bioihbjkbjnl/mcl2 huggingface dataset:
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the relationship between drug plasma levels and safety, tolerability and
      efficacy in patients with essential tremors after dosing with Sodium oxybate
    


Intervention name(s): Sodium Oxybate; Sodium Oxybate; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dose 1; Dose 2; Dose 3
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolomic Analysis of Lung Cancer
Condition: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Small Cell Lung Carcinoma
Study type: Observational

Summary: 
      The purpose of this study is to learn more about the metabolic properties of lung cancer
      cells.
    

Detailed description: 
      It has long been known that cancer cells absorb and break down substances in the body
      differently than healthy, non-cancer cells. This process of absorbing and breaking down
      substances is known as metabolism and is increased in cancer cells. Recent research suggests
      that this increased metabolic activity makes it easier for cancer cells to multiply. The
      objective of the study is to characterize the metabolism of glucose by lung tumors by serum
      metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in
      nature.
    

Intervention name(s): 13-C-glucose
Intervention type(s): Other
Intervention description(s): 10 grams of 13-C-glucose intravenously, as a 30-minute "piggyback" infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Group 1 (experimental group): 250 lung cancer patients undergoing surgery, with
             13-C-glucose infusion);

          -  Group 2 (control group): 250 lung cancer patients undergoing surgery, without
             13-C-glucose infusion); and

          -  Group 3 (healthy subjects): 250 subjects to provide 1 blood sample and 1 urine sample.
      
Keywords: lung cancer; non-small cell lung cancer; small cell lung cancer; cancer metabolism
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Carcinoma
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of nano drug interventional
      therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by
      mixing Gemzar® with Compound Glycyrrhizin Injection.
    

Detailed description: 
      By enrolling patients with lung cancer adapted to enrolled criteria, this study will document
      for the first time the safety and the short and long term efficacy of nano drug
      interventional therapy using digital subtraction angiography（DSA）for lung cancer.

      The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's
      size is detected by laser diffraction particle size analyzer.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): Lung cancer patients received drug interventional therapy using the digital subtraction angiography（DSA.）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Cancer; Nano drug
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
Condition: Avascular Necrosis of Hip; Osteoarthritis, Hip; Rheumatoid Arthritis; Inflammatory Arthritis; Post-traumatic; Arthrosis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Hip; Necrosis
Study type: Interventional

Summary: 
      The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the
      safety and efficacy of this device in the young and/or active patient with advanced hip
      disease.
    

Detailed description: 
      This is a multi-center, prospective, non-controlled post market surveillance study. The
      objective of this study is to obtain survival and outcome data on the Zimmer Hip Resurfacing
      System. This will be assessed by analysis of standard scoring systems, radiographs and
      adverse event records. Data will be used to monitor pain, mobility and survivorship, and to
      confirm the safety and efficacy of the Zimmer Hip Resurfacing System. Serum metal ion levels
      (cobalt and chromium) will also be collected pre-operatively and again at 6 months, 1 year, 2
      years and 5 years. This procedure will offer an option to these patients who would otherwise
      require and likely outlive a conventional total hip replacement.
    

Intervention name(s): Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
Intervention type(s): Diagnostic Test
Intervention description(s): Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
Intervention MeSH terms: Cobalt; Chromium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip resurfacing; Medical Device; Safety; Hip prosthesis
Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to look at safety aspects and effects of repeat inhaled doses of
      GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic
      obstructive pulmonary disease (COPD)
    


Intervention name(s): GW870086X; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times; Placebo matching GW870086X will be administered by subjects
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW870086X Asthma Crossover repeat dose inhaled
Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore changes in efficacy, cognitive functioning, and
      safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
    


Intervention name(s): Brexpiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally; Up to 20 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mental Disorders; Psychotic Disorders; Antipsychotic; Cognitive testing
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
Condition: Neoplasms
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as an open label, single-dose, explorative study with patients
      with histologically proven cancer and, preferably, tumor positive lesions in previously
      performed nuclear medicine imaging examinations.

      The investigational drug will be given as a single administration in a dose of </= 0.1 mg
      BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be
      approximately 8 days.
    


Intervention name(s): PET tracer (BAY94-9392)
Intervention type(s): Drug
Intervention description(s): A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostatic Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Melanoma; Neoplasm Metastasis
COVID-19 Treatment in South Africa
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory study is a randomized, single center, open label study of four different
      experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection
      in symptomatic outpatients with mild disease at the time of enrollment.
    

Detailed description: 
      This phase 2, exploratory study will be an adaptive, randomized, open label, trial for
      treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The
      primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs
      in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative
      swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety
      evaluation, progression to LRTI (defined by resting blood oxygen saturation level [SpO2] <93%
      sustained for two readings two hours apart and presence of subjective dyspnoea or cough),
      disease severity, clinical resolution rate, and cumulative incidence of hospitalization or
      mortality at Day 28.
    

Intervention name(s): Standard of care (Paracetamol); Artesunate-amodiaquine; Pyronaridine-artesunate; Favipiravir plus Nitazoxanide; Sofosbuvir/daclatasvir
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed; SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days; SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days; SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days; SOC plus sofosbuvir/daclatasvir (SOF/DCV)
1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days
Intervention MeSH terms: Acetaminophen; Sofosbuvir; Artesunate; Favipiravir; Pyronaridine tetraphosphate, artesunate drug combination; Amodiaquine; Nitazoxanide; Pyronaridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Pyramax; Pyronaridine; Artesunate; Chloroquine; Zinc; Amodiaquine; Favipiravir; Nitazoxanide; Sofosbuvir; Daclatasvir
Thermosoftening of Double-lumen Tube to Reduce Sore Throat
Condition: Hoarseness; Sore Throat; Vocal Cord Injuries
MeSH terms: Pharyngitis; Hoarseness; Dysphonia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of double-lumen tube thermosoftening
      before intubation to reduce postoperative hoarseness and sore throat.
    


Intervention name(s): non-thermosoftening; thermosoftening
Intervention type(s): Procedure; Procedure
Intervention description(s): Intubation is performed with a double-lumen tube put into normal saline at room temperature.; Intubation is performed with a double lumen tube put into warm normal saline (40°C).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: double-lumen tube; intubation; thermosoftening
A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics,
      safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of
      hepatic impairment and normal hepatic function.
    


Intervention name(s): Tivozanib hydrochloride
Intervention type(s): Drug
Intervention description(s): Single oral capsule 1.5 mg tivozanib hydrochloride
Intervention MeSH terms: Tivozanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety Study of a Refrigerator-stable Formulation of VARIVAX®
Condition: Varicella; Measles; Mumps; Rubella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first
      single dose injection in 12 to 15 month-old infants in the 42-day follow-up period
      post-vaccination.

      Secondary objectives: NA
    


Intervention name(s): VARIVAX®; M-M-RTM II
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Prevention of : Varicella; Measles; Mumps; Rubella
Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages
Condition: Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional

Summary: 
      The purpose of this trial will certify the efficacy of using staging acupuncture and
      moxibustion to treat Bell's Palsy
    

Detailed description: 
      The result of this trial (available in 2009) aims to testify the efficacy of using staging
      acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture
      treatment among these five different methods for treating Bell's Palsy
    

Intervention name(s): acupuncture; acupuncture and moxibustion; electroacupuncture; acupuncture along yangming tendons; acupuncture
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): staging acupuncture; staging acupuncture and moxibustion; staging electroacupuncture; staging acupuncture along Yangming musculature; non-staging acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral Facial Paralysis; Acupuncture; RCT
Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos
Condition: Meningitis, Meningococcal, Serogroup C
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial phase I, randomized, double blind, where 30 individuals will receive the
      experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate
      vaccine already licensed in Brazil and available in the National Immunization Program for
      children less than 12 months of age. The primary outcome of the study is to evaluate the
      safety profile of the vaccine under test, which should allow its application in humans.
      Secondly, the investigators will study its immunogenicity from the evaluation of the
      correlates of seroprotection for meningococcal, defined by the World Health Organization
      (WHO).
    

Detailed description: 
      Study design - This is a clinical study Phase I, randomized, double blind with 60
      individuals. 30 individuals will receive the experimental vaccine by Bio-Manguinhos/Fiocruz
      and 30 individuals will receive a meningococcal C conjugated vaccine used in the National
      Immunization Program.

      Location of Study - Clinical Trials Unit for Immunobiology by Bio-Manguinhos/Fiocruz.

      Primary objective - Evaluate the safety of the meningococcal C vaccine by
      Bio-Manguinhos/Fiocruz for use in humans.

      Secondary objective - To evaluate the immunogenicity of the meningococcal C vaccine by
      Bio-Manguinhos in young adults.

      specific objectives

        1. To evaluate the frequency / intensity of adverse events occurring up to 30 days after
           vaccination.

        2. To evaluate the seroconversion defined as pre-immunization serum nonreactive (negative)
           and post-immunization reactor (positive) antigens, with getting titles 8 (rabbit
           complement) to the target strain used in the test of bactericidal power of the sera from
           immunized volunteers, a 4-fold increase in titers following vaccination compared to
           pre-vaccination and antibody titers after immunization.
    

Intervention name(s): 'MenCC-Bio'; MENJUGATE
Intervention type(s): Biological; Biological
Intervention description(s): The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.; The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: meningococcal conjugate vaccine serogroup C; Prevention
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone
      sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
    


Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: opioid dependence
The Cognitive and Cerebral Blood Flow Effects of Resveratrol
Condition: Cognitive and Cerebral Blood Flow Effects of Resveratrol
Study type: Interventional

Summary: 
      Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by
      interacting with nitric oxide (NO). Research also shows that acute administration of
      metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance
      in young, healthy humans. The aim of this investigation was to determine if the consumption
      of resveratrol could modulate cerebral blood flow and if this in turn could influence
      cognitive performance by increasing access to blood borne metabolic fuel. Results showed that
      compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total
      haemoglobin were significantly higher in the frontal cortex of young, healthy participants
      during cognitive task completion. Cognitive performance was not effected.
    


Intervention name(s): Trans- resveratrol; Placebo (silica)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.; All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.
Other intervention name(s): Transmax from Biotivia.; Pharmaceutical grade silica
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: resveratrol; cerebral blood flow; NIRS; cognitive performance
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Condition: Globus Pharyngeus
MeSH terms: Globus Sensation
Study type: Observational

Summary: 
      It is well known that 'globus sensation in throat' is caused by the chronic irritation and
      inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and
      chronic postnasal drip.

      Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal
      change of the oral cavity and pharynx.

      However, no previous studies have documented the prevalence of salivary hypofunction in
      patients with globus pharyngeus.

      Through this clinical investigation, we hypothesized that the salivary hypofunction might be
      one of the leading cause of globus pharyngeus.
    

Detailed description: 
      Subjects: patients with symptoms of globus pharyngeus

      Globus symptom scoring: 0(mild) to 5(severe)

      Subjective symptom analysis by "Standard Table for Xerostomia and Pharyngoxerosis"

      Subjective physical finding analysis by "Standard Table for Xerostomia and Pharyngoxerosis"

      Objective analysis of Salivary function by 99m-Tc Salivary scintigraphy

      --> Define the prevalence of salivary hypofunction in patients with globus pharyngeus
      (Primary end point)

      Subsequent analysis (Secondary end point)

        1. Group 1: Globus patients with objective salivary hypofunction

        2. Group 2: Globus patients with normal salivary function

      Intervention: Active management for xerostomia (Moisturizing, Gargling, Humidification,
      Massage of salivary gland, Stimulant of salivary secretion, Artificial saliva)

      Evaluation of the change of globus symptoms after active management of xerostomia between the
      Group 1 and Group 2 (at 1 months, at 3 months after the initiation of intervention)
    

Intervention name(s): Conservative management for xerostomia
Intervention type(s): Behavioral
Intervention description(s): Active hydration (drinking more than 10 cups of water per day), Humidification, Oral gargle with a diluted (0.05% to 0.1%) chlorhexidine solution, Sugarless chewing gum, Saliva-stimulating sour juice (sugarless orange juice), Commercial artificial saliva, Nasal saline spray 3 to 4 times a day, Warm massage of the 4 major salivary glands.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Globus phryngeus patients (complaining foreign body sensation in the throat, but not having
        true mass lesions)
      
Keywords: Globus Pharyngeus; Xerostomia; Salivary Hypofunction; Pharyngoxerosis