bioihbjkbjnl/mcl2 huggingface dataset:
Nicotine Treatment for Pulmonary Sarcoidosis: A Clinical Trial Pilot Study
Condition: Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if nicotine treatment is beneficial for the
      treatment of sarcoidosis. Sarcoidosis is a disease of unknown cause that leads to
      inflammation. This disease affects your body's organs.
    

Detailed description: 
      Participants will be randomly divided into two groups. One group will receive a nicotine
      patch to use for approximately 7 months; the other group will receive placebo for nicotine
      patches to use for the same time period.

      Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the
      duration of the study to monitor for any side effects.

      The following information and samples will be collected:

      Questionnaires Medical History Spirometry CT Scans Physical Exam Blood Samples for nicotine
      and nicotine metabolites
    

Intervention name(s): Habitrol; Placebo to Habitrol
Intervention type(s): Drug; Drug
Intervention description(s): Patch used daily for 28 weeks
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Boston Migraine and Contraception Study
Condition: Headache
MeSH terms: Headache
Study type: Observational

Summary: 
      The objectives of this prospective, descriptive study are to:

        1. generate estimates of the incidence, prevalence, persistence, clinical impact and
           attributable risk of migraine due to hormonal contraception (HC) use; and

        2. identify predictive factors for clinically significant changes in headache attributable
           to HC use.

      The investigators hypothesize that:

        1. Most women with pre-existing migraine will have no significant change from baseline
           headache frequency or clinical impact attributable to HC at 3 months following
           initiation; a minority will report clinically significant worsening or improvement

        2. The incidence of headache and migraine in HC users will not be significantly different
           from their incidence in NHC users

        3. There will be identifiable risk factors for development or worsening of
           headache/migraine in the minority of HC users where that occurs.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health female adults, patients of Planned Parenthood League of Massachusetts
      
Keywords: Headache; Contraception
The Impact of Cytochrome P450 Abnormalities in Patients With Delirium.
Condition: Delirium, Cytochrome P-450 Enzyme System
MeSH terms: Delirium
Study type: Observational

Summary: 
      Objectives:

        1. To examine whether patients with delirium have higher prevalence of cytochrome-P450
           abnormalities compared to patients without delirium.

        2. To examine whether the severity of delirium is related to a specific cytochrome P450
           genotype.

        3. To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome
           p450 abnormalities

        4. To examine whether delirium persistence is impacted by types of medications administered
           during their hospital stay.
    

Detailed description: 
      Delirium is a costly and devastating illness affecting older patients in the hospital. Its
      prevalence increases as patients get older and sicker. There is scientific evidence that
      delirium affects cognitive function for a prolonged period of time and in many cases
      irreversibly. The economic burden on health care and emotional burden on the caregivers of
      patients with delirium is tremendous. We think that our study may contribute to developing
      prevention strategies for delirium in the hospital. We propose genetic testing of older
      patients to determine their ability to metabolize commonly used medications in the hospital.
      This will give medical professionals and pharmacists an ability to adjust dosages of
      medications based on the patient's genetic profile.
    

Intervention name(s): Cytochrome P450 test
Intervention type(s): Diagnostic Test
Intervention description(s): Blood samples will be drawn for cytochrome P450 testing.
Other intervention name(s): CYP2D6, CYP2C9, CYP2C19
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the Rehabilitation Unit at Lutheran General Hospital will be
        approached to participate in this case-control study. Patients will be assigned to the case
        group once identified with delirium by the Psychology staff. Control group will consist of
        patients without delirium upon assessment by the Psychology staff. The Delirious patients
        will then be matched to a control patient hospitalized in the Rehabilitation Lutheran
        General Unit.
      
