bioihbjkbjnl/mcl2 huggingface dataset:
The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of physician's counseling on participation
      and utilization of sedation in a primary colonoscopy-based colorectal cancer (CRC) screening
      program
    

Detailed description: 
      Participation rate is one of the major factors influencing the effectiveness of screening
      programs. Participation rates in CRC screening, including primary colonoscopy programs,
      remain suboptimal. It is known that one of the strongest predictors of CRC screening
      participation rate is a physician, especially primary care physician (PCP), recommendation.
      Engaging a PCP tends to improve participation rate in organized and opportunistic cancer
      screening programs.

      To our best knowledge there are no randomized controlled trials, dedicated specifically to
      assess the effect of physician's counseling on participation rate in primary colonoscopy CRC
      screening programs. There is also no data on the impact of physician's counseling on
      patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.

      In this study we aimed to quantitatively estimate the impact of a PCP's counseling on
      screening participation rate and utilization of sedation in the opportunistic primary CRC
      screening program when compared to the effect obtained by using a standardized information
      leaflet only.
    

Intervention name(s): Physician's counseling; Information leaflet
Intervention type(s): Other; Other
Intervention description(s): Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.; Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal Neoplasms; Colonoscopy; Early Detection of Cancer; Patient Selection; Patient Participation; Physicians, Primary Care; Conscious Sedation
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
Condition: RSV Illness in ≤12 Months of Participants
Study type: Interventional

Summary: 
      The primary objective of this study is to describe the effect of a single dose of medication
      compared to placebo in the upper respiratory tract in previously healthy children less than
      or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
    

Detailed description: 
      The primary objective of this study is to describe the effect of a single 30 mg/kg or 100
      mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral
      load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain
      reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of
      age who are hospitalized with lower respiratory tract illness.
    

Intervention name(s): Motavizumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.; A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.
Other intervention name(s): MEDI-524
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus illness; RSV
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote
      ER is safe in the reduction of occurrence of migraine headaches in adolescents.
    


Intervention name(s): divalproex sodium
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Depakote ER; Divalproex sodium
Red Clover Botanical Dietary Supplements - Metabolism and Safety in Women
Condition: Food-drug Interaction
Study type: Interventional

Summary: 
      Human safety studies were carried out to test whether red clover botanical dietary
      supplements used by peri- and post-menopausal women are safe to use with Food and Drug
      Administration (FDA)-approved drugs. To test this, a red clover dietary supplement
      (previously tested in women at the University of Illinois at Chicago without any harmful
      effects) was given with four selected FDA-approved drugs to determine if the red clover
      supplement can increase or decrease how these medications are absorbed, metabolized and
      excreted by the human body. Preclinical studies predicted that the red clover supplement
      might affect the metabolism or break down of these probe drugs.
    

Detailed description: 
      At the start of a study, subjects were administered low doses of a mixture of four
      FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial
      blood samples were drawn and analyzed for the concentration of each drug over time.
      Afterwards, participants took the red clover dietary supplement twice orally daily for 14
      days to allow for potential inhibition or induction of drug metabolizing enzymes and
      transporters. Thereafter, the same drugs were taken again to obtain a second measure of drug
      concentrations in blood over time. Changes in the concentration-time curve values for each
      probe drug obtained before and after ingestion of the supplement were evaluated to determine
      if metabolism of the probe drugs was impacted by the red clover dietary supplement.
    

Intervention name(s): Trifolium pratense
Intervention type(s): Dietary Supplement
Intervention description(s): Red Clover extract standardized to isoflavone content.
Other intervention name(s): Red Clover
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus; Hypogonadism
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.

      Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by
      hyperinsulinaemia and insulin resistance.

      Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with
      low normal levels of bioavailable testosterone and type 2 DM.
    

Detailed description: 
      Background Inadequate levels of androgens have been associated with an increased risk of
      chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been
      shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in
      hypogonadal men.
    

Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/dose/day for 24 weeks; placebo on the skin for 24 weeks
Other intervention name(s): Testim
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
Condition: Lyme Borreliosis
MeSH terms: Borrelia Infections; Lyme Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment
      groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase
      vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.

      In the Booster Phase subjects from the higher dose group who completed their primary
      immunization schedule according to protocol will be randomized 2:1 to receive an additional
      higher dose VLA15 vaccination or Placebo at Month 18.

      Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study
      Duration is estimated to be 22 months.

      Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

      Study duration per subject in the Main Study Phase and Booster Phase together is estimated to
      be a maximum of approximately 33 months.

      Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is
      estimated to be approximately 37 months.
    

Detailed description: 
      This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved
      in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2
      study.

      In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized
      2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase
      vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month
      2) and Day 180 (Month 6).

      Subjects from the higher dose group who completed their primary immunization schedule
      according to protocol, will be randomized 2:1 to receive an additional injection of the
      higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is
      administered as intramuscular injection approximately 18 months after the first immunization.
    

Intervention name(s): VLA15; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate; PBS (Phosphate Buffered Saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: VLA15; Lyme Borreliosis; Vaccine
Epirubicin Versus Docetaxel Plus Cyclophosphamide in Lymph Node Negative, ER-positive, Her2-negative Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and efficacy of epirubicin plus
      cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen
      receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast
      cancer patients as adjuvant chemotherapy.
    

Detailed description: 
      This is a non-inferiority study. According to previous study results, the investigators
      hypothesize the incidence of grade 3-4 neutropenia is 40%, with a α of 0.05 and β of 0.8, a
      sample size of 264 cases if needed.
    

Intervention name(s): Epirubicin; Docetaxel; cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): epirubicin, 90mg per square meter, every 3 weeks, day 1; docetaxel, 75mg per square meter, every 3 weeks, day 1; cyclophosphamide, 600mg per square meter, every 3 weeks, day 1
Other intervention name(s): anthracycline; taxotere
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Asynchronies in NIV With External Gas
Condition: Non-invasive Ventilation
Study type: Observational

Summary: 
      NIV can be combined with other treatments that require to introduce gas into the circuit
      during the treatment. This external gas produces trigger asynchronies that worse depending on
      the model ventilator, trigger design and gas source. It is advisable to monitor NIV when
      these treatments are requiring in chronic NIV.
    


Intervention name(s): external gas during NIV
Intervention type(s): Device
Intervention description(s): The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients from the Pulmonology Service of the Corporació Sanitària Parc Taulí (Sabadell,
        Barcelona) who met the following criteria: over 18 years of age, hospital admission for
        acute chronic respiratory failure, home NIV (single-limb system with intentional leakage)
        users for more than 6 months with adequate compliance (greater than or equal to 5
        hours/night). Patients with underlying psychiatric disease were excluded. The study was
        conducted during the patient's predischarge phase (the same day or the day before)
      
Keywords: Non-invasive Ventilation; trigger asynchronies; autotriggering; bench study
Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure
Condition: Arterial Stiffness, Blood Pressure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the acute effect of a standardized extract of KRG
      (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial
      stiffness and blood pressure, as measured by the following parameters: aortic augmentation
      index, peripheral blood pressure, central blood pressure
    


Intervention name(s): Ginseng; Wheat Bran
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400mg of encapsulated Rg3-KRG; 400mg of encapsulated wheat bran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ginseng; clinical trial; vascular; ginsenosides; blood pressure
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose,
      non-inferiority and multicentre study designed to evaluate the efficacy and safety of
      lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.
    


Intervention name(s): Lurasidone tablets; Risperidone tablets
Intervention type(s): Drug; Drug
Intervention description(s): Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo); Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Other intervention name(s): LATUDA
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; Lurasidone; LATUDA
Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic
Condition: Kidney Diseases; Heart Diseases; Diabetes Mellitus
MeSH terms: Kidney Diseases; Heart Diseases; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to assess the benefits of a combined cardiac, kidney, and
      diabetes clinic versus multiple clinics.

      Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems
      which may be overcome by the introduction of a combined care clinic.
    

Detailed description: 
      This is a randomized control trial to compare health care resource utilization, and
      achievement of stated targets of therapy (BP, Hgb, glucose control, use of preventive
      medications) as well as patient and health care team satisfaction, and longer term patient
      outcomes in patients with kidney disease who have either or both diabetes and heart disease,
      and currently attend either a diabetic or heart function clinic (or both) in addition to a
      kidney care clinic. In addition, we will also establish and refine the specialized
      cross-disciplinary care model, within a framework in Vancouver, and evaluate its functioning
      from the perspectives of allied health and medical professionals.

      This is a systematic evaluation of health care delivery methods to a complex group of
      patients, which will serve as a nidus for ongoing research in both health outcomes research,
      and biomedical research.

      The creation of this multifaceted clinic in an organized manner would permit evaluation of
      all of the components of it, and also demonstrate the importance of collaboration between
      disciplines and between public health care initiatives and industry partners, who would fund
      this clinic infrastructure and research components in the initial phase.
    

Intervention name(s): The Combined Cardiac Kidney Diabetes Care Clinic
Intervention type(s): Procedure
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combined Clinic; Chronic Kidney Disease; Diabetes
A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of 4 new formulations
      of abiraterone acetate compared to the current commercial formulation.
    

Detailed description: 
      This is a randomized (individuals will be assigned by chance to study treatments), open-label
      (individuals will know the identity of study treatments), 4-period, 5-treatment crossover
      study in order to evaluate the relative bioavailability of 4 new formulations of abiraterone
      acetate compared to the current commercial formulation. Approximately 32 healthy adult males
      will participate. The total study length is up to 68 days. This study will consist of a
      screening phase followed by an open-label treatment phase consisting of 4 single-dose
      treatment periods separated by a washout period of at least 7 days between dosing.
      Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose of 1000 mg
      abiraterone acetate will be given in each treatment period under fasted conditions.
      Participants will be confined to the study center from Day -1 of each treatment period until
      completion of the 96-hour blood sample collection on Day 5 of each treatment period. A
      follow-up visit will occur between 5 to 7 days after the last study procedure. Serial
      pharmacokinetic (study of what the body does to a drug) samples will be collected during the
      open-label treatment phase as detailed in the protocol. Safety will be monitored throughout
      the study.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions; 1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions; 1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions; 1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions; 1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Bioavailability; Abiraterone acetate; ZYTIGA
PENS or TENS for Pain in Liver Cancer
Condition: Pain; Cancer Pain; Liver Neoplasms
MeSH terms: Liver Neoplasms; Cancer Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and
      transcutaneous nerve stimulation (TENS) for pain relieving in patients with liver cancer.
      Patients will randomly allocated into PENS group, Tens group and control group.
    

Detailed description: 
      PENS and TENS have been reported with analgesic effect in patients with pain, including
      cancer pain, lower back pain, neck pain, stomachache and so on. Effect and mechanism of PENS
      on pain relieving has been widely researched. With additional electrical stimulation in
      certain frequency and intensity to conventional acupuncture, pain controlling effect has been
      largely enhanced. However, invasive operation limits its application and acceptability,
      especially on pancreatic cancer. TENS is an advanced technique generated from PENS, which is
      much more welcome for its noninvasive character. Further more, its analgesic effect on cancer
      pain has been proved by several multi-central, randomized, clinical trials.
    

Intervention name(s): PENS; TENS
Intervention type(s): Device; Device
Intervention description(s): percutaneous electrical nerve stimulation; transcutaneous electrical nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with liver cancer pain.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: percutaneous electrical nerve stimulation; transcutaneous electrical nerve stimulation; pain; liver cancer; hepatocellular carcinoma