bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery
Condition: Laparoscopy
Study type: Interventional

Summary: 
      There have been no studies exploring the efficacy of incision support using an elastic
      abdominal binder after laparoscopy to date. The investigators performed therefore a
      randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use
      on enhanced recovery after surgery (ERAS) in patients with gynecologic disease.
    

Detailed description: 
      An abdominal elastic binder (girdles, trusses, abdominal belts, longuette, etc.) is a wide
      belt that surrounds the abdomen and supports the incision . Abdominal binder is routinely
      used after open surgery and Cesarean section, because it has been reported, according to a
      recent systematic review, to facilitate enhanced recovery after surgery (ERAS) such as pain
      relief, reduced risk of seroma formation, improved respiratory function, and assisted
      physical function using additional support to the lower abdominal musculature.

      However, the routine use of abdominal binder after laparoscopy has been challenged due to a
      potential risk of postoperative pulmonary complications and deep venous thrombosis due to
      increased intra-abdominal pressure. Also, abdominal binders after laparoscopy have been
      criticized for being uncomfortable and hot to wear and for impinging the breast line in
      females. Therefore, some laparoscopists prefer the use of abdominal binder in patients
      undergoing laparoscopy, while other laparoscopists did not. However, there have been no
      studies exploring the efficacy of incision support using an elastic abdominal binder after
      laparoscopy to date. The investigators performed therefore a randomized controlled trial to
      determine the effect of post-laparoscopic abdominal binder use on ERAS in patients with
      gynecologic disease.
    

Intervention name(s): Experimental group; Control group
Intervention type(s): Device; Device
Intervention description(s): In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. The binder was placed on the abdomen across the laparoscopic incision, with the upper border not higher than the lower margin of the rib cage, ensuring minimal restriction of lateral costal expansion and diaphragmatic excursion. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed.; In subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IV Cocaine Abuse: A Laboratory Model - 4
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on
      the physiological and subjective effects of cocaine, including cocaine craving in non-opiate
      dependent cocaine users.
    


Intervention name(s): Pergolide
Intervention type(s): Drug
Intervention MeSH terms: Pergolide
Primary purpose: Treatment
Keywords: cocaine dependence
Insulin on Post Burn Hypermetabolism
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of insulin on helping burn patients
      recover faster from their burns.
    

Detailed description: 
      Severe injuries produce profound hypermetabolic stress responses which cause severe loss of
      lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related
      bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery
      from injury. The results of hypermetabolism persist for weeks to months depending on the
      severity of the insult. Massive burns can cause severe catabolism and are an excellent model
      to study the general effects of injury on protein metabolism. Severe burns are characterized
      by dramatic increases in energy utilization and alterations in the metabolism of
      carbohydrates, fat, and protein.

      Insulin treatment improves net protein synthesis in the severely burned, principally through
      improved muscle protein synthesis. Although controversy exist as to whether insulin is
      effective as an anabolic hormone through increasing protein synthesis or decreasing protein
      breakdown, we believe that consideration of the methods and experimental protocols used in
      the various studies bear consideration when evaluating this topic.
    

Intervention name(s): Insulin; Stable Isotopes; Indocyanine Green
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV insulin; IV administration of stable isotopes; IV administration of ICG
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe burns; Hyperinsulinemia; Insulin; Muscle protein kinetics; Immune function; Exercise
Reducing Prescription Opioid Misuse: ROPEs Pilot Trial
Condition: Knowledge, Attitudes, Practice
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      This is a randomized controlled pilot trial to establish methodological feasibility and
      determine whether a web-based, continuing dental education intervention regarding opioid
      prescribing risk mitigation strategies - consistent with ADA guidelines - produces
      pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of
      risk mitigation strategies when prescribing opioids in dental practice. The current study
      involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or
      attention control intervention, completion of a self-report post-test (immediately following
      intervention/control completion), and completion of 1-month self-report follow-up assessment.
    


Intervention name(s): Responsible Opioid Prescriber Education (ROPES); Active Comparator Control
Intervention type(s): Other; Other
Intervention description(s): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.; An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Reducing Obesity and Type 2 Diabetes in High Risk Youth
Condition: Obesity; Type 2 Diabetes
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills
      training delivered to high school students on BMI, nutrition and physical activity behaviors,
      and self-efficacy over 6 months.
    


