bioihbjkbjnl/mcl2 huggingface dataset:
Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis
Condition: Pancreatitis, Acute Necrotizing
MeSH terms: Pancreatitis; Pancreatitis, Acute Necrotizing
Study type: Interventional
Phase: Phase 4

Summary: 
      Infected pancreatic necrosis and its related septic complications are the major cause of
      death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of
      great clinical value in the treatment of AP.

      Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced
      CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic
      infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its
      effects in preventing pancreatic infection was not well studied. To evaluate the effects of
      TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical
      outcomes in patients with AP,we aimed to design this study.
    

Detailed description: 
      Study Background & Rationale:

      Infected pancreatic necrosis and its related septic complications are the major cause of
      death in patients with acute pancreatitis1, therefore prevention of pancreatic infection is
      of great clinical value in the treatment of AP.

      Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced
      CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic
      infection2, 3. Thymosin alpha 1 has been shown to have immunomodulatory properties and its
      effects in preventing pancreatic infection was not well studied4.

      Aim of This Study:

      To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection,
      immunomodulation and clinical outcomes in patients with AP.

      Sample Size Estimation:

      The prevalence of pancreatic infection was reported to be around 25% in AP episodes. To
      demonstrate a 40% reduction in the prevalence of pancreatic infection with 80% power at a
      two-sided alpha level of .05, we projected an estimated sample size of 500 participants.
      Considering possible 2% withdraw, we plan to randomize 510 patients in total.
    

Intervention name(s): Thymosin Alpha 1; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.; Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
Other intervention name(s): Thymosin Group; Placebo Group
Intervention MeSH terms: Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acute Pancreatitis, prevent,Necrotizing
GM03 - Platelet RNA Signatures of Aspirin
Condition: Platelet Aggregation Inhibitors; Aspirin; Ticagrelor; RNA
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will involve healthy volunteers and patients with Type 2 diabetes. Eligible
      healthy volunteers will be invited to enroll into one of two protocols (A or B) and eligible
      patients with diabetes will be enrolled into protocol A.
    

Detailed description: 
      Protocol A This will be a randomized, cross-over design comparing low- and high-dose aspirin
      as well as a non-aspirin platelet inhibitor ticagrelor. This antiplatelet exposure study will
      be conducted at the DCRU using two separate cohorts: 1) healthy adult volunteers 2) patients
      with Type 2 diabetes. Subjects within each cohort will but in general will have platelet
      function testing and biospecimen collection before, four weeks, and eight weeks after low- or
      high-dose aspirin exposure. Subsequently there will be a period of aspirin washout and a
      four-week exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at
      various time points peripheral blood RNA, purified platelets, DNA, serum, fecal samples
      and/or plasma will be collected.

      Protocol B This will be a single arm study of the platelet inhibitor ticagrelor that is
      essentially the last two visits of Protocol A. This study will be conducted at the DCRU and
      will only be open to healthy adult volunteers and patients with Type 2 diabetes. Subjects who
      elect to participate in this protocol will follow the protocol outlined in Figure 2 and in
      general will have platelet function testing and biospecimen collection before and four weeks
      after exposure to ticagrelor, a non-aspirin platelet inhibitor. In all subjects and at
      various time points (see Figure 2 and Table 2) peripheral blood RNA, purified platelets, DNA,
      serum, and/ plasma will be collected. In order to align the visits with that of Protocol A,
      the two visits under this protocol will be labelled V4 and V5.
    

Intervention name(s): Aspirin; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks. or Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks.; Ticagrelor 90mg BID x 4 weeks
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Aspirin 81mg/day x 4 weeks, Aspirin 325mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.
Aspirin 325mg/day x 4 weeks, Aspirin 81mg/day x 4 weeks, Aspirin washout, Ticagrelor 90mg BID x 4 weeks.
Masking: None (Open Label)
Primary purpose: Basic Science
Acetylsalicylic Acid and Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Antioxidant Enzyme System
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in
      patients with type 2 diabetes
    

Detailed description: 
      A randomized, double blind placebo controlled clinical trial was carried out in 21 adult
      patients with type 2 diabetes. Acetylsalicylic acid 300mg/d was administered orally for 3
      months to study group (n=11) and placebo to the control group (n=10).
    

