bioihbjkbjnl/mcl2 huggingface dataset:
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
Condition: Infrarenal Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional

Summary: 
      The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase
      II. The primary objectives of the Phase II study is to assess the safety and effectiveness of
      the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA).
      The secondary objectives of this study are to assess additional clinical outcomes
      measurements associated with treatment of AAA using the Anaconda Stent Graft System
    

Detailed description: 
      Abdominal aortic aneurysms afflict a large number of patients in the United States and
      world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior
      to the presentation of symptoms or rupture. Thus aneurysm repair can be viewed as a
      prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured
      aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio.
      Treatment options include medical management of co-morbidities (hypertension, pulmonary
      disease, etc.) with observation of the aneurysm, open surgical aneurysm repair through a
      transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to
      intervene is based upon physician judgment. Once the decision to intervene is made, the mode
      of the intervention must be chosen. Although open surgical repair is more invasive and has
      been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, few
      argue with the effectiveness of the procedure. To date, open surgical repair remains the gold
      standard of care for the aneurysm patient. Endovascular repair has several beneficial
      characteristics in comparison to an open surgical approach. They include the potential for
      decreased need for blood transfusions, shorter intensive care unit and total hospital stays,
      the lack of endotracheal intubation, to name a few. However, the procedure requires adequate
      imaging prior to graft placement and during the follow-up period, in addition to the
      availability of a trained team to ensure proper device placement.
    

Intervention name(s): Anaconda Stent Graft System; Anaconda ONE-LOK Stent Graft System
Intervention type(s): Device; Device
Intervention description(s): Endovascular device; Endovascular device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Mulligan Movement Mobilization Technique on Elbow Joint Proprioception
Condition: Healthy
Study type: Interventional

Summary: 
      Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint
      Proprioception
    

Detailed description: 
      Investigating The Effects of Mulligan Movement Mobilization Technique on Elbow Joint
      Proprioception by joint position sense assessment
    

Intervention name(s): mulligan mobilisation; sham
Intervention type(s): Procedure; Procedure
Intervention description(s): an active mobilisation with movement on elbow according to mulligan's protocol; a lateral glide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Condition: Obesity; Inflammation
MeSH terms: Inflammation; Weight Loss
Study type: Interventional

Summary: 
      Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to
      assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to
      increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the
      biological markers of chronic inflammation in obese patients following a weight-loss
      programme.
    

Detailed description: 
      Will include obese patients (BMI between 30 and 35) who are following a standardized,
      multidisciplinary weight-loss programme (PronoKal® Method), which consists of a
      very-low-calorie diet based on protein packets and vegetables with a low glycemic index, into
      which natural foods are gradually reintroduced, accompanied by physical exercise and
      emotional support.

      Patients who are being treated with acetylsalicylic acid (ASA), non-steroidal
      anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs
      (glitazones); and patients with immune disorders (rheumatoid arthritis, Lupus, etc.) and/or
      inflammatory disease (ulcerative colitis, Crohn's disease, etc.) who may alter the biological
      markers of inflammation,will be excluded.

      Treatment: In addition to the vitamin and oligoelement supplements which are part of the
      standard weight-loss programme, the patients will receive an additional 500 mg/day supplement
      of DHA omega-3 fatty acids in capsule form (study group) or a placebo capsule (control
      group).

      The follow up will be 6 months and patients will be monitored over the course of 6 control
      visits: baseline, 7 days, 15 days, 30 days, 60 days and 180 days.

      The main objective is to assess the effectiveness of providing additional DHA supplements to
      increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the
      biological markers of chronic inflammation in obese patients following a weight-loss
      programme.
    

Intervention name(s): Omega-3 DHA; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients take daily 2 tablets of Docosahexaenoic Acid; Patients in control group take daily 2 placebo capsule
Other intervention name(s): Docosahexaenoic Acid; omega-3 fatty acid; PUFA; placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Docosahexaenoic Acids; Fatty Acids, Omega-3; Obesity; Inflammation
Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis
Condition: Perforated Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy
      on complication rates and resource utilization following appendectomy for perforated
      appendicitis
    

Detailed description: 
      Appendicitis is the most common cause of abdominal pain requiring emergent surgical
      intervention in children and approximately one third of patients present with perforation.
      Perforated appendicitis has been demonstrated to have a significant impact on patients and
      families due to the prolonged hospitalization, high complication rates, and tremendous
      economic burden from treatment. The most significant complication following operative
      treatment of perforated appendicitis is intra-abdominal abscess, which develops in
      approximately 20% of children following appendectomy in recent literature. Due to this
      frequent and morbid complication, continued research has been driven at determining the most
      efficacious and cost-effective postoperative antibiotic treatment regimen to reduce
      post-operative abscess. As postoperative abscess rates following appendectomy for perforated
      appendicitis remain high, the primary aim of this study was to evaluate a new postoperative
      antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with
      randomization into ten day completion course of home antibiotics with IV ertapenem versus
      oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer
      reduced rates of postoperative abscess, with no major difference between completion courses
      of home IV versus oral antibiotics.
    

