bioihbjkbjnl/mcl2 huggingface dataset:
Primary Versus Secondary Metal Stent Implantation in PTBD
Condition: Bile Duct Obstruction; Extrahepatic Cholestasis
MeSH terms: Cholestasis; Cholestasis, Extrahepatic
Study type: Interventional

Summary: 
      The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal
      stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in
      terms of adverse events.
    

Detailed description: 
      Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when
      endoscopic access was not successful or not possible due to anatomical changes after
      abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in
      patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually
      performed as a two step-procedure with primary drainage of the accumulated bile fluid by an
      external or an external/internal plastic stent and a secondary metal stent implantation at an
      interval of a few days. PTBD with primary metal stent implantation might shorten the hospital
      stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided
      biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent
      implantation which is probably associated with lesser adverse events (AE) than PTBD with
      secondary metal stent implantation. However, it is not clear whether PTBD with primary metal
      stent implantation shows fewer adverse events than PTBD with secondary stent implantation.
      The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs
      with primary or secondary metal stent implantation in patients with proximal and distal
      malignant bile duct obstruction. The focus of this single center study will be to compare the
      two approaches in terms of adverse events. Adverse events in PTBD might range from very mild
      to fatal. Therefore, the severity of the adverse events has been considered in the
      calculation.
    

Intervention name(s): Percutaneous transhepatic implantation of self-expandable metal stent
Intervention type(s): Device
Intervention description(s): A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Retrospective comparison of two similar interventions with small modification
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bile Duct Obstruction; Self Expandable Metallic Stents
Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that the intestinal absorption of calcium from a
      novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg)
      and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in
      urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.
    

Detailed description: 
      The drug being tested in this study was called Calcichew D3. Calcichew D3 was being tested to
      assess how it is processed by the body in healthy men and postmenopausal women. This study
      looked at lab results in people who take Calcichew D3.

      The study enrolled approximately 27 participants. All participants received the same
      treatment:

      • Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants were
      asked to take one tablet each morning of the treatment period.

      This single-centre trial was conducted in France. The overall time to participate in this
      study was up to 44 days. Participants made 2 visits to the clinic, including one 7-day period
      of confinement to the clinic, and were contacted by telephone 14 days after last dose of
      study drug for a follow-up assessment.
    

Intervention name(s): Calcichew D3; Noncarbonated Water
Intervention type(s): Drug; Drug
Intervention description(s): Calcium 500 mg and vitamin D3 1000 IU chewable tablets; Noncarbonated water 200 mL
Intervention MeSH terms: Calcium Carbonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug therapy
Interventions to Reduce Excess Weight Gain in Pregnancy
Condition: Overweight and Obesity; Pregnancy
MeSH terms: Overweight; Weight Gain
Study type: Interventional

Summary: 
      The study will use a comprehensive behavioral intervention adapted for pregnant women to
      change dietary intake, eating behavior and physical activity. The central hypothesis of this
      study is that the intervention will reduce excess gestational weight gain and achieve
      clinical and metabolic benefits in obese and overweight pregnant women and their infants over
      the first year of life.
    


Intervention name(s): Intervention to reduce excess weight gain during pregnancy
Intervention type(s): Behavioral
Intervention description(s): Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: weight; pregnancy; behavioral intervention; obesity
Ultra-wide Fluorescein Angiography in Patients With Central Retinal Vein Occlusion Treated by Afilbercept
Condition: Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Observational [Patient Registry]

Summary: 
      In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and
      safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in
      United States and GALILEO study performed in Europe and Asia/Pacific.

      With the project of Hermes Study, the first observational study conducted in France in
      patients with CRVO and treated with aflibercept, we would like to evaluate in real life the
      monitoring and the use of Aflibercept. The primary objective of this study will also be based
      on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal
      perfusion will be particularly evaluated by using ultra wide field angiography technology.
    

Detailed description: 
      The pathophysiology of Central Retinal Vein Occlusion (CRVO) is incompletely understood, but
      a significant slow-down in blood flow, caused by various predisposing factors, results in the
      release of VEGF, leading to the breakdown of the blood-retinal-barrier and finally to macular
      edema. The level of VEGF has been also correlated with neovascularization and vascular
      permeability in patients with ischemic CRVO. Several treatments have been used to treat
      patients with CRVO such as hemodilution, surgery, laser treatment and corticoids injection.
      However anti-vascular endothelial growth factor (anti-VEGF) agents administered by
      intravitreal injection, improve both visual and anatomic outcomes in patients with macular
      edema secondary to CRVO. Aflibercept is a fusion protein, use by intravitreal injection. In
      patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety
      in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United
      States and GALILEO study performed in Europe and Asia/Pacific. In these studies, anatomic
      outcomes such as ischemic progression and retinal perfusion status were evaluated as
      secondary objectives; the primary objective of these studies was visual outcome.

      With the project of Hermes Study, the first observational study conducted in France in
      patients with CRVO and treated with aflibercept, we would like to evaluate in real life the
      monitoring and the use of Aflibercept. The primary objective of this study will also be based
      on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal
      perfusion will be particularly evaluated by using ultra wide field angiography technology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with central retinal vein occlusion
      
Keywords: Central retinal vein occlusion; OCT-A; CRVO
Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Pregnancy
Condition: Ultrasound
Study type: Observational

Summary: 
      The aim of this double blinded study is to assess the abilities of the SpineNav3DTM
      technology (Accuro) to identify the lumbar epidural space in parturients using as comparator
      a standar ultrasound (US) device.
    

Detailed description: 
      SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans
      by automating spinal bone landmark detection and depth measurements and providing a real-time
      assessment of scan plane orientation in 3D.

      Assuming a Type I error rate of 5% (α = 0.05) and a Type II error rate of 20% (β=0.2), a
      minimum of 76 subjects will be required. All the subjects will have their lumbar area scanned
      for the measurements of the depth of the epidural space (recorded in cm) by two
      anesthesiologist, one expert in UD and the other a novice, previously instructed to the use
      of the Accuro device.

      All measurements will be performed either in the sitting or in the supine position at L1/L2,
      L2/L3 and L3/L4 levels. The expert operator will assess the lumbar spine by using both the
      devices (standard US and Accuro) while the novice will use only the Accuro.

      The primary end-point of the study will be the accuracy of the Accuro to determine the depth
      of the epidural space using a midline approach using as comparator the measurement obtained
      with the standard ultrasound device performed by the expert operator.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy single fetus pregnant
      
Keywords: epidural block, ultrasound
Lovastatin and Its ß-hydroxy Acid From Four 600 mg LipoCol Forte® Capsules Compared to That of One 20 mg Mevacor® Tablet in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the relative bioavailability of lovastatin and its
      ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor®
      Tablet after single oral administration in healthy subjects using a 2x2 crossover design.
    

Detailed description: 
      Healthy subjects were randomly allocated to receive a single dose of either four 600 mg red
      yeast rice capsules or one 20 mg lovastatin tablet; after 7-day washout period, they received
      a single dose of the alternative drug. The subjects were fasted at least 10 hour before
      dosing. The investigational products were administered with 240 mL of water with the subject
      in an upright position. The blood samples were collected at prior to the drug administration
      (T0), and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after dosing.
    

Intervention name(s): LipoCol and Mevacor
Intervention type(s): Drug
Intervention description(s): To evaluate the relative bioavailability of lovastatin and its ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor® Tablet after single oral administration in healthy subjects using a 2x2 crossover design.
Intervention MeSH terms: Lovastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Red yeast rice; Lovastatin; Bioavailability
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
Condition: Covid 19 Infection
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study will be conducted on eighty patients of both sexes with age ranging from 35 to
      45years. The will be recovered from COVID-19 infection with chest symptoms. They will be
      selected from Nasr city police authority hospital. They will be randomly assigned into 3
      equal groups.
    

Detailed description: 
      This study will be conducted on eighty patients of both sexes with age ranging from 35 to
      45years. The will be recovered from COVID-19 infection with chest symptoms. They will be
      selected from Nasr city police authority hospital. They will be randomly assigned into 3
      equal groups.

      Participants will be assigned into 3 groups equal in number (group A, group B, group C)

      Group A (Respiratory Training Group) : It will include 30 patients of both sexes, recovered
      from COVID-19 infection. In addition to medical drugs, they will receive respiratory training
      for 6 weeks.

      Group B : (Aerobic Training Group) : It will include 30 patients of both sexes, recovered
      from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for
      6 weeks

      Group C : (control group) :It will include 20 patients of both sexes, recovered from COVID-19
      infection on medical drugs only will receive no exercise as control group.
    

Intervention name(s): Respiratory Training; Aerobic training
Intervention type(s): Other; Other
Intervention description(s): Respiratory training in form of :
Diaphragmatic breathing,Segmental breathing, Incentive spirometer:; aerobic exercises are customized according to the patient's underlying disease and residual dysfunction. These exercises will include walking on treadmill. After an initial, 5-minute warm-up phase performed on the treadmill at a low load, each endurance training session lasted 30 minutes and ended with 5-minute recovery and relaxation phase. A total of 3-5 sessions are carried out per week. Patients who are prone to fatigue should perform intermittent exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prospective Evaluation of Biomarkers Variability in Knee Prosthetic Surgery
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Bone quality is an important factor influencing the outcome of total knee replacement (TKR)
      surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the
      choice of the most appropriate prosthetic implant.

      The primary goal of this study is to measure serum and tissue levels of some proteins
      involved in bone remodelling.
    

Detailed description: 
      Aseptic implant loosening after TKR causes knee pain, reduces knee function and may require
      revision surgery.

      Several proteins have been identified, which are involved in bone metabolism and remodelling;
      variations in serum levels of some of these proteins after TKR loosening have also been
      described.

      However, preoperative identification of risk factors for aseptic loosening remains a
      challenge.

      An observational study is conducted to evaluate how levels of the following serum biomarkers
      vary after TKR:

        -  osteoprotegerin (OPG)

        -  receptor activator of nuclear factor kappa-B (RANK)

        -  receptor activator of nuclear factor kappa-B ligand (RANK-L)

        -  sclerostin

        -  cathepsin K

      To avoid bias caused by inflammatory states, C reactive protein (CRP), interleukin 1 (IL-1),
      interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) levels and erythrocyte sedimentation
      rate (ESR) will be measured.

      Secondary goals are to evaluate the mRNA expression of OPG, RANK-L, cathepsin K and
      sclerostin on tibial bone biopsies and to study if changes in serum biomarkers levels after
      surgery are associated with:

        -  clinical outcomes

        -  periprosthetic bone density

        -  variation of two bone reabsorption markers, the postoperative change of which has
           already been described in details: type 1 collagen cross-linked C-terminal telopeptide
           (CTP1) and type 1 procollagen N-terminal telopeptide (P1NP).

      One day before surgery, after having signed informed consent, patients will undergo a
      vertebral and femoral dual-energy X-ray absorptiometry (DEXA) scan and blood samples will be
      collected.

      During surgery a tibial biopsy will be collected. Between 4 and 7 days postoperatively and 3,
      6 and 12 months after surgery patients will again undergo periprosthetic DEXA scans and blood
      samples will be collected.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing TKR surgery.
      
Biospecimen description: 
      Serum, tibial bone biopsy.
Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      IBI306 is a fully human monoclonal antibody that binds proprotein convertase
      substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density
      lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and
      low-density lipoprotein cholesterol（LDL-C）uptake. In phase I study IBI306 was shown to be
      safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and
      lipoprotein (a) in healthy subjects. This study is a randomized, double-blind,
      placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the safety and
      tolerability of a novel PCSK-9 anti-body, IBI306, in Chinese patients with
      hypercholesterolemia.
    

Detailed description: 
      A total of 60 patients who meet the criteria for admission and have a clinical diagnosis of
      hypercholesterolemia and have received statin for at least 4 weeks will be randomized and
      receive different dose groups of IBI306 or matching placebo. Ascending dose design includes 6
      dose levels: 75 mg Q2W, 140 mgQ2W, 300 mg Q4W，420mg Q4W, 450 mg Q6W，and 600 mg Q6W. Total
      duration of the study per subject is 12 weeks.
    

Intervention name(s): IBI306; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W; Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This 8 arm study will evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single ascending doses of R1671 or placebo in patients with mild,
      intermittent, asymptomatic asthma. Patients will be randomized to receive placebo or R1671,
      at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in
      subsequent groups of patients after a satisfactory assessment of the data from the previous
      dose. The anticipated time on study treatment is <3 months, and the target sample size is
      <100 individuals.
    


Intervention name(s): RG1671
Intervention type(s): Drug
Intervention description(s): Administered iv at escalating doses (with a starting dose of 0.0015mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose
      crossover study was conducted to compare the relative bioavailability of equal doses of the
      test and reference products under non-fasted conditions.
    

Detailed description: 
      This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose
      crossover study was conducted to compare the relative bioavailability of equal doses of the
      test and reference products under non-fasted conditions. The study was conducted with 36 (31
      completing) healthy adults in accordance with Protocol No. 10940308 (Revision 0). In each
      study period, a single 10 mg tablet of donepezil hydrochloride was administered to all
      subjects following a standardized high fat, high calorie breakfast, preceded by an overnight
      fast of at least 10 hours. The test formulation was donepezil hydrochloride 10 mg tablet (OHM
      Laboratories, Inc., USA a subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) and the reference
      formulation was ARICEPT® (donepezil hydrochloride) 10 mg Tablets (Eisai Inc.). The subjects
      received the test product in one study period and the reference product in the other period;
      the order of administration was according to the dosing randomization schedule. Subjects were
      confined at the clinical facility from at least 10.5 hours prior to dosing until after the 24
      hour blood collection. Subjects returned to the clinical facility for the 36, 48, and 72 hour
      blood sample collection. There was a 28-day interval between treatments.

      Blood samples were collected pre-dose and at intervals over 72 hours after dosing in each
      period. The plasma samples from all subjects were shipped to Warnex Bioanalytical Services
      for determination of donepezil concentrations.

      Statistical analysis was performed by Ranbaxy Laboratories Limited to compare the
      bioequivalence of the test formulation to the reference product. Bioequivalence was
      determined based on the confidence intervals for the major pharmacokinetic parameters,
      AUC0-72 and Cmax, for donepezil.
    

Intervention name(s): Donepezil
Intervention type(s): Drug
Intervention description(s): 10 mg tablets
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)