bioihbjkbjnl/mcl2 huggingface dataset:
Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy
Condition: Myoma
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous
      two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.
    

Detailed description: 
      Significant hemorrhage is major perioperative concern in myomectomy, and can result in need
      of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and
      postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood
      loss during myomectomy in women wishing to preserve their uterus and fertility are important
      and must be developed.
    

Intervention name(s): LM with TESTO; LM without TESTO
Intervention type(s): Procedure; Procedure
Intervention description(s): In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.; In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Early Postpartum Intrauterine Contraception
Condition: Unplanned Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective clinical trial of ultrasound guided intrauterine contraception
      insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month
      follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.

      The objective of this study is to measure intrauterine device (IUD) expulsion and the
      feasibility of conducting a future clinical trial to evaluate placement of the
      levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
    

Detailed description: 
      This was a single arm cohort study of women who desired to receive a levonorgestrel releasing
      intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.

      Women were enrolled during a prenatal care visit when they reported they desired to use the
      LNG-IUS after the birth of their infant.

      Forty women stated enrolled in the study prior to labor, and baseline data were obtained.
      After delivery 29 women remained both interested in the study and were still eligible to
      receive the LNG-IUS prior to discharge from the hospital.

      Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an
      LNG-IUS expulsion prior to 6 months postpartum.
    

Intervention name(s): Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Intervention type(s): Drug
Intervention description(s): Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
Other intervention name(s): LNG-IUS
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: levonorgestrel releasing intrauterine device; levonorgestrel releasing intrauterine contraception; unintended pregnancy prevention; postpartum contraception
Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The use of Event Related Potentials (ERP) and neurocognitive performance in patients
      following concussion has been examined previously in small cohorts and relatively long after
      concussion occurred. However, little is known about the immediate changes in brain activity
      in specific brain regions and connectivity across them associated with performance on
      specific neurocognitive tests following a concussion, and the subsequent changes over time.
      The proposed study will provide initial evidence for the feasibility of an ERP based
      biomarker for concussion reflecting temporal and spatial changes in brain activity as well as
      brain functional connectivity associated with concussion.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Experimental subjects will include males and females with a recent sports-related
        concussion (less than 10 days post-concussion) recruited from approximately 50 high schools
        and colleges with UPMC-affiliated certified athletic trainers (ATC) on staff and from
        patients at the UPMC Sports Medicine Concussion Program.
      
Keywords: mild Traumatic Brain Injury; mTBI; Concussion
Gabapentin for Alcohol Relapse Prevention
Condition: Alcohol Use Disorder; Alcohol Withdrawal
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol
      dependence will get medication, which might help them to reduce or stop their drinking, or a
      placebo ( placebo is a capsule that looks the same as the investigational drug, but has no
      real medication. It is a "sugar pill").
    

Detailed description: 
      This treatment study is a 16-weeks outpatient clinical trial where subjects will get
      medication, which might help them to reduce or stop their drinking or a placebo ( placebo is
      a capsule that looks the same as the investigational drug, but has no real medication. It is
      a "sugar pill"). This study will recruit and randomize subjects who have expressed an
      interest in receiving treatment for alcohol dependence. Upon enrollment into this study there
      will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): gaba potentiating medication; a pill that looks exactly like the active medication but does not contain medication
Other intervention name(s): neurontin; Sugar Pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Condition: Lung Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30
      participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen,
      and meeting all eligibility criteria.
    

Detailed description: 
      All participants will undergo a single night polysomnography testing in a sleep lab while
      they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which
      participants will receive their oxygen prescription in two different modes at different times
      during the night. The assignment (sleep vs. continuous mode) to which participants will
      initiate the night will be randomized, and all participants will utilize each of the two
      modes during the study. The hypothesis of this study is that there will not be a significant
      difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator,
      set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous
      flow oxygen during sleep during the course of the one night sleep study.
    

Intervention name(s): Pulse Dose (Sleep Mode); Continuous Dose
Intervention type(s): Device; Device
Intervention description(s): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.; SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oxygen
A Comparison of PF708 and Forteo in Osteoporosis Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of two teriparatide products, PF708 and
      Forteo, in patients with osteoporosis.
    

Detailed description: 
      This is a randomized, multi-center study conducted in the United States. Men and women with
      osteoporosis will be enrolled in a parallel-group, open-label study design to compare the
      effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be
      randomized to receive PF708, and the other half will be randomized to receive Forteo.
    

Intervention name(s): Teriparatide (PF708); Teriparatide (Forteo)
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress, Distress Intolerance, and Drug Dependence
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus
      a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to
      emotional cues for drug use as part of a comprehensive, yet brief, treatment strategy. These
      treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in
      a comprehensive methadone maintenance program who have failed to respond adequately to
      current treatments.
    

Detailed description: 
      This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for
      Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's
      tolerance to the myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations,
      etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the
      link between these emotional cues and drug-related attempts to avoid emotional distress) for
      intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients.
      Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on
      opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic
      stress translates into chronic drug use; (2) a focus on the way in which stress-related
      symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of
      treatment that will inform treatment-matching efforts, including a focus on gender
      differences and emotional avoidance/distress intolerance; and (4) the examination of
      treatment outcome in a Stage II treatment trial.
    

Intervention name(s): Cognitive Behavioral Therapy; Individual Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy; 12 weekly sessions and 3 booster sessions of individual counseling
Other intervention name(s): CBT; ICT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Substance Dependence; Cognitive-Behavior Therapy; Opiate Dependence; Treatment Moderators
A Study of Baricitinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  If there are any differences in the amount of baricitinib in the blood/body when taken
           in two different forms.

        -  How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.

        -  The safety and tolerability of baricitinib.

      The study has two parts. Individuals will participate in only one part.

      Participants will be admitted to the clinical research unit (CRU) and will be discharged from
      the CRU following the completion of 3 overnight stays.

      Each part of this study will last from 8-10 days, not including screening. Follow-up will
      occur 7 to 14 days after the last dose of baricitinib.
    


Intervention name(s): Baricitinib suspension; Baricitinib tablet
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104; LY3009104
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy
Condition: Digestive System Disease
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic
      sulphate-based laxative preparation given on the day before colonoscopy has non-inferior
      efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in
      adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a
      colonoscopy for a routinely accepted diagnostic indication.
    


Intervention name(s): Eziclen®/Izinova®; Klean-Prep®
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution taken the evening before the colonoscopy; Oral solution taken the evening before the colonoscopy
Other intervention name(s): Suprep®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Bowel preparation
Cytokine Profiles in Children With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to compare the cytokine profile of tonsillar and peripheral
      blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the
      blood mononuclear cell cytokine secretion profile between patients with obstructive sleep
      apnea and controls without apnea.
    

Detailed description: 
      We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood
      sample and portion of their tonsils after the induction of general anesthesia. The
      mononuclear cells will be isolated from both these tissues and stimulated with different
      markers and cytokines assayed and compared. We will also recruit patients with no symptoms of
      OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the
      parents fill out a sleep questionnaire. We will then collect blood samples from these
      patients after the induction of anesthesia and examine the cytokine secretion profile and
      compare it to that of the children with OSA.
    

Intervention name(s): tonsillectomy
Intervention type(s): Procedure
Intervention description(s): medically indicated tonsillectomy in subjects with and without OAS
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pediatric Obstructive sleep apnea syndrome
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
Condition: Anticoagulation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of two 4-Factor PCC formulations on
      Apixaban pharmacodynamics in healthy adult subjects.
    


Intervention name(s): Apixaban; Cofact (4-Factor PCC); Beriplex P/N (4-Factor PCC); Placebo (Saline solution)
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may
      be more effective treatment for cancer of the pancreas than surgery to remove the pancreas
      and some of the small intestine alone. Radiation therapy uses high-energy x-rays to damage
      tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing
      so they stop growing or die. Combining surgery, radiation therapy, and chemotherapy may be an
      effective treatment for cancer of the pancreas.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the
      pancreas and a portion of the small intestine with or without removing lymph nodes, followed
      by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma
           undergoing extended versus standard pancreatoduodenectomy.

      OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with
      extended lymph node resection after an exploratory laparotomy.

      Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases
      are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin
      calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of
      week 1 and days 29-31 of week 5.

      Patients are followed every 4 months for the first year, then every 6 months for the next 2
      years.

      PROJECTED ACCRUAL: 50 patients will be accrued per group for a total of 100 patients.
    

Intervention name(s): fluorouracil; leucovorin calcium; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Leucovorin; Fluorouracil; Calcium; Levoleucovorin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; adenocarcinoma of the pancreas
GSK2982772 Study in Subjects With Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1)
      kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will
      be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or
      placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg
      three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of
      experimental and clinical endpoints will be employed to obtain information on the
      pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no
      formal hypothesis will be tested, these endpoints will enable a broader understanding of the
      mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days
      of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo
      orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who
      complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg
      three times daily for an additional 42 Days (6 weeks). After the open label (Part B)
      treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3
      Days) post the last administration of study medication. The total duration of participation
      in the study will be approximately 20 Weeks from screening to the last study visit.
    


Intervention name(s): GSK2982772; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets three times a day as directed.; Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets three times a day as directed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tolerability; GSK2982772; Safety; Pharmacokinetics; RIP1 kinase inhibitor; Ulcerative colitis; Pharmacodynamics
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period
      crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization
      in healthy adult men and women
    

Detailed description: 
      The purpose of this randomized, double-blind, placebo-controlled and open label
      active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and
      supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched
      change from baseline using individually corrected QT (QTcI) interval durations in adult
      healthy volunteers.
    

Intervention name(s): BIA 2-093; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): ESL, Eslicarbazepine acetate; avalox; PLC
Intervention MeSH terms: Moxifloxacin; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients
Condition: Cardiovascular Disease
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its
      impact on morbidity and cardiovascular risk factors in chronic renal failure patient.
    

Detailed description: 
      The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus
      conventional high flux hemodialysis in term of adverse events occuring during dialysis
      sessions between day 30 and day 120 of treatment and to evaluate:

        -  Quality of life evaluated with the KDQOL questionnaire

        -  Incidence of cardiovascular events

        -  Influence of the technic on cardiovascular, inflammatory and infectious risk factors

        -  Mortality
    

Intervention name(s): On line Hemodiafiltration; Hemodialysis
Intervention type(s): Procedure; Procedure
Intervention description(s): 3 sessions/week; 3-4 hours per session; 3 sessions/week; 3-4 hours per session; high flux dialyzers
Other intervention name(s): on line HDF; HDF; conventional hemodialysis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: on line hemodiafiltration; tolerance; quality of life; cardiovascular risk; Hemodialysis patients