bioihbjkbjnl/mcl2 huggingface dataset:
Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations
Condition: Healthy Males
Study type: Interventional
Phase: Phase 4

Summary: 
      the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with
      and without water is similar relative to the conventional oral tablet of sildenafil
      administered with water.
    


Intervention name(s): Treatment A; Blood samples for the analysis of sildenafil in plasma; Treatment B; Blood samples for the analysis of sildenafil in plasma; Treatment C; Blood samples for the analysis of sildenafil in plasma
Intervention type(s): Drug; Drug; Drug; Other; Drug; Other
Intervention description(s): Viagra® 100 mg tablet, administered with water single dose; Blood samples for the analysis of sildenafil in plasma; Sildenafil 100 mg CT administered with water single dose; Blood samples for the analysis of sildenafil in plasma; Sildenafil 100 mg CT administered without water single dose; Blood samples for the analysis of sildenafil in plasma
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aimed to verify the mechanical and clinical effects of instrumented massage on
      myofascial trigger points of trapezius muscle in adult subjects.
    

Detailed description: 
      Background: There are several therapies currently used to treat myofascial trigger points,
      including conservative and invasive techniques. It has been shown that conservative
      techniques including therapeutic massage, stretching, transcutaneal electrical nerve
      stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied
      treatments for myofascial pain syndrome, but no single strategy has proved to be universally
      successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back
      pain, and only one study (case report) on myofascial trigger points. This study aimed to
      verify the mechanical and clinical effects of instrumented massage on myofascial trigger
      points of trapezius muscle in adult subjects.

      Methods/Design: The study includes 31 volunteers with myofascial trigger points on right
      trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS,
      algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was
      measured. Subjects were randomly allocated into one of two groups: Instrumented massage or
      Manual massage. The intervention consisted in a single 20 minutes session of massage on the
      back and neck by the same therapist, depending of the group, massage was applied manually or
      instrumented.
    

Intervention name(s): Instrumented massage; Manual massage
Intervention type(s): Procedure; Procedure
Intervention description(s): The first group will receive a 20 min session of instrumented massage on back and neck areas. Subjects will be in prone position and physical therapist will applied instrumental massage in a protocolised way from low back until neck muscles, both in left and right side of the body.; The second group will receive a 20 min session of manual massage on back and neck areas. Subjects will be in prone position and physical therapist will applied manual massage in a protocolised way from low back until neck muscles, both in left and right side of the body.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      To investigates the feasibility, practicability, safety and subjective as well as functional
      outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
    

Detailed description: 
      Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce
      surgical access trauma leading to a more painless surgery and enhancing a fast postoperative
      recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show
      that such NOTES procedures are feasible and safe. And also, lots of experimental studies and
      small case series reporting the feasibility of transanal anterior resection with single
      incision laparoscopic surgery(SILS) port or other devices. However any prospective
      feasibility study demonstrating the safety of the procedure and functional outcomes
      (sphincter function, sexual function, QOF) are missing. This study investigates the
      feasibility, practicability, safety and subjective as well as functional outcome of transanal
      minimal invasive total mesentery excision for rectal cancer.
    

Intervention name(s): conventional laparoscopic total mesentery excision; transanal hybrid-laparoscopic total mesentery excision
Intervention type(s): Procedure; Procedure
Intervention description(s): conventional laparoscopic total mesentery excision; transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
Other intervention name(s): LTME; TLTME
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal cancer; laparoscopic; taTME; TME
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomised study to compare the similarity of a combination
      Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and
      fed conditions in healthy volunteers.
    

Detailed description: 
      A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0
      mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage®
      Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the
      Fasted and Fed States
    

Intervention name(s): Dapagliflozin + Glucophage tablet fasted; Dapagliflozin/metformin IR FDC tablet fasted; Dapagliflozin + Glucophage tablet fed; Dapagliflozin/metformin IR FDC tablet fed
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state; single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state; Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state; single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; cross-over study; Bioavailability; Bioequivalence; Cmax; tmax; AUC; AUC(0-t); λz; tlast
Effects of Sensory Motor Training on Balance and Proprioception Among Post-Menopausal Obese Women
Condition: Post Menopaused Female
Study type: Interventional

Summary: 
      Postmenopausal obese women often have difficulties with balance and proprioception.
      Sensorimotor training is an important part of physical therapy interventions, with emerging
      evidence that it could be beneficial for postmenopausal obese women.

      Objective: To find the impact of sensorimotor training on balance and proprioception among
      postmenopausal obese women.
    

