bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of
      this study is to find out the effects of botulinum toxin A on hip joint dislocation in
      cerebral palsy patients.
    

Detailed description: 
      -  Design: Prospective study

        -  Inclusion criteria of patient group: who has a cerebral palsy and GMFCS level 3,4,5

        -  Intervention: applied medication Botulinum A injection (meditox 200unit)

        -  Main outcome measures: The investigators will measure for finding evidence by checking
           the x-ray photograph, hip adductor and muscles pressure test and electromyography(EMG
           test) test of hip adductor, abductor and spine muscles.
    

Intervention name(s): medication Botulinum A injection.
Intervention type(s): Drug
Intervention description(s): In cerebral palsy patients, Botulinum toxin within the allowable dose of 16 U / kg per body weight will injected into both adductor longus, adductor magnus muscle at 3 U / kg, adductor brevis, and gracilis muscle at a dose of 1 U / kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hip dislocation; GMFCS level 3,4,5
Analyze the Relationship Between the Density of Fat Tissue and Cellulite With the Lumbar Lordosis Degree
Condition: Lordosis
MeSH terms: Lordosis; Swayback; Cellulite
Study type: Observational

Summary: 
      The aim of this study is analyze the relationship between the density of visceral and
      subcutaneous fat and cellulite with the lumbar lordosis degree.
    

Detailed description: 
      There are two types of abdominal fat: subcutaneous adipose tissue which is more superficial,
      lying above the abdominal muscle wall and visceral adipose tissue, corresponding to the
      intra-abdominal fat witch is more harmful to health.

      The accumulation of fat tissue differs between genders and age. Men have a huge propensity
      for developing central fat and women accumulate more subcutaneous fat tissue on the
      gluteal-femoral region. Some authors suggest that the accumulation of fat tissue increases
      with age.

      Several studies have concluded that there is a relationship between the abdominal fat storage
      and the degree of lumbar curvature.

      In addition, some authors also suggest that there is a relationship between the degree of
      lumbar lordosis and cellulite, which is related to circulatory changes.

      However these relationships are not yet clarified in the literature.
    

Intervention name(s): Transversal Study so there is no intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All the comunity of the School of Allied Health Technologies
      
Keywords: Central Fat; Subcutaneous Fat; Lumbar Lordosis Degree; Cellulite
MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in
      adolescents younger than 18 years according to the Diagnostic and Statistical Manual of
      Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably
      diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD
      exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly
      shown to be effective in treating adult BPD, but in the case of adolescents, only individual
      MBT have been tested and found to be effective.

      Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory
      programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As
      Usual (TAU) in treating adolescents with BPD or subthreshold BPD.

      Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region
      Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V
      BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up
      will be at three and 12 months.

      Discussion: Early intervention is especially important in relation to personality
      psychopathology and has long-term benefits for patients, their families and society. In
      addition to being cost effective, using the group modality in the treatment of BPD may have
      several advantages. This is the first Randomized Controlled Trial (RCT) to test the
      effectiveness of MBT in groups for adolescents.
    


Intervention name(s): Mentalization Based Treatment; Treatment As Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment As Usual
Other intervention name(s): MBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mentalization-based Treatment; Adolescence; Borderline Personality Disorder
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study was to test the efficacy of 2 tablets (twice daily) of
      ABT-712, compared to placebo, administered over a 4-week period in participants with moderate
      to severe mechanical chronic low back pain (CLBP).
    

Detailed description: 
      The study used a randomized withdrawal design with an open label (OL) period prior to a
      double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712
      during the OL period were randomized into the DB period. Study drug was given for a total of
      8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper.
      During the OL period, all participants took increasing doses of ABT-712 until they were
      taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2
      ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group
      took 2 placebo tablets twice daily.
    

Intervention name(s): ABT-712; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABT-712 extended-release tablet; Placebo tablet
Other intervention name(s): Hydrocodone and acetaminophen extended-release; Hydrocodone bitartrate and acetaminophen extended-release
Intervention MeSH terms: Acetaminophen; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Effect on sleep interference by pain
Molecular Stethoscope
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The study aims to provide a more complete characterization and understanding of the genetic
      causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this
      study will be used to develop early detection tests for colorectal cancer that are minimally
      invasive (based on a blood test). It is hoped that reliable, minimally invasive, early
      detection methods will lead to improved screening rates, increased screening safety, longer
      colorectal cancer survival, and overall cost savings.

