes; Alcohol; Cessation; Intervention; Young adults; Internet; Social media
Validation of Triggered EMG Values for Pedicle Screws Using a Powered Screwdriver
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Previous studies have shown how triggered electromyogram (EMG) pedicle screw stimulation can
      be used to effectively test correct pedicle screw placement in the lumbar and thoracic
      vertebrae. Most papers agree that if more than 6mA of current are needed to elicit a response
      the screw is correctly placed in the bone. If there is a response with less than 6mA there is
      a strong likelihood of a breach of the pedicle wall or invasion of the spinal canal.
      Typically this triggered EMG stimulation is done after all the screws have been placed with a
      ball-tipped probe and is paired with intraoperative fluoroscopy to ensure correct placement
      of the screws. Another method of testing the current for each screw is with a powered
      screwdriver, which can stimulate and give a reading as the surgeon places each screw. Both of
      these methods are currently used by surgeons, however the powered screwdriver has been found
      to be a faster method. The investigator's aim with this study is to compare these two methods
      of testing triggered EMG values. The investigators plan on doing this by testing each screw
      with both the ball-tipped probe and the powered screwdriver, in order to see if there are any
      statistically significant differences between the readings.
    

Detailed description: 
      The purpose of the study is to compare two methods of testing triggered EMG values. All study
      measurements will be recorded during the surgical procedure. No follow up is required with
      the patient involved and no personal health information will be recorded from the patients.
    

Intervention name(s): Spinal Fusion
Intervention type(s): Procedure
Intervention description(s): The investigators are studying the use of triggered EMG via the IPC POWEREASE screwdriver (Product Codes HBE, HWE, GWF) during spinal fusion surgery in adolescent idiopathic scoliosis by comparing it to the traditional triggered EMG OrthoMon probe system (Product Codes GWF, IKN).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 8-21 years of age with a diagnosis of adolescent idiopathic
        scoliosis (AIS) who will be receiving a spinal fusion.
      
Keywords: Scoliosis; EMG; Pedicle screw; Neuromonitoring
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Condition: Unidentified Gastrointestinal Symptoms Following Pulses Consumption
MeSH terms: Gastrointestinal Diseases; Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal
      fermentation rates of the study products as measured by breath hydrogen and methane in adult
      population with self-reported mild abdominal sensitivity to pulses. The study products are a
      pulse products with two different cereals.
    

Detailed description: 
      The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim
      is to recruit 25 subjects to the trial. The study will be conducted with a cross-over
      setting, where the subjects will go through exposure meals and breath gas measurement two
      times (two different test products) in a randomized order. The study meals are identical in
      appearance but differ in fiber content. After study breakfast the breath gases are analyzed
      every 15 minutes during 8 hours.
    

Intervention name(s): Pulses and cereals
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Is Fluidotherapy Effective in Rheumatoid Hand?
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the efficacy of fluidotherapy primarily on
      function and quality of life, secondarily on pain, morning stiffness, grip strength, and
      disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this
      prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2
      groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2
      (n=46) was the control group. All patients received joint protection and exercise program.
      The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index
      (DHI) and secondary outcome measures were pain and morning stiffness assessed using the
      Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28
      (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week
      12 after treatment.
    


Intervention name(s): Fluidotherapy treatment; Joint protection and exercise
Intervention type(s): Other; Other
Intervention description(s): fluidotherapy and joint protection and exercise; joint protection and exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid hand; Fluidotherapy; Rehabilitation
Athena Pelvic Muscle Trainer - DUETS Trial
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device
      effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic
      floor muscles by collecting data from the patient on the

        1. Over Active Bladder Questionnaire

        2. The 7-Day Urine Diary questionnaire

           This study will also look at whether or not there is an improvement in sexual health
           after using the device by collecting data frm the patient on the

        3. Female Sexual Function Index questionnaire
    

Detailed description: 
      This is a Phase IV, prospective, open-label, multi-center, observational study to assess the
      effectiveness of the Athena PMT to relieve or eliminate the symptoms of female urinary
      incontinence.

      The study will enlist approximately 100 or more Nurse-Practitioners in Women's Health as the
      principle investigators from community-based primary care centers (OB-GYN, Internal Medicine,
      Family Practices or Women's Health Centers) who will enroll approximately 500 or more
      subjects who suffer from urge and/or stress urinary incontinence and who may benefit from
      strengthening of Kegel muscles of the pelvic floor.
    

Intervention name(s): Athena Pelvic Muscle Trainer
Intervention type(s): Device
Intervention description(s): The Athena PMT is a vaginally inserted electrical stimulator that induces the pelvic floor muscles to contract and relax, similar to Kegel exercises intended to strengthen the pelvic floor muscles.
Other intervention name(s): Athena PMT; PMT; Pelvic Muscle Trainer; Athena
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Urinary Urge Incontinence; Urinary Stress Incontinence; Urinary Mixed Incontinence
Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Up to 78% of women diagnosed with breast cancer experience impairments in their cognitive
      function (e.g., frequent forgetfulness, slow processing speeds, and difficulties in
      concentration, multitasking and/or word retrieval) in the course of cancer treatment. These
      cognitive impairments (CI) have negative effects on patients' social relationships, overall
      life satisfaction, and treatment adherence. Dietary intake may be an important factor in
      mitigating risk of CI that breast cancer patients experience. Several studies have suggested
      that dietary intake of specific nutrients and foods (e.g., carotenoids, B-vitamin, and
      omega-3 fatty acids rich foods) can be helpful to decrease the severity of cancer-related
      cognitive impairment (CRCI). High-quality dietary patterns can be also helpful to protect
      white matter volume and its integrity; damage to and changes in white matter contributes to
      CRCI. However, despite the high incidence of CRCI in breast cancer patients, very little is
      known about etiology of CRCI. Thus, the purpose of this observational study with
      cross-sectional design is to examine the relationships of diet with brain structural and
      functional outcomes of breast cancer patients. The study will aim to enroll 30 female
      postmenopausal breast cancer survivors (age 45-75) who have recently completed chemotherapy
      treatment within 3-12 months from study enrollment. Participants will complete study
      questionnaires online, and will have an in-person study visit to complete a functional
      magnetic resonance imagine (MRI) scan, cognitive testing, and blood sample collection via
      fingerstick and venous blood draw. It is expected that this study will advance the field's
      understanding and ability to early assess, manage, and prevent CRCI.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer survivors from the Central Ohio area, including those who were seen at The
        Ohio State University Wexner Medical Center James Cancer Hospital for cancer treatment.
      
Biospecimen description: 
      Whole blood dried blood spots; whole blood venous blood samples
    
Keywords: Chemotherapy; Cognitive impairment; Breast cancer survivor; Diet
A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors
      (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be
      encountered during infection) and endogenous nucleic acids (as might be released during
      tissue damage during autoimmune disease). In vitro and in multiple animal models of
      autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In
      Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC
      injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were
      well-tolerated, with mild injection site reactions and no pattern of systemic reactions or
      laboratory changes.

      The current study represents the first clinical trial of IMO-8400 in patients with active
      autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of
      activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist
      which demonstrated clinical improvement in this patient population.
    

Detailed description: 
      Eligible subjects will be enrolled and randomized to receive one of the four treatments
      (three dose levels of IMO-8400 or Saline Placebo). Treatments will be administered once
      weekly by subcutaneous injections. Subjects will received treatment for 12 weeks and then be
      followed for an additional 6 weeks to assess the durability of the response.
    

Intervention name(s): IMO-8400 Regimen 1; IMO-8400 Regimen 2; IMO-8400 Regimen 3; Saline Placebo; IMO-8400 Regimen 4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection; IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection; IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection; Saline q wk x 12 wk by subcutaneous injection; IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: plaque psoriasis; autoimmune disease; Toll like receptor
Schizophrenia Cognition Scale Development
Condition: Schizophrenia; Cognition Disorders
MeSH terms: Schizophrenia; Cognition Disorders
Study type: Observational

Summary: 
      The objective of this protocol is to develop items for a patient-reported outcome (PRO)
      measure to assess the patient's perspective and subjective experience of cognitive impairment
      associated with schizophrenia (CIAS).
    

Detailed description: 
      Cognitive impairment associated with schizophrenia (CIAS) has been shown to be the strongest
      predictor of functional impairment among people with schizophrenia because it is associated
      with poor response to psychosocial interventions, employment status, and social functioning.
      Because the subjective experience of CIAS is likely to be associated with patient burden,
      distress, and motivation for treatment, it is important that this experience be assessed in a
      reliable and valid manner and from the perspective of the patient's self report. No existing
      instrument to assess CIAS has been developed with patient input directly about their
      qualitative experience of impaired cognition during the item generation stage, in accordance
      with FDA guidance for patient-reported outcome (PRO) measures.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with formal dx of schizo aged 18-55, stabe (non-acute phase), on stable medications
      
Biospecimen description: 
      No biospecimens collected
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
Condition: Focus: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal
      Spray as compared to an IM injection of cyanocobalamin (European reference product).
    

Detailed description: 
      This is an open-label, randomized, single-dose, two-way crossover study. The study consists
      of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two
      confinement periods will be separated by a washout period of at least 28 days.
    

Intervention name(s): Nascobal nasal spray (cyanocobalamin, USP); Vitamin B12-ratiopharm N, injection solution
Intervention type(s): Drug; Drug
Intervention description(s): Single intranasal administration; One single intramuscular administration
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; pharmacokinetics; cyanocobalamin; intranasal; intramuscular