bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Condition: Autism; Pediatric Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of memantine
      in the treatment of autism in pediatric patients.
    

Detailed description: 
      This is a 48-week multicenter extension study comprised of a 6-week double-blind
      dose-titration period followed by a 42-week open-label maintenance period.

      In the Forest autism trials conducted in children ages 6-12, dosing with an extended release
      formulation of memantine was weight-based. These weight based dose limits were selected to
      ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of
      2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No
      observed adverse effect level) of 15 mg/kg/day in juvenile rats.

      The weight-based dose limits in these studies were as follows:

        -  Group A: ≥ 60 kg; max 15 mg/day

        -  Group B: 40-59 kg; max 9 mg/day

        -  Group C: 20-39 kg; max 6 mg/day

        -  Group D: < 20 kg; max 3 mg/day
    

Intervention name(s): Memantine HCl
Intervention type(s): Drug
Intervention description(s): Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
Other intervention name(s): Namenda; Namenda XR
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Namenda; Autism; Memantine; Pediatric; Forest Laboratories
Effectiveness of Ergonomic Intervention
Condition: Low Back Pain; Neck Pain; Upper Extremity; Lower Extremity
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This Research study aims to investigate the long term effectiveness of a workstation
      ergonomic intervention for work-related posture and low back pain (LBP) of Video Display
      Terminal (VDT) workers
    

Detailed description: 
      A non-randomized, crossover trial design was used with follow-up repeated 6, 12, and 30
      months from baseline in the first intervention period and then beginning at 6 months
      following the crossover.

      The administrative offices in the two main buildings of the town hall of Forlì, Italy.

      The study population was composed of 400 employees, who used VDTs for at least 20 hours a
      week, of whom we randomly selected 100 participants from each building. Of the 200 initial
      participants, 153 completed the study; the dropouts were due to illness/injury or maternity.

      Participants were assigned to intervention or control during the first period and then
      crossed over after a 30-month washout. The intervention used in this investigation was an
      ergonomic adjustment of the VDT workstation design.

      Our study showed that the workstation ergonomic adjustment improved work-related posture and
      in reducing LBP in VDT operators among subjects who received the intervention both in the
      first period and in the crossover, and maintained these positive effects for at least 30
      months.
    

Intervention name(s): Ergonomic Intervention
Intervention type(s): Other
Intervention description(s): The intervention used in this investigation was an ergonomic adjustment of the VDT workstation design
Other intervention name(s): Preventive Intervention of Musculoskeletal Disorders
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Ergonomic intervention; Musculoskeletal disorders; Low back pain; Posture; Video display terminal
Effects of Respiratory Muscle Training on Pulmonary Function
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study was conducted to determine the effects of respiratory muscle training on pulmonary
      function and musculoskeletal parameters in patients with chronic neck pain. It included 43
      patients, 20-40 years old males and females having non-specific chronic neck pain for more
      than three months and with low maximum voluntary ventilation (MVV) values were included.
      Control group (n=21) received conventional physiotherapy with diaphragmatic breathing
      exercises and experimental group (n=23) received conventional physiotherapy with specially
      designed respiratory exercise protocol. It concluded that RMT in addition to conventional
      physiotherapy is effective to improve musculoskeletal and pulmonary parameters in CNP
      patients.
    

Detailed description: 
      To determine the effects of respiratory muscle training on pulmonary function and
      musculoskeletal parameters in patients with chronic neck pain.

      Study design: A randomized controlled trial Place and Duration of Study: Riphah
      Rehabilitation and Research Center in Railway General Hospital and Benazir Bhutto Hospital,
      Rawalpindi from January 2019 to July 2019.

      Methodology: 43 patients, 20-40 years old males and females having non-specific chronic neck
      pain for more than three months and with low maximum voluntary ventilation (MVV) values were
      included. Control group (n=21) received conventional physiotherapy with diaphragmatic
      breathing exercises and experimental group (n=23) received conventional physiotherapy with
      specially designed respiratory exercise protocol. They were assessed prior to, at 2nd week
      and after 4 weeks of treatment.
    

Intervention name(s): Neck stretching exercises
Intervention type(s): Other
Intervention description(s): Neck stretching exercises towards lateral flexion, ipsilateral flexion and rotation and towards flexion each for 30 sec and repeated 2-3 times
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Participant)
Primary purpose: Treatment
Does Improving Insulation and Heating Improve Health?
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The Housing, Heating and Health Study has enrolled 409 households with ineffective heaters,
      who have a child with asthma between 6 and 12 years.

      In the winter of 2005, houses were insulated and baseline measures taken of indoor
      temperatures, nitrogen dioxide, with more intensive indoor air quality monitoring in a
      sub-sample of 33 homes.

      Objective data are being collected on the household's health and energy usage. The households
      randomly assigned to the intervention group will have new heaters installed over the summer.

      Results will be available after the follow-up data collection in 2006.
    

Detailed description: 
      1. Introduction New Zealand houses are relatively poorly constructed and maintained for the
           temperate climate and most homes are heated to less than the WHO recommended minimum
           winter temperature of 18°C. Excess winter mortality is comparable to the levels in
           Portugal and Scotland. The Group's previous Housing, Insulation and Health Study has
           shown that insulating existing homes leads to a small but significant improvement in
           health and energy consumption, but raised the question as to whether installing more
           sustainable heating could increase these gains.

        2. Study design

      We have enrolled 409 households, who use either plug-in electric heaters or unflued gas
      heating, and where there is a child with asthma, aged between 6 and 12 years. In the winter
      of 2005, uninsulated houses were insulated and baseline measures taken of indoor temperatures
      in the living room and the child's bedroom, and levels of nitrogen dioxide. Intensive
      monitoring of indoor air quality is being carried out in a sub-sample of 33 homes. All
      members of the child's family have filled out detailed questionnaires of their health and the
      heads-of -household have completed a questionnaire on the characteristics of the household's
      energy usage. Objective measures are also being collected of the household's fuel bills, the
      child's attendance at school and the family's health care utilisation.

      Households are randomised so that the intervention group will have their choice of new, more
      efficient and sustainable heaters (heat pumps, wood pellet burners, or flued gas heaters)
      that heat more of the house and which emit no internal emissions installed over the summer.
      In the winter of 2006, follow-up measures will be taken and then the control households will
      receive their choice of new heaters.
    

Intervention name(s): Installation of an energy efficient heater
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Childhood; Asthma; Heating; Insulation; Respiratory symptoms
RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Our aim is to perform a randomized-controlled trial comparing air insufflation sedated
      colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by
      supervised trainees. Randomized trials demonstrating reduced need for sedation medications
      without compromising patients' comfort, cecal intubation rates or polyps detection may cause
      a paradigm shift and positively alter the way traditional colonoscopy is performed and future
      endoscopists are trained.
    

Detailed description: 
      Background: A novel water method permitted 52% of patients accepting on-demand sedation to
      complete colonoscopy without medications and significantly increased successful cecal
      intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

      Aim: To perform a randomized controlled trial comparing air insufflation (conventional
      method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated
      patients by supervised trainees.

      Hypothesis: Compared with the conventional method, patients examined by the study method have
      lower pain scores and require less medication but have similar cecal intubation rate and
      willingness to repeat future colonoscopy.

      Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and
      standard bowel preparation, patients received pre-medications administered as 0.5 increment
      of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The
      conventional and the study method for colonoscopy were implemented as previously described.
      Additional pain medications were administered at the patients' request.

      Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to
      repeat colonoscopy.

      Limitations: Single VA site, older male population
    

Intervention name(s): Colonoscopy for colorectal cancer screening; Water Infusion Colonoscopy; Air insufflation colonoscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): water infusion in lieu of air insufflation for screening colonoscopy; Conventional colonoscopy with air insufflation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Colorectal cancer screening; Optical colonoscopy; Water method; Sedation
Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study will employ clinical assessment tools to examine the effects of
      modified constraint-induced therapy (mCIT) on the more affected upper extremity of children
      with cerebral palsy.
    

Detailed description: 
      The study included threefold: (1) It will employ kinematic analysis, along with clinical
      assessment tools to examine the effects of mCIT on the more affected upper extremity of
      children with cerebral palsy with asymmetric motor impairments after treatment immediately
      and 1 year following. The clinical tools will include Motor Activity Log (MAL),
      Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales
      (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual
      coordination and the less affected upper extremity. (3) It investigated the effects of forms
      (group vs. individual intervention) on upper extremity performance.
    

Intervention name(s): Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm; Hospital-based mCIT; Hospital-based TR
Intervention type(s): Other; Other; Other
Intervention description(s): the mCIT group with individualized intervention; the mCIT group with individualized intervention; OT or PT or therapist-based training
Other intervention name(s): Hospital-based modified constraint-induced therapy(mCIT); Hospital-based modified constraint-induced therapy(mCIT); Hospital-based traditional rehabilitation (TR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Modified constraint-induced therapy; Children with cerebral palsy; Kinematic analysis; Group therapy
Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
Condition: Anal Squamous Intraepithelial Lesion (ASIL); HPV DNA
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This study is designed to establish the prevalence of anal squamous intraepithelial lesion
      (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
    

Detailed description: 
      IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched
      healthy controls are screened for eligibility. Informed consent is obtained for eligible
      subjects. An anonymous self-administered questionnaire is administered to assess risk factors
      for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.

      An anal pap smear is performed at the time of a clinic visit or at the time of an already
      scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a
      blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed
      on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred
      to a colorectal surgeon for further recommendations or treatment, which includes a
      high-resolution anoscopy.
    

Intervention name(s): Anal Pap smear and HPV DNA testing
Intervention type(s): Procedure
Intervention description(s): Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: ASIL; Anal dysplasia; IBD; HPV DNA
Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The present trial investigates a possible use of oral bosentan, which is currently approved
      for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering
      from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i)
      peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary
      hypertension after pulmonary endarterectomy.
    


Intervention name(s): bosentan
Intervention type(s): Drug
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CTEPH; bosentan
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical
      activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.
    

Detailed description: 
      The study will enroll up to 40 subjects, with up to 5 dose escalating cohorts of 8 patients
      enrolled in a 3:1 ratio. Subjects will receive either itolizumab or placebo administered
      subcutaneously every two weeks (over 8 weeks) for a total of 5 doses with 4 weeks of
      follow-up.
    

Intervention name(s): EQ001; EQ001 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Itolizumab [Bmab 600]; EQ001 Placebo
Other intervention name(s): Bmab600; Itolizumab
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: up to 5 cohorts of 8 patients randomized 3:1 with ascending doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate-to-severe asthma
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the safety and tolerability of long-term treatment with oral trofinetide in
      girls and women with Rett syndrome
    


Intervention name(s): Trofinetide
Intervention type(s): Drug
Intervention description(s): Trofinetide solution of 30-60 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Children undergoing anesthesia are often very frightened by the experience. This can lead to
      bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can
      influence their future experiences with anesthesia and surgery. The investigators believe the
      presence of a parent via video might work better as parental fear is not transferred to the
      child. The investigators also believe that parents who are coached on how to assist their
      child during anesthesia will have a better impact. As such the investigators are carrying out
      this study to assess whether parents who are coached and are present in either video or
      physical form will be more effective in reducing anxiety at induction of anesthesia.
    

Detailed description: 
      The investigators' goal in this study is to investigate the effects of virtual parental
      presence and coaching of parents on anxiety in children at induction of anesthesia. The
      primary hypothesis is virtual parental presence during induction of anesthesia is superior to
      physical parental presence during induction of anesthesia in reducing anxiety in children at
      induction of anesthesia. The secondary hypothesis is that the coaching of parents modulates
      the effect of physical or video parental presence at induction anesthesia on children's
      anxiety.
    

Intervention name(s): virtual; coaching; physical; no coaching
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Parent is present via an internet pad (iPad); Parent learns what to say verbally to soothe child; Parent is present in the operating room; Parent does not learn what to say verbally to soothe child
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Other
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of etrasimod on clinical remission in
      participants with moderately to severely active ulcerative colitis (UC).
    


Intervention name(s): Etrasimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period; Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Other intervention name(s): APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Etrasimod; APD334
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will
      be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200
      mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon
      alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending
      on response. Treatment-experienced patients categorized as relapsers, partial responders and
      viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be
      randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus
      for 48 weeks. Treatment-experienced patients categorized as null-responders to previous
      pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus
      Pegasys and Copegus for 48 weeks.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]; placebo; ribavirin [Copegus]; setrobuvir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 180 mcg sc weekly; Orally b.i.d.; 1000 mg or 1200 mg orally daily; Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
Other intervention name(s): ANA598
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy
      to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment