bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Anti TNFa Upon Deep Endometriosis Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Deep endometriosis associated pain is believed to be caused by inflammation. Anti TNFa has
      been proved to be an effective treatment for other inflammation related conditions as Crohn's
      disease Endometriosis is associated with an inflammatory response in the pelvis, which is
      mediated by a number of cytokines including TNF-α. It has therefore been suggested that
      infliximab, an anti-TNF-α monoclonal antibody, might relieve pain in affected women.
    

Detailed description: 
      In this pilot study, 21 women with severe endometriosis-associated pain and a rectovaginal
      nodule, at least 1 cm in diameter on clinical examination, were randomised in a 2 to 1 ratio
      to receive intravenous infliximab (n=14) or placebo (n=7) in the three months prior to
      laparoscopic laser excision of the nodule.

      After a 1 month observation period, all women received three infusions of infliximab (5mg/kg)
      or placebo over the course of 6 weeks. Surgery was performed 3 months later and follow-up
      continued for a further 6 months. The primary endpoint was the total pain burden
      (dysmenorrhoea, deep dyspareunia and non-menstrual pain) rated on a daily basis by the
      patient using standard pain scales and analgesic intake as the outcome measures . Secondary
      endpoints included the volume of the endometriotic nodule assessed clinically and on
      transvaginal ultrasound, the amount of pelvic tenderness on clinical examination and the
      presence of other endometriotic lesions at laparoscopy.
    

Intervention name(s): anti TNFa monoclonal antibody - Infliximab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Chimeric A2 (infliximab, RemicadeTM) IgG ; 100 mg infliximab IgG, Infliximab was freshly prepared immediately before each administration. Infliximab or placebo was administered as a slow infusion of 250mL on weeks 0, 2 and 6. Women were closely observed during, and for 1 hour after, the infusion in the event of any serious adverse reactions.; Placebo
Intervention MeSH terms: Infliximab; Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep endometriosis; pelvic pain; infliximab; anti TNFa
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Condition: Mycobacterium Infections, Atypical
MeSH terms: Infections; Communicable Diseases; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous
Study type: Observational

Summary: 
      To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients
      with Non-tuberculous Mycobacterial Pulmonary Infections.
    

Detailed description: 
      Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America
      guidelines recommend a clarithromycin-based combination therapy for treatment of
      Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of
      continuous treatment after bacilli negative conversion. However, supporting data are
      insufficient.

      Objectives: To obtain data on the clinical outcome of clarithromycin-based regimens by
      conducting a nationwide prospective study mainly of MAC lung disease.

      Methods: In accordance with the guidelines, patients were enrolled in this survey according
      to their chest radiographic findings and microbiologic test results. They were treated with a
      multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin
      -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data
      were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months
      after the end of treatment."
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for
        treatment with Klaricid
      
Keywords: Mycobacterium Infections, Atypical
Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In
      immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may
      be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease.
      Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a
      high associated morbidity. Following acute disease, patients enter into an indeterminate
      phase which can last 10-20 years. The earliest sign of cardiac involvement usually is
      electrocardiogram abnormalities. The most common abnormality is right bundle branch block
      (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block
      (LBBB). Recent studies have shown that treatment of patients at this stage with
      antiparasitics may delay the progression of overt cardiomyopathy.

      At the University of California, Los Angeles, there is a large population of immigrant
      patients from countries endemic to Chagas disease. The researchers propose that screening
      patients with conduction abnormalities on electrocardiogram may be a potentially useful
      method to identify patients with early cardiac manifestations of Chagas disease. The
      researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on
      electrocardiogram to determine the incidence of Chagas disease in this patient population.
    


Intervention name(s): Trypanosoma cruzi serology
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Latin American immigrant patients with newly diagnosed nonischemic cardiomyopathy at
        one U.S. medical center were asked to participate in this study.
      
Keywords: chagas; trypanosoma cruzi
Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the study is to evaluate the bioequivalence of a new formulation of
      ibuprofen 400 mg/10 mL oral suspension vs. the marketed reference product MOMENTACT 400 mg
      film-coated tablet, when administered under fasting conditions as single oral dose to healthy
      male and female volunteers, in two consecutive study periods.
    


Intervention name(s): Ibuprofen 400 mg/10 mL oral suspension; MOMENT 400 mg coated tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Ibuprofen 400 mg/5 ml; Moment 400 mg coated tablet; Oral Suspension
Single Dose Monurol for Treatment of Acute Cystitis
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Cystitis
Study type: Interventional

Summary: 
      Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting
      approximately one-half of women by their late 20's. One of the most common antibiotics used
      to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days.
      However, concerns about increased antibiotic resistance have led to increased interest in
      studying other antibiotics for UTI.

      An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin
      (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not
      well studied. The purpose of this research study is to determine what the cure rates are with
      a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.
    

Detailed description: 
      Procedures subjects will undergo once they have read and signed the consent are:

      Questions about their medical and sexual history and current symptoms of UTI. They will be
      asked to provide a urine and peri-urethral sample and then are randomly assigned to one of
      the two treatment groups.They will be given a sheet to record symptoms at home. They will be
      asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic
      therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected
      at each visit.
    

Intervention name(s): TMP/SMX; Fosfomycin
Intervention type(s): Drug; Drug
Intervention description(s): Take one twice daily for 3 days for urinary tract infection; Mix sachet with 1/2 glass cold water and stir. Drink immediately
Other intervention name(s): Septra; Bactrim; Monurol
Intervention MeSH terms: Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UTI
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Condition: Safety Issues
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in
      Indonesian Population
    

Detailed description: 
      To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after
      immunization in Indonesian population.

      To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects
    

Intervention name(s): Quadrivalent Influenza Vaccine; Trivalent Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age; 1 dose of Trivalent Influenza Vaccine
Other intervention name(s): QIV; TIV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      The study is examining if an over-the-counter device (Theravent) worn while sleeping can
      reduce acute mountain sickness upon awakening in a high altitude trekking population.
    

Detailed description: 
      The specific aim of this study is to evaluate if an inexpensive and disposable end-expiratory
      pressure device can prevent acute mountain sickness (AMS). AMS is a common disorder found in
      25-75% of hikers and trekkers in N. America and Europe who expediently ascend high altitude
      (>8,000 ft). This environmental malady is insidious in onset and prevention is necessary not
      just to limit progression to severe or fatal disease, but also to limit physiologic
      deterioration in those who seek enjoyment or employment at high altitudes. One of the
      hallmarks of both healthy and sick individuals sleeping at high altitude is an oscillating
      pattern of respiration marked by periods of hyperventilation alternating with apnea or
      hypopnea. This distressing "periodic breathing" pattern leads to a feeling of suffocation,
      prevents restful sleep, and the hypoxic events may well worsen ensuing AMS. Prior studies
      have found positive end-expiratory pressure (PEEP) an effective non-pharmacologic method to
      prevent nocturnal desaturations and decreasing both AMS incidence and severity.

      Traditionally, PEEP devices are cumbersome and expensive, and while showing promising
      efficacy, are limited by both cost and portability as a useful non-pharmacologic option for
      AMS prophylaxis. The SLEEP-AID methodology is designed to prospectively enroll participants,
      randomized in a double blind placebo-controlled fashion to either the intervention [Theravent
      (Ventus Medical) which is single use, inexpensive, and very small] or a visually identical
      "sham" placebo group, and gather physiologic data to accurately reflect sleep patterns of
      high altitude travelers and objective as well as subjective outcomes of the intervention. The
      benefit of this approach will be to provide definitive data in a large and diverse cross
      section of a real hiking population that is generalizable to the majority of tens of millions
      of hikers, climbers, and high altitude tourists in the United States, Europe, Asia, and South
      America.
    

Intervention name(s): Theravent; Control
Intervention type(s): Device; Device
Intervention description(s): nasal EPAP device; Sham device without EPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: positive end expiratory pressure; acute mountain sickness; prevention; high altitude
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Cardiovascular Risk
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging
      lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic
      patient involvement in the preventive decision with the help of a decision aid has an impact
      on cardiovascular (CV) risk reduction superior to usual care.

      METHOD: The design is a cluster randomised clinical trial. Participants are
      hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of
      Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are
      excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is
      by doctor. Intervention group will receive information about their CV risk and the risk and
      benefits of different preventive measures. They will have access to a decission aid that will
      help them in the choice of the preventive measures.The material (printed and software) is
      adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and
      DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective
      health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment,
      treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month
      assessment. The study, financed by FIS, will begin the 01-07-2007.

      RESULTS: The expected results are a higher reduction on the CV risk factors in the
      intervention group versus regular care.

      CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
    


Intervention name(s): Share decision tool
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cardiovascular diseases; patient education; primary health care; consumer participation; decision aids
THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING
Condition: Web-based Breastfeeding Counseling
Study type: Interventional

Summary: 
      This randomized controlled study evaluates the effect of Web-Based Breastfeeding Counseling
      given to mothers on breastfeeding exclusively with breast milk in the first 6 months,
      breastfeeding motivation and breastfeeding problems.The main hypotheses it aims to answer
      are:

        1. The web-based breastfeeding counseling given to the mothers in the experimental group is
           effective on the breastfeeding only for the first six months.

        2. The web-based breastfeeding counseling given to the mothers in the experimental group is
           effective on the breastfeeding motivation of the mothers.

        3. The web-based breastfeeding counseling given to the mothers in the experimental group is
           effective on the breastfeeding problems of the mothers.
    

Detailed description: 
      In the study, 66 mother will randomly assigned to web-based breastfeeding
      counseling/experimental group and control group. To the web-based breastfeeding
      counseling/experimental group (n =33), during the first 6 months after birth, they will be
      directed to the web-based breastfeeding consultancy website. On this page, mothers will
      receive counseling on breastfeeding (written, visual, audio materials and telephone
      counseling) from birth. On the other hand, no other intervention will be applied to the
      control group other than routine treatment and midwifery care. The primary outcome of the
      research is the effect of web-based breastfeeding counseling on the breastfeeding only for
      the first six months of mothers. The secondary outcome of the study is to determine the
      effect of web-based breastfeeding counseling on the breastfeeding motivation of the mothers.
      The tertiary outcome of the study is to determine the effect of web-based breastfeeding
      counseling on the breastfeeding problems of the mothers.
    

Intervention name(s): The web-based breastfeeding counseling
Intervention type(s): Other
Intervention description(s): To the web-based breastfeeding counseling/experimental group (n =33), during the first 6 months after birth, they will be directed to the web-based breastfeeding consultancy website. On this page, mothers will receive counseling on breastfeeding (written, visual, audio materials and telephone counseling) from birth. In addition, the Web-based breastfeeding counseling/experimental group will fill out data collection forms in the first 24 hours, 1st, 2nd, 4th and 6th months after delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breastfeeding counseling; Breastfeeding motivation; Web-based; Breast milk; Breastfeeding problems
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well the vaccine is tolerated at sites where
      administrations are given and any effects it may have on subjects' wellbeing. The study will
      also test the ability of vaccine to cause particular immune responses in the body.
    

Detailed description: 
      Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads
      around the world in seasonal epidemics, killing hundreds of thousands of people and having
      high economic consequences due to healthcare costs and lost productivity. Each year
      governments recommend groups who are at risk of influenza or its complications to receive
      influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this
      recommendation were to be taken up by all. This study is part of the clinical development of
      a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of
      influenza.This study will investigate the safety and tolerability of this vaccine as well as
      assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.
    

Intervention name(s): Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: PowderMed, DNA vaccine, influenza
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Condition: Tumor; Cancer Pain; Breakthrough Cancer Pain; Neuropathic Pain
MeSH terms: Neuralgia; Cancer Pain
Study type: Observational

Summary: 
      The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs
      either spontaneously, or in relation to a specific predictable or unpredictable trigger,
      despite relatively stable and adequately controlled background pain".

      The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer
      pain). The prevalence of BTcP is equal to 56%.

      Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in
      the three sub-types: voluntary, non- voluntary and procedural.

      The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe
      changes in the intensity of pain during the day, so it is necessary to differentiate slight
      fluctuations from the presence of real episodes of BTCP, for which is necessary to use a
      rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm,
      present in the literature, to perform the diagnosis of BTCP.

      In the presence of BTCP, is important both a correct controlled background pain with major
      opioids, which can reduce the number and the intensity of the painful episodes, both
      implement an adjunctive therapy, called "rescue", to be administered at the time which takes
      over the painful episode using, in this case, an opioid greater.
    


Intervention name(s): Morphine; Fentanyl; Methadone; Buprenorphine; Oxycodone; Hydromorphone; Tapentadol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Fentanyl; Morphine; Oxycodone; Buprenorphine; Methadone; Hydromorphone; Tapentadol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study involves a longitudinal evaluation of BTCP in cancer patients with pain, through
        a follow-up of 4 weeks, which will examine in a dynamic clinical aspects (variation over
        time of the number and duration of episodes, painful intensity, changes in ATC and rescue
        therapy).
      
Keywords: Breakthrough cancer pain; Neuropathic pain; Major opioid; Analgesics