bioihbjkbjnl/mcl2 huggingface dataset:
Enhanced Recovery for Patients Undergoing Radical Cystectomy.
Condition: Post Procedural Discharge
Study type: Interventional

Summary: 
      Investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the
      postoperative hospital stay after radical cystectomy is reduced, and also postoperative
      complications are decreased.
    

Detailed description: 
      Radical cystectomy (RC) is believed to be associated with high morbidity and prolonged length
      of hospital stay even with advances in perioperative medical care. Enhanced Recovery After
      Surgery (ERAS) pathways are multidisciplinary, multimodal evidence-based approaches to
      perioperative protocol by which patients are treated. The most important aims of this
      multimodal approach are modifying as many of the factors contributing to the morbidity of RC
      as possible, the improvement of patients' preoperative status, and the perioperative
      maintenance of homeostasis by minimizing stress response and inflammation to improve patient
      outcomes and decrease the length of inpatient hospital stay. The investigators hypothesize
      that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay
      after radical cystectomy is reduced, and also postoperative complications are decreased.
    

Intervention name(s): ERAS; Non ERAS pathway
Intervention type(s): Other; Other
Intervention description(s): Preoperative: Preoperative explanation of ERAS. Preoperative medical optimization. Smoking cessation 4-8 weeks before surgery. Nutritional status assessment. Preoperative fasting: 2hours for Clear fluids and water, 6hours for Semi-solid foods and 8 hours for Solid food. Preoperative carbohydrate loading. Pre-anesthetic medication: Avoid long active sedatives. Thromboembolic prophylaxis and Compression stockings Intraoperative: Antimicrobial prophylaxis and skin preparation. Epidural analgesia. Prevention of intraoperative hypothermia. Intraoperative fluid management. Minimize incision. Drain strategy Postoperative: Nasogastric intubation. Early oral intake. Early mobilization. Prevention of postoperative ileus through. Prevention of postoperative nausea and vomiting. Multimodal opioid sparing analgesia. Discharge criteria: Patients have resumed adequate oral intake and normal bowel function, Effective oral pain management and No other clinical or biochemical concerns; standard preoperative preparation intraoperative: combined general and epidural anesthesia postoperative standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in
      this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate
      in the gastrointestinal tract.
    

Detailed description: 
      This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study
      of orally administered ALLN-346. The study will evaluate the safety and tolerability,
      inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy
      volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which
      includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up
      Period through Day 28 following dosing.
    

Intervention name(s): ALLN-346; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.; Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
Other intervention name(s): Engineered urate oxidase; Matching placebo capsule
Intervention MeSH terms: Rasburicase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hyperuricemia; gout; urate oxidase; uric acid
Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients
Condition: Percutaneous Coronary Intervention; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based
      everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as
      compared with early generation DES. BP-BES with DP-EES have been directly compared in 2
      randomized trials, showing no differences between the two devices in all-comer patients
      during long-term follow-up. It is unknown whether these results are consistent in real-world
      patients with diabetes mellitus during long-term follow-up. To evaluate the safety and
      efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared
      to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes
      mellitus during long-term follow-up.

      Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or
      DP-EES implantation were included in a multicenter registry between January 2007 and May
      2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity
      score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse
      events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel
      revascularization (TVR). Secondary endpoints are the individual components of the primary
      endpoint as well as definite stent thrombosis (ST).
    


Intervention name(s): percutaneous coronary interventions
Intervention type(s): Device
Intervention description(s): Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive diabetic patients with coronary artery diseases undergoing percutaneous
        coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can
      affect the body's immune response to vaccines. The trial will also evaluate the efficacy of
      tralokinumab when it is given concomitantly with vaccines.> The trial includes a screening
      period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week
      off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible
      subjects may transfer to an open-label, long-term trial at Week 16 or later.
    

Detailed description: 
      Subjects with atopic dermatitis (AD) will be treated with either tralokinumab or dummy
      treatment (placebo) for 16 weeks. All subjects will receive 2 vaccines at Week 12. The
      vaccines are: >

        1. Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis
           (whooping cough) vaccine. This combination vaccine is also known as the Tdap vaccine and
           is used to prevent these 3 diseases.>

        2. Meningococcal vaccine. This vaccine is used to prevent meningococcal diseases (infection
           of the brain and spinal cord) and blood poisoning.> > The primary objective of the trial
           is to demonstrate non-inferiority of tralokinumab versus placebo with respect to immune
           responses to concomitantly administered vaccines.> The secondary objective is to
           evaluate efficacy of tralokinumab concomitantly administered with vaccines.
    

Intervention name(s): Tralokinumab; Placebo; Tdap vaccine; Meningococcal vaccine
Intervention type(s): Drug; Drug; Biological; Biological
Intervention description(s): Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.; Placebo contains the same excipients in the same concentration only lacking tralokinumab.; Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.; This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ABRE Clinical Study of the Abre Venous Self-expanding Stent System
Condition: Iliofemoral Venous Obstruction
Study type: Interventional

Summary: 
      Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for
      treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous
      occlusive disease.
    


Intervention name(s): Abre venous self-expanding stent system
Intervention type(s): Device
Intervention description(s): venous stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Health Effects of Consuming Olive Pomace Oil
Condition: Healthy; Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either
      olive pomace oil (OPO) or sunflower oil (SO) as the only dietary fat in a randomized,
      crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function,
      inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.
    

Detailed description: 
      The intervention aimed at studying the potential health effects of olive pomace oil in
      comparison with sunflower oil.

      After a 3-weeks run-in, 31 healthy (normocholesterolemic) and 37 hypercholesterolemic
      subjects were randomized to consume either OPO or SO (45 g/d) during 4 weeks, followed by a
      3-week wash-out during which volunteers consumed the same amount of corn oil. During all the
      study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake
      was monitored by 3-d food records in each intervention stage and volunteers were instructed
      to maintain their normal physical and dietary habits (except for the changes in the
      consumption of other oils and fats).

      At the beginning and end of each intervention stage, blood and urine samples were obtained,
      and blood pressure and anthropometric measurements were performed. A complete batch of
      analysis were performed, including serum lipids, endothelial function (endothelial nitric
      oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules,
      E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose
      homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation
      (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical
      absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid)
      quenching capacity) and anthropometry, along with determination of incretins, adipokines, and
      other clinical and hematological parameters.
    

Intervention name(s): Olive pomace oil; Sunflower oil
Intervention type(s): Other; Other
Intervention description(s): Volunteers consumed during 4 weeks 45 g/d of olive pomace oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.; Volunteers consumed during 4 weeks 45 g/d of sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
Other intervention name(s): OPO; SO
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After a 3-week run-in, healthy and at risk (hypercholesterolemic) volunteers were randomly allocated to one of each arm.
Each intervention stage lasted 4 weeks and was separated by a 3-week wash-out.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Olive pomace oil; Lipaemia; Glucose homeostasis; Inflammation; Oxidative stress biomarkers; Endothelial function
In-Home Adjustment of New Spinal Cord Injury Caregivers
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the
      proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for
      informal caregivers of individuals with SCI during the transition from hospital to home. The
      TAP was previously developed for stroke caregivers and has been found to decrease caregiver
      strain and depression. In the proposed study, the TAP will be modified for SCI and
      implemented at a state-of-the-art SCI rehabilitation facility with a very high volume of SCI
      treatment and with telehealth technology already in place through which to test the
      intervention.
    

Detailed description: 
      SCI Caregivers will be randomly assigned to either the TAP group or to a control receiving
      the standard care provided by the rehabilitation facility. The TAP begins before discharge
      and extends across six weeks. It includes three components to improve caregiver mental health
      and informal care: (1) skill development, (2) education, and (3) supportive problem solving.
      TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an
      SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at
      1, 2, 4, and 6 weeks after discharge by the same clinician. Data will be collected from
      caregivers and individuals with SCI at baseline immediately before discharge and at 2 and 4
      months after discharge.
    

Intervention name(s): Transition Assistance Program
Intervention type(s): Behavioral
Intervention description(s): TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Glycemic Response of Sorghum
Condition: Blood Glucose
Study type: Interventional

Summary: 
      Given the interest in gluten-free foods and discovering dietary means to prevent metabolic
      disorders, this study was designed to determine the glycemic responses of four (4) grains and
      flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects
      and blood glucose will be collected prior to and after eating over the course of two hours. A
      dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as
      the control treatment.
    

Detailed description: 
      Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened
      by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a
      stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The
      consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample
      collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose,
      22g) that was assigned for that day -- they returned for the other gruel meals or sucrose
      control determined by Latin Square randomization. Finger stick blood samples where then
      collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.
    

Intervention name(s): Glycemic response of F-1000; Glycemic response to sumac sorghum flour; Glycemic response to MMR sorghum flour; Glycemic response to wheat flour; Glycemic response to sucrose
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.; The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.; The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.; The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.; The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)
Other intervention name(s): Fontanelle flour; sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: sorghum health
Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer
Condition: Breast Cancer; Gynecologic Cancer
Study type: Interventional

Summary: 
      The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to
      help women manage their sexual and body image concerns after cancer (Mindful After Cancer,
      MAC) to a videoconference format and 2) assess the feasibility, acceptability, and
      preliminary effects of the program among breast and gynecologic cancer survivors.
    

Detailed description: 
      The specific aims are: 1) Assess the feasibility of the MAC program when delivered via
      videoconference and 2) Assess preliminary effects of the the program.
    

Intervention name(s): Mindful After Cancer
Intervention type(s): Behavioral
Intervention description(s): The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Vitamin D of Chinese Children and Adolescents
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin
      D inadequacy of Chinese children and adolescents aged 6-17y.
    

Detailed description: 
      In this study, we analyzed the vitamin D status of Chinese children and adolescents aged
      6-17y, and related risk factors (such as gender, region strata, ambient UVB level at area of
      residence, season, and outdoor time, etc.). Serum 25 hydroxyvitamin D [25(OH)D] was measured
      with a radioimmunoassay kit in 15 000 children and adolescent participants in Chinese
      national nutrition and health survey (CNNHS) 2010-2012. Age, gender, region type, ethnicity,
      outdoor time, vitamin D supplementation were recorded in unified design questionnaires.
      Season was recorded by the date of blood taken; location was divided into north and south by
      China's Qinling mountains and Huaihe river; and ambient ultraviolet B (UVB) radiation level
      was classified according to the corresponding dose of each participant living area from
      National Aeronautics and Space Administration data.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The participants of this study were aged 6-17y selected from the Chinese national nutrition
        and health survey
      
Biospecimen description: 
      2 mL of fasting venous blood was collected and centrifuged at 1500×g for 15 minutes within 30
      minutes after blood taken. The upper serum was aliquoted and stored in brown vessel at -20℃
      in the laboratory where the investigation point was located. All the serum specimens from all
      the 150 investigation points were transported to our laboratory by cold chain. All the
      samples were preserved at -70℃ refrigerator before determination.
    
Keywords: 25 hydroxyvitamin D; 6-17 years old; vitamin D deficiency
A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED
Condition: Anger; Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see how different forms of "Anger Management" compare in
      reducing anger and impulsive aggressive symptoms in people. "Anger Management" is a common
      form of "talk therapy" used to help people with anger problems. There are different types of
      "talk therapy" used to help people for anger problems and this study will compare two types
      of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in
      which there are frequent and sudden outbursts of anger (yelling, throwing and breaking
      things, hitting people) that lead to problems with other people socially or at work.
    

Detailed description: 
      Intermittent Explosive Disorder (IED) is increasingly acknowledged as a common, potentially
      disabling psychiatric condition. Despite this, there are currently no empirically supported
      behavioral treatments for patients with IED. The purpose of the proposed study is to assess
      the short-term and long-term efficacy of a cognitive-behavioral treatment (CBT), previously
      found to be successful in treating dysfunctional anger, for treating IED. Secondary goals of
      the project are to:

        1. explore mechanisms involved in the successful treatment of IED, and

        2. examine individual differences associated with treatment response.

      Seventy-two subjects meeting for both research and DSM IED criteria will be randomly assigned
      to either 12 weeks of individual CBT, 12 weeks of group CBT or 12 weeks of a wait-list
      control condition. Subjects will be assessed before and after therapy/wait-list as well as at
      3 month and 6 month follow-up. Primary outcome measures will assess aggressive behavior,
      anger, and the presence of an IED diagnosis at post-treatment, 6-month follow-up and 12-month
      follow-up. Social and emotional information processing will be evaluated as potential
      mechanism of change. Trait aggression will be assessed as a potential moderating variable.
    

Intervention name(s): anger management therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anger; intermittent; explosive