Biospecimen description: 
      One pink (K2EDTA) 6.0 mL (also acceptable: light blue (3.2% sodium citrate) 2.7 mL)
Concurrent Bupropion / Varenicline for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study focuses on the first step in developing an algorithm for maximizing quit-smoking
      success based on an adaptive approach, which changes treatment from the initial nicotine
      replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT
      "non-responders" are switched (in double-blind fashion) before the quit date to receive
      either varenicline alone or varenicline paired with bupropion. Some participants who would
      otherwise have failed at their quit smoking attempt could be "rescued" by switching to
      alternative pharmacotherapies. The proposed study will evaluate the combination treatment
      against varenicline alone in an adaptive trial design
    


Intervention name(s): Varenicline; Bupropion; Nicotine patches; Nicotine Inhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.; For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.; Nicotine Replacement Therapy Groups:
For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
For smokers with high baseline CO: 42 mg/24 h for 1 week
For smokers with low baseline CO: 21 mg/24 h for 1 week; Nicotine inhaler to use as needed after quit date
Other intervention name(s): Chantix; Zyban; Nicoderm; Nicotrol Inhaler
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nicotine addiction; Cigarette smoking; Smoking cessation; Zyban; Chantix; Nicotine patches; Nicotrol Inhaler; varenicline; bupropion
Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose
      levels in both fasting and postprandial states and preserves pancreatic beta cell function in
      patients with type 2 diabetes. Their mechanism of action is derived from increased incretin
      (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit
      glucagon secretion from pancreas. Recent studies reported that combination therapy with
      DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose
      level, preserving beta-cell mass and function as well as enhancing insulin sensitivity.
      However, there have been few studies about the difference of glucose lowering effect of
      combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of
      pancreas.

      The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may
      have more favorable glucose lowering effect in type 2 diabetic patients who have preserved
      pancreatic secretory function. The researchers plan to investigate the difference of glucose
      lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with
      metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.
    


Intervention name(s): sitagliptin, metformin
Intervention type(s): Drug
Intervention description(s): sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.
Other intervention name(s): Januvia
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Sitagliptin; C-peptide; Glucagon
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a pilot, randomized controlled trial to provide feasibility and conduct
      preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga
      intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have
      demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes
      are available to the public and a specialized yoga protocol for individuals with cLBP is
      needed. This study's goal is to quantify trunk strength and flexibility to better understand
      how these potential physical mechanisms specifically lead to improvement in pain-related
      outcomes including pain and disability. This knowledge will be used to design a large scale
      trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be
      randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will
      receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga
      intervention will be offered weekly yoga classes and instructional materials will be provided
      for home practice.
    


Intervention name(s): Yoga; Self-Directed Mind-Body Program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor
Condition: Malignant Gliomas
MeSH terms: Glioma; Neoplasms
Study type: Observational

Summary: 
      In support of the US marketing application for 5-ALA, this single arm trial is being
      conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly
      diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as
      an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with
      malignant histopathology. The primary objective in this single arm study is to define the
      positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at
      the time of initial resection and first use of FGS by taking a biopsy of tissue presenting
      with red fluorescence when observed during the course of resection of new or recurrent
      malignant gliomas. The functionality and performance reliability of the blue light excitation
      microscope platforms will be assessed.
    

Detailed description: 
      Primary Objectives

        -  To determine whether Gliolan® (5-ALA)-induced PPIX fluorescence correlates with
           malignant tumor histopathology (in a minimum of 3-5 serial biopsies taken from the red
           fluorescent region of tissue resection).

        -  To determine the patient safety profile of both oral Gliolan® (5-ALA), as well as use of
           the fluorescence operative microscope. These will include use of commonly accepted
           toxicity measures as well as recording surgically-related neurological deficits within
           the six weeks after surgery.

        -  To determine functionality and performance reliability of the blue light excitation
           microscope platforms (Zeiss Pentero, Leica OH4, Leica OH6 and others).

      Secondary Objectives

        -  To correlate PPIX-containing extracellular microvesicles recovered from blood (at
           multiple time points prior to and following tumor resection) with the pre-operative MRI
           tumor volume.

        -  To characterize the presence and longitudinal changes in microvesicle biomarkers
           recovered from blood evaluating EGFRvIII, IDH1/2 wt and mutations and others. These
           microvesicular blood genes will be identified and correlated with the same
           microvesicular genes identified in tissue at the time of surgery.
    

Intervention name(s): Gliolan®; Fluorescence-Guided Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively; performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.
Other intervention name(s): 5-ALA; FGS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with new or recurrent malignant gliomas
      
Biospecimen description: 
      whole blood, tumor samples
    
Keywords: Malignant Gliomas; 5-ALA; tumor resection; malignant tumor
NF1-Attention: Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional
Phase: Phase 4

Summary: 
      Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence
      of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be
      common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double
      blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to
      evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents
      Conners' Rating Scale. In a parallel exploratory study we will compare the nature of
      attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. Children aged 7 to
      12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty
      subjects (25 for each period) were required for testing the primary study hypothesis.
    


Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Neurofibromatosis type 1; Attention deficit with hyperactivity disorder school difficulties; methylphenidate
Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
Condition: Ischemia Reperfusion Injury; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after
      ischemic exercise in the non-dominant forearm.
    

Detailed description: 
      3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been
      found to reduce cardiovascular events. This protective effect has been traditionally
      explained by lowering plasma cholesterol and subsequent reduced progression of
      atherosclerosis. However in animal experiments statins have also shown the ability to induce
      pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the
      beneficial effect of statins on reducing of cardiovascular events. In order to differentiate
      between these two mechanisms of protection we will study the effect of atorvastatin on
      ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering
      effect of atorvastatin becomes apparent.
    

Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention description(s): atorvastatine 80mg, during 3 days
Other intervention name(s): lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemia reperfusion injury; atorvastatine; preconditioning; cardiovascular disease
Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized clinical trial assessing the outcome of two surgical strategies to treat
      severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss
      and weight loss maintenance but other factors as body composition, eating pattern, metabolic
      normalisation, energy expenditure will also be assessed.
    


Intervention name(s): Laparoscopic gastric bypass; Laparoscopic VBG
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic gastric bypass surgery; Laparoscopic vertical banded gastroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; weight loss; surgery; gastric bypass; VBG
Connecticut Child STEPs
Condition: Anxiety; Depression; Trauma; Behavior Problems
MeSH terms: Depression; Problem Behavior
Study type: Interventional

Summary: 
      Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of
      MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children
      seeking services at four Department of Children and Families (DCF) funded clinics in the
      state of Connecticut. The study will evaluate child outcomes following two forms of therapist
      training in the MATCH model.
    

Detailed description: 
      This randomized controlled trial (RCT) will investigate the effectiveness of a modular,
      transdiagnostic treatment protocol for youth with anxiety, depression, trauma, and/or
      behavioral problems (MATCH-ADTC) in four DCF funded clinics in the state of Connecticut.
      MATCH synthesizes common elements found across dozens of evidence-based treatments into one
      model that is flexible and responsive to the complex needs of children and families. The RCT
      will evaluate child outcomes following two forms of therapist training in the MATCH model:
      (1) the 6-day MATCH training only; (2) the 6-day MATCH training plus weekly ongoing case
      consultation with a MATCH consultant. Participating children are between the ages of 7 and
      15.
    

Intervention name(s): Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; Monitoring and Feedback System
Intervention type(s): Behavioral; Other
Intervention description(s): MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.; For each child, the web-based MFS provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Brief Problem Monitor (BPM) and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all weeks of treatment.
Other intervention name(s): MATCH; MATCH - ADTC; MFS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; depression; trauma; behavior problems; evidence-based treatments; manualized treatments; cognitive-behavioral therapy; youth; mental health
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Itopride is a new compound that is already marketed in Japan and in some countries of Eastern
      Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia.
      Patients suffering from this condition have difficulties digesting food. They feel full after
      eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to
      see if itopride helps to relieve the symptoms of functional dyspepsia.
    

Detailed description: 
      The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a
      sugar pill called placebo. They have equal chances of receiving either treatment. After
      having completed this study, patients may be eligible to continue treatment for a longer
      period. At that point, all patients receive itopride.

      Patients need to come to the clinic for evaluations 4 times during the trial. Various
      evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the
      heart condition, and questionnaires need to be completed by the patient to see if the drug
      helps them in relieving their symptoms.
    

Intervention name(s): Itopride Hydrochloride; itopride
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg tid; 100 mg three times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional dyspepsia; Abdominal Symptom relief; Fullness; Bloating; Indigestion