bioihbjkbjnl/mcl2 huggingface dataset:
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Condition: Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional
Phase: Phase 1

Summary: 
      to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of
      Distal Ureteric Calculi.
    

Detailed description: 
      to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of
      Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and
      quickly cures the disease thus enabling the person to return to routine activity with less
      adverse effects.
    

Intervention name(s): Silodosin; Tamsulosin
Intervention type(s): Drug; Drug
Intervention description(s): The patients used Silodosin for Medical expulsive therapy of ureteric calculi; The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi
Intervention MeSH terms: Tamsulosin; Silodosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Condition: Vaccine Efficacy
Study type: Interventional
Phase: Phase 4

Summary: 
      FSME-Immun® is registered for application into the muscle. This study investigates if
      application under the skin leads to a comparable immune response.
    

Detailed description: 
      Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular
      application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular
      application is not always possible. The aim of this clinical trial is to investigate whether
      a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus
      humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in
      healthy volunteers will be compared.
    

Intervention name(s): FSME-Immune vaccination
Intervention type(s): Biological
Intervention description(s): booster vaccination with FSME-Immune
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
Condition: Neonatal Hypothermia
MeSH terms: Hypothermia; Birth Weight
Study type: Interventional

Summary: 
      Hypothermia in preterm infants during the immediate postnatal phase is associated with
      morbidity and mortality and remains an unresolved, worldwide challenge.

      A list of interventions, including adequate room temperature, use of infant warmers,
      polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to
      prevent thermal loss at birth in very preterm infants has been recommended, but a certain
      percentage of very preterm infants are hypothermic at the time of the neonatal intensive care
      unit (NICU) admission suggesting that further measures are needed. The thermal
      servo-controlled systems are routinely used in the NICU to accurately manage the patients'
      temperature, but their role during the immediate postnatal phase has not been previously
      assessed.

      We hypothesized that using a thermal servo-control system at delivery could prevent heat loss
      during this delicate phase and increase the percentage of very low birth weight infants
      (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of
      this study will be to compare two modes of thermal management (with and without the use of a
      thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.
    


Intervention name(s): Thermal servo-controlled system
Intervention type(s): Device
Intervention description(s): All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
Condition: Hepatic Function Abnormal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate
      the impact of hepatic impairment on venglustat exposure following treatment with venglustat.

      The purpose of this study is to assess the effect of mild, moderate, and severe hepatic
      impairment on PK, safety, and tolerability of venglustat compared with normal hepatic
      function in male and female participants aged 18 to 79 years.

      Study details include:

        -  The total study duration per participant will be up to 42 days, including up to 21 days
           for screening and approximately 21 days from institutionalization to the end of study
           (EOS).

        -  Institutionalization is mandatory until the activities on D5 have been completed.

        -  Each participant will receive a single dose of venglustat.

        -  For hepatically impaired participants there will be a screening visit, a multi-day
           institutionalization visit, and 7 site visits after D5 discharge, including the end of
           study (EOS) visit.

        -  For healthy volunteers there will be a screening visit, a multi-day institutionalization
           visit and 3 site visits after D5 discharge, including the end of study (EOS) visit.
    

Detailed description: 
      The duration of the study for a participant in any arm will be up to 42 days. The treatment
      and follow up periods will last for a combined total of approximately 20 days, while the
      screening period will be up to 3 weeks, but may be shorter on an individual basis.

      Screening period: up to 3 weeks (Days -21 to -2).

      Open-label treatment period with compulsory institutionalization (Days -1 to 5).

      Follow up period lasting until approximately day 20 ± 2 days post administration. This will
      include 7 additional site visits (including the EOS visit) for hepatically impaired groups.
      The group with normal hepatic function will only need to return D6 and D7 for study visit
      after institutionalization is completed.
    

Intervention name(s): Venglustat (GZ402671)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: Venglustat
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this clinical trial are to compare the quality of life of the subjects, the
      efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin
      phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily,
      against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to
      moderate acne vulgaris.
    

Detailed description: 
      Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is
      characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and
      scars, generally located on the face, chest and back. Acne pathogenesis is recognized as
      multifactorial.

      Acne vulgaris is the most common dermatological disorder. It affects approximately 85%
      individuals at some point in their lives, generally between 12 and 24 years of age. Although
      acne is prevalent within this age range, it can persist for many years and its long-term
      physical and psychological implications can be significant.

      There are several medicinal products used to treat acne. However, the therapeutic challenge
      remains, therefore it is essential to continue investigating effective strategies for the
      treatment of this disease.
    

Intervention name(s): Duac Gel; Differin gel
Intervention type(s): Drug; Drug
Intervention description(s): Duac® Gel will be applied to the face once daily at night, for 12 weeks.; Differin Gel will be applied to the face once daily at night, for 12 weeks.
Other intervention name(s): Duac; Differin
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Differin; quality of life; Acne; Duac; Acne Vulgaris
Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The association between levels of zonulin and occludin and behavioral/emotional problems in
      children with ADHD are investigated.
    

Detailed description: 
      Inclusion criteria for the ADHD group are (a) newly diagnosed ADHD (b) no prior psychotropic
      treatment for ADHD or any psychiatric disorder (c) age 6-12 years. Exclusion criteria were:
      (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease (b)
      any special diet history within the past year (c) use of corticosteroids or regular intake of
      medication in the last 6 months, (d) body mass index (BMI) [kg/m2] > 30), and (e) cognitive
      deficits by developmental history.
    

Intervention name(s): Zonulin; Occludin
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Serum zonulin level; Serum occludin level
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to further explore an effective dose range of PD0200390 for the
      treatment of patients with insomnia.
    


Intervention name(s): PD 0200390; PD 0200390; PD 0200390; PD 0200390; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.; oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.; oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.; oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.; oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe
      and effective treatment for patients with mild to moderate Alzheimer's disease.
    

Detailed description: 
      Alzheimer's disease is the leading cause of dementia and one of the most common diseases of
      the aging population. It is a chronic brain disease that involves gradual memory loss,
      decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss
      of language skills, impairment of judgment, and personality changes in affected individuals.
      The neurodegenerative nature of the disease eventually leads to the failure of other organ
      systems and death.

      Perturbations in calcium homeostasis in the central nervous system, such as those associated
      with Alzheimer's disease and aging as well as stroke and head trauma can result in an
      increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to
      cellular dysregulation and cell death. The role of calcium in these neurodegenerative
      processes led to the hypothesis that controlling calcium levels may be beneficial,
      particularly where progressive neuronal damage results in cognitive dysfunction and memory
      loss.

      MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central
      nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human
      dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel
      modulators.
    

Intervention name(s): MEM 1003; MEM 1003; Placebo for MEM 1003
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg twice a day; 90 mg MEM 1003 twice a day; Placebo twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cognition; Alzheimer's; Cognitive impairment
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to compare the 2 Groups with respect to antibody responses to inactivated
      influenza vaccine.

      Observational Objectives:

        -  To describe the percentage of participants with protective Hemagglutinin (HAI) antibody
           titers to each of the 3 vaccine antigens in both study groups following each
           vaccination.

        -  To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in
           both study groups following each vaccination.

        -  To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in
           both study groups.
    

Detailed description: 
      This is a descriptive study that will provide preliminary comparative information about the
      safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine
      at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
    

Intervention name(s): Influenza Virus Vaccine; Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular; 0.25 mL, Intramuscular
Other intervention name(s): Fluzone® 2005-2006 Pediatric Formulation; Fluzone® 2005-2006 Pediatric Formulation
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fluzone® vaccine; Influenza
The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
Condition: Examination, Gynecological; Examination, Pelvic; Examination, Vaginal
Study type: Interventional

Summary: 
      The purpose of this study is to determine if lubricating gel affects patients' perception of
      discomfort during speculum insertion, as compared to water.
    

Detailed description: 
      The outcome measure is patient discomfort as measured by a visual analogue scale.
    

Intervention name(s): Lubricating gel used during speculum insertion.; Water used during speculum examination.
Intervention type(s): Procedure; Procedure
Intervention description(s): Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.; Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: lubricating; gel; speculum; Pain, Pelvic; Examination, Gynecological
Randomized Controlled Trial of Stress Management Training in HIV
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The introduction of highly active antiretroviral therapy (HAART) has dramatically changed the
      consequences of an HIV infection, which is now viewed as a chronic disease. As in other
      chronic diseases, emotional distress and depressive symptoms are highly prevalent in
      HIV-infected patients. Psychological factors such as these have been associated with lower
      quality of life, lower adherence to therapy and also with a higher risk for mortality and
      disease progression. Psychosocial interventions, such as group-based cognitive behavioral
      stress management (CBSM) training, have been shown to reduce distress and psychological
      symptoms in HIV-infected patients. These psychosocial effects are paralleled by changes in
      physiological parameters, such as cortisol, DHEA-S, testosterones, catecholamines, and naïve
      T-cell counts. While these results are congruent with recent evidence of the interaction
      between psychological, neuroendocrine and immunological parameters in HIV-infected patients,
      it needs to be shown whether the reported effects hold true in the HAART era. Most
      importantly, it also needs to be ascertained whether these interventions have an impact on
      immunological and virological HIV parameters as well as on mortality and morbidity in HIV
      patients. We propose a randomized controlled one-year prospective evaluation of a group-based
      CBSM training in 80 HIV-infected patients. Participating patients will be recruited at
      cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or
      waiting control group condition. At baseline, post-training and two follow-up (6 and 12
      months) assessments, effects of the CBSM on psychological, physiological and clinical
      out-come variables in HIV-infected patients under HAART will be evaluated. Additionally, the
      effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected
      patients will be assessed, thus evaluating a possible direct pathway between emotional
      distress and physiological HIV-relevant parameters. In conclusion, the planned research
      project evaluates the effectiveness of a standardized psychosocial intervention as a possible
      component of a comprehensive disease management in HIV-infected patients under HAART.
    


Intervention name(s): Cognitive behavioral stress management training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-controlled Trial
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess if a sequential treatment regimen better eradicates H. pylori than does a triple
      drug regimen in adults with dyspepsia or peptic ulcer disease.
    

Detailed description: 
      Background: Antimicrobial resistance has decreased eradication rates for H. pylori worldwide.

      Objective: To assess if a sequential treatment regimen better eradicates H. pylori than does
      a triple drug regimen in adults with dyspepsia or peptic ulcer disease.

      Design: Placebo-controlled trial. Setting: Two Italian Hospitals between September 2003 and
      April 2006. Patients: 300 dyspeptic or peptic ulcer patients Measurements: 13C urea breath
      test, upper endoscopy, histology, rapid urease test, bacterial culture, and antibiotic
      resistance assessment.

      Intervention: 10-day sequential regimen (pantoprazole 40 mg, amoxicillin 1 g plus placebo for
      the first 5 days, followed by pantoprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg
      for the remaining 5 days) in 150 patients or standard 10-day therapy (pantoprazole 40 mg,
      clarithromycin 500 mg, and amoxicillin 1 g) in 150 patients. All drugs were given twice
      daily.

      Results: There were 295 patients (Intent to treat) of whom 91% (95% CI: 86.5-95.7) had
      successful eradication with sequential therapy compared to 78% (95% CI: 71.2-84.5) for
      standard therapy (difference: 13.3%; 95%). The sequential therapy was significantly more
      effective in patients with clarithromycin resistant strains (88.9% patients vs. 28.6%; P =
      0.0034). The incidence of major and minor side effects did not differ between therapy groups
      (17% vs. 17%).

      Limitations: Follow-up was incomplete in 4.6% and 2.7% patients in sequential and standard
      therapy, respectively. The higher efficacy of sequential regimen should be confirmed outside
      Italy.

      Conclusions: Sequential therapy is superior to conventional therapy for the eradication of H.
      pylori and it is significantly more effective in patients harbouring clarithromycin resistant
      strains.

      The incidence side effects did not differ between therapy groups.
    

Intervention name(s): Placebo amoxicillin pantoprazole clarithromycin tinidazole
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin; Clarithromycin; Tinidazole; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Helicobacter pylori infection; Treatment; Double blind placebo controlled trial