      In order to assess the test's ability to detect tumor DNA, 25 participants with known
      colorectal cancer who will be undergoing surgical resection of the colon as part of their
      clinical care will be recruited. The investigators will collect blood from participants prior
      to surgery, tumor and normal tissue removed during surgery, a series of blood samples after
      surgery for up to one year and relevant medical records. DNA variants identified in blood
      will be compared against tissue samples. Serial samples will be analyzed to assess the
      variance in amount of circulating tumor DNA across time with standard treatment.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with colorectal cancer that will be receiving surgical removal of their cancer as
        part of their care.
Online Psychoeducation for Intolerance of Uncertainty
Condition: Intolerance of Uncertainty; Anxiety
Study type: Interventional

Summary: 
      Randomized control trial examining the efficacy of an online intolerance of uncertainty
      focused psychoeducation intervention.
    

Detailed description: 
      Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU)
      focused psychoeducation intervention among females elevated in IU.
    

Intervention name(s): Active IU-focused Psychoeducation Intervention; Health-focused Psychoeducation Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty.; This intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Intolerance of Uncertainty; Anxiety
Sodium-Potassium Blood Pressure Trial in Children
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the effects of nutritional intervention on the rate of rise of blood pressure in
      late childhood and early adolescence.
    

Detailed description: 
      BACKGROUND:

      Since 1970, children and adolescents with hypertension have been detected with increasing
      frequency. Many of them were thought to have primary or essential hypertension and it
      remained unclear how they should be managed. Additionally, since tracking of blood pressure
      occurred even in early life, it was believed that youngsters with blood pressures
      persistently in the upper deciles for age were at increased risk for later hypertension. No
      clinical trials had been performed in this age group to examine the effects of
      non-pharmacologic or drug therapy in lowering blood pressure. The trial was one of the first
      attempts to examine the effects of a nutritional intervention on the rate of rise of blood
      pressure in late childhood and early adolescence.

      DESIGN NARRATIVE:

      Randomized, partial-blind. After 19,542 fifth to eighth grade students were screened, 210
      (105 boys and 105 girls) from the upper 15 percentiles of blood pressure distribution were
      randomly assigned to one of three groups: low sodium diet (70 mmol sodium intake per day),
      potassium chloride supplementation (normal diet plus 1 mmol/kg potassium chloride per day),
      and placebo (normal diet plus placebo capsule). Capsules for the potassium chloride and
      placebo groups were administered in a double blind protocol. Blood pressure was measured
      every three months for three years. The effect of the intervention was determined by
      comparing the rate of rise (slope) of blood pressure among the groups using a
      random-coefficient growth curve model.
    

Intervention name(s): diet, sodium-restricted; diet, potassium-supplemented
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first-in-human study for an oral investigational compound, PF-06282999, in order
      to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose
      levels.
    


Intervention name(s): PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo; PF-06282999; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution, doses range from 20 to 200 mg, single dose; Solution, single dose; Methylcellulose suspension, doses range 125 to 500 mg, single dose; suspension, single dose; Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose; suspension, single dose; Methylcellulose or simethicone suspension, 500 mg dose, single dose; suspension, single dose; Simethicone or methylcellulose suspension, up to 1500 mg, single dose; suspension, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; pharmacokinetics; oral; single ascending dose; placebo-controlled; healthy subjects
Self-management of Anticoagulation Treatment
Condition: Atrial Fibrillation; Venous Thromboembolism; Artificial Heart Valve
MeSH terms: Atrial Fibrillation; Thromboembolism; Venous Thromboembolism
Study type: Interventional

Summary: 
      The aim of the study was to compare self-management of anticoagulant treatment with
      conventional anticoagulant treatment in Norway.
    

