bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Cardiovascular Vitamin, CardioLife
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Evaluation of the metabolic and physiological characteristics of patients with diagnosed
      Cardiovascular Disease following administration of the Cardiovascular vitamin, CardioLife.
    

Detailed description: 
      The goal of this study is to evaluate the safety and efficacy of cardiovascular nutraceutical
      supplement, CardioLife™ in patients with diagnosed Cardiovascular Disease (CVD). CardioLife
      is a novel nutraceutical intended for the prevention and management of cardiovascular risk
      factors, enhancement of cardiac performance and the treatment of cardiac dysfunction. This is
      an oral vitamin supplement comprising of the following main ingredients: garlic co-enzyme
      Q10, Arjuna, Hawthorn, Guggul, Red Yeast Rice, Policosanol, Nattokinase, Tumeric/curcumin,
      ashangandha, L-carnitine, grape seed extract, and vitamin B12.
    

Intervention name(s): CardioLife
Intervention type(s): Dietary Supplement
Intervention description(s): Participants randomized to treatment arm will take dietary supplement as instructed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: cardiovascular supplement; cardiovascular disease; coronary artery disease
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is
      overexpressed manifold on prostate cancer cells and is well-characterized as an imaging
      biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is
      a nuclear medicine procedure based on the measurement of positron emission from radiolabeled
      tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA.
      The strength of functional imaging methods is in distinguishing tissues according to
      metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can
      detect prostate cancer lesions with excellent contrast and a high detection rate even when
      the level of prostate specific antigen is low.

      The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in
      locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at
      initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score.
      This is of interest because non-invasive risk stratification may be possible in the future.
    


Intervention name(s): 18F-DCFPyL PET/CT
Intervention type(s): Drug
Intervention description(s): 18F-DCFPyL PET/CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Condition: Rotator Cuff Injury
MeSH terms: Rotator Cuff Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Randomized controlled trial on efficacy of single injection or continuous interscalene
      brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.
    


Intervention name(s): Baxter INFUSOR System; Single Injection of Local Anesthetic
Intervention type(s): Device; Drug
Intervention description(s): Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia; Single injection of 20 ml ropivacaine 0.5%
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder arthroscopy; 24-week follow-up; quality of life; rehabilitation achievement; rotator cuff repair
A Study to Compare the Bioavailability Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE™ FLUTICASONE With 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2)
Condition: Mild to Moderate Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440
      µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.
    


Intervention name(s): Flovent HFA; OPTINOSE™ FLUTICASONE
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
Condition: Volume Deficiency of the Midface
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the degree of improvement in appearance after
      treatment with different hyaluronic acid (HA) fillers. Product selection is based on
      Investigator assessment of participant tissue coverage and main treatment goal (volumizing,
      lifting or contouring).
    


Intervention name(s): Restylane Volyme; Restylane Defyne; Restylane Lyft Lidocaine
Intervention type(s): Device; Device; Device
Intervention description(s): Hyaluronic based filler; Hyaluronic based filler; Hyaluronic based filler
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
Condition: Lymphoma, Malignant
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      Combination of involved field radiotherapy for the control of macroscopic disease and CD20
      antibody Rituximab for the control of microscopic remainders in other regions in patients
      with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.
    

Detailed description: 
      The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial
      combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) in
      combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the
      combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the
      study is progression free survival. Secondary endpoints are response rate to Rituximab,
      complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival,
      overall survival, toxicity and quality of life.

      More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage
      follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a
      prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): 375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated
Hippocampal Neurogenesis in Human Subjects
Condition: Hippocampal Neurogenesis in Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Observational

Summary: 
      This study is being done to measure the number of brain cells that grow in the brain
      throughout our lives while determining an effective way to complete this with an MRI
      (Magnetic Resonance Imaging) scanner. The number of these brain cells may be affected by
      cocaine use. Researchers are trying to understand the long-term effects of cocaine use on the
      brain.
    

