bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Research of Retrograde Infraclavicular Brachial Plexus Blockade
Condition: Upper Extremity
Study type: Interventional

Summary: 
      Brachial plexus block is a frequently used technique for upper extremity surgery. All present
      approaches and techniques have certain advantages and disadvantages. It's necessary to
      develop a new approach to brachial plexus block which 1) provides reliable anesthesia, 2) is
      easy to perform, 3) isn't restricted by posture, 4) provides extensive sensory distribution,
      5) causes as few complications as possible, 6) easily place a secured catheter for
      post-operative analgesia. The investigators established the retrograde infraclavicular
      brachial plexus block approach. The investigators compared and verified the feasibility,
      efficacy and safety of this new approach with other classic approaches to brachial plexus
      block.
    

Detailed description: 
      Traditional brachial plexus block approaches have certain limitations. This study evaluated
      the effectiveness, safety and feasibility of a new retrograde infraclavicular brachial plexus
      block as compared with interscalene and supraclavicular approaches. 90 patients scheduled for
      elective upper limb surgery were recruited and randomized into three groups, 30 for each
      group. Patients of Group A received retrograde infraclavicular block, interscalene (by
      Winnie) approach for Group B and supraclavicular (by Kulenkampff) approach for Group C. The
      retrograde infraclavicular block was performed with the insertion point medial to the
      coracoid process and the needle advanced to ipsilateral interscalene groove. Neurostimulation
      was used and 40ml of 0.5% ropivacaine were injected. Sensory block, adverse effects and
      complications were evaluated and recorded every 5 minutes until 30min after local anesthetic
      injection. The needle insertion depth, angles in coronary and sagittal planes of Group A were
      also recorded. Success rate of each nerve sensory block, sensory block result, complications,
      rate of satisfaction, rate of failure and incidence rate of adverse effects are all compared
      among groups.
    

Intervention name(s): brachial plexus block
Intervention type(s): Procedure
Intervention description(s): 0.5% Ropivacaine 40ml
Other intervention name(s): NAROPIN® 1.0%
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Supraclavicular; Interscalene; Infraclavicular; Brachial plexus block; Ropivacaine
Deep NMB in Ambulatory Gynecological Laparoscopy
Condition: Muscle Relaxation
Study type: Interventional
Phase: Phase 4

Summary: 
      Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim
      of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR
      [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative
      pain and other physiological changes [3], which could influence the postoperative QOR
      negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].
    

Detailed description: 
      Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications
      in laparoscopic surgery [6,7,8,9]. However, it is unknown whether deep NMB improves
      postoperative QOR in ambulatory gynecological laparoscopy.

      Therefore, we designed a double blind randomised trial to compare the effects of deep and
      moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We
      hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary
      outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical
      conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption
    

Intervention name(s): Rocuronium; Rocuronium bromide
Intervention type(s): Drug; Drug
Intervention description(s): DEEP block to PTC 1-3; MODERATE block to TOF1-2
Other intervention name(s): Neuromuscular blocker; Neuromuscular blocker
Intervention MeSH terms: Bromides; Rocuronium; Neuromuscular Blocking Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of intoplicine in treating patients who
      have advanced or metastatic solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally
      advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in
      these patients. III. Determine the principal and dose limiting toxicities of intoplicine in
      these patients, and determine the duration and reversibility of the toxicities. IV. Determine
      the magnitude of plasma concentrations that are achieved and maintained on this regimen and
      relate this parameter to toxicity outcome and antitumor activity. V. Determine preliminary
      evidence of antitumor activity of intoplicine in these patients.

      OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by
      continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of disease
      progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive escalating
      doses of intoplicine, first by increasing the number of days that the drug is infused to 10,
      15, and 21, then by increasing the dosage and keeping the infusion time constant at 21 days.
      The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6
      patients experience dose limiting toxicity during course 1 or 2.

      PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
    

Intervention name(s): intoplicine
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter
Condition: HRV
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the measuring accuracy of the Wristband for
      registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor
      (LabTech Ltd).
    

