bioihbjkbjnl/mcl2 huggingface dataset:
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
Condition: Staphylococcus Aureus Bacteraemia
MeSH terms: Staphylococcal Infections; Bacteremia
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with
      staphylococcus aureus bacteraemia.

      The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct
      thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus
      bacteremia.
    

Detailed description: 
      Single center randomized controlled trial of direct thrombin inhibitors versus standard
      enoxaparin.

        -  Feasibility: proportion of patients eligible for randomization; clinically attained
           concentration of DTI and resulting staphylothrombin inhibition

        -  Safety: bleeding events (major/ clinically relevant non-major)

        -  Efficacy: thrombotic events during the thromboprophylactic treatment + 3 days

        -  Secondary outcome measures

             -  Coagulation parameters: evolution of D-dimers from day 0-4; other lab parameters of
                coagulation (PT/APTT/fibrinogen/platelet count)

             -  Inflammatory parameters: CRP, white blood cell count, neutrophilia

             -  Clinical outcomes: metastatic infections, assessed clinically or by PET/CT; relapse
                of S. aureus bacteremia; defervescence; persistent positive blood cultures;
                hospital stay, mortality.
    

Intervention name(s): direct thrombin inhibition; enoxaparin
Intervention type(s): Drug; Drug
Other intervention name(s): dabigatran; argatroban; clexane
Intervention MeSH terms: Enoxaparin; Dabigatran; Argatroban; Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Comparison of HFNC and COT to Diaphragm Function of Post-upper Abdominal Surgery Patients
Condition: Post Abdominal Surgery
Study type: Interventional

Summary: 
      This study aims to compare diaphragm thickness, air lung distribution, and several clinical
      and laboratory parameters on post abdominal surgery patients with conventional oxygen therapy
      vs high-flow nasal cannula
    

Detailed description: 
      "Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were recruited using consecutive sampling method.
      Subjects underwent upper-abdominal surgery were screened. Eligible and consented subjects
      were randomized into intervention group (high-flow nasal cannula) and control group
      (conventional oxygen therapy). Subject and operation characteristics were recorded prior to
      intervention.

      Clinical parameters (vital signs, Borg Score, ICON) were recorded in 10 specific times.
      diaphragm thickness data using abdominal ultrasonography (USG) and air lung distribution data
      using Electrical Impedance Tomography were collected in 7 specific times while lactate and
      blood gas analysis were done 4 times. "
    

Intervention name(s): HFNC; COT
Intervention type(s): Procedure
Intervention description(s): "HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HFNC; conventional oxygen; EIT; diaphragm thickness
Bioavailability Study of Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is

        -  To characterize the pharmacokinetic profile of the Ramipril 10 mg capsules relative to
           that of ALTACE@ 10 mg capsules in healthy, adult, human, male subjects under fasting
           conditions and to assess the bioequivalence.

        -  To monitor the safety of the subjects.
    

Detailed description: 
      A Two-way open label crossover experimental evaluation of relative bioavailabilities of
      Ramipril 10 mg capsules of Dr.Reddy's Laboratories and ALTACE@ 10 mg capsules of King
      Pharmaceuticals in healthy adult human male subjects under fasting conditions.
    

Intervention name(s): Ramipril; Altace
Intervention type(s): Drug; Drug
Intervention description(s): Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited; Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
Other intervention name(s): Altace@10 mg Capsules
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Ramipril
COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Observational

Summary: 
      A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy
      in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on
      therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the
      current MS AllianceTM program versus patients enrolled in this program prior to October 2007.
    

Detailed description: 
      Study Design

      Five hundred patients will be enrolled in the prospective portion of the study, all of whom
      will receive AVONEX. Patients will join the study by signing the attached Informed Consent
      Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide
      the drug to approximately 40 new patients per month, so it will take about twelve to fourteen
      months to enroll all of the study subjects, assuming that all agree to participate. Once the
      recruitment period is over, it will take another 22 months to complete the study to the
      22-months point for the last subject.

      In the retrospective arm of the study, 500 chart reviews will be completed for patients who
      had participated in the MS Alliance program two (2) to three (3) years ago to determine
      persistence to therapy over a similar 22 month period.

      Study Objectives

      Primary Objectives:

      - To assess patients' compliance (as defined above) with AVONEX therapy in the prospective
      arm using self-reported patients questionnaire, as well as to compare patients' persistence
      on therapy (as defined above) between prospective and retrospective arms.

      Secondary Objective:

      - Evaluate patients' satisfaction with new MSA program.

      Patients and Methods

      Only patients enrolled in the MSA program will be included in this study. There will be no
      interventions above the current standard of care with the MSA program. Two distinct patient
      arms will exist for this study: the prospective arm and the retrospective (chart review) arm.

      Inclusion Criteria

        -  Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)

        -  Prescription of AVONEX® PS (prefilled syringes)

        -  Enrolment in the MS AllianceTM program
    

Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled in the MS AllianceTM program
Magnesium Sulfate Versus 5% Dextrose With Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      The proposed study is a 1-week, randomized, double-blind, placebo-controlled, trial to
      evaluate the efficacy of an IV infusion of magnesium sulfate on symptoms of treatment
      resistant mild and moderate depression in 20 males and females (21-70 years of age).
      Participants will be assessed at screening/baseline, day 1, day 2, day 7, and day 8. Each
      subject will be randomized in a double-blind fashion to receive either IV infusion of
      magnesium sulfate or 5% dextrose followed by a washout period of 5 days then crossover to
      receive either IV infusion of 5% dextrose or magnesium sulfate.
    

Detailed description: 
      Purpose:

        1. To determine the magnesium deficient status in treatment-resistant mild and moderate
           depression patients via 24-hour urine magnesium assessment before and after IV magnesium
           infusion.

        2. Correlation of intracellular magnesium (EXATEST), urine magnesium, and serum magnesium
           as well as sensitivity to the IV magnesium infusion.

        3. To assess the effectiveness of magnesium sulfate infusion on treatment resistant mild
           and moderate depression patients.

      Objectives:

      Primary:

        1. To investigate the magnesium deficient status in treatment-resistant mild and moderate
           depression patients via assay of 24-hour urine magnesium, blood magnesium, and EXATEST
           of intracellular magnesium of epithelial cells before and after IV infusion.

        2. To assess the effectiveness of the magnesium sulfate infusion on the mean change in
           scores on the Hamilton Rating Scale for Depression and the Patient Health Questionnaire
           (PHQ-9) for depression.

      Secondary:

      1. To correlate the levels of magnesium with the scores on the Hamilton Rating Scale for
      Depression and the Patient Health Questionnaire (PHQ-9) for depression.
    

Intervention name(s): Magnesium sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): 4 grams magnesium sulfate in 100 ml IV over 4 hours
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild moderate treatment-resistant depression; magnesium sulfate
Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated
      balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate
      the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation
      lesions when compared with traditional single drug eluting stent(DES) strategy, so as to
      simplify the procedure for treatment of coronary bifurcation lesions and extending the
      clinical indications of paclitaxel DCB in China.
    

Detailed description: 
      Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly
      and homogenously to inhibit excessive neointima proliferation and is associated with rapid
      healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis.
      Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding
      risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB.
      Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB
      procedure and this advantage completely eliminates adverse events associated with allergic
      reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small
      lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause
      much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs
      by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.
    

Intervention name(s): Paclitaxel DCB; DES
Intervention type(s): Device; Device
Intervention description(s): Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.; MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angioplasty; drug-coated balloon; bifurcation
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Condition: Hepatitis; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin
      and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated
      with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in
      developing countries compared to that in advanced countries with a similar dose schedule.
      Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis
      drugs induced hepatic injury. The oxidative stress is closely associated with decrease of
      glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was
      investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver
      injury.
    


Intervention name(s): N Acetylcysteine
Intervention type(s): Drug
Intervention description(s): 1200 mg, BD, 2weeks
Other intervention name(s): ACC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain
Condition: Spondylarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Observational

Summary: 
      The general main objective of our study is to investigate the psychometric properties, the
      levels and determinants of the extent of SF- 6D utility in patients followed for recent back
      pain inflammatory disease.

      The specific objectives are :

        -  Study the feasibility of the tool considering missing data, distribution, construct
           validity, reproducibility, sensitivity to change or clinically different groups
           (discriminative ability) the extent of SF -6D utility .

        -  Study the impact of socio-demographic characteristics, disease characteristics and
           quality of life, comorbidities at baseline on the measurement of utility and sensitivity
           to change.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        708 patients with early inflammatory low back pain included in the French cohort DESIR
Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose
      Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device
      is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin
      aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but
      not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is
      when used with different insulin delivery settings in the iLet™ in people with type 1
      diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use
      the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to
      2 different insulin delivery settings for 7 days on each setting. The setting participants
      get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will
      have 4 visits and 1 phone contact with the study or staff.
    


Intervention name(s): Fast-acting insulin aspart; iLet™
Intervention type(s): Drug; Device
Intervention description(s): In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements.; The bionic pancreas including pigtail adapters, used in insulin-only configuration
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery
Condition: Cervical Compression Myelopathy; Ischemia; Reperfusion Injury; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases; Reperfusion Injury; Bone Marrow Diseases; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess whether a large clinical trial testing the effect of
      RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is
      warranted.
    

Detailed description: 
      Spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and
      mortality after elective cervical decompression surgery.Remote ischemic
      preconditioning(RIPC)is a phenomenon whereby brief periods of ischemia followed by
      reperfusion in one organ provide system protection from prolonged ischemia.The hypothesis of
      this protocol is that limb ischemic preconditioning could reduces spinal cord
      ischemia-reperfusion injury induced by elective cervical decompression surgery.Serum s-100B
      and NSE concentration will be measured before and after induction ,and at 6 hours,1,3,5 and
      7days after surgery.JOA scores in all the cases will be evaluated before operation and at
      7days ,1,3,6 month after surgery.
    

Intervention name(s): limb remote ischemic preconditioning (LRIPC)
Intervention type(s): Procedure
Intervention description(s): LRIPC consists of three 5-min cycles of right upper limb ischemia induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mmHg,with an intervening 5 min reperfusion during which the cuff is deflated.
Other intervention name(s): an automated cuff-inflator made in China
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remote ischemic preconditioning; cervical compression myelopathy; spinal cord; neuron-specific enolase; s-100B
Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      -  There will be a significant difference in cognitive function between cognitive
           intervention group (group therapy) and a wait list control group.

        -  There will be a significant difference in cognitive function between a home-based
           cognitive intervention group and a wait list control group.
    

Detailed description: 
      The change of Modified ADAS-cog score from the baseline to post-intervention will be compared
      between the cognitive intervention group and wait list control group.
    

Intervention name(s): group cognitive intervention; Home-based cognitive intervention
Intervention type(s): Other; Other
Intervention description(s): The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.; The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild cognitive impairment; cognitive therapy; prevention
The Effect of Resistance Exercise on Inflammation in Young and Older Adults
Condition: Aging; Inflammatory Response
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Healthy young and older adults will complete two trials in a randomized crossover
      counter-balanced order, including resistance exercise and sedentary control. During each
      trial, blood samples will be collected.

      The investigators hypothesized that an acute bout of resistance exercise exert different
      inflammation responses in young and older adults.
    


Intervention name(s): Resistance exercise
Intervention type(s): Other
Intervention description(s): 4 total resistance exercises that target all major muscle groups.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to characterize the rheological properties of cystic fibrosis
      (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF
      and healthy sputum. By collaborating with Genentech, the investigators (scientists at UCSF)
      plan to incorporate the latest scientific findings into our work to discover and develop new
      treatments for CF.
    

Detailed description: 
      There are two major mechanisms for mucus clearance in the airway, both of which are dependent
      upon optimal mucus viscosity and elasticity. These mechanisms are severely impaired in cystic
      fibrosis. The physical properties of sputum can be measured using rheological methods,
      enabling comparison between mucus in health and in disease. Therapies which enhance mucus
      clearance from the airway and decrease the volume of airway secretions are collectively
      called "mucoactive agents." Therapies which specifically disrupt innate mucus architecture by
      breaking intermolecular entanglements and bonds are called mucolytic agents. Mucolytic drugs
      can be considered in three general categories: classic mucolytics (n-acetylcysteine), peptide
      mucolytics (Pulmozyme®), and non-destructive mucolytics (hypertonic saline). Using
      state-of-the-art rheological methods, we can characterize the physical properties of CF mucus
      and measure the rheologic effects of mucoactive drugs more accurately and reproducibly than
      what has been previously done in the literature. In this way, we will determine which of the
      current mucoactive agents are most effective in normalizing sputum rheology in CF, and we
      will gain important insights about the limitations of current mucoactive drugs.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People who have cystic fibrosis and those who do not have any lung disease
      
Biospecimen description: 
      Sputum