Detailed description: 
      New neurons are generated through the process of neurogenesis. Although most active during
      pre-natal development, neurogenesis persists throughout the human lifespan. In adulthood,
      neurogenesis occurs predominantly in the subgranular zone of the hippocampal dentate gyrus. A
      highly novel methodology using Magnetic Resonance Spectroscopy (MRS) has recently been
      developed to measure the formation of hippocampal newborn stem cells in the human brain. We
      propose to assess Neural Progenitor Cells (NPCs) in the neuropsychiatric disorder cocaine
      dependence, a chronic disease process associated with pathology of the hippocampus and
      impaired neurogenesis. In addition, we will assess other measures associated with
      neurogenesis, including hippocampal (dentate gyrus) cerebral blood volume (CBV) using
      Vascular-Space-Occupancy (VASO) Magnetic Resonance Imaging. We predict that newborn
      hippocampal cells [or neuronal progenitor cells (NPCs] will be attenuated in recently using
      cocaine-addicted participants relative to abstinent and control participants, and that these
      changes will be paralleled by changes in CBV. In this pilot study, we will assess for these
      changes in cocaine-addicted subjects who are actively using cocaine and those who are
      recently abstinent (three to six months) as well as age-, race-, and gender-similar control
      participants.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from residential sober living and outpatient facilities.
        Patients will also be recruited through flyers placed locally. Healthy controls will be
        recruited from the Greater Dallas community.
      
Keywords: Neurogenesis; Addiction; Cocaine; MRI; MRS
Metflex: The Effectiveness of a Dietary Intervention
Condition: Metabolic Flexibility
Study type: Interventional

Summary: 
      This study is testing the effectiveness of a dietary intervention by means of measuring the
      change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the
      kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge
      before and after a 6-week dietary intervention. The challenges will be applied to investigate
      whether the kinetic response is a better measure for health and wellbeing when compared to
      fasting (baseline) levels. In addition, several measures that reflect perceivable benefits
      like mood, quality of life, sleep quality, cognitive and physical performance will be
      assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable
      benefits.

      Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6
      weeks. Before and after the intervention several measurements will take place. The low
      glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts,
      and low in glycemic carbohydrates. All these dietary factors have been shown to improve
      glycemic control and/or to reduce metabolic syndrome risk factors.
    


Intervention name(s): Low glycaemic load diet; Western diet
Intervention type(s): Other; Other
Intervention description(s): Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks.; Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Observational

Summary: 
      The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32
      weeks) in real life situation and the management of RDS.
    

Detailed description: 
      Description includes gestational age, birth clinical characteristics in particular the
      respiratory function, evaluation of the mother prenatal corticosteroids treatment in
      prophylaxis of RDS, mother medical and obstetric history, premature babies care in the
      delivery room with a special focus on the Curosurf use: prophylactic or curative use / other
      surfactant / no surfactant. A special focus is on the Prophylactic use.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        900 premature babies in 2 groups/cohorts : group 1 - babies born before 28 weeks GA ;
        groupe 2 - babies born at 28 - 32 weeks GA
      
Keywords: pulmonary surfactant; Respiratory distress syndrome; Newborn; prophylaxis
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional

Summary: 
      Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big
      challenge. The aim of the study was to compare the long-term results of antimicrobial
      photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical
      therapy in patients with aggressive periodontitis. Clinical parameters of probing depth,
      clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9
      and 12 months after treatment.
    

Detailed description: 
      Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis)
      represents a big challenge. The aim of the study was to compare the long-term results of
      antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to
      conventional non-surgical therapy in patients with aggressive periodontitis. Materials and
      methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C
      periodontitis) were divided into two groups: the test group (TG) received non-surgical
      therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of
      670nm associated with HELBO Blue photosensitizer, and the control group (CG) received
      non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days).
      Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP)
      were assessed at baseline, 3, 6, 9 and 12 months after treatment.
    

Intervention name(s): antimicrobial photodynamic therapy; systemic antibiotics
Intervention type(s): Device; Drug
Other intervention name(s): HELBO TheraLite Laser; Amoxicillin (Hiconcil); Metronidazole (Efloran)
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Metronidazole; Anti-Infective Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Photodynamic therapy; Antibiotic therapy
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
Condition: END STAGE RENAL DISEASE
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this explorative trial is to collect preliminary data on efficacy and safety
      of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent
      influenza vaccine in hemodialysis patients. The final aim is that of gathering information
      needed for planning a following confirmatory study on the efficacy and safety of Thymosin
      alpha 1 in the same indication.
    

Detailed description: 
      The emergence and spread of the novel influenza A (H1N1) virus has been of great concern
      globally.

      Uremic patients are especially vulnerable to infections and it is generally recommended to
      vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on
      haemodialysis (HD) the vaccination response has been considered suboptimal.

      Decreased antibody response to T-cell dependent antigens may be one factor that accounts for
      insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody
      responses have also been reported in patients with end-stage renal disease. The evidence for
      impairment of cell-mediated immunity in hemodialysis patients has been attributed to
      incompetence in T-cell-mediated immune responses.

      Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of
      Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be
      effective.
    

Intervention name(s): MF59 adjuvanted H1N1 influenza monovalent vaccine; Thymosin alpha 1; Thymosin alpha 1
Intervention type(s): Biological; Drug; Drug
Intervention description(s): One/two single administration; 1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0); 1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)
Other intervention name(s): Focetria™; Zadaxin; Zadaxin
Intervention MeSH terms: Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ESRD
Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the
      efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a
      neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast
      cancer.

      The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The
      neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each
      cycle will be 21-28 days.
    

Detailed description: 
      The duration of treatment for each subject will be 63 - 84 days (or 3 cycles). The cycle will
      be initiated at Day-1 (D1 of the 1st cycle). The subsequent cycles will start on Day-22 (D1
      of the 2nd cycle) and Day-43 (D1 of the 3rd cycle). DLBS1425 capsules will be administered
      orally every day (starting from D1 of each cycle) during the study period. All subjects will
      be under direct supervision of a medical doctor during the study period.

      Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety
      will be performed at baseline and at the end of every cycle over the study course; whilst
      breast-CT scan will be performed at baseline and at the end of study course.

      In addition, at the end of study, at the discretion of Investigator and subjects' own
      willingness, subjects with good response to treatment (i.e. RECIST and pathological
      evaluation are regarded as complete or partial response) may continue their breast-cancer
      therapy with DLBS1425.
    

Intervention name(s): DLBS1425; Placebo DLBS1425
Intervention type(s): Drug; Drug
Intervention description(s): DLBS1425 capsule 150 mg thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.; Placebo DLBS1425 capsule thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant therapy; Stage II/III
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in
      patients with fixed orthodontic appliances.This study is a double blind randomized controlled
      trial.
    


Intervention name(s): Acacia catechu; Chlorhexidine gluconate; Distilled water
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Hexidine
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Acacia; Chlorhexidine; Gingivitis; Orthodontic appliances.
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
Condition: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that
      are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or
      relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity
      of nilotinib as secondary objectives.
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Intervention description(s): Nilotinib capsules were delivered in bottles with dose strengths of 50mg, 150mg and 200mg.
Patients were administered nilotinib 230 mg/m2 (per BSA) bid, orally, rounded to the nearest 50 mg (max single dose 400 mg) for 28 days (1 cycle) for up to 12 cycles prior to protocol amendment 3 and up to 24 cycles post amendment 3. Capsules were to be swallowed whole with water. Apple sauce (puréed apple) may have been used as a vehicle for dosing where capsules were not able to be swallowed whole with water.
Other intervention name(s): AMN107
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Ph+ CML; Ph+ ALL; pediatric; nilotinib; imatinib; chronic phase; accelerated phase; newly diagnosed Ph+ CML; dasatinib
Parent-Adolescent Interactions and Adolescent Development
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to observe parent-adolescent interactions and to examine the
      parenting behaviors and adolescent emotional and physiological responses that are associated
      with youth's substance use.
    

Detailed description: 
      The study examines parenting behaviors and adolescent emotional responses during
      parent-adolescent interactions and whether these predict youth's current and future substance
      use over a 3 year follow-up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        12-14 year olds and their primary caregivers.
      
Biospecimen description: 
      Retain saliva sample.