bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation
Condition: Non-cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of
      this study is to find out how a medicine called BI 1323495 is tolerated by people with
      non-cystic bronchiectasis.

      The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is
      decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or
      placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but
      do not contain any medicine. Participants can also continue taking standard medicines for
      noncystic bronchiectasis throughout the study.

      Participants are in the study for about 4 months. During this time, the participants visit
      the study site about 11 times and get about 2 phone calls. At the visits, doctors check the
      health of the participants and note any health problems that could have been caused by BI
      1323495.
    


Intervention name(s): BI 1323495; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1323495; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dried Plums and Chronic Disease Markers
Condition: Healthy, Postmenopausal Women
Study type: Interventional

Summary: 
      This study evaluates whether the consumption of California dried plums can be beneficial to
      your health. Previous studies using dried plums have shown beneficial effects on bone and
      cardiovascular health. In addition the investigators hope to learn how dried plums might
      change your bowel habits, and if the carbohydrates in the plums are fermented in your
      digestive tract.
    

Detailed description: 
      The aging of the U.S. population presents a number of challenges, many of which that can be
      addressed through nutritional approaches. Postmenopausal women are particularly at-risk for a
      number of diseases such as osteoporosis (By 2020 it is estimated that 50 percent of women at
      50 years and older will either suffer from or be at-risk of bone loss), and cardiovascular
      disease, the number one killer of postmenopausal women. Polyphenolic compounds in fruits and
      nuts have been the focus of extensive research regarding their potential to reduce risk for a
      number of chronic diseases. All fruits are not created equally, so determining if dried plums
      (Prunus domestica L.) have certain phytochemicals in amounts that promote health when
      consumed in realistic amounts is important. This demonstration is likely to impact market
      demand for dried plums. Indeed, favorable research on other California specialty crops
      (walnuts, almonds, strawberries, grapes) is a key strategy to help growers increase sales.

      While hundreds of plum cultivars exist, with varying amounts of phenolic compounds, the
      process of drying results in high amounts on hydroxycinnamic acids, a family of compounds
      that have been shown, in animal models, to be protective of bone health by both reducing bone
      loss and improving bone growth. Hydroxycinnamic acids have also been proposed to improve
      vascular function by protecting the smooth endothelial lining of the blood vessels in animal
      models. Whether these encouraging observations also occur in humans is unknown. Therefore,
      the overall objective of this project is to conduct the first human study exploring the
      effects of California dried plums on markers of bone health and vascular function. Favorable
      results from this project will increase awareness of the unique benefits of dried plums for
      bone health and vascular health, two topics of great interest to aging baby boomers and other
      health-conscious consumers, both in the U.S. and internationally.
    

Intervention name(s): Two Dried Plums per day; Six Dried Plums per day
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume Two Dried Plums per day; Subjects will consume Six Dried Plums per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess the safety and tolerability of ascending multiple
      oral doses of SCA-136 administered to healthy Japanese male subjects.
    


Intervention name(s): SCA-136
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care
Condition: Stress, Psychological; Burnout, Professional; Adjustment Disorders
MeSH terms: Burnout, Professional; Mental Disorders; Psychotic Disorders; Stress, Psychological; Adjustment Disorders
Study type: Interventional

Summary: 
      The aim of this project is to develop a model for return to work (RTW) for patients sick
      listed due to stress related mental disorders, which takes into account each patient's
      specific situation; includes the workplace, and is well adapted to the Swedish primary care
      setting.

      In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and
      private primary care centers will be offered a one-day training about work and workability
      for patients with stress related mental disorders. Also, the participants will be trained in
      a specific method that includes the patient's employer early in the rehabilitation process

      The project has a quasi-experimental and longitudinal design. The intervention will be
      conducted on 15 different primary care centers, which will be matched with a comparison
      group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18
      months after sick-listing. The hypothesis is that patients who are sick-listed at primary
      care centers that completely or partially implemented the specific method on average will
      return earlier to work than patients sick-listed at primary care centers that did not
      implement the method.

      Alongside studying if the intervention has an effect on the patients' RTW over time, the
      investigators aim to investigate the mechanisms explaining the effects and the individual and
      organizational level (primary care units) circumstances necessary for these mechanisms to be
      triggered. To gain deeper knowledge about mechanisms and context, the investigators will
      conduct interviews with the treatment staff and collect registry data about the primary care
      units.
    


Intervention name(s): Work-related measures
Intervention type(s): Behavioral
Intervention description(s): After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exhaustion Disorder
Clinical and Immunohisochemical Evaluation of Chemopreventive Effect of Thymoquinone on Oral Potentially Malignant Lesions.
Condition: Premalignant Lesion
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to
      75 years) suffering from oral potential premalignant lesions. Patients will be randomly
      assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B:
      Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
    

Detailed description: 
      The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to
      75 years) suffering from oral potentially premalignant lesions. Patients were randomly
      assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B:
      Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
    

Intervention name(s): Nigella sativa buccal tablets 10mg; Nigella sativa buccal tablets 5mg; Placebo buccal tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg; thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg; capsules with the same color and form as the active ones but without active ingredient will be given to the patients
Other intervention name(s): Nigella Sativa; thymoquinone; Nigella Sativa; thymoquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
Condition: ATROPHIC ACNE SCARS
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Microneedling with topical INSULIN is a simple, effective tool for building body's new
      collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The
      skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure
      that can be performed in the office without complications, with a good cost-benefit because
      it is economically viable without any effect on patient's daily activities. 9
    


Intervention name(s): PRP( platelet rich plasma) and Insulin human
Intervention type(s): Drug
Intervention description(s): Microneedling with autologus PRP reduces inflammationin acne scars. Insulin human is a new topical drug which is used nowadays for acne scars as it is more effective in producing collagen formation as well as new blood vessel formation
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
Condition: Hypertension; Coronary Atherosclerosis
MeSH terms: Hypertension; Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients with hypertension who undergo elective PCI, the effects of long-term
      administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively
      by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).
    

Detailed description: 
      Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events
      in patients with coronary artery disease. Recently, suppression of the development of
      coronary atherosclerotic plaque by calcium antagonists has been reported as one of the
      mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing
      the progression of the coronary atherosclerosis. Various calcium antagonists are clinically
      available at present and these drugs may differ from each other with respect to the
      anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare
      the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque
      quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5
      mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI.
      The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks
      after PCI. Percent change in plaque volume from the baseline value will be used as the
      primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group
      for a total of 200 patients.
    

Intervention name(s): Calcium channel blockers (amlodipine, azelnidipine)
Intervention type(s): Drug
Intervention description(s): Drug: amlodipine Drug: azelnidipine
Intervention MeSH terms: Amlodipine; Calcium Channel Blockers; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; PCI; Calcium Channel Blockers; IVUS; Plaque
A Trial of Grazax in Subjects With Hayfever
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to evaluate the efficacy and safety of specific immunotherapy with
      Grazax for treatment of grass pollen induced allergy.
    


Intervention name(s): Grazax
Intervention type(s): Drug
Intervention description(s): Tablets 75,000 SQT and matching placebo. One tablet daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BiPAP for Cardiomyopathy With Central Sleep Apnea
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional

Summary: 
      We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive
      airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would
      improve LV function.
    


Intervention name(s): bilevel positive airway pressure; bilevel positive airway pressure (Device)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Stress on Heroin-Related Memory Retrieval
Condition: Heroin Dependence; Learning and Memory
MeSH terms: Heroin Dependence
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cortisol and propranolol are effective in
      the modulation of stress induced heroin-related retrieval enhancement.
    


Intervention name(s): propranolol and cortisol
Intervention type(s): Drug
Intervention MeSH terms: Hydrocortisone; Propranolol
Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the persistence of the immune response of GSK134612
      vaccine up to 68 months after vaccination in the primary vaccination study (NCT number =
      NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and
      immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary
      vaccination study with either GSK134612 vaccine or Menjugate®.

      This protocol posting deals with objectives & outcome measures of the persistence and booster
      epochs. The objectives & outcome measures of the primary epoch are presented in a separate
      protocol posting (NCT number = NCT00674583)
    

Detailed description: 
      Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with
      Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood
      samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects
      will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood
      sample will be taken 1 month after administration of the booster dose.
    

Intervention name(s): Nimenrix (GSK134612 vaccine); Menjugate
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular, 1 dose; Intramuscular, 1 dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Persistence; Safety; Conjugate vaccine; Meningococcal vaccine
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of
      birch pollen induced allergy
    

Detailed description: 
      Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
    

Intervention name(s): Sublingual immunotherapy; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): once daily intake of sublingual drops; once daily intake of sublingual drops
Other intervention name(s): SLITone(TM) Birch
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Valproic Acid and Its Effects on HIV Latent Reservoirs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether the co-administration of valproic acid
      (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV
      latent reservoirs in infected CD4 cells.
    

Detailed description: 
      Participants must be on HAART with a suppressed viral load (< 50 copies/ml) for at least the
      previous 12 months. They will be randomly assigned to one of two groups, one group will start
      the valproic acid right away at week 1 for 16 weeks, and the other group will wait until week
      17 to add valproic acid to their treatment for 32 weeks. Subjects will be followed every four
      weeks for one year and evaluated by a variety of assays, all carried out using
      well-established methods, to assess the main outcome defined by changes in HIV reservoir size
      measured by the mean frequency of resting CD4 memory cells carrying HIV proviral DNA.
    

Intervention name(s): Valproic Acid; HAART
Intervention type(s): Drug; Drug
Intervention description(s): Oral valproic acid twice daily for 16 or 32 weeks. Dosage varies based on plasma levels.; As per standard of care.
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infections; Histone deacetylase Inhibitor; HIV Reservoirs; Peripheral Blood Mononuclear Cells; Valproic Acid; Treatment Experienced
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
Condition: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to evaluate the safety and tolerability of cinacalcet
      after a single oral dose in children aged 28 days to less than 6 years with chronic kidney
      disease receiving dialysis.
    


Intervention name(s): Cinacalcet
Intervention type(s): Drug
Intervention description(s): Single, oral dose of 0.25 mg/kg cinacalcet
Other intervention name(s): Sensipar®; Mimpara®
Intervention MeSH terms: Cinacalcet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; CKD; dialysis; paediatric
Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori
Condition: Helicobacter Pylori Eradication Rate
Study type: Interventional
Phase: Phase 4

Summary: 
      Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1),
      especially 47-66% in China.
    


Intervention name(s): Modified non-clarithromycin triple therapy; Sequential therapy
Intervention type(s): Drug; Drug
Intervention description(s): H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.; H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Sequential therapy; Modified non-clarithromycin triple therapy
Health Related Quality of Life of Youth and Young Adults With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The relevance of the study will be in establishing whether Health Related Quality of Life
      (HRQoL) measures obtained repeatedly during hemophilia care are sensitive to significant
      changes in health or personal circumstances related to the transition from youth to
      adulthood. This may support the future use of HRQoL measures as part of routine care in order
      to identify important changes that are not detectible by other clinical means.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study is focused on youth (14.0 to 18.0 years of age) and young adults (18.01 to 29.99
        years of age), living in Canada, who have moderate and severe Hemophilia A, and who are
        using Helixate FS either on-demand or as prophylaxis treatment.
      
Keywords: Quality of Life; HRQoL; Hemophilia A; Helixate FS
Vigorous Exercise for Depressed Smokers
Condition: Nicotine Dependence; Depression
MeSH terms: Tobacco Use Disorder; Depression
Study type: Interventional

Summary: 
      In this project the investigators will develop and pilot test a supervised, vigorous
      intensity exercise intervention for depressed female smokers. If the pilot intervention is
      successful the investigators will have a blueprint for a large randomized controlled trial.
      The long term objective is to develop interventions for depressed women that will ultimately
      reduce their risk of tobacco-caused disease and mortality.
    

Detailed description: 
      This project will be the first to evaluate supervised vigorous exercise for depressed smokers
    

Intervention name(s): exercise; health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): vigorous intensity exercise; education
Other intervention name(s): physical activity; health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; depression; smoking