cyrilzakka/clinical-trials huggingface dataset:
Mechanism of Sarcopenia in Heart Failure

The aim of the study is to provide information on the interaction between socioeconomic factors, daily physical activity, nutrition and lifestyle on loss of muscle mass and muscle function in patients with heart failure.

A total of 200 consecutive heart failure patients will be included and 50 age and sex-matched individuals with no history of cardiovascular disease will serve as controls.

Baseline variables of body composition, physical capacity, daily physical activity, nutritional status, quality of life, socioeconomic status and insulin resistance will be obtained along with a skeletal muscle tissue biopsy and blood samples for laboratory analyses.

Baseline variables from heart failure patients will be compared to healthy controls.

Patients and controls will be invited to follow-up visits at 12 and 36 months. Changes in baseline variables will be analyzed.

Events will be identified through national registries.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide valid informed consent.
2. Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.

Exclusion Criteria:

1. Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not exclude patients).
2. Severe musculoskeletal or neurological disability.
3. Severe lung disease with a forced expiratory volume 1 \< 40% of predicted. Treatment with anticoagulants (warfarin, apixaban, edoxaban, dabigatran and rivaroxaban) is an exclusion criterion for muscle biopsy. Patients with anticoagulant treatment will be invited to participate in the study without muscle biopsy.
4. Other comorbidities that prevent the patient from participating in the study examinations as judged by the investigator.
Care Pathways for Colorectal Cancer Surgery

EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY

This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.

Eligibility Criteria:
Inclusion Criteria:

1. All consecutive scheduled admissions starting September 2, 2013;
2. Minimum age of 18 years;
3. Elective admission for colorectal cancer surgery

Exclusion Criteria:

1. Emergency (not planned) admission for colorectal cancer surgery;
2. Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.
Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults

Polypharmacy in the older adults is common and promotes the risk of drug interactions. The hypothesis evoked is that a virtual platform with artificial intelligence applied to the health, and in particular to the good use of the drug, could bring aids to the doctors them of the prescription of drugs. The main objective of this study is to evaluate the impact of geriatric use of the Synapse platform on the frequency of inappropriate medication prescriptions (STOPP criteria) in discharge orders for patients 65 years of age or older hospitalized in geriatric department.

The French 2018-2022 National Health Strategy plan aims to reduce the proportion of potentially harmful medication use. One particular challenge is the phenomenon of polypharmacy and inappropriate medication use in elderly, which is associated to an increased risk of drug-drug interactions. Several scales and tools have been proposed to identify inappropriate drugs prescription in older adults. Among them, the STOPP / START criteria (Screening Tool of Older Persons' Prescriptions / Screening Tool to Alert to Right Treatment) are internationally recognized.

The Synapse platform offers a panel of functions that may help physicians to prescribe medications. For instance, the prescriber can interact with the Synapse platform by asking any type of question about a drug (dosage, contraindication, interaction ...) before prescription. It also allows them to take a picture of prescription. The software detects in less than 10 seconds criteria for inappropriate medication prescriptions and potential drug-drug interactions.

More precisely, the Synapse platform provides information on a particular drug or prescription analysis regarding:

* Indications, contraindications, dosage and adverse effects of drugs.
* STOPP criteria.
* START criteria.
* Associations at risk for drug-drug interactions.

Multiple new health technologies are emerging, but few of them have demonstrated their scientific and medical added value using an evidence-based medicine approach.

This clinical trial aims to validate the clinical interest of the Synapse application in a geriatric environment.

Prescriptions made by geriatricians participating in this study will be analyzed by two independent experts, including one pharmacist and one geriatrician.

Eligibility Criteria:
* Inclusion criteria:

  * Male or female age aged more than 65 years
  * Hospitalization in geriatric department at Bordeaux University Hospital or Libourne Hospital
  * Initial drug prescription with at least 2 active pharmaceutical ingredients
  * Affiliation to French social security
  * Written informed consent signed by participant and investigator
* Exclusion criteria:

  * Adults protected by law
  * Subject included in a clinical trial with an experimental treatment
  * Subject during exclusion period relative to another trial
Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin.

PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.

OBJECTIVES:

Primary

* To investigate the feasibility of implementing individualized dosing of isotretinoin in patients with high-risk neuroblastoma after course 1 of treatment, based on isotretinoin pharmacokinetics and toxicity.
* To minimize the large inter-patient variation in plasma concentrations of isotretinoin.
* To ensure that patients are not exposed to potentially sub-optimal plasma concentrations of isotretinoin during long-term treatment, particularly for patients who are not able to swallow isotretinoin capsules.