Detailed description: 
      Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training
      program where they learned how to analyse International Normalised Ratio (INR) using the
      point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their
      skills through a test before considered self-managing. They continued to measure INR weekly
      for two years. All INR values during the training program and self-control period were
      collected. In addition, the patients were told to notify if they had any complications during
      this period. INR values and complications two years before enrolment was collected from INR
      cards and/or their general practioner. The participant filled in a quality of life-questioner
      at enrolment and after two years of self-management.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): Patients were trained to measure INR and dose warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: warfarin; self-management; Conventional management; Training; TTR; Complications; Quality of life
The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2
      hours preoperatively on the onset and the duration of the spinal anesthesia in total knee
      arthroplasty and the role of pregabalin in postoperative analgesia.
    


Intervention name(s): Pregabalin 150mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery; The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Executive Functions and Preterm Children in 11 to 12 Year Old
Condition: Preterm Infant
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Preterm children have a high risk for neurodevelopmental impairments. The impact on motor
      functions and neurosensory functions is demonstrated but the incidence of executive functions
      is not described for preterm infants.
    

Detailed description: 
      It is an epidemiologic, observational, prospective study. All patients, included in the LIFT
      cohort, in 11 to 12 year old during the period study, are contacted by mail. Patients with
      congenital anomalies or genetic syndromes are excluded. Children with parents who do not
      speak French are excluded. Antenatal and postnatal criteria known to be associated with
      disorders of executive functions are collected as gestational age, sex, multiple pregnancy,
      intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral
      injuries and socio-economic status. After a couple of weeks, parents are contacted by a study
      manager, by phone call, to collect parental consent and answer some parental questions. After
      consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF
      teacher questionnaire to the mean teacher. Teachers send by themselves their response. An
      informatic version is available with a personal link given especially by mail for each child.
      All data are anonymous. BRIEF questionnaire is composed of 86 items, exploring 2 main
      domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire.
      In case of no questionnaire return after one month, parents are contacted by phone. The
      investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response
      expected is 300 questionnaires.
    

Intervention name(s): BRIEF parental survey
Intervention type(s): Other
Intervention description(s): estimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients which former preterm of gestational age less than 34 weeks
Evaluation of the Dental Vibe Injection Comfort System
Condition: Anesthesia, Local; Pain
Study type: Interventional

Summary: 
      This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen
      anesthesia pain through pulsed vibration, a form of counter-stimulation. The study's aims
      were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB)
      and inferior alveolar nerve (IAN) injections and the time needed to achieve complete
      anesthesia during an IAN block.
    

Detailed description: 
      Objective: Pain from local anesthesia injections can be reduced by distraction and
      counter-stimulation techniques. This study investigated the Dental Vibe Injection Comfort
      System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of
      counter-stimulation.

      Design: Our study's aims were to evaluate DV's efficacy in reducing pain/discomfort from
      intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed
      to achieve complete anesthesia during an IAN block.

      Methods: The sixty subjects, equally split by sex, ages 21-32, rated injection pain on a
      visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection
      on a modified symptom severity index. Each subject received bilateral LB injections and an
      IAN block. Using block design, DV Generation 3 (DV3) was randomly assigned to either the
      first or second LB injection and to thirty subjects on their third injection, the IAN block.
      No topical anesthesia was applied.
    

Intervention name(s): Dental Vibe
Intervention type(s): Device
Intervention description(s): Use of Dental Vibe during dental anesthesia intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia, local; Pain
Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
Condition: IUCD Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine
      device (IUD) insertion reduces failed insertions, insertion-related complications and pain in
      in Women Delivered Only by Cesarean Delivery.
    

Detailed description: 
      Women may experience pain and technical difficulties may be encountered when insertion of an
      intrauterine device is attempted through a narrow cervical canal. intrauterine device
      insertion- related complications and side effects are more common among women who had never
      delivered vaginally.
    

Intervention name(s): INH; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.; 3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
Other intervention name(s): isonicotinic acid hydrazide
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single
      intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive
      adults.

      The secondary objectives of the study are:

        -  To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart
           rate (HR) in healthy normotensive and otherwise healthy hypertensive adults

        -  To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV)

        -  To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381

        -  To evaluate the immunogenicity of single IV doses of REGN5381
    


Intervention name(s): REGN5381; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose REGN5381 administered via IV infusion; Placebo matching single dose REGN 5381 administered via IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Normal Blood Pressure (BP); Mildly Elevated BP