Intervention name(s): HEALTH[e]TEEN; HEALTH[e]TEEN + CST
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 lessons over 6-8 weeks; 12 lessons over 6-8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Internet; School based; Obesity Prevention Program; Adolescents
Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug
      interaction between DWC20141 and DWC20142 in healthy adult subjects.
    


Intervention name(s): DWC20141; DWC20142; DWC20141, DWC20142
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and
      chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb
      34714 administration on the steady-state plasma levels of phenytoin.
    


Intervention name(s): Brivaracetam (ucb34714)
Intervention type(s): Drug
Intervention MeSH terms: Brivaracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
A Study in Subjects With Liver Function Injury and Subjects With Normal Liver Function
Condition: Subjects With Liver Function Injury; Normal Liver Function Subject
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the pharmacokinetic differences of the main metabolite 116-N1 of JT001 in subjects
      with mild and moderate liver function impairment and those with normal liver function,
      providing a basis for formulating clinical medication plans for patients with liver function
      impairment;
    

Detailed description: 
      This study adopts a non randomized, open, parallel controlled, single dose experimental
      design and is divided into three experimental groups: mild liver function impairment group
      (Group A), moderate liver function impairment group (Group B), and normal liver function
      subject group (Group C). Subjects in each experimental group took 0.3g of JT001 orally on an
      empty stomach and collected blood samples before and after administration for pharmacokinetic
      analysis.

      After both groups A and B were enrolled, Group C subjects will be enrolled subsequently and
      should be matched with subjects with liver function impairment (Group A and Group B) as
      following:

      The average body weight of Group C is within ± 10 kg of the average body weight of the group
      of subjects with liver function impairment (Groups A and B).

      The average age of Group C is within ± 10 years of the average age of the group of subjects
      with liver function impairment (Groups A and B).

      The number of subjects of each gender in Group C is similar to that in the liver function
      impairment group (A and B groups) (± 1 subject/gender).

      The study is divided into three stages: screening period, baseline period, and experimental
      period.
    

Intervention name(s): Deuremidevir Hydrobromide Tablets
Intervention type(s): Drug
Intervention description(s): JT001 single dose, 0.3g
Other intervention name(s): JT001
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a humanized monoclonal antibody
      (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
    


Intervention name(s): efalizumab
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Intellectual Impairment in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think,
      learn, and remember. Gathering information about a woman's genes, brain function, and
      personal history may help doctors learn more about the disease and plan the best treatment.

      PURPOSE:

        1. To determine changes in brain function that occur following breast cancer chemotherapy.

        2. To gain further understanding of the individual differences in brain function changes
           and recovery based on demographic, medical and treatment variables.
    

Detailed description: 
      This study aims to determine some of the genetic, neurobiologic and demographic factors that
      are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to
      test novel behavioral interventions designed to improve executive function skills following
      BC treatment.
    

Intervention name(s): Cognitive Rehabilitation; Active Neurofeedback Training; Neurofeedback Training (placebo / Sham)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The cognitive rehabilitation procedure will involve a curriculum of game-like cognitive exercises designed to facilitate graded practice of EF skills including attention, processing speed, mental flexibility, planning and logic. The exercises will be delivered to participants via a secure, password protected website created specifically for this study by the PI. Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.; Neurofeedback training is a type of biofeedback during which the subjects will be trained to improve cognitive function by implementing certain cognitive strategies while receiving feedback of their own brain activity. This is done using an infrared spectroscopy (NIRS) system. NIRS measurements will be performed using an ETG-4000 NIRS system (Hitachi Medical, Tokyo, Japan), at two wavelengths of near-infrared light (695 and 830 nm). Each participant will have 2 or 3 sessions, each lasting approximately 30 minutes.; Neurofeedback training: 2-3, 30 min training sessions. For the sham placebo group, fabricated real-time data will be provided to the subject as feedback information hence enabling the subject to view information identical to experimental subjects but without accurate data pertaining to their own brain activation. The technician will be blinded to the subject's treatment condition assignment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pre-chemotherapy participants are randomized between active neurofeedback, and a sham (placebo) neurofeedback.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Quality of life
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
Condition: Cystinuria
MeSH terms: Cystinuria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the minimum effective dose of the cysteine binding
      thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine
      solubility in the urine, in patients with cystinuria to evaluate the effect of escalating
      doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal
      will be to help guide therapy and ultimately minimize unnecessary side effects caused by
      larger dosages.

