bioihbjkbjnl/mcl2 huggingface dataset:
Tramadol Versus Lidocaine Infiltration for Tonsillectomy
Condition: Peri-tonsillar Analgesic Infiltration; Tonsillectomy; Postoperative Pain; Inflammatory Response
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators postulate that the use of pre-incisional peritonsillar infiltration of
      tramadol or lidocaine reduces both the inflammatory response and postoperative analgesic
      consumption, without harmful effects. Therefore, the present study is designed to evaluate
      the effects of infiltration of tramadol or lidocaine on the postoperative acute-phase serum
      protein, C-reactive protein, and analgesic consumption after tonsillectomy.
    


Intervention name(s): peritonsillar infiltration
Intervention type(s): Drug
Intervention description(s): 1.5 ml around each tonsil, 3 minutes before surgical incision as per group description
Other intervention name(s): as in description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Anaesthesia; tonsillectomy; inflammatory response; stress response; tramadol; lidocaine
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Recent research on the effects of nicotine on the brain and behavior presents an opportunity
      to advance medication development.

      The purpose of this study is to develop a laboratory model for early-stage testing of new and
      existing treatments for nicotine addiction. Specifically, the investigators will develop a
      laboratory model of relapse to cigarette use in nicotine dependent volunteers.
    

Detailed description: 
      Tobacco use is the leading preventable cause of death in the United States. Recent research
      on the effects of nicotine on the brain and behavior presents an opportunity to advance
      medication development. The goal of this study is to develop a laboratory model for
      early-stage testing of new and existing compounds for the treatment of tobacco and nicotine
      addiction. In addition, the objective of this study is to develop a laboratory model of
      relapse induced by cigarette exposure that would reproduce the psychological and
      physiological processes that are involved when abstinent individuals progress from initial
      cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be
      used to study the mechanisms of relapse and to screen medications that might be effective in
      preventing relapse in treatment seekers.

      This study will consist of two phases. Each phase will consist of a 5-day inpatient stay.
      During the first portion of inpatient stay, participants will not be permitted to smoke.
      During the second portion of inpatient stay, smoking reinstatement will be modeled, as
      participant will have opportunity to smoke, following the exposure to tobacco-related or
      control cues. A variety of behavioral, subjective, physiological, and performance measures
      will be assessed throughout the study.
    

Intervention name(s): Neutral or active cigarette cues
Intervention type(s): Behavioral
Intervention description(s): Packets of cigarettes or cigarette smoke.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tobacco use
Change in Reward System Activation and Gut Microbiota Following RYGB and Sleeve Gastrectomy for Weight Loss vs. Control-Heads Up Ancillary
Condition: Bariatric Surgery Candidate
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Bariatric surgery is considered an effective long-term intervention for the treatment of
      obesity and associated complications. While bariatric surgery has been shown to result in a
      large sustained weight loss, the degree of weight loss and maintenance thereafter varies
      greatly. The Heads Up Surgical Demonstration Project (Heads Up) is a 5 year project examining
      weight loss after an intensive medical intervention (IMI) and the 2 most widely used
      bariatric surgeries (roux-en-y gastric bypass or RYGB and sleeve gastrectomy or SG). Baseline
      data are collected prior to surgery and follow-up data are collected at 6 months and annually
      thereafter. A recent meta-analysis revealed that RYGB resulted in greater weight loss and is
      more effective in resolving obesity related comorbidities than SG, although SG has been shown
      to result in a reduction of perioperative complications and reoperations1. Full elucidation
      of the mechanisms leading to variation in success for weight loss interventions is crucial to
      understanding the most effective and reliable treatments for obesity and associated
      comorbidities.
    


Intervention name(s): Bariatric Surgery
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Weight Loss; Magnetic Resonance Imaging; gut microbiota
Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess safety, tolerability and pharmacokinetics (PK) of single intravenous (i.v.)
      doses of BIIB 722 CL
    


Intervention name(s): BIIB 722 CL; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hydroxypropyl-beta-cyclodextrin (HPβCD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Condition: Foot and Ankle Surgeries; Bunion
MeSH terms: Bunion
Study type: Interventional
Phase: Phase 4

Summary: 
      Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often
      underestimated. However there has been growing emphasis on identification of these injuries
      and practice patterns.
    

Detailed description: 
      Approximately 20% of all foot and ankle fractures are open. Excellent operative field without
      measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss
      can increase the risk of infection, hematoma formation and wound complications. Presence of
      blood in synovium not only has direct corrosive effects but also causes increased intra
      capsular pressure leading to capsular fibrosis culminating as ankyloses.

      Tourniquets are employed to optimize surgical field visualization thereby limiting operative
      duration and improving technical precision. There are several unwanted effects that can arise
      from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence
      there is a growing interest in achieving the same operative goals without the use of
      tourniquet.

      Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in
      reducing intra operative and post operative blood loss is well documented in cardiac surgery,
      hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic
      antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen,
      plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot
      degradation. It has been effectively used as IV, oral, topical as well as intra articular
      dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic
      surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood
      loss and transfusion requirements. Reduced bleeding translates to decreased incidence of
      wound hematoma and other complications.

      Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this
      study is to not only evaluate effectiveness of intravenous TXA in reducing post operative
      blood loss during foot and ankle surgeries but also if it modulates to reduced wound
      complications and reduced narcotic consumption.
    

Intervention name(s): Tranexamic Acid; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): administered prior to surgical incision; administered prior to surgical incision
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: foot and ankle surgeries; tranexamic acid; wound healing; blood loss
Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary
Condition: Cancer of Unknown Primary Site
MeSH terms: Neoplasms, Unknown Primary
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling
      in predicting primary site and directing therapy in patients with cancer of unknown primary.
    


Intervention name(s): tissue-of-origin (ORIGIN-PanCA○R) profiling
Intervention type(s): Genetic
Intervention description(s): 90-gene assay to predict the primary tumor site
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Tissue-of-origin test
Masking: None (Open Label)
Primary purpose: Treatment
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
Condition: Asthma, Exercise-Induced
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of an approved medication being studied
      in support of a new approach in the prevention of exercise-induced asthma (a worsening of
      asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who
      have a history of worsening asthma after exercise.
    


Intervention name(s): Comparator: Montelukast; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge; Placebo tablet administered orally as a single witnessed dose before exercise challenge
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
Condition: Pregnancy; Breech Presentation
MeSH terms: Breech Presentation
Study type: Interventional

Summary: 
      We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the
      success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or
      epidural analgesia) during version for breech presentation increases successful fetal
      rotation and decreases the incidence of Cesarean delivery for malpresentation.
    

Detailed description: 
      At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries
      are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal
      breech delivery. Cesarean delivery, the safer option for the baby, however, is associated
      with a higher incidence of maternal complications for both the current and subsequent
      pregnancies. External cephalic version is a procedure commonly used to attempt to manually
      rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids
      higher maternal and/or neonatal complications.

      Obstetricians perform versions after 36 weeks gestational age with a reportable success rate
      of 30-80%. The most common technique involves external manipulation of the fetal position
      preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the
      form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use
      of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used
      for labor and delivery analgesia.

      Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and
      satisfaction, there is conflicting evidence if they improve the success rate of version
      procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated,
      "Currently there is not enough evidence to make a recommendation favoring or opposing
      anesthesia during ECV (external cephalic version) attempts."

      We propose to conduct a prospective, single blinded, randomized clinical trial to assess the
      impact of combined spinal-epidural analgesia on the success rate of external version for
      breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a
      secondary outcome.
    

Intervention name(s): Combined spinal-epidural analgesia; Intravenous fentanyl (50mcg)
Intervention type(s): Procedure; Procedure
Intervention description(s): Combined spinal-epidural; Intravenous fentanyl
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; 37 Weeks Gestation; Breech Presentation; Version Procedure; Pain Control; Neuraxial analgesia
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Condition: Hepatitis; Hepatitis B, Chronic; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study was conducted to compare the safety and effectiveness of the
      investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by
      the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The
      results for patients taking LdT will be compared to results for patients taking lamivudine.
    

Detailed description: 
      Multicenter, multinational, randomized, double-blind study designed to compare the safety and
      efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults
      with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were
      pre-stratified by screening Child-Turcotte-Pugh score (CTP score < 9 or ≥ 9) and ALT level
      (within normal limits (WNL) or > 1.0 x ULN) to help assure similar degrees of hepatic
      insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment,
      participants were followed-up with for an additional 16 weeks.
    

Intervention name(s): Telbivudine; Lamivudine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600mg/day oral tablet for 104 weeks; 100mg/day oral tablet for 104 weeks; Telbivudine matching placebo or lamivudine matching placebo tablet.
Other intervention name(s): LDT600
Intervention MeSH terms: Lamivudine; Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Left Ventricular Diastolic Dysfunction in Kidney Recipients
Condition: Kidney Transplantation
MeSH terms: Ventricular Dysfunction, Left
Study type: Observational

Summary: 
      The purpose of this study is to examine the relationship between pre-operative LV diastolic
      function and post-operative complications and kidney function in living-donor kidney
      transplantation patients.
    


Intervention name(s): medical records
Intervention type(s): Other
Intervention description(s): review of medical records
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elective kidney transplantation patients
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study
      are to characterize the pharmacokinetic (PK) profile and to determine the safety and
      tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to
      moderate acute pain.
    

Detailed description: 
      This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with
      diclofenac potassium oral solution, based on weight, every 6 hours as needed for the
      treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected
      through 6 hours after the first dose. Safety data will be collected throughout the study.
    

Intervention name(s): diclofenac potassium oral solution
Intervention type(s): Drug
Intervention description(s): Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
Other intervention name(s): diclofenac
Intervention MeSH terms: Diclofenac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain; NSAID; nonsteroidal anti-inflammatory drug
Vasodilation Effect of Inhalational Anesthetics
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Previous studies on animals suggest that inhalational anesthetics can reduce vascular tension
      in vitro resulting in vasodilation and decrease in blood pressure. This role for inhalational
      anesthetics has essential clinical implications such as the condition of sepsis or septic
      shock or other shock-associated states during which the blood vessel constricts strongly and
      leads to circulation dysfunction. The vasodilation property of these anesthetics including
      halothane, isoflurane, sevoflurane, desflurane and enflurane enables them to be better
      options than other general anesthetics in many clinical conditions needing the vasculature to
      be dilated. The investigators hypothesized that these inhalational anesthetics can evoke
      vasodilation measured with ultrasonography during general anesthesia in vivo as the in vitro
      studies displayed.
    


Intervention name(s): Halothane; Isoflurane; Sevoflurane; Desflurane; Enflurane
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen; Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen; Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen; Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen; Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Other intervention name(s): Fluothane; Forane; Sevorane; Suprane; Ethrane
Intervention MeSH terms: Sevoflurane; Desflurane; Isoflurane; Halothane; Enflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inhalant anesthetic; Vasodilation; General anesthesia; Ultrasonography
Transversalis Fascial Plane Nerve Block in Iliac Crest Bone Graft
Condition: Upper Limb Surgery; Iliac Crest Bone Harvest
MeSH terms: CREST Syndrome
Study type: Interventional

Summary: 
      Hand or wrist surgery often requires the use of bony material in order to accomplish any
      associated reconstructive aspects required for the surgery. The iliac crest is often used as
      the source of bone for such surgery and harvesting from this site is performed simultaneously
      with the hand/wrist surgery. In terms of anesthesia, patients typically receive a
      supraclavicular nerve block for the hand/wrist surgery, and a general anesthestic for the
      bone graft, though spinal block may also be performed. This study will look at the use of a
      transversalis fascia plane (TFP) nerve block (ie, to numb the nerves going to the iliac
      crest) in combination with a general anesthetic to see if post-operative pain and opioid
      consumption is reduced using the TFP block.
    


Intervention name(s): Active treatment; Placebo Arm
Intervention type(s): Drug; Drug
Intervention description(s): US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine; US-guided TFP block with 20ml of 5% dextrose solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: supraclavicular nerve block; regional anesthesia; transversalis fascia plane block; ultrasound guided; opioid consumption; iliac crest bone harvest; hand surgery; wrist surgery; Upper limb surgery combined with iliac crest bone harvest.
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188
      monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks
      double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility
      criteria will be randomized to one of two treatment groups: RGH-188 or placebo
    


Intervention name(s): Cariprazine (RGH-188); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cariprazine 3 mg - 12 mg oral administration, once per day.; Dose-matched placebo oral administration, once per day.
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mania; Bipolar I Disorder; Acute Mania Associated with Bipolar I Disorder
Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican)
      administered to pediatric renal transplant recipients, and to provide additional safety data.
    


Intervention name(s): Certican
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; renal; transplant recipients; de novo; De novo renal pediatric transplant