bioihbjkbjnl/mcl2 huggingface dataset:
The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent
Condition: Arterial Occlusive Diseases
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent
      System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm)
      in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency
      rate at 6 and 12 months post procedure.
    

Detailed description: 
      This is a German multi-center prospective, randomized, two-arm study evaluating performance
      of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard®
      Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated
      that a total of 200 patients will be entered into the study.

      The study population will consist of approximately 200 symptomatic peripheral vascular
      disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long
      de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic
      imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least
      one distal popliteal artery must be patent as well as one calf vessel. Reference vessel
      diameter must be >= 4.0 to <= 6.0 mm.

      Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
      or to the Bard® Luminexx™ 6F Vascular Stent.

      Patients will be followed for twelve months post-procedure. Study examinations will be done
      at screening, procedure time, discharge, six, and twelve months post procedure.

      This study will be conducted over up to 15 investigational sites in Germany.
    

Intervention name(s): Smart Stent; Luminexx Stent
Intervention type(s): Device; Device
Intervention description(s): Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System; Bard® Luminexx™ 6F Vascular Stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Occlusive Disease
Drug Interaction Study Between Dorzagliatin and Sitagliptin
Condition: Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of
      glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics
      and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be
      studied.
    


Intervention name(s): Sitagliptin; Dorzagliatin
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin (Januvia® 100 mg tablets for oral administration); Glucokinase activator currently under development
Other intervention name(s): Januvia; HMS5552
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study examines the impact of an online decision tool for patients with early stage
      invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly
      diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas.
      Participants will be randomized to receive either a basic version of a decision tool (similar
      to existing website with breast cancer information) or an enhanced version (featuring a
      knowledge building component, a values clarification exercise, and a patient activation
      module). Our hypothesis is that patients who use the enhanced version of the tool will have
      greater knowledge of their test and treatment options, have a higher rate of high quality
      (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the
      decision-making process.
    

Detailed description: 
      Patients newly diagnosed with breast cancer face a series of complex decisions regarding
      locoregional and systemic treatment. Currently many of these decisions do not meet the
      definition of a high quality decision, defined as one that is both informed (i.e., based on
      an accurate understanding of the treatment risks and benefits) and preference-concordant
      (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of
      evaluative tests has made these decisions more complicated for many patients. There is a need
      to improve the quality of locoregional and systemic treatment decisions for breast cancer
      patients, and to help patients understand the role of evaluative tests in this decision
      process. Ensuring patients can deliberate effectively about these decisions, assert their
      views and communicate with their clinicians is likely to improve their overall decision
      preparedness and satisfaction. This study will focus on the third pillar of individualized
      care by evaluating the impact of an innovative decision tool on locoregional and systemic
      therapy decision making for newly diagnosed breast cancer patients. The innovative online
      decision tool has been developed and tested over the past two years by the CanSORT team (R21
      CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and
      decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is
      enhanced in collaboration with our Communication and Dissemination Core, on the quality of
      decision making for locoregional and systemic breast cancer treatment decision making.
    

Intervention name(s): Static version of CanSORT tool; CanSORT Online Tool
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
mHealth ALIBIRD: A Digital Health Care Model
Condition: Thoracic Neoplasms
MeSH terms: Thoracic Neoplasms
Study type: Interventional

Summary: 
      The aim of this pilot study was to evaluate the feasibility and acceptability of the ALIBIRD
      platform, a new mobile health (mHealth) application prototype design for personalized and
      remote support on the follow-up of cancer patients. The ALIBIRD platform is a mHealth
      intervention that tracks PROs, improving symptom control and allowing real-time feedback, and
      provides personalized recommendations and educational content, promoting empowerment and
      encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active
      treatment.
    

Detailed description: 
      The investigators have developed an innovative mHealth platform that provides personalized
      recommendations based on Patient Reported Outcomes (PROs) records and the study of patient´s
      nutrigenomics and gut microbiome. The usability of the ALIBIRD mHealth platform prototype is
      being tested in a 28-week pilot study carried out at Infanta Sofía Hospital. A small group of
      stage IV thoracic neoplasms patients (n=20) were asked to participate. All the participants
      gave informed consent.
    

Intervention name(s): ALIBIRD mHealth platform
Intervention type(s): Device
Intervention description(s): Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Active Treatment
Gaze Contingent Feedback in Major Depressive Disorder (MDD)
Condition: Depression, Unipolar; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether giving gaze-contingent feedback is an
      effective attention modification procedure, helping in the treatment of Major Depressive
      Disorder (MDD)
    

Detailed description: 
      The study examines giving depressive participants gaze-contingent feedback as a novel
      attention training procedure. Half of the participants will receive contingent feedback while
      the other half would receive non-contingent "placebo" feedback.
    

Intervention name(s): Attention Modification
Intervention type(s): Behavioral
Intervention description(s): Feedback according to participants' viewing patterns, in order to modify their attention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; cognitive bias modification; MDD; major depressive disorder; attention bias modification treatment
Enhancement of in-Vitro GC Function in Patients With COPD
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigator wish therefore to continue these studies on theophylline principally by
      conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind,
      placebo-controlled, parallel-group study.
    

Detailed description: 
      The global burden of COPD - a common and debilitating chronic inflammatory disease that is
      characterised by the progressive development of airflow limitation (shortness of breath -
      SOB) and is poorly reversible with currently available drugs -is increasing. Cigarette
      smoking is strongly linked with the ongoing inflammation; inflammation that can continue even
      when the patient has stopped smoking. The severity of airflow limitation (SOB) is correlated
      with the degree of pulmonary (lung) inflammation.

      Histone deacetylases (HDACs)are important molecules in suppressing this pulmonary
      inflammation. We have recently shown that patients with COPD have a reduction in total HDAC
      which correlates with the severity of their lung disease.

      Corticosteroids (anti-inflammatory treatment) act, at least in part, by recruitment of these
      HDACs to the site of active inflammatory gene transcription (which reduces the production of
      inflammatory molecules) and are widely used in COPD in patients with severe disease.
      Unfortunately, in COPD, inhaled corticosteroids seem to have little effect on the underlying
      inflammation (though in a selective group of patients with COPD they do reduce the number of
      infections a patient may have by a small amount).

      Theophylline has been used in the treatment of asthma and COPD for over 70 years, but its use
      has recently declined. Data so far obtained in primary cells (cells from patients used in the
      laboratory) from COPD patients suggests that low dose theophylline (~5mg/l) should be
      effective in restoring steroid sensitivity in patients with COPD (and hence reduce
      inflammation thus improving SOB).
    

Intervention name(s): Fluticasone Propionate; placebo; Theophylline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 u; Theophylline placebo capcule
Intervention MeSH terms: Fluticasone; Xhance; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Teleconsultation in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects on glycemic control of Teleconsultation
      versus standard visit in outpatient clinic for patients affected by type 1 diabetes mellitus.
    

Detailed description: 
      The growing incidence of diabetes and the need to contain health care costs empower the
      necessity to identify new models to cope with regular periodic follow up of patients affected
      by diabetes mellitus. Telemedicine offers an acknowledged instrument to provide clinical
      health care at a distance, increasing patient compliance and the achievement of therapeutical
      goals. This study wants to verify the feasibility and the efficacy of teleconsultation in
      patients with type 1 diabetes mellitus. In particular by a randomized controlled approach the
      effects on glycemic control of patients followed by teleconsultation or traditionally in
      standard visit in the outpatient clinic. The patients in the teleconsultation group will
      arrange their bookings on a website (http://www.telediabete-fid.it/) In this website they
      could also access to web educational courses (mainly nutrition, insulin management, glucose
      monitoring auto-control) or to nutritional and psychological counselling.
    

Intervention name(s): Teleconsultation; Standard
Intervention type(s): Other; Other
Intervention description(s): The patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling; Group of patients followed in a traditional way
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: teleconsultation; insulin therapy; HbA1c
Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      A number of studies have reported the presence of polyphenolic compounds in artichokes, being
      the most abundant the caffeoylquinic acids (CQAs), which are esters between quinic acid and
      the hydroxycinnamate caffeic acid. The fate of artichoke polyphenols in humans after
      ingestion is currently unknown. The acute study will provide novel information on the
      bioavailability and metabolism of artichoke polyphenols, which will give important insights
      to understand the potential health benefits of artichoke consumption.

      Health men and women participants (n=8) aged between 18 to 40 years old will be recruited.
      Participants will consume a normal ration of artichokes once. The participants will provide
      the investigators with urine and blood samples for polyphenol analysis at baseline and at
      different time points until 24 hours.
    


Intervention name(s): Artichokes
Intervention type(s): Dietary Supplement
Intervention description(s): Approximately 200 g of cooked artichokes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?
Condition: Total Knee Athroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes
      (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients
      receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low
      pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid
      consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents).

      It is not clear if the PAI component is necessary, given the theoretically nearly complete
      analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that
      some surgeons at HSS routinely use the PAI and some do not, without obvious large differences
      in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in
      addition to ACB/IPACK, it is not desirable to perform unnecessary procedures.

      In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA
      patients.
    


Intervention name(s): Periarticular Injection (PAI); Saline Control Periarticular Injection (PAI)
Intervention type(s): Drug; Drug
Intervention description(s): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.; equal volume of saline will be used in place of analgesics used in PAI injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: TKA; PAI; ACB; IPACK; Knee Arthroplasty
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This a prospective randomized double blind study involving patients at high risk of OHSS
      development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in
      patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant
      hCG 1,500 IU 35 hours after GnRH agonist trigger.
    

Detailed description: 
      Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian
      hyperstimulation which may result in significant morbidity and rarely mortality as well as
      significant financial and psychological distress. GnRH agonist trigger has been shown to be
      effective in OHSS prevention. However, the adoption of its use has not been widely accepted
      in view of concerns regarding potential impairment of implantation.

      Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important
      due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has
      been shown that optimal conception rates is not achieved for high risk patients with peak
      serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed
      that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later
      will rescue some of the corpora lutea and help improve corpora lutea function and improve
      pregnancy rates.

      The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000
      pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy
      rates or risk of OHSS. Markers of corpus luteum function such as serum 17
      hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help
      elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus
      luteum function.
    

Intervention name(s): hCG; hCG
Intervention type(s): Drug; Drug
Intervention description(s): Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger; Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Other intervention name(s): Pregnyl, Profasi; Pregnyl, Profasi
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF
Project Chill: Tailored Youth Drug Intervention In Primary Care
Condition: Marijuana Use
MeSH terms: Marijuana Use
Study type: Interventional

Summary: 
      This study examines the impact of tailored computer-delivered and therapist-delivered brief
      motivations prevention/interventions both for adolescents who have not initiated marijuana
      use (prevention), and those who use marijuana (intervention). Key moderators of
      prevention/intervention effectiveness will be examined, including behavioral intentions,
      self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and
      potential health consequences such as STD/HIV risk behaviors. This project will provide the
      critical first step toward the development and implementation of marijuana use
      prevention/intervention programs that have the potential to be delivered to a large segment
      of youth who seek care in our nation's primary care settings.
    

Detailed description: 
      The primary care setting represents an underutilized venue for prevention interventions
      addressing drug use/abuse among youth. The purpose of the study is to: (1) develop and refine
      promising, empirically-derived, BMI prevention/intervention modules delivered by a clinician
      or a computer to target marijuana use, and (2) test the effectiveness of BMI in preventing
      initiation/escalation of marijuana use among youth in community health clinics. This
      randomized controlled trial screened adolescents in primary care clinics in Flint, MI. A
      random sample of those who screened negative for past year marijuana use were selected to
      participate in the study and all subjects who screened positive for past year use were
      enrolled in the study. These subjects were stratified by gender, age, and past year marijuana
      use and randomized to one of three conditions: 1) computer-delivered brief motivational
      approach (BMI-C); 2) therapist-delivered brief motivational approach (BMI-T); or 3) a NIDA
      drug education booklet. Primary outcomes are evaluated at 3-, 6- and 12-months and include
      marijuana, alcohol, tobacco and other drug use. Key moderators of effectiveness will be
      examined, including behavioral intentions, self-efficacy, stage of change, school
      involvement, susceptibility to peer pressure, and potential health consequences (e.g.,
      STD/HIV risk behaviors). This project will provide the critical first step toward the
      implementation of tailored marijuana prevention and intervention in primary care clinics.
    

Intervention name(s): BMI-T; BMI-C
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).; Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research