bioihbjkbjnl/mcl2 huggingface dataset:
Exercise, Oxidative Stress and HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to compare oxidative stress markers and the immunologic
      characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic
      exercise followed by resistance exercises
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants of the HIV group were recruited at the outpatient HIV/AIDS care unit of
        the Hospital de Clínicas de Porto Alegre (HCPA), whereas the control group (non-HIV) was
        formed by volunteers of the city of Porto Alegre, Rio Grande do Sul, Brazil
The Immediate Effects of Kinesio-Taping on Scapular Muscle Endurance and Strength in Asymptomatic Subjects
Condition: Asymptomatic Subjects
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the immediate effects of Kinesio-taping (KT) on
      scapular muscle endurance and strength and compared to placebo Kinesio-taping in asymptomatic
      subjects.
    

Detailed description: 
      Thirty-nine asymptomatic subjects (20 females and 19 males, mean age 20.46±1.09 years, mean
      BMI 21.99±3.02 kg/m2) were included in this study. Subjects were randomly allocated to KT
      (with the muscle facilitation technique) and placebo-KT (without any technique and tension).
      Scapular isometric muscle endurance was measured with a scapular muscle endurance test. The
      strength of the upper, middle, and lower trapezius, and serratus anterior was assessed using
      a hand-held digital dynamometer. Data were analyzed with 2x2 [groups (KT and Placebo-KT) x
      time (pre- and post-intervention)] mixed-model ANOVA.
    

Intervention name(s): -Scapular endurance test; -Muscle strength test
Intervention type(s): Other; Other
Intervention description(s): The resistance of the trapezius and serratus anterior muscles to fatigue was assessed using the scapular muscle endurance test.; Upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) muscle strengths were tested using a hand-held digital dynamometer (Lafayette Manual Muscle Tester, Model 01165).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Kinesio-taping; Scapula; Endurance; Muscle strength; Fatigue
Promoting Adherence to Treatment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The project evaluates a culturally adapted, family-based intervention designed to promote
      treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled
      design in a public mental health setting. Mexican-American patients with schizophrenia and
      their families were randomly assigned to either: 1) one year of multi- family groups that
      emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived
      and actual adherence skills in maintaining adherence, added to ongoing customary outpatient
      care; 2) standard multi-family groups without an emphasis on medication adherence, added to
      customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy
      sessions and additional services as clinically needed). The study hypotheses are that
      subjects assigned to the adapted multi-family group would have better medication adherence,
      less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the
      study (one year of treatment and one year of follow up) compared to the comparison
      conditions.
    

Detailed description: 
      As above
    

Intervention name(s): multifamily group-adherence; multifamily group-standard
Intervention type(s): Behavioral; Behavioral
Intervention description(s): multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior; multifamily groups held twice a month focused on general problem solving method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medication adherence; schizophrenia; Mexican American; multifamily groups
Blood and Urine Sample Collection From Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as
      a healthy control group for cross-cohort comparisons.
    

Detailed description: 
      The aim of the study is to obtain peripheral venous blood samples and a urine sample from 100
      healthy volunteers on one day at three different times of the day, to serve as a healthy
      control group for cross-cohort comparisons.

      With the help of the urine and blood samples obtained in this context, a cohort of a healthy
      collective is to be established for further research purposes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers who met all inclusion and none of the exlusion criteria
Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect on driving performance of a single dose of
      amphetamine extended-release tablets (20 mg/tablet) compared with placebo at 45 minutes and
      10 hours post-dose in young adults with ADHD.
    

Detailed description: 
      At a single US-based study site, a driving simulation will be used to assess the effect on
      driving performance for the co-primary endpoints, study subjects' driving performance at 45
      minutes and 10 hours post-dose, compared with placebo. Eligible subjects will be prescreened
      for ADHD but otherwise healthy, aged 18-25 years.

      Driving simulations that simulate common driving events to which the study subject must
      react. The reactions to each event will be assessed. Using a parallel-group design, subjects
      will be assessed while on study drug, and while on placebo.

      Safety assessments will include spontaneously reported treatment-emergent adverse events and
      vital signs at 4 hours post-dose.
    

Intervention name(s): Amphetamine Extended Release (ER) Tablet 20 mg
Intervention type(s): Drug
Intervention description(s): A single 20 mg dose of amphetamine ER Tablet, orally administered
Other intervention name(s): Amphetamine extended-release oral tablet 20 mg
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nadolol Versus Propranolol in Children With Infantile Hemangiomas
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of oral propranolol versus
      nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled,
      double-blinded study.
    

Detailed description: 
      The study objective is to compare the efficacy and safety of oral propranolol in comparison
      with oral nadolol in patients with IH. Patients will be randomly assigned to either
      propranolol or dose equivalent nadolol. The duration of the study will be 24 weeks, however,
      patient will be monitored for up to 1 year post study enrolment. Both efficacy and safety
      will be closely monitored and captured.
    

Intervention name(s): Nadolol; Propranolol
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day. In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be escalated (by 0.5 mg/kg/day at any following study visit) up to 3 mg/kg/day based on the clinical response to maintain the dose that led to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.
S/he will be monitored until Week 52.; Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day.
In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be increased by investigator, based on clinical response by 0.5 mg/kg/day at any study visit (up to 3 mg/kg/day divided twice a day) to maintain the dose that lead to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.
S/he will be monitored until Week 52.
Other intervention name(s): N/A (any brand ); N/A (any brand)
Intervention MeSH terms: Propranolol; Nadolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemangioma, propranolol, nadolol
The Role of the Fujinon Intelligent Chromo Endoscopy (FICE™) in Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      The purpose of this study to assess post ablation, if there are areas of Barrett's mucosa
      post ablation and to assess the ability of the Fujinon FICE system to detect this, as
      compared to white light endoscopy. A subgroup will also be compared with laser confocal
      microscopy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Barrett's esophagus
      
Keywords: Barrett's Esophagus; Surveillance
Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study
Condition: Motor-incomplete Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The research proposed here will determine the effect of a novel treadmill gait training
      strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with
      SCI. The effect of the new therapy will be evaluated by analyzing changes in functional
      ambulation and gait patterns during walking.
    

Detailed description: 
      Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In
      total, 20 participants will be recruited and randomly assigned to one of 2 types of
      body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the
      level of assistance that the Lokomat provides to the leg movements while walking. Therapy for
      both groups will take place 3 times/week for 12 weeks. During each session, participants will
      first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy.
      Rest breaks will be provided as needed, but participants should complete 45 minutes of
      walking per session.
    

Intervention name(s): Body-weight supported treadmill training; Body-weight supported treadmill training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.; BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Spinal cord injury; walking; gait training; body-weight supported treadmill training; rehabilitation
Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy
Condition: Pancreas Cancer; DVT; Pulmonary Embolism
MeSH terms: Pancreatic Neoplasms; Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 1

Summary: 
      Study investigators will examine the absorption characteristics of apixaban, a direct-acting
      oral anticoagulation, in patients who have underwent a particular kind of surgery
      (pancreaticoduodenectomy) which involves resection of the duodenum.
    

Detailed description: 
      This study will examine apixaban pharmacokinetic exposure (AUC(0-24)) and maximum
      concentration (Cmax) when administered as a single oral dose in patients who have undergone
      pancreaticoduodenectomy (PD) compared to historical controls. This is a phase one, single
      dose pharmacokinetic study in stable patients who have undergone pancreaticoduodenectomy.
      Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the
      class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor
      Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved
      by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip
      replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in
      patients with nonvalvular atrial fibrillation. This study aims to compare the
      pharmacokinetics and absorption of oral apixaban in patients who have undergone
      pancreaticoduodenectomy to that of apixaban in historical controls.
    

Intervention name(s): Apixaban
Intervention type(s): Drug
Intervention description(s): Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Other intervention name(s): Eliquis
Intervention MeSH terms: Apixaban
Intervention model: Single Group Assignment
Intervention model description: Single-dose pharmacokinetic study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: apixaban; pancreaticoduodenectomy; whipple; pharmacokinetic
The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      This is one project of a larger ongoing study related to the immune system's response to the
      flu virus. This study is designed to investigate the immune response to the live attenuated
      influenza vaccine (LAIV) vs. the Inactivated Influenza Vaccine (IIV) in identical and
      fraternal twins.
    

Detailed description: 
      This is a Phase I mechanistic study of licensed influenza vaccines. The study requires 10
      monozygotic and 10 dizygotic sets of twins (40 total participants) to enroll.

      The duration of the study for an individual volunteer will be 4 weeks including screening and
      active participation. The study has a total of 3 visits.