      Cystinuria is a rare genetic disease that can lead to significant morbidity in affected
      patients due to the recurrent nature of the disease. This study will follow the levels of
      urine cystine capacity in order to help guide treatment and to use lower than usually
      prescribed Tiopronin doses to decrease the potential side effects while maintaining
      therapeutic benefit. This will increase adherence with the medications by decreasing the
      burden of the large number of pills that need to be taken daily.
    


Intervention name(s): Tiopronin
Intervention type(s): Drug
Intervention description(s): Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Condition: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may
      be an effective treatment for patients with advanced cancer who are unable to maintain their
      body weight.

      PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating
      patients with advanced cancer who have significant weight loss.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer
           patients with cachexia.

        -  Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients
           (phase I completed 12/1999).

        -  Determine whether omega-3 fatty acids will result in an antitumor response.

      OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by
      the extent of weight loss (2-5 percent or greater than 5 percent in the past month).

      Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch
      for 4 months or until weight loss is observed.

      Dose is escalated in cohorts of two patients, although dose escalation is allowed in
      individual patients. The maximum tolerated dose (MTD) is defined as the highest dose level at
      which no greater than one-third of the patients treated, including escalated patients from a
      lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).
    

Intervention name(s): omega-3 fatty acid
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Electromyographic Biofeedback on Performance of Vastus Medialis Oblique Muscle in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study intends to determine the Effects of Electromyographic biofeedback on performance
      of vastus medialis oblique muscle in knee osteoarthritis.
    

Detailed description: 
      This is a single blinded randomized controlled trial, will be conducted at Railway General
      Hospital.Rawalpindi.

      (EMG) biofeedback as an adjunct therapy to standard exercise regime for increasing muscle
      strength ,this study is planned to determine the effects of electromyographic biofeedback on
      performance and thickness of vastus medialis oblique muscle, knee pain and on lower extremity
      function in patients with Knee Osteoarthritis. The sample size was calculated to be n=34
      through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%.

      After the completion of therapeutic protocols, the participants will be assessed with the
      help of Numeric Pain Rating Scale (NPRS), WOMAC, Lequesne questionnaire , 1 Repetition
      maximum( RM) and with MSK ultrasound
    

Intervention name(s): Electromyographic Biofeedback; Quadriceps Isometric exercises
Intervention type(s): Device; Other
Intervention description(s): Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength .Electromyographic (EMG) biofeedback is a specific form of biofeedback. The biofeedback device records muscle activity through the application of electrodes superficially or subcutaneously when targeting specific muscles; In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two treatment groups of participants, Experimental group will receive Isometric exercises with EMGBF( Electromyographic Biofeedback ) and control group receive exercises without EMGBF.
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Anthrax Vaccine, GC1109
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective
           in preclinical studies.

        2. OBJECTIVE

           - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy
           male volunteers.

        3. STUDY DESIGN

             -  single-blinded

             -  randomized

             -  placebo controlled

             -  phase 1 study
    


Intervention name(s): Low-dose GC1109; High-dose GC1109; Low-dose Placebo; High-dose Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 50ug/dose; 100ug/dose; 0.9% Saline 0.5 mL; 0.9% Saline 1.0 mL
Other intervention name(s): GC1109 50ug/dose (0.5 ml) vaccination; GC1109 100ug/dose (1.0 ml) vaccination; 0.9% Saline 0.5 mL vaccination; 0.9% Saline 1.0 mL vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: anthrax; vaccine; bioterrorism; efficacy; safety
Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be
      effective in detecting ovarian cancer.

      PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging
      in detecting ovarian cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the effectiveness of folic acid conjugated with indium In 111 to
      diagnose ovarian cancer and locate metastatic disease.

      OUTLINE: This is a diagnostic study. Patients receive an injection of folic acid conjugated
      with indium In 111. The patient then undergoes imaging studies at various time points (e.g.,
      1, 4, and 24 hours). Patients then undergo exploratory surgery, the results of which are then
      compared to the imaging studies.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): radionuclide imaging; indium In 111 folic acid
Intervention type(s): Procedure; Radiation
Intervention MeSH terms: Folic Acid
Primary purpose: Diagnostic
Keywords: stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; ovarian stromal cancer; stage I ovarian germ cell tumor; stage II ovarian germ cell tumor; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; borderline ovarian surface epithelial-stromal tumor; ovarian sarcoma