Intervention name(s): Acetylsalicylic acid; Calcined magnesia
Intervention type(s): Drug; Drug
Intervention description(s): Acetylsalicylic acid 300 mg per capsule; Calcined magnesia 300 mg per capsule
Other intervention name(s): Aspirin; Placebo
Intervention MeSH terms: Aspirin; Magnesium Oxide
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A randomized double blind, placebo controlled clinical trial was carried out in 21 drug naïve adults (35-50 year of age) with DM2 with <5 years since diagnosis. They were overweight or obese (BMI 25.0 - 35.0 kg/m2), had glycosylated hemoglobin A1C (HbA1c) level between 6.5 - 9%. This protocol study was reviewed and approved by the hospital based ethics committee, and written informed consent was obtained from all volunteers. Subject was selected from the same residential area and socioeconomic status. No participants were excessively sedentary or participated in heavy physical activity. All individuals were nonsmokers. Their body weight was stable for al last 3 months before the study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acetylsalicylic acid; antioxidant enzyme system; stress oxidative; type 2 diabetes mellitus.
Myfortic for the Treatment of Non-infectious Intermediate Uveitis
Condition: Uveitis, Intermediate
MeSH terms: Uveitis; Uveitis, Intermediate; Pars Planitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of
      enteric-coated mycophenolate sodium (Myfortic®) in combination with low-dose corticosteroids
      (Decortin H®) compared to a monotherapy with low-dose corticosteroids (Decortin H®) in
      subjects with chronic intraocular inflammation (non-infectious intermediate uveitis).
    

Detailed description: 
      Mycophenolate mofetil (MMF), a pro-drug containing mycophenolic acid (MPA) as active agent,
      is approved for the treatment of acute graft rejection after kidney-, heart- and
      liver-transplantation, and was shown in 1995 to be effective in inhibiting the development of
      experimental autoimmune uveoretinitis. Further studies proved it to be a safe and effective
      steroid-sparing immunomodulatory for reducing the recurrence rate of non-infectious
      intermediate uveitis in humans. Although the adverse effect profile of MMF is comparatively
      benign, gastrointestinal adverse effects are a major concern and may limit its clinical
      benefit, because they may necessitate dose reduction, interruption, or even discontinuation
      of MMF.

      An enteric-coated formulation of mycophenolate sodium (EC-MPS, Myfortic) has been developed
      especially to reduce MPA-related gastrointestinal adverse events. This clinical trial is a
      prospective controlled study to evaluate whether a Myfortic based regimen will be able to
      reduce the probability of a relapse compared to steroid therapy alone and to test whether a
      Myfortic based therapy provides a superior behaviour compared to a steroid regimen.
    

Intervention name(s): Myfortic; Decortin
Intervention type(s): Drug; Drug
Intervention description(s): Myfortic 360 mg BID (during week 1) Myfortic 720 mg BID (from week 2 on) Maintenance dose Decortin 5mg/d; Maintenance dose 5 mg/d
Other intervention name(s): Mycophenolate Sodium; Prednisolone
Intervention MeSH terms: Mycophenolic Acid; Prednisolone; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Condition: Cardiovascular Disease; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600,
      900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the
      inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the
      production over time of several inflammatory markers.
    

Detailed description: 
      Inflammation is an important biological process initiated by the immune system in response to
      injury, irritation or infection. Prolonged or chronic inflammation is involved in the
      etiology of several diseases such as cardiovascular disease (CVD), diabetes, rheumatoid
      arthritis, cancer, and neurodegenerative diseases such as Alzheimer disease. The evidence
      base clearly demonstrates benefits of diet in ameliorating inflammation and reducing the
      burden of chronic disease. With respect to marine-derived omega-3 fatty acids and various
      markers of inflammation related to cardiovascular disease (CVD), both population studies and
      randomized controlled supplementation trials have yielded mixed results.

      Some studies have demonstrated a dose-response relationship between dietary eicosapentaenoic
      acid and docosahexaenoic acid (EPA + DHA) and increased membrane (phospholipid) EPA and DHA.
      Red blood cell (RBC) EPA + DHA content has been proposed as a potential, modifiable marker
      for coronary heart disease (CHD) risk. It is well established that these fatty acids are
      precursors of series-3 prostanoids, thromboxanes, 5-series leukotrienes, and novel lipid
      mediators such as resolvins and protectins that have anti-inflammatory effects. We
      hypothesize that nutritionally-relevant intakes of omega-3 fatty acids are able to blunt the
      usual response to an inflammatory stimulus. We propose to test this hypothesis using both in
      vivo (i.v. endotoxin challenge) and ex vivo (endotoxin-stimulated monocytes) models in a
      6-month, dose-response study with marine-derived omega-3 fatty acid supplements in healthy
      volunteers.
    

Intervention name(s): Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
Intervention type(s): Biological
Intervention description(s): Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period
Other intervention name(s): Omega-3 Fatty Acids; Fish Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cardiovascular disease; Inflammation; Fish Oil; Omega-3 Fatty Acids; LPS; Endotoxin
Escitalopram in Patients With Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of
      treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients
      who respond to escitalopram during the treatment period, and to evaluate safety of
      escitalopram.
    

Detailed description: 
      The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The
      patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as
      dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance
      with the national Summary of Products Characteristics (SPC).
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other intervention name(s): Cipralex, Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; SAD; Antidepressant; Anxiolytic
An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different
      Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic,
      Moderate-to-Severe Osteoarthritis Knee Pain.
    

Detailed description: 
      This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and
      ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a
      single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with
      chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the
      investigational product, CNTX-4975-05, will be controlled primarily through adjunct
      controlled joint cooling and secondarily by pre-medication with IA lidocaine.
    

Intervention name(s): CNTX-4975-05; Lidocaine without epinephrine; ElastoGel; Breg Ice Water Pump
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): Osteoarthritis (OA) intra-articular injection of CNTX-4975-05; 15 mL lidocaine intra-articular injection; Cooling Device; Cooling Device
Other intervention name(s): capsaicin; Lidocaine
Intervention MeSH terms: Lidocaine; Epinephrine; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; knee pain; non opioid; analgesic; capsaicin; pain; intra-articular
Reduction of Falls in the Elderly - Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study
      (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls
      prevention program for patients with Parkinson's Disease (PD). This program contains
      PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention
      program. The intervention will be tailored to each individual's specific risk profile for
      falls, as identified during detailed baseline examination.
    

Detailed description: 
      Falls and postural instability are common complications of advanced Parkinson's Disease (PD).
      Falls in PD often have devastating consequences, leading to a poor overall prognosis. In
      addition, falls in PD are associated with substantial medical expenses due to treatment of
      injuries and nursing home admission. The risk of falls in older PD patients is aggravated by
      "generic" age-related factors, such as sedative medication or poor vision. Observations on
      elderly persons without PD suggest that a multifactorial prevention program might be more
      effective. We propose to investigate the effectiveness of a multifactorial prevention program
      aimed at the prevention of falls in PD, which is based on disease-specific treatment
      strategies with demonstrated efficacy in PD, as well as prevention strategies with proven
      effectiveness for the general elderly population.

      In this study an individualised multifactorial program aimed at the prevention of falls in PD
      containing PD-specific elements and a generic falls prevention program will be compared to
      usual care.
    

Intervention name(s): Multifactorial fall prevention program; Usual care
Intervention type(s): Other; Other
Intervention description(s): Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements; Usual care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Accidental falls; Prevention; Treatment effectiveness
Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery
Condition: Anxiety Postoperative
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The prospect of pediatric surgery is a source of preoperative anxiety for children and their
      parents. It affects 50% of children waiting for surgery and the causes vary according to age.
      It has been shown that pre-operative anxiety in children often leads to behavioral changes.
      Pre-operative anxiety is often managed by pharmacological premedication. However, there are
      many alternative techniques to reduce children's anxiety before surgery.

      The use of an application dedicated to pediatric anesthesia used from the moment of the
      anesthesia consultation would allow to reduce this anxiety by allowing a varied course of
      information involving the child in his preparation before the surgery.

      First, it allows an evaluation of the pre-operative anxiety level of children via validated
      scales. Secondly, it provides information to the children using methods adapted to their age
      and level of understanding.

      Thus, if this method were validated, other hospitals could use this application to develop a
      tool that would benefit the many children who undergo surgery each year.
    


Intervention name(s): KOALOU(®) digital application
Intervention type(s): Behavioral
Intervention description(s): Digital app that prepares children for the ambulatory surgery care pathway by assessing their anxiety and educating them about anesthesia and surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Preoperative anxiety; Ambulatory surgery; Pediatrics anesthesia; Digital application; Postoperative maladaptative behavioral
Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The primary objective of this trial was to assess the presence of susceptibility to
      tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The
      secondary objective was to examine clinicians' use of HIV drug resistance testing in
      treatment experienced patients currently failing a PI based HAART regimen.
    


Intervention name(s): NO BI Drug administered
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Condition: Endometriosis; Adhesion; Surgery
MeSH terms: Endometriosis; Tissue Adhesions
Study type: Interventional

Summary: 
      prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after
      surgery because of endometriosis of the pelvic side wall or the ovary or both
    


Intervention name(s): ovariopexy; placebo operation
Intervention type(s): Procedure; Procedure
Intervention description(s): if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall; in arm D sutures are transabdominal only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: endometriosis; ovariopexy; adhesion prevention; laparoscopy; complications; AMH
Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?
Condition: Post Operative Analgesia; Regional Anesthesia; Sciatic Nerve Block
Study type: Interventional

Summary: 
      Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the
      popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa,
      the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN).
      Studies have shown that when both branches are blocked separately distal to the bifurcation
      site, block onset time is reduced by 30%. Through clinical observation, the investigators
      found that onset time is further shortened when ultrasound-guided SNB is performed at the
      site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose
      of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block
      at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and
      CPN) distal to sciatic nerve bifurcation.
    


Intervention name(s): Distal; Interneural
Intervention type(s): Procedure; Procedure
Intervention description(s): Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation; Sciatic nerve blockade at the site of bifurcation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Regional anesthesia; Sciatic nerve block; foot surgery; ankle surgery; Interneural local anesthetic