      First visit: Procedures during this visit are: Informed consent process, enrollment, study
      assessments, 20 ml blood draw, and vaccination. Participants will be randomized to receive
      either LAIV or IIV.

      The time required to complete the first study visit will be about 30-40 minutes.

      2nd (day 7 post vaccination) and 3rd (day 28 post vaccination ) visit: 20 ml blood will be
      obtained and the visit will take approximately 15 minutes.
    

Intervention name(s): Live attenuated influenza vaccine (LAIV4); Inactivated Influenza Vaccine (IIV4)
Intervention type(s): Biological; Biological
Intervention description(s): LAIV4 vaccine dosage is 0.2 mL. The vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose-divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.; IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection.
Other intervention name(s): FluMist® Quadrivalent; Fluzone® Quadrivalent vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Confocal Endomicroscopy During Endoscopy
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The main objective of this study is to determine the role of epithelial cell homeostasis in
      the pathogenesis of intestinal diseases.

      Background: Alterations in intestinal barrier function may play a significant role in the
      pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The
      intestinal epithelium functions as a barrier to the luminal contents, thereby preventing
      undesirable solutes, micro-organisms and other luminal antigens from entering the body.
      Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may
      contribute to increased intestinal permeability, at least locally. In our study, we want to
      determine the contribution of epithelial cell shedding to intestinal permeability in vivo in
      patients with inflammatory bowel disease compared to controls.

      Scope:

      In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other
      indications).

      Methods:

      We will perform confocal endoscopy during the patient's endoscopic procedure.

      Procedure:

      The patient will receive intravenous fluorescein, followed by confocal imaging of the
      gastrointestinal tissue. The images are captured on the computer. The proposed study will
      provide important insights into epithelial cell shedding as a contributor to altered
      intestinal permeability.
    


Intervention name(s): Confocal endomicroscopy; Confocal endomicroscopy
Intervention type(s): Device; Device
Intervention description(s): Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the control group will be compared to the diseased group.; Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Other intervention name(s): laser confocal endomicroscopy; laser confocal endomicroscopy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing endoscopy: study group are patients evaluated for IBD symptoms and
        control patients for other indications such as colon cancer screening, positive fecal
        occult testing, constipation or diarrhea.
      
Biospecimen description: 
      Biopsy samples
    
Keywords: Crohn's disease; Ulcerative colitis; dysplasia
Exercise for Elderly Peripheral Revascularized Patients
Condition: Peripheral Artery Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional

Summary: 
      The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation
      program will improve claudication distances, free-living daily physical activity, and
      health-related quality of life of older, revascularized patients with peripheral arterial
      disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation
      affects the above functional outcomes are through alterations in walking efficiency,
      peripheral circulation, and cardiopulmonary function.
    

Detailed description: 
      Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have
      improved peripheral circulation following infrainguinal revascularization. Despite this
      hemodynamic benefit, little change in functional status occurs, and many patients have
      residual ambulatory dysfunction. The lack of functional improvement in revascularized
      patients may be due to extreme physical deconditioning secondary to their pre-existing
      critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic
      exercise training is necessary to optimize ambulation, free-living daily physical activity,
      and health-related quality of life through the mechanisms of improved walking economy,
      peripheral circulation, and cardiopulmonary function.

      This is a prospective, randomized controlled clinical trial comparing an exercise group
      undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty
      PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise
      control group (N = 40) following successful lower extremity arterial bypass or angioplasty.
      The 3-month exercise program will consist of graded treadmill walking 3 times per week with
      progressive increments in exercise duration from 15 to 40 minutes, and progressive increments
      in exercise intensity from 50 to 80% of exercise capacity.
    

Intervention name(s): Treadmill exercise
Intervention type(s): Behavioral
Intervention description(s): Graded treadmill walking 3 times per week for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: functional ability; gait; musculoskeletal disorder therapy; peripheral blood vessel disorder
Evaluation of Two Daily Disposable Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate the product performance of SofLens daily
      disposable contact lenses packaged in the investigational Test solution versus SofLens daily
      disposable contact lenses packaged in Control, solution as it relates to comfort when used by
      subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers,
      electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an
      average of 4 hours per day over a week's time for a minimum of 4 days each week.
    


Intervention name(s): Experimental- Soflens; Marketed - Soflens
Intervention type(s): Device; Device
Intervention description(s): A new pair of lenses will be worn each day while the subject is in the study; A new pair of lenses will be worn each day while the subject is in the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: contact lens