bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
Condition: Menorrhagia; Pelvic Pain; Hysterectomy
MeSH terms: Menorrhagia; Pelvic Pain
Study type: Interventional

Summary: 
      Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic
      surgery with little direct evidence that it is if not better than traditional laparoscopic
      surgery, at least equivalent. We designed a randomized-controlled trial to compare operative
      times, length of hospital stay, estimated blood loss, and post-operative complications
      associated with these two methods of minimally invasive hysterectomy.
    

Detailed description: 
      The proposed study will be a non-blinded randomized control trial. Patients will be
      randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and
      Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data
      collection will occur during the following points of patient interaction: pre-operative
      appointment, the surgical procedure, the patient's hospitalization, first post-operative
      appointment, and final post-operative appointment.

      The care for the patients enrolled in this study will not deviate from the standard care of
      patients who are currently undergoing laparoscopic and robot-assisted laparoscopic
      hysterectomy. The patients who present to the office for pre-operative history and physical
      examination for laparoscopic hysterectomy will be counseled about participation in this
      study. Basic data collection will commence at the pre-operative visiting, including: patient
      demographics, past medical history, past surgical history, physical exam findings, and
      imaging results. The pre-operative appointment will occur between one to thirty days prior to
      surgery. Intra-operative and immediate post-operative data will be collected by the surgical
      assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic
      or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and
      complications.
    

Intervention name(s): Hysterectomy
Intervention type(s): Procedure
Intervention description(s): Hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hysterectomy; Robot-assisted; Laparoscopy
Assessing Online Interventions for Men's' Mental Health and Wellbeing
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The purpose of this study is to test a comprehensive, male-oriented, online screening and
      referral (Screening for Mental Health; SMH) and male-oriented online information and referral
      intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on
      prevention of suicide and help-seeking behaviors among middle-aged men. The online programs
      will be offered together to maximize the effect on reducing suicide behavior and increasing
      mental health help-seeking behaviors for men. If successful in decreasing suicide behavior
      and ideation and increasing suicide help-seeking behavior, this intervention could be scaled
      up to contribute to a reduction in suicide behaviors and deaths across the country.
    


Intervention name(s): Screening for Mental Health only; Screening for Mental Health & Man Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.; Participants assigned to Screening for Mental Health, plus Man Therapy (SMH+MT) group will be offered the Man Therapy program in conjunction with Screening for Mental Health. MT provides online early intervention services designed specifically for men who are at risk for suicide and are less likely to engage in help-seeking behavior. MT takes an innovative and humorous approach to mental health education and help seeking through a fictional "therapist" named Dr. Rich Mahogany, who is a no-nonsense "man's man" who informs men about the importance of honest talk about life's challenges in addressing their problems. The web portal allows review "manly mental health information, facts and tips," explore "man therapies," and view videos of men with lived experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Suicide prevention; men's mental health; depression; suicide ideation and behaviors
The PREVAIL Study
Condition: In-stent Restenosis; Ischemic Heart Disease; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases
Study type: Interventional

Summary: 
      To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon
      Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis
      with coronary lesions previously treated with drug-eluting or bare metal stents in native
      coronary arteries.
    

Detailed description: 
      This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50
      subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the
      coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated
      Balloon Catheter.

      Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for
      percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm
      to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.

      Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes
      and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
    

Intervention name(s): Medtronic Coronary Drug-Coated Balloon Catheter
Intervention type(s): Device
Intervention description(s): Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to quantify postoperative pain after functional endoscopic sinus
      surgery (FESS) and investigate whether preemptive analgesia may positively impact
      intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and
      improve patient functional outcomes.
    

Detailed description: 
      The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain
      and headache of various etiologies and has been widely used during functional endoscopic
      sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB
      may positively impact postoperative pain and functional outcomes after FESS.

      A prospective, double-blind randomized placebo-controlled study was performed. 60 patients
      (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to
      receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment
      group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before
      the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain
      scale, SNOT-20, CT & Endoscopic scores were compared between the two groups.
    

Intervention name(s): Bupivacaine Block; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine local anesthesia block prior to start of FESS procedure.; placebo is identical in appearance in comparison to active drug.
Other intervention name(s): Local Block; Placebo saline injection
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study
Condition: Ischemic Heart Disease; Cardiomyopathy; Heart Failure; Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Heart Failure; Heart Diseases; Cardiomyopathies; Myocardial Ischemia; Coronary Artery Disease; Endocrine System Diseases
Study type: Observational

Summary: 
      Aim of this study is to define the possible detrimental effect of a lack of growth hormone,
      on the well-being and life expectation of patients affected by heart failure.
    

Detailed description: 
      Growth hormone and its main effector IGF-1 have well-documented roles in the regulation of
      cardiac and circulatory function. Evidence suggests that GH/IGF-1 exert a beneficial effect
      on cardiac load, cardiac growth and remodeling, despite their hypertrophying action. Several
      studies in the last years have demonstrated worse cardiovascular outcomes in adult patients
      with GH deficiency and/or low levels of IGF-1.

      A wide range of alterations in the GH/IGF-1 axis have been described to date in patients with
      chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of
      peripheral resistance to GH, in particular in patients with severe heart failure and cardiac
      cachexia. Our study hypothesis is that an actual status of GH deficiency coexists with CHF in
      a large percent of patients, and that it may represent a predictor of worse functional status
      and possibly of a worse prognosis. Aim of this study is to explore the latter hypothesis,
      comparing the clinical and functional evolution of patients with CHF and GHD with that of a
      general CHF population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic heart failure due to left ventricular systolic dysfunction
      
Biospecimen description: 
      Sera of the patients at time-points upon recruitment and after 12 months
    
Keywords: heart; failure; growth; hormone; igf; dilative; cardiomyopathy
Effect of Tai Chi on Functional Fitness of Elderly Patients With Degenerative Arthritis
Condition: Exercise Training
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Degenerative arthritis is a common disease in the elderly , in recent years, there are young
      trends, the symptoms often cause great pain in the elderly, associated with lower physical
      exercise caused by decreased muscle mass, functional fitness performance Is also poor,
      affecting the ability of elderly people to live independently. Therefore, this study mainly
      explores whether the intervention of tai chi can improve the functional fitness of the
      elderly and reduce the pain index of the elderly. The study was designed to take the sample,
      which was divided into experimental group and control group. It was expected to receive 100
      people. The subjects were asked to use the basic information, Karnofsky scale, The functional
      fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research
      tools. The SPSS system was used to analyze whether the functional fitness index and the pain
      index were significantly different before and after exercise intervention. Whether the
      exercise intervention has an effect on the elderly.
    

Detailed description: 
      Degenerative arthritis is a common disease in the elderly , in recent years, there are young
      trends, the symptoms often cause great pain in the elderly, associated with lower physical
      exercise caused by decreased muscle mass, functional fitness performance Is also poor,
      affecting the ability of elderly people to live independently. Therefore, this study mainly
      explores whether the intervention of tai chi can improve the functional fitness of the
      elderly and reduce the pain index of the elderly. The study was designed to take the sample,
      which was divided into experimental group and control group. It was expected to receive 100
      people. The subjects were asked to use the basic information, Karnofsky scale, The functional
      fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research
      tools. The SPSS system was used to analyze whether the functional fitness index and the pain
      index were significantly different before and after exercise intervention. Whether the
      exercise intervention has an effect on the elderly.
    

Intervention name(s): tai chi
Intervention type(s): Behavioral
Intervention description(s): tai chi exercise intervention，two times a week and each time cost one hour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effects of Physical Activity on Cardiovascular Risk Markers in School-Aged Mexican Children
Condition: Obesity; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Childhood obesity is a public health problem; in Mexican children a high prevalence of
      cardiovascular risk factors are present. Physical activity has been proposed as a strategy to
      reduce this risk. We conducted a pre-posttest intervention study of 214 school-aged Mexican
      children (4th to 6th grade), to assess the effects of two physical activity routines with
      different duration and intensity (40 minute aerobic routine vs. 20 minute routine) on
      cardiovascular risk markers. Physical activity routines were assigned randomly to two public
      schools in Toluca, Mexico (20 min: group 1 (n= 117), 40 min: group 2 (n=97)). The routines
      were implemented Monday through Friday for 12 weeks. Nutrition assessment was done before and
      after the intervention and included anthropometric measurements (weight, height, body mass
      index, waist circumference and body composition), blood pressure and biochemical analysis
      (triglycerides, total cholesterol LDL-cholesterol, HDL-Cholesterol, glucose and insulin).
      Heart rate was monitored 3 times during the intervention to evaluate the routine´s intensity.
    


Intervention name(s): physical activity
Intervention type(s): Other
Intervention description(s): physical activity routines 5 times a weeks for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: school-aged; children; obesity; cardiovascular risk; physical activity
Discrete(TM) Safety Clinical Trial GLAD-01
Condition: Safety and Tolerability in Healthy Volunteers
Study type: Interventional

Summary: 
      This study will assess the safety and tolerability of a new liquid anti-adhesion device,
      Discrete(TM), in healthy volunteers, in order to determine the best volume of Discrete(TM) to
      go forward into clinical efficacy research.

      The clinical trial will progress in accordance with first-in-human study guidance from the
      United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA).

      It will be conducted as a randomized, controlled, double-blinded, single ascending volume,
      single-center, interventional safety trial. Participants will remain blinded to treatment
      until end of clinical trial. A maximum of 7 cohorts will be studied to assess maximum
      tolerated volume of investigational medical device compared with Control Lactated Ringer's
      solution (LRS) administered intraperitoneally. The trial will commence with a low volume and
      progress in a sequential, stepwise volume-escalating schema until defined maximum tolerated
      volume criteria are met. Following determination of the maximum tolerated volume, it is
      anticipated that up to 2 additional cohorts will be enrolled, wherein all participants will
      also receive a single standard dose of a commonly used anticoagulant as used in surgeries.

      A maximum of 81 participants will be enrolled. Eligible and consented adult men and women
      will be sequentially enrolled within each cohort at a ratio of 6 participants on Discrete(TM)
      to 3 participants on Control LRS. Participants will be followed for up to 10 days after
      intraperitoneal application.

      An independent Data and Safety Monitoring Committee will closely review safety in the
      clinical trial.
    


Intervention name(s): Discrete(TM); Control Lactated Ringer's Solution (Control LRS)
Intervention type(s): Device; Other
Intervention description(s): A designated volume of Discrete(TM) (according to cohort) is applied intraperitoneally; A designated volume of LRS (according to cohort and equivalent to volume of Discrete(TM)) is applied intraperitoneally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerated dose (MTD), safety,
      pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when
      administered orally twice daily to patients with advanced solid tumors.
    

Detailed description: 
      Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of
      E7050 given orally, twice-daily, in patients with advanced tumors that have progressed
      following effective therapy.
    

Intervention name(s): E7050
Intervention type(s): Drug
Intervention description(s): The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Gastrointestinal Cancer
Study Assessing the Efficacy of Eductyl® for the Treatment of Patients With Dyschesia
Condition: Dyschesia
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment
      of patients with dyschesia.
    


Intervention name(s): Eductyl suppository; Placebo suppository
Intervention type(s): Drug; Drug
Intervention description(s): One suppository every morning during 21 days; One suppository every morning during 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyschesia treatment; Inconfort related to dyschesia; Quality of life; Bowel function index
Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
Condition: Overweight/Obese Adults
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a open and multiple dose escalation phase I clinical study, aiming to evaluate
      the pharmacokinetic characteristics and safety of Benaglutide Injection in overweight/obese
      adults after multiple subcutaneous injections.

      This study will enroll 16 overweight/obese adults, both male and female. The trial was
      divided into two batches, including 4 subjects who completed all dosing, safety assessment
      and telephone follow-up, and the remaining 12 subjects who were enrolled for the trial. All
      subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence,
      followed by the next dose after completing the previous multiple dosing. The administration
      time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg
      for 5 days.

      Subjects will be screened at D-14-D-2, and eligible subjects D-2 will be admitted to the
      phase I clinical trial ward at D-2. D-1 Blank blood samples were collected at different time
      points before and after breakfast for PK test baseline correction. D1 began by subcutaneously
      injecting different doses of benaglutide injection 5 minutes before the daily three meals,
      collecting biological samples at different time points after the first administration of D6,
      D7, D11, D12 and D16 to evaluate the pharmacokinetic characteristics of Benaglutide. Subjects
      will be discharged after all samples are collected and safety assessed at D17. Telephone
      follow-up was performed on the 7th day after discharge (D24±2) to further observe safety.
    


Intervention name(s): Benaglutide Injection
Intervention type(s): Drug
Intervention description(s): All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Central Executive Training for ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Feasibility study of Central Executive Training (CET) for ADHD. The goal of the current
      project is to develop and assess the feasibility, acceptability, engagement, and usability of
      a novel, central executive (CE) working memory training intervention.
    

Detailed description: 
      The goal of the core study is to develop a central executive training (CET) intervention for
      children with attention-deficit/hyperactivity disorder (ADHD) and examine its feasibility,
      acceptability, engagement, and usability. This will involve early developmental work on
      software and treatment manuals followed by evaluation of the feasibility of enrolling,
      retaining, and treating ADHD children with CET. An evidence-informed intervention targeting
      central executive functioning in children with ADHD has the potential to result in clinically
      significant improvements in ADHD symptoms relative to extant behavioral treatments and
      capacity-based (short-term memory) training interventions. The long-term goal is to develop
      an efficacious and acceptable CET intervention with the potential for generalized
      improvements in, or normalization of, ADHD-related impairments in peer, family, and academic
      functioning.
    

Intervention name(s): CET: Central Executive Training; CET: Comparison Executive Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CET: Central Executive Training; CET: Comparison Executive Training
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment