bioihbjkbjnl/mcl2 huggingface dataset:
Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Condition: Brachial Plexus Block; Pain, Postoperative
MeSH terms: Pain, Postoperative; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Many patients have strong pain at brachial plexus block resolution after operations for
      distal radius fractures with a volar plate. This study investigates if a single dose of
      dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The
      primary endpoint is difference in the highest pain score first 24 hours after surgery. The
      investigators will also look at pain scores and analgesics consumption first few hours after
      surgery and at different times up to 2 years after surgery.
    

Detailed description: 
      This double-blind randomized clinical study evaluates pain, analgesic consumption and
      different measurements of patients satisfaction after operations for distal radius fractures
      with a volar plate in the day-care surgery unit. All patients will receive paracetamol and
      etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial
      plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a
      single dose of 16 mg dexamethasone during the operation. Patients in the control group will
      receive NaCl iv.

      After surgery, iv and oral rapid release oxycodone as needed while in hospital. After
      discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3
      doses. Rapid release oxycodone as needed.

      Patients will be followed up by telephone interviews at different times after surgery.
    

Intervention name(s): Dexamethasone; NaCl (Control); Paracetamol; EtoriCoxib; Oxycodone; Ropivacaine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 ml DexaGalen 4 mg/ml; 4 ml NaCl 9 mg/ml; Premedication and as needed after operation; Premedication and first 2 postoperative days.; Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.; In brachial plexus block
Other intervention name(s): DexaGalen; NaCl; Arcoxia; OxyContin; OxyNorm
Intervention MeSH terms: Acetaminophen; Dexamethasone; Etoricoxib; Oxycodone; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in
      treating patients with relapsed or refractory lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or
           refractory lymphoma.

        -  Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or
           refractory lymphoma.

      Secondary

        -  Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion.

        -  Assess the response rate and duration of response in patients treated with SL-11047.

        -  Assess the level of SL-11047 within tumor tissues following intravenous administration
           of the drug.

        -  Determine the sensitivity of abnormal circulating macrophages to SL-11047.

      OUTLINE: This is an open-label, nonrandomized, dose-escalation study.

      Patients receive SL-11047 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the
      absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): polyamine analogue PG11047
Intervention type(s): Drug
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent mycosis fungoides/Sezary syndrome; splenic marginal zone lymphoma
A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in
      modulating brain processing of emotional and cognitive stimuli on the amygdala and related
      brain structure using fMRI in in unmedicated patients with depression.
    


Intervention name(s): BI 1358894; Placebo matching BI 1358894; Citalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Film-coated tablet
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Open Label Trial of Acamprosate in Bipolar Alcoholics
Condition: Alcohol Dependence; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether acamprosate (Campral) is safe and effective
      in treating alcohol dependence in individuals with bipolar disorder. All subjects in the
      study must be currently stabilized on mood-stabilizing medication. Half of the subjects will
      receive acamprosate in addition to their mood-stabilizing medication; control subjects will
      be maintained on their mood-stabilizing medication alone. Measures of alcohol use as well as
      mood stability will be obtained weekly throughout the active phase of the study.
    


Intervention name(s): Acamprosate
Intervention type(s): Drug
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acamprosate; Addiction; Alcoholism; Alcohol dependence; Bipolar disorder; Depression; Impulsivity; Mania; Substance abuse
Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to increase our knowledge of receptor function in the
      brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has
      been approved for the treatment of alcohol dependence. Receptors are special molecules in the
      brain to which other molecules (neurotransmitters) attach during the normal every-day
      workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence
      suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking
      behavior. This study will try to determine if naltrexone's ability to attach to these
      receptors is related to its effectiveness. We will use PET (positron emission tomography) for
      this study. PET is a type of imaging device found in nuclear medicine. It is used for
      tracking the presence of injected radioactive materials in the body.
    


Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): Naltrexone 100 mg titrated over one week
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism
Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional

Summary: 
      Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly
      influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who
      cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted
      into the liver incisal margin after tumor was resected could reduce the recurrence rate of
      HCC after liver resection.According to this, we proceed this RCT to prospectively observe the
      effect of sustained released 5-FU,and we also want to know whether combined with sustained
      released cisplatin will get better effect in preventing the tumor recurrence,especially in
      short time after liver resection.
    

Detailed description: 
      150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be
      randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained
      released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be
      implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50
      cases) will be the controlled one which will not be implanted any chemotherapeutic drugs. All
      patients will accepted TACE 30 days after liver resection. We will follow up all patients
      until they are dead or missed connected. Related adverse reaction will be recorded. Total
      survival time (TST) and disease free survival time (DFST) will be calculated too. At the end
      of the study we will compare the difference of adverse reaction, complication, TST and DFST
      between the 3 groups. According to the result we will estimate these drugs' antitumor effect
      and safety.
    

Intervention name(s): sustained released 5-FU and sustained released cisplatin; sustained released 5-FU; TACE
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): 600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.; 600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.; All patients will accept TACE one month after tumor was resected.
Other intervention name(s): 5-FU+Cisplatin group; 5-FU group; Postoperative TACE
Intervention MeSH terms: Cisplatin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatocellular carcinoma; liver resection; intraoperative chemotherapy
Drug-drug Interaction Study Between Edaravone and 2-Aminoethanesulfonic Acid in Compound Edaravone Injection
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      An experiment to evaluate the drug-drug interaction of formula edaravone and formula
      2-aminoethanesulfonic acid in compound edaravone injection.
    


Intervention name(s): Compound Edaravone Injection; Edaravone Injection; 2-Aminoethanesulfonic Acid Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 min intravenous infusion; 30 min intravenous infusion; 30 min intravenous infusion
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-cycle crossover study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug Interaction; Edaravone; 2-Aminoethanesulfonic Acid; Compound Edaravone Injection
Early Limited Formula for Treating Lactation Concerns
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This is a randomized, controlled trial designed to evaluate a new strategy for promoting
      continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn
      period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed
      to each baby by syringe after each breastfeeding prior to the onset of mature milk
      production. The study intervention is discontinued at the onset of mature milk production,
      and the investigators will then follow mothers and infants for 12 months to assess the effect
      of ELF on breastfeeding duration, maternal experience and healthcare utilization.
    


Intervention name(s): Early Limited Formula; Standard Care
Intervention type(s): Other; Other
Intervention description(s): 10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production; Continue exclusive breastfeeding unless otherwise directed by a health care provider
Other intervention name(s): ELF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: breastfeeding; lactation; newborn
Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to better understand the systems-level neuronal mechanisms by which general
      anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress
      consciousness by disrupting the functioning of large-scale brain networks that support
      information integration in the brain.
    


Intervention name(s): Functional Magnetic Resonance Imaging (fMRI)
Intervention type(s): Other
Intervention description(s): Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.
Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Music; Propofol
Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction
Condition: Bilateral Vestibular Hypofunction
MeSH terms: Kinesiophobia
Study type: Interventional

Summary: 
      Background: The vestibular rehabilitation is an exercise-based method, aiming to maximize
      central nervous system(CNS) compensation at vestibular nuclear and other CNS levels for
      vestibular pathology. A minimal number of studies have documented the impact of Vestibular
      rehabilitation on the recovery rate of patients with Bilateral Vestibular Hypofunction(BVH).

      Objective: The purpose of this study was to investigate the effectiveness of structured
      vestibular rehabilitation (VR) programs on severity of dizziness, kinesiophobia, balance,
      fatigue, quality of sleep, activities of daily living( ADL) and quality of life(QoL) in
      subjects with chronic BVH.

      Method: Twenty-five participants diagnosed with BVH were included in the study. A structured
      VR program was applied in 50-minute sessions once a week and as a home exercise program 3
      days a week over 8 weeks. Participants were evaluated for severity of dizziness with the
      Visual Analog Scale (VAS), for kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), for
      balance with the Semitandem, tandem, and standing tests, for quality of sleep with the
      Pittsburgh Sleep Quality Index (PSQI), for ADL with the Vestibular Disorders Activities of
      Daily Life (VADL), for QoL with Dizziness Handicap Inventory (DHI) and for fatigue with the
      Fatigue Severity Scale (FSS) at the baseline (T0), at 4th week (T1), 8th week (T2), and 20th
      week (T3) after study started.
    


Intervention name(s): structured vestibular rehabilitation program
Intervention type(s): Other
Intervention description(s): The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bilateral Vestibular Hypofunction; Dizziness; Kinesiophobia; Balance; Quality of Sleep; Quality of Life; Structured Exercise
Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
Condition: Circulating Tumor Cells; Colorectal Cancer; Gastric Cancer
MeSH terms: Neoplastic Cells, Circulating
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare both short-term and long-term treatment
      effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on
      circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out
      principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary
      purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric
      and rectal cancer treatment using CTC as a biomarker.
    

Detailed description: 
      Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with
      advantages of minimal invasion and rapid recovery compared to open approach. However, for
      progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted
      by NCCN guideline (2015).

      Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been
      identified as potential blood-based biomarkers capable of providing prognostic and predictive
      Information.

      In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan,
      China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect
      CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs.
      open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC)
      test results as well as disease-free survivals, and figure out principles of laparoscopic
      approach for progressive gastric and rectal cancer. Secondary purpose is to establish an
      evaluation system for laparoscopic surgery for progressive gastric and rectal cancer
      treatment using CTC as a biomarker.
    

Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): Laparoscopic or open surgery for resection of gastric or rectal cancer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international, multicenter, open-label, long-term safety study of ZX008 in
      subjects with Dravet syndrome.
    

Detailed description: 
      This is an international, multicenter, open-label, long-term safety study of ZX008 in
      pediatric and young adult subjects with Dravet syndrome who participated in one of the core
      studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an
      extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE)
      Treatment Period and a 2-week Post-Dosing Period.
    

Intervention name(s): ZX008 (Fenfluramine Hydrochloride)
Intervention type(s): Drug
Intervention MeSH terms: Fenfluramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seizure; tonic clonic; epilepsy; myoclonic; encephalopathy