bioihbjkbjnl/mcl2 huggingface dataset:
Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries
Condition: Coronary Atherosclerosis of Native Coronary Artery; Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The Tryton Side Branch Stent System has been designed to address the procedural difficulty
      surrounding treatment of bifurcation lesions and to ensure patency of the side branch with
      similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength)
      that are currently available with conventional coronary stents designed for straight (non
      bifurcation) lesions.

      The Tryton Side Branch Stent is intended to treat and maintain patency in the side
      branch/carina by providing better ostial side branch conformability and is intended for use
      in conjunction with currently approved balloon-expandable drug-eluding stents for treatment
      of the main branch.
    

Detailed description: 
      The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES
      reduces the rate of restenosis int he main branch (5-10%); however, results int he side
      branch are not optimal. A study of T stenting in true bifurcation lesions showed a restenosis
      rate int he main branch of approximately 6% using the CYPHER stent. However, the same study
      demonstrated that the restenosis rate remained high int he side branch (20%) despite stent
      implantation and when restenosis occurs, it is generally located at the ostium of the side
      branch. Further, in half the cases where PTCA alone was the intended strategy for the side
      branch, a side branch stent had to be placed to address sub-optimal procedural results.

      These findings are consistent with previous metal stent studies and suggest the best
      long-term results are obtained when a side branch stent is not placed. This study and others
      suggest that the outcomes are related to the way the stents sit within in the vessel; and
      therefore a stent designed specifically for bifurcation lesions will be needed to reduce
      restenosis rates and improve long-term outcomes.
    

Intervention name(s): Tryton Side Branch Stent with main branch DES; POBA
Intervention type(s): Device; Device
Intervention description(s): Tryton Side Branch Stent; Balloon angioplasty
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bifurcation lesions
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in
      different ways and stop tumor cells from growing.

      PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with
      stage IV pancreatic cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine clinical response (partial and complete responses) in patients with
           unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma
           treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
           (MDX-010).

      Secondary

        -  Determine whether observed responses correlate with the incidence of autoimmunity in
           patients treated with this drug.

      OUTLINE: This is an open-label study. Patients are stratified according to status of disease
      (locally vs distantly metastatic).

      Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
      (MDX-010) IV over 90 minutes on days 0, 21, 42, and 63. Treatment repeats every 84 days for
      up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with
      disease progression after achieving a partial response or complete response receive 2
      additional courses of therapy.

      After completion of study treatment, patients are followed at 3 weeks, every 3 months for 1
      year, every 6 months for 2 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per stratum) will be accrued for this
      study within 2-4 years.
    

Intervention name(s): ipilimumab
Intervention type(s): Biological
Intervention MeSH terms: Ipilimumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer
Stress and Inflammation in Late-Life Depression
Condition: Depression; Inflammation
MeSH terms: Inflammation; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that
      there is a link between depression and inflammatory disease. This study investigates the
      relationship between inflammation in the brain and depression. Comparing biological and
      psychological differences in depressed and non-depressed people allows researchers to find
      better ways to treat and prevent depression. All participants will have: neuropsychological
      tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant
      coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for
      six weeks. The investigators are trying to correlate brain function with depression levels
      and biomarkers from the blood and spinal fluid.
    


Intervention name(s): Escitalopram + Celecoxib; Escitalopram + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive celecoxib in addition to escitalopram; Participants will receive a placebo in addition to escitalopram.
Intervention MeSH terms: Celecoxib; Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Geriatric; Inflammation
Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Tramadol-abuse Patients
Condition: Analgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Increasing duration of local anesthetic action is desired for prolongation of postoperative
      patient comfort, as well as decreasing perioperative opioid consumption and subsequent side
      effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for
      use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which
      is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically
      increased in Egypt since 2008 and has led to many admissions to addiction treatment
      centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric
      bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much
      shorter in chronic opium abusers compared with non-abusers.
    


Intervention name(s): Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml); normal saline (NS)
Intervention type(s): Drug; Other
Intervention description(s): coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.; 1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Delayed Embryo Transfer in Poor Responders
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the
      current study the investigators will attempt to compare antagonist and short protocols
      regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be
      performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still
      implantation and pregnancy rates are considered secondary outcomes.
    


Intervention name(s): IVF/ICSI
Intervention type(s): Procedure
Intervention description(s): controlled ovarian hyperstimulation with various protocols, follow up till stimulated follicles measure from 18-20 mm, then ovum pickup followed by embryo transfer is done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tai Chi Exercise on Balance and Awereeness
Condition: Young Adult
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of Tai chi exercises on balance and body
      awareness in younger adults. Forty-two healthy subjects between the ages of 18-25 who do not
      have any restriction to exercise participate in our study. After recording the
      sociodemographic characteristics of the subjects, static and dynamic balance and body
      awareness will be evaluated. Kinesthetic Ability Trainer will be used to assess static and
      dynamic balance and body awareness will be evulated with Body Awareness Questionnaire. All
      assessments will be done before and 12 weeks after the tai chi exercise. Tai-chi training
      will be performed as a group exercise. Duration for tai chi exercise will be 60 minutes for 2
      days per week totally 12 weeks.
    

Detailed description: 
      Tai-chi training was performed as a group exercise. Duration for tai chi exercise was 60
      minutes for 2 days per week for 12 weeks. Each session includes 10 min warm-up and cool-down
      and 40 min Tai Chi exercises. During exercises, attention was paid to correct positioning of
      the upper and lower extremity joints, and mentally concentration was achieved. Slow and
      controlled movements were carried out by a specialized physiotherapist
    

Intervention name(s): Tai-chi training
Intervention type(s): Other
Intervention description(s): Group exercise apply with physiotherapist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; Awareness; posture
Study of Orally Administered BEBT-503 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in
      which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be
      assessed in healthy adult subjects.

      The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of
      healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of
      Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect
      of food
    


Intervention name(s): BEBT-503 20mg; BEBT-503 40mg; BEBT-503 80mg; BEBT-503 120mg; BEBT-503 180mg; placebo 20mg; placebo 40mg; placebo 80mg; placebo 120mg; placebo 180mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BEBT-503 capsule; BEBT-503 capsule; BEBT-503 capsule; BEBT-503 capsule; BEBT-503 capsule; placebo capsule; placebo capsule; placebo capsule; placebo capsule; placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant
Condition: B-cell Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor
      prognosis. Currently, there is no standard treatment for such patients. Bexxar is a
      radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted
      patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of
      Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous
      transplant.
    

Detailed description: 
      High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the
      standard of care for relapsed/refractory chemotherapy-sensitive non-Hodgkin's lymphomas
      (NHL). However, one-half to two-thirds of such patients will relapse after ASCT, with
      subsequent poor prognosis, and new therapies are urgently needed for this patient population.
      Radioimmunotherapy (RIT) as a single agent therapy in patients with CD20 antigen-expressing
      relapsed or refractory low-grade, follicular, or transformed NHL has demonstrated overall
      response rates of 60-80% and has been approved by the FDA for use in this setting. While RIT
      is currently under investigation as a component of conditioning regimens for ASCT, the safety
      and efficacy of RIT after ASCT has not yet been well described. We will conduct a
      single-center Phase I dose-escalation trial of Bexxar (Tositumomab and 131I Tositumomab) for
      treatment of relapsed or residual CD20 antigen-expressing B-cell lymphomas following ASCT.
      Our primary aim will be to determine the safety, dose-limiting toxicity, and maximum
      tolerated dose of Bexxar in this post-ASCT patient population. Our secondary aim will be to
      describe the overall response rate, progression-free survival, time to treatment failure, and
      overall survival. Should Bexxar prove to be safe in this population, subsequent trials will
      be designed to investigate further the efficacy of RIT in the post-transplant setting.
    

Intervention name(s): Bexxar
Intervention type(s): Drug
Intervention description(s): Day 0: Tositumomab, IV (in the vein) followed by test dose of 131I-Tositumomab, IV (in the vein) to determine treatment dose of 131I-Tositumomab.
1-2 weeks after Day 0: Tositumomab, IV (in the vein) followed by therapeutic dose 131I-Tositumomab (in the vein).
Intervention MeSH terms: Tositumomab I-131
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; Non-Hodgkin's lymphoma; B-cell lymphoma; Radioimmunotherapy; Bexxar; tositumomab; autologous hematopoietic stem cell transplantation
Antimullerian Hormone in Endometriomas
Condition: Endometriomas
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol
      sclerotherapy of endometriomas versus conventional surgery.
    

Detailed description: 
      Between 5-10% fertile women are affected by endometriosis, and ovarian endometrioma is
      present in 17-44% of cases, with 40% of patients with endometriomas being sterile. However,
      the "gold standard" treatment is laparoscopic ovarian cystectomy and this therapy is
      associated with a diminished ovarian reserve, with a significant antimullerian hormone (AMH)
      decrease.

      Alcohol sclerotherapy is a new minimal invasive procedure in endometrioma treatment whose
      potential beneficial effect in fertility preservation is not still demonstrated.

      The investigators would like to demonstrate that this procedure improves fertility
      preservation and reduces morbidity and costs in contrast with conventional surgery.
      Moreover,the investigators would like to demonstrate that this procedure could be performed
      in different centers with similar results.
    

Intervention name(s): Surgical technique; Alcohol sclerotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic surgery; US-guided sclerotherapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ultrasound suspicion of ovarian endometrioma (4-10 cm)
A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy
      of a second course of TPX-100 administered by intra-articular injection to subjects with
      osteoarthritis of the knee who participated in study TPX-100-1.
    

Detailed description: 
      Recruit up to 70 subjects whom participated in protocol TPX-100-1. The opposing knee that was
      treated will be getting 200mg in 4 weekly injections. The knee that was treated in TPX-100-1
      will get randomized to either 200mg dose or a placebo lookalike. The investigators will
      follow these subjects for 6 months. Two MRIs of bi-lateral knees will be assessed. Also
      collection of ADA samples at 4 time points through the 6 month period.
    

Intervention name(s): TPX-100 200 mg 4 times weekly for 4 weeks; TPX-100 200 mg 4 times weekly for 4 weeks
Intervention type(s): Drug; Drug
Intervention description(s): Ea. subject will received active TPX-100 200mg in the Left knee; TPX-100 100mg Right
Other intervention name(s): TPX-100 100mg Left; TPX-100 100mg Left
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir
      tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting
      condition.
    

Detailed description: 
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 6 days. During each session, the subjects will be administered
      a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg)
      under fasting condition.
    

Intervention name(s): Ritonavir Tablet 100mg; NORVIR tablet 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.; NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine
      or placebo was administered, will be approached for inclusion into this study which is purely
      for blood draw. The sera will be used for assay development.
    

Detailed description: 
      The purpose of this protocol is to analyze the collection of blood volumes (approximately 200
      to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As
      such, the inclusion and exclusion criteria are consistent with the Australian Red Cross
      guidelines for blood donation.

      The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized,
      placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086
      with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon
      completion of participation in the 6108A1-500 study, subjects will be approached to
      participate in this blood sampling study. The sites participating in this blood sampling
      study are the same sites participating in the 6108A1-500 study.
    

Intervention name(s): blood draw
Intervention type(s): Procedure
Intervention description(s): Blood draw from subjects previously vaccinated in 6108A1-500 trial
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Adult
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving
      ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment
      panel (ATP) III guidelines
    


Intervention name(s): simvastatin (+) ezetimibe; Comparator: atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks); atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Other intervention name(s): MK0653A; Vytorin®; Lipitor®
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolaemia
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Many breast cancer patients treated with chemotherapy complain of problems with concentration
      and memory. This has been referred to as chemo fog. The current study is investigating this
      phenomenon by measuring mental function of breast cancer patients prior to and after exposure
      to chemotherapy, and by comparing mental function in those patients who receive chemotherapy
      and those who do not.
    

Detailed description: 
      Many breast cancer patients treated with chemotherapy complain of problems with concentration
      and memory. This has been referred to as chemo fog. The current study will investigate this
      phenomenon by measuring neuropsychological functioning in early stage breast cancer patients
      prior to and after exposure to chemotherapy, and by comparing change in cognitive function in
      patients who receive chemotherapy to similar breast cancer patients receiving hormonal
      therapy only.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast Cancer
      
Keywords: breast cancer; chemotherapy; hormonal therapy; cognitive function; chemo fog