bioihbjkbjnl/mcl2 huggingface dataset:
Electromyographic (EMG) on the Anaesthesia Monitor
Condition: Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors
      to show misleadingly high values. The investigators want to investigate whether this EMG
      activity can be visually seen on the anaesthesia monitor.
    

Detailed description: 
      Patients are anaesthetized with target controlled infusion of propofol. To facilitate
      intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg.
      BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer.
      The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS,
      Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.
    

Intervention name(s): Rocuronium bromide; Rocuronium bromide
Intervention type(s): Drug; Drug
Intervention description(s): Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose; Rocuronium, iv, single dose, single bolus, 1.2 mg/kg
Other intervention name(s): Esmeron; Esmeron.
Intervention MeSH terms: Bromides; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electroencephalogram; Electromyogram; Entropy Index; Bispectral Index; Neuromuscular blockade; rocuronium; Propofol; Intubation
Combination of Cryosurgey and NK Immunotherapy for Recurrent Pharyngeal Cancer
Condition: Recurrent Pharyngeal Cancer
MeSH terms: Pharyngeal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent pharyngeal cancer.
    

Detailed description: 
      By enrolling patients with recurrent pharyngeal cancer adapted to enrolled criteria, this
      study will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharyngeal cancer; Cryosurgery; NK immunotherapy
The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
Condition: Meniscus Lesion; Pain (Knee); Diagnostic Knee Artroscopy; Minor Knee Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to
      placebo when it comes to analgetic efficacy after Knee-Arthroscopy.
    


Intervention name(s): Adductor-Canal-Block, Ropivacain; Adductor Canal Block, Placebo (saline)
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.; Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
Other intervention name(s): Naropin (Ropivacain)
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor Canal Block (ACB); Diagnostic Knee Arthroscopy; Saphenous nerve; Pain; Ultrasound block
HKI-272 Ketoconazole Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole
      when co-administered.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; healthy subjects
Respiratory-Swallow Coordination in Cardiothoracic Surgical Patients
Condition: Thoracic Diseases; Cardiovascular Diseases
MeSH terms: Thoracic Diseases; Cardiovascular Diseases
Study type: Observational

Summary: 
      Dysphagia (swallowing impairment) is a common complication of cardiothoracic surgery (CS).
      Although alterations in respiratory-swallow coordination is a known underlying
      pathophysiologic mechanism of dysphagia in multiple patient populations, no group has
      examined respiratory-swallow physiology in CS patients. The proposed study will examine
      respiratory-swallow physiology in CS patients and determine its association with unsafe
      swallowing and inferior health-related outcomes.
    

Detailed description: 
      The proposed study will examine respiratory-swallow physiology in cardiothoracic surgical
      patients and determine its association with unsafe swallowing and inferior health-related
      outcomes. Participation will involve a single postoperative research exam of approximately
      60-90 minute duration. Participants will be seated upright and positioned for simultaneous
      instrumental imaging of swallow physiology, nasal airflow monitoring, and respiratory
      inductance plethysmography testing.
    

Intervention name(s): Videofluoroscopic swallow exam with concurrent monitoring of respiratory-swallow coordination
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will undergo simultaneous videofluoroscopy, nasal airflow and respiratory inductance plethysmography testing.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 individuals undergoing cardiothoracic surgery will be enrolled in this study.
      
Keywords: Dysphagia; Extubation; Respiratory-swallow coordination; Swallow
Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single
      dose group stratified study in renal impaired and healthy subjects.
    


Intervention name(s): BAY85-3934; BAY85-3934; BAY85-3934
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose, 20 mg; single dose, 40 mg (optional); single dose, 80 mg (optional)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anemia
AM-101 in the Treatment of Acute Tinnitus 3
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to test the safety and effectiveness of the study drug,
      AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an
      injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with
      tinnitus can take part in the study, if their tinnitus started within the last 3 months or
      within the last >3 to 6 months.
    

Detailed description: 
      This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of
      repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to
      3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).
    

Intervention name(s): AM-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AM-101 gel for intratympanic injection; Placebo gel for intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This protocol will use leukapheresis to collect lymphocytes to study immune responses
      following vaccination with BCG in BCG-naïve participants. These studies will include, but not
      necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses,
      anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses
      will provide a detailed framework characterizing the immune responses that are induced and
      responses that are not induced in humans by BCG, a partially protective TB vaccine. This
      framework will allow new hypotheses to be formulated and tested regarding what new and more
      effective TB vaccines should target for optimal protective immunity.
    

Detailed description: 
      This is an open-label protocol in up to 15 healthy adults who are BCG-naïve. All participants
      will receive a total of two doses of BCG, by intradermal injection, approximately 6 months
      apart. Participants will be followed by a combination of visits and telephone contacts
      through Study Day 264. Participants will undergo TST testing 3 months after the second BCG
      vaccination and QuantiFERON TB Gold in-Tube (QTBGT), or the equivalent, if necessary. Two BCG
      vaccinations given 6 months apart were chosen for this study to give optimal T cell and
      antibody responses for future study. Leukapheresis will be conducted prior to the first BCG
      vaccination and at 56 days after the second BCG vaccination (Hoft, 2002; Brown, 2003; de
      Valliere, 2005). The final leukapheresis timing was selected based on results from functional
      biological assays, which suggest analysis of samples at this time point may provide insight
      into the protective immune responses elicited by BCG, and on results of prior clinical trials
      describing the peak immune responses to BCG (Hoft, 2002; Brown, 2003; de Valliere, 2005). The
      study will be conducted at a single site in the US (Saint Louis University [SLU]).
    

Intervention name(s): bacillus Calmette-Guérin
Intervention type(s): Biological
Intervention description(s): BCG injection for prevention of tuberculosis
Other intervention name(s): BCG
Intervention MeSH terms: BCG Vaccine
Intervention model: Single Group Assignment
Intervention model description: All participants (N=17) will receive BCG on Study Day 0 and Study Day 180 by intradermal administration.
Masking: None (Open Label)
Primary purpose: Basic Science
Cocaine Abuse and ADHD - 10
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of buproprion in treating
      individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine
      dependence.
    


Intervention name(s): Flupenthixol
Intervention type(s): Drug
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Primary purpose: Treatment
Keywords: cocaine dependence
A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication
Condition: Autoimmune Thyroid Disease; Congenital Hypothyroidism
MeSH terms: Congenital Hypothyroidism; Thyroid Diseases; Hypothyroidism
Study type: Observational

Summary: 
      Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m
      pertechnetate produced by high energy cyclotron at CHUS.
    

Detailed description: 
      The proposed clinical trial will be a prospective, case-controlled Phase I, open label,
      single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC
      standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent
      case-matched controls, will receive GPERT and will also have additionnal whole body scan.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 18 and 80 years of age with thyroid scan indication
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Condition: Partial Onset Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce
      seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with
      refractory partial onset seizures. It is hypothesized that both doses of pregabalin will
      demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure
      frequency and that pregabalin will be safe and well tolerated.
    


Intervention name(s): Pregabalin Dose Level 1; Pregabalin Dose Level 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase; Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Partial Onset Seizures; Epilepsy; Safety; Efficacy; Tolerability; Pregabalin; Lyrica; Adjunctive treatment; Placebo controlled; blinded; Eligibility Criteria
Tongxinluo Improve High on Clopidogrel Platelet Reactivity Patients With Coronary Heart Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent
      reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this
      prospective randomized study,all patients in control group will receive blank placebo ,all
      patients in test group will receive tongxinluo.All patients will be followed up for one year.
    

Detailed description: 
      The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary
      endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and
      MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events
      at 1 year.
    