Secondary

* To obtain preliminary data on the potential impact of isotretinoin therapeutic monitoring on clinical response and toxicity in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral isotretinoin twice daily on days 1-14. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and during courses 1-3 for pharmacokinetic studies and determination of each patient's individual therapeutic-dose level requirement. Genotyping to identify genes that metabolize enzymes is conducted via PCR.

After completion of study therapy, patients are followed up periodically for up to 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed high-risk neuroblastoma
* Concurrent isotretinoin as part of clinical treatment

PATIENT CHARACTERISTICS:

* Not pregnant
* Fertile patients must use effective contraception
* Has a single- or double-lumen central venous catheter in place

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Adults In The Making Prevention Trial

This study was a randomized prevention trial investigating the efficacy of the Adults in the Making (AIM) prevention program against a control condition. The primary outcome variable is alcohol use. The study sample were 367 African American seniors in high school and their primary caregivers. The AIM program is a 6 session (12 hour) family-centered intervention designed to deter alcohol use.

The study investigators designed a multicomponent prevention program to deter substance use among African American emerging adults in rural Georgia (SAAF-Emerging Adult Program, SAAF-EAP). The intervention's delivery is modeled after an existing prevention program designed by Dr. Brody called, The Strong African American Families (SAAF) program and included a series of separate weekly sessions for emerging adults, their parents, and extended family members, as well as sessions in which participants interact with one another to apply the skills learned in the separate sessions. The sample consisted of 690 families with a high school senior, half of whom will be assigned randomly to a prevention group and half of whom will be assigned to a control group. Pre-intervention, post-intervention, and follow-up assessments of emerging adults' substance use were conducted with the entire sample. The study started when the participants were high school seniors, and followed them and their families as the youths enter emerging adulthood. The conceptual model that guided the program incorporated the following predictors: (1) autonomy-promoting parenting and responsive family relationships, characterized by developmentally appropriate instrumental and emotional support, expectations and discussions about emerging adults' roles and responsibilities, affectively positive relationships that feature open communication, and adaptive racial socialization that includes strategies for dealing with discrimination; (2) contextual stressors, including racial discrimination, poverty, and limitations in educational and occupational opportunities; (3) negative emotions and the avoidant coping responses they elicit; (4) emerging adults' future orientation, self-regulation, emotion regulation, racial identity, and sense of adult status; (5) affiliations with substance-using friends and romantic partners; and (6) cognitive antecedents of substance use, including prototypes of substance-using agemates and willingness to use substances in risk-conducive situations. To examine these constructs, the investigators implemented a multi-informant design that included assessments from emerging adults, their friends and romantic partners, their primary caregivers, and their extended family members.

Eligibility Criteria:
Inclusion Criteria:

* Residence in county where sampling was targeted
* Youth self identified as African American or Black

Exclusion Criteria:

* Unable to complete survey measures or participate in intervention due to mental health concerns
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery

This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).


Eligibility Criteria:
Inclusion Criteria:

1. Patient and disease factors deemed suitable for Robotic-Assisted Trans Oral Robotic Surgery (TORS) procedure using the Versius Surgical System
2. Aged 18 or over with signed, written informed consent
3. Histologically confirmed squamous cell carcinoma of the oropharynx {UICC/AJCC TNM (7) stage T1-3, N0-N2b / TNM (8) T1-3, N0-1 disease} OR Histologically confirmed squamous cell carcinoma in 1 or more cervical lymph nodes, with no discernible primary tumour (cancer unknown primary)
4. Patients considered fit for surgery and potential adjuvant treatment (WHO performance status 0-2)
5. Multidisciplinary team (MDT) decision to treat with primary surgery
6. Surgical site and anatomical factors allowing access and freedom of operating using Versius Surgical System

Exclusion Criteria:

1. T4 tumours, or T1-T3 where transoral surgery is not considered feasible due to anatomy, location, or disease factors; these may include (but not limited to) tumour visualisation, endophytic growth pattern and resulting defect functional concerns
2. Disease / anatomical factors limiting access and freedom of operating using Versius Surgical System
3. Patients with distant metastatic disease as determined by pre-operative staging
4. UICC/AJCC TNM (7) stage N2c-N3 disease; TNM (8) N2-3 disease
5. American Society of Anaesthesiologists (ASA) Class IV or above
6. WHO Performance status 3 or above
7. Unwilling or unable to sign an informed consent form
8. Morbid Obesity (BMI ≥40)
9. Active pregnancy
10. Medical Contraindication for general anaesthesia
11. Patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery
12. Patients with a history of radiotherapy to the head or neck
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ulcerative colitis (UC)
* Moderately to severely active UC, defined by modified Mayo score
* Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
* Screening laboratory test results within the parameters specified in the protocol

Exclusion Criteria:

* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
* UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Presence of a stoma
* Presence or history of a fistula
* Receiving prohibited medications and/or treatment
Tracking and Improving Trust/Respect

This study will examine the efficacy of a feedback system for providers that tracks patient trust/respect on an ongoing basis and to test the hypothesis that receiving feedback on trust/respect will lead to improvements in patient satisfaction, functioning, symptoms, and trust/respect.

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This is a randomized effectiveness trial in which real-world providers will be given feedback on patient trust/respect. Approximately 40 clinicians, and up to 180 consumers will be enlisted participate in the randomized effectiveness trial. All enrolled patients will complete the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities Scale on handheld tablets or desktop computers at baseline. Patients will be randomized to one of two conditions. Patients in the first condition will attend therapy with clinicians who have received a standard automated outcome report, plus a report that contains information on the patient's trust/respect with suggestions for interventions if low/declining trust/respect is apparent. Patients in the second condition will attend therapy and complete the same measures as patients in the first condition, but their therapists will only receive a standard automated outcome report, without any patient information on trust/respect. At the time of the first therapy appointment and for all remaining therapy appointments, patients will complete four total measures: the new measure of trust/respect, the BASIS-24, the Satisfaction with Care scale, and the Satisfaction with Social Roles and Activities scale.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read at least at the 4th grade level
* 18 years of age and older
* Willingness to participate in research.

Exclusion Criteria:

* N/A
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle

Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 and ≤ 80 years
* Orthopedic (trauma) surgery to the foot and/or ankle
* Incision \>3 cm

Exclusion Criteria:

* Open fractures
* Antibiotic treatment at the time of the operation for a concomitant disease or infection
* Insufficient comprehension of the Dutch language
* Patients with immune-deficiencies
* Inability to address negative pressure wound therapy device
* Active infection
Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients

The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment. Secondary aims correlation with the maximal walking distance.

The WELSH is self completed by the patients and scored by the physician after self-completion. Patients perform a 6 minutes walking test on a 30m corridor

Eligibility Criteria:
Inclusion Criteria:

* •Signed consent for the data treatment as a database

Exclusion Criteria:

* Rebuttal to participate
Shockwave Treatment of Diabetic Foot Ulcer: Step I

Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.

In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.

The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.

That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Diabetes Type I or II
* Chronic ulcer on the foot
* Ulcer present for at least 6 weeks
* Wagner Grade 1 or 2

Exclusion Criteria:

* Chronic rest pain
* Critical ischemia
* Gangrene
* Ankle-Arm-Index \< 0,5
* Critical ischemia treated within 6 weeks before possible enrollment
* Ulcer of Grade 3 or worse according to the Wagner Classification
* Osteomyelitis
* Affection of toes
* Necessity of surgical intervention
* Malalignment of the foot sustaining the ulcer
* Treatment of Ulcer with Prostaglandins or vasodilatators within the last 2 weeks
* Current therapy with corticoids
* Infection with HIV; Hepatitis
* Suppression of immune system (due to illness or medication)
* Medication with Vitamin-K-Antagonists
* Known hemophilia
* Sever Hypalbuminemia \< 2 g/dl
* Severe anemia
* Ulcer other than of diabetic origin
* Pregnant or breast-feeding women
* Known coagulopathies
* Implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material
* Patients participating on other studies
* Chemotherapy within the last 60 days
* Mentally disabled patients
Imaging-Guided Vessel Sizing in the Tibial Arteries

This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

This is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. The evaluation of OCT is primarily to: (a) establish feasibility and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. Operator-determined sizing will be compared against University Hospitals Core Imaging Laboratory assessment of OCT, IVUS (when applicable), and quantitative vessel analysis (QVA).

Subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. Wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. Wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patients with presence of Rutherford IV-VI
* Presence of ≥1 tibial artery involvement requiring endovascular treatment

Exclusion Criteria:

* Patients who do not have tibial disease appropriate for intervention
* Estimated glomerular filtration rate \<30 mL/min not on hemodialysis