cyrilzakka/clinical-trials huggingface dataset:
YoPA - A Youth-centred Participatory Action

Background

A vast majority of adolescents do not meet guidelines for healthy physical activity, sedentary behaviour, and sleep, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway linking urban living and poor health. How to develop and implement sustainable and effective interventions focused on adolescent health and wellbeing in urban vulnerable life situations is a key challenge and research gap. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions using an evidence-informed youth-centred co-creation approach, for structural improvement of the lifestyles of adolescents in urban vulnerable life situations.

Methods

In diverse urban environments in Denmark, the Netherlands, Nigeria, and South Africa, academic researchers will engage adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (e.g., policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system for needs and opportunities; tailoring interventions to their local context; implementing and evaluating interventions during participatory meetings over the course of three years. YoPA applies a participatory mixed methods design guided by the newly developed SUPER-AIM framework assessing: (i) the local Systems, (ii) User perspectives, (iii) the Participatory co-creation process, (ii) Effects, iv) Reach, (vi) Adoption, (vii) Implementation, and (viii) Maintenance of interventions, in an integrated manner.

Discussion

YoPA aims to fill various research gaps, including the development of a practical protocol guiding the application of co-creation to tailor evidence-informed interventions to divers, multi-country contexts. Additionally, it focuses on advancing the research gap in physical activity and health within Sub-Saharan Africa and the involvement of adolescents in shaping their physical and social environments. Academic researchers envision that the YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally.


Eligibility Criteria:
Inclusion Criteria:

* aged 12 to 19 years
* living in a disadvantaged area in Aalborg (Denmark), Amsterdam (the Netherlands), Osogbo (Nigeria), or Soweto (South Africa)
* active informed consent by the adolescents and at least one parent/caregiver where applicable for the participation of the adolescent

Exclusion Criteria:

* none
The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence

More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.


Eligibility Criteria:
Inclusion Criteria:

* localized prostate cancer (stage: cT1-cT2, N0, M0)
* 4-6weeks after prostatectomy
* postprostatectomy prostate specific antigen (PSA) test below cured level
* incontinence one month after surgery
* ECOG score:0-1

Exclusion Criteria:

* history of neoadjuvant hormonal therapy
* history of transurethral resection of the prostate (TUPR)
* history of operation on pelvis
* history of incontinence before prostatectomy
ERAS and Pediatric Scoliosis Surgery

The aim of this study is to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Enhanced recovery after surgery (ERAS) is a multimodal approach focused on reducing the stress response and associated physiologic changes related to surgery. Over the past 20 years, ERAS programs have been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains very scarce.Therefore this study was designed to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Eligibility Criteria:
Inclusion criteria:

* patient with age \< 18 years
* patient scheduled for scoliosis surgery

Exclusion criteria:

* patient with age \> 18years
* patient with medical follow up by pediatric chronic pain departement
An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.

Secondary objectives are:

* To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
* To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
* To assess SSR411298 plasma concentrations.
* To assess plasma endocannabinoid concentrations.

The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patient with recurrent Major Depressive Disorder

Exclusion Criteria:

* Duration of current depressive episode greater than 2 years;
* Mild depression as measured by standard clinical research scales;
* Cognitive disturbance;
* Significant suicide risk;
* Other psychiatric conditions that would obscure the results of the study;
* History of failure to respond to antidepressant treatment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS

This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years with histologically confirmed advanced or metastatic STS
* Eastern Cooperative Oncology Group performance status of 0 to 2
* life expectancy of ≥ 3 months
* have not received chemotherapy before
* at least one measurable lesion
* LVEF≥50%
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans
* patients with symptomatic brain metastases
* active clinical severe infection
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 25 years-old
* Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
* Symptomatic patient refusing hormonal treatment and/or surgery.
* Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
* Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
* Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
* No curent pregnancy (negative BHCG \<72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
* Patient agreeing not to change her hormone treatment for the duration of the study.
* Patient accepting the study constraints
* Health insurance affiliated patient or beneficiary of an equivalent coverage

Exclusion Criteria:

* Virgin patient
* Ongoing uro-genital infection
* Anorectal anatomy incompatible with HIFU therapy
* History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
* Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
* Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
* Latex allergy
* Patient with contraindications to MRI
* Patient with contraindications to Gadolinium injection
* Patient previously treated with HIFU for a rectal endometriotic lesion
* Patient not speaking nor reading French
* Patient deprived of liberty following a legal or administrative decision
* Patient under guardianship or tutelage measure
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2

Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development.

The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.

Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. In addition, the objective of this study is to develop a laboratory model of relapse induced by cigarette exposure that would reproduce the psychological and physiological processes that are involved when abstinent individuals progress from initial cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be used to study the mechanisms of relapse and to screen medications that might be effective in preventing relapse in treatment seekers.

This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke, following the exposure to tobacco-related or control cues. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nicotine dependence with psychological dependence
* Smokes at least 15 cigarettes per day for the three months prior to enrollment
* Currently not seeking treatment for nicotine dependence
* Medically healthy, on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
* Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

* Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
* Current Axis I diagnosis or current treatment with psychotropic medications within the 3 months prior to enrollment
* History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
* Currently seeking treatment for nicotine disorders
* On parole or probation
* History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
* History of significant recent violent behavior
* Blood pressure greater than 150/90
* History of eating disorders
* Pregnant
Study of the TearCare System in Dry Eye Disease

This study is being conducted to evaluate the short-term (1 month) safety and effectiveness of a single TearCare procedure to treat adult patients with dry eye disease.

NOTE: All sites have been selected for this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with dry eye disease
* Signs and symptoms of dry eye disease
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with study procedures
* Willing and able to provide consent

Exclusion Criteria:

* Active ocular infection or inflammation
* History of eyelid, conjunctiva or corneal surgery within the past year.
* Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
* Contact lens wearer
* Significant ocular surface or eyelid abnormalities, recent ocular trauma
* Certain corneal surface abnormalities
* Use of medications for treatment of dry eye or medications that cause dry eye
* Systemic disease that results in dry eye
Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg

Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.

Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.

Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.

Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 28
* Written consent before study start

Exclusion Criteria:

* Diabetes
* Inclusion in other studies using ionizing radiation.
* Allergic to egg or soy
General Anesthetic Mode and Postoperative Complications

The relationship between anesthetic medication and postoperative major cardiac and cerebral complications will be studied using logistic regression model.

The study group try to find out if there is a connection between the use of different anesthetic methods with different narcotic drugs and postoperative major cardiac and cerebral complications.

Eligibility Criteria:
Inclusion Criteria:

* non-cardiac surgery, with age\> = 18 years old, ASA grade I-IV, under general anesthesia

Exclusion Criteria:

* non-general anesthesia, without the use of target-controlled infusion of remifentanil or sufentanil, absence of intraoperative or perioperative information.
Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease

This protocol represents a pilot randomized-controlled trial evaluating the effect of an electronic health record (EHR)-based peripheral artery disease (PAD) screening tool on rates of new non-invasive testing, diagnosis and treatment of PAD over a 6-month period. An EHR-based PAD screening tool will be applied to the Stanford EHR, which will generate a group of patients of varying risks of having undiagnosed PAD. Patients with the highest risk of having undiagnosed PAD will then be evaluated for inclusion in this study. 1:1 randomization will be performed on a consecutive basis until study enrollment is completed (25 patients per arm).

Physicians of patients randomized to the intervention arm will be sent notification via an EHR message detailing the patient's risk of undiagnosed PAD and suggestions for referral to vascular medicine for risk assessment and/or non-invasive ankle brachial index (ABI) testing. The primary outcome is number of patients receiving ABI testing for PAD at 6 months, with secondary outcomes including number of new PAD diagnoses, number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery, and/or cardiology) and number of patients receiving initiation of new cardiovascular medications (anti-platelet agents, statins, and/or antihypertensive agents).


Eligibility Criteria:
Inclusion Criteria:

* Are 50-85 years old
* Currently an outpatient, actively obtaining care at Stanford
* Have at least 1 year of data within the Stanford EHR (including at least 2 clinical visits)
* Have no prior diagnosis of peripheral artery disease as determined by no chart term mentions or ICD-9/10 codes in their EHR data

Exclusion Criteria:

* Have less than 1 year of data available or less than 2 clinical visits at Stanford
* Enrolled in a previous related study
* Receiving treatment for a potentially terminal condition
* Prior diagnosis of peripheral artery disease by ICD code or term mention in their EHR data.
Effects of Breathing Retraining in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle strength, and health related quality of live but not pulmonary function in patients with chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary rehabilitation plus breathing retraining will be better than that of patients undergoing a conventional pulmonary rehabilitation.

To address this uncertainty, we performed a randomized controlled trial to assess the effects of a 4-week rehabilitation program including breathing retraining on pulmonary function (PFT), cardio-pulmonary exercise capacity (CPET), health related quality of life (HRQL) and cardiac autonomic modulation (CAM).

A randomized controlled trial comparing the effects of a conventional 4-week pulmonary rehabilitation program with those of a 4-week pulmonary rehabilitation program plus breathing retraining on pulmonary function (FEV1), cardiopulmonary exercise capacity (6-minute walking distance, 6MWD), health related quality of life (chronic respiratory questionnaire, CRQ) and cardiac autonomic function (rMSSD) was performed.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable patients with COPD (GOLD-classification I-IV)

Exclusion Criteria:

* Patients with clinical signs of COPD exacerbation
* Cardiac arrhythmia
* Coronary artery disease
* Primary pulmonary vascular disease
* Oxygen desaturation to less than 80% during exercise on room air
Modulation of Visual-Spatial Learning in Healthy Young Adults by tDCS

The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine the underlying neuronal mechanism.


Eligibility Criteria:
Inclusion Criteria:

* right handednesss
* unobtrusive neuropsychological screening
* age: 18-35 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological disease, e.g. previous major stroke, brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)
Determining the Risk Elevation After Maternity

Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with preeclampsia in pregnancy.

Preeclampsia is a complication of pregnancy that happens in about 5-7% of all births. It is diagnosed when a mother has high blood pressure in pregnancy combined with protein in the urine which is sign that the kidneys are not functioning properly. When a mother has preeclampsia, the placenta makes abnormal amounts of several important proteins that damage the lining of the mother's blood vessels. The blood vessel damage that occurs places women at up to 10 times higher risk of having a heart attack or stroke at a younger age than women who did not have preeclampsia. It usually takes between 8 and 15 years after preeclampsia is diagnosed for the first heart attack or stroke to occur.

Unfortunately, this blood vessel damage is usually silent, meaning that women and their doctors are not aware of it. This makes it hard to predict which women are at highest risk of a heart attack or stroke and therefore need extra medical care to prevent it. Abnormal levels of the placenta proteins in the blood (right after delivery and at three and six months after delivery) as well as abnormalities of the placenta itself may be the earliest way to predict which women with preeclampsia are at risk of premature heart disease or stroke.

The purpose of this study is to collect blood and placentas from women with preeclampsia and without preeclampsia to measure and compare the levels of proteins in the blood and find abnormalities of the placentas that are associated with preeclampsia. We will then see if these tests can predict which women will go on to develop high blood pressure and ultimately be at higher risk of premature heart attack or stroke after pregnancy.

Eligibility Criteria:
Inclusion Criteria:

Women with a pregnancy complicated by pre-eclampsia and women who are healthy and have had a normal singleton pregnancy(controls)

Exclusion Criteria:

Women with any of the following conditions will be excluded in both the control \& preeclampsia groups:

1. known kidney disease prior to pregnancy or laboratory evidence of proteinuria prior to pregnancy
2. diabetes (Type I, Type II or Gestational Diabetes)
3. known Cardiovascular Disease (myocardial infarction, angina, stroke, or transient ischemic attack
4. multiple pregnancies (twins or more)
5. who do not understand English or French will be excluded In addition to those listed above, for the control group, women must have no other major maternal pregnancy complications.