cyrilzakka/clinical-trials huggingface dataset:
Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients

The goal of clinical trial is to evaluate the impact of use of health-connected devices and of an Internet-based Intensive follow-up on physical activity recovery during the 6-month period after bariatric surgery in obese patients.

90 patients with morbid obesity, having recently benefited from an act of bariatric surgery will be recruited for clinical trial if they meet the inclusion and no inclusion criteria. This is a single-center, open, controlled, randomized, 2 parallel-groups:

* "Mobility Coaching" group
* "Diet Coaching" group

The "Diet Coaching" group will be the "control group" of "Mobility Coaching" group and vice versa.

Patients in both groups will be equipped with a connected-scale and a wristwatch equipped with a pedometer connected. The online tools available to patients will be used to motivate patients to progress and alert the coaches and the medical team in case of difficulties to achieve the objectives.

Eligibility Criteria:
Inclusion Criteria:

* Primo-surgery bariatric surgery a week before their inclusion
* Absence of surgical side events related to the surgical procedure
* Adult female or male
* Weight ≤ 150 kg
* Knowing read and write French routinely,
* Possessing an internet connection at home,
* Possessing and knowing how to use a computer or tablet,
* Owning a smartphone,
* Affiliated with a social security scheme
* Not Trust
* Having signed the informed consent letter

Non-inclusion criteria • Patient with major disabilities causing a definitive loss of mobility

Exclusion Criteria:

• None
IT-based Training in Obesity

Though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. The aim of the study is to compare the influence of different personal and IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the minimum level of service necessary for a maximum increase in activity and weight reduction.


Eligibility Criteria:
Inclusion Criteria:

* Physical activity of less than once per week
* Body-Mass-Index 28-35 kg/m2
* Age 35-65
* Men and women

Exclusion Criteria:

* CHD
* Diabetes
* Other chronic diseases with conditions prohibiting regular physical activity
* Drug abuse
* BMI \< 28 or \> 35
* Regular physical activity
* Pregnancy
* Mental illness
Breathing Training and Exercise Capacity in Non-CFB

The purpose of this research is to investigate whether a home-based and health coach supported specific breathing and respiratory muscle training program improves the ability to exercise, the function of the lungs and breathing muscles, and general clinical status in people with non-cystic fibrosis bronchiectasis (non-CFB).


Eligibility Criteria:
Inclusion Criteria:

* Mayo Clinic patient with confirmed diagnosis of Non-Cystic Fibrosis Bronchiectasis (non-CFB): Non-CFB as confirmed by clinical history, including cough, shortness of breath, exertional dyspnea, pulmonary function tests, and high-resolution computed tomography. Patients will be considered clinically stable if there is no evidence of an exacerbation or change(s) in medical therapy in the previous three weeks.
* Able and willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Presence of significant coexisting disease, neurological conditions, and/or orthopedic complications that affect ability to undertake exercise.
* Presence of advanced heart failure.
* Current use of antibiotics.
* Acute exacerbation(s) within 3-weeks prior to study commencement.
* Participation within a pulmonary rehabilitation program within 6-months prior to study commencement.
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.
* Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
* Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
* Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
* Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

* Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
* A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
* Status epilepticus within 1 year prior to visit 1.
* Seizures related to drugs, alcohol, or acute medical illness.
* Progressive structural CNS lesion or a progressive encephalopathy.
Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation

The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.


Eligibility Criteria:
Inclusion Criteria:

• patients with liver failure undergoing liver transplantation

Exclusion Criteria:

* Age less than 18 years;
* Active overt infection;
* Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders...etc);
* Patients undergoing re-transplantation.
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women

The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity.

Thirty-six postmenopausal women participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 18) or the control group (CON, n = 18). The EX group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. The CON group did not participate in any exercise, dietary, or behavioral intervention. Blood glucose, insulin, homeostatic model of insulin resistance (HOMA-IR), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of EX or CON.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal (cessation of menses for at least 12 consecutive months)
* abdominal obesity (waist \> 80 cm)

Exclusion Criteria:

* current smoker (smoking within 6 months of participation)
* cardiovascular disease
* renal disease
* pulmonary disease
* thyroid disease
Factors Affect Outcomes in Cardiovascular Surgery

Identify factors that contribute to perioperative morbidity and mortality in patients undergoing cardiac surgery that involves cardiopulmonary bypass.

Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

Identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

Here are some examples, but may not limited the following factors:

1. demographic data
2. perioperative medications
3. comorbidity

Eligibility Criteria:
Inclusion Criteria:

Patients greater than or equal to 18 years old that underwent cardiovascular surgery at UC Davis Medical Center from 01/01/2001 to 07/15/2013.

Patients will only be included that underwent cardiovascular surgeries with or without cardiopulmonary bypass.

Exclusion Criteria:

Patients that did not undergo cardiovascular surgeries and age\< 18 years old will be excluded from the study.
ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved

Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD).

Approximately 1,500 BDD donors have one or more organs removed each year. Despite the growing demand for transplanted organs, the number of organs available from deceased donors has remained stable over the past few decades. This highlights the need to optimize the management of potential BDD, in order to increase both the quality and number of transplanted organs. Several studies have found an association between the characteristics and management of BDD donors and the number of organs, or even the function of transplanted organs. Data suggest that hemodynamic, respiratory, and metabolic therapeutic targets during BDD management prior to multi-organ procurement were associated with a higher number of transplanted organs compared to standard care. However, this has never been confirmed in a French population. Furthermore, while the impact of these therapeutic goals has been studied after the donor is in a state of brain death, the events occurring in the ICU before reaching brain death status and their impact on the number of organs retrieved have not been investigated. Lastly, the intensity of the therapeutic interventions used to achieve these goals, and certain management delays, have only been partially studied.

