bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Condition: Advanced Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to collect health economic data depicting the initial
      levels and natural progression over time of resource usage, Parkinson's disease (PD)-related
      costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients
      treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about
      one-third were Duodopa-naïve prior to the start of the study.
    


Intervention name(s): Levodopa-carbidopa intestinal gel (LCIG); CADD-Legacy® 1400 ambulatory infusion pump; percutaneous endoscopic gastrostomy tube (PEG tube); jejunal extension tube (J-tube)
Intervention type(s): Drug; Device; Device; Device
Other intervention name(s): DUOPA™ (carbidopa and levodopa Enteral Suspension); DUODOPA®; ABT-SLV187
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Health economics,Quality of life
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
Condition: Chronical Rotator Cuff Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      In the first part of the the study two new outcome measurements (force reproducibility and
      subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be
      assessed.

      In a second part of the study 60 patients will be randomly allocated to two groups. Group A
      (n=30) will perform a traditional training program and group B (n=30) will perform an
      eccentric training program.

      Before the onset of the training programs, pain, function, maximal force, range of motion,
      subacromial space and force reproducibility will be assessed. Both training programs will be
      accomplished at home. The first six weeks there will be an appointment with the therapist
      once a week to explain, correct and when necessary, aggravate the exercises. The next six
      weeks these appointments will be diminished to once every two weeks.

      After 6 and after 12 weeks of training the patients will be reassessed for all the
      parameters.
    


Intervention name(s): Eccentric training program; Traditional training program
Intervention type(s): Procedure; Procedure
Intervention description(s): Eccentric training program; Traditional training program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients
Condition: Head and Neck Cancer Patients
MeSH terms: Xerostomia
Study type: Interventional
Phase: Phase 4

Summary: 
      Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) .
      The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012).
      Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells,
      and so affecting the quality of life of patients. Honey is one of the methods studied by CIM
      for management of HNC treatment side effects due to its properties. (Brennan et al., 2002;
      Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).

      Thyme honey is a new alternative for management of xerostomia, which is a propolis gel
      product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of
      thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating
      health effects. Due to the high sugar concentration in honey, it is believed that its
      presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to
      produce saliva.
    

Detailed description: 
      28 post radiation cancer patients were randomly assigned into two equal groups.The
      intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified
      water) 3 times per day starting in the 4th week of radiotherapy and for one month after
      completion of radiotherapy. Patients in the control arm followed the same protocol with
      normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry
      mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and
      one month after starting of the treatment protocol (Charalambous et al., 2017).

      Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et
      al., 2020).
    

Intervention name(s): thyme honey mouth rinse; saline mouth rinse
Intervention type(s): Drug; Drug
Intervention description(s): oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017); saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: xerostomia; thyme honey; nitric oxide
Enoxaparin Versus Aspirin in Patients With Cancer and Stroke
Condition: Cancer Patients First-ever Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      Patients with cancer who develop stroke are at high risk for future strokes or other clotting
      events. These patients are routinely treated with medicines that thin their blood, including
      enoxaparin or aspirin. However, it is unclear which medicine is best and whether these
      medicines can be adequately studied in a clinical trial.

      The purpose of this Phase I/II study is to determine if a clinical trial of different blood
      thinners in patients with cancer and stroke is possible. In addition, the study aims to
      compare the effects, good and/or bad, of enoxaparin with those of aspirin on patients with
      cancer and recent stroke.
    


Intervention name(s): Enoxaparin; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.; Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
Intervention MeSH terms: Aspirin; Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enoxaparin; Aspirin; stroke; 12-264
Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort
Condition: Exposure; Health Behavior; Environment
Study type: Interventional

Summary: 
      ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of
      the life course, which will integrate data on the external, chemical, physical,behavioral,
      and social domains of the exposome, as well as on health outcomes and biological omics
      responses, from preconception until adolescence. As part of ATHLETE, the investigators will
      follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).
    


Intervention name(s): HELIX's follow-up
Intervention type(s): Other
Intervention description(s): Visit 1 (Day 0): clinical examination (anthropometry, bioimpedance, blood pressure,spirometry), neurodevelopment computer testing, questionnaires (Physical activity,diet, psychological distress, tobacco exposure, pubertal development, sleeping patterns, light exposure before going to sleep, outdoor environment (green spaces, noise), address history, home environment, socio-economic status, noise, psychological distress, medical history, medication use) 7 consecutive days (minimum) of personal exposure monitoring including wearing an actigraph, a Smartphone (GPS data), carrying a NO2 diffusion tube, collection of hair, stool, urines (2 urines during 6 consecutive days) and filling a sleep and physical activity diary
Visit 2 (Day 8): blood collection early in the morning and collection of all the 7- days personal monitoring material, and stools and urines samples.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
Condition: Metastatic Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety
      run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when
      given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind,
      placebo controlled comparison of the efficacy, safety and tolerability of the dose of
      olaparib selected from Part A when given in addition to abiraterone, versus placebo given in
      addition to abiraterone. Abiraterone is indicated in combination with prednisone or
      prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5
      mg twice daily (bid) will be administered with the abiraterone in this study.
    

Detailed description: 
      This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety
      run-in study to assess the safety, tolerability and PK of olaparib when given in addition to
      abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled
      comparison of the efficacy, safety and tolerability of the dose of olaparib selected from
      Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.

      Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of
      patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with
      the abiraterone in this study, but throughout this protocol the treatment will be referred to
      simply as abiraterone.

      For Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be
      enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12
      patients may be recruited into a 3rd cohort if necessary.

      For Part B of the study, approximately 140 patients who have received prior chemotherapy
      containing docetaxel will be randomised from approximately 40 sites in North America and
      Europe. Patients who have been dosed in Part A of the study may not participate in Part B.
    

Intervention name(s): Olaparib; Placebo; Abiraterone; Prednisone or prednisolone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Olaparib bid; Placebo bid; Abiraterone 1000 mg; Prednisone or prednisolone 5 mg bid will be co-administered with the abiraterone in this study.
Other intervention name(s): PARP inhibition; Placebo to PARP inhibition
Intervention MeSH terms: Prednisone; Prednisolone; Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Olaparib; castration-resistant, metastatic prostate cancer; Prior Docetaxel Chemotherapy
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating
      women who have stage III breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the clinical and pathological response rate of sequential doxorubicin and
           docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast
           cancer.

        -  Measure signal transducer and activator of transcription (STAT) activation before and
           after this neoadjuvant chemotherapy regimen in this patient population.

        -  Correlate response to chemotherapy with STAT activation before and after this
           neoadjuvant chemotherapy regimen in these patients.

        -  Determine how other potential predictors of response correlate with STAT activation by
           measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the
           tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in
           these patients.

        -  Correlate response to chemotherapy with levels of STAT activation in association with
           the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and
           apoptotic index in these patients.

        -  Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense
           fashion in these patients.

      OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks
      of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses.
      Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and
      docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo
      surgery with mastectomy or lumpectomy and axillary lymph node dissection.

      PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.
    

Intervention name(s): Filgrastim; Docetaxel; Doxorubicin; Surgery
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention description(s): Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.
Other intervention name(s): G-CSF; Taxotere®; doxorubicin hydrochloride; Adriamycin; Rubex
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer
Dynamics of Stroke Volume and Cardiac Output During Parabolic Flight, and Its Relationship to Intravascular Volume
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      To understand the cardiovascular reactions of the human body to changing conditions of
      gravity is an important aim of space science. In this context, cardiac output (CO) is a key
      value to estimate the human cardiovascular system.

      The main objective of this experiment is to determine the effects of parabolic flight on
      intravascular volume, and how these changes modulate the complex haemodynamics induced by the
      parabolas.
    


Intervention name(s): Parabolic flight; plasma volume measurements
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Health Mindset as a Driver of Efficacy of a Diabetes Prevention Program in the Blackfeet Community
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall goal of this project is to understand whether the established Diabetes prevention
      program works to reduce diabetes risk by shifting mindsets about health.
    

Detailed description: 
      The Diabetes Prevention Program (DPP), a lifestyle intervention which aims to modify health
      behaviors, has reduced diabetes risk across several American Indian Communities. However,
      there were significant attrition rates, and non-completers were at the highest risk at
      baseline. One's mindset about health (i.e. whether it is fixed or malleable) may affect their
      likelihood of completing the intervention and its efficacy in reducing risk. With an existing
      CAB, I will develop a culturally congruent adaptation of the DPP, the Mindset-DPP (M-DPP).
      The M-DPP will include a discussion of mindset in each session and will present material
      focused on the plasticity of health, including evidence that one's mindset can affect
      outcomes that relate to risk for diabetes. The investigators will implement the DPP and the
      MDPP in a sample of 40 Blackfeet community members at risk for diabetes and test whether the
      M-DPP associates with greater shifts towards a growth health mindsets (i.e. health can be
      changed by effort) compared to the DPP, and whether the M-DPP associates with greater
      increases in physical activity levels and greater reductions in waist circumference, and
      greater retention compared to the standard DPP.
    

Intervention name(s): Diabetes Prevention Program; Health Mindset modified diabetes prevention program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is the established Diabetes prevention program curriculum.; This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will receive the original diabetes prevention program curriculum, and other group will receive modified health mindset curriculum.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the behavioral effects of alcohol during maintenance on placebo,
      duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated
      human laboratory methods.
    


Intervention name(s): Alcohol; Placebos; Duloxetine; Methylphenidate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.; Subjects will receive placebo capsules.; Subjects will receive duloxetine capsules.; Subjects will receive methylphenidate capsules.
Intervention MeSH terms: Duloxetine Hydrochloride; Methylphenidate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial
Condition: Myopia
MeSH terms: Myopia; Disease Progression
Study type: Interventional
Phase: Phase 4

Summary: 
      Orthokeratology is becoming popular for the treatment of myopia children. Many studies have
      shown that orthokeratology is effective in temporarily reducing refractive error, and is also
      helpful for controlling myopia progression. However, the mechanism for its slowing myopia
      progression and rebound effect after the treatment have not been clearly studied. In
      addition, the effect of orthokeratology among Chinese children has not been evaluated with
      randomized controlled trial.This study is to assess the effect of orthokeratology versus
      spectacles on myopia progression in school-aged Chinese children during two years.
    


Intervention name(s): Orthokeratology; Spectacle
Intervention type(s): Device; Device
Other intervention name(s): Glasses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myopia progression; Orthokeratology
Parent-Adolescent Interpersonal Processes in the Science of Behavior Change
Condition: Sleep Deprivation; Adolescent Behavior
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This study seeks to examine a novel interpersonal target; namely, parent-teen conversations
      about youth health behavior change. The rationale is that parents have profound impacts on
      teen risk and vulnerability. Yet parents receive minimal training in the elements of
      conversations that optimally inspire their children toward engaging in healthy behaviors. A
      theoretically grounded and reliable taxonomy of behavior change techniques (BCTs) will be
      used as a basis for scientifically deriving the conversational elements, or micro-mechanisms,
      that reduce parent-teen conflict and facilitate upward spirals of healthful behavior change.
      This proposal builds on pilot data from a recently completed NICHD-funded R01 in which a
      sleep treatment improved sleep and reduced risk on selected outcomes in youth. While
      sleep-related health behaviors will be the focus of this R21, the research is designed to be
      relevant to a broad range of health behavior change. As part of an Administrative Supplement
      to the R21 awarded in Fall, 2019, two changes are made. First, measures of psychophysiology
      have been added to the Hot Topics Task. Second, an independent sample of teens who are
      healthy sleepers (n = 20), and their parents, will be tested on the protocol twice, 9 weeks
      apart. This comparison group is included to control for the passage of time and for
      completing the protocol twice. They do not receive an intervention.
    


Intervention name(s): Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)
Intervention type(s): Behavioral
Intervention description(s): PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment