bioihbjkbjnl/mcl2 huggingface dataset:
Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus
      bevacizumab as first line treatment in patients with metastatic triple negative breast
      cancer. Furthermore, the efficacy of the combination therapy will be correlated with the
      presence of circulating tumor cells (CTCs) in this population
    

Detailed description: 
      Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative)
      does not respond to hormonal or biological therapy with trastuzumab. However, triple negative
      breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and
      carboplatin administered on a weekly basis is active and well tolerated. Recently, initial
      therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged
      progression-free survival, as compared with paclitaxel alone
    

Intervention name(s): Carboplatin; Bevacizumab; Paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression; Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression; Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression
Other intervention name(s): Avastin; Taxoprol; Paxene; Taxol
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Triple negative; Chemotherapy; Anti-angiogenesis therapy
A Phase 2 Trial Testing ZP1848 in Patients With SBS
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed
      dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
    


Intervention name(s): ZP1848
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.
Condition: Microbiota; Dietary Fibers
Study type: Interventional
Phase: Phase 1

Summary: 
      NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat
      starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble
      in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon
      where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this
      ingredient is a "soluble dietary fiber." The objective of this research is to determine,
      among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and
      digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed
      by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by
      volunteers.
    


Intervention name(s): NUTRIOSE FB06; GLUCIDEX 21
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 15g/day NUTRIOSE FB06; 15g/day GLUCIDEX 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: functional food; digestive tolerance; microbiota; bifidogenic effect
Effect of Two Colonoscopy AI Systems for Colon Polyp Detection
Condition: Adenoma; Colonoscopy; Sessile Serrated Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Computer-aided detection (CADe) systems have been actively researched for polyp detection in
      colonoscopy. The investigators aim to identify the effect of two CADe systems according to
      the system performance on false positive rate
    

Detailed description: 
      Artificial intelligence technology based on deep learning is being applied in various medical
      fields, and research is being actively conducted to develop computer-aided detection (CADe)
      systems for colonoscopies to overcome the limitation of the variance of human skills. These
      well-trained CADe systems demonstrated high performance for neoplastic polyp detection and
      reported a 44% increase in adenoma detection rate (ADR) for endoscopists. However, the level
      of performance in the CADe system is not clear for expert endoscopists to be useful for ADR
      increase.

      Furthermore, false positives(FPs) of the CADe system may negatively influence ADR during a
      screening colonoscopy. Accordingly, the investigators sought to identify the effect of the
      colonoscopy CADe system according to FP performance in endoscopists with various levels. The
      investigators hypothesized that the CADe system with low FPs would be useful to prevent the
      decrease in ADR in case of a high endoscopy workload according to the performance of CADe
      systems.
    

Intervention name(s): Assist by artificial intelligence system for colon polyp detection
Intervention type(s): Device
Intervention description(s): Assist by artificial intelligence system for colon polyp detection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The primary outcome was the comparison of ADR between the control and AI groups according to the intervention system (SCAI vs ENAD system).
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: endoscopist; adenoma detection rate; colonoscopy; artificial intelligence
Metabolome and Microbiomic in Fecal Samples
Condition: Infant
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effects of storage and handling on fecal samples
      collected for metabolomic, proteomic and microbiomic and analysis.
    

Detailed description: 
      Background

      Human fecal collection for clinical or research studies usually occurs at the residence of
      the subject, an environment not equipped with measures to accommodate proper preparation and
      storage of samples for microbiome and metabolome analysis.

      Aims

      To evaluate the effects of storage and handling on fecal samples collected for metabolomic,
      proteomic and microbiomic and analysis.

      Methods

      Fecal samples will be collected within several minutes of voiding from healthy infants at the
      time of diaper change at day-care center.

      Samples will be divided into 7 tubes, and subjected to different storage temperatures, before
      preforming microbial analysis by DNA sequencing, and metabolome analysis by H1NMR
      spectroscoty.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy toddlers in a day care center
      
Biospecimen description: 
      Stool samples
    
Keywords: microbiome; metabolome; stool; fecal samples; handling; toddler
A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label study will evaluate the safety and efficacy of riluzole in patients with
      PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient,
      with a one month follow up at week 16.
    


Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention MeSH terms: Riluzole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy
Condition: Pharmacoresistant Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The aim of this study is to compare analgesic efficacy of two non invasive techniques based
      on motor cortex stimulation in neuropathic pain patients. High frequency repetitive
      transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to
      induce an analgesic effect significantly different from placebo; this effect is clinically
      useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct
      current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its
      efficacy in neuropathic pain has been not yet established. The investigators propose to
      compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using
      HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed
      before and after the five sessions of rTMS and tDCS, in order to reveal the potential
      plasticity induced within motor somatotopic map of the primary motor cortex.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; neuropathic; cortical stimulation; motor cortex; plasticity; rTMS; tDCS
Clinical Evaluation of M22 ResurFX 1565nm Module
Condition: Wrinkles; Striae
Study type: Interventional

Summary: 
      At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2
      clinical sites; each clinic will enroll at least 15 subjects.

      Subjects should present visible wrinkles and/or striae requiring treatment.

      Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at
      least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least
      50% using VAS as compared to baseline, for at least 75% of the subjects.
    


Intervention name(s): M22 ResurFX module
Intervention type(s): Device
Intervention description(s): The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea
Condition: Rosacea; Wrinkles
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in
      wrinkle and rosacea treatment.

      Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then
      twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the
      clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.
    


Intervention name(s): Luxe
Intervention type(s): Device
Intervention description(s): Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Re-evaluation of Blind Intubation Through the Air-Q Intubating Laryngeal Airway
Condition: Techniques of Endotracheal Intubation in Pediatrics
Study type: Interventional

Summary: 
      To compare the success rate of blind technique with correction manoeuvres versus fiber optic-
      guided Intubation through the air Q laryngeal airway in pediatric patients
    

Detailed description: 
      A prior G-power analysis was done to estimate the sample size. The primary outcome of this
      study was the first trial success rate. Using fibre exact test and assuming alpha (type I
      error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be
      sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of
      cases was expected; therefore 63 patients were required in each group to detect the
      difference.
    

Intervention name(s): Blind tracheal intubation through AirQ; Fiberscopic tracheal intubation through AirQ
Intervention type(s): Procedure; Procedure
Intervention description(s): underwent blind intubation with correction manoeuvres; : underwent fibreoptic guided intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: air-Q, blind intubation, correction maneuvers, fiberoptic guided intubation
Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of food insulin index (FII) on metabolic
      parameters and appetite in obese adolescents with insulin resistance. A randomized,
      single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin
      resistance. All participants were submitted two different breakfasts: low glycemic index, low
      insulin index (LGI-LII) and low glycemic index, high insulin index (LGI-HII), with a 1-week
      washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180
      and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and
      appetite was evaluated by visual analog scale. At the end of four hours, participants were
      served ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy
      and nutrient analysis was calculated.
    


Intervention name(s): LGI-LII Breakfast; LGI-HII Breakfast
Intervention type(s): Other; Other
Intervention description(s): This test meal with low GI and low FII amounts were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.; In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Pediatric Obesity; Insulin Resistance; Diet
FlowTriever Pulmonary Embolectomy Clinical Study
Condition: Pulmonary Embolism; Acute Pulmonary Embolism; Submassive Pulmonary Embolism; Massive Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of
      emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.
    


Intervention name(s): FlowTriever System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thromboembolism; Thrombectomy; Right Heart Strain; Submassive PE; Right Ventricle Dysfunction; Massive PE
A Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Cancer Patients With Advanced Solid Tumors.
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether amrubicin is safe and effective in the
      treatment of patients with advanced solid tumors. The study will assess the pharmacokinetics
      of the amrubicin and if it has an effect on the heart.
    


Intervention name(s): Amrubicin
Intervention type(s): Drug
Intervention description(s): 40mg/m^2 5 minute IV infusion for 3 consecutive days (21 day cycle)
Intervention MeSH terms: Amrubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MK-8237 (SCH900237) Biomarker Study in Participants With Allergic Rhinitis or Rhinoconjunctivitis (MK-8237-009)
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect on various biomarkers of treatment with
      MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the study
      healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM)
      extract in order to verify the operational performance of NAC and associated sample
      collection methods. Part 2, the main study, is a placebo controlled, double blind study of
      participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary
      hypotheses are that the changes from baseline in post-allergen challenge HDM-specific
      Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after
      treatment with MK-8237 than after treatment with placebo.
    


Intervention name(s): MK-8237; Placebo; NAC
Intervention type(s): Biological; Other; Biological
Intervention description(s): A single tablet of MK-8237 with 12 DU, administered sublingually, at approximately the same time each day for 84 days (+/- 5 days); A single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days); 0.1 mL fixed volume of 10,000 BU/mL of HDM extract is delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1; and in Part 2 on Days -14, 56 and 84
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
Condition: Deep Vein Thrombosis; Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      A preliminary clinical usability study to assess design, comfort, wearability, and acceptance
      of Recovery Force's Deep vein thrombosis (DVT) cuff
    

Detailed description: 
      A single site, observational study will be conducted at the University of Southern California
      (USC) with participants who have and/or have had previous experience with DVT pneumatic
      cuffs. Study staff will examine participants overall experience, product functionality and
      perceived adherence to Recovery Force's DVT II cuff.
    

Intervention name(s): Deep Vein Thrombosis (DVT) Cuff
Intervention type(s): Device
Intervention description(s): Recovery Force's DVT II Cuff
Other intervention name(s): RF1400
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults
Condition: Influenza; Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).

      The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among
      three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per
      patient with a 3 week interval between vaccination in healthy young adults.

      Immunogenicity will be confirmed by both microneutralization (MN) antibody and
      hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving
      different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a
      total of 90 healthy young adults aged 20-40 years enrolled in this study.
    


Intervention name(s): UMN-0501; UMN-0501; UMN-0501
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart; 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart; 2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart
Other intervention name(s): UMN-05; UMN-05; UMN-05
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: H5N1; Vaccine; Influenza H5N1; Avian influenza H5N1; Pandemic
Efficacy of Topical Cyclosporin for Ocular Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective
      in the treatment of ocular rosacea
    

Detailed description: 
      The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of
      Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients
      presently controlled on topical corticosteroids
    

Intervention name(s): Cyclosporine 0.05%; Ocular lubricant
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Finances First: A Health Intervention in Low Income Single Mother Households
Condition: Financial Stress
MeSH terms: Financial Stress
Study type: Interventional

Summary: 
      The purpose of this prospective, randomized, controlled three-year study is to compare the
      effect of a year-long financial education program versus usual care on health outcomes in
      single mother low income households.
    


Intervention name(s): Financial Education
Intervention type(s): Behavioral
Intervention description(s): Participants randomized to financial education will undergo a year long financial education. This involves 9 weeks of weekly classes followed by one on one coaching for a year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Osteopathic Techiniques on Intraocular Pressure
Condition: Intraocular Pressure; Osteopathic Manipulative Treatment
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects osteopathic techniques at the upper
      cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.
    

Detailed description: 
      The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1
      that will receive a technique of manipulation of the upper cervical, an experimental group 2
      that will receive a technique of manipulation of the sphenopalatine ganglion and a control
      group that will not receive any intervention. Each volunteer will participate in the 3
      groups. There will be 4 assessments, one before the procedure and one just after each
      procedure, including the control.
    

Intervention name(s): Upper cervical manipulation; Sphenopalatine ganglion manipulation
Intervention type(s): Other; Other
Intervention description(s): The patient will receive an upper cervical manipulation as described in the Experimental Group 1.; The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intraocular pressure; sphenopalatine ganglion; superior cervical ganglion; aqueous humour