Our hypothesis is that achieving a bundle of therapeutic goals, and the intensity of the interventions used to reach these goals, both before and after BDD, are associated with a greater number of organs retrieved.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, hospitalized in the ICU
* In a state of brain death
* No objection to organ donation during their lifetime
* Patients with social security coverage

Exclusion Criteria:

* Objection to the use of their data during their lifetime
* Registration in the national refusal registry
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start
* Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Patients with serious diabetic complications and other serious complications
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual clinical practice -without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Woman between the ages of 30 and 65 (both included).
2. Able to read and understand the Patient Information Sheet and the Informed Consent form.
3. Accept participation in the study and sign the Informed Consent form.
4. Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
5. Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
6. Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it.

Exclusion Criteria:

1. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
2. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
3. To had been vaccinated against HPV.
4. Other symptomatic vulvovaginal infections.
5. Surgical cervical excision in the last year or total hysterectomy.
6. Previous history of gynecological cancer.
7. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the study.
8. Any planned surgery that prevents the correct compliance with the protocol.
9. Use of vaginal contraceptives or other vaginal hormonal treatments.
10. Contraindications for Papilocare gel use or known allergies to any of its components.
11. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Reflex Excitability in Post-stroke Stiff-Knee Gait

The purpose of this study is to examine the reflex excitability of the rectus femoris in individuals with and without post-stroke Stiff-Knee gait. We use electrical stimulation of the peripheral nerve innervating the rectus femoris for a well-controlled reflex stimulus. We are investigating whether reflex excitability of the rectus femoris correlates with gait kinematics.

The purpose of this study is to investigate the role of hyperreflexia in post-stroke Stiff-Knee gait function. In one aim,

Eligibility Criteria:
Inclusion criteria:

* Aged at least 18
* Premorbidly independent
* If post-stroke, mild to moderate impairment determined by standard practices per the physical therapist
* Able to continuously walk for 30 minutes
* If post-stroke, reduced knee flexion during walking relative to unimpaired side
* If post-stroke, hemiparesis
* Ability to provide informed consent

Exclusion criteria:

* No history of serious lower limb musculoskeletal injury
* No functionally relevant osteoarthritis and weight-bearing restrictions
* No functionally relevant polyneuropathy
* No functionally relevant cognitive impairment
* No functionally relevant vision impairment
Personalized Ultrasonic Brain Stimulation for Depression

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65, any gender
2. Primary diagnosis of major depressive disorder or bipolar disorder
3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10
5. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
6. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
7. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

1. History of serious brain injury or other neurologic disorder
2. Poorly managed general medical condition
3. Pregnant or breast feeding
4. Implanted device in the head or neck
5. MRI intolerance or contraindication
6. Brain stimulation (e.g., ECT, TMS, VNS) in the past month
7. Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
8. Lifetime history of a serious suicide attempt
9. Moderate-to-severe substance use disorder (past 3 months)
10. Obsessive compulsive disorder (past month)
11. Posttraumatic stress disorder (past month)
12. Schizophrenia-spectrum disorder (lifetime)
13. Neurocognitive disorder (past year)
14. Personality disorder as a current focus of treatment
15. Clinically inappropriate for participation in the study as determined by the study team
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of moderate to severe chronic plaque psoriasis
* Either start therapy with ustekinumab for the treatment of psoriasis within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study; a. the treatment decision must have been taken independently of and prior to a participant's inclusion in the study; b. where participants have started therapy with ustekinumab before the first assessment in the study, appropriate baseline data at the start of ustekinumab treatment must be documented, including psoriasis area and severity index (PASI), physician global assessment of disease (PGA), body surface area (BSA) and children's dermatology life quality index (CDLQI) scores where available
* Participants (and/or a legally-acceptable representative/guardian where applicable) must sign a participation agreement/informed consent form (ICF) allowing source data collection and verification in accordance with local requirements and the participants (and/or a legally-acceptable representative/guardian where applicable) must be able to understand and complete the requested patient-reported outcomes (PROs)
* Be willing to participate in the study

Exclusion Criteria:

* Is enrolled in an interventional clinical trial
The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions

The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness.


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* Do not take psychiatric drugs on a regular basis
* Geriatric Depression Scale score less than 3
* Mini-Mental State Examination score higher than 27
* Healthy and able to exercise at medium intensity

Exclusion Criteria:

* All others
Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

Stroke and silent cerebral infarction are a real risk with thoracic enodvascular aortic repair (TEVAR). The investigator propose to prospectively observational study with enrolment of all patients undergoing TEVAR for thoracic and thoracoabdominal conditions including aneurysmal degeneration, Type B dissection and acute aortic syndromes over a 24 month period, equating to a minimum of 20-30 patients per year. Patients undergoing juxtra-renal and infra-renal aortic stenting will form a control group.

TEVAR involves the insertion of a stent into the thoracic aorta to re-line it and prevent life-threatening haemorrhage from rupture, and ultimately death. The stent is inserted through a small cut in the femoral artery in the groin that is able to track to the desired location in the thoracic aorta over wires. The thoracic aorta and the branches it provides to supply the brain are diseased with atherosclerotic plaques and thrombus. The manipulation of wires and stents over these diseased locations can lead to small fragments breaking off and travelling to the brain to block the blood supply to areas of the brain (cerebral embolisation).

Cerebral embolic protection devices (CEPDs) consist of filters that can be placed into the branches of the thoracic aorta that supply the brain(supra-aortic branches) before TEVAR and can capture and remove solid debris, preventing it from reaching the brain.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring TEVAR as decided upon by a multidisciplinary meeting

Exclusion Criteria:

* Contraindication to MRI scanning
* Unable to give consent