Intervention name(s): Tongxinluo; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tongxinluo,3 capsules/time 3times/day for 1 year; 3 capsules/time，3times/day for 1 year
Other intervention name(s): Tongxinluo capsule; placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: high on-treatment platelet reactivity; Coronary Heart Disease; Tongxinluo
The Bioavailability of Polyacetylenes From Carrots Study
Condition: Healthy
Study type: Interventional

Summary: 
      Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and
      anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the
      polyacetylenes could have an effect in vivo, this study aims to determine whether they are
      detectible in human biofluids after the consumption of a portion of carrots and whether a
      difference is seen between a large and small portion.
    

Detailed description: 
      Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample
      either the night before or the morning of the test session. They will have fasted blood taken
      before eating a portion of carrots with bread and butter. Further blood samples will be taken
      at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will
      be collected up to 48 hours after the carrot dose. They volunteers will attend two test
      sessions and will be randomised to receive high and low doses of carrot. At least a week will
      separate testing sessions.
    

Intervention name(s): Carrot
Intervention type(s): Dietary Supplement
Other intervention name(s): polyacetylene; falcarinol; falcarindiol; falcarindiol-3-acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Polyacetylenes; Falcarinol; Falcarindiol; Falcarindiol-3-acetate; Carrot; Biological Availability
Cannabidiol and Oral Contraceptive Pills: Exploring a Drug-Drug Interaction
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess how Cannabidiol (CBD) impacts the effectiveness of
      oral contraceptive (birth control) pills and if CBD changes the possible side effects of
      birth control pills when CBD and birth control pills are taken at the same time.

      This study explores the potential interaction between CBD and birth control pills by
      assessing serum levels of the contraceptive steroid hormones ethinyl estradiol and
      levonorgestrel in birth control pill users when they also use CBD.
    

Detailed description: 
      Participants will be randomized to either the CBD or placebo for cycle one, followed by a
      washout cycle. For cycle three, participants will take the opposite of what they received in
      Cycle one. For example if they received CBD during cycle one they will take placebo for cycle
      3.
    

Intervention name(s): Cannabidiol Oil; Placebo; Combined oral contraceptive pill
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.; Placebo will be administered daily along with oral contraceptives daily for 24 days.; All participants will receive oral contraceptives
Other intervention name(s): Cannabidiol + OCP; Placebo + OCP
Intervention MeSH terms: Cannabidiol; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Cannabidiol; Combined oral contraceptives
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
Condition: Stage 2 Diastolic Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of first-line treatment with a free
      combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2
      diastolic hypertension (DBP>= 100 mmHg).
    


Intervention name(s): nebivolol and lisinopril (free combination); nebivolol monotherapy; lisinopril monotherapy; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks
nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks
nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks; nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)
nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks; lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks; Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks
Intervention MeSH terms: Lisinopril; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A single oral dose study to investigate the PK and safety of olorofim in mild and moderately
      hepatically impaired subjects compared to subjects with normal hepatic function.
    


Intervention name(s): Olorofim
Intervention type(s): Drug
Intervention description(s): single oral dose
Other intervention name(s): F901318
Intervention MeSH terms: Olorofim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Using Mobile Phones to Improve Adherence to Inhaled Steroids
Condition: Asthma
Study type: Interventional

Summary: 
      This study has two main goals. The first goal is to test whether a mobile phone intervention
      can increase adherence to daily inhaled steroid medications in African American adolescents
      prescribed this type of medication by his/her asthma doctor. The second goal is to use a
      mobile phone intervention to better understand real life patterns of use of quick-relief
      (beta2-adrenergic agonist) asthma medication in this population.
    


Intervention name(s): Asthma Supervision; Mobile Phone; Inhaled Corticosteroid Mobile Phone Application; Beta2-adrenergic agonist Mobile Phone Application
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.; Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.; The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.; The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.
Intervention MeSH terms: Adrenergic Agents; Adrenergic Agonists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health Status Disparities; Minority Health; Pediatrics; Behavioral Intervention; Cellular Phone; Peer Group