bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Many medical interventions, including dressing change of central venous catheters, can cause
      anxiety and pain in children with cancer. The aim of this study is to determine the effect of
      cartoon watching technique on anxiety and pain during central venous catheter dressing
      changes in children with cancer.
    

Detailed description: 
      This was a parallel randomized controlled trial with 80 children with cancer. They were
      randomly assigned to one of two groups, including 40 children in the control group and 40
      children in the cartoon group.

      Each child's anxiety was evaluated by the child using the Children's Fear Scale before,
      during and after central venous catheter dressing changes, and each child's pain during and
      after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale.
      Each child's heart rate and oxygen saturation were measured with a pulse oximeter device
      before, during and after the procedure.

      The children in the cartoon group started watching a cartoon of their choice 2 minutes before
      the procedure and they kept watching until the procedure was ended.

      No intervention was performed to reduce anxiety and pain for children in the control group.

      Parent was with their children during the procedure in both groups.
    

Intervention name(s): Watching Cartoon
Intervention type(s): Behavioral
Intervention description(s): Children in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; Cancer; Cartoon; Central Venous Catheter; Child; Pain
Effectiveness of Exercise Applications on Hepatic Steatosis and Physical Fitness in Patients With NAFLD
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Purpose of the study will investigate the effects of two different training programs on
      hepatic steatosis and physical fitness parameters. This trial is designed in a randomized
      controlled study plan and aerobic training (40 minutes) wil be combined with Whole Body
      Vibration Training (WBVT for 15 minutes) which is made up of a shorter time application. WBVT
      to be applied instead of the resistance exercises.
    


Intervention name(s): Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercise wil be held for 40 minutes. Dynamic exercises will be accompanied by physiotherapist on the vibration platform for 15 minutes. Same excercises will be held stable platform (when the devices turned off) by control group for 15 minutes.
Other intervention name(s): Whole Body Vibration Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aerobic Exercise; Whole Body Vibration Therapy
Everyday Memory Intervention
Condition: Aging
Study type: Interventional

Summary: 
      Evaluates an intervention designed to improve everyday memory function, contrasting people
      receiving the intervention with a group that receives traditional memory strategy training.
    

Detailed description: 
      This project seeks to develop and validate a novel approach to training everyday memory
      functioning in older adults. The approach (1) trains people to use simple but effective
      memory skills that have broad applicability in everyday life and (2) shapes a set of skills
      and habits of mind that will increase the likelihood of effective use of skills and memory
      aids. It is based on a metacognitive perspective on self-regulation in cognitively demanding
      situations and informed by recent theories about how suboptimal habit patterns can be
      altered. The approach has not yet been used in an everyday memory intervention in
      high-functioning, community-dwelling older adults. The proposed research validates ecological
      momentary assessment methods to get actual behavioral measures of forgetting in everyday
      life. It then uses these procedures in a randomized experiment that contrasts the everyday
      memory intervention group with a traditional memory-strategy training group. The hypothesis
      is that the everyday memory training intervention will reduce everyday memory errors and
      memory complaints, whereas the memory strategy training will alter strategy use and memory
      performance, with little cross-over effect. The hypothesized pattern will establish the
      explicit benefits of our everyday memory intervention procedures and demonstrate the
      limitation of standard memory training for that purpose.
    

Intervention name(s): Everyday Metacognitive Memory Intervention; Memory Strategy Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Provides training in use of techniques and procedures to enhance proactive self-regulatory control over everyday memory demands, including strategies for learning information, planning for meeting everyday goals, and monitoring of efficacy of goal pursuit.; Trains use of standard mnemonic techniques such as imagery and sentence generation for learning new associations and organizational and distinctiveness-based strategies for learning sets of items (e.g., word lists).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: everyday memory; ecological momentary assessment; memory complaint; metacognition; mnemonics; external aids
A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3
      medication comparator.
    

Detailed description: 
      The primary objective is to determine the comparative bioavailability and pharmacodynamics
      effects of single and multiple doses of MAT9001 versus an active omega-3 medication
      comparator.
    

