bioihbjkbjnl/mcl2 huggingface dataset:
Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS)
Condition: Asthma; Asthma Attack; Asthma Persistent; Covid19
MeSH terms: COVID-19; Asthma
Study type: Interventional

Summary: 
      A digital tool, called ReferID has been developed to facilitate the review of asthma
      patients. It aims to assist in the identification of patients with uncontrolled and/or severe
      asthma and to ensure a timely referral to secondary care where appropriate. To validate the
      tool, patients will be randomised to have a review with a healthcare professional using tool
      to facilitate the review or to continue receiving usual care. Outcome measures including
      exacerbation frequency and level of asthma control will be assessed at 12 months.
    


Intervention name(s): ReferID
Intervention type(s): Device
Intervention description(s): The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
Condition: Non-squamous Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the similarity between QL1101 and Avastin®
      respectively combined with chemotherapy in terms of efficacy and safety in patients with
      non-squamous non-small cell lung cancer. The study intends to include first-line patients
      with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic
      chemotherapy CP (paclitaxel + carboplatin). The regimen is consistent with the usage and
      dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small
      cell lung cancer.
    

Detailed description: 
      The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III
      study. It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell
      lung cancer (NSCLC). Subjects are randomized into the QL1101 combined with
      paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a
      ratio of 1:1, and stratified by age (≥65 years, <65 years), sex (male, female) and EGFR
      subtype (sensitive mutation type, wild type).
    

Intervention name(s): QL1101; Avastin®; Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): targeted vascular endothelial growth factor (VEGF) monoclonal antibodies; targeted vascular endothelial growth factor (VEGF) monoclonal antibodies; 175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.; AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.
Other intervention name(s): bevacizumab
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
Condition: Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and
      Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.
    

Detailed description: 
      Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal
      cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and
      several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX)
      demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and
      S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities.
      Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in
      preclinical models but also in subsequent clinical trials.
    

Intervention name(s): OS (oxalipaltin+S-1); XELOX (oxalipaltin+capecitabine)
Intervention type(s): Drug; Drug
Intervention description(s): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days; Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Other intervention name(s): Eloxatin; TS-1; Eloxatin; Xeloda
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Neoplasm; S-1; Capecitabine; Oxaliplatin
Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics
Condition: Cirrhosis With Ascites
MeSH terms: Peritonitis; Recurrence; Ascites
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of
      cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility
      and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate
      whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the
      efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.

      Methods: A prospective, double blind, randomized controlled trial was conducted in
      consecutive high-risk cirrhotic patients with ascites who had either recovered from an
      episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for
      development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary
      prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis
      JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million,
      Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once
      daily with placebo (group II) was given and occurrence of SBP within a period of 6 months
      (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were
      recorded. Every patient received IV albumin to maintain a serum albumin level of >3.2 g/dl.
      SBP was treated with intravenous antibiotics with albumin.
    


Intervention name(s): Norfloxacin + Synbiotic; Norfloxacin + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d.; Norfloxacin 400 mg once daily with placebo
Intervention MeSH terms: Norfloxacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of
      PF-06730512 in healthy subjects.
    


Intervention name(s): PF-06730512; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Comparison of different dosages of PF-06730512 to Placebo; Comparison of Placebo to different doses of PF-06730512
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of prucalopride is safe and effective in
      patients with chronic constipation.

      Hypothesis:

      Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation
      whereas 0,5 mg is a suboptimal dose.
    

Detailed description: 
      This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase
      (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will
      receive either R093877 0.5 mg b.i.d., 1 mg b.i.d. or 2 mg b.i.d. or placebo for a period of
      12 weeks.

      Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented
      and the existence of constipation confirmed. At the start of this period all existing
      laxative medication is withdrawn and patients will be instructed not to change their dietary
      habits, in particular their fiber intake during the trial. Patients will enter the
      double-blind phase if constipation has been shown to be present during the run-in period.

      If the definition of constipation was not met during the 4 weeks of the run-in period, the
      patient will be considered ineligible for the double-blind period.

      Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be
      treated for 12 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given twice daily
      (one capsule is taken before breakfast and one is to be taken before the evening meal).

      Patients admitted to the double blind treatment period will be randomly allocated to one of
      the 4 treatment arms.
    

Intervention name(s): Prucalopride; Prucalopride; Prucalopride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg bid; 1 mg bid; 2 mg bid; bid
Other intervention name(s): Resolor; Resolor; Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Training in Inpatient Treatment for Substance Use Disorders
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study examines whether computer tasks can improve memory and other cognitive functions
      among patients receiving inpatient treatment for substance use disorders.
    

Detailed description: 
      Participants will complete cognitive training sessions on a regular basis during inpatient
      treatment. Alternate versions of the computer tasks will be compared in a randomized design.
      Primary and secondary outcomes will consist of changes in cognitive performance before and
      after the training period.
    

Intervention name(s): Cognitive training activities; Inpatient psychosocial therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training activities consist of computer tasks designed to improve memory and cognition. The intervention consists of 45-minute training sessions delivered regularly during inpatient treatment.; Group psychosocial therapy delivered in an inpatient setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Auricular Neurostimulation for Cyclic Vomiting Syndrome
Condition: Cyclic Vomiting Syndrome; Abdominal Migraine
MeSH terms: Migraine Disorders; Syndrome; Vomiting
Study type: Interventional

Summary: 
      This study evaluates the efficacy of auricular neurostimulation via an non-invasive
      percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting
      syndrome.
    

Detailed description: 
      Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional
      gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe
      abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.

      The vagus nerve carries signals of nausea, vomiting and pain between the brain and the
      gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous
      system appears to be in imbalance in patients with CVS during a vomiting cycle. By
      stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms
      and quality of life in both children and adults with CVS.

      Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy
      for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active
      vs sham) at the onset of the next CVS cycle. Subjects in a separate sub-study receive 6 weeks
      of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of
      life, potential side effects and overall symptom improvement will be monitored before and
      after therapy for the entire study.
    

Intervention name(s): Percutaneous neurostimulation
Intervention type(s): Device
Intervention description(s): Auricular percutaneous neurostimulation
Other intervention name(s): Neuro-Stim System (NSS)-2 BRIDGE
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject randomized to active vs sham therapy, then cross over to the other during next illness cycle
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on
      alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in
      women with a history of recurrent BV.
    

Detailed description: 
      Eligible participants, with both a history of recurrent BV and a current episode of BV, will
      receive a seven-day course of oral metronidazole. Participants who are successfully treated
      for their BV, and continue to be eligible, will be randomly assigned to receive either 1%
      SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

      The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

      Participants who experience a BV recurrence will be considered to have completed the study.
      Such participants will receive BV treatment in line with local practice and will not attend
      any further study visits.

      Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week
      follow-up phase to Week 28.

      Participants will attend a study visit at 4-weekly intervals throughout the duration of the
      study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse
      events.
    

Intervention name(s): Metronidazole oral tablets 500mg; 1% SPL7013 Gel; Placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet taken orally twice daily for seven consecutive days; 5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.; 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
Other intervention name(s): VivaGel; astodimer sodium
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids
Condition: Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study explores whether a beta-blocker (propranolol) can prevent a person from
      becoming more sensitive to pain after administration of an opioid (remifentanil). Beta
      blockers inhibit the sympathetic (fight or flight) response and are often used to treat
      angina and high blood pressure. In a previous study in human volunteers, the investigators
      demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid
      remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.
    

Detailed description: 
      Recent evidence suggests that opioid therapy may cause a biphasic response, i.e. initial pain
      relief followed paradoxically by a longer lasting hypersensitivity to pain. Recent genetic
      analysis in mice suggests that beta adrenergic receptor antagonists reduce opiate-induced
      hyperalgesia (OIH). The purpose of this study is to determine the analgesic and
      antihyperalgesic properties of the beta-blocker propranolol on remifentanil-induced
      hypersensitivity in humans.

      The investigators want to determine the analgesic and antihyperalgesic properties of the
      beta-blocker propranolol on remifentanil-induced hypersensitivity in humans. The
      investigators hope to learn whether the administration of beta-blocker propranolol will
      significantly diminish the hyperalgesic response after administration of an opioid.

      The primary outcome measure for this study is change in size (area) of secondary hyperalgesia
      after cessation of remifentanil infusion, a measure of OIH.
    

Intervention name(s): Propranolol; Placebo to Match Propranolol; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propranolol administered intravenously, initially set to target plasma concentration of 5 ng/mL, titrated upward in 5 ng/mL intervals until a final concentration of 15 ng/mL is achieved.; Remifentanil administered intravenously at a plasma concentration of 3 ng/mL.
Other intervention name(s): Hemangeol; Inderal; Innopran
Intervention MeSH terms: Propranolol; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Effectiveness of a physical therapy program focussed on core stability exercise and massage
      as a recovery method in breast cancer survivors after oncology treatment.
    

Detailed description: 
      Eligibility Criteria

      1, had a diagnosis of breast cancer (stage I-IIIA); 2, between 25-65 years; 3, finished
      co-adjuvant treatment except hormone-therapy; 4, not having active cancer; 5, interest to
      improve their lifestyle increasing physical activity; and, 6, present 3 to 5 of the following
      physical findings, judged by the oncologist who referred the patient: neck or shoulder pain
      symptoms, reduced range of motion in neck- shoulder area, reduced physical capacity, any
      psychological problem, increased fatigue, sleep disturbances, or any problem in coping with
      reduced physical and psychosocial functioning.

      Principal Outcomes Fatigue Score: Piper Fatigue Scale Mood State:Profile of Mood State
      Quality of Life: QLQ-BR23
    

Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): Core Stability Exercise, Endurance training, recovery massage
Other intervention name(s): Exercise; Relaxation techniques; Recovery techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breast cancer; physical therapy; massage; core stability
Optic Nerve Head Autoregulation During Changes in Arterial Blood Pressure
Condition: Decreased Vascular Flow
Study type: Interventional

Summary: 
      Constant despite changes in perfusion pressure. It is observed in many vascular beds of the
      human body to prevent that variations in perfusion pressure are directly transmitted into
      changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased
      blood flow and bleeding or increased capillary pressure during increased blood flow.

      In the eye, several studies have reported that retinal blood flow is autoregulated over a
      wide range of ocular perfusion pressures. Unfortunately only few data are available for the
      optic nerve head. To gain data about autoregulation is of special importance given that
      several important ocular diseases such as glaucoma and age-related macular degeneration are
      associated with impaired autoregulation. In humans most data were collected using laser
      Doppler flowmetry.

      The present study aims to investigate the phenomenon of transient reduction in blood flow and
      to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric
      exercise.
    


Intervention name(s): Isometric exercise
Intervention type(s): Other
Intervention description(s): use of a handgrip for 3x2 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Blood flow autoregulation; optic nerve head blood flow; isometric exercise; Autoregulation; ocular physiology
The ParkCycle Study: Aerobic Exercise in PD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The primary goal of this study is to determine the neuroprotective qualities of long-term, in
      home, exercise therapy program in human PD patients. It is hypothesized that an exercise
      intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection).
      The first part involves a pilot-study in which the feasibility of the intervention and
      outcome measures will be tested.
    

Detailed description: 
      Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical
      need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise
      improves motor function and may have neuroprotective properties. The promising animal results
      have not been translated to patients with PD so far. This is a two-cluster randomised control
      trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention
      on a stationary virtual reality bike and twenty patients (10 at each site)will serve as
      controls.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): six-months long exercise intervention on a stationary virtual reality bike, 3-5 times a week, each session lasting 30-45 minutes at a target heart rate (60-85% heart rate reserve).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Neuroprotective; Intensive exercise