bioihbjkbjnl/mcl2 huggingface dataset:
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, randomized, double-blind, placebo-controlled, within-subjects study
      design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using
      functional magnetic resonance imaging (fMRI) to determine central nervous system engagement.
      Safety and tolerability also will be assessed.
    


Intervention name(s): ITI-214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
Condition: Asthma; Bronchospasm
MeSH terms: Asthma; Bronchial Spasm
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover
      and dose-ranging design. This study aims to evaluate the efficacy and initial safety
      profiles, and to identify the optimum dose of A006, from a select dose-range for future
      clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy,
      adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to
      Screening.
    


Intervention name(s): albuterol inhalation powder; albuterol inhalation powder; albuterol inhalation powder; albuterol inhalation powder; Placebo; albuterol inhalation aerosol; albuterol inhalation aerosol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation; A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation; A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations; A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations; placebo, lactose inhalation carrier; albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations; albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
Other intervention name(s): Proventil; Proventil
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; bronchospasm; COPD; chronic respiratory disease
Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Respiratory Aspiration; Fibrosis
Study type: Interventional

Summary: 
      It is extensively reported in the literature that patients with chronic obstructive lung
      disease may have impairments in balance and postural control which further increase the
      disease burden. Mechanisms related to these impairments include, but are not limited to
      increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic
      inflammation. Since the similar symptoms are reported for the children with cystic fibrosis,
      it is hypothesized that balance and postural control may also be compromised in these
      patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and
      pulmonary function. Considering the relation between diaphragm which is one of the core
      muscles, and balance, IMT may also have an impact on postural control and balance alongside
      the standard clinical parameters such as respiratory muscle strength, pulmonary function and
      functional capacity in these patients. Thus, the aim of this study was to investigate the
      effects of inspiratory muscle training and conventional chest physiotherapy on postural
      stability, balance, pulmonary function and functional capacity in children with cystic
      fibrosis.
    


Intervention name(s): Conventional chest physiotherapy; Inspiratory muscle training
Intervention type(s): Other; Other
Intervention description(s): Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Inspiratory Muscle Training; Chest Physiotherapy; Balance; Postural Stability; Pulmonary Function Test; 6-Minute Walk Test
Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD
Condition: Temporomandibular Disorder; Myofascial Pain; Cannabis; Electromyography
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Marijuana Abuse
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin
      application in patients with TMD
    

Detailed description: 
      Cannabis sativa has a very wide application in various fields of medicine. In patients with
      temporomandibular disorder, especially with myofascial pain of masticatory muscles there is a
      special need to seek an effective pain therapy and muscle relaxing methods. Patients with TMD
      suffer from chronic pain and depression, cannabis topical skin application therapy seems
      promising in that field. Patients attending The Department of TMD in Zabrze, Polska were
      randomly divided into two groups: experimental and placebo. sEMG activity values were
      compared during 14 days therapy with cream. Positive results were obtained confirming the
      efficacy of the cannabis cream used in the study, compared to placebo.
    

Intervention name(s): Cannabis Cream; Placebo Cream
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles; Topical, bilteral skin application of placebo cream with self-massage of masseter muscles
Other intervention name(s): Cannabis cream topical skin application; Placeo cream topical skin application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups parallel study: experimental and control group
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: temporomandibular disorder; Cannabis; Electromyography; Masticatory muscles; Topical application
Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg
      every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether
      IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year
      sustained the treatment effect. The study was started in 2003 an finished in 2008.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): 5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with active ankylosing spondylitis with BASDAI>4
      
Biospecimen description: 
      Serum samples
    
Keywords: Ankylosing Spondylitis; infiximab; single armed trial
The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function
Condition: Elderly; Pre-diabetic
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke
      Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the
      effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin
      sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise
      provides more improvements in glucose control for pre-diabetic patients than vigorous
      intensity. The investigators hypothesize that moderate intensity exercise might be beneficial
      for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging
      excess protein acetylation (measured in muscle biopsy), 2. Improving the
      acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function
      as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing
      insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend
      to use the results of this study to show feasibility in measuring mitochondrial function at
      Duke for a larger federal grant submission. Investigators hypothesize that carnitine
      insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments
      in glucose tolerance and insulin action.
    


Intervention name(s): Acute Exercise; Acute Exercise
Intervention type(s): Other; Other
Intervention description(s): Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.; Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carnitine; Acylcarnitine; Exercise; Exercise Intensity; Insulin Sensitivity
Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug, and giving them after surgery, may
      kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of
      paclitaxel and cisplatin, given after surgery in treating patients with cancer of the
      esophagus or stomach.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with
      adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving
      post-operative adjuvant paclitaxel plus cisplatin.

      OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study.
      Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous
      cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease
      recurrence or unacceptable toxic effects are removed from the study. Patients are followed
      every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months
      thereafter.

      PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.
    

Intervention name(s): cisplatin; paclitaxel; surgical procedure
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Paclitaxel; Cisplatin
Primary purpose: Treatment
Keywords: stage II gastric cancer; stage III gastric cancer; stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Condition: Healthy
MeSH terms: Pituitary Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy,
      reproductive-aged women using three different regimens of oral contraceptives (OCs). Two
      extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days
      followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg
      for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia
      (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
    


Intervention name(s): Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)]; Seasonique (LNG/EE and EE); Portia (LNG/EE)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet daily; 1 tablet daily; 1 tablet daily x 28 days
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Self-management Program in Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck
      movements or sustained neck postures. The onset and course of this pain is influenced by
      environmental and personal factors.Many studies report that participants preferred self-care
      measures for the management of neck pain and they sought professional help only when those
      measures fail.
    

Detailed description: 
      Neck pain is the fourth leading cause of disability worldwide causing an enormous impact on
      individuals and their families, communities and healthcare systems.While neck pain can be
      severely disabling and costly, treatment options have shown moderate evidence of
      effectiveness. No previous study has used foam roller in patients with neck pain. In
      addition, it has been suggested that neurodynamic interventions provide a peripheral
      stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal
      transport and nerve conduction. It was hypothesized that a self-administered intervention
      focused on myofascial release of main muscles related to neck pain and upper-limb active
      neurodynamics could reduce the presence of active trigger points and pain, improving
      functionality and active mobility.
    

Intervention name(s): self-managmeent program
Intervention type(s): Other
Intervention description(s): One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain
Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is study testing the feasibility of collecting neurophysiological measures of outcome
      related to body-based interventions for low back pain. The investigators will collect fMRI
      and psychophysical data about pain sensitivity before and after the interventions.
      Participants will be randomly assigned to either spinal manipulation or therapeutic touch
      groups. Participants will attend two practice sessions prior to the first data collection.
      There will be two follow-up assessments.
    

Detailed description: 
      Participants will be enrolled from VA pain clinical at the North Florida/South George VA
      Medical Center.

      The investigators will collect functional magnetic resonance imaging data of resting state
      and pain-related events (i.i. during thermal pain sensitivity testing, as well as
      psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using
      thermal and mechanical stimuli. These data will be collected before and after the
      interventions, in addition to two follow-up sessions after intervention.

      In addition, clinical measures of pain intensity in the low back, as well as trunk range of
      motion and strength will also be collected.
    

Intervention name(s): Spinal manipulation; Therapeutic touch; fMRI; Pain Sensitivity Testing; Questionnaires; Physical Impairment
Intervention type(s): Procedure; Procedure; Procedure; Behavioral; Other; Behavioral
Intervention description(s): Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.; Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.; Both groups will receive an fMRI.; Both groups will receive an Pain Sensitivity Testing; Both groups will receive Questionnaires; Both groups will receive testing on physical impairment.
Other intervention name(s): Functional MRI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease
Condition: Lipedema; Dercum Disease
MeSH terms: Lipedema; Adiposis Dolorosa
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat
      above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will
      receive RZL-012.
    

Detailed description: 
      This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat
      above the knee and men with Dercum's disease.

        -  The 1st cohort will be comprised of subjects with Dercum's disease.

        -  The 2nd cohort will be comprised of subjects with lipedema with substantial fat above
           the knee

      Within each cohort dosing of the subjects will progress consecutively from one individual to
      the other with a minimum 7 days between subjects to asses safety. The study design will allow
      the physicians to monitor safety for at least 7 days prior to dosing the next subject. Cohort
      2 will be conducted in a dose escalation manner and the decision to proceed to the next dose
      level will be made after reviewing all safety data collected by Day 14 within 2+/-1 day of
      the last dosed subject. The trial will proceed within a cohort provided that no more than one
      subject experience intolerable side effects in a cohort, and based on the decision made by
      the Principal Investigator (PI) and the medical monitor.
    

Intervention name(s): RZL-012
Intervention type(s): Drug
Intervention description(s): The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the safety and efficacy of an herbal treatment in children and
      adolescents with ADHD.

      Study Design:

        -  Randomized

        -  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

        -  Placebo Control

        -  Parallel Assignment
    

Detailed description: 
      ADHD is a common childhood disorder associated with attention problems and disruptive
      behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort
      /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and
      atomoxetine naive patients. This study will determine the safety and efficacy of an herbal
      treatment in children and adolescents with ADHD.

      Participants will be randomly assigned to receive either an herbal product or placebo twice a
      day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8
      weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side
      effects will be monitored continuously and also assessed by rating scales.
    

Intervention name(s): Sedariston; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): St. John´s Wort (100 mg) Valerian Extract (50 mg); Placebo
Other intervention name(s): Sedariston Concentrate(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; children; adolescents; St. John's Wort; Valerian extract; Safety; Efficacy
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this exploratory study is to compare the treatment effect on dentinal
      hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile
      sensitivity. This proof of concept study will compare the test dentifrice with three other
      treatment groups.
    

Detailed description: 
      This will be a single center, eight week, randomized, controlled, examiner blind, four
      treatment arms, parallel design study in participants with at least two sensitive teeth that
      meet all the criteria at the Screening and Baseline visit. Participants will be assessed at
      baseline, four and eight weeks to monitor clinical efficacy and safety.
    

Intervention name(s): 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; Sodium monofluorophosphate dentifrice; Sodium Fluoride dentifrice
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate; No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate; Sodium monofluorophospate dentifrice (1000 ppm F); Dentifrice containing 1100ppm F as sodium fluoride
Intervention MeSH terms: Calcium, Dietary; Listerine; Calcium; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment