bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Outcome After Surgical Treatment of Osteoid Osteoma
Condition: Osteoid Osteoma
MeSH terms: Osteoma; Osteoma, Osteoid
Study type: Observational

Summary: 
      Purpose of the study:

      To retrospectively determine the clinical results in an unselected group of consecutive
      patients with osteoid osteoma treated by surgery.

      Materials and Methods:

      In 150 consecutive patients with clinical and/or radiological evidence for osteoid osteoma at
      any location, the clinical symptoms and imaging findings (radiographs and computed tomography
      (CT)) were assessed before and after surgery. There were no exclusion criteria for this
      study. A good response was defined as disappearance of symptoms that were manifested at
      presentation and were attributed to osteoid osteoma. Clinical assessment after the procedure
      was performed prior to discharge; within 2 weeks after the procedure; and at 3, 6, and 12
      months follow-up. After 24 months, a postal questionnaire was used for assessment.
      Radiographic evaluation (radiographs and thin-slice CT) was performed routinely
      pre-operatively and one year after surgery.

      In case of persisting or recurring symptoms the follow-up protocol was again performed
      according to the initial protocol.

      All patients gave their informed consent both for the surgical intervention as for the use of
      their patient data in this retrospective study.
    


Intervention name(s): surgical removal of osteoid osteoma
Intervention type(s): Procedure
Intervention description(s): surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with osteoid osteoma at any location.
      
Keywords: osteoma, osteoid; surgical procedures, operative; bone neoplasms
Randomized Controlled Trial of Cognitive Therapy Based Self Help Manual for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      While CBT (Cognitive Behaviour Therapy)has been found to be effective in treating depression
      in West, only limited amount of research has been conducted to find assess its effectiveness
      in low and middle income countries. We have developed culturally sensitive CBT during the
      last few years in Pakistan. Pakistan has high rates of depression. And there is currently a
      need to develop and test evidence based treatments which are culturally sensitive and cost
      effective. IN this project we will be assessing the effectiveness of a culturally sensitive
      CBT based self help intervention for depression in Pakistan against care as usual, using a
      randomized controlled design.
    


Intervention name(s): Culturally adapted CBT based Self Help
Intervention type(s): Behavioral
Intervention description(s): Intervention was based on our initial work using mixed methods, using mixed methods,in Pakistan. It focused on psycho-education, symptoms management, changing negative thinking, behavioral activation, problem solving, improving relationships and communication skills. One person from the family was involved in all cases. The intervention consists of 7 chapters. Manual can be used by the patient's or carers with at least 5 years of education. A member of the research team called them once every week to remind them of the next chapter and also to discuss any issues o problems that emerged during the previous week. This manual can be downloaded from PACT website (http://www.pactorganization.com/)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: culture, depression, cognitive therapy, behaviour therapy,
High-Speed Yoga and Executive Function
Condition: Executive Dysfunction; Parkinson Disease; Quality of Life
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this research study is to establish if a novel high-speed yoga program which
      incorporates visual cues can make a positive change in the participant's ability to make
      decisions and move as measured by several cognitive, balance and functional tests. It has
      been shown that yoga can improve balance and movement in those diagnosed with Parkinson's
      disease.
    

Detailed description: 
      The purpose of this research study is to establish if a novel high-speed yoga program which
      incorporates visual cues can make a positive change in the participant's ability to make
      decisions and move as measured by several cognitive, balance and functional tests. It has
      been shown that yoga can improve balance and movement in those diagnosed with Parkinson's
      disease. Subjects will be randomly assigned to either the high-speed yoga group or an
      inactive control group. All subjects will be tested before and after the 16 week training
      period using tests of balance, cognition and functional movement. The high-speed yoga group
      will receive yoga sequences lead by a certified yoga instructor during each of the 32 visits
      to the yoga studio. Each session will last one hour and be conducted two times per week. The
      program will consist of several different balance poses and movements where participants are
      encouraged to move quickly. Participants will also be asked to move in different directions
      based on colored lines placed on the yoga mat. To ensure a safe environment, several
      assistants will be present to help participants move into each pose. In addition, several
      assistive devices such as chairs and yoga blocks will be available if participants chose to
      use them.
    

Intervention name(s): High-speed yoga multi-directional yoga
Intervention type(s): Behavioral
Intervention description(s): The yoga training will be performed over a 4-month period where classes will be held two times per week. Each session will include a warm-up, speed and balance training section, and cooldown phase. The yoga program will include four separate progressions with the first four weeks serving as a familiarization phase, where the participants will be introduced to the poses and proper technique will be demonstrated. The second four-week phase will emphasize a speed component used to target improvements in aerobic capacity. The same poses previously learned will be used. The final two phases will increase in intensity maintaining the speed element and include skill-based training, where the participants will be asked to complete each pose moving as quickly as possible in response to visual and auditory cues.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Therapy
Vitamin D Supplementation and Muscle Function in Older Adults
Condition: Neuromuscular Function
Study type: Interventional

Summary: 
      The purpose of this study is to see if vitamin D supplementation improves muscle function in
      older adults.
    

Detailed description: 
      This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89
      yrs) men and women with initial 25(OH)D concentrations of 18-<30 ng/mL to determine the
      effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation
      on 1) change in neuromuscular functions that are established risk-factors for falls in older
      adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset
      of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3
      or placebo. Lower extremity muscle strength and power, physical performance, and postural
      sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle
      biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle
      fiber type, contractility, and denervation, and number and differentiation stage of satellite
      cells.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2,000 IU/ day of Vitamin D3; Placebo
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Muscle power; Muscle fiber; Falls; Aging
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the amount of GLPG0187 present in the blood
      (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy
      subjects.

      Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and
      dose proportionality of the best formulation.

      Furthermore, during the course of the study, safety and tolerability will be characterized.
    


Intervention name(s): GLPG0187 prodrug
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of the Incretinpathy in Type 2 Diabetes Initiated After Sixty Years Old
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      Type 2 diabetes (T2DM) is characterized by hyperglycemia, insulin resistance, absolute or
      relative insulin deficiency, hyperglucagonemia, increased hepatic glucose production,
      frequently accelerated gastric emptying and obesity. The known effects of the incretin
      hormone glucagon-like peptide-1 (GLP-1) on the metabolism are stimulation of insulin
      secretion, inhibition of glucagon secretion and hepatic glucose production, reduction in
      gastric emptying and modulation of the appetite. T2DM have disturbances in this system,
      providing a rationale for therapeutic use of GLP-1 in T2DM. Furthermore, GLP-1 seems to exert
      trophic effects on the beta-cell.

      Dipeptidyl Peptidase IV (DPP-IV) inhibitors represent a new class of oral anti-hyperglycemic
      agents for the treatment of T2DM. The therapeutic utility of these antihyperglycemic agents
      rests on their ability of to increase active (intact) levels of incretin peptides, including
      GLP-1 and GIP.

      Twenty four T2DM volunteers will be evaluated by a meal tolerance test (MTT) for incretin
      hormone measurements, and by the hyperglycemic clamp followed by an arginine test for
      assessing the beta-cell function and the acute insulin response. Others parameters as body
      composition and basic biochemistry will be also evaluated at Laboratory of Investigation on
      Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.

      T2DM in elderly are behaving differently. Elderly patients have no increase in liver
      production of glucose; when obese, have normal insulin secretion, however, display extreme
      resistance to its action. In non obese individuals, the concentration of glucose necessary
      for insulin secretion is increased and the action is standard. These findings suggest
      therefore that the approach should be differentiated treatment for these individuals.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult Type 2 Diabetes subjects
      
Biospecimen description: 
      Sera and plasma
    
Keywords: diabetes mellitus, type 2; Insulin resistance; Aging; Incretins; DPP-IV protein, human; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; insulin; glucagon; ghrelin
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in
      relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone
      injections in all subjects. The primary outcome measure is a reduction in relapses.
    

Detailed description: 
      Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy.
      This proposal will establish whether oral treatment with estriol, the major estrogen of
      pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS)
      subjects when used in combination with injectable Copaxone. Previously, in a pilot study, it
      has been demonstrated that treatment of RRMS subjects with oral estriol for six months
      resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs
      (Annals of Neurology, 2002; 52:421-428) and caused a favorable shift in immune responses
      (Journal of Immunology, 2003; 171:6267-6274). This is an add-on study aiming to extend these
      previous findings by treating longer and focusing on clinical outcomes. The combination of
      Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection
      plus placebo pill in a double blind trial. The duration of treatment will be two years and
      the primary outcome measure will be relapse rate. Other outcomes will include disability
      measures and brain MRI outcomes. Safety measures (blood tests and gynecologic evaluations)
      will also be followed and correlations will be made between serum estriol levels with
      efficacy and safety. The overall goal of this study will be the development of a new oral
      treatment, estriol, for RRMS.
    

Intervention name(s): Estriol; Placebo; Copaxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estriol 8 mg capsule, once per day, duration of treatment is 2 years; Placebo capsule, once a day, treatment duration is 2 years; Injection, once a day, all subjects
Other intervention name(s): E3; estrogen; "sugar pill"; glatiramer acetate
Intervention MeSH terms: Glatiramer Acetate; Estrogens; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple sclerosis; estrogen; estriol; progesterone
PET and MRI Brain Imaging of Bipolar Disorder
Condition: Bipolar Disorder; Bipolar Depression; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      The primary aims of this study are to:

        1. Quantify serotonin transporter (5-HTT) binding potential (BP) in vivo in bipolar
           disorder patients (BPD) during a major depressive episode (MDE).

        2. Assess the effect of lithium treatment of bipolar disorder on 5-HTT.

        3. Assess the effect of lithium treatment of bipolar disorder on 5-HT1A BP.

        4. Assess the effect of lamotrigine treatment of bipolar disorder on 5-HTT and 5-HT1A BP.

        5. Assess the effect of lithium treatment of unipolar depression on 5-HTT BP.
    

Detailed description: 
      PET and MRI imaging will be used to investigate the aims described above in patients who have
      bipolar disorder or unipolar depression and are currently experiencing a depressive episode.
      Both healthy controls and depressed participants with bipolar disorder or unipolar depression
      will be recruited. Patients who are on medication before enrolling in the study will have a
      three week washout. At baseline, healthy controls and patients will have an MRI consisting of
      both structural and functional sequences. Psychological measures will also be obtained at
      baseline. Within one week of the MRI, both patients and healthy controls will have one CUMI
      and one DASB PET scan.

      Following the baseline PET scans, patient participants will begin medication treatment with
      either lithium or lamotrigine, based on the clinical judgement of the treating psychiatrist.
      Psychological measures will be obtained every 2 weeks. After 6 weeks of medication treatment
      at a therapeutic dose, patients will be assessed for remission (defined as a 50% decrease in
      the HDRS score from baseline). If this criteria is met, patient participants will then have
      follow-up PET scans (one CUMI and one DASB). If this criteria is not met, the patient will be
      switched to the other medication under study and will be reevaluated after an additional 4
      weeks of medication treatment. Patients who still do not demonstrate a 50% decrease in their
      HDRS will be considered non-responders and will have repeat CUMI and DASB scans.
    

Intervention name(s): Lithium; Lamotrigine
Intervention type(s): Drug; Drug
Other intervention name(s): lithium carbonate; Lamictal
Intervention MeSH terms: Lamotrigine; Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bipolar disorder; bipolar depression; serotonin transporter; serotonin receptors; binding potential; brain imaging; unipolar depression
Half-normal Saline in Atrial Fibrillation Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters
      during atrial fibrillation ablation. By increasing the efficacy of radiofrequency
      energy-mediated lesion formation, half-normal saline has the potential to reduce procedural
      times and improved acute and long-term outcomes.
    


Intervention name(s): Half-normal saline; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Use of half-normal saline as an irrigant for open-irrigated ablation catheters; Use of normal saline as an irrigant for open-irrigated ablation catheters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to evaluate the efficacy and safety of compound danshen dripping pills in
      preventing and treating acute mountain sickness.
    

Detailed description: 
      Compound danshen dripping pills is mainly used for the treatment and prevention of coronary
      heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi
      (Radix Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the
      nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying
      capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced
      heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic
      system, reduce blood viscosity, clear the microcirculation, promote blood circulation,
      increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being
      conducted to evaluate the efficacy and safety of compound danshen dripping pills in
      preventing and treating acute mountain sickness, when compared with placebo.
    

Intervention name(s): Placebo; Compound danshen dripping pills
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Placebo Placebo,10pills,tid,treat 1 weeks.; Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Mountain sickness; Compound Danshen Dripping Pills
Sinupret Extract Coated Tablets in Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the
      treatment of chronic rhinosinusitis (CRS) in adults.
    

Detailed description: 
      The aim of the present double-blind, placebo-controlled, parallel-group, randomized, phase
      III clinical trial is to assess the efficacy, safety, and tolerability of Sinupret extract (3
      x 160 mg = 480 mg daily) taken for up to 16-weeks compared with placebo in the treatment of
      chronic rhinosinusitis (CRS) in adults. In addition, in an exploratory approach to identify
      potential pharmacological modes of action underlying the expected treatment benefit, the
      anti-inflammatory activity of Sinupret extract will be assessed in a subset of CRS patients.
    

Intervention name(s): Sinupret extract coated tablets; Placebo coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 coated tablet 3 times a day for 16-weeks (1-1-1); 1 coated tablet 3 times a day for 16-weeks (1-1-1)
Other intervention name(s): Sinupret extract; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic rhinosinusitis; Sinupret extract; herbal medicinal product