bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo
      administered orally, on airway function, lung volume, and quality of life in patients with
      chronic obstructive pulmonary disease (COPD)
    


Intervention name(s): QBW251; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QBW251 capsule(s) taken orally twice per day; Matching placebo capsule(s) taken orally twice per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD,; chronic bronchitis,; inflammation,; airway,; LCI,; pulmonary function test,; lung function,; controlled clinical trial,; randomized,; airflow,; smoker
Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
Condition: Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than
      5%. About 25% of patients have the opportunity for radically surgical resection when
      diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical
      trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced
      overall survival for patients who have undergone surgery to remove their tumor.
      Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies
      showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival
      and overall survival of metastatic pancreatic cancer patients. The present study is intended
      to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel
      as adjuvant chemotherapy in treating patients with pancreatic cancer after curative
      resection.
    


Intervention name(s): nab-paclitaxel; gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.; Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
Other intervention name(s): Abraxane; GEMZAR
Intervention MeSH terms: Paclitaxel; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; Pancreatic Adenocarcinoma; Nab-paclitaxel; Gemcitabine; Adjuvant Therapy
Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      this study was to compare the early and short-term effects of high-frequency transcutaneous
      electrical nerve stimulation (TENS) versus connective tissue manipulation (CTM) in
      participants with primary dysmenorrhea. Half of the participants received CTM, while the
      other half received TENS.
    

Detailed description: 
      CTM and TENS each relieve dysmenorrhea pain, but they do so by different. The electrotherapy
      modality that is most commonly used in the treatment of dysmenorrhea is TENS. It has been
      reported in studies that high-frequency TENS is more effective in reducing pain than either
      low-frequency TENS or placebo TENS.

      A scan of the literature reveals that although there are differing opinions and applications
      related to the number and duration of CTM, it has been shown that women with primary
      dysmenorrhea experience reduced pain after CTM,
    

Intervention name(s): Connective Tissue Manipulation; Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Other; Other
Intervention description(s): The application was delivered with the participant in a sitting position, with the entire back and sacral regions left exposed. The treatment was administered to the sacral, lower thoracic and pelvic regions.; TENS was administered with the participant lying face down with a flat cushion underneath the abdomen. TENS was administered via 2 channels of electrodes placed with the sacral region in the middle. The intensity of the current was increased until the participant felt it.
Other intervention name(s): CTM; TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary dysmenorrhea; Connective tissue manipulation (CTM); Transcutaneous electrical nerve stimulation (TENS); Pain
Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
Condition: Bone Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      Prostate and breast cancer continues to be the most common cancer among men and women,
      respectively. The exact assessment of the cancer spread with detection of possible bone
      metastasis is crucial for treatment decision. In the current study 50 patients with prostate
      cancer and 50 patients with breast cancer at high risk for bone metastases or with know
      metastatic disease will be studied with multiple imaging modalities. Patients will be
      recruited from the Department of Oncology, Turku University Hospital. Planar bone
      scintigraphy (BS), single photon emission computed tomography combined with low-dose computed
      tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT)
      and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective
      is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is
      to calculate the sensitivities and specificities of the four imaging modalities on a
      patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal
      imaging protocol for detection of prostate and breast cancer bone metastasis will be
      developed and validated.
    


Intervention name(s): BS, SPECT/CT, PET/CT, MRI
Intervention type(s): Radiation
Intervention description(s): Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Alveoscopy, Endoscopic Confocal Microscopy and Lung Rejection, Parenchymal Lung Diseases in Vivo
Condition: Lung Transplant
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Lung transplantation is indicated when end-stage lung diseases no longer respond to available
      standard therapy, making life expectancy short and associated with disability. Acute and
      chronic rejection are common complications following transplantation, indicating screening
      bronchoscopies and transbronchial biopsies at three month intervals the first two years, in
      addition to clinically indicated procedures when rejection or infection is suspected.
      Transbronchial biopsies carry associated risks (bleeding, pneumothorax). Chronic rejection is
      characterized by progressive obliteration of distal airways (Bronchiolitis Obliterans-BO-).
      BO requires open lung biopsy for diagnosis. Alternatively, a clinical surrogate
      (Bronchiolitis Obliterans Syndrome), characterized by decline in Forced Expired Volume in 1
      second not explained by acute rejection or infection is used for diagnosis. The new technique
      of confocal endo-microscopy enables sub-surface visualization of tissue in vivo during
      bronchoscopic procedures using a probe-based confocal microscope, integrated to a standard
      endoscope. Bronchiolar and alveolar structures can be visualized at a cellular and nuclear
      level, and these images can be saved and reviewed. This new technology could potentially
      identify acute and chronic rejection, thus offering and alternative to transbronchial
      biopsies. We expect to describe a new alternative to diagnose acute and chronic rejection
      using confocal microscopy images obtained endoscopically, obviating complications of
      transbronchial biopsies.

      Endoscopic confocal endomicroscopy can detect and classify common bronchiolar and alveolar
      pathological conditions in real time. Specifically, we hypothesize that confocal
      endomicroscopy images of bronchiolar and alveolar structures during standard bronchoscopy
      could help to recognize and classify the presence/absence of acute rejection and/or
      bronchiolitis obliterans syndrome in lung transplant recipients. This technology could also
      identify the histological characteristics lung diseases such as interstitial, obstructive or
      vascular end stage lung diseases, and thus lead to more efficient, safer and more accurate
      diagnosis of these lung conditions during routine bronchoscopies.
    


Intervention name(s): Confocal imaging
Intervention type(s): Other
Intervention description(s): At the time of the standard of care bronchoscopy, confocal images will be obtained from each consented patient.
Other intervention name(s): AlveoloFlex Confocal Miniprobes; Cellvizio-Lung system
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled to undergo bronchoscopy either before or after lung transplantation.
      
Keywords: Lung rejection
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To measure the effectiveness of influenza vaccination in school children by comparing,
      between target(i.e., children are offered FluMist) and control (i.e., children are not
      offered FluMist) school families.
    


Intervention name(s): FluMist
Intervention type(s): Biological
Intervention description(s): 0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CAPTURE Registration Trial of the Thrombectomy System for the Treatment of Acute Ischemic Stroke.
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      As this will be a pre-market registration trial, in which devices will be used in accordance
      with appropriately labeled indications, pre-study notifications and approval requests will be
      addressed with CFDA. All trial results will be shared with CFDA.
    


Intervention name(s): Stent Retriever
Intervention type(s): Device
Intervention description(s): Stent Retriever for acute ischemic stroke
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily
      (both administered in combination with other anti-diabetic drugs) based on the change in
      HbA1c from baseline to 24 weeks
    

Detailed description: 
      This trial is a multi-center, open-label, randomized, parallel group trial in patients with
      T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®.
      Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the
      selection criteria will be included in the trial. This will be followed by a 24-week
      randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine
      or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will
      be a follow-up visit; 4 weeks after the patient has been put back on approved medications.
    

Intervention name(s): Mylan's insulin glargine; Lantus®
Intervention type(s): Drug; Drug
Intervention description(s): Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.; For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Antidepressants in Chronic Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This 12 week placebo controlled clinical trial tests the individual and combined effects of
      an antidepressant medication and cognitive behavioral therapy for chronic back pain.
    

Detailed description: 
      This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low
      concentration desipramine (< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration
      desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine
      mesylate).
    

Intervention name(s): cognitive behavioral therapy; desipramine hydrochloride; cognitive behavioral therapy; benztropine mesylate 0.125 mg daily; desipramine hydrochloride
Intervention type(s): Behavioral; Drug; Behavioral; Drug; Drug
Intervention description(s): cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life; desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml; cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life; benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride; desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other intervention name(s): Anafranil; Cogentin; Anafranil
Intervention MeSH terms: Benztropine; Desipramine; Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; back pain; antidepressants
Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma
Condition: Multiple Myeloma; Auto Stem Cell Transplant
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      High dose chemotherapy with stem cell transplantation is commonplace in the treatment of
      multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used
      in several thousand bone marrow transplant recipients worldwide for the same or similar
      disorders.
    

Detailed description: 
      Many patients with multiple myeloma receive 2 stem cell transplantations within a few months
      of each other as part of their treatment. Usually the drug Melphalan is used for both
      transplants.

      Bortezomib is a drug that is used for treating multiple myeloma and has been used in
      combination with melphalan for stem cell transplantation for patients with multiple myeloma.

      The purpose of this trial is to study the effects of doing 2 transplants, first using
      melphalan and second using melphalan and bortezomib. The trial is aiming to find out if
      adding the Bortezomib to the second transplant will increase the chances of staying in
      remission longer.
    

Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): Bortezomib 1.6mg/m2 on day -4 and day -1
Other intervention name(s): Velcade
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Cytokines in Children With Opsoclonus-Myoclonus Syndrome
Condition: Opsoclonus-myoclonus Syndrome
MeSH terms: Opsoclonus-Myoclonus Syndrome; Myoclonus; Ocular Motility Disorders; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine if cytokines, inflammatory mediators, are increased
      in spinal fluid and blood, correlate with disease activity, and could serve as biomarkers or
      therapeutic targets in children with opsoclonus-myoclonus syndrome (OMS), an autoimmune
      complication of the tumor neuroblastoma.
    

Detailed description: 
      In this translational research, immunological mechanisms that underlie the assault of the
      immune system on the brain in paraneoplastic opsoclonus-myoclonus syndrome (OMS) are under
      evaluation. To test our principal hypothesis that there is an imbalance of pro-inflammatory
      (Th1) and anti-inflammatory (Th2) cytokines in OMS, a comprehensive cytokine panel will be
      measured by enzyme-linked immunosorbent assay (ELISA) and multiplexed fluorescent bead-based
      immunoassay detection (LUMINEX 100 Lab MAP system)in blood and cerebrospinal fluid (CSF) of
      400 children. To test the second hypothesis that cytokines could serve as biomarkers of
      disease activity in OMS, cytokine concentrations will be correlated with clinical variables,
      such as disease severity, OMS duration, prior relapses, and remissions, as well as
      immunological variables, such as lymphocyte subset analysis. The cytokine 'biomarker profile'
      could aid decision making for early intervention by identifying children at high risk for
      relapse and poor outcome and allow targeting of the most implicated inflammatory cytokines by
      cytokine therapies. To test our third hypothesis that lack of response to immunotherapy is
      due in part to failure to increase the expression of anti-inflammatory Th2 cytokines, we will
      make paired pre/post comparisons of the impact of immunotherapies given in the course of
      clinical care [steroids, adrenocorticotropin (ACTH), intravenous immunoglobulins (IVIg),
      rituximab, chemotherapy, other drugs, combinations] on the cytokine and clinical profile.
      This research could lead to the application of commercially-available cytokines and cytokine
      blockers or to the development of new ones for OMS.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Referrals to National Pediatric Myoclonus Center Website, www.omsusa.org
      
Biospecimen description: 
      serum, plasma, cerebrospinal fluid
    
Keywords: paraneoplastic; neuroblastoma; Kinsbourne syndrome; autoimmune disease; immunotherapy; ataxia
Coffee Interaction With the Antihypertensive Drug Felodipine
Condition: Food-Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Coffee is a globally popular beverage. More than half of the United States population spends
      an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits
      can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for
      less than one day per week consumption in one survey. In the case of occasional consumption,
      coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This
      pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups
      of coffee. A major active constituent in coffee is caffeine, which is the most widely used
      pharmacological substance in the world.

      Drug therapy plays a major role in the management of hypertension. However, the interaction
      between coffee or caffeine and blood pressure lowering drugs has been assessed in only three
      clinical studies that were reported more than three decades ago.

      We conducted a comprehensive interaction study involving a commonly ingested amount of a
      particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral
      (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics
      were evaluated.
    


Intervention name(s): Black Coffee; Grapefruit Juice; Water; Felodipine
Intervention type(s): Other; Other; Other; Drug
Other intervention name(s): Plendil; Renadil
Intervention MeSH terms: Felodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coffee; Grapefruit Juice; Felodipine; Calcium Channel Blocker; Hemodynamics; CYP3A4
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
Condition: HIV Infections
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the physiological and immunological responses in healthy HIV seronegative adult
      volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope
      glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will
      include:

        1. The course of physiological responses to vaccination, including (a) lesion development,
           progression, and resolution; (b) physiological changes such as temperature, malaise,
           itching at the site, etc. and (c) any observable AE.

        2. The appearance, identity, quantity, and duration of humoral antibodies against HIV and
           vaccinia virus.

        3. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV
           and vaccinia virus.

        4. The adequacy of a procedure using a special dressing to contain viral shedding from the
           vaccination site.

        5. The safety, humoral and cellular immune responses of a booster injection of the
           recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.
    


Intervention name(s): Smallpox Vaccine; HIVAC-1e; gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; Smallpox Vaccine; HIV-1; AIDS Vaccines; HIV Seronegativity