Detailed description: 
      Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the
      measuring accuracy of the Wristband for registration of ECG RR intervals for one hand,
      SenceBand in real-world condition during 24-hours of routine duties in comparison to a
      predicate device (Holter monitor). For monitoring HRV each subject will put heart rate
      monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed
      in standard configurations places. Data will be collected during routine duties. SenceBand
      will collect data from 5-minutes intervals each 30 minutes, Holter will collect data
      continuously over 24 hours.
    

Intervention name(s): SenceBand
Intervention type(s): Device
Intervention description(s): Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: R-R intervals; Heart rate; HRV
Relations Between Myotonia and Fitness
Condition: Congenital Myotonia
MeSH terms: Myotonia Congenita; Myotonia
Study type: Interventional

Summary: 
      Investigators aimed to investigate whether training can increase fitness levels in patients
      with myotonia, and thereby reduce the symptom of myotonia.
    

Detailed description: 
      Investigators aimed to investigate whether a 10-week bicycle exercise program can increase
      fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in
      everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six
      statements concerning self-rated myotonia, and a number of performance tests that objectively
      describes the degree of myotonia.

      The effect of the training program is assessed by an incremental test, measuring maximal
      oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase
      (CK) is measured in plasma to follow muscle injury and safety during the training.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): 30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congenital myotonia; Myotonia congenita; Thomsons disease; Becker type; Training; Exercise
A Prospective Multicenter Post Approval Study to Evaluate the Long-term Safety and Efficacy of the Resolute Integrity in the Japanese All-comers Patients With Coronary Artery Disease (PROPEL)
Condition: Coronary Artery Disease; Drug-eluting Stent
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective, multicenter, historical controlled study. The present clinical study
      will measure non-inferiority of 12 month TLF rate compared to historical control.The selected
      historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is
      a prospective, multicenter, randomized, two-arm, international, open-label study.The
      historical control did not have angiographic follow up before 12 months, in the present
      clinical study, only subjects with clinical follow-up conducted at 12 months without any
      pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of
      this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up
      cohort) will be included in this analysis cohort.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Among 1,200 patients to be registered at the website database, the first 900 continuously
        registered patients will be then assigned to the clinical follow-up cohort, and the
        remaining 300 patients to the routine angiographic follow-up cohort.
      
Keywords: Coronary artery disease; Heart disease; Myocardial ischemia; Cardiovascular disease; Arteriosclerosis; Vascular disease
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized,
      placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to
      compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on
      depression in patients aged 18-65. Data from the two trials will be reported in both
      individual and pooled analyses. Pooling the two studies will allow for increased power to
      detect differences between duloxetine and placebo on secondary and exploratory objectives.
      Only one data lock is planned for this study, when all patients have completed all study
      procedures.
    


Intervention name(s): Duloxetine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Exogenous Ketones on Exercise Performance in Young Healthy Adults
Condition: Exercise; Ketones; Dietary Supplements
Study type: Interventional

Summary: 
      The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can
      be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a
      ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance
      but this has not been adequately studied. The purpose of this study is to determine whether
      supplementing with an acute dose of ketone salts can alter fuel use during exercise and
      improve exercise performance.
    


Intervention name(s): Ketone Salt; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily
      for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal
      dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a
      total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects
      with one of the following clinical diagnoses will be enrolled: schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced
      TD; or gastrointestinal disorder with metoclopramide-induced TD.

      For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which
      may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an
      optimal dose of NBI-98854 for each subject
    

Intervention name(s): NBI-98854; NBI-98854; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg capsule; 50 mg capsule
Intervention MeSH terms: Tetrabenazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treating Thought Problems in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will compare Cognitive Adaptation Training (CAT) to minimal schizophrenia
      treatment. This study will also determine whether the intensity of CAT can be reduced and
      still provide benefits to patients with schizophrenia.
    

Detailed description: 
      Many schizophrenia patients have serious difficulties that affect their quality of life.
      Cognitive Adaptation Training (CAT) may improve adaptive functioning, quality of life, and
      rates of relapse in schizophrenia patients. CAT, which involves compensatory strategies or
      environmental supports, is tailored to each individual and is based on executive functioning
      levels and other factors.

      Participants are randomly assigned to CAT, Minimal Environmental Supports (MES), or treatment
      as usual for 2 years. Participants receiving CAT will have a trained therapist make weekly
      visits to their home for 9 months. Over the following 3 months, the frequency of CAT visits
      will be slowly reduced to once a month. For the remaining 12 months of treatment, patients
      receive CAT only once a month.

      Participants assigned to the MES group receive a generic set of supplies and equipment
      (calendar, alarm clock, watch, bus passes, etc.) at the beginning of the 2-year period. Each
      month, the supplies are replenished as necessary during the patient's scheduled clinic visit.

      In all groups, assessments of adaptive function and quality of life occur at study start and
      at 3, 6, 9, 18, and 24 months.
    

Intervention name(s): Cognitive Adaptation Therapy (CAT); Minimal Environmental Supports (MES)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effects of a single dose of 200
      milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe
      substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in
      participants with moderate to severe psoriasis.
    

Detailed description: 
      This is an open-label, multi-center study. The total duration of study will be approximately
      17 weeks per participant, including Screening phase (up to 4 weeks prior to first probe
      cocktail administration). Participants will have 4 in-patient periods on Day 1, 8, 15 and 36
      (3 periods consisting of 3 days and 2 nights each and 1 consisting of 2 days and 1 night)
      followed by follow up period (up to Day 92). All Participants will receive a single 200 mg
      subcutaneous (SC) injection (2*100 mg) of guselkumab on Day 8 and probe cocktail on Days 1,
      15 and 36. Blood samples will be collected for the evaluation of pharmacokinetics and
      immunogenicity at pre-dose and post-dose of study treatment. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Guselkumab; Midazolam; Warfarin; Omeprazole; Dextromethorphan; Caffeine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2*100 mg) on Day 8.; Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.; Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.; Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.; Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.; Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.
Intervention MeSH terms: Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Guselkumab; Cytochromes P450
Older Volunteers' Competence Training
Condition: Volunteers
Study type: Interventional

Summary: 
      This project was aimed to evaluate the effectiveness of the competence training program in
      improving the knowledge and skills of volunteer work, the motivation for volunteering,
      self-efficacy, and satisfaction with volunteer work among older volunteers.
    

Detailed description: 
      A cluster-randomized controlled trial was conducted to test the effects of a 3-month
      comprehensive competence training program in improving the knowledge and skills of volunteer
      work, the motivation for volunteering, self-efficacy, and satisfaction with volunteer work
      among older volunteers. Using convenience sampling, 10 senior activity centers with 162 older
      volunteers were recruited and cluster-randomized to the intervention group (5 centers) or
      wait-list comparison group (5 centers). The intervention group received a 3-hour weekly
      course training session in four consecutive weeks and provided services to community-dwelling
      older adults for two months; the comparison group provided their routine services at senior
      activity centers. Data were collected at baseline, one month, and three months into the
      study.
    

Intervention name(s): Competence training program; Control
Intervention type(s): Other; Other
Intervention description(s): A 3-hour weekly course training session in four consecutive weeks and provided services to community-dwelling older adults for two months.; This group provided their routine services at senior activity centers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: knowledge and skills; motivation; self-efficacy; satisfaction
Ketogenic Diet for Child Epilepsy and Seizure Control
Condition: Epilepsy; Seizures; Lennox-Gastaut Syndrome
MeSH terms: Epilepsy; Seizures; Lennox Gastaut Syndrome
Study type: Interventional

Summary: 
      Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even
      when treated with currently available anticonvulsant medications. Children with
      Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures.
      Preliminary data suggest that even when other medications have failed, these seizures may
      respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose
      of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure
      frequency, medication toxicity, and improves quality of life.
    

Detailed description: 
      The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of
      fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet.
      Studies suggest it is useful in children whose seizures could not be controlled by any of the
      medicines available. This study is designed to test, in a carefully controlled fashion, how
      well the diet works in children with "drop" seizures. Children who experience 15 or more drop
      seizures each day, despite having used at least two medications, may be eligible to
      participate. This study requires children to undergo periods of fasting and to maintain a
      carefully controlled diet. Parents of participating children monitor their children's diets
      and keep daily meal and seizure diaries.
    

Intervention name(s): Ketogenic diet
Intervention type(s): Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: child; children; epilepsy; seizure; ketogenic; diet; Lennox-Gastaut Syndrome; LGS