bioihbjkbjnl/mcl2 huggingface dataset:
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201
Condition: Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity
MeSH terms: Neurotoxicity Syndromes
Study type: Observational

Summary: 
      RATIONALE: Assessing the effects of methotrexate on brain function in children may improve
      the ability to plan treatment and decrease side effects.

      PURPOSE: Clinical trial to compare brain function of children who have been previously
      treated with methotrexate.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in
           children previously treated with methotrexate on protocols POG-9605 versus POG-9201.

      OUTLINE: This is a multicenter study.

      More than 3 years after completion of therapy, patients undergo 9 different tests to assess
      intelligence, memory, learning, attention, concentration, processing of information,
      functioning, and visual-motor integration. Patients also undergo MRI of the head.

      PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be
      accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605
      will be accrued for this study.
    

Intervention name(s): management of therapy complications
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Previously enrolled on POG-9201 or POG-9605
      
Keywords: neurotoxicity; long-term effects secondary to cancer therapy in children
Efficacy of Dexmedetomidine on Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized, double-blind study is designed to evaluate the postoperative
      analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in
      patients undergoing radical mastectomy. The investigators hypothesis is that the
      administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the
      plane in the erector spinae is less effective in controlling acute postoperative pain in
      radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.
    

Detailed description: 
      Patients undergoing radical mastectomy are randomly assigned to receive, in addition to
      standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose
      of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine
      at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using
      anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose
      of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected
      with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular
      relaxation with cisatracurium at a dose of 0.1 mg / kg.
    

Intervention name(s): Ropivacaine plus dexmedetomidine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Erector spinae block with ropivacaine at a dose of 0.5% plus dexmedetomidine at 0.3 mcg / kg.; Erector spinae block with ropivacaine at a dose of 0.5%.
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized double-blinded study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary
      fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients
      with functional constipation through randomized controlled trials. The influence of tract
      flora is expected to provide a basis for related therapies for patients with functional
      constipation.
    


Intervention name(s): Prebiotics or Probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
Condition: Muscle Strength
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this randomized, triple-blind, comparator controlled, parallel clinical
      trial is to investigate the functional equivalence of three test products compared to whey
      protein on muscular performance in a healthy, sedentary adult population.
    

Detailed description: 
      Whey, a by-product of cheese manufacturing, is commonly used as an ingredient in meat
      products, dairy products, baked goods, snacks, beverages, and infant formula. Its widespread
      use is due to its advantageous effects on health, economics, and high nutritional value by
      containing lactose, minerals, vitamins, and soluble proteins. Due to allergies, dietary
      restrictions and/or personal dietary choices there is a need for an alternative protein
      source(s), and plant-based protein options are in demand for these reasons. Roquette produces
      the NUTRALYS® Pea Protein family of ingredients, supplying the widest range of pea protein
      ingredients to the food industry suitable for use in a plethora of plant-based foods. Few
      studies have examined the equivalence between pea protein and whey on muscle performance in
      sedentary adults. The objective of this randomized, triple-blind, comparator controlled,
      parallel clinical trial is to investigate the functional equivalence of three test products
      compared to whey protein on muscular performance in a healthy, sedentary adult population.
    

Intervention name(s): Test Product 1; Test Product 2; Test Product 3; Comparator
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Pea Protein powder; Pea & Oat Protein Powder; Oat Protein Powder; Whey Protein Isolate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, triple-blind, comparator controlled, parallel clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: pea protein; oat protein; whey protein
Triple Negative Breast Cancer: Identification Pilot Study of Predictive Transcriptome Profiles of Early Tumor Drug Resistance Observed in 18F-Fluorodeoxyglucose (FDG) PET
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer is a major public health problem. In France, it is the leading cause of cancer
      death in women. According to the National Cancer Institute (INCA), approximately 49,000 new
      cases were diagnosed in 2012 in France.

      It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior,
      biological and prognosis differ. Amongst these entities, the breast cancer triple negative
      (TN) is defined by the absence of expression of estrogen receptor and progesterone and the
      absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and
      occurs more frequently in young women. This is a very proliferative tumor phenotype with
      metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified
      molecular target, no targeted therapy has today shown benefit in terms of survival compared
      to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this
      tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is
      a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy
      treatment non-responder patients to treatment with low probability of pathologic complete
      response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be
      performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective
      of this pilot, single-center, prospective study is a preliminary identification of recurrent
      genomic alterations among triple-negative tumors with early chemoresistance, identified by
      PET in the first cycle of neoadjuvant therapy.
    


Intervention name(s): PET with FDG; Tumor exome analysis
Intervention type(s): Other; Other
Intervention description(s): A PET with FDG will be performed before the treatment is started and after 6 cycles of chemotherapy.; A biopsy of the tumor will be performed before the treatment is started and after 6 cycles of chemotherapy. Tumor exome analysis will be performed before treatment is started and after 6 cycles of chemotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults
Condition: Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal
      powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of
      age who are eligible for study participation will be enrolled in the trial. It is expected
      that 10 subjects will be screened to obtain 7 subjects who will be eligible for study
      participation.

      The primary objective is to determine the frequency and severity of local and systemic
      adverse events of vaccine.

      The secondary objective is to assess the immunogenicity of the vaccine based on geometric
      mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
    


Intervention name(s): GelVac™ nasal powder H5N1 influenza vaccine.; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril; subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Condition: Type1diabetes; Fear of Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)
      is to address the critical need of identifying and decreasing fear of hypoglycemia, which
      will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy
      of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in
      adolescents with Type 1 Diabetes (T1D) and their parents.
    


Intervention name(s): Fear of Hypoglycemia; Treatment As Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will receive exposure and response prevention and/or hypoglycemia awareness training.; Treatment As Usual
Other intervention name(s): Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)
Condition: Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ
MeSH terms: Uterine Cervical Dysplasia; Adenocarcinoma in Situ
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil®
      (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and
      young women aged 20-26 years. The primary hypothesis of the study states that at 1 month
      postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for
      serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to
      young women aged 20-26 years.
    

Detailed description: 
      The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged
      20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month
      7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be
      eligible to participate in the Extension Stage and will be followed up to Month 60. No study
      vaccine will be administered during the Extension Stage.
    

Intervention name(s): V501
Intervention type(s): Biological
Intervention description(s): 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other intervention name(s): (Gardasil®) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; qHPV
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)
Condition: Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the
      maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral
      suberoylanilide hydroxamic acid in participants with solid tumors.
    


Intervention name(s): vorinostat
Intervention type(s): Drug
Intervention description(s): vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration
Other intervention name(s): MK-0683; L-001079038; suberoylanilide hydroxamic acid (SAHA)
Intervention MeSH terms: Vorinostat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumors
RPFNA Assessment of Exercise Effect in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study is being done to see if the investigators can measure changes that occur in breast
      tissue when women at risk of developing breast cancer start an exercise program. The
      investigators are interested in studying this because research shows that women who exercise
      regularly are less likely to develop breast cancer, but there is not very much information
      explaining how exercise could affect breast cells in a way to prevent cancer from occurring.
      In this research study the investigators will use a research technique called breast random
      fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The
      investigators will look at breast cells before and after a participant takes part in an
      exercise program to see if the investigators are able to see any changes in breast cells that
      could have happened due to the exercise program. This research will help us to develop larger
      projects to see if exercise programs could be helpful in preventing breast cancer.
    


Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: High risk
Fluoxetine on Motor Rehabilitation After Ischemic Stroke
Condition: Ischemic Stroke; Motor Impairment
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no
      treatment able to enhance recovery has yet been validated. Some drugs may have a positive
      effect when combined with physical rehabilitation. Previous studies have shown a potential
      effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our
      group has demonstrated in a small group of stroke patients (n=8) that a single dose of
      fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and
      modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind,
      randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin
      (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic
      stroke.
    

Detailed description: 
      We project to include in the study a maximum of 168 patients with a recent (5 to 10 days)
      ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine
      stroke centers in France are involved.

      Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo.

      Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.
    

Intervention name(s): fluoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fluoxetine per os 20 mg daily; placebo per os daily
Other intervention name(s): PROZAC
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stroke recovery; Pharmacological modulation; Selective Serotonin Reuptake Inhibitor (SSRI); Fluoxetine; Brain plasticity; Ischemic Stroke and Motor impairment; Modulation of recovery and cerebral plasticity by Fluoxetine
A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test
Condition: Contraception; Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      The purpose of the post approval study is to evaluate the effectiveness and safety of the
      Essure System when a NovaSure Endometrial Ablation procedure is performed following a
      successful Essure Confirmation Test.
    

Detailed description: 
      This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc.,
      Bayer is now the sponsor of the trial.
    

Intervention name(s): ESS305 (Essure, BAY1454032); NovaSure
Intervention type(s): Device; Procedure
Intervention description(s): Essure Permanent Birth Control; Nova Sure Endometrial Ablation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinics and hospitals
      
Keywords: Endometrial Ablation; Permanent Sterilization; Essure; NovaSure; Prevention of Pregnancy
Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Condition: Granuloma; Aluminum Allergy
MeSH terms: Granuloma
Study type: Interventional

Summary: 
      Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce
      itching granulomas at the injection site. This is usually diagnosed by patch testing. Another
      way of detecting metal allergy is by investigation metal-specific cells in the blood.

      We include participants both with and without granulomas, all have a blood test taken where
      we investigate if any participants have aluminium-specific cirkulation cells, and whether we
      can detect a difference between participants with and without granulomas.
    

Detailed description: 
      Aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas
      at injection site. Most children have concormitant aluminium contact allergy diagnosed by
      path testing, but in adults the allergy can rarely be detected by patch tests.

      An alternative to patch testing is the blood in vitro lymphocyte proliferation test (LPT),
      which we investigated using a well-established LPT protocol. This has previously been shown
      to detect and characterize metal-specific cells and was used to detect circulating
      aluminium-specific proliferation. The LPT test is based on a single blood sample and has
      mostly been used to detect drug hypersensitivity. Still, its role in detecting metal allergy
      is expanding, with recent studies suggesting using the test as a supplement to the patch test
      when only a few allergens are to be investigated.
    

Intervention name(s): Aluminum; Tetanus toxoid
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Different concentrations of aluminium added to the blood test in vitro; Used as control substance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: aluminum; allergy; contact dermatitis; vaccination granuloma; LPT; SCIT