Intervention name(s): Drug Omega 3; Drug Omega-3 Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 4 g (4 capsules) once a day, administered with food; 4 g (4 capsules) once a day, administered with food
Other intervention name(s): MAT9001; Active Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effects of zoledronic acid administered at the
      same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone
      mineral density (BMD) gain in the lumbar spine and total hip
    


Intervention name(s): Zoledronic acid; Placebo; Teriparatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid.; Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to allow an infusion of 100 mL total volume in a ready-to-infuse plastic bottle; Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. Each pre-filled delivery device is filled with 3.3 mL to deliver 3 mL.
Each mL contains 250 μg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetate acid, 0.10 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3.0 mg Metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Each cartridge pre-assembled into a pen device delivers 20 μg of teriparatide per dose each day for up to 28 days.
Other intervention name(s): Reclast, Aclasta; Forteo/Forsteo™
Intervention MeSH terms: Zoledronic Acid; Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone Mineral Density (BMD); C-Telopeptides (CTx); dual x-ray absorptiometry (DXA); pro-collagen type 1 N-propeptide (P1NP); teriparatide; zoledronic acid; Osteoporosis; postmenopausal women
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Condition: HIV Infections; Cytopenias
MeSH terms: HIV Infections; Anemia
Study type: Interventional

Summary: 
      To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS
      patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.
      Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.
    


Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Masking: Double
Primary purpose: Treatment
Keywords: Recombinant Proteins; Injections, Subcutaneous; Erythropoietin; Acquired Immunodeficiency Syndrome; Anemia; Zidovudine
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil
      fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus
      standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults
      with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen
      (HBsAg).

      The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks
      + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment,
      participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and
      those meeting TDF retreatment and flare management criteria will be eligible to receive TDF
      monotherapy during a retreatment phase, up to Week 120.
    


Intervention name(s): TDF; Peg-IFN
Intervention type(s): Drug; Drug
Intervention description(s): TDF 300 mg tablets administered orally once daily; Peg-IFN 180 µg administered via subcutaneous injection once weekly
Other intervention name(s): Viread®; Pegasys®
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; Hep B; Non cirrhotic; Tenofovir disoproxil fumarate (TDF); Peginterferon α-2a (Peg-IFN)
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the clinical success of DePuy Spine Titanium
      Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one
      or two levels of degenerative disc disease of the lumbar spine. The observed success rate at
      24 months will be compared to an historical control group treated with the Lumbar I/F Cage
      with VSP System.
    

Detailed description: 
      This is a single arm multi-center study to determine the clinical success of the DePuy Spine
      Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment
      of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).

      Study Success is as a compound endpoint requiring:

        -  Radiographic Fusion,

        -  Improvement in Pain/Function,

        -  Maintenance/Improvement in Neurologic Status, and

        -  Freedom from Secondary Surgical Intervention.

        -  The rate of Adverse Events must be no worse than in the control group as well.

      Secondary Endpoints Include:

        -  Adverse Events

        -  SF-36 Health Related Quality of Life

        -  Disc Space Height

        -  Work Status

      Comparison:

      Results will be compared to an historical control group treated with the Lumbar I/F Cage with
      VSP System.
    

Intervention name(s): Lumbar I/F with cage and pedicle screws
Intervention type(s): Device
Intervention description(s): Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative disc disease at up to 2 levels (L2-S1)
New Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in
      the immune privilege of the hair follicles causing non scarring hair loss.

      Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically,
      dermatoscopically and pathologically as alopecia areata Data were enrolled from department of
      dermatology and venereology, Al-Hussein hospital.
    

Detailed description: 
      For each patient the following will be done :

        1. History taking including ( age, sex, disease duration, family history, history of drug
           intake, smoking and history of any associated disease ).

        2. All patients will give a written, informed consent for induction.

        3. Basic photographs will be taken to assess site, size (by cm), number, Extent of the
           patch using D5300 camera with lens (18-55).

        4. Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month
           apart.

        5. serial photographs and dermoscopic examination every month will be done and patient will
           be score.

        6. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and
           texture of growing hair.

        7. histopathological examination will be done before the first session and one month after
           third session.
    

Intervention name(s): Trichloroacetic acid
Intervention type(s): Drug
Intervention description(s): 5. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alopecia areata AA
The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery
Condition: Aortic Stenosis; Coronary Heart Disease; Heart Failure
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Aortic Valve Stenosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the cardioprotective effects of a short term
      infusion of glucose-insulin-potassium (GIK) during heart surgery.
    

Detailed description: 
      Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a
      wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in
      significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low
      cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of
      glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during
      cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting.
      We will investigate the impact of short term GIK on the extent of myocardial injuries as well
      as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac
      surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery
      and patients with severe aortic stenosis.
    

Intervention name(s): Glucose-insulin-potassium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping; 60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cardiac surgery; Cardioprotection; Aortocoronary bypass graft; Aortic stenosis
A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529
      administered as BMS-663068
    


Intervention name(s): BMS-663068 (1 tablet at 600 mg); BMS-663068 (4 tablets at 150 mg each tablet)
Intervention type(s): Drug; Drug
Intervention description(s): BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified.; BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified.
Intervention MeSH terms: Fostemsavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assisting in Decisions in Emergency Departments: (ED-AID) Study
Condition: Suicide; Emergencies
MeSH terms: Emergencies; Suicide
Study type: Interventional

Summary: 
      This study will test a patient decision aid about safe firearm storage during suicidal
      crisis. The investigators hypothesize that participants with higher quality decisions after
      the decision aid will be more likely to change their firearm storage to reduce access during
      the time of crisis.
    

Detailed description: 
      Limiting access to a firearms during suicidal crisis can save lives. This study will test a
      patient decision aid about safe firearm storage during crisis. The investigators will enroll
      60 adult emergency department patients being evaluated for suicidal risk and have at least
      one firearm at home. If available, the investigators will also enroll a family member or
      friend. Participants will randomly receive one of two things: the decision aid or general
      suicide prevention information. A week later, the investigators will call participants to see
      how both groups choose to store their firearms. This trial tests the acceptability of the
      decision aid, effects on decision making, effect on home storage, effect on suicide outcomes,
      and feasibility of a larger trial. The investigators hypothesize that participants with
      higher quality decisions after the decision aid will be more likely to change their firearm
      storage to reduce access during the time of crisis; should the pilot demonstrate feasibility,
      in a subsequent larger trial this hypothesis would be tested directly.
    

Intervention name(s): Decision Aid
Intervention type(s): Behavioral
Intervention description(s): This intervention is a tablet based Lethal Means Decision Aid with proposed use to augment lethal means counseling in emergency departments for patients at risk of suicide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: firearm; lethal means; decision aid
Diindolylmethane in Preventing Cancer in Healthy Volunteers
Condition: Healthy, no Evidence of Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical trial studies the side effects and best dose of diindolylmethane in
      preventing cancer in healthy volunteers. Diindolylmethane is formed in the stomachs of people
      who eat a chemical that is normally found in vegetables, including cabbage, broccoli,
      Brussels sprouts, cauliflower, and watercress. Diindolylmethane may prevent the development
      of cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine single oral doses of 3,3' di-indolylmethane (DIM) (diindolylmethane) that are
      safe and well- tolerated.

      II. To determine the pharmacokinetics of these single oral doses of DIM.

      OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 2 treatment
      arms.

      ARM I: Participants receive a single dose of diindolylmethane orally (PO) on day 1.

      ARM II: Participants receive a single dose of placebo orally (PO) on day 1.

      After completion of study treatment, participants are followed up on days 2, 3, and 6.
    

Intervention name(s): diindolylmethane; placebo; pharmacological study; laboratory biomarker analysis; quality-of-life assessment
Intervention type(s): Drug; Other; Other; Other; Other
Intervention description(s): Given PO; Given PO; Correlative studies; Correlative studies; Ancillary studies
Other intervention name(s): DIM; PLCB; pharmacological studies; quality of life assessment
Intervention MeSH terms: 3,3'-diindolylmethane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention