bioihbjkbjnl/mcl2 huggingface dataset:
Hepatic Arterial Chemotherapy With Raltitrexed and Oxaliplatin Versus Standard Chemotherapy in Unresectable Liver Metastases From Colorectal Cancer After Conventional Chemotherapy Failure
Condition: Colorectal Cancer; Liver Metastases
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan
      alone or in association with fluoropyrimidines, oxaliplatin in association with
      fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen
      the national reference frame on the basis of phase II study proposes an association of
      fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with
      progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical
      in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic
      metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic
      parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver
      during the first passage, a high intra-tumoral concentration and a low systemic
      concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with
      fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not
      available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does
      not require a prolonged perfusion and could be a good substitute.In a previous pilot study we
      demonstrated the feasibility, safety and efficacy of combination of raltitrexed and
      oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to
      evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association
      versus standard chemotherapy for patients with metastases of colorectal origin restricted to
      the liver after failure of conventional chemotherapy.
    


Intervention name(s): oxaliplatin; raltitrexed; other intravenous chemotherapy drugs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 130 mg/m²Every 21 days; 3 mg/m² with a maximum of 6 mg every 21 days
Intervention MeSH terms: Oxaliplatin; Raltitrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non resectable metastases; liver of colic or rectal origin; after failure of the conventional treatments
Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults
Condition: Zika Virus
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893
      Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
    


Intervention name(s): mRNA-1893; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Zika vaccine; 0.9% sodium chloride
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: mRNA-1893; zika vaccine; Moderna
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
Condition: Mild Intermittent Asthma
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded,
      randomized, crossover study in which single doses of placebo, will be compared to Fluticasone
      propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen
      challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from
      post-allergen peak)
    

Detailed description: 
      The aim of this pilot study is to evaluate whether fluticasone propionate affects the late
      allergic reaction after a single dose post-allergen challenge administered following
      cessation of the early allergic reaction.

      Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of
      asthma will be and includes the presence of variable airflow limitation and AHR (PC20
      methacholine < 16 mg/mL). Subjects will be asked to participate if they demonstrate an
      allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1,
      respectively.

      The study will consist of 4 periods, composed of a screening allergen period with 3
      subsequent allergen challenge/treatment periods. Each period will be separated with a washout
      of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening
      period will be selected for randomization to treatment.
    

Intervention name(s): Fluticasone propionate (Flovent Diskus) 250 mcg; budesonide 400 mcg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Flovent Diskus 250 mcg; budesonide 400 mcg; Placebo
Other intervention name(s): fluticasone propionate Flovent Diskus250 mcg; Pulmicort Turbuhaler 200 mcg
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: late allergic response; fluticasone propionate
PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.
Condition: Light; Therapy, Complications
MeSH terms: Infections
Study type: Interventional

Summary: 
      We are evaluating the effect of methylene blue and visible light activation on the microbiome
      of the skin.
    

Detailed description: 
      Antiseptics are routinely utilized to prevent infections of vascular catheters. We are
      evaluating the addition of methylene blue and light activation on skin to determine whether
      this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream
      infections of long-term vascular catheters. This is a pilot study of normal volunteers to
      determine the effect on the microbiome of the addition of methylene blue and light activation
      on antiseptic-treated skin.
    

Intervention name(s): Methylene blue and light treatment
Intervention type(s): Procedure
Intervention description(s): Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
Intervention MeSH terms: Methylene Blue
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I clinical study to assess the safety, tolerability and biologic activity of
      in vivo AAV-mediated delivery of CERE-110. Up to 12 subjects will receive open label CERE-110
      in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of
      CERE-110 for a total of four (Dose A and B) and six (Dose C) injections to target the basal
      forebrain region of the brain containing the nucleus basalis of Meynert (NBM). All study
      participants will be observed for a 24-month period and then followed annually.
    


Intervention name(s): CERE-110: Adeno-Associated Virus Delivery of NGF
Intervention type(s): Genetic
Intervention description(s): CERE-110 2.0 x 10^10 vg, CERE-110 1.0 x 10^11 vg, CERE-110 2.0 x 10^11 vg
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Gene Transfer
The Analysis of Correlation About the Spot Urine Sodium and the Blood Pressure in General Population According to the Income Level
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Increasing sodium intake raises blood pressure. And high salt intake could hinder the
      management of chronic disease. Much previous research has confirmed that dietary habits are
      affected by economic status. So we compared sodium intake with economic status. We
      investigated the prevalence, extent and management, and the relevance of sodium intake with
      income level.
    


Intervention name(s): 24_hours_urine_sodium
Intervention type(s): Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        general population
Efficacy and Safety Study of SP2086 in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      SP2086 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the
      efficacy and safety of SP2086 in combination therapy with Metformin in patients with Type 2
      Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control
    


Intervention name(s): Placebo /Metformin; SP2086(50 mg q.d.)/Metformin; SP2086 (100 mg q.d.)/Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too; patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks; patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SP2086; Phase II; combination therapy
Prediction of Response to IUCD Associated Menorrhagia Using Doppler
Condition: Women's Health: Amenorrhea/Dysmenorrhea
MeSH terms: Menorrhagia; Dysmenorrhea; Amenorrhea
Study type: Interventional

Summary: 
      Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in
      women having IUCD associated menorrhagia
    


Intervention name(s): Doppler
Intervention type(s): Device
Intervention description(s): Doing doppler for women having IUCD associated menorrhagia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The overall goal of this project is to conduct a randomized controlled 12-week after school,
      gardening, nutrition and cooking program (called "LA Sprouts") to improve dietary intake and
      reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles.
      Approximately 400 3rd - 5th grade students participating in the LA's Best after school
      program will participate. Four elementary schools in Los Angeles will be selected to
      participate in the study. Schools will be randomized by region to either receive the
      intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed
      intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts
      intervention will take place at the elementary schools, with gardens on campus specially
      designed and built for this project. The program will be held once a week for 12 weeks and
      will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University
      of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute
      nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by
      Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body
      fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and
      lipids), dietary intake and related behaviors, and school performance will be measured before
      and after the implementation of the program in both intervention and control participants.
      Approximately 10 additional students of the same age will be asked to participate in a focus
      group to evaluate the questionnaire developed for this study. In addition, approximately 20
      additonal students of the same age will be asked to participate in a test-retest session to
      validate the reliability of the questionnaire.
    


Intervention name(s): LA Sprouts intervention
Intervention type(s): Behavioral
Intervention description(s): see arm 1 description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gardening; cooking; nutrition education; Hispanic Americans
Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The clinical trial aims to address the critical challenge of differentiating aggressive from
      indolent prostate cancers by correlating prospectively collected MultiParametric (MP)
      Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical
      prostatectomy specimens (reference standard).

      The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound
      guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to
      the suspicious areas identified by MRI.

      The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer
      aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within
      the prostate gland for guiding biopsies.

      Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better
      inform clinicians and patients to improve risk stratification and facilitate decision making
      on subsequent treatment.

      Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy,
      which could obviate the need for multiple biopsies.
    

Detailed description: 
      There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging
      (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan
      treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up
      to one in three men, the histology of radical prostatectomy specimens is different from the
      histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to-
      and is a sign of- poor risk stratification of men with localised PCa.

      The research aims to answer the following questions:

        1. Can image-fusion techniques allow investigators to reliably target abnormal areas seen
           on MP-MRI?

        2. How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?

      The investigators envisage that MP-MRI information will reduce unnecessary biopsies and
      over-detection of indolent PCa, while improving the detection of aggressive disease.

      Primary Objectives

      • To determine whether using MP-MRI can improve cancer detection and characterization of
      prostate cancer

      Secondary Objectives

      • To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative
      biopsies.
    

Intervention name(s): TRUS Biopsy; TRUS/FUSION Biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard of Care Treatment; Interventional Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Image-guided biopsy; Tumour detection; Diagnostic; Biomarkers
Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis
Condition: Bronchiectasis Adult
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in
      Patients with Bronchiectasis between the ages of 30-55
    

Detailed description: 
      Investigating the effect of yoga training on functional capacity and quality of life and
      comparing with previous studies
    

Intervention name(s): Yoga Training Program (exercises)
Intervention type(s): Other
Intervention description(s): Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. The patients will start with breathing exercises, then relaxation exercises, warm-up exercises, asanas (posture exercises) and finally the yoga training program will be completed with deep relaxation technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Yoga Training; Quality of Life; Functional Capacity; Bronchiectasis
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Condition: Neuropathic Pain
MeSH terms: Neuralgia; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of TENS in addition to routine care
      in patients with chronic pain of predominantly neuropathic origin, compared to treatment with
      routine care alone."

      Hypothesis:

      An eventually neuropathic pain component is needed to be identified and alleviated in chronic
      pain patients to improve the quality of rehabilitation.

      0-hypothesis:

        -  TENS is not better than than placebo, medication or standard rehabilitation program.

        -  A neuropathic pain component does not demand special considerations in rehabilitation of
           chronic pain patients.
    

Detailed description: 
      Setting:

      Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for
      chronic pain patients, rheumatic diseases and orthopedic postoperative patients.

      Duration:

      Until 18 months of intervention + 6 months of follow up and preparation.

      Intervention:

      Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation
      (short-term efficacy). TENS or placebo-TENS is added to routine care.

      Follow-up:

      If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to
      borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the
      active group, the placebo group and for the group of patients who discontinued the use of
      TENS/placebo-TENS (long-term efficacy).
    

Intervention name(s): Transcutaneous Nerve Stimulation (TENS); Cefar Primo Pro TENS device
Intervention type(s): Device; Device
Intervention description(s): Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months.; Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises.
Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcutaneous Electrical Nerve Stimulation; Chronic pain; Neuropathic pain; Short-term efficacy; Long-term efficacy
Orthopilot Elite Post-Market Clinical Follow-Up
Condition: Degenerative Osteoarthritis; Rheumatoid Arthritis; Posttraumatic Arthropathy; Instability, Joint; Stiffness of Knee, Not Elsewhere Classified; Deformity of Knee
MeSH terms: Osteoarthritis; Joint Instability
Study type: Observational

Summary: 
      Prospective, multicenter, observational, comparative clinical trial on the equivalence of two
      different OrthoPilot® navigation system generations applied for computer-assisted total knee
      arthroplasty
    

Detailed description: 
      The study is designed as a prospective, non-interventional, multicenter, comparative cohort
      study. The product under investigation will be used in routine clinical practice and
      according to the authorized Instructions for Use (IfU). Those data that are obtained in
      routine clinical use will be documented in the Case Report Form (CRF).

      The study design is based on a two-arms design. The patients for the both groups will be
      recruited consecutively, starting with group A. The study will prove the equivalence of the
      groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis)
      and any deviation >3° from neutral alignment is defined as an outlier.
    

Intervention name(s): Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1; Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0
Intervention type(s): Device; Device
Intervention description(s): Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1; Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients
      
Keywords: Navigation; Computer Assisted Orthopedic Surgery; OrthoPilot®; Total Knee Arthroplasty