bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases
Condition: Cognitive/Functional Effects; Metastatic Cancer; Radiation Toxicity
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the
      effects of the treatment and may help improve cancer treatment.

      PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation
      therapy for brain metastases.
    

Detailed description: 
      OBJECTIVES: I. Determine the feasibility of performing a test battery consisting of five
      neurocognitive measures and a quality of life instrument following radiotherapy in patients
      with brain metastases.

      OUTLINE: Patients undergo radiotherapy 5 days a week for 3 weeks. Quality of life and
      neurocognitive function is assessed before study, at completion of radiotherapy, and at 1
      month after completion of radiotherapy. Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 months.
    

Intervention name(s): management of therapy complications; quality-of-life assessment
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: tumors metastatic to brain; radiation toxicity; cognitive/functional effects
Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Substituting whole milk intake for defatted milk will improve indicators of cardiovascular
      risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density
      Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican
      children 6-13 years of age.
    

Detailed description: 
      Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools
      will be randomized to distribute three types of milk namely: full fat milk (3% fat),
      partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure
      (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day
      (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they
      will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24
      h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and
      at the end of the intervention.
    

Intervention name(s): Modification of the content of fat in milk; Modification of the content of cows milk; Modification of the fat content of cows´ milk
Intervention type(s): Other; Other; Other
Intervention description(s): Comparison of three levels of fat content in cow´s milk; Comparison of three levels of fat content in cows' milk; Comparison of three levels of fat content in cow´milk
Other intervention name(s): Liconsa milk; Liconsa low fat milk; Liconsa defatted milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: epidemiological risk; diet; fat intake
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
Condition: Iron Deficiency, Anaemia in Children; Iron-Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 1

Summary: 
      The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric
      Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in
      comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.
    

Detailed description: 
      Phase I, open label, randomized, repeat dose, multicentre, pharmacokinetic study to assess
      the Safety and Tolerability of Ferric Maltol in 3 different dosages.

      36 eligible patients will be randomized in a 1:1:1 ratio to one of the following 3 dosages
      for 9 days BID and a single dose on Day 10:

        -  30mg ferric maltol capsules

        -  16.6 mg ferric maltol capsules

        -  7.8 mg ferric maltol capsules

      Subject participation in the study will consist of 3 stages:

      Screening: up to 14 days Treatment period: 10 days treatment period with 2 visits on Day 1
      and Day 10 for PK blood sampling. Patients will be randomly allocated to one of the three
      Ferric Maltol dose groups according to centralized treatment allocation scheme.

      Post-treatment Safety Follow-up:3-10 days following completion of the treatment period or
      premature discontinuation of study medication
    

Intervention name(s): Ferric Maltol
Intervention type(s): Drug
Intervention description(s): To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Other intervention name(s): ST10; Feraccru
Intervention MeSH terms: Ferric maltol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1:1 ratio and stratified by co-variates for age and sex. This will ensure that a minimum of 25% of each gender and at least 3 children per age group are enrolled in each Ferric Maltol dose group.
Masking: None (Open Label)
Primary purpose: Other
Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis
Condition: Silicosis
MeSH terms: Silicosis
Study type: Observational

Summary: 
      Silicosis is a chronic and incurable occupational disease that can progress independent of
      the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may
      help to improve our understanding of the changes in lung mechanics, as well as in the
      detection of these changes.

      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory
      impedance and evaluated the diagnostic use of the FOT in these patients. For this, the
      investigators used spirometry to classify airway obstruction, which resulted in four
      categories: control, patients with normal exam, mild obstruction, and moderate-to-severe
      obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the
      resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the
      mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was
      evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic
      potential was evaluated by investigating the area under the receiver operating characteristic
      curve (AUC).
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The control group will consist of healthy subjects, nonsmokers, who had no episode of
        respiratory infection thirty days before the examinations.

        The group with diagnosis of silicosis was established based on a history of substantial
        exposure to silica dusts and compatible radiological features, together with exclusion of
        other competing diagnoses.
      
Keywords: Silicosis; forced oscillations; respiratory mechanics
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged
      50 years and older. Half of participants will receive high doses of the vaccine,while the
      other half will receive low doses of the vaccine in phase I clinical trial. At the phase II
      clinical trial, participants will be distributed equally to four groups(low、middle, high
      doses of the vaccine and placebo).
    


Intervention name(s): the vaccine with high doses of virus content between 4.7～5.0 lgPFU; the vaccine with low doses of virus content between 4.7～5.0 lgPFU; the vaccine with high doses of virus content between 4.3～5.0 lgPFU; the vaccine with middle doses of virus content between 4.3～5.0 lgPFU; the vaccine with low doses of virus content between 4.3～5.0 lgPFU; placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vaccine; safety; immunogenicity
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with
      oxaliplatin works as second-line therapy in treating patients with stage III or stage IV
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as
           second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer.

        -  Determine overall response in patients treated with this regimen.

      Secondary

        -  Determine time to progression, time to treatment failure, and overall survival of these
           patients.

        -  Determine the type, frequency, severity, timing, and relatedness of all adverse events
           during treatment and for 30 days after completion of study treatment.

        -  Assess the quality of life of these patients.

        -  Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from
           these patients.

      OUTLINE: This is an open-label, nonrandomized study.

      Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV
      over 2 hours on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the
      absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, at the beginning of each course, at the completion
      of study treatment, and then every 6 weeks thereafter.

      After completion of study treatment, patients are followed every 3 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): gemcitabine hydrochloride; oxaliplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir,
      identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with
      famotidine results in atazanavir exposures similar to those when
      atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy
      subjects.
    


Intervention name(s): Atazanavir+Ritonavir+Tenofovir; Atazanavir+Ritonavir+Tenofovir+Famotidine; Atazanavir+Ritonavir+Tenofovir+Famotidine; Atazanavir+Ritonavir+Tenofovir+Famotidine; Atazanavir+Ritonavir+Tenofovir+Famotidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.; Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.; Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.; Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.; Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
Other intervention name(s): Abilify; Abilify; Abilify; Abilify; Abilify
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Aripiprazole; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HIV; Protease Inhibitor
Management of Post-Tonsillectomy Pain in Pediatric Patients
Condition: Pain, Postoperative; Tonsillar Hypertrophy; Tonsillitis
MeSH terms: Tonsillitis; Pain, Postoperative; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the
      effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of
      post-operative tonsillectomy pain in the pediatric population. 100 children undergoing
      tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen
      regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed
      every 3 hours.
    


Intervention name(s): Alternating Acetaminophen and Ibuprofen; Combined Acetaminophen and Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.; Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Other intervention name(s): Alternating regimen; Combined regimen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, randomized, open-label, non-inferiority treatment pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Aripiprazole in First Episode Psychosis
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the efficacy and safety of aripiprazole in patients
      with first episode psychosis.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): 6 week prospective study
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an
      effective treatment for patients with glioma. Stereotactic radiation therapy may be able to
      deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet
      known if standard radiation therapy is more effective when followed by stereotactic radiation
      therapy.

      PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation
      therapy with or without stereotactic radiation therapy in treating patients who have glioma.
    

Detailed description: 
      OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without
      fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma.
      II. Compare the quality of life of these patients after these therapies.

      OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade
      (III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo
      stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients
      undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized
      to receive additional treatment receive stereotactically guided conformal boost radiotherapy
      for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is
      assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months
      for 1 year, every 6 months for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.
    

Intervention name(s): radiation therapy; stereotactic radiosurgery
Intervention type(s): Radiation; Radiation
Allocation: Randomized
Primary purpose: Treatment
Keywords: adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma
The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
Condition: Healthy Male Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in
      healthy male subjects.
    


Intervention name(s): CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; CKD-501 placebo tablet, Glimepiride 4 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.; From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.
Other intervention name(s): CKD-501 : Lobeglitazone; CKD-501 : Lobeglitazone
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: CKD-501; Glimepiride; Placebo; Healthy male volunteer; Pharmacokinetic; Metabolite
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia
Condition: Critical Limb Ischemia; Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Arterial Occlusive Diseases; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow
      derived stem cells for the treatment of Critical Limb Ischemia
    


Intervention name(s): PTA + Infusion of MSC_Apceth; PTA
Intervention type(s): Biological; Procedure
Intervention description(s): percutaneous transluminal angioplasty followed by infusion of MSC_Apceth; percutaneous transluminal angioplasty only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical Limb Ischemia; Peripheral Arterial Occlusive Disease; Peripheral Artery Disease; Peripheral Vascular Disease; Stem Cell Therapy; Mesenchymal Stem Cells
Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction
Condition: Nasal Obstruction
MeSH terms: Airway Obstruction; Nasal Obstruction
Study type: Interventional

Summary: 
      This study evaluates subjective and objective measures of treatment outcome after using the
      Aerin Medical Vivaer™ Stylus to treat nasal obstruction
    

Detailed description: 
      This is a non-significant risk, prospective, non-randomized study to evaluate subjective and
      objective measures of nasal obstruction both before and after treatment with the Vivaer
      Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to
      improve symptoms in those diagnosed with nasal airway obstruction.
    

Intervention name(s): Vivaer Stylus
Intervention type(s): Device
Intervention description(s): Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Other intervention name(s): Aerin Medical Stylus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal valve; nasal airway obstruction
SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers
Condition: Cystic Fibrosis; Adolescent Behavior
MeSH terms: Cystic Fibrosis
Study type: Observational

Summary: 
      prospective multicentric study protocol in french CF center, exploring adolescent avec
      parents needs during transition from pediatric CF center to adult CF center
    

Detailed description: 
      Adolescent's and parent's needs will be studied, before the transition and their experiences
      of transition, in order to propose organizational national recommendations semi structured
      interview with adolescents and parents separately, before and after transition.

      semi structured interviews will be conducted twice for each (adolescent and parents), the
      first in the 6 months before transition and the second in the 6 months after transition.

      After their verbatims will be analyzed and the optimal organisation will be determined for
      the transition based according to their point of view.

      At the end, the data from this study will be matched with data collected in a former study
      from care givers practices during transition in the french CF centers.
    

Intervention name(s): semi structured interviews for all adolescents and their parent
Intervention type(s): Other
Intervention description(s): Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CF adolescent and their parents , for whom the transition to the adult center is scheduled
        within six months and witch have freely agreed to participate in the interviews their age
        will be between 17 and 23 years old. living followed in one of the 3 CF center
      
Keywords: transition; care program; needs