cyrilzakka/clinical-trials huggingface dataset:
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

This observational study will prospectively collect data on treatment options, patient/investigator satisfaction, requirement for retreatment or additional treatment, and long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide additional health economics and utilization data.

This is a prospective, multi-center, observational study. Patients will be recruited based on the usual care presentation at each investigative site, as regular practice would dictate. Consecutive patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for Dupuytren's contracture according to the standard of care and clinical practice at each study site. No study-specific visits will be required as part of the study. Treatment and Follow-up Visits will be determined by the treating physician. Treatments received for Dupuytren's contracture will be recorded (ie, XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy), including initial treatment and any subsequent therapy. The full prescribing information and medication guide for XIAFLEX is provided in this protocol as reference (Appendix B). Patient data (including treatment outcomes, joint contracture measured by the treating physician, and evidence of recurrence) and health care resource utilization data will be drawn from the patients' medical records, examination, and patient interviews. These data will be recorded via a web-based electronic data collection (EDC) system.

PROs will be collected by self-completed questionnaires given to each patient via web-based data collection or telephone interviews. The site will follow up with the patient according to usual practice. Information from the patient's visit may include goniometry and the physician's assessment of treatment outcome and healthcare utilization. Patients will be considered enrolled in the study for a maximum of 4 years post-enrollment or until death, withdrawal of consent, loss to follow-up, or study closure.

Eligibility Criteria:
Inclusion Criteria:

* Women or men 18 years of age or older
* Patients with a Dupuytren's contracture of at least a single joint and a desire for correction
* Patients who are able to read and understand English
* Patients who are capable of understanding and cooperating with the requirements of the study
* Patients who are willing and able to respond to the posttreatment assessments via telephone or internet
* Patients must provide written informed consent, indicating that they understand the purpose of and requirements of the study and are willing to participate in the study.

Exclusion Criteria:

* Patients who decide not to pursue correction of the Dupuytren's contracture.
Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction.

The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.

Participants will be randomized towards control (standard of care, SOC) or intervention group.

Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT.


Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction ≤ 40%, assessed LVEF with imaging within last three months before randomization (TTE/KT/MIBI/MRI)
* NYHA ≥ II

Exclusion Criteria:

* Hemodynamic instability
* Recent acute coronary syndrome (\< 1 month before randomisation)
* Already on quadruple heart failure therapy or on triple GDMT in case of eGFR \< 30ml/min/1.73m2 or a potassium above 6mmol/L
* eGFR \< 20ml/min/1.73², planned for dialysis or already actively treated with chronic dialysis.
* Implantation of a cardiac resynchronization therapy (CRT) within 3 months
* Adult congenital heart disease
* Previous heart transplantation or currently/planned for ventricular assist device
* Women who are pregnant or breastfeeding
* Unable to participate in 3 months follow-up
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise

The objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.

In this open-label, three-period crossover study, 12 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have three lidocaine topical systems applied to their back for 12 hours with 7-day washout between treatments. In each treatment period, the subject will either exercise (Treatment A), apply a heating pad (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 48 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.

Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* History of addiction, abuse, and misuse of any drug
* Use of nicotine-containing products within 30 days
Comparison of 1 vs 3 Sets of Resistance Training on Muscular Hypertrophy

This study is designed to investigate the effects of two levels of resistance weight training on body composition, energy expenditure, and energy intake in men and women. The weight training will take about one hour to complete. Participants will perform the training 3 days per week for 9 months in a private exercise room equipped with state of the art equipment and a personal trainer to help guide you through the exercises.

The project lasts 21 months total with one follow-up visit 1-year from your last training date. You will be required to stay in the Lawrence area and train 3 day/week over the summer \& holidays.

We propose to conduct a randomized controlled efficacy trial (RT-1 set vs. RT-3 sets vs. non exercise control) to evaluate the potential for a longer intervention (9 months RT with body composition assessments 1 yr post RT completion) with a higher volume of RT (3 sets) to enhance the effects on body composition and energy expenditure observed in the pilot, and to determine the impact of the 2 levels of RT on free-living energy balance (expenditure by doubly labeled water and intake by digital photography and 24-hr recalls). This investigation will be conducted in a sample of healthy, normal and overweight, sedentary, young adult men and women; a group at high risk for development of overweight and obesity. The specific aims of this project are to determine the impact of the volume (1 vs. 3 sets) of a progressive RT protocol for inducing muscular hypertrophy, as recommended by the American College of Sports Medicine, on body weight and body composition (fat mass, fat-free mass (FFM), % body fat) and energy balance. Our results will provide information relative to the minimum volume of RT that may be associated with body weight/fat gain which may inform the development of guidelines for RT to prevent weight gain or to alter body composition. If RT has a favorable impact on energy balance and body composition, it may provide an attractive alternative to aerobic exercise for weight management for busy young adults, as RT requires minimal time, and no need to change clothes or shower (i.e. minimal or no sweating).

Eligibility Criteria:
Inclusion Criteria:

* BMI 22-\<30
* 18- 30 years old
* sedentary
* no medications
* weight stable for at least 3 months

Exclusion Criteria:

* Tobacco/Drug user
* metabolism altering medication
* gain/lost 10lbs in the last 3 months
* current exerciser
Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance

This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.

The situation of type 2 DM prevention in China is serious. The commonly accepted natural course of type 2 DM is as follows: obesity, insulin resistance(hyperinsulemia), abnormal glucose tolerance, DM and complications of DM; correspondently, the function status of pancreas islet β cells are: normal, compensatory, decompensatory, impaired and failure. Post researches have proved that using medical interventions after the period of insulin resistance when the function status of β cells were compensatory, the course could not be reversed. There were few clinical researches about effects of medical interventions in the period of insulin resistance . This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 28kg/m2
* diagnosis of insulin resistance

Exclusion Criteria:

* abnormal glucose tolerance
* function impairment of heart, liver or kidney
High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke

Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. High resolution magnetic resonance imaging (HRMRI) can accurately assess the status of intracranial and extracranial arterial plaque, and has high consistency with histopathology. Thus, HRMRI technology has been widely used to monitor the efficacy of drug treatment for atherosclerotic plaque in clinical trials or practice.

As a non-invasive technique, HRMRI make it possible to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery in vivo. It can quantitative analysis including components such as lipid-rich necrotic core, fiber cap thickness, intra-plaque hemorrhage, calcification, etc. Therefore, it is crucial for evaluating the etiology of ischemic stroke and developing secondary prevention strategies.

At present, there is a lack of large-scale and prospective study to evaluate the etiology of ischemic stroke including cryptogenic stroke based on HRMRI. In this context, this study aims to establish a multi center HRMRI database of intracranial arteries among Chinese patients with ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient age ≥40 years
* 2. Time of stroke onset: within 2 week
* 3. Baseline NIHSS score ≤16
* 4. Ischemic stroke confirmed by head CT or MRI
* 5. Premorbid mRS ≤1
* 6. The degree of stenosis of extracranial arteries including internal carotid artery, vertebral artery on the lesion side ≤50%
* 7. The culprit plaque or possible culprit plaque with plaque burden of 40% or more found by HRMRI in the proximal part of the middle cerebral artery M1 segment or basilar artery of ipsilateral lesion
* 8. Signed informed consent

Exclusion Criteria:

* 1. Intracranial hemorrhage found by head CT
* 2. Had a contraindication to MRI,or could not complete required MRI sequences
* 3. Intracranial tumor, arteriovenous malformation, or aneurysm
* 4. Comorbidity with any serious diseases and life expectancy is less than one year
* 5. Pregnancy
* 6. Patients not suitable for this clinical studies considered by researcher
Using PRP and Cord Blood in Treatment of Covid -19

covid - 19 is a critical viral infection that affects humans

Covid -19 pandemic started was declared in 2020

Eligibility Criteria:
Inclusion Criteria:

* patients with positive covid -19 and has symptoms and isolated in the hospital

Exclusion Criteria:

* patients with negative test for covid -19
Evaluating Antibiotic Stewardship Assisted by Computer in the University Hospital of Nancy (MACABAO)

Antibiotic resistance is one of the most pressing health threats that mankind faces now and in the coming decades. Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. In order to tackle antibiotic resistance, a computerized-decision support system (CDSS) facilitating antibiotic stewardship and an electronic surveillance software (ESS) facilitating infection prevention and control activities will implement in our tertiary care university hospital.

The investigators conduct a pragmatic, prospective, single-centre, before-after uncontrolled study with an interrupted time-series analysis 12 months before and 12 months after the introduction of the CDSS for antibiotic stewardship (APSS) and ESS for infection surveillance (ZINC). APSS and ZINC will assist respectively the antibiotic stewardship and the infection prevention and control teams of Nancy University Hospital (France). The investigators will evaluate the impact of the CDSS/ESS on the antibiotic use in adult (≥ 18 years) inpatients (hospitalised ≥ 48h). The primary outcome is the prescription rate by all healthcare professionals from the hospital of all systemic antibiotics expressed in defined daily doses/1 000 patients/month. Concurrently, the investigators will assess the safety of the intervention, its impact on the appropriateness of antibiotic prescriptions and on additional precautions (isolation precautions) as recommended in guidelines, and on bacterial epidemiology (multidrug-resistant bacteria and Clostridioides difficile infections) in the hospital. Finally, the investigators will evaluate the users' satisfaction and the cost of this intervention from the hospital perspective.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital

Exclusion Criteria:

* The paediatric and gynaeco-obstetric departments
A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York

This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.

PRIMARY OBJECTIVES:

I. Examine the feasibility of the I CAN intervention. II. Examine the acceptability of the I CAN intervention. III. Examine topic areas selected for action within participants' I CAN plans for action.

OUTLINE:

Participants attend an I CAN intervention workshop over 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Able to participate in English

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements
Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants

Neonates undergo several painful procedures and these pain experiences can alter clinical outcome and behavior. The investigators aim to investigate the analgesic effect of low level laser for procedural pain during heel lancing of term neonates.

This open-label, randomized controlled trial involves 130 term newborn infants (gestational ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are randomly assigned to low level laser group or breast milk group. Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. Then heel lancing is performed and two observers who are blinded to the intervention record the physiological (heart rate and oxygen saturation) and behavioral parameters (duration of crying and modified neonatal facial coding scores) following the procedure. Heart rate variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is used to detect the infant's salivary cortisol and amylase level as biomarker for stress evaluation. During the study course, digital cameras continuously record participants' behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* healthy fullterm neonates (37-42 gestational age)
* Apgar score \>= 7
* will receive newborn screening

Exclusion Criteria:

* \>42 or \< 37 gestational age
* perinatal asphyxia
* major malformations or any other disease that need intensive care
* drug withdrawal received previous treatment
Safety and Tolerability of STP206 in Healthy Adult Subjects

The study will assess the safety, tolerability and fecal shedding of STP206 when given as a single dose and when given as daily doses for one week.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers, 18 - 55 years of age
2. In general good heath as established by medical history, physical examination, and laboratory assessment
3. The subject is willing and able to comply with the protocol and complete all visits and procedures
4. Provide written informed consent after the nature of the study has been explained

Exclusion Criteria:

1. Subjects with any chronic illness or conditions that require treatment
2. Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation
3. Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment
4. Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)
5. Subjects who are lactose intolerant
6. Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy
7. Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug
8. Subjects who have received a "live" vaccine within 30 days of the first dose of study drug
9. Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug
10. Subjects who have received and investigational drug with 30 days prior to the first dose of study drug
11. Subjects with a history of illicit drug use or alcohol abuse
12. Subjects with any other medical condition that may influence the objectives or outcomes of the study
13. Female subjects who are pregnant or lactating
14. Female subjects of childbearing potential who are not using an FDA approved birth control method
15. Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals
16. Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV
17. Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.
Audit of Surgery for Colorectal Cancer

The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat during a two-years period. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

Quality improvement initiatives and in particular the accreditation procedure raises the inevitable question of measuring quality in health. Several surgical audits have been carried out internationally, showing the importance of collecting reliable and valid information on the quality of care. This approach allows an evaluation and improvement of the quality of care provided, significantly correlated to a direct impact on morbidity and mortality. In addition, it provides valuable information for evidence-based medicine research as it provides data on patients often excluded from therapeutic trials.

Colorectal cancer is the first digestive cancer and the third cancer worldwide. Surgical resection is the main curative treatment. Surgical quality is associated with better short and long term results. Quality improvement measures, with the goal to improve surgical care of colorectal cancer, are becoming a standard worldwide.

The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 January 2018 and 31 December 2019.

Exclusion Criteria:

* Colon or rectal resections for other histologic types than adenocarcinoma.
* Palliative intent surgery.