bioihbjkbjnl/mcl2 huggingface dataset:
Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam
Condition: Rotavirus; Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to measure the effect of host human genetics on the resulting
      immunological responses and long-term protection following rotavirus immunization of a study
      population of infants in Ho Chi Minh City, Vietnam.

      The secondary objectives are to assess the temporal immunological responses following
      rotavirus vaccination, and to investigate the role of maternally derived antibodies, and
      other factors that could potentially affect immunological responses following rotavirus
      vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.
    

Detailed description: 
      This study will be an open single arm, single centre, interventional study conducted in Ho
      Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between
      8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the
      rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be
      requested to bring the infants 2-3 days following each Rotarix vaccination to receive the
      standard EPI vaccinations. The infants will then be under passive and active surveillance for
      rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post
      vaccination and at 6, 12 and 18 month old visits will be collected.
    

Intervention name(s): Rotarix vaccine
Intervention type(s): Biological
Intervention description(s): In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rotavirus; Vaccine; Diarrhea; Host genetics
Clinical Evaluation of Two Approved Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical
      performance of two FDA-approved contact lens.
    


Intervention name(s): TEST Contact Lens; CONTROL Contact Lens
Intervention type(s): Device; Device
Other intervention name(s): senofilcon A; stenfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy
Condition: Lymphoma; Multiple Myeloma; Influenza A Virus, H1N1 Subtype
MeSH terms: Influenza, Human; Multiple Myeloma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether adults with hematologic malignancies on
      active systemic therapy or shortly after bone marrow transplantation need one or two doses of
      adjuvanted vaccine to achieve best possible rates of protection. An additional research
      question is whether baseline biomarkers of the cellular and humoral immune systems are
      associated with an antibody response to vaccination.
    

Detailed description: 
      The novel influenza H1N1 virus responsible for a world-wide pandemic throughout 2009
      (H1N1(2009)) is expected to cause a second wave of infection during the 2009/10 winter
      season. Vaccines against H1N1(2009) will be available in early November, 2009. Adults with
      hematologic disorders are at high risk of influenza-related complications, including death.
      Given that the vaccination dosing for the pandemic vaccine has been developed on healthy
      individuals, it is unknown whether this subgroup of patients will respond similarly. We will
      evaluate the safety and efficacy of the pandemic vaccine in patients with lymphoid
      malignancies receiving active systemic treatment, or who have recently undergone stem cell
      transplantation. Patients will be randomized to one or two doses of the approved adjuvanted
      vaccine; immune responses will be measured to identify the optimal regimen. Also, we will
      look for an association between biomarkers of the immune system and a response to the
      vaccine; this will be done by measuring baseline CD3, 4, 8, 19, and 56 cells by flow
      cytometry.
    

Intervention name(s): AS03-adjuvanted H1N1 pandemic influenza vaccine
Intervention type(s): Biological
Intervention description(s): One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.
Other intervention name(s): Arepanrix(R); ATC Code J07BB02
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Lymphoma; Multiple myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Influenza A Virus, H1N1 Subtype; Influenza Vaccines; Bone Marrow Transplantation
Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns
Condition: Propofol Overdose; EEG
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 4

Summary: 
      In the world, 230 million surgeries are performed per year and a significant part is
      performed in patients over 65 years of age. These patients are more labile, especially from
      the neurocognitive point of view with a high risk to develop neurocognitive complications,
      such as postoperative delirium. Recent studies have linked this type of complication with an
      overdose of general anesthetics during surgery. For this reason, in recent years, the use of
      brain function monitors during the intraoperative period has been recommended to adapt the
      dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics.
      However, to date, the available monitors that process the electroencephalographic signal are
      not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic
      studies have been performed that analyze changes that occur in the electroencephalogram (EEG)
      signal secondary to increases in complications from general anesthetics. Thus, the
      investigators design this study with the main aim to determine the changes in
      electroencephalographic patterns induced by a stepped increase of propofol until the burst
      suppression is reached.
    

Detailed description: 
      The investigators will carry out a prospective analytical observational clinical study at the
      Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who
      a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and
      propofol concentration will be estimated using the Marsh model. First, the concentration of
      propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil
      (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL.
      After that, the concentration of propofol that caused the LOS will be maintained for 20
      minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an
      episode of burst suppression will be observed. In the complete protocol, EEG activity will be
      acquired using a SedLine® monitor.
    

Intervention name(s): Propofol; Electroencephalogram recording
Intervention type(s): Drug; Device
Intervention description(s): Stepped propofol concentration after 20 min of LOS; Acquisition of EEG activity
Other intervention name(s): Dosage increase
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Propofol; General anesthesia; EEG; Burst suppression
A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, placebo-controlled study, three-period crossover study to examine the
      likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting
      MPH (RITALIN LAÒ 90mg). Hypotheses are as follows:

      Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH (RITALIN LAÒ) in its Tmax
      (time to Cmax).

      Hypothesis 2: The subjective feelings of detection and likeability would be greater for
      SODOS-MPH (RITALIN LAÒ) than for an equivalent total dose of OROS-MPH (CONCERTAÒ).
    

Detailed description: 
      Our recent work has suggested that the potential euphoriant risk associated with MPH may be
      moderated by the oral delivery system in which a longer delivery system may be safer than the
      immediate release one. OROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH
      over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID
      treatment. Another new long-acting MPH formulation is the spheroidal oral drug absorption
      system (SODAS). SODAS-MPH consists of capsules with two types of beads in a 1 to 1 ratio.
      Evaluating whether different long acting formulations of MPH will differ in their rate of
      onset of MPH action (plasma level) is of high clinical, scientific and public health
      relevance. Since the rate of delivery of MPH is a key factor previously associated with
      detection and likeability of MPH.
    

Intervention name(s): OROS methylphenidate HCl; SODAS methylphenidate HCl
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Effect of Spinal Dexamethasone During Transuretheral Prostatectomy
Condition: Postspinal Shivering
Study type: Interventional
Phase: Phase 2

Summary: 
      Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it
      extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone
      in Transuretheral prostatectomy.
    

Detailed description: 
      Spinal anesthesia for endoscopic urology surgery like transurethral resection of the prostate
      is a well-established technique. Opioids are extensively used as an adjunct to local
      anesthetics in neuraxial blockade to enhance the duration of postoperative analgesia.
      However, worrisome adverse effects like pruritus, urinary retention, postoperative vomiting
      and respiratory depression limit its use. The aim of this study was to investigate the
      effectiveness of Intrathecal dexamethasone as adjunct to local anesthetics.
    

Intervention name(s): Dexamethasone; Pethidine; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally; Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally; Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
Other intervention name(s): Mepredine
Intervention MeSH terms: Dexamethasone; Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two
      consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be
      randomized to a community based peer counseling support group or clinic based standard of
      care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the
      efficacy of the intervention in improving adherence and virologic suppression.
    

Detailed description: 
      Title The Peer Support Intervention - supporting HIV positive adolescents in Zimbabwe to
      improve HIV care continuum outcomes

      Short Title The Peer Support Intervention

      Study Design Prospective randomized study

      Study Duration 2 years

      Study Population 250 Youth (ages 10-24 years) with virologic failure

      Study Outcomes Primary Outcomes

      1. Virologic suppression rate in the The Peer Support Intervention group compared with the
      standard of care group following 48 weeks in the Peer Support Intervention.

      Secondary Outcomes

        1. Frequency of acquired drug resistance mutations among youth failing ART.

        2. Baseline prevalence of psychological distress among adolescents and young adults failing
           first line therapy

        3. Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of
           enrolment in the Peer Support Intervention compared with the standard of care

        4. Association between self-reported adherence, pill counts and objective surrogate markers
           of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).

        5. Effectiveness of point mutation assays for the detection of drug resistance as compared
           with standard sequencing techniques.

      Description of Intervention Youth with evidence of virologic failure defined as an HIV VL>400
      copies/mL on two consecutive occasions at least 1 month apart will be eligible for
      enrollment. Youth will be randomized to a community based peer counseling support group or
      clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month
      intervals to determine the efficacy of the intervention in improving adherence and virologic
      suppression.

      Study Sites Parirenyatwa Hospital Family Care Centre
    

Intervention name(s): Peer Support
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
To Evaluate Eye Installation-Tear Free
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The primary objective of this study was to compare the human eye stinging potential of
      experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50
      X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.
    


Intervention name(s): SPF 50 Y49 091 (BAY 987516); SPF 50 X15 158 (BAY 987516); SPF 50 X15 160 (BAY 987516); SPF 50 X57 162 (BAY 987516); J & J baby shampoo, X46 046 (control)
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.; 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.; 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.; 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.; 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Eye stinging potential
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based,
      battery of neuro-psychometric tests in adults with ADHD.
    


Intervention name(s): Lisdexamfetamine Dimesylate (LDX); Immediate Release Mixed Amphetamine Salts (MAS-IR); LDX Placebo + MAS-IR Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo; Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo; Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ADHD
Control and Burden of Asthma and Rhinitis
Condition: Asthma; Rhinitis
MeSH terms: Rhinitis; Asthma
Study type: Observational

Summary: 
      An observational cross-sectional study will include 750 individuals of all ages, divided in 4
      groups: 1) Patients with a self-reported diagnosis of asthma alone (n=150), 2) Patients with
      a self-reported diagnosis of rhinitis alone (n=150), 3) Patients with a self-reported
      diagnosis of asthma and rhinitis (n=150) and 4) Patients with no history of respiratory
      symptoms or diseases (n=300)
    

Detailed description: 
      During 2010, we've conducted two cross-sectional, telephonic national surveys that assessed
      the prevalence (Portuguese Asthma Prevalence Survey - PAPS) and the control (Portuguese
      Asthma Control Survey - PACS) of asthma and rhinitis. Before these surveys there was no
      country-wide data on prevalence or about the control of asthma in Portugal.We propose an
      additional study that will apply a comprehensive set of diagnostic tests and clinical
      assessment to a sub-sample of participants in the PACS study. The effect of asthma, rhinitis
      and their control on personal and social burden will be studied comparing patients with
      current asthma and/or rhinitis and individuals with no respiratory symptoms.Sample size
      calculations were based on the comparison of quality of life measured by WHOQOL-BREF in
      patients with different diagnosis. Data collection includes anthropometric measurements, lung
      function & inflammation tests, allergy tests, a structured clinical interview and
      standardized questionnaires. Research assistants performing the evaluations will be blinded
      to the subject classification in PAPS and PACS and to the results of the questionnaires
      administered, namely the GA2LEN survey instrument and CARAT. The data collection will be
      organized with the local Public Health delegate and will take place as close as possible to
      the participants' communities at a local health unit or in the surrounding area, in order to
      minimize dropouts.
    

Intervention name(s): Diagnostic tests, medical interview and questionnaires
Intervention type(s): Other
Intervention description(s): All patients will perform these interventions.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample.
      
Biospecimen description: 
      Serum will be retained.
    
Keywords: Asthma; Rhinitis; Control; Burden
Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization
Condition: Feeding; Difficult, Newborn
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      Feeding is one of the most common problems encountered by preterm infants. Besides, effective
      and safe feeding is one of the important discharge criteria. Feeding problems of premature
      infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding
      protocol was developed based on evidence-based feeding protocol (such as cue-based,
      infant-driven feeding) and individualized developmental care.

      The aim of the study is to determine the effect of the SINC feeding protocol on weight gain,
      transition to oral feeding and the length of hospitalization in premature infants according
      to traditional feeding method.

      Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either
      Standard Feeding or SINC Feeding Protocol.
    


Intervention name(s): SINC Feeding Protocol
Intervention type(s): Other
Intervention description(s): Safe individualized nipple-feeding competence protocol for premature infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Premature Infants; SINC feeding protocol
Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular
      invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment
      model，then to clarify the probability of bladder preservation, corresponding cancer specific
      survival, and the quality of life.
    


Intervention name(s): Intensity modulated radiation therapy, Radical cystectomy
Intervention type(s): Procedure
Intervention description(s): Postoperative Intensity modulated radiation therapy(IMRT) will be applied to effective team.Radical cystectomy will be applied to ineffective team.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
Condition: Systemic Sclerosis
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      PSSc-001 (LOTUSS)

      This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and
      tolerability study of pirfenidone in participants with systemic sclerosis-related
      interstitial lung disease (SSc-ILD).
    


Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pirfenidone; SSc-ILD; scleroderma; systemic sclerosis; interstitial lung disease