bioihbjkbjnl/mcl2 huggingface dataset:
Structured Aerobic and Resistance Exercise and Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various
      degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize
      glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is
      recommended to continue or initiate exercising with moderate intensity. However, available
      data on the effects of physical activity on GDM are based on a small number of trials. The
      aim of the trial is to examine and add new scientific evidence on possible health-related
      effects of application of structured programme consisting of aerobic and resistance exercises
      on the course and outcomes of GDM. Primary goal of research is to determine how proposed
      exercise programme effects glycaemic control, rate of complications during pregnancy, labour,
      delivery, immediate after delivery and health status of newborn. Main hypothesis is that
      parameters of glycaemic control, course of GDM, complications during delivery and birth
      outcomes directly and significantly correlate with participation in structured programme of
      exercise. Research will be conducted as experimentally designed randomized controlled trial.
      Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without
      comorbidities. Women in the experimental group will be included in exercise programme two
      times per week with duration of 50 minutes. Training sessions will start right after the
      diagnosis and will be performed until the end of the pregnancy. The training protocol will
      follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011).
      Women in the control group will receive standard medical care.
    


Intervention name(s): Structured Exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: GDM; Exercise; Diabetes; Pregnancy
The Effect of Triflusal on Peripheral Microcirculation Dysfunction
Condition: Vasospastic Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation
      dysfunction. Triflusal is a salicylate compound approved in several countries as
      antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to
      explore if there is a improvement of peripheral microcirculation by triflusal.
    


Intervention name(s): Triflusal; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.; Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
Other intervention name(s): Disgren®; Astrix
Intervention MeSH terms: Aspirin; Triflusal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vasospastic syndrome; Vascular dysregulation
Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The Primary Objective is to evaluate the progression-free survival (PFS).

      The secondary objectives are:

        -  To compare the disease control rates of different doses of Docetaxel+Cisplatin as
           first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST)
           criteria;

        -  To evaluate the overall response rate (ORR);

        -  To evaluate the time to disease progression (TTP);

        -  To evaluate the overall survival (OS);

        -  To evaluate the toxicity.
    

Detailed description: 
      The study consists in:

        -  A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle
           contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or
           docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) ,

        -  A maintenance treatment phase: participants with disease control (complete response
           [CR], partial response [PR] or stable disease [SD]) after the initial treatment receive
           up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC).

        -  A follow-up period from the end of study treatment until participant death or end of
           study.
    

Intervention name(s): Docetaxel; Cisplatin; Best supportive care (BSC)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Formulation: concentrated solution for intravenous infusion (IV)
Route(s) of administration: 1-hour IV; Formulation: concentrated solution for intravenous infusion (IV)
Route(s) of administration: 1-3-hour IV; Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
Other intervention name(s): Taxotere®
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
Condition: Bronchitis, COPD
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to examine the clinical efficacy of synatura in patients with chronic
      bronchitis type COPD in Korea.
    

Detailed description: 
      Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper
      respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III
      studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and
      expectorant effects were confirmed in patients with acute upper respiratory infection and
      chronic inflammatory bronchitis. However, no studies have been conducted for the effects of
      Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis
      type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore,
      Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients
      with chronic bronchitis accompanied by COPD.
    

Intervention name(s): Synatura® 15 mL
Intervention type(s): Drug
Intervention description(s): All subjects will receive Synatura® 15 mL every day three times for 3 months.
Other intervention name(s): AG NPP709
Intervention model: Single Group Assignment
Intervention model description: Experimental(Single arm):
The enrolled patients will be prescribed Synatura® following measurement of pre-dose pulmonary functions, quality of life and systemic inflammatory state. Pulmonary functions, quality of life and systemic inflammatory state will be repeatedly measured after taking Synatura® for 3 months, and the changes from pre-dose measurements will be observed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Synatura; Chronic Obstructive Pulmonary Disease; Ahn Gook Pharmaceuticals
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet
      under fasted conditions.
    


Intervention name(s): buprenorphine hydrochloride
Intervention type(s): Drug
Intervention description(s): single dose 8 mg sublingual tablet
Other intervention name(s): SUBUTEX
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Relief for Thrombosed External Haemorrhoids
Condition: Thrombosed External Hemorrhoid
MeSH terms: Hemorrhoids; Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Thrombosed external haemorrhoids are one of the most frequent anorectal emergencies. They are
      associated with swelling and intense pain. This study evaluated the efficacy and safety of an
      intersphincteric injection of botulinum toxin for pain relief in patients with thrombosed
      external haemorrhoids
    

Detailed description: 
      Background: Thrombosed external haemorrhoids are one of the most frequent anorectal
      emergencies. They are associated with swelling and intense pain. Internal sphincter
      hypertonicity plays a role in the aetiology of the pain. This study evaluated the efficacy
      and safety of an intersphincteric injection of botulinum toxin for pain relief in patients
      with thrombosed external haemorrhoids. Methods: Thirty patients with thrombosed external
      haemorrhoids who refused surgical operation were randomized into two groups. Patients
      received an intrasphincteric injection of either 0·6 ml saline or 0·6 ml of a solution
      containing 30 units botulinum toxin. Anorectal manometry was performed before treatment and 5
      days afterwards.Results: After 5 days of treatment, the maximum resting pressure fell in both
      groups, but was significantly lower in the botulinum toxin group (P = 0·004). Pain intensity
      was significantly reduced within 24 h of botulinum toxin treatment (P < 0·001), but only
      after 1 week in the placebo group (P = 0·019). Conclusion: A single injection of botulinum
      toxin into the anal sphincter seems to be effective in rapidly controlling the pain
      associated with thrombosed external haemorrhoids, and could represent an effective
      conservative treatment for this •condition.
    

Intervention name(s): injection of botulinum toxin; injection of saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received a 0·6-ml injection of a solution containing 30 units botulinum toxin into the internal anal sphincter; Patients received a 0·6-ml injection of a saline solution into the internal anal sphincter
Other intervention name(s): botox injection; saline injection
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: botulinum toxin; thrombosed external haemorrhoids; pain
Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intravenous lidocaine infusion during a
      video-assisted chest surgery is effective in reducing the pain involved after the surgery.
      The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic
      surgery (VATS) reduces morphine consumption and postoperative pain.
    

Detailed description: 
      Despite newer surgical techniques, many patients still experience moderate to severe
      postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often
      associated with severe postoperative pain. To relieve the pain, potent narcotics have to be
      used, which have many side effects. Surgical patients would therefore benefit from an
      intra-operative analgesic regimen that is safe and effective, has minimal side effects and
      can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown
      previously to relieve cancer pain, chronic pain, and pain after other types of surgery.
    

Intervention name(s): Lidocaine Infusion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of lidocaine 3mg/min or 2mg/min during surgery; Saline Infusion at same rate as experimental arm
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: video-assisted; thoracic surgery; VATS; lidocaine infusion; VATS procedures
A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination
      with either famotidine or omeprazole in healthy participants under fed conditions.
    


Intervention name(s): AMG 510; Omeprazole; Famotidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Tablet; Capsule; Tablet
Other intervention name(s): Sotorasib
Intervention MeSH terms: Sotorasib; Omeprazole; Famotidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; AMG 510; Famotidine; Omeprazole
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      People who are infected with the influenza virus may develop respiratory illnesses, such as
      pneumonia, or other life-threatening complications. Currently, there are four antiviral
      medications that are used to treat influenza. This study will examine one of these
      medications, oseltamivir, to examine how it affects the shedding of influenza virus in
      infected people.
    

Detailed description: 
      Seasonal influenza is responsible for excess hospitalizations and, despite effective
      antivirals, causes significant morbidity and mortality (about 24,000 deaths each year in the
      United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1)
      caused fewer deaths (12,000 flu-related deaths in the U.S.) but in contrast to seasonal flu,
      nearly 90% of the deaths with the 2009 H1N1 occurred among people younger than 65 years of
      age. Although there are four currently licensed anti-influenza medications (amantadine and
      rimantadine, oseltamivir, and zanamivir), previous studies have not demonstrated conclusively
      to what extent these medications affect influenza viral shedding. This study will evaluate
      whether oseltamivir modifies the viral shedding during the treatment of uncomplicated
      influenza in an adult population and also assess methods to detect viral replication in the
      upper respiratory tract.

      Subjects who presented with an influenza-like illness without any risk factors for severe
      disease were screened for the study. Those with a confirmatory test for influenza (rapid
      antigen or polymerase chain reaction [PCR]) were randomized in a 1:1 manner to receive a
      blinded study treatment consisting of either the oseltamivir or placebo for 5 days. Clinical,
      virologic, and laboratory assessments on Days 1, 3, 7, and 28 were used for both safety and
      efficacy analysis.
    

Intervention name(s): Oseltamivir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.; Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: H1N1; Complications; PCR; Seasonal Influenza; Viral Shedding
Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
Condition: Ventricular Tachycardia; Sudden Cardiac Death
MeSH terms: Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac; Death
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and
      docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and
      ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into
      cellular membranes after regular ingestion of fatty fish or fish oil.

      This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on
      inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.

      The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase
      the electric stability of the myocardial cells, so that VT is more difficult to induce.

      In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a
      high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously
      before a non-invasive electrophysiologic examination performed via the ICD and following a
      predefined protocol.

      The main outcome is inducibility of VT. If sustained VT is induced in a patient after both
      n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo
      is compared.
    


Intervention name(s): Omegaven; Isotonic saline
Intervention type(s): Drug; Drug
Intervention description(s): Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h); Intravenous infusion, 100 mL, 25mL/h
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: ICD-pacemaker
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
Condition: ICU Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous
      IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years
      old] requiring sedation under intensive care unit
    


Intervention name(s): Dexmedetomidine hydrochloride
Intervention type(s): Drug
Intervention description(s): 45 weeks CGA to < 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state
6 years old to < 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The China-Anhui Birth Cohort Study (C-ABCS)
Condition: Environmental Exposures; Other Pregnancy With Abortive Outcome; Birth Defects; Children Development
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The China-Anhui Birth Cohort Study (C-ABCS) was set up to examine the delayed, cumulative and
      interactive effects of maternal environmental exposures on birth outcomes and children's
      development. The C-ABCS recruited pregnant women from six major cities of Anhui province,
      China, between November 2008 and October 2010. A range of data (including demographic,
      obstetric, occupational, nutritional and psychosocial factors) were collected by both
      interviews and laboratory tests. In each trimester, women's blood samples were drawn, and
      pregnancy complications were abstracted from physician's medical records. By the end of 2011,
      birth outcomes/birth defects were observed/identified by clinicians within 12 months after
      the delivery of 11 421 singleton live births of six cities and those outcomes among the
      remaining 2033 live births are still being observed. In addition, 4668 children from
      Ma'anshan city will be further followed up during the pre-school period till they reach
      adolescence to obtain the data on familial environmental exposures as well as children's
      physical, psychological, behavioural and sexual development. The interview data and
      information on laboratory examinations are available on request from archives in the Anhui
      Provincial Key Laboratory of Population Health & Aristogenics.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The China-Anhui Birth Cohort Study (C-ABCS) is a prospective population-based cohort study
        that recruited 16766 pregnant women from six major cities of Anhui province in China
        between November 2008 and October 2010. Six cities were selected for study sites, including
        Hefei, Ma'anshan, Wuhu, Jieshou, Lu'an and Ningguo. Anhui province is located in the
        south-east of China. Its socio-economic development is ranked at the mid-level in China.
        Six cities were selected according to their social and geographic characteristics. These
        cities are located in Central, Southern and Northern regions of Anhui Province and may
        represent socio-economic, geographic and cultural variations. In addition, strong local
        support was one of the important factors to consider in selecting these cities.
      
Keywords: birth cohort study; environmental exposures; birth defects; pregnant outcomes; children development
Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new
      therapeutical strategies are needed. The symptomatic treatment with topical and systemic
      antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has
      immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative
      properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new
      relevant therapeutical agent.
    


Intervention name(s): Mutaflor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule contains 2.5 - 25 billion viable bacteria of the strain E. coli Nissle 1917, 1 capsule daily over the first 4 days, 2 capsules daily until the end of treatment; 1 placebo capsule matching the experimental treatment, according to the experimental arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: E.coli; Mutaflor; grass pollen; rhinoconjunctivitis; rhinoconjunctivitis caused by grass pollen