bioihbjkbjnl/mcl2 huggingface dataset:
Nifedipine vs Placebo for Maintenance Tocolysis of Preterm Labor.
Condition: Obstetric Labor, Premature; Venous Thrombosis
MeSH terms: Obstetric Labor, Premature; Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor
    

Detailed description: 
      To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs
      pregnancy and improves neonatal outcomes.
    

Intervention name(s): Nifedipine
Intervention type(s): Drug
Intervention description(s): Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours.
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
Condition: Intracranial Aneurysm; Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Intracranial Aneurysm; Aneurysm; Hemorrhage
Study type: Interventional

Summary: 
      HYBRID study is prospective randomized open label controlled multi center trial, to compare
      Hydrocoil and bare platinum coil for recanalization after endovascular treatment of
      intracranial aneurysms.
    

Detailed description: 
      At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use
      in Control arm.

      Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint
      are:

        1. aneurysmal rupture within 1 year after embolization

        2. any event within 30 days after embolization

        3. recanalization within 6 months after embolization

        4. aneurysmal retreatment within 1 year after embolization

        5. aneurysmal rupture and any death within 1 year after embolization

        6. any stroke within 1 year after embolization

        7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1
           year after embolization

        8. change in aneurysmal occlusion

        9. any comlicaion within 1 year after embolization

       10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.
    

Intervention name(s): Hydrogel coil; Bare platinum coil
Intervention type(s): Device; Device
Intervention description(s): at least one Hydrogel coil have to use for embolization; only bare platinum coil have to use for embolization
Other intervention name(s): Hydrocoil; HydroSoft; HydroFrame; detachable coil; GDC; Microvention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracranial aneurysm; endovascular therapy; detachable coil; recanalization
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for
      injection compared to propofol for sedation in mechanically ventilated ICU patients.
    

Detailed description: 
      This is a randomized, open-label, small sample study using fospropofol disodium and propofol
      for sedation in mechanically ventilated ICU patients. Subjects are randomized to different
      treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is
      co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol
      disodium are to be evaluated.
    

Intervention name(s): Fospropofol disodium for injection; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.; Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
Other intervention name(s): Remifentanil; Remifentanil
Intervention MeSH terms: Remifentanil; Propofol; Fospropofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fospropofol; Propofol; Sedation; Intensive care unit
BEYOND Weight Loss Maintenance Study
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      A study to determine the effectiveness of two weight loss maintenance interventions in
      Counterweight Plus, a structured weight management programme.
    

Detailed description: 
      Introduction: Long-term maintenance of non-surgical weight loss remains the most significant
      problem in obesity treatment. This study will compare the effectiveness of two different
      weight loss maintenance strategies used as part of the Counterweight Plus weight management
      programme. This study will also evaluate the behavioural impact of the Counterweight Plus
      interventions and include process evaluations and cost analysis.

      Methods: 80 patients and 10 practitioners will be recruited into the study. Main inclusion
      criteria for patients are:

      Completed Counterweight Plus, which includes 12-20 weeks total diet replacement (TDR), 8
      weeks food reintroduction (FR) and achieved >10kg weight loss. All participants will be
      followed up for 18 months in total.

      Results: The primary outcome of this study is the difference in weight change between the two
      groups at 6 months. Frequency of use of behavioural strategy will be quantified for both
      practitioners and patients during voice recorded consultations. The relationship between
      weight change and the use of behavioural strategy will be assessed.

      Hypothesis: This study will establish if the novel intermittent use of formula diet strategy
      is more effective at preventing weight regain in comparison to usual care. It will also
      provide evidence of the frequency of use of behavioural strategies within routine
      Counterweight Plus delivery, as well as establishing the cost of the intervention.
    

Intervention name(s): Continuous energy restriction; Intermittent energy restriction
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 x formula food (202-209kcal) meal replacement per day; 4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss maintenance
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary
      peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight
      ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of
      progesterone the body makes.

      PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in
      treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal
      cancer, or fallopian tube cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of mifepristone in patients with recurrent or
           persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.

        -  Determine the toxicity of this drug in these patients.

      Secondary

        -  Determine the duration of progression-free survival and overall survival of patients
           treated with this drug.

        -  Determine the potential impact of platinum sensitivity, initial performance status, and
           age on prognosis in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral mifepristone once daily on days 1-28. Treatment repeats every 4 weeks
      in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed periodically for 5 years.

      PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
    

Intervention name(s): mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; primary peritoneal cavity cancer; fallopian tube cancer
Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin
Condition: Migraine
Study type: Interventional

Summary: 
      The involvement of calcitonin gene-related peptide (CGRP) in the cinnamaldehyde-induced
      dermal blood flow increase and in the mechanism of action of triptans will be investigated.
      The capsaicin-induced dermal blood flow will be incorporated as a positive control; histamine
      skin pricks as a negative control. Changes in dermal blood flow will be measured with laser
      speckle contrast imaging.
    


Intervention name(s): Sumatriptan; Ubrogepant
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan 100 mg; Ubrogepant 100 mg
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether the investigators can develop a computer
      algorithm to predict which individual patients will respond to injections of hyaluronic acid
      (HA) products for knee osteoarthritis.
    

Detailed description: 
      Background Osteoarthritis (OA) of the knee is a debilitating condition that affects an
      estimated 21 million Americans. This number is expected to rise steadily as the population
      ages. The medical expenditures associated with arthritis and other rheumatic conditions in
      the United States have increased from $50 billion in 1997 to $86 billion in 2003. In 2003,
      almost 420,000 total knee replacements were performed, primarily for arthritis. Injections of
      hyaluronic acid (HA) have been shown to provide symptom relief for many OA patients who have
      failed to respond to conservative interventions. Many other patients, however, experience
      only slight or no improvement. The results from this study will allow physicians to identify
      whether a patient is likely or not likely to respond well to HA therapy leading to improved
      treatment success rates.

      Goals This study has two related goals: 1) to identify patient and treatment factors that
      predict response to intra-articular injections of hyaluronic acid for knee osteoarthritis
      using multivariable analysis and 2) develop mathematical and statistical models that will
      predict individual patient response to HA for knee OA.

      It is anticipated that the investigators will develop computer software in this study that
      can support clinical decision making related to viscosupplementation in the treatment of knee
      OA. If this project yields successful patient predictive models, physicians who are
      considering a trial of HA for a patient will have some empirical basis for treatment
      selection. Eventually a physician would be able to assess a relatively small number of
      variables for a patient and then be provided with predictions regarding treatment response.

      **Please note that the study site at the Naval Medical Center in Portsmouth, Virginia can
      only enroll patients who are eligible to be treated at a military facility.
    

Intervention name(s): hylan G-F 20; 1% sodium hyaluronate
Intervention type(s): Device; Device
Intervention description(s): Three 2 cc injections at weekly intervals; Three 2 cc injections at weekly intervals
Other intervention name(s): Synvisc; Euflexxa
Intervention MeSH terms: Hyaluronic Acid; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Effects of Yoga on Heart Rate and Heart Rate Variability Responses to Stress
Condition: Cardiovascular Reactivity to Stress
Study type: Interventional

Summary: 
      Introduction: Yoga has been shown to reduce stress and have benefits for a number of
      stress-related disorders. However, the effects of an acute bout of yoga practice on cardiac
      autonomic response to and recovery from stress remain unclear. This study aimed to examine
      the effect of a single bout of yoga on heart rate (HR) and heart rate variability (HRV)
      response to and recovery from mental stress.

      Materials and Methods: This study was conducted with a randomized, counterbalanced, crossover
      design. A total of 44 participants completed two sessions (yoga and video watching (VW)) in
      randomly assigned order. After each condition, participants underwent a Stroop task and
      mental arithmetic task. Electrocardiogram was measured and HR and HRV for resting, each
      condition, and the stress and recovery periods were analyzed.
    


Intervention name(s): Hatha Yoga; Video Watching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The yoga poses were chosen for providing a restorative session based on their purported relationship to restorative effects to best promote cardiac autonomic recovery from mental stress.; The video was about the history of the Earth which encompasses the development of the planet Earth from its formation to the present day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: yoga, mental stress, cardiac autonomic function, stress response
A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blind, positive drug parallel controlled equivalence clinical
      trial initiated at about 30 sites in China.

      In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a
      ratio of 1:1 to receive the test drug and the positive control.
    


Intervention name(s): SIBP-02; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Injection，100mg/10ml; Injection，100mg/10ml
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I study to assess the safety and tolerability of AZD2281 in combination with
      Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to
      establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with
      advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled
    


Intervention name(s): AZD2281; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Tablets Oral BID; IV every 3 weeks
Other intervention name(s): Olaparib; Lynparza
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid tumours; Poly(ADP ribose) polymerases; homologous deficiency; BRCA1
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how well tolerated and safe AZD8566 is at different
      dose levels. This study will also determine how AZD8566 is distributed around the body and
      how it leaves the body.
    


Intervention name(s): AZD8566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution. Specific dose will be selected by the safety review committee; Single 10ml oral solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; Safety; Tolerability; AZD8566; study
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL
      administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis
      either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject
      self-administration with autoinjector/pen (AI/Pen)
    


Intervention name(s): romosozumab HCP administration with PFS; romosozumab self-administration with AI/Pen
Intervention type(s): Drug; Device
Intervention description(s): 210 mg romosozumab SC QM by HCP administration with 2 PFS; 210 mg romosozumab SC QM by self-administration with 2 AI/Pens
Other intervention name(s): Evenity; AMG785; Evenity; AMG785
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After signing the informed consent form (ICF), subjects will undergo the following periods:
Screening period (35 days) to complete eligibility assessments
Open-label treatment period (6 months)
Follow-up period (3 months) During the open-label treatment period, subjects will be randomized to receive romosozumab either via HCP administration with PFS or via self-administration withAI/Pen.
During the follow-up period, subjects will be followed for an additional 3 months to ensure appropriate follow-up for anti-romosozumab antibody formation and adverse events.
The primary analysis will be performed after all subjects have had the opportunity to complete the Month 6 visit. The final analysis will be performed after all subjects have had the opportunity to complete the Month 9 visit.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-Menopausal osteoporosis
Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
Condition: Stress; Blood Pressure
Study type: Interventional

Summary: 
      The purpose of this study is to determine the potential efficacy of real-time functional
      magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI)
      -NF) in regulating brain activity and psychophysiological functions.
    

Detailed description: 
      The overall goal of the outlined study is to establish a real-time functional magnetic
      resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and
      psychophysiological functions. About two weeks after the initial training session it will be
      estimated how stable training effects have been. The two weeks in between, subjects will
      receive ambulatory training of the strategies via a smartphone-based application.
    

Intervention name(s): real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF); Ambulatory Training
Intervention type(s): Other; Behavioral
Intervention description(s): Subjects are provided with RT-fMRI-NF.; Subjects are provided with an ambulatory training.
Other intervention name(s): There are no specific branded names etc. associated with the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: fMRI; Neurofeedback; Blood pressure; Psychophysiology
Impact of 100mL Lipid Emulsion for Intravenous for Suppression of Myocardial Glucose Metabolism in 18F-FDG PET/CT
Condition: Metabolic Preparation; Myocardial Inflammation
MeSH terms: Myocarditis; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      There is increasing evidence that [18F]-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT is useful
      in the identification and treatment of disease processes that involve cardiac inflammation
      and infection. Current applications include imaging intra-cardiac device and prosthetic valve
      infections, evaluating patients with known or suspected cardiac sarcoidosis or other
      inflammatory cardiomyopathies.

      However, because normal myocardium can metabolize both glucose and free fatty acids (FFAs),
      physiological accumulation of FDG in the myocardium can interfere with the recognition of
      abnormal FDG uptake.

      The use of a low-carbohydrate diet with a prolonged fast ≥ 12 h nutrition followed by a fast
      of at least four hours is the effective preparation recommended to suppress physiological
      myocardial FDG uptake.

      However, the rate of suppression of physiological accumulation of FDG with this method in our
      center is only 50%.
    

Detailed description: 
      Methodology :

      Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled,
      compared to a group with the last 30 patients referred for cardiac FDG PET in the nuclear
      medicine department of the Centre Hospitalier Princesse Grace.

      Procedures :

      Infusion of 100mL lipid emulsion for intravenous two hours before cardiac FDG PET/CT:

        -  Infusion rate will be 20 mL/hour during the initial 10 minutes (3 mL Intralipid)

        -  The dose will be then increased to 40 mL/hour for the next 10 minutes (6 mL Intralipid)

        -  Finally, for the next 50 minutes the dose will be increased to 100 mL/hour (83mL
           Intralipid)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group of 30 consecutive patients with cardiac FDG PET prescribed, prospectively enrolled,
        compared to a group with the last 30 patients referred for cardiac FDG PET.