bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension
Condition: Hypertension; Medicine, Chinese Traditional
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Research purpose: This study was a multicenter, randomized, double-blind, placebo-controlled,
      post-marketing clinical study in Chinese patients with essential hypertension to evaluate the
      efficacy and safety of Qianglidingxuan tablets(QLT) in the treatment of blood pressure in
      patients with mild to moderate essential hypertension.

        1. Subject:

           Patients diagnosed as essential hypertension with clinical grade 1-2.

        2. Interventions:

           ①Basic treatment plan:Patients in both groups were required to have a low-salt, low-fat
           diet, quit smoking, limit alcohol, eat more vegetables, moderate exercise, control body
           weight, and amlodipine besylate tablets (5mg, QD).

           ②Treatment group: Based on the basic treatment, QLT was given 6 tablets/time, 3 times a
           day, and warm water was given for 12 weeks.

           ③Control group: Based on basic treatment, QLT mimetic were given 6 tablets/time, 3 times
           a day, and warm water was given for 12 weeks.

        3. Treatment and follow-up cycle:

           Patients in both groups were treated for 12 weeks and followed up to the end of 48th
           week after treatment.

        4. Provisions of concurrent treatment:

           Any combined treatment used during the study should be recorded in the CRF, including
           drug name (generic name/trade name), starting time, administration dose, method of
           administration, termination time, indication, etc

        5. Efficacy evaluation:

           ①Primary outcome measure: the change from baseline in office blood pressure after 12
           weeks of treatment.

           ②Secondary efficacy indicators: 24-hour ambulatory blood pressure, heart rate, blood
           lipids, homocysteine, CRP, baPWV. TCM syndromes (including vertigo, headache, impatience
           and irritability, red face, red eyes, dry mouth, bitter mouth, tinnitus, insomnia,
           multiple dreams, constipation, urination, etc.)

           ③Safety indicators: adverse events, vital signs, physical examination, laboratory
           examination

        6. Statistics:

      SAS® 9.4 was used for all statistical analyses.
    


Intervention name(s): Treatment group
Intervention type(s): Drug
Intervention description(s): Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypertension; Qianglidingxuan tablet; Traditional Chinese medicine; Randomized controlled trial; Chinese patent medicine
Aspirin Responsiveness in Women With Coronary Artery Disease
Condition: CAD
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The purpose of this study is to measure the percentage of women with known Coronary Artery
      Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 45 and 85 years of age with known CAD on low dose Aspirin (81 mg) seen at the
        Cardiac Center of Creighton University
      
Keywords: aspirin resistance; hyporesponsive; CAD; women
Beraprost-314d Added-on to Tyvaso® (BEAT)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess
      the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in
      patients with pulmonary arterial hypertension.

      Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of
      experience is achieved to ensure drug tolerability before enrolling in the study.

      Treatment groups consist of one active and one placebo group. Subjects will be randomly
      allocated in a 1:1 ratio to one of the two treatment groups.
    


Intervention name(s): Beraprost Sodium 314d Modified Release Tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration; Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR
Intervention MeSH terms: Beraprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses
Condition: Hemodialysis Complication; Dialysis; Complications; Vascular Access Site Haematoma; Vascular Access Complication; Dialysis Access Malfunction; Fistula; Graft Av
MeSH terms: Fistula; Hematoma
Study type: Interventional

Summary: 
      Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal
      nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has
      been widely adopted in nephrology and shown to reduce complications of vascular
      interventions. With broader adoption of handheld US devices in clinical services, renal
      nurses could acquire this point-of-care technique to increase the successful cannulation rate
      while facilitating confidence build-up during training and practice. We aim to evaluate the
      use of handheld US on difficult AVF/AVG cannulation in a hospital-based dialysis unit.
    

Detailed description: 
      We conducted a prospective randomised controlled study from January 2021 to January 2022. Ten
      renal nurses were trained by an interventional nephrologist before patient recruitment and
      had completed a pre- and post-training questionnaire on their confidence level. Fifty
      haemodialysis patients with complex AVF were randomised to US-guided or conventional
      cannulation. The total time spent on cannulation and patients' pain scores were also
      collected.
    

Intervention name(s): Handheld US device
Intervention type(s): Device
Intervention description(s): Handheld US-guided AVF/AVG cannulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: haemodialysis; dialysis; arteriovenous fistula; arteriovenous graft; ultrasound; vascular access
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5
      mg in comparison with placebo, when administered over a long-term period, on an "as needed"
      basis, in patients with chronic primary insomnia.

      Secondary objectives of the study are to evaluate the drug taking behavior over a long-term
      period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to
      placebo administered over a long-term period, on an as needed basis.
    


Intervention name(s): zolpidem-MR (SL800750)
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: primary insomnia; chronic insomnia
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
Condition: Streptococcal Infections
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered
      concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time
      of first vaccination.
    

Detailed description: 
      Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine +
      DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® +
      Infanrix™ hexa
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM (SEQUOIA-HCM)
Condition: Obstructive Hypertrophic Cardiomyopathy (oHCM)
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in
      adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract
      obstruction
    


Intervention name(s): CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg); Placebo to match CK-3773274
Intervention type(s): Drug; Drug
Intervention description(s): CK-3773274 tablets administered orally; Placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Hypertrophic Cardiomyopathy; oHCM; CK-3773274; CK-274; Aficamten; SEQUOIA-HCM; CY 6031; SEQUOIA
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of
      doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered
      over 12 weeks in subjects with type 2 diabetes mellitus.
    


Intervention name(s): Biphasic Remogliflozin Etabonate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Experimental Drug; Placebo Comparator
Intervention MeSH terms: Remogliflozin etabonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first administration of GSK2890457 in humans. The study will be conducted
      in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and
      tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as
      evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of
      Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites)
      will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2
      diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of
      Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up
      periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD
      in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening,
      Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.
    


Intervention name(s): GSK2890457; Metformin; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Provided as powder and capsule.; Tablet
Part A: Single doses on Day 1 and Day 42 orally
Part B: Subject continues usual metformin dose through Run-in, and resumes after Treatment Period completed
Part C: Subject continues usual metformin dose throughout study; Provided as powder and Capsule.; Provided as Injection. 6mg/mL, 3mL injector pen that permits doses of 0.6mg, 1.2mg, and 1.8mg
Subcutaneous injection 18 weeks dosing (Stabilization and Treatment Periods, Part B only
Other intervention name(s): Victoza
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metformin; diabetes; obesity; liraglutide
Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
Condition: Cisplatin Nephrotoxicity
Study type: Interventional
Phase: Phase 2

Summary: 
      Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief
      dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose
      cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC)
      ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the
      protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.

      Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin
      nephrotoxicity in humans compared to mannitol and to each other.

      Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin
      were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving
      acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using
      serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed
      using RIFLE criteria. Patients' liver function tests and hematological parameters were also
      monitored.
    


Intervention name(s): Acetazolamide; Acetylcysteine; Mannitol; saline; Cisplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity; patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity; patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.; saline hydration 2500 ml before cisplatin therapy; patients with tumours already prescribed cisplatin
Other intervention name(s): ACTZ; NAC
Intervention MeSH terms: Acetylcysteine; Mannitol; Acetazolamide; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery
Condition: Spinal Stenosis; Spinal Disease; Zygapophyseal Joint Arthritis; Joint Instability; Arthrodesis; Laminectomy; Post Laminectomy Syndrome
MeSH terms: Spinal Stenosis; Spinal Diseases; Joint Instability
Study type: Observational

Summary: 
      Background : Segmental spinal instability after a laminectomy, and adjacent segment disease
      (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require
      re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy
      intervention under general anesthesia, in often fragile patients.

      Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is
      a minimally invasive technique involving the placement of screws through the posterior facet
      joints, improving spinal stability.

      Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS)
      and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of
      low back pain and/or radiculalgia related to focal instability secondary to laminectomy or
      ASD.

      Methods : TFF were performed in 24 patients having a history of spinal surgery such as
      laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University
      Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were
      measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI),
      collected prospectively at systematic 6-month and 1-year follow-up visits. Long term
      evolution were assessed by phone consultation.
    


Intervention name(s): Trans-Facet fixation
Intervention type(s): Other
Intervention description(s): Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients treated at Nice University Hospital between 2017 and 2021 by transfacet
        arthrodesis, with history of spinal surgery ( laminectomy and/or classic arthrodesis),
        andsigns of subsequent instability.
Pharmacokinetics and Safety of BI 695501
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after
      single injection using either auto injector or prefilled syringe.
    


Intervention name(s): BI695501 Prefilled syringe; BI695501Autoinjector
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc
      herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6
      months. These patients were followed for 3 years for the clinical and functional outcomes.
    

Detailed description: 
      150 patients were enrolled in this study and only 97 patients were finally analyzed for
      primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and
      secondary outcome measures of Visual analogue scale for back pain and leg pain as well as
      length of hospital stay and time to return for daily activities. Assessments done at
      different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.
    

Intervention name(s): Lumbar Microdiscectomy at 6 weeks of symptoms; Lumbar Microdiscectomy at 3 months of symptoms; Lumbar Microdiscectomy at 6 months of symptoms
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms; Microscope assisted lumbar discectomy done at 3 months of starting symptoms; Microscope assisted lumbar discectomy done at 6 months of starting symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duration of symptoms; Outcomes; Lumbar Microdiscectomy; Oswestry disability index; Roland-Morris Questionnaire
The Predictive Ability of 4MGS in IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study investigates whether usual walking speed, measured by the 4 metre gait speed test
      (4MGS), and change in usual walking speed over 6 months predicts death and hospital
      admissions in patients with Idiopathic Pulmonary Fibrosis.
    

Detailed description: 
      This observational study is investigating a simple test of usual walking speed, measured
      using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic
      Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is
      a lack of reliable measurements that can assess the effectiveness of treatment. Death and
      hospital admissions are currently considered meaningful endpoints in research trials due to
      the lack of fully validated surrogate endpoints in IPF. Using surrogate endpoints could
      reduce the sample size, cost and duration of clinical trials in IPF perhaps permitting more
      rapid drug development. Slow walking speed has been shown to be consistently associated with
      survival and a risk factor for disability, institutionalisation and hospitalisation in older
      adults and people with another lung disease called Chronic Obstructive Pulmonary Disease
      (COPD). We are interested to see whether usual walking speed and change in usual walking
      speed over 6 months predicts death and hospital admissions in IPF patients. This will help
      inform us of the potential use of 4MGS as a surrogate endpoint. To do this, participants who
      consent to taking part in the study will be timed walking at their usual walking speed over a
      distance of 4 metres (13.12 feet) at one time point and then six months later. Incidence of
      mortality and non-elective hospital admissions will be assessed at 12 months.
    

Intervention name(s): 4MGS
Intervention type(s): Other
Intervention description(s): Usual walking speed measured over 4 metres
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with IPF according to NICE guidelines
      
Keywords: Gait speed; Mortality; Morbidity
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
Condition: B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI,
      up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like
      regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who
      achieved at least a PR, ASCT started with a BEAM regimen.
    

Detailed description: 
      Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment
      of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We
      updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and
      toxicity in 42 patients who underwent HDT with ASCT.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab infusion on day 1 dose: 375mg/m²
Other intervention name(s): Mabthera®
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aggressive large B-cell lymphoma (DLBCL); Intensive chemotherapy; Rituximab; ASCT