Detailed description: 
      Randomized clinical trial was conducted on postmenopausal obese women population with
      impaired balance and proprioception on inclusion & exclusion criteria, sample size of 40,
      ages ranged from 45 to 65 years included. Group A received SMT and Group B received CT. The
      interval of treatment was 6 weeks. Data is collected from THQ Samundri. FRT, TUG, OLS
      utilized to assess the pre-and post-estimations of postural strength.
    

Intervention name(s): Sensorimotor training exercises; Without Sensorimotor training exercises
Intervention type(s): Other; Other
Intervention description(s): Sensorimotor training exercises include wall slides , core exercises (Planks, leg raises, crunches, bridging) balance exercises (single leg side lift, leg lift with dumble, balance on stability ball) on unstable surface for 50-60 min (3 sets of 10 rep) of exercises and gait training (different patterns of walking; Cut back on high-fat foods. Drink plenty of water Use sugar and salt in moderation. Eat fruits and vegetables Get enough calcium Pump up your iron. Get enough fiber
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postmenopausal, Obese, Balance, Proprioception
e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects
      will continue with their prescribed medications. Our main objective is to assess whether
      preventive e-counseling (provided through a website of the Heart and Stroke Foundation)
      improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will
      also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and
      adherence to prescribed medications. Finally, we will quantify the amount of e-counseling
      support that is required during REACH to evoke a significant reduction in blood pressure. It
      is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and
      lifestyle behaviours at the 12-month assessment. The findings of this trial will provide
      information that is critical to our understanding of how internet-based programs can help to
      improve blood pressure and to reduce the risk for cardiovascular disease.
    


Intervention name(s): e-Counseling plus Usual Care; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12. Each email will contain an e-link to lifestyle counseling activities designed to enhance motivation and skill to initiate and maintain lifestyle change. e-Counseling includes video-based education and counseling as well as e-tools to self-monitor and reinforce adherence to self-management behavior for exercise, diet, prescribed medications and smoke-free living.; The control group will receive general educational material on heart healthy living. 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Urinary Incontinence and Practice of Physical Exercises
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      Introduction: Urinary incontinence is often seen as a problem that affects multipara and
      old-aged women, however, there is evidence that during high impact physical activity, mainly,
      or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is
      common, even among young women, physically active, and without known risk factors.

      Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women
      who regularly practice physical activities.

      Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years
      old) who exercise regularly. They were divided into 3 groups according to the regular
      practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included
      jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were
      questioned about the perception of leakage of urine during the practice of exercises. The
      established exclusion criterion included: surgeries of urinary tract, urinary infections,
      gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form
      of physical activity.
    

Detailed description: 
      The assessment was carried out in academies of the city of Franca. All participants were
      questioned about the perception of loss of urine during the practice of exercises.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old)
        who exercise regularly. They were divided into 3 groups according to the regular practice
        of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included jump,
        step and dancing classes, and (G3) swimming. All participants were questioned about the
        perception of leakage of urine during the practice of exercises.
      
Keywords: urinary incontinence; physical exercise
Knee Muscle Force Recovery After Minimally Invasive Surgery (MIS) Total Knee Replacement (TKR)
Condition: Total Knee Replacement Approach; Muscle Torque
Study type: Observational

Summary: 
      To compare muscle torque recovery between patients under subvastus approach and those under
      midvastus approach after total knee replacement
    

Detailed description: 
      Total knee Arthroplasty is a common operated surgery in each hospitals, and a lots of
      patients benefit from this surgery. Traditionally the frequently used surgical approach is
      parapatellar approach. However, recently the subvastus and midvastus approach has gained a
      world-wide population. These two methods had less damage to the quadriceps tendon and
      theoretically should have better post-operative muscle power recovery, less lateral
      retinaculum release because of better patellar tracking. The only differences between these
      two approaches are that the midvastus approach will split the vastus medialis muscle and
      denervation may occur. In this study we will use HSS or KSS functional score and Cybex
      dynamometer to evaluate the functional recovery, and use Merchant's view radiography to
      evaluate the result of patellar tracking. The follow-up period will not be limited and we
      will use mixed-model statistic's random effect to gain the natural history of muscle power
      recovery, which will become the base of other study. We can also compare the difference of
      results between PS type and CR type and different surgical approach. The natural history of
      the knee score will also be obtained.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after total knee replacement without severe systemic disorders
      
Keywords: Total knee replacement; Subvastus; Midvastus; Isokinetic; Quadriceps
Effect of Countermeasures on Nocturnal Driving Performance
Condition: Sleepiness
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because
      of conflicts between physiological needs and social or professional activities, it is
      necessary to develop affordable countermeasure to sleepiness. In real-life driving studies,
      nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect
      of caffeine is quick but brief and varies between individuals. There is a need for more
      knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic
      light (blue light) decreases subjective sleepiness and improves performances. One objective
      of this project is to investigate whether blue light exposure during driving would be useful
      in a real driving situation when sleepiness becomes acute. Owing to the fact that our
      knowledge of the effects of exercise on driving is very sparse and to the absolutely need to
      standardize the bouts of exercise that will be applied to the subjects. One objective of the
      present study will be to investigate in a simulator study the effects of a bout of moderate
      exercise on participants driving ability when sleepiness becomes acute. Nocturnal
      neurobehavioral performance varies widely between individuals and only certain subjects seem
      significantly affected by sleep loss. It is of interest to find biological markers for sleep
      drive to identify vulnerable drivers to sleep deprivation or to identify responders to
      sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to
      determine individual differences (genetic, hormonal and cognitive) in the impairment of
      driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and
      coffee).
    


Intervention name(s): Real driving situation; Driving simulator
Intervention type(s): Other; Other
Intervention description(s): Continuous blue light exposure during driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time real driving situation. Inside this arm, each volunteer will be randomly allocated and will all receive : continuous blue light exposure, coffee and coffee placebo at each driving session with at least 1 week between each condition.; 15 minutes of physical activity at a low intensity before driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time driving simulator. Inside this arm, each volunteer will be randomly allocated and will all receive : 15 minutes of physical activity, coffee and coffee placebo at each driving session with at least 1 week between each condition.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sleepiness; driving; countermeasures; coffee; blue light exposure; physical activity
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Condition: Dementia, Alzheimer Type
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to compare the efficacy of aripiprazole with placebo in
      patients with psychosis associated with Alzheimer's dementia.
    

Detailed description: 
      Open label Extension Phase: The 130-week Extension Phase was conducted to provide information
      regarding long-term safety and efficacy of aripiprazole in participants who were diagnosed at
      the onset of the Acute Phase with psychotic symptoms associated with dementia of the
      Alzheimer's type who responded to treatment in the 10-week Acute Phase of this study.

      Treatment beyond 140 week: A country-specific amendment for France, allowed participants
      treated with aripiprazole who, according to the investigator's opinion, showed improvement at
      the Week 140 visit to continue treatment beyond 140 weeks. The termination was to be
      determined by clinical benefit to he participant.

      Study design:

      Acute Phase: Randomized, double-blind, placebo-controlled, flexible-dose, parallel-group
      study.

      Extension Phase: Open label; flexible-dose.
    

Intervention name(s): Aripiprazole (BMS-337039); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks
Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks; Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neurodevelopmental Disorders in Youth With Criminal Behaviors
Condition: Attention Deficit Disorder With Hyperactivity; Autistic Spectrum Disorder; Conduct Disorders in Adolescence
MeSH terms: Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Conduct Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      1. Describe the prevalence of neurodevelopmental disorders among youth with criminal
           behaviors

        2. Explore the relationship between specific neurodevelopmental disorders and the rates and
           types of crime

        3. Examine the roles of psychiatric comorbidities and sociodemographic factors in juvenile
           criminality
    


Intervention name(s): collect data
Intervention type(s): Other
Intervention description(s): The Juvenile Affairs Division provided the records without person-identifiable data (i.e., name, ID) to the researchers. The researchers coded the above data (i.e., the offenders' sociodemographic data, medical history, and criminal history).
Demographic characteristics were collected, which are the offenders' age, gender, occupation, education level, and residence (district). We recorded the offenders' household members (without the name or age), main caregivers (e.g., father, or mother), and the parents' socioeconomic and marital status. We also tracked whether the offenders live with family members with mental illness, whether they are from at-risk families, and whether had been victims of domestic violence. The medical history and deviant (or criminal) behaviors will be collected in the attached measure.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study is based on the counseling registry of the Juvenile Affairs
        Division of Taipei City Police Department. The dataset encompasses around 1000 juvenile
        offenders who were actively followed up by the counselors of the division. The records
        include the offenders' sociodemographic data, medical history, and criminal history without
        person-identifiable data (i.e., name, ID).
      
Keywords: neurodevelopmental disorder; criminality; adolescence