bioihbjkbjnl/mcl2 huggingface dataset:
Manual Therapy Effectiveness in Comparison With Electric Nerve Stimulation (TENS) in Patients With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study investigated effectiveness of manual therapy (MT) with Electric Nerve Stimulation
      (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized
      multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units
      in Madrid Region.
    

Detailed description: 
      The purpose of tis study is to evaluate the effectiveness of manual therapy (MT) with
      Electric Nerve Stimulation (TENS) to reduce pain intensity in patients with mechanical neck
      disorder (MND). Design: randomized multi-centered controlled clinical trial. Location: 12
      Primary Care Physiotherapy Units in Madrid Region. Ninety patients were included with
      diagnoses of subacute or chronic MND without neurological damage, 47 patients received MT and
      43 TENS. The primary outcome was pain intensity measured in millimeters using the Visual
      Analogue Scale. Also disability, quality of life, adverse effects and sociodemographic and
      prognosis variables were measured. Three evaluations were performed (before, when the
      procedure finished and six months after). Seventy one patients (79%) completed the follow-up
      measurement at six months. In more than half of the treated patients the procedure had a
      clinically relevant "short term" result after having ended the intervention, when either MT
      or TENS was used. The success rate decreased to one third of the patients 6 months after the
      intervention. No differences can be found in the reduction of pain, in the decrease of
      disability nor in the quality of life between both therapies. Both analyzed physiotherapy
      techniques produce a short term pain reduction that is clinically relevant.
    

Intervention name(s): Manual therapy (MT); TENS
Intervention type(s): Other; Other
Intervention description(s): Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. MT techniques: neuromuscular technique, postisometric stretching, spray and stretching and Jones technique.; Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. TENS electrode placement were: in the painful area, in the metamere or in the nerve´s pathway. It was applied at a frequency of 80 Hz, with ≤150 µs pulse duration and adjusted amplitude.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neck pain; Primary Health Care; Manual Therapy; TENS
A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of
      ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old,
      inclusive (up to 11 years 364 days) with pain due to injury or nonmalignant disease, to the
      PK in adults, with respect to the PK parameter AUC∞ (area under the curve) of racemic
      tramadol. PK explores how the drug is absorbed in the body, distributed within the body, and
      how it is removed from the body over time.
    

Detailed description: 
      This is a multicenter, open-label (all people know the identity of the intervention),
      2-group, single dose study. Within each group of participants for Parts 1 and 2, at least 1/3
      of the participants will be female, at least 1/3 of the participants will be male, at least
      1/3 of the participants will be below the age of 8 years, and at least 1/3 of the
      participants will be above the age of 10 years. Participants will be assigned to 1 group
      only. Each group of participants will receive a single oral dose of ULTRAM ER on 1 occasion.
      Group 1 will receive a dose of ULTRAM ER that is closest to 2 mg/kg, based on the
      participant's body weight and adjusting the dose in 25 mg increments. Following completion of
      all evaluations of Group 1, the pharmacokinetic data will be evaluated to target a dose for
      Group 2 that will achieve a level of exposure similar to that seen with a single 200 mg
      ULTRAM ER dose in adults. The maximum dose of ULTRAM ER should not exceed 6 mg/kg or 300 mg.
      When the study physician, the investigators, and the medical monitors agree that the PK of
      the drug is well-characterized and that the drug is well tolerated, enrollment will begin for
      Group 2 of the study. The sponsor's responsible Medical Officer will evaluate the safety of
      the calculated dose in Group 2 participants by evaluation of adverse drug events paying
      particular attention to events suggestive of either opioid toxicity or serotonin toxicity.
    

Intervention name(s): ULTRAM ER; ULTRAM ER
Intervention type(s): Drug; Drug
Intervention description(s): One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.; The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.
Intervention MeSH terms: Tramadol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; ULTRAM ER; Tramadol hydrochloride; Children
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on
      diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension.

      Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood
      pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood
      pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral
      regimen of 4 doses of ACT-132577.
    

Detailed description: 
      Participation in the study is planned to last up to 18 weeks. A single-blind placebo run-in
      period of 4 to 6 weeks after which participants will be randomized into a double-blind
      treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study
      visit approximately 12 weeks after randomization.
    

Intervention name(s): Aprocitentan 5 mg; Aprocitentan 10 mg; Aprocitentan 25 mg; Aprocitentan 50 mg; Lisinopril 20 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.; Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.; One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.; One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.; One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan; One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
Other intervention name(s): ACT-132577; ACT-132577; ACT-132577; ACT-132577
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparing Oxygen Saturation in Post Anesthesia Care Unit After Different Methods of Pain Relief
Condition: Cryptorchidism
MeSH terms: Cryptorchidism
Study type: Observational

Summary: 
      To determine the which method of pain relief is better after current anesthesia care.
    

Detailed description: 
      We hypothesized that in children, the current anesthesia care (combined light general
      anesthesia and caudal analgesia) may decrease incidence of intra and or postoperative
      de-saturation( SaO2 < %95), the need of oxygen during child's transport to the PACU and
      during his stay in the recovery room, compared with children who receive intravenous
      narcotics for intra and postoperative pain relief.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children scheduled for elective uni or bilateral orchidopexy.
      
Keywords: Caudal Block; Oxygen Saturation; Uni or Bilateral Orchidopexy
Plasma Neurofilament Light and Its Relationship With Omega-3 Status and Soccer Heading in Women Soccer Players
Condition: Brain Trauma
MeSH terms: Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to (1) assess how a competitive season of purposeful gameplay
      soccer heading in collegiate women soccer players is related to a blood biomarker for
      sports-related brain injury, plasma neurofilament light (NF-L), and (2) examine how a
      player's omega-3 status is related to plasma NF-L concentration changes during and after a
      competitive season of gameplay soccer heading.
    


Intervention name(s): Plasma Neurofilament Light (NF-L); Omega-3 Index; HeadCount Questionnaire
Intervention type(s): Other; Other; Other
Intervention description(s): Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.; Omega-3 Index is the omega-3 fatty acid content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) within the erythrocyte cell membrane. It is expressed as EPA+DHA as a percent of total identified fatty acids.; HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Collegiate women soccer players who actively compete at the NCAA Division 1-A competition
        level.
      
Biospecimen description: 
      Plasma
    
Keywords: Soccer, Heading, Omega-3, Neurofilament Light, Subconcussive, Women
Transversus Abdominis Plane (TAP) Block in Laparoscopic Gastric-bypass Surgery
Condition: Gastric-bypass Surgery; Opioid Consumption; Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      Laparoscopic gastric-bypass surgery (LGBS) is one of the surgical treatments for morbid
      obesity, which is performed under general anesthesia. TAP block is an analgesic strategy
      covering the dermatomes from T6 to L1 and consists of injecting local anesthetic in the TAP
      between the costal margin and the iliac crest, where the thoracolumbar nerves (T6-L1) are
      located. As far as the investigators know, this analgesic technique has never been studied in
      LGBS. The investigators objective is to determine whether an ultrasound (US)-guided TAP block
      provides improved analgesia during the first 24 hours after laparoscopic gastric-bypass
      surgery, compared to conventional therapy only.
    


Intervention name(s): TAP-Block; Conventional Managment
Intervention type(s): Procedure; Other
Intervention description(s): Block needle will be inserted out-of-plane to the ultrasound beam, perpendicular to the skin surface, until the tip lies deep between the fascia of the transversus abdominis muscle and the internal oblique muscle. 30 ml of the study solution in each side will be injected at this location and should be observed to spread in an anterior-posterior direction between two muscles. Each patient will receive a total dose of 60 ml of 0.25% bupivacaine (150 mg) + 1:200,000 epinephrine.; For these group.no TAP block administration. just conventional management for post operative pain.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Laparoscopic gastric-bypass surgery; TAP block
Do Young Triathletes Have a Greater Predisposition to Suffer Running Injuries
Condition: Gait Retraining; Kinematics
MeSH terms: Disease Susceptibility
Study type: Interventional

Summary: 
      In running 70% of the lower limb, injuries are produced in the running segment. The vast
      majority of sports-related musculoskeletal injuries in young athletes are caused by overuse.
      Previous research has shown a clear association between running-related injuries and
      kinematic patterns, showing the existence of a causal relationship between biomechanical
      alterations and injures.

      According to the evidence, that real-time visual and auditory feedback based on gait
      retraining should be considered to treat injured runners or prevent injuries. However, no
      previous studies have been carried out on whether gait retraining decreases running-related
      injuries incidence in young triathletes.

      The investigators propose a study to determine the effect of gait retraining on the decrease
      in the number of running-related injuries and improve the running efficiency in young
      triathletes.
    


Intervention name(s): Gait retraining
Intervention type(s): Other
Intervention description(s): 5 gait retraining sessions of continuous feedback in real time during running sessions; using videotape feedback, a digital metronome to increase step rate, and verbal feedback to reduce the tendency to heel strike upon ground contact. Verbal feedback is offered during the 25- to 30-minute running sessions following a series of drills aimed at improving running mechanics.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gait Analysis; Triathlon; Running; Gait Retraining
A Study in Patients With Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the safety, tolerability and activity of SXC-2023
      when dosed for 6 weeks versus placebo in adult patients with moderate to severe
      Trichotillomania.
    

Detailed description: 
      This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study
      consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment
      period, followed by an up to 2 week safety follow-up period after the last dose of study
      medication.

      Patients will be randomized to one of four treatment groups. Patients will participate for a
      total of up to 10 weeks, including screening, the 6-week treatment period and follow-up.
    

Intervention name(s): SXC-2023; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SXC-2023 oral capsules; Matching Placebo oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Promentis Pharmaceuticals; TTM; SXC-2023
Gamification and Energetic Behavior Changes
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the
      United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile or
      ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and
      physical activity, but change in these behaviors requires self-monitoring and support, and
      weight loss is not always successful.

      Parent involvement and parent weight-loss can help their children to lose weight and
      successfully change their behavior. Guidance from pediatricians can also help to facilitate
      weight loss among obese adolescents. That said, treatment of obesity through behavior change
      within the time constraints of a Pediatric practice visit is limited by treatment adherence
      and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep
      adolescents with severe obesity engaged in therapy outside of standard practice is a critical
      need.

      The effects of monetary incentives through games (gamification), and a comprehensive remote
      digital monitoring system on sleep, physical activity, and dietary intake, has been
      successful in adults, but has not been tested in adolescents with obesity.
    


Intervention name(s): Way to Health
Intervention type(s): Behavioral
Intervention description(s): An online platform (Way to Health) will be used to test if self-monitoring plus gamification principles can increase steps per day and lower sugar sweetened beverage consumption per day, among obese children and adults, compared to self-monitoring alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Variability of Physical Assessments in an Older Population That is Overweight or Obese
Condition: Obesity; Aging
MeSH terms: Overweight
Study type: Observational

Summary: 
      Variability of physical assessments in an older population that is overweight or obese.
    

Detailed description: 
      The purpose of this study is to understand difficulty in obtaining physical assessment
      measurements and assess the variability of these assessments when performed by people who are
      overweight or obese. Data collected in this protocol will be used to inform the design of
      future clinical studies.
    

Intervention name(s): Short Performance Physical Battery (SPPB Test); 30 Second Chair Stand Test (30CST); Hand grip dynamometry
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.; The 30CST measures the number of times a person can rise from a seated to standing position within 30 seconds.; Grip strength is used as a marker of overall muscle strength.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Approximately 60 male and female participants 45 years of age or older who are overweight
        or obese will be enrolled. To ensure data are collected from a wide age range, 20
        participants will be enrolled per specified age ranges. The study population must include
        at least 40% females in the overall study.
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the effects of a once daily subcutaneous injectable
      formulation of setmelanotide in obese participants with Prader-Willi syndrome on
      tolerability, weight loss, and hyperphagia-related behavior. The study drug (setmelanotide
      and placebo) was administered in a blinded fashion.
    


Intervention name(s): Setmelanotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; Subcutaneous injection
Other intervention name(s): RM-493
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prader-Willi Syndrome; obesity; hyperphagia
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy
      in paediatric subjects using easypod™ electromechanical device for growth hormone treatment
      to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/
      subjects will provide their Informed Consent/assent to upload their data for population-based
      analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from
      the easypod™ device combined with physician data entry of outcome measures. Data will be
      collected retrospectively and prospectively. This will allow the establishment of adherence
      profiles and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

      Secondary Objective:

        -  To identify adherence subject profiling

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on
      subjective wake after sleep onset in subjects with primary insomnia.
    


Intervention name(s): PD 0200390; PD 0200390; PD 0200390; PD 0200390; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days; Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days; Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days; Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days; Matched oral placebo for weeks 2-7.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in
      adolescent participants with AD.
    


Intervention name(s): Nemolizumab
Intervention type(s): Biological
Intervention description(s): Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nemolizumab; Atopic dermatitis