bioihbjkbjnl/mcl2 huggingface dataset:
ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of transcranial direct current
      stimulation (tDCS) on patients with Parkinson's disease during sleep.
    

Detailed description: 
      The clinical study will follow a counterbalanced crossover design during which subjects will
      undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS
      (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the
      sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second
      sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order
      such that approximately half of the subjects receive active tDCS first while the other half
      receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
    

Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Procedure; Procedure
Intervention description(s): Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour; Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Transcranial direct current stimulation
Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)
Condition: Platelet Transfusion; Hematological Malignancy; Palliative Care
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Observational

Summary: 
      Limited data is available for end of life care in hematologic malignancies, moreover with
      thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow
      involvement in those diseases or its treatments. Yet, a few studies was interested in,
      whereas platelet transfusion is the only treatment indicated. As it represent a scarce,
      limited resource, the ethical principles are in conflict in this setting and there's a lack
      of recommendation. The final decision is take by the clinician and his patient, but no study
      exist in representation of the two parts. We provide a qualitative study to understand what
      this decision is made of.
    


Intervention name(s): multi method questionary (developped by De Rosa, in 1995 and 2014)
Intervention type(s): Other
Intervention description(s): questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with advanced hematological malignancies, transfused in platelet regulary,
        hematologist's nurses who practice platelet transfusion and hematologist who prescribe the
        transfusion.
      
Keywords: social representation
A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer
Condition: Breast Cancer; Neoplasm Metastasis
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison
      with standard AC for metastatic breast cancer
    

Detailed description: 
      power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs.
      AC-D.

      Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03.
      Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia
      (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D
      and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and
      35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7
      months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4,
      25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was
      shown by the adjusted Cox model.

      Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D
      tended to be superior to AC in response rate and overall survival. Survival benefit of
      front-line docetaxel should be re-evaluated by further long follow-up.
    

Intervention name(s): AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles; Docetaxel 60mg/m2 every 21 days for 6 cycles; AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic breast cancer; drug therapy; doxorubicin; docetaxel
Lycopene in Preventing Prostate Cancer in Patients Who Are at High Risk of Developing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from
      forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may
      keep prostate cancer from forming in patients at high risk of developing prostate cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in
      preventing prostate cancer in patients who are at high risk of developing prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Define the toxicity and safety of lycopene administered as a food-based delivery system
           as a chemoprevention agent in patients who are at a high risk of developing prostate
           cancer.

        -  Define the pharmacokinetics and tissue distribution in patients receiving this regimen.

        -  Characterize surrogate endpoint biomarkers (SEBs) in the peripheral blood, buccal
           mucosa, and the prostate itself, which will provide evidence of biological activity
           relevant to a chemoprevention effect.

             -  Characterize the oxidative stress state of the individual by studies of DNA
                oxidation in the prostate and buccal mucosa, as well as DNA oxidation and lipid
                peroxidation within the peripheral blood.

             -  Define the effects of lycopene through a food delivery system on prostate histology
                (prostatic intraepithelial neoplasia), markers of cellular proliferation [PCNA],
                and apoptosis in the prostate.

             -  Evaluate the effects of lycopene on the serum levels of total prostate-specific
                antigen (PSA), free PSA, and PSA density.

        -  Provide the basic knowledge in reference to toxicity, pharmacokinetics, and SEBs needed
           to proceed to a large phase II or III lycopene study in these patients.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients receive oral lycopene in tomato paste and olive oil, once, twice, or three times
      daily for 3 months.

      Cohorts of 6 patients receive escalating doses of lycopene until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose-limiting toxicity.

      Patients undergo buccal scrapings and blood collection periodically during study for
      pharmacokinetics and biomarker studies.

      After completion of study treatment, patients are followed for 1 month.

      PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
    

Intervention name(s): lycopene; laboratory biomarker analysis
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Lycopene
Primary purpose: Prevention
Keywords: prostate cancer
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The aim of this feasibility study was to assess the lipid-lowering effects and safety of a
      Ayurveda formulation containing Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and
      piperine (as bioenhancer)
    

Detailed description: 
      The COVID-19 related lockdowns severely affected the healthcare in India, specially in second
      wave of COVID-19. This research presents the applicability of Ayurveda formulation to analyze
      the impact on lipid profile during the lockdown.

      Patients with hyperlipidemia who referred to Gyansanjeevani were recruited. All participants
      were enrolled in the study after a complete physical examination and medical history remotely
      over the virtual secure platform.
    

Intervention name(s): Cardio-complement
Intervention type(s): Combination Product
Intervention description(s): Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.
Intervention MeSH terms: Complement System Proteins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ayurveda; Cholesterol; Cardiovascular Diseases; Hyperlipidemia
Empagliflozin vs Metformin in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This a randomised open-label parallel study involving women with polycystic ovary syndrome
      (PCOS). The patients will be randomised either to metformin 1500mg or empagliflozin 25mg
      daily for three months. The aim of the study is to examine the effect of empagliflozin on
      hormonal, metabolic and cardiovascular risk markers and quality of life in women with PCOS.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a very common condition in women that may present with
      irregular periods, excessive hair growth on the face and body, acne and cysts in the ovaries.
      PCOS is also associated with increased risk of problems later in life like diabetes, high
      cholesterol levels and heart disease.

      In this study, a medication named Empagliflozin will be tested. Empagliflozin belongs to a
      class of medicines known as SGLT-2 inhibitors. SGLT-2 stands for sodium glucose
      co-transporter 2. Empagliflozin, in simple terms, helps in reducing high blood glucose levels
      by increasing the amount of glucose passed in your urine. This medicine is usually used in
      patients with type 2 diabetes and has led to improved blood pressure and weight loss in
      addition to improving blood glucose levels.

      We want to give Empagliflozin to women with PCOS to see its effect on hormones related to
      PCOS and the risk factors for diabetes and heart disease. We will be comparing its effects to
      metformin (another drug for diabetes) which has already been used in PCOS with very good
      results.
    

Intervention name(s): Empagliflozin; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Each participant will receive empagliflozin 25mg daily for 3 months.; Each participant will receive metformin 1500mg daily for 3 months.
Other intervention name(s): Jardiance; Glucophage SR
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Observational

Summary: 
      The research project is part of the evaluation of the therapeutic approaches in mental
      health. Its framework infant and juvenile units that have developed "integrative devices,"
      taking into account recent advances in knowledge and providing care, education and
      pedagogical approach. The evolution of autistic children receiving these integrative devices
      is studied to determine the validity of the devices mentioned. The methodology is based on
      case studies in a natural situation. Clinicians are committed to network among themselves and
      with researchers in a multicenter study.
    


Intervention name(s): Integrative practices
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 3 to 6 years with a diagnosis F84.0 and F84.1 according to CIM-10, supported in
        care units that meet the criteria defined integrative practices.
      
Keywords: Children; aged; 3 to 6 years
Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction
Condition: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Occupational Diseases; Tobacco Use Disorder
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Occupational Diseases; Tobacco Use Disorder
Study type: Observational

Summary: 
      Airway macrophage impairment is a central feature in the immunopathogenesis of chronic
      obstructive pulmonary disease, regardless of smoking status.
    

Detailed description: 
      In the United States, a variety of farming operations can generate significant amounts of
      dust. Chronic organic dust exposure to workers in this industry can result in several
      respiratory health conditions including chronic bronchitis, chronic obstructive pulmonary
      disease (COPD), and exacerbations of asthma. Organic dust is a complex mixture containing
      particulate matter and microbial-associated components from gram positive and gram negative
      bacteria. Airway macrophages are key innate immune cells that are rapidly activated by
      exposure to inhaled toxins and organic dust.

      The literature indicates that subjects with tobacco-induced chronic bronchitis/COPD have
      alveolar macrophages that have impaired function. It has been hypothesized that the impaired
      lung macrophage function may contribute to the increased susceptibility to infections and
      chronic bacterial colonization that is a central feature in subjects with chronic
      bronchitis/COPD. It is unknown at this time if impaired macrophage function is secondary to
      tobacco-induced effects, or is a central pathologic feature of chronic bronchitis/COPD.

      We will explore the expression of innate immune cell surface molecule expression involved in
      antigen presentation, phagocytic ability, and ex vivo cytokine responses in airway
      macrophages obtained by induced sputum. We will also collect blood to determine if ex vivo
      stimulation of blood mimics the inflammatory responses observed with airway macrophages.
      Comparisons to our past findings in vitro studies, which demonstrated that repetitive organic
      dust exposure impairs monocyte derived macrophage immune cell surface markers and function,
      could then be made. This information could lead to future investigations centered on
      therapeutic interventions to prevent or reverse the underlying lung disease experienced by
      farmers in this industry.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Three groups Group One : Healthy non-smoking controls Group Two : Smoking adults with
        chronic bronchitis/COPD Group Three: Non-smoking adults with chronic bronchitis/COPD
      
Keywords: Pulmonary disease, chronic obstructive; Airway macrophages; Sputum milieu; Airway inflammation; Occupational diseases
Study of AT-527 in Healthy Subjects (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in
      healthy subjects.
    


Intervention name(s): AT-527 Formulation 1; Placebo Comparator; AT-527 Formulation 2
Intervention type(s): Drug; Other; Drug
Intervention description(s): AT-527 Formulation 1 (R07496998); Placebo Comparator; AT-527 Formulation 2 (R07496998)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Protein Requirements In Active Female Populations
Condition: Increased Metabolic Requirement; Healthy
Study type: Interventional

Summary: 
      Protein requirements in active individuals have been suggested to be greater than the current
      recommended dietary allowance (RDA).

      Nutritional requirements for dietary amino acids in adults have traditionally been determined
      utilizing the nitrogen balance technique, which is prone to underestimating protein
      requirements. As a result, there is a need to re-evaluate recommendations in order to
      characterize how dietary amino acid needs may be modulated by physical activity.

      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique
      have suggested that protein requirements in young men are at least 50% higher than the RDA
      based on nitrogen balance data.

      The purpose of this study is to measure the protein requirement in active, young adult
      females using the IAAO technique in the presence of a variable intensity exercise stimulus.
    


Intervention name(s): Amino acid intake
Intervention type(s): Dietary Supplement
Intervention description(s): Amino acid intakes will be varied at 0.2-2.6 g/kg/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled parallel group study will assess the effect
      on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of
      RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will
      be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6
      weeks, in addition to their stable antipsychotic medication. Anticipated time on study
      treatment is 6 weeks.
    


Intervention name(s): Placebo; RO4917838; Standard Antipsychotic Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orally daily for 6 weeks; 10 mg daily orally for 6 weeks; Participants will continue to receive their current antipsychotic treatment (as they are receiving at the time of screening). Protocol does not specify any particular standard antipsychotic therapy.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of an Alginate Based Beverage on Weight Loss
Condition: Obesity; Type 2 Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The project aims to examine the efficacy of a 12-week intake of alginate based ready to drink
      supplement on development in body weight and body composition, and risk markers for type-2
      diabetes and cardiovascular disease in obese subjects.
    

Detailed description: 
      The study consists of a parallel RCT with 96 overweight/obese subjects enrolled into two
      treatment arms: placebo or active for 12 weeks. They will undergo examination at time points
      0 and 12 weeks where a DXA scan will be performed to assess body composition and a fasting
      blood sample will be taken. At time points 0, 2, 4, 6, 8, 10 and 12 weeks their weight and
      waist circumference and number of test products not consumed will be recorded. In addition
      all subjects receive dietary counselling during the 12 weeks.
    

Intervention name(s): Alginate beverage; Control beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dosage is 3x500ml daily; The dosage is 3x500ml daily
Other intervention name(s): Protanal; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment