bioihbjkbjnl/mcl2 huggingface dataset:
Liposomal Amphotericin in Disseminated Leishmaniasis
Condition: Disseminated Leishmaniasis
MeSH terms: Leishmaniasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with
      increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular
      and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of
      lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40%
      of the cases.

      DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been
      documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte
      de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of
      high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to
      relevant drug toxicity, high morbidity due to a long lasting disease, with an important
      socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate
      than historic cure rates of pentavalent antimony in the treatment of disseminated
      leishmaniasis.
    


Intervention name(s): Liposomal Amphotericin B
Intervention type(s): Drug
Intervention description(s): Liposomal Amphotericin B will be administered by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment. Complete hemogram, aminotransferases (AST, ALT), blood urea and creatinine will be determined in all patients on days -1, and three times/week up to the end of therapy. Patients will bemonitored for side effects daily. Patients will be followed-up at 1, 2, 3, 4 and 6 months post-therapy. Clinical and laboratory adverse events will be graded according to the Common Toxicity Criteria (CTC) of the National Cancer Institute.
Other intervention name(s): Ambisome
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Disseminated leishmaniasis; Liposomal Amphotericin B; Leishmania braziliensis
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of exercise in comparison to wellness
      education to determine if they can improve the effects of prolonged exposure therapy (PE) in
      reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In
      addition, the two strategies (i.e., exercise and wellness education) will be compared in
      terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF).
      BDNF is a protein that helps to support the survival of existing neurons and stimulate the
      growth new neurons and synapses. BDNF is important to learning and memory in general and
      therefore may be associated with the learning and memory as it relates to PE and
      corresponding symptom PTSD improvement.
    


Intervention name(s): Prolonged Exposure; Exercise; Wellness Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders; 30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure; 30 minutes of wellness education prior to Prolonged Exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Anxiety; Behavior Therapy; Prolonged Exposure; Exercise; Wellness; Posttraumatic; Stress
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit
      vaccine administered at 0 and 2 months.
    


Intervention name(s): 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a); 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)
Intervention type(s): Biological; Biological
Intervention description(s): o,5 mL suspension for injection x 2 with 2 months interval; o,5 mL suspension for injection x 2 with 2 months interval
Other intervention name(s): Antigen H1 + adjuvant IC31; Antigen H1 + adjuvant IC31
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Ag85B; ESAT-6; IC31
Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome
Condition: NEPHROSIS, LIPOID
MeSH terms: Infections; Virus Diseases; Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid
Study type: Observational

Summary: 
      The primary purpose of the study is to evaluate the association of a latent infection of
      lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The
      thirty nine units of general pediatrics and pediatric nephrite covering the parisian area
      will participate to the study. We speculate that hybridization of the genome, or a part of
      the genome, of a virus in lymphoid cells is responsible specific changes of genes expression,
      leading to the development of the disease.
    

Detailed description: 
      An additional blood volume will be sampled in patients and controls during a scheduled
      biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well
      as adenovirus will be searched for using PCR reaction in total blood DNA extract. The
      frequency of a latent hybridization of virus genome within human genome will be compared
      between patients with steroid sensitive nephrotic syndrome and controls matched for age and
      sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients
      according to the occurence of a latent viral hybridization, the epidemiology of idiopathic
      nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity
      and dependency. If necessary, the chromosomal localization of viral hybridization will be
      studied with fluorescence in situ hybridization using specific probes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        From the thirty nine units of general pediatrics and pediatric nephrology covering the
        Parisian area
      
Biospecimen description: 
      whole blood, serum, red cells and DNA
    
Keywords: LATENT VIRAL INFECTION; GENOME HYBRIDIZATION; HERPES VIRUS; ADENOVIRUS
Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA
Condition: Unilateral Primary Osteoarthritis of Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the clinical outcome of the two different, but widely
      used, surgical approaches (Posterior approach and Lateral approach) of primary total hip
      arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main
      study and two sub-studies. The main study investigates the patient-reported outcome measures
      (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the
      level of physical function and pain within the first 3 month after surgery, and ii)
      investigate the potential difference the two approaches have on gait-patterns and maximal
      isometric hip-muscle-strength, within the first year after surgery. Both approaches are
      described with potential drawbacks. Posterior approach has a higher risk of dislocation of
      the prostheses and revision due to dislocation compared with Lateral approach. Contrary,
      Lateral approach is described with the potential drawbacks of pain, lower physical function,
      gait abnormalities and muscle weakness, leading to less satisfied patients. However,
      according to a Cochrane analysis from 2004 concludes, more investigation is needed to
      determine the extent of differences.
    


Intervention name(s): Total hip arthroplasty
Intervention type(s): Procedure
Intervention description(s): The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Controlled Clinical Trial; Operative Surgical Procedures; Treatment Outcome; Pain Measurement; Quality of Life; Questionnaires/standards; Activities of Daily Living; Biomechanics; Gait*; Hip Joint/physiology*; Hip Joint/surgery*; Recovery of Function/physiology
Tobacco Status Project: Social Media Intervention for Young Adult Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      This randomized clinical trial will test the efficacy of a Facebook intervention based on the
      Transtheoretical Model (Prochaska and DiClemente) and US Public Health Service Clinical
      Practice Guidelines with young adults who smoke cigarettes who are age 18 to 25 (N=480).
    

Detailed description: 
      Participants will be randomized to one of two conditions: (1) a Facebook-delivered
      intervention tailored to readiness to quit smoking; or (2) the control condition (referral to
      the Smokefree.gov website). The intervention will include 12 weeks of Facebook-based messages
      and activities tailored to participants' stage of change.

      Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include
      measures on smoking patterns and thoughts about abstinence. All participants who report no
      past 7-day smoking will be asked to give biochemical verification of smoking status with
      saliva cotinine test kits that will be mailed to participants.
    

Intervention name(s): Facebook intervention; Smokefree.gov
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 90 days of Facebook messaging, weekly Ask the Doctor sessions; referral to the NCI Smokefree.gov website
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco; cigarettes; cessation; intervention; young adults; Internet; social media; mobile health
Study Evaluating The Effect of Bosutinib (SKI-606) On Cardiac Repolarization (Rhythms Of The Heart)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of SKI-606 on rhythms of the heart
      (cardiac repolarization)
    


Intervention name(s): SKI-606; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Bosutinib
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AST-120 Used to Treat Mild Hepatic Encephalopathy
Condition: Mild Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether AST-120 is safe and effective in the
      treatment of mild hepatic encephalopathy.
    


Intervention name(s): AST-120
Intervention type(s): Drug
Intervention description(s): AST-120
Other intervention name(s): Spherical carbon adsorbent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatic encephalopathy; Mild hepatic encephalopathy; HE; MHE; Cognitive impairment; Cognitive dysfunction; Liver Disease; Cirrhosis
Pharmacokinetics of Tenofovir, Emtricitabine, Maraviroc, and Raltegravir in Cervical, Vaginal, and Rectal Tissues and Secretions
Condition: Healthy Adult Females
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop a predictive antiretroviral pharmacokinetic model of
      mucosal fluid and tissue distribution in genital tract fluid, rectal fluid and 3 mucosal
      tissues. This will be accomplished by determining the pharmacokinetic disposition and dose
      proportionality of four antiretrovirals (tenofovir, emtricitabine, maraviroc, and
      raltegravir) in human rectal and cervicovaginal fluid and rectal, cervical, and vaginal
      tissue.
    


Intervention name(s): Pharmacokinetic Sampling
Intervention type(s): Other
Intervention description(s): Blood plasma, Rectal, Cervical, and Vaginal Tissues and Secretions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy; Female; Volunteer
Endoscopic Findings in Patients With Typical Gastroesophageal Reflux Disease (GERD) Symptoms
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      Gastroesophageal reflux disease (GERD) is diagnosed on the basis of characteristic reflux
      symptoms (i.e. troublesome heartburn and/or acid regurgitation). Empirical therapy without
      diagnostic endoscopy is suggested for those GERD patients presenting without alarm symptoms
      in Western countries. Whether such "treating instead of testing" strategy should be applied
      in Asia, an area with higher prevalence of Helicobacter pylori and gastric cancer, remains
      uninvestigated.
    

Detailed description: 
      This study amis to investigate upper endoscopic findings of typical acid reflux patients with
      and without alarm symptoms in Taiwan During the period from May 2008 to December 2009,
      consecutive adult outpatients, who receive upper endoscopy for characteristic reflux symptoms
      of heartburn or acid regurgitation, are invited to participate. All study participants are
      evaluated for presence of pre-defined alarm symptoms including odynophagia or dysphagia,
      gastrointestinal bleeding, involuntary body weight loss and anemia.

      Upper endoscopic procedures are performed with standard electronic videoendoscope (GIF-Q240
      or GIF-Q260; Olympus, Tokyo, Japan) by experienced endoscopists; each of them had previously
      performed a minimum of 2,000 upper endoscopy exams. Representative images are taken and
      stored as electronic files in a digital image system for later analysis.

      The following five significant endoscopic findings are pre-defined endpoints of this study:
      1) any malignant lesion in the upper digestive tract, 2) Barrett esophagus, 3) severe erosive
      esophagitis (LA grade C or D), 4) peptic stricture, 5) peptic ulcer.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adult outpatients with characteristic GERD symptoms, in a district general hospital
      
Keywords: Gastroesophageal reflux disease; Alarm symptoms; Gastrointestinal endoscopy
Gadofosveset Trisodium for Heart Imaging Studies
Condition: Obstructive Coronary Artery Disease; Coronary Arteriosclerosis; Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis
Study type: Observational

Summary: 
      Background:

      - Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and
      radio waves to take pictures of the body. To help the images show up more clearly, a contrast
      agent is injected into a vein. Researchers are interested in finding contrast agents that can
      help show problems with the blood vessels around the heart. They want to test an agent called
      Gadofosveset Trisodium to see how it works in MRI scans.

      Objectives:

      - To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.

      Eligibility:

      - Healthy volunteers between 18 and 45 years of age.

      Design:

        -  Participants will be screened with a physical exam and medical history. They will
           provide blood samples before the scanning sessions.

        -  Participants will have an MRI scan after the screening visit. They will have a dose of
           the contrast scan before the study.

        -  Participants will return for one additional MRI scan within 1 to 2 months of each scan.
           Different doses of the contrast agent will be used for each scan.

        -  An additional blood sample will be collected within 1 week of the second MRI scan.
    

Detailed description: 
      The purpose of this study is to determine if the diagnostic quality of contrast-enhanced
      coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower
      dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular
      contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy
      participants will be recruited who do not have a clinical indication for MR angiography but
      do have safety clearance for IV gadolinium contrast and MR scanning.

      Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and
      contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose
      contrast agent. Parameters will be compared with paired t-testing for significance.
    

Time perspective: Prospective
Keywords: Gadolinium Contrast; Cardiac MRI; MRA; MRI; MRI Safety
Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes
Condition: Coronary Atherosclerosis; Diabetes Mellitus
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to compare the difference of diagnostic efficiency between
      coronary CT angiography and myocardial perfusion single photon emission computerized
      tomography in asymptomatic patients with type 2 diabetes mellitus.
    

Detailed description: 
      Coronary artery disease (CAD) is the leading cause of death in patients with diabetes.
      Patients with diabetes are known to have silent myocardial ischemia more frequently than
      those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in
      advance stage, and morbidity and mortality are higher than those without diabetes. Early
      screening and treatment of CAD in asymptomatic patients with diabetes might reduce high
      morbidity and mortality.

      Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a
      gold standard method in detecting silent myocardial ischemia in asymptomatic patients with
      diabetes. Despite of the power of detecting myocardial ischemia functionally, there are
      limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In
      recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary
      atherosclerosis. However, there is a paucity of information comparing the diagnostic power
      between SPECT and CTA.

      Therefore in our study, we compare the difference of diagnostic efficiency between coronary
      CT angiography and myocardial perfusion single photon emission computerized tomography in
      asymptomatic patients with type 2 diabetes mellitus.

      In this study, we will recruit asymptomatic patients with diabetes. At the time of
      enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days
      apart. When patients had positive result in either study, they will undergo coronary
      angiography for confirmation. We will evaluate the results of two studies comparing with
      coronary angiography. When the patients are eligible for study, investigators will give
      information about the study and obtain written consent. The presence of chest pain symptom
      will be screened with Rose questionnaire. Medical history and physical examination will be
      performed, and baseline laboratory work-up will be performed. Investigators will evaluate the
      status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Asymptomtaic type 2 diabetes mellitus with multiple risk factors
      
Keywords: Coronary Atherosclerosis; Diabetes Mellitus
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate activity and toxicity of the combination of
      carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or
      recurrent endometrial carcinoma.
    

Detailed description: 
      Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40
      mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment
      administration and dose reductions have been planned according to toxicity.
    

Intervention name(s): liposomal doxorubicin; carboplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced; recurrent; chemotherapy; first-line