bioihbjkbjnl/mcl2 huggingface dataset:
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      In the present study we will measure and compare the unbound, i.e. microbiologically active
      concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose
      tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis
      technique, which allows for the continuous measurement of unbound drug concentrations in the
      interstitial space fluid. The findings of the present study will help to assess whether
      currently employed therapy regimens with doripenem provide effective antimicrobial
      concentrations in different compartments in man
    


Intervention name(s): doripenem
Intervention type(s): Drug
Intervention description(s): doripenem once i.v.500mg
Intervention MeSH terms: Doripenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Factors Predicting Postoperative Cesarean Section Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      In spite of identical analgesic protocols, parturients suffer different levels of pain
      postoperative lay. In this study we hope to identify factors which influence the perception
      of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women after cesarean section
      
Keywords: Cesarean section; Pain; Wound hyperalgesia
The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.
Condition: Diabetes Mellitus, Type 2 AND Metformin
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus.
      Different pharmaceutical types of metformin are available. As a clinical trial, we compared
      the efficacy and complications of metformin produced by "Pars Mino pharmaceutical company,
      Iran" with "Apotex pharmaceutical company, Canada", in type 2 diabetic patients.

      Method: 18 eligible women with type 2 diabetes were given metformin "Pars Mino" or "Apotex"
      (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study.
      These two groups randomly under treatment with generic metformin (manufactured by Pars Mino
      company) or non-generic (manufactured by Apotex Canada). After 2 weeks washout period another
      6 weeks period with another Brand of metformin was prescribed. FBS, HbA1C, lipid profile
      (Cholesterol, TG, HDL, and LDL), weight, and BMI were assessed before and after each
      treatment phase. The results were compared with each other by paired sample T-test,
      Independent sample T-test.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes mellitus, type 2, Metformin, Generic, Efficacy
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the
      treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP
      will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac
      camera will guide the GP ablation procedure.
    

Detailed description: 
      Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory
      atrial fibrillation (AF). However, ablation success for patients even in the early stages of
      AF is currently only around 70% and may require multiple procedures.

      The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been
      shown to be a critical element responsible for the initiation and maintenance of AF.
      Autonomic inputs to the heart converge at several locations; these convergence points are
      typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain
      autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left
      atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency
      stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive
      electrophysiology (EP) study.

      A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT,
      Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution
      and can provide novel imaging information on previously 'invisible' structures like the GP.
      Using this 3D image information to guide GP ablation could significantly facilitate AF
      ablation and result in improved ablation outcomes.
    

Intervention name(s): Image guided GP ablation; D-SPECT dedicated cardiac nuclear camera
Intervention type(s): Procedure; Device
Intervention description(s): 3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure.
Other intervention name(s): D-SPECT dedicated cardiac nuclear camera
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ganglionated plexi
Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of rosiglitazone on the bone in
      postmenopausal women with type 2 diabetes mellitus
    


Intervention name(s): Rosiglitazone; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): up to 8mg/day; up to 2000mg/day
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; bone; x-ray absorptiometry; bone biomarkers; dual-energy; bone mineral density
Observational Cohort Study of TachoSil (TC-018-IN)
Condition: Blood Loss, Surgical
MeSH terms: Blood Loss, Surgical
Study type: Observational

Summary: 
      The purpose of this study is to collect information, after exposure to TachoSil ®, of all
      thromboembolic events, immunological events and drug interactions leading to thromboembolic
      events or major bleeding. In addition, pharmacoeconomic data will be collected.
    


Intervention name(s): Fibrinogen (human) + thrombin (human) (TachoSil)
Intervention type(s): Drug
Intervention description(s): treatment in surgery for improvement of haemostasis where standard techniques are insufficient
Intervention MeSH terms: Thrombin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients exposed to TachoSil® of all thromboembolic events, immunological events and drug
        interactions leading to thromboembolic events or major bleeding.
      
Keywords: Collection of all thromboembolic events,; immunological events and drug interactions leading to thromboembolic events or major; bleeding after exposure to TachoSil®.
E1K Intra Articular(IA) Treatment for Knee Osteoarthritis
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of pain relief treatment
      on knee osteoarthritis when administered E1K or placebo in patients with knee osteoarthritis
      aged 40 to 70 to determine the optimal dose.
    


Intervention name(s): E1K 1,200 ㎍/joint; E1K 2,400 ㎍/joint; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection of E1K 1,200 ㎍/joint/ml on target lesion; Injection of E1K 2,400 ㎍/joint/ml on target lesion; Injection of 3ml saline on target lesion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Hydroxychloroquine in Prevention of Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal
      mortality and morbidity The only effective treatment is delivery, which leads to significant
      neonatal morbidity and mortality if carried out preterm, especially when the disease occurs
      early in pregnancy. Vascular endothelial dysfunction and immunological impairment are
      associated with preeclampsia. To date, there is no effective or optimal therapeutic approach
      for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic,
      lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is
      an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed
      for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus
      erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic
      histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve
      placental function in pregnancies associated with heightened inflammation.
    


Intervention name(s): Hydroxychloroquine; Folic acid; Low-dose aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hydroxychloroquine 400 mg at start of pregnancy; 5 mg; 75 mg
Intervention MeSH terms: Aspirin; Folic Acid; Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate enzyme availability in the central nervous system
      before and after CC-97489 administration in healthy participants
    


Intervention name(s): CC-97489; [18F]T-401; [11C]MK-3168
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-97489; Healthy Adults; Phase 1; Positron Emission Tomography (PET) Imaging
Perioperative Muscle Relaxant and Postoperative Outcomes
Condition: Postoperative Complications
MeSH terms: Muscle Hypotonia; Postoperative Complications
Study type: Observational

Summary: 
      Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular
      blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during
      surgery, but may increase the risk of residual blockade after surgery. Residual blockade has
      been reported to increase risk of morbidity. In this study, we tend to observe the
      postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And
      to compare the outcomes in patients received different depth of neuro-muscular blockade.
    


Intervention name(s): No Response to Train of Four Stimulation; 1-2 Response to Train of Four Stimulation
Intervention type(s): Other; Other
Intervention description(s): No response is observed during Train of Four stimulation monitoring during surgery; 1 to 2 response is observed during Train of Four stimulation monitoring during surgery
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for laparoscopic surgery are consecutively screened with inclusion and
        exclusion criteria.
      
Keywords: muscle relaxant; general anesthesia; Chinese patient
A Study of Aripiprazole in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess
      the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned
      open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder
      who demonstrate an incomplete response to a prospective eight week trial of the same assigned
      open-label marketed antidepressant therapy.
    


Intervention name(s): Aripiprazole+ ADT; Placebo+ ADT
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks; Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Single or recurrent; non-psychotic episode of Major Depressive Disorder
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The primary aim of this project is to understand whether it is possible to reduce medical
      risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and
      functional outcomes. We will examine the role of behavioral risk factors and presumed
      behavioral mediators and moderators of health risk in individuals suffering from bipolar I
      disorder. The investigators will employ an innovative behavioral intervention with guideline
      based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target
      modifiable medical risk factors.
    

Detailed description: 
      IRRI is aimed at improving sleep/wake and social rhythm disturbance and achieving modest
      weight reduction by increasing physical activity and improving nutrition and dietary habits,
      while at the same time providing optimal psychiatric care and medical monitoring. This will
      allow us to investigate the role that improvements in sleep/wake and social rhythm
      regularity, diet, and physical activity have in improving psychiatric and functional
      outcomes. In order to examine another set or possible pathways (i.e., that it is the
      amelioration or psychiatric symptoms that leads to the improvements in physical health), we
      will contrast outcomes of subjects receiving IRRI with those of subjects receiving
      psychiatric care with medical monitoring (PCMM), which incorporates the same optimal
      psychiatric care plus monitoring of medical conditions. These aims will be achieved in a
      24-month randomized treatment trial of 144 adult subjects with bipolar I disorder.
    

Intervention name(s): IRRI; PCCM
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will remain in their assigned treatment condition for 24 months. IRRI subjects will meet with the lifestyle coach 25-27 times throughout the duration of the study.; Subjects will remain in their assigned treatment condition for 24 months.
Other intervention name(s): Integrated Risk Reduction Intervention; Psychiatric care with medical monitoring condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Medical Risks; Integrated Risk Reduction Intervention; Currently in Remission; BMI
A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13
      SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis (RA).
    

Detailed description: 
      A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative
      to the intravenous regimen where subcutaneous infliximab injection typically takes less than
      2 minutes. The availability of a subcutaneous formulation of infliximab would increase the
      treatment options available to patients, particularly those wishing to self-administer their
      therapy. This Phase I/III Study randomized, double-blinded (Part 2 only), multicenter,
      parallel-group study was designed to evaluate Efficacy, Pharmacokinetics and Safety between
      Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active RA.
    

Intervention name(s): CT-P13; CT-P13; CT-P13; CT-P13; CT-P13; CT-P13
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks; CT-P13 (90 mg) by single SC injection every other week; CT-P13 (120 mg) by single SC injection every other week; CT-P13 (180 mg) by double SC 90 mg injections every other week; CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.; CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28
Other intervention name(s): Infliximab; Infliximab; Infliximab; Infliximab; Infliximab; Infliximab
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole
      (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with
      symptomatic erosive esophagitis
    

Detailed description: 
      Patients:

      Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation,
      heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive
      esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1)
      coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence
      of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4)
      previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated
      questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los
      Angeles Grade A and B erosive esophagitis.

      Outcome parameters:

      The main outcome measures

        1. Rate of complete symptom relief (CSR) at the end of initial treatment phase

        2. rate of symptom relapse within 12 weeks after stopping initial therapy
    

Intervention name(s): Esomeprazole 40 mg
Intervention type(s): Drug
Intervention description(s): Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Other intervention name(s): Nexium 40mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Jitongning Tablet to Treat Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint
      function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore
      the optimal dosage.
    

Detailed description: 
      Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex
      Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis,
      Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted
      to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial
      spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation),
      when compared with placebo and to explore the optimal dosage.
    

Intervention name(s): Jitongning tablet(High-dose ); Jitongning tablet(Low-dose ); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Jitongning tablet,3tablets,bid,treat 12 weeks; Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks; Jitongning tablet placebo,3tablets,bid,treat 12 weeks
Other intervention name(s): Jitongning tablet,3tablets; Jitongning tablet,2tablets,Jitongning tablet placebo,1tablet,; Jitongning tablet placebo,3tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Jitongning Tablet, Spondyloarthritis
An Affect Management Intervention for Juvenile Offenders
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Adolescents are at risk for HIV because of sexual and drug behavior initiated during this
      developmental period. Adolescents in the juvenile justice system are at increased risk for
      HIV due to higher rates of substance use and psychopathology than their non-offending peers.
      Juvenile justice youth may therefore also be less likely to benefit from frequently used
      skills based interventions. It appears that emotional lability, frequently found in this
      population, disrupts skills learned. This project will implement and evaluate an affect
      management HIV prevention intervention for adolescents in a juvenile drug court program.
      Affect management and general health promotion interventions will be compared to determine
      which intervention best reduces risk behavior among adolescents in the drug court.
    


Intervention name(s): Affect Management; General Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training; 5 session group focused on delivering general health promotion information in didactic format
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; HIV seronegativity