bioihbjkbjnl/mcl2 huggingface dataset:
Celecoxib and Radiation Therapy in Treating Patients With Stage II or Stage III Soft Tissue Sarcoma of the Arm, Hand, Leg, or Foot That Has Been Removed by Surgery
Condition: Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma
MeSH terms: Sarcoma; Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy
      after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when
      given together with radiation therapy in treating patients with stage II or stage III soft
      tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of adjuvant celecoxib administered with
           radiotherapy in patients with resected stage II or III soft tissue sarcoma of the
           extremity.

      OUTLINE: This is a dose-escalation study of celecoxib.

      Beginning within 10 weeks of the most recent resection, patients undergo standard
      radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib
      twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
      of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the
      MTD.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
    

Intervention name(s): celecoxib; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chondrosarcoma; adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; childhood angiosarcoma; childhood fibrosarcoma; childhood leiomyosarcoma; childhood liposarcoma; childhood neurofibrosarcoma; childhood synovial sarcoma; nonmetastatic childhood soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; childhood malignant hemangiopericytoma; localized childhood malignant fibrous histiocytoma of bone
The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objectives: Use both listed and relatively safe drug, Silymarin,s to improve the
      intestinal side effect of the patients undergoing FOLFIRI chemotherapy.
    

Detailed description: 
      Primary Objective:

      Use both listed and relatively safe drug, Silymarin, to improve the intestinal side effect of
      the patients undergoing FOLFIRI chemotherapy.

      Patient Selection and Enrollment:

      Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to
      reach approximately 70 patients in total.

      Plan of the Study:

      Study Design This is an open-label, randomized, comparative, double arm, single center study
      to assess efficacy of Silymarin as adjuvant therapy on metastatic colorectal cancer patients
      undergoing FOLFIRI chemotherapy in Taiwan.

      Subject Number Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach
      approximately 70 patients in total.

      Study Schedule Study date: the time getting approval letter issued by both regulatory
      authority and institutional review board (IRB) Duration of study: From the date of the IRB
      was approved till the 70th patient was collected.

      Duration of Enrollment: From the date of the IRB was approved till the 70th patient was
      collected.

      Duration of treatment: From the 1st patient starting chemotherapy till the 70th patient
      finishing the 6th cycle chemotherapy.

      Duration of follow-up: From the 1st patient starting chemotherapy till 3 months after the
      70th patient finishing the 6th cycle chemotherapy
    

Intervention name(s): Silymarin
Intervention type(s): Drug
Intervention description(s): During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPT-11(irinotecan); silymarin; GI toxicity
Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single doses of
      ILV-095 in healthy subjects.
    


Intervention name(s): ILV-095; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of GENEVAX-HIV, a Possible Vaccine
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV
      vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV
      injected into the muscle to the effects of the drug when injected into the skin.
    

Detailed description: 
      Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and
      cellular responses are assessed accordingly.
    

Intervention name(s): APL 400-003
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Injections, Intradermal; Injections, Intramuscular; HIV Antibodies; Immunity, Cellular; AIDS Vaccines; HIV Seronegativity; Dose-Response Relationship, Immunologic; Vaccines, DNA; Immunity, Mucosal
Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults
Condition: Young; Healthy
Study type: Observational

Summary: 
      This study has as objective to characterize the start of pharyngeal phase of swallowing, in
      the various food consistencies and volumes, with and without the influence of verbal orders,
      observed on videofluoroscopy of deglutition.
    

Detailed description: 
      Quantitative study, transverse and observational study, in the period January to March 2010,
      in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza,
      Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %)
      female and five (12.5%) male gender. was carried out an assessment videofluoroscopy
      swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste
      (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and
      solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and
      the images were carried out in the lateral position. From the beginning of the rapid movement
      of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 Young adults and healthy, individuals with ages ranging between 20 and 30 years without,
        mean age 23.5 years, ranging between 20 and 30 years 87.5% (35/40) female 12.5% (5/40)
        male.
      
Keywords: Deglutition; Fluoroscopy
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in
      combination with pegylated interferon alpha and ribavirin, are safe and demonstrate
      sufficient anti-hepatitis C virus activity.
    


Intervention name(s): Daclatasvir; Daclatasvir; Daclatasvir; Placebo; Peginterferon alpha-2a; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral, 3 mg, Daily, 48 weeks; Tablets, oral, 10 mg, Daily, 48 weeks; Tablets, oral, 60 mg, Daily, 48 weeks; Tablet, oral, 0 mg, Daily 48 weeks; Syringe, subcutaneous, 180 µg, Weekly, 48 weeks; Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antivirals
Proactive and Reactive Attention to Negative Templates
Condition: Healthy
Study type: Interventional

Summary: 
      EEG Measures during Visual Search Task. In this line of research, the researchers having
      participants receive a positive (target) template cue, negative (distractor) template cue, or
      neutral (non-informative) template cue. Note: This is a re-analysis of previously collected
      data.
    

Detailed description: 
      When finding a search target, receiving a target cue or distractor cue can increase search
      efficiency compared to a neutral cue. The researchers are examining the neural basis of
      visual search when participants receive a positive (target) cue, negative (distractor) cue,
      or neutral (baseline) cue. Note: This is a re-analysis of previously collected data.
    

Intervention name(s): Attentional Cue Type
Intervention type(s): Behavioral
Intervention description(s): Positive cue (target), negative cue (distractor), or neutral cue (baseline)
Intervention model: Single Group Assignment
Intervention model description: Within-Subjects Design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: attention; visual search; electroencephalogram (EEG)
Effects of Berries and Berry Fractions on Metabolic Diseases
Condition: Type 2 Diabetes; Atherosclerosis
MeSH terms: Atherosclerosis; Metabolic Diseases
Study type: Interventional

Summary: 
      The study hypothesis is that the bioactive compounds of sea buckthorn berries (Hippophaë
      rhamnoides), their fractions, and bilberries (Vaccinium myrtillus). have positive effects on
      lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic
      diseases.
    

Detailed description: 
      The aim of the project was to investigate whether it is possible to reduce the risk of
      metabolic diseases with supplementing the diet with sea buckthorn berries (Hippophaë
      rhamnoides), their bioactive fractions, and bilberries (Vaccinium myrtillus). The study
      design was a randomized cross-over clinical trial. The participants were slightly and
      moderately overweight female subjects. In total, 110 female volunteers were recruited, and
      they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic
      extract and sea buckthorn oil) in a randomized order for 33-35 days. Each intervention was
      followed by a wash-out period of 30-39 days. Blood samples were drawn and physical
      measurements were performed after each period. Eighty volunteers completed the study.
      Different markers of lipid and carbohydrate metabolism and inflammation were measured form
      the blood samples.
    

Intervention name(s): Bilberries; Sea buckthorn berry; Sea buckthorn phenolic extract; Sea buckthorn oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Frozen bilberries, 100 g/d; Dried sea buckthorn berries, 20 g/d; Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin); Sea buckthorn oil, 4 g (8 capsules)/d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of Hydrotherapy in Peripheral Neuropathy
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in
      patients affected by neuropathy.
    


Intervention name(s): hydrotherapy; on land therapy
Intervention type(s): Other; Other
Intervention description(s): 30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks; 30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes
Condition: Erectile Dysfunction; Diabetes Mellitus, Type 2
MeSH terms: Erectile Dysfunction; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effect on erectile function in a population of type 2 diabetic men with
      erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a
      daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an
      as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II).
      To assess safety and tolerability of this dosing regimen and to investigate its effects on
      endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR)
      questionnaire.
    


Intervention name(s): sildenafil; placebo; sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.; In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.; Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Observational [Patient Registry]

Summary: 
      Primary objective of this study is to construct and validate a modified luminous efficiency
      function that addresses the distinct total eye light transmittance of patients that underwent
      bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs)
      implantations.
    

Detailed description: 
      Present study aims to identify in which degree multifocal IOLs modify eye light transmission
      and estimate the necessary task and environmental lighting adjustment in order to address
      lighting needs of patients following bilateral pseudophakic presbyopic corrections.
      Specifically, the aim of this study is to identify the minimum light intensity in which
      patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their
      maximum visual acuity (measured when lights are at the 100% lighting level)
    

Intervention name(s): Phacoemulsification with bilateral trifocal diffractive IOLs
Intervention type(s): Procedure
Intervention description(s): Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral
        trifocal intraocular lenses implantation
      
Keywords: pseudophakic presbyopic correction; trifocal intraocular lens; light intensity; eye light transmittance; light efficiency function
Renal Impairment Study
Condition: Clinical Trial, Phase I
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe
      renal impairment compared to age; weight, and gender-matched healthy subjects.
    


Intervention name(s): Fulacimstat (BAY1142524)
Intervention type(s): Drug
Intervention description(s): single oral dose of 25 mg immediate-release tablet BAY1142524
Intervention MeSH terms: Fulacimstat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Yoga for Substance Use Risk Factors in a School Setting
Condition: Adolescent Development
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of yoga taught during school to positively influence
      risk and protective factors of substance use and the initiation and severity of substance
      use. The study hypothesis is that, compared to a control group participating in regular
      physical education classes, subjects who participate in 32 yoga sessions across an academic
      year will improve in negative internalizing behaviors and self-regulatory skills that are
      known risk and protective factors for substance use. This study will also test the hypothesis
      that the yoga intervention will reduce both severity of substance use and the degree of
      substance use initiation.
    

Detailed description: 
      The long-term, programmatic goal of this research is to advance prevention of addictive
      behaviors especially substance use in normal adolescent psychological development. The
      overall goal of this proposal is to pilot test a novel, preventive intervention for
      adolescent substance use. More specifically, it will evaluate the efficacy of yoga taught
      during school to positively influence risk and protective factors of substance use and the
      initiation and severity of substance use.

      This study involves a group randomized, controlled trial of yoga compared to physical
      education-as-usual for one school year, with a 6-month and 1-year follow-up, in order to
      accomplish the following specific aims:

      Specific Aim 1 - To evaluate the efficacy of a school-based yoga program for reducing
      negative internalizing behaviors (negative mood, perceived stress, impulsivity) which are
      risk factors for adolescent substance use.

      Specific Aim 2 - To evaluate the efficacy of this yoga program for promoting self-regulatory
      skills as protective factors against substance use in adolescence.

      Specific Aim 3 - To conduct a preliminary evaluation of the efficacy of this yoga program for
      reducing substance use initiation and severity of use.
    

Intervention name(s): Yoga during physical education
Intervention type(s): Behavioral
Intervention description(s): 12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.
Other intervention name(s): Kripalu Yoga In The Schools
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mental health; Substance use; Substance use initiation; Education; Mind Body Therapies; Yoga; Meditation; Adolescent; Adolescence; Child; Children; Middle School
Insulin Glulisine in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to compare the effect of insulin glulisine, insulin
      lispro and unmodified human insulin on endogenous glucose production during euglycemic
      glucose clamps using stable labeled glucose in type 1 diabetic subjects.

      The secondary objectives of the study were to assess:

        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma
           nonesterified free fatty acids (NEFA) and glycerol levels

        -  the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma
           lactate levels

        -  the safety and tolerability of insulin glulisine in comparison to insulin lispro and
           unmodified human insulin.
    


Intervention name(s): Insulin Glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of a light meal and a high-fat meal on
      the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants.
      Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat
      meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of
      the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions
      will be assessed.
    


Intervention name(s): BMS-986205
Intervention type(s): Drug
Intervention description(s): Single dose, 100 mg administered at Day 1 and at Day 15.
Intervention MeSH terms: Linrodostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cancer; Tumor; Healthy Participants; Healthy Subjects; Neoplasm