bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and
      Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old
      Vaccinia-Experienced Subjects
    


Intervention name(s): IMVAMUNE; IMVAMUNE
Intervention type(s): Biological; Biological
Intervention description(s): Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose; One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males
Condition: Healthy
Study type: Interventional

Summary: 
      The present study will seek the quantify the simultaneous muscle protein synthesis and
      breakdown response with and without amino acid provision in humans following 2 days of
      immobilisation.
    


Intervention name(s): Postabsorptive; Postprandial; Immobilisation
Intervention type(s): Other; Other; Procedure
Intervention description(s): Saline will be infused to mimic postabsorptive circulating amino acid concentrations; An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations; One leg will undergo 2 days immobilisation prior to the test day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Nose Selection Using Rhnoscope on Epistaxis of Nasotracheal Intubation
Condition: Nasotracheal Intubation
MeSH terms: Epistaxis
Study type: Interventional

Summary: 
      Rhinoscope is useful to exam intranasal structure. This information could be utilized to
      select more suitable nose for nasotracheal intubation. Nastoracheal intubation using more
      patent nose could be associated with decrease of the development of epistaxis which is most
      common complication in nasotracheal intubation.
    

Detailed description: 
      Anterior rhinoscopy using rhinoscope is a simple way to view the intranasal structure, which
      allows you to observe the nasal mucosa, the inferior nasal concha, and in some cases, the
      nasal concha. You can see the nasal septum, polyps, and intranasal malformations. In
      addition, even when there are no structural abnormalities in the nasal cavity, the wider
      nasal cavity can be intuitively identified. This information is expected to assist in the
      selection of nostrils. It has not yet been studied whether anesthesiologists select nasal
      cavity for nasotracheal intubation using prosthesis can affect the occurrence of epistaxis.

      The purpose of this study is to determine whether the selection of a nostril for nasotracheal
      intubation by rhinoscope affects the incidence and severity of epistaxis.
    

Intervention name(s): rhinoscope
Intervention type(s): Diagnostic Test
Intervention description(s): more suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: epistaxis; rhinoscope
Biseko Versus Albumin in Systemic Inflammatory Response Syndrome (SIRS) Patients
Condition: Systemic Inflammatory Response Syndrome
MeSH terms: Syndrome; Systemic Inflammatory Response Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Morbidity and mortality in patients suffering from systemic inflammatory response syndrome
      (SIRS) remain high. The primary aim of the present study is to assess the efficacy of a
      standardized 5% serum-protein solution containing immunoglobulins on serum cytokine levels.
      The secondary aim is to evaluate survival of the patients.
    

Detailed description: 
      Out of 40 patients randomised, 18 patients received albumin, 20 patients received Biseko and
      2 patients died before receiving the complete study medication. During days 1-6 of the study
      period, serum-levels of IL-1ß were significantly lower in patients with Biseko-therapy
      compared to patients receiving albumin (IL-1ß-Area under the curve 65.04 ± 71.09 days.pg/ml
      and 111.05 ± 156.97 days.pg/ml respectively, P=0.03). No difference could be found in
      serum-levels of IL-6, TNF-α and TNF-R between both groups. While a statistically not
      significant trend towards better survival was observed in the Biseko-group on day 28, the
      survival rate on day 180 was significantly higher in the Biseko-group [9/18 (50%)] vs.
      albumin- group [2/20 (10%), (P=0.008)].

      Conclusion: Data suggest that Biseko treatment was associated with significantly lower IL-1ß
      plasma concentrations (d1 to 6) and improved long-term survival rates.

      The data provided in our study are the first to be collected in a randomized, controlled
      trial. Certainly, the small number of patients and the variety of diseases limit our study,
      however, the variety of diseases reflects the realistic large scale of morbidity in the
      medical intensive care unit.
    

Intervention name(s): Albumin (5% serum-protein solution containing immunoglobulins); Biseko
Intervention type(s): Drug; Drug
Intervention description(s): 5% albumin was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.; Standardised 5% serum-protein solution (Biseko, Biotest, Dreieich, Germany) was given intravenously at a volume of 1,000 ml on the first day and 500 ml/day during the following four days.
Other intervention name(s): Albumin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Immunoglobulins; inhibitor proteins; human albumin; systemic inflammatory response syndrome; interleukins; standardized serum-protein solution
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation
Condition: Healthy Volunteers; Pharmacokinetics
Study type: Interventional

Summary: 
      Poor adherence to tenofovir (TDF) and emtricitabine (FTC) for Human Immunodeficiency Virus
      (HIV) pre-exposure prophylaxis (PrEP) is common and the leading cause of therapeutic failure.
      The investigators need better ways to measure adherence in patients on PrEP. This application
      will address the need to measure adherence by evaluating an integrated technology system,
      Proteus Discover, when combined with Truvada. The Proteus Sensor System (PSS) will confirm
      that Truvada was taken, monitor adherence in both recent and long term dosing, and provides
      feedback to encourage adherence. The goal of this study is to determine whether the use of
      the PSS with Truvada will vary the drug concentrations of FTC/TDF. Participants will have 2
      study visits where they will be randomized to either start with the combined PSS with Truvada
      or just Truvada alone. Study participants will come to the Clinical & Translational Research
      Center (CTRC) in the morning and take the assigned dose and will then have blood drawn at
      about .25, 0.5, 1, 2, 4, 6, and 10 hours after medication is taken. Participants will then
      return to the CTRC for blood draws 24, 48, and 72 hours after they took the dose on the first
      day. The second visit will mimic the first except that the participant will take the other
      dose form.
    


Intervention name(s): TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA]; Proteus Sensor System
Intervention type(s): Drug; Device
Other intervention name(s): Truvada; PSS
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; pharmacokinetics
Childhood Hypertonia of Central Origin: A Trial of Anticholinergic Treatment Effects
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open-label trial of trihexyphenidyl in children with upper extremity
      dystonia due to cerebral palsy. It is hypothesized that trihexyphenidyl in doses up to
      0.75mg/kg/day would be well-tolerated and show significant changes on the Melbourne scale of
      upper extremity function.
    

Detailed description: 
      BACKGROUND: Although trihexyphenidyl has been used to treat both primary and secondary
      dystonia in children, previous studies have not investigated efficacy in secondary dystonia.
      We describe the results of a prospective, open-label, multi-center trial of high-dose
      trihexyphenidyl in children with secondary dystonia of the arms due to cerebral palsy.

      METHODS: Twenty-six children age 4-15 years with cerebral palsy and dystonia that impairs
      function of the dominant upper extremity were enrolled. All children were given
      trihexyphenidyl at increasing doses over 9 weeks up to 0.75mg/kg/day. Trihexyphenidyl was
      subsequently tapered over 5 weeks. Visits occurred at baseline, 9 weeks, and 15 weeks. The
      primary outcome measure was the Melbourne assessment of upper extremity function, tested in
      the dominant arm.

      RESULTS: Three children withdrew due to non-serious adverse events (chorea, drug rash,
      hyperactivity). 3 children reduced dosage due to non-serious adverse events. The 23 children
      who completed the study showed a significant improvement in arm function at 15 weeks
      (p=0.045) but not at 9 weeks. Post-hoc analysis showed that a subgroup (N=10) with
      hyperkinetic dystonia worsened at 9 weeks (p=0.04) but subsequently returned to baseline
      following taper of the medicine.

      CONCLUSIONS: Trihexyphenidyl appears to be safe and effective for treatment of arm dystonia
      in children with cerebral palsy. Children with hyperkinetic dystonia may worsen. A larger
      randomized prospective trial is needed to confirm these results.
    

Intervention name(s): trihexyphenidyl
Intervention type(s): Drug
Intervention MeSH terms: Trihexyphenidyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood; cerebral palsy; dystonia; secondary; trihexyphenidyl; pediatric dystonia
Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
Condition: Childhood Myelodysplastic Syndromes; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Ringed Sideroblasts; Refractory Cytopenia With Multilineage Dysplasia; Secondary Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Preleukemia; Anemia; Myelodysplastic Syndromes; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of lenalidomide in treating
      young patients with relapsed or refractory solid tumors or myelodysplastic syndromes.
      Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking
      blood flow to the cancer. It may also stimulate the immune system in different ways and stop
      cancer cells from growing.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the maximum tolerated dose and recommended phase II dose of lenalidomide in
      pediatric patients with relapsed or refractory solid tumors.

      II. Determine the toxic effects of this drug in these patients. III. Determine the
      pharmacokinetics of this drug in these patients.

      SECONDARY OBJECTIVES:

      I. Determine, preliminarily, the feasibility of administering this drug to pediatric patients
      with relapsed or refractory myelodysplastic syndromes.

      II. Determine, preliminarily, the antitumor activity of this drug in both patient
      populations.

      III. Determine immunologic changes in patients treated with this drug.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
      diagnosis (solid tumor vs myelodysplastic syndromes [MDS]).

      Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days
      for up to 12 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients with solid tumors receive escalating doses of lenalidomide until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 6 patients experience dose-limiting toxicity. Patients with MDS receive a fixed
      dose (do not undergo dose escalation) of lenalidomide. After completion of study treatment,
      patients are followed annually.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): lenalidomide
Intervention type(s): Drug
Intervention description(s): Given orally
Other intervention name(s): CC-5013; IMiD-1; Revlimid
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Energy Profile and Low Intensity Activity (PROFILE)
Condition: Healthy
Study type: Interventional

Summary: 
      The recent literature has highlighting the importance of the time of SB and the level of
      physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are
      well recognized as one of the causes of mortality. As with physical activity, a dose-response
      relationship appears to exist: mortality would increase with time spent in sedentary
      behaviors. However, this relationship would not be linear: the more the daily sitting time
      increases, the more the consequences on mortality are important. It is now well demonstrated
      that time spent in sedentary adult behaviour finds primarily its origin in the work,
      characterized by prolonged and uninterrupted periods of sitting. Many strategies have been
      settled to break the prolonged sitting time. The most promising one seem to be the use of
      active workstations (standing, walking, cycling, stepping) because they reduce sedentary time
      at work and increase physical activity with positive effects on the global health. However
      inter variability in energy response have been identified during a sit to stand allocation
      with subject "savers" profile showing an increase in energy expenditure while others
      categorized as "non-savers" increased significantly their energy expenditure between sitting
      and standing position. As others active workstation strategies exist, this study aim to
      first, better characterize energy response to posture and activity allocation (15min
      sit-15min stand-15min sit-15min low intensity cycling), secondly to identify parameters that
      could explain different energy profile.
    

Detailed description: 
      Subject will have an inclusion visit during a medical consultation where the eligibility
      criteria to participate to this study will be checked.

      During a second experimental visit, subjects will have to take a calibrated breakfast. Three
      hours after the breakfast, body composition will be assessed and energy expenditure and
      substrates oxidation will be measured with an indirect calorimetry device during 15min in a
      sitting position fallowed by 15min in standing position , 15min in a sitting position and
      15min of low intensity cycling with a cycling desk.

      Then subjects will underwent physical capacity test :

        -  6min step test

        -  Handgrip test

        -  lower limb strength test Finally, subjects will be equipped with accelerometer and
           inclinometer device they will need to wore during 7 days.
    

Intervention name(s): physical activity
Intervention type(s): Other
Intervention description(s): 15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Active workstation; cycling; energy expenditure; sedentary
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing
      Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate
      brachytherapy. There are 2 eligible populations of men, all of whom will have selected
      brachytherapy as their treatment of choice for their prostate cancer. Either they have an
      enlarged prostate that requires size reduction to render brachytherapy technically feasible,
      or they require androgen ablation in conjunction with brachytherapy for optimal tumor
      control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in
      > 30% of men.
    

Detailed description: 
      All men will have a baseline transrectal ultrasound for brachytherapy planning that has
      demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the
      informed consent document they will have a loading dose of 240 mg Degarelix and then monthly
      maintenance dose injections of 80 mg until such time as sufficient prostate reduction has
      occured (2-3 months) or they complete the 6 months of required androgen ablation for their
      disease status.
    

Intervention name(s): Degarelix; Degarelix
Intervention type(s): Drug; Drug
Intervention description(s): 240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months; 240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate neoplasm; brachytherapy; androgen ablation; benign prostatic hypertrophy; prostate size reduction; localized prostate cancer with prostate volume > 40 cc
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to
      standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week
      between the 2 immunosuppressive (IS) treatment groups: delayed or standard Prograf together
      with induction therapy, and then convert to Advagraf usage in donation after cardiac (or
      circulatory) death (DCD) kidney transplant recipients.

      This study will also compare the clinical outcome within 6 month post-transplant between the
      2 IS treatment groups and compare the safety throughout study period between the 2 IS
      treatment groups.
    


Intervention name(s): Tacrolimus immediate-release formulation; Tacrolimus prolonged-release formulation; Induction therapy; Mycophenolic acid drugs; Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; All participants will receive induction therapy. The dosage and administration of induction immunotherapy will be a single kind of drug determined by the investigator.; All participants will receive mycophenolic acid drugs in combination with corticosteroids. The dosage and administration of mycophenolic acid will be determined by the investigator.; All participants will receive corticosteroids in combination with mycophenolic acid drugs. The dosage and administration of corticosteroids will be determined by the investigator.
Other intervention name(s): Prograf; FK506; Advagraf; FK506
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney transplant; Tacrolimus; Prograf; Advagraf; FK506
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Detailed description: 
      Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy,
      cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG.
      To evaluate TCDS wearability (including adhesion).
    

Intervention name(s): AG200-15 (cycles 1-13); Lessina crossover to AG200-15
Intervention type(s): Drug; Drug
Intervention description(s): AG200-15 containing ethinyl estradiol and levonorgestrel; Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Other intervention name(s): transdermal patch; hormonal oral contraception and transdermal patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraceptive