cyrilzakka/clinical-trials huggingface dataset:
Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG

Early feasibility study of the DurVena Photochemical Tissue Passivation (PTP) device for treatment of saphenous vein grafts in participants undergoing elective coronary artery bypass graft (CABG) surgery. Study to be conducted outside the U.S.

The Photochemical Tissue Passivation (PTP) treatment of a saphenous vein graft (SVG) is indicated for the reduction of intimal hyperplasia and graft failure rate in SVGs after coronary bypass graft (CABG) surgery. The primary study objective, in this early feasibility study outside the US, is to characterize the safety profile of the PTP device when used during CABG surgery in participants with multivessel atherosclerotic coronary artery disease (CAD).

This is a prospective, randomized, within-subject controlled early feasibility study.

Up to 15 participants with multivessel CAD will be recruited for this study and followed for a minimum of 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
2. Age 21 years or older.
3. Planned and scheduled on-pump, arrested heart CABG.
4. Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
5. IMA graft indicated for the LAD.
6. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 2 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively.

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Exclusion Criteria:

1. Concomitant non-CABG cardiac surgical procedure.
2. Prior cardiac surgery.
3. Emergency CABG surgery (e.g., cardiogenic shock, inotropic pressure support, intraaortic balloon pump, ECMO).
4. Contraindication for on-pump CABG with cardioplegic arrest (e.g., severely calcified aorta).
5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
6. Platelets \< 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.
7. Infection (WBC ≥12.5 x 103/ml and or temperature ≥100.5°F/38°C).
8. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months.
9. Unwilling or unable to receive blood transfusion.
10. Inability to undergo treatment with heparin.
11. Participants on dialysis or GFR of \<30 ml/min/1.73m2.
12. Primary liver disease with bilirubin, SGOT, or SGPT \> 4X upper limit of normal.
13. Prior history of allergic reaction to contrast media with anaphylaxis or severe peripheral edema.
14. Any medical condition that, in the opinion of the investigator, would compromise the safety of the participant or quality of the study data.
15. Pregnancy and nursing or lactating.
16. Current, or past participation in a clinical trial within the past 30 days.
A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC

This primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.


Eligibility Criteria:
Inclusion Criteria:

1. Joined the study voluntarily and signed informed consent form.
2. Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy.
3. Both genders.
4. Esophageal squamous cell carcinoma confirmed by pathology.
5. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th).
6. No radiotherapy, chemotherapy or other treatments prior to enrollment.
7. PS ECOG 0-2，wight loss\<30% during the latest 6 months.
8. Life expectancy of more than 3 months.
9. Hemoglobin（Hb）≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN.Renal function: creatinine \< 1.5 x ULN.
10. No immuno-deficiency
11. No heart diseases that need cardiac glycoside
12. Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

1. Complete esophageal obstruction.
2. Deep esophageal ulcer.
3. Esophageal perforation.
4. Haematemesis.
5. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy.
6. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years.
7. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
8. Drug addiction,Alcoholism or AIDS.
Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain

Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients.

The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term.

The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery.

This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic low back pain requiring prosthesis or arthrodesis surgery on one or two levels
* Subject affiliated or beneficiary of a health insurance plan.
* The patient must have given their free and informed consent

Exclusion Criteria:

* Patients with organic low back pain (infection, tumor, inflammatory rheumatism)
* Patient with a neurological deficit (cauda equina syndrome or motor testing MRC \< 3 on a muscle group of the lower limbs)
* Patient who has already undergone lumbar surgery (except single discectomy)
* Patient with serious concomitant pathologies
* Patients participating in a therapeutic study prohibiting participation in another study
* Patient in an exclusion period from a different study
* It is impossible to give the subject informed information
* Patient is unable to express consent
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique

A population-based COVID19 surveillance in a household cohort will be set-up using an existing Household demographic surveillance system (HDSS). From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during 12 months. Demographic, epidemiological and clinical data of possible cases and of the source population will be recorded at baseline.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

The investigators will use the established HDSS to set up population-based COVID19 surveillance in a household cohort. From any individual in this population with any respiratory symptom or loss of smell or taste, with or without fever, investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months. These cases will be identified through bi-weekly household visits, through an alert system involving community leaders and HDSS interviewers, or when presenting with symptoms at healthcare centres or the referral hospital. Demographic, epidemiological and clinical data (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source population will be recorded at baseline; recent illness, potential risk exposure of each household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of measures to reduce exposure/transmission, and barriers to the uptake of such measures, will be recorded/updated during every household visit.