Intervention name(s): home intravenous ertapenem; home oral amoxicillin-clavulanate; peripheral inserted central Catheter
Intervention type(s): Drug; Drug; Device
Intervention description(s): see arm description; see arm description; All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
Other intervention name(s): Invanz; Augmentin; PICC
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appendectomy
O2 Tension During TAVI
Condition: Troponin
Study type: Interventional

Summary: 
      Hyperoxemia can produce various complications including oxidative stress and myocardial
      injury. We hypothesized that the normoxic group would have lower myocardial injury compared
      to hyperoxic group after transcatheter aortic valve replacement.
    

Detailed description: 
      Hyperoxemia can produce various complications, such as excessive oxidative stress,
      hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant
      myocardial injury. Previous studies have been observed higher mortality in patient group
      maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the
      effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve
      replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group
      would have lower myocardial injury compared to hyperoxic group after TAVR.
    

Intervention name(s): normal inspired oxygen fraction; high inspired oxygen fraction
Intervention type(s): Other; Other
Intervention description(s): receives inspired oxygen fraction of 0.3; receives inspired oxygen fraction of 0.8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyperoxemia; myocardial injury; transcatheter aortic valve replacement
Interventional Strategies in Treatment of Atrial Fibrillation: Percutaneous Closure of the Left Atrial Appendage Versus Catheter Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, associated with an
      increased risk of morbidity and mortality1. The management of AF patients is aimed at
      reducing symptoms and at preventing severe complications associated with AF. In the last
      years, two new strategies have emerged with different objectives. In the PROTECT AF study2,
      percutaneous closure of the Left Atrial Appendage (LAA) with a closure device provided an
      alternative strategy to oral anticoagulation for stroke prophylaxis. The AFFIRM trial3 has
      shown that drug-based management of AF with a rhythm-control strategy conferred no advantage
      over a rate-control strategy in cardiovascular mortality and might be associated with an
      increased noncardiovascular death rate4. Catheter ablation has gained a greater place in the
      rhythm control strategy, showing superiority in maintaining sinus rhythm in comparison with
      AAD5. However, in persistent AF, repeat ablation procedures are necessary in up to 70% of
      patients to achieve sinus rhythm at a long-term follow-up6-7.

      This prospective, randomized trial will compare the percutaneous closure of the LAA combined
      with a rate-control strategy to catheter ablation in the management of patients with
      persistent AF. Patients who are eligible for catheter ablation as well as LAA closure device
      implantation and are willing to participate in the study will be randomly assigned to
      catheter ablation or percutaneous closure of the LAA by a closure device implantation in the
      relation 1:1. The primary endpoint of the study is a composite endpoint at 12 months of all
      cause death, thrombo-embolic events, major bleeding (BARC type 3), re-hospitalisation and
      severe symptoms due to arrhythmias. Secondary endpoints include a composite endpoint of
      bleeding, a composite endpoint of thrombo-embolic events, cardio-vascular mortality, total
      duration of hospitalisation, sustained discontinued anticoagulation, quality of life
      improvement, use of Antiarrhythmic Drugs (AAD), total costs, freedom from arrhythmia and
      average ventricular frequency in 7-day holter ECG at 12 months.

      The objective of the study is to assess the superiority of percutaneous closure of the LAA
      combined with rate-control to catheter ablation in patients with oligosymptomatic AF.
    


Intervention name(s): Percutaneous closure of LAA; Catheter ablation of AF
Intervention type(s): Procedure; Procedure
Intervention description(s): Percutaneous closure of LAA; Catheter ablation of AF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; catheter ablation; percutaneous closure of LAA; intervention
TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND
      CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with
      concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in
      endemic area.
    

Detailed description: 
      This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical
      trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined
      with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary
      endpoint is failure free survival (FFS）.The secondary endpoints are overall
      survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS),
      distant metastasis free survival（DMFS)and toxicities.
    

Intervention name(s): Drug: Taxol,cisplatin and capecitabine; Drug: Cisplatin and 5-Fluorouracil
Intervention type(s): Other; Other
Intervention description(s): Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.; Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Intervention MeSH terms: Cisplatin; Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma; induction chemotherapy
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional

Summary: 
      The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become
      common, particularly in the treatment of cancer. Because traditional trials are designed to
      evaluate one agent at a time, the evaluation of therapies in combination requires specialized
      trial designs. In place of the traditional separate phase I and II trials, this trial uses a
      single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of
      combination dose levels, and select the optimal combination dose.

      Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and
      radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and
      neck cancer. The trial begins with an initial period of dose escalation (Phase I) to
      investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in
      combination with CRT.

      Using the MTD determined in the Phase I portion, the randomized phase II trial in 94
      participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to
      evaluate the efficacy and safety of Debio 1143.
    


Intervention name(s): Cisplatin; Radiotherapy; Debio 1143; Placebo
Intervention type(s): Drug; Radiation; Drug; Drug
Intervention description(s): A total of three cycles of cisplatin will be administered in a 1-hour IV infusion on days 2, 23 and 44. Cisplatin will be administered 0.5 hours after Debio 1143.; Standard fraction radiotherapy to the primary tumour will be delivered daily for 5 days per week over 7 weeks.; Debio 1143 solution; Matching placebo solution
Other intervention name(s): Concomitant Chemotherapy; Concomitant Radiotherapy
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential for clinical drug-drug interactions between
      omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug
      transporters.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone; Midazolam oral solution; Repaglinide 1 MG; MetFORMIN 500 Mg Oral Tablet; Rosuvastatin; Digoxin tablet; Gemfibrozil Tablets; Itraconazole capsule; Verapamil Pill
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg capsules; 2 mg/mL oral solution; 1 mg tablet; 500 mg tablet; 10 mg tablet; 0.25 mg tablet; 600 mg tablet; 100 mg capsule; 120 mg tablet
Other intervention name(s): RTA 408
Intervention MeSH terms: Metformin; Repaglinide; Itraconazole; Digoxin; Verapamil; Midazolam; Rosuvastatin Calcium; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RTA 408; RTA 408 capsules; omaveloxolone; omaveloxolone capsules; DDI
Evaluating an Ebola and a Marburg Vaccine in Uganda
Condition: Ebola Virus Disease; Marburg Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if
      they are safe, if they have side effects, and if they create an immune response in people who
      receive them.
    

Detailed description: 
      The Ebola and Marburg viruses are both filoviruses known to induce hemorrhagic fever-a set of
      symptoms characterized by sudden onset, aching, fever, and bleeding in the internal organs.
      Both filoviruses are associated with high mortality rates, and the Centers for Disease
      Control (CDC) lists them as Category A bioterrorism agents because of their potential for a
      major public health impact. Vaccines for both viruses are under development using a
      prime-boost strategy that involves multiple injections over a period of time to confer
      long-lasting immunity. Preliminary research supports the vaccines' safety. This study will
      test these experimental vaccines for the Ebola and Marburg viruses, first administered
      separately and then together, to ensure they are safe and do not have side effects.

      Participation in this study will entail 11 study visits over 2 years. The study will have two
      parts, to be completed sequentially, and three groups. In part one, participants will be
      randomly assigned to the first group, which will receive the experimental Ebola DNA vaccine,
      or the second group, which will receive the experimental Marburg DNA vaccine. In part two,
      the third group will receive both the Ebola and the Marburg vaccines, one shot in each arm.
      One fifth of the participants in each group will be controls and receive placebo injections.
      All vaccines and placebos will be delivered via an intramuscular injection at three time
      points: at study entry, after 4 weeks, and after 8 weeks.

      Participants will complete study assessments at 12 points in time: at baseline and at Weeks
      2, 4, 6, 8, 10, 12, 24, 32, 52, 78, and 104. At each assessment, changes in health and
      medications will be recorded and blood will be drawn. Participants will also complete a diary
      card daily for 5 days after receiving each injection. In it, they will record their
      temperature and any skin changes at the injection site.
    

Intervention name(s): Ebola vaccine; Marburg vaccine; Placebo injection
Intervention type(s): Biological; Biological; Other
Intervention description(s): 4 mg of Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8; 4 mg of Marburg DNA plasmid vaccine, VRC-MARDNA025-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8; 4 mg of saline injection delivered at Weeks 0, 4, and 8
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Vaccine
An [^11C]T-773 Positron Emission Tomography (PET) Study to Determine Phosphodiesterase10A Occupancy by TAK-063
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain
      following a single dose of TAK-063.
    

Detailed description: 
      The drug being tested in this study is called TAK-063. TAK-063 is was tested to estimate
      phosphodiesterase10A (PDE10A) occupancy in the brain following a single dose of TAK-063. This
      study used positron emission tomography (PET) scans to look at changes in the volume of
      tissue distribution before and after TAK-063 administration to calculate PDE10A occupancy in
      the brain.

      The study enrolled 13 participants. Participants were assigned to a treatment group based on
      an enrollment schedule. The first 4 participants were assigned to the Pilot Cohort and
      received one dose of TAK-063 30 mg or 1000 mg tablets. The remaining participants were
      enrolled into the Main Cohort and received one dose of TAK-063 at 3, 10, 30 or 100 mg.
      Participants in both cohorts also received 3 separate intravenous infusions of [^11C]T-773 <8
      μg; 400MBq ± 10% followed by a PET scan.

      This single-centre trial was conducted in Sweden. The overall time to participate in this
      study was 46 days. Participants made 3 visits to the clinic, including one 3-day period of
      confinement to the clinic. Participants were contacted by phone on Day 16 for follow-up
      safety assessments.
    

Intervention name(s): TAK-063; [^11C]T-773
Intervention type(s): Drug; Drug
Intervention description(s): TAK-063 tablets; [^11C]T-773 IV solution
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy