bioihbjkbjnl/mcl2 huggingface dataset:
Preemptive Analgesia in Total Knee Arthroplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute Pain is the most common early complication after total knee arthroplasty that caused
      delayed mobilization, demands of morphine, and higher operative cost. There were many
      researches that had been done in analgesia method to find the most effective analgesia,
      lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and
      pregabalin were reported to give a promising outcome.

      In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for
      total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were
      divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour
      before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily
      started from 3 days before operation, and the last group was given placebo. The outcome was
      measured with VAS, knee ROM, and post-operative mobilization
    


Intervention name(s): Celecoxib and Pregabaline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose versus repetition dose; Placebo
Intervention MeSH terms: Celecoxib; Pregabalin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This is an observational study. Forty females with type 1 diabetes (age 18-40) using a
      continuous glucose monitor and an insulin pump will be enrolled for a 3-month data
      collection. Study participants will include free-cycling females and females following oral
      contraceptive therapy. All study appointments may be completed virtually.
    

Detailed description: 
      Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump,
      will be provided a study continuous glucose monitor (CGM) in order to collect 3 full
      menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants
      will include free-cycling females and females following oral contraceptive therapy. Study
      CGMs and activity trackers will be provided for the entire data collection period. During
      data collection, all participants will be asked to record meals consumed and free-cycling
      females will be asked to confirm ovulation by means of study-provided ovulation kits. The
      Clue app will be recommended to study participants to record dates of beginning of menses and
      ovulation (if applicable).
    

Intervention name(s): Continuous Glucose Monitor
Intervention type(s): Device
Intervention description(s): Data collection only
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females between the ages of 18 and 40 with no signs of menopause either free cycling or
        taking a monophasic contraception.
      
Keywords: Menstrual Cycle; Continuous Glucose Monitor (CGM); Oral contraceptives; Free cycling
TENS of MENS for Rotator Cuff Tear
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study was to clarify the effectiveness of physiotherapeutic intervention
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial
      thickness rotator cuff tear.
    

Detailed description: 
      The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a
      secondary feature, leading to further disability.

      The aim of this study was to clarify the effectiveness of physiotherapeutic intervention
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial
      thickness rotator cuff tear.
    

Intervention name(s): MENS; TENS
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Investigation of a Combination Treatment of Escitalopram and rTMS
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      We intend to test in a randomized, rater blinded, placebo controlled, prospective study the
      primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the
      treatment of refractory major depression assessed with the Hamilton Depression Rating Scale
    

Detailed description: 
      We intend to test in a randomized, rater blinded, placebo controlled, prospective study the
      primary hypothesis that an escitalopram-rTMS-combination treatment is more efficacious in the
      treatment of refractory major depression assessed with the Hamilton Depression Rating Scale
      compared to placebo.

      A second hypothesis is that the treatment of MDE with escitalopram (that means in the
      "Placebo group") alone lead to typical changes like

        -  An increase in neurotrophic factors concentration (measured by blood concentrations of
           nerve growth factor (NGF) and brain derived nerve growth factor (BDNF),

        -  An increase in hippocampal metabolites (measured with magnetic resonance spectroscopy
           (MRS

        -  An increase in motor cortical inhibitory activity (measured with motor evoked potentials
           (MEP

        -  An increase in serotonergic activity (measured with EEG parameters, Moreover, it is
           hypothesized that similar but pronounced changes occur in the group treated with the
           combination treatment.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major depressive disorder; Repetitive transcranial magnetic stimulation
Lifestyle Modification for Weight Loss in Schizophrenia
Condition: Obesity; Schizophrenia; Schizoaffective Disorder
MeSH terms: Weight Loss; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to find out how effective lifestyle modification group therapy
      is on reducing body weight when compared to usual care in individuals with schizophrenia
      and/or schizoaffective disorder.
    


Intervention name(s): Nutritional Lifestyle Modification Group; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Manualized group treatment to educate about basic nutritional concepts to help improve eating choices with the goal of losing weight.; Care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Schizophrenia; Schizoaffective disorder; weight loss
Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Obesity
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The effects of a 16-week exercise training program on insulin resistance and adiposity in
      overweight/obese women with Polycystic ovary syndrome (PCOS).
    

Detailed description: 
      Young, overweight/obese women with PCOS along with age and BMI-matched healthy controls
      without PCOS will be enrolled in this study. Participants will have assessments of body
      composition (by DEXA), visceral and ectopic fat (by MR), ovarian parameters (follicle size
      and number, by MRI) insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial
      lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes),
      aerobic fitness (by VO2max test) and a fat biopsy performed across two clinic visits (1
      outpatient visit, and 1 overnight stay). Participants in the control group will undergo these
      assessments once only, whereas participants in the PCOS Group will have these assessments
      twice, once at baseline and once following a 16 week supervised aerobic exercise program.
      Throughout the exercise program body weight will be measured weekly and menstrual cycle
      frequency will be documented on a calendar. Additionally, vital signs, weight, waist and hip
      circumferences will be measured and a fasting blood sample collected every 4 weeks.
    

Intervention name(s): 16-week exercise training program; Control Group without PCOS
Intervention type(s): Other; Other
Intervention description(s): The primary objective of the study is to investigate the effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with PCOS.; A group of overweight/obese women without PCOS will be enrolled as a control group and will be studied only once at baseline to allow for comparisons between the two study populations.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
Condition: Risk Reduction Behavior; Health Behavior; Sexual Behavior; Adolescent Behavior; Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This research is studying behaviors that young people engage in that may place them at risk
      for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational
      program works best to reduce these risky behaviors.
    

Detailed description: 
      During baseline assessment, a computer questionnaire is administered, including questions
      about participants' attitudes, beliefs, and behaviors regarding sexual behavior, condom use,
      and drug use. A saliva sample is provided as well. A "Time-Line Follow-Back" is conducted,
      noting on which days certain activities occurred, such as sexual intercourse, alcohol use,
      marijuana use, and cigarette use. A urine sample is also collected in order to test for the
      STD's chlamydia and gonorrhea (if results are positive, we schedule a meeting with the
      participant to administer medication to treat the STD).

      In the second session, a 3-hour interventional health class is held with groups of
      same-gender participants. There are 3 different health classes (one focusing just on sex risk
      reduction, one focusing on sex and alcohol risk reduction, and one focusing on sex, alcohol,
      and marijuana risk reduction); participants are randomly assigned to one.

      Participants are contacted 3 months after the intervention, 6 months after, 9 months after,
      and 12 months after, in order to meet. These meetings entail completing another Time-Line
      Follow-Back and completing another questionnaire. At the final 12 month meeting, we collect
      another urine sample to again test for chlamydia and gonorrhea. As before, if results are
      positive, we schedule a meeting with the participant to administer medical treatment.
    

Intervention name(s): INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY); SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH); SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion; Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion; Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
Other intervention name(s): INFO-ONLY; (SRRI+ETOH); (SRRI+ETOH+THC)
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have conducted a prospective, double-blind, randomized study to assess the
      comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions
      (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF.
      Results were assessed after follow-up of at least 3 years with the use of an implanted
      monitoring device (IMD).
    


Intervention name(s): Pulmonary vein isolation; Ganglionated plexi ablation; Linear Lesion Ablation
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arrhythmias; Ablation
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months
      after the first dose of the hepatitis B primary vaccination course.

      Subjects were aged 11 to 15 years at the time of the primary vaccination course.

      At the time of enrollment in the present long-term follow-up study subjects were aged 13 to
      18 years.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      All subjects who participated in the primary study, in which they received either 2 or 3
      doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the
      long-term follow-up at Month 42 were contacted by the investigators.

      No additional subjects will be recruited during this long-term follow-up study and no vaccine
      will be administered.
    

Intervention name(s): Engerix™-B (thiomersal-free) 20µg; 10 μg Engerix™-B (preservative-free); placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): In the primary study: 2 deep intramuscular injections (Months 0, & 6); In the primary study: 3 deep intramuscular injections (months 0, 1 & 6); In the primary study: 1 deep intramuscular injection (month 1)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Persistence; Hepatitis B vaccine
Diaphragm Training Post-Cardiac Surgery
Condition: Diaphragmatic Paralysis
MeSH terms: Respiratory Paralysis; Paralysis
Study type: Interventional

Summary: 
      Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery
      of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a
      program of diaphragm muscle training by means of the Threshold variable resistance device
      could improve the rate of complete diaphragm mobility recovery in a shorter time period.
      Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific
      training protocol or to a generic non-training physical activity.
    

Detailed description: 
      Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined
      diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve
      substitution or both.

      Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication
      to home oxygen therapy, neuromuscular diseases.

      Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung
      function tests.
    

Intervention name(s): Threshold; sham threshold
Intervention type(s): Device; Device
Intervention description(s): Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.; non-training physical activity
Other intervention name(s): Threshold IMT, Respironics,Cedar Grove NJ, USA; HS730EU-010
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: diaphragmatic paralysis; cardiac surgery; respiratory muscle training
Intra- And Inter-operator Reliability Of Isometric Back And Abdominal Muscle Strength Testing In Healthy Controls And Persons With Nonspecific Chronic Low Back Pain.
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is currently the most common cause of functional impairment with regard
      to the musculoskeletal system1. LBP occurs in men and women in all age groups and has a peak
      incidence between 30 and 65 years. Although 10% of the persons with LRP can be diagnosed with
      a specific underlying pathology (e.g., disc herniation, canal stenosis, spondylolysis, ...),
      90% have symptoms with an unclear origin. 23% of the latter group will eventually develop
      chronic nonspecific low back pain (CNSLBP)2.

      Exercise therapy is seen as an important component in the rehabilitation of persons with
      CNSPLBP3. Because previous research showed reduced muscle strength of the back muscles4,
      exercise therapy that improves / recovers muscle strength is being investigated. However,
      there is still a lack of clarity concerning the effect that reduced muscle strength has on
      the development and further development of back pain5-6. The objective testing of back muscle
      strength remains a recurring issue. Up to now, back muscle strength has been mainly tested by
      a battery of clinical tests (eg Sorensen test) or the use of "iso machines"7. These Iso
      machines contain a dynamometer that can very specifically reflect the isometric or isokinetic
      force on an axis of rotation. Different types of these iso machines (eg Cybex, Biodex) have
      already been developed, each with specific designs (eg differences in the hip angle,
      differences in the stabilization of the participant). However, to date no standardized
      protocols are available for evaluating both abdominal and back muscle strength. Furthermore,
      it is also essential that before such systems can be used in clinical intervention studies,
      the reliability of such systems is investigated and that reference data from healthy subjects
      are collected with which data from patients can be compared.

      The aim of the current research is therefore to investigate the intra- and inter-operator
      reliability of a standardized protocol drawn up according to the latest scientific evidence.
      A second goal is to set standard values for healthy persons for the developed protocol using
      the Biodex 3 dynamometer system.
    


Intervention name(s): Biodex-assisted isometric strength testing
Intervention type(s): Device
Intervention description(s): The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Treatment of Class II Malocclusion Combined With Low-level Laser
Condition: Malocclusion, Angle Class II
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      This experimental study will evaluate the effect of combined treatment with low-level laser
      and functional appliances (twin-block) on the correction of Class II malocclusion, compared
      with the control group treated with functional appliances (twin-block) only.

      The study sample will consist of 40 patients with Class II malocclusion. The sample will be
      allocated randomly into two groups: a control group and an experimental group.

      Functional appliance (twin-block) will be applied for all patients. Low-level laser will be
      applied for the experimental group only. The skeleto-dental changes occurring after
      functional treatment will be assessed using cephalometric radiographs; pre- and post-
      treatment changes for each group will be evaluated individually.
    

Detailed description: 
      Class II malocclusion is considered as the most common malocclusion between patients.

      Recently low-level laser enters the world of dentistry, some studies assessed the effect of
      low-level laser on the growth of mandibles and condyles in animals and showed that there is a
      good effect of laser on the mandible growth.

      This study will evaluate the effect of low-level laser on the growth of the mandible and the
      duration of functional treatment.

      Twin-block will be applied in two groups: The control group will receive the twin-block only,
      and the experimental group will receive the twin-block combined with low-level laser therapy
      on the TMG region.

      Cephalometric radiographs will be gotten before and after functional treatment to evaluate
      the dento-skeletal changes.
    

Intervention name(s): Twin-block appliance; Low level laser
Intervention type(s): Device; Other
Intervention description(s): Functional treatment will be achieved using the Twin-block appliance; Functional treatment will be combined with low-level laser therapy on the TMG region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low-level laser; functional treatment; twin-block; RCT