An age-stratified serial sero-survey will be conducted at baseline in a subset of the population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after confirmation of community transmission.

Eligibility Criteria:
Inclusion Criteria:

* Any individual enrolled in the Polana Caniço-HDSS: All members residing in the household for at least 3 months (infants, children, adults, elderly), regardless of age, underlying conditions, medical history, infection or disease status or history
* Able and willing to provide written informed consent: by the household head for the surveillance; by each selected participant for the sero-survey.

No Exclusion Criteria
Smoothies and Blood Sugars

Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Body mass index 18-30 kg/m2

Exclusion Criteria:

* diagnosis of any form of diabetes
* intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
* Fructose malabsorption
* Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
* pregnant or lactating
* any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.

HIV is a virus that weakens a person's immune system and can cause AIDS. It is most commonly transmitted through unprotected sexual contact. People with a mental illness who are sexually active may be at risk of HIV infection, but most interventions for reducing risk of HIV infection do not target this particular population. This study will test an intervention aimed at reducing behaviors with a high risk of causing HIV infection in sexually active people with a mental illness.

Participation in this study will last 15 months. At study entry, participants will complete a baseline interview with a research assistant. This interview will evaluate sexual activity, knowledge of HIV, the participant's psychiatric diagnosis and symptoms, attitude toward condoms, and stigma related to mental illness experienced by the participant.

Participants will then be randomly assigned to either an HIV risk reduction group or a general health group. Both of these groups will meet once a week for 8 weeks. Those in the HIV risk reduction group will learn information and take part in activities aimed at reducing behaviors that place people at a high risk of being infected with HIV. Those in the general health group will learn about long-term serious medical conditions, such as diabetes and high blood pressure, that may be common in people with a mental illness.

Participants will complete two follow-up visits after their 8-week intervention, one the week after and one 3 months after. Participants will then complete a "booster" of three weekly group sessions covering the same information from their 8-week intervention. More follow-up visits will occur 1 week and 6 months after participants complete the booster sessions. All follow-up visits will involve an interview similar to the one held at study entry. Additionally, feedback forms will be completed at the first interview at study entry, after the eight group sessions, after the three booster sessions, and at the last interview.

Eligibility Criteria:
Inclusion Criteria:

* Being treated as a patient in one of the study psychiatric clinics
* Sexually active in the past 3 months

Exclusion Criteria:

* Primary alcohol or other drug use disorder
* Acutely psychotic or actively suicidal at the time of the screening interview
* Developmental disability as a primary diagnosis
* Unable to speak Portuguese
Memory Imaging of Normal Aging

The purpose of this study is to develop imaging techniques that can distinguish functional brain changes in people at high risk for dementia years prior to onset of clinical memory problems from those with normal changes of aging.

The overall goals of this project are to identify consistent patterns of variance in brain function in patients at risk for Alzheimer's Disease by using APOE ε4 as a marker for disease risk. The activation Blood Oxygen Level Dependency (BOLD) signal will be compared to both resting and activation perfusion signals to assess the variability of cerebral blood flow as it relates to the BOLD signal. Each participant will be imaged on a 3T MRI scanner while performing an associate episodic memory task.

A total of 90 individuals will be recruited for this study. Participants will be non-demented, right handed, adults with or without at least one APOE ε4 allele. Groups will be split as follows: A) ages 25-39: non-ε4 (n=15); B) ages 25-39: +ε4 (n=15); C) ages 40-49: non-ε4 (n=15); D) ages 40-49: +ε4 (n=15);.E) ages 50-65: non-ε4: F) ages 50-65: +ε4 (n=15). These groups will be matched for mean age, mean years of education, gender distribution, as well as the presence or absence of a family history of AD in a first degree relative.

There will be 2 scanning sessions for each participant. Scan session #1 and Scan session #2 will be acquired within 2 weeks of each other and will take approximately one hour each.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* Major medical illnesses
* History of significant head trauma with residual cognitive deficits
* Other neurological or major psychiatric disorders such as schizophrenia, bipolar disorder, developmental learning disorder, and alcohol or substance abuse
* MRI contra-indications
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas

The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.
* Patients who agree to participate to the study.
Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.

Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes, is considered one of the most effective techniques for controlling the motor fluctuations of Parkinson's disease. The particularity of this surgery is the necessity of the awakening of the patient for the correct positioning of the electrodes, it is therefore a difficult test for the patient.

Medical sophrology is an ideal strategy to optimize the comfort of the patient during the operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance of a good patient vigilance favoring the cooperation with the operating room team. Indeed, sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga, which makes it possible to find a balance between emotions, thoughts and behaviors. It has already been applied in other fields such as oncology, pain management, preparation for childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep brain stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age greater than or equal to 18 years)
* Patient with idiopathic Parkinson's disease with programmed deep brain stimulation (VIM target, NST, single or bilateral GPI);
* Planned intervention in an awake patient (implying MOCA\> 21 (Montreal Cognitive Assessment));
* Patient understanding the course of the study;
* Patient who has given informed consent in writing;
* Patient benefiting from a system of social insurance.

Exclusion Criteria:

* - Intervention under general anesthesia;
* Pregnant or nursing women;
* Major person under protective measures (safeguard of justice, curatorship and guardianship);
* Person deprived of liberty.
* Patient having already had a practice in yoga, sophrology, hypnotherapy superior or equal to 5 sessions
Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles

Background: Many lifestyle-related health disorders are influenced by physical activity level and physical function. Health examinations which focus on musculoskeletal function of people who have risk factors for lifestyle-related disorders, combined with person-centered advice based on risk profiles can give people knowledge and guidance to manage their own lifestyle priorities.

Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT) which will examine the preventive effects of musculoskeletal function examinations and person-centered advice on inactive middle-aged people.

Methods: Physically inactive middle-aged people will be invited to participate in a two-part health examination with follow-up after three months in a pilot study. Part 1 is a standard health examination including blood tests and Part 2 is a functional examination of fitness, strength, mobility, balance and posture according to our protocol based on validated tests. The intervention group receives feedback based on both parts of the examination while the control group receives feedback only from Part 1. Physical activity level will be measured objectively with accelerometers at inclusion and follow-up.

Expected results: The pilot study is expected to show whether the planned RCT is practically feasible and to give relevant support for the power analysis for a later full-scale RCT. Better understanding of personal physical function and risk factors can facilitate lifestyle decisions on the individual level which can reduce the risk for later ill-health and need of health-care. Preventive interventions may contribute to reduce the ever-increasing level of lifestyle-related ill-health.


Eligibility Criteria:
Inclusion Criteria:

* Born 1982 (aged 40 years). Self-assessed as physically inactive. Self-reported normal general mobility - can walk without support and has full use of all 4 extremities.

Exclusion Criteria:

* Self-reported regular moderate-to-intensive physical activity more than once per week. Pregnancy. Ongoing treatment requiring hospital-based services. Severe mental illness or intellectual impairment. Need of interpreter to participate in the study or answer the questionnaires.
Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE

Purpose:

In a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.

Methods. In the developing study, three variables were found as predictors of mayor outcomes and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of daytime sleepiness as quantified by the Epworth questionnaire and the presence of current cardiovascular disease. The index (OSA-SCORE) has a value between 0 (less risk) to 5 (more risk). For each point, a significant increment in the risk of death was found. In the retrospective validation study, a number of potential variables will be recorded, all of them also predictors of major outcomes. Data will be recorded by trained personnel on-site at the respiratory Sleep Units around the country. The final cohort will include 1100 subjects aged \> 18 years . The observation time will be considered since the time at diagnosis to fatal event and the patient will be censored when non-invasive ventilation was started or at the recorded time if the patient is alive. The primary outcome is all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (\> 18 years)

Exclusion Criteria:

* Under 18 years old
* Unable to complete sleep study
Reliability of Functional Measures in Hemodialysis Patient.

The investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).

Patients suffering from End Stage Renal Disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. Haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity and health related quality of life (HRQoL). Many studies show that functional capacity, physical activity level and HRQoL is significantly worse than their healthy sedentary age - matched counterparts. It is unknown if low physical activity, uraemia or anaemia are responsible for the decreased functional capacity of this cohort. Physical performance tests are frequently used to assess haemodialysis patients since is a feasible and low-cost evaluation. The purpose of the present study is quantified how the functional capacity changes over a -6 months period in a group of haemodialysis patients. Additionally the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).

Eligibility Criteria:
Inclusion Criteria:

* people under hemodialysis treatment at least 3 months
* be medicable stable
* complete all the physical tests

Exclusion Criteria:

* heart stroke in the previous 6 weeks of the study
* inferior limb amputation without artificial aids
* cerebral vascular disease (ictus, ischemic)
* disability to complete functional tests