cyrilzakka/clinical-trials huggingface dataset:
Characterization of Sitting Postures in Healthy Subjects

The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

* The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients.
* This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.

Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old
* age between 20 and 30 years old
* affiliation to social security or similarly regime

Exclusion Criteria:

* Person with pacemaker
* Person with a history of lumbar pain, chest or/and cervical pain.
* Person with an history of lumbar, chest or/and cervical muscular disorders,
* Person with history of circulatory problems,
* Person with history of skin pathologies at the seat area,
* Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
* Person having a total annual compensation for the participation in biomedical research higher than €4460.
Sonographic Assessment and Visualization of Ectopics in Emergency Medicine

Observational study of the use of ultrasound by emergency physicians in the evaluation of patients at risk of ectopic pregnancy.

Emergency Physicians who have undergone training according to the American College of Emergency Physicians Guidelines will be evaluated in the accuracy of performing pelvic ultrasounds among patients at risk for ectopic pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* pregnant females in 1st trimester
* present to emergency department
* complaint of abdominal/pelvic pain or vaginal bleeding

Exclusion Criteria:

* previous ultrasound diagnostic of location of pregnancy
Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial

Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* surgeon determined need for ventral hernia repair

Exclusion Criteria:

* \<18 \& \>99 years of age
* Pregnant
* Medical indication for open repair
A Novel Machine Learning Algorithm to Predict the Lewy Body Dementias

Parkinson's disease dementia (PDD) and Dementia with lewy bodies (DLB) are dementia syndromes that overlap in many clinical features, making their diagnosis difficult in clinical practice, particularly in advanced stages. We propose a machine learning algorithm, based only on non-invasively and easily in-the-clinic collectable predictors, to identify these disorders with a high prognostic performance.

The algorithm will be develop using dataset from two specialized memory centers, employing a sample of PDD and DLB subjects whose diagnostic follow-up is available for at least 3 years after the baseline assessment. A restricted set of information regarding clinico- demographic characteristics, 6 neuropsychological tests (mini mental, PD Cognitive Rating Scale, Brief Visuospatial Memory test, Symbol digit written, Wechsler adult intelligence scale, trail making A and B) was used as predictors. Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), will be investigated for their ability to predict successfully whether patients suffered from PDD or DLB.

Eligibility Criteria:
Inclusion Criteria:

the PDD group comprised of patients fulfilling the Criteria for probable PDD of the Movement Disorders Society (b) the DLB group comprised of patients, according to the recent revised criteria for probable DLB .

Exclusion Criteria:

* major psychiatrics disorders, depression
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)

Exclusion Criteria:

1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value \<600 mg/dL at screening.
4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:

   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon® suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital

Exclusion Criteria:

* No exclusion criteria have been set
Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids

Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification.

This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Current opioid analgesic dependence
* History of at least 2 years of oral opiate analgesic use
* Prescribed opioids for chronic pain
* Pain episode of at least 6 months duration within the 5 years prior to study entry
* Available for the duration of the study
* Good general health

Exclusion Criteria:

* Currently using any illicit substance
* Meets criteria for alcohol dependence
* History of heroin use
* History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
* Evidence of current maximal primary pain
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events).

Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses.

Secondary: Evaluation of objective tumour response

The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of malignant melanoma.
* Previously untreated and non-resectable disease
* Measurable or evaluable tumour.
* Age ≥ 18 and ≤ 75 years.
* Performance status ECOG-WHO 0, 1 and 2 (Appendix III)
* Written informed consent (Appendix II)
* Adequate bone marrow liver, heart and renal function:
* WBC count \>3.0 x 109/L and platelets count \>100 x 109/L.
* ASAT, ALAT \<2 x upper normal laboratory value.
* Serum creatinine \<2 x upper normal laboratory value.

Exclusion Criteria:

* Previous treatment with chemotherapy.
* Clinical signs of brain metastases.
* Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease.
* Severe active infections such as HIV or hepatitis B or Hepatitis C.
* Medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids).
* Pregnancy, breast-feeding or absence of adequate contraception for fertile patients.
* Simultaneously participation in other clinical studies.
* Any reason why, in the opinion of the investigator, the patient should not participate.
Efficacy and Safety of SPD503 in Combination With Psychostimulants

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
* Aged 6-17 years with a sub-optimal
* Partial response to stimulants
* Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale

Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 and ≤ 65 years
* patients with patent foramen ovale
* written informed consent

Exclusion Criteria:

* previous IMA, stroke or TIA
* arrhythmia or severe cardiac disease
* hypertension, diabetes or renal disease
* psychiatric disease
* neurological or neurodegenerative disease
* dementia
* assumption of drugs known to interfere with cognitive function
* inability to be subjected MRI analysis
* participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia

HAAL project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

The HAAL study is a feasibility study. The general objectives of the HAAL project is to be assessed the stress relief at work for formal and informal caregivers, the improvement in the perceived quality of life for informal caregivers and person with dementia, the reduction in case load for the formal caregivers and the increased cost-effectiveness of the HAAL solution in comparison to the available services. The experimentation will be carried out in 3 sites: Italy, The Netherlands and Taiwan. The study consists in a alpha phase (5 older adults with dementia, 5 formal caregivers and 5 formal caregivers) and in a beta phase (10 older adults with dementia, 10 formal caregivers and 10 formal caregivers).

Eligibility Criteria:
Inclusion Criteria:

* being the caregiver of a person with cognitive impairment or dementia;
* availability of time to participate;
* visit the assisted person at least two times at week or live with him/her.

Exclusion Criteria:

* Lack of written informed consent
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.

Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, \>3 cm in diameter)
* WHO performance status ≤2
* age ≤85years
* BCG naive
* patients not treated with intravesical chemotherapy in the last 3 months.

Exclusion Criteria:

* presence of T1G3 or CIS
* preoperative urinary cytology positive for high-grade atypia
* inadequate bone marrow reserve (white blood cells \<3 x 109/l, platelets \<100 x 109/l)
* history of genito-urinary tuberculosis
* presence of uncontrolled urinary infections.
Myoglobin Removal by High Cut-off CVVHD

A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.

Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied.

Significant clearance for myoglobin has been reported for high flux membranes from \< 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI.

Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.

Eligibility Criteria:
Inclusion Criteria:

* Acute Rhabdomyolysis
* placed central venous catheter
* Indication for RRT due to Serum CK level \> 5000 u/L
* Age ≥ 18 years
* Signed ICF

Exclusion Criteria:

* End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
* Pregnancy or lactation
* Palliative treatment
* Participation in other clinical studies
A Treatment Legacy Effect of Metformin in Obese Women With PCOS

Metformin has multiple health promoting effects and it may serve as a preventive measure for individuals who are at high risk for metabolic complications.

According to the latest international guidelines it should be considered as an adjunct therapy to lifestyle intervention in all overweight/obese women with PCOS, independently of their glucose homeostasis and menstrual regularity. However, there is no clear answer for how long metformin should be prescribed in this subset of women with PCOS and for how long the beneficial impact would sustain after treatment cessation.

The investigators compared the consequences of metformin withdrawal after long-term therapy as opposed to the consequences of metformin suspension after short term therapy in overweight/obese women with PCOS that had previously responded to metformin by means of moderate weight loss, improved menstrual frequency and sustained normal glucose homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* PCOS defined by the National Institute of Child Health and Human Development (NICHD) criteria
* obesity with body mass index ≥ 30 kg/m2
* normal glucose homeostasis at metformin treatment

Exclusion Criteria:

* known type 1 or type 2 diabetes mellitus
* heart failure
* renal insufficiency with serum creatinine more than 125 umol/L
* arterial hypertension
* pregnancy
* BMI below 25 kg/m2
Thresholds of SLR Maneuver in Obese Patients

There is an increasing interest in High resolution manometry (HRM) in the preoperative assessment of patients with obesity, in order to identify the best surgical option. Sleeve gastrectomy (SG) has been known to increase the risk of gastro-esophageal reflux disease (GERD). Different techniques have been recently developed and validated to offer to these patients protection against pathologic GERD after SG.

A recent study found a significant correlation between straight leg raise (SLR) maneuver during HRM and a positive pH-study. However, these maneuver has not been validated in an obese population, therefore the normality cut-off remain unknown.

A multicenter study with a large number of patients undergoing pre-operative assessment for bariatric surgery could provide a precise threshold to predict pathologic esophageal acid exposure time.


Eligibility Criteria:
Inclusion Criteria:

* Complete and adequate HRM and pH-impedance study performed within 2 weeks
* Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)
* Obese with BMI\>35 Kg/m2

Exclusion Criteria:

* Patients under the age of 18
* Patients with prior foregut surgery
* Paraesophageal hiatal hernia
* Scleroderma
* Eosinophilic esophagitis
* Pregnancy
Evaluating Community Health Centers' Adoption of a New Global Capitation Payment

The investigators are conducting a prospective analysis of the Alternative Payment Methodology (APM) demonstration project sites. The investigators' goal is to conduct a cross project analysis of findings. The investigators propose to use mixed methods to study processes and outcomes associated with the APM natural experiment in payment reform. The investigators hypothesize that Community Health Centers (CHCs) participating in the APM demonstration project will redesign their workflows to better focus on patient and population health needs, resulting in reallocation of financial resources, lower overall costs, changes in utilization patterns, and improved quality.

Led by the Oregon Primary Care Association, three community health center (CHC) organizations in Oregon developed an Alternative Payment Methodology (APM). Under this APM pilot participating CHCs will receive a prospective payment system (PPS) payment as a capitated equivalent in a per-member-per-month rate for all of their Medicaid patients. Oregon CHC organizations (several clinic sites) implemented Phase I of this demonstration project on March 1, 2013; Phase II A was implemented on July 1, 2014; Phase II B on October 1, 2014; and Phase III began July 1, 2015.

We are a prospective analysis of the APM project sites. We propose to use mixed methods to study processes and outcomes associated with the APM natural experiment in payment reform. We hypothesize that CHCs participating in the APM demonstration project will redesign their workflows to better focus on patient and population health needs, resulting in reallocation of financial resources, lower overall costs, changes in utilization patterns, and improved quality.

The study will include baseline qualitative data collection as clinics are transitioning to the APM methodology. We will conduct 2 site visits to each intervention clinic to observe practice changes that occurred post APM-implementation (first visit approximately 12-18 months post-APM implementation; second visit approximately 30-36 months post-APM implementation). We will also assemble and analyze of pre-post quantitative and qualitative datasets, and interpretation and dissemination of study findings.

Eligibility Criteria:
Inclusion Criteria:

1. Total clinic population:

   established patients at intervention and control clinics aged 2-64
2. Medicaid Population:

Medicaid-enrolled patients at intervention and control clinics aged 2-64

Exclusion Criteria:

1. Total clinic population:

   non-established patients at intervention and control clinics aged 2-64
2. Medicaid Population:

non-Medicaid-enrolled patients at intervention and control clinics aged 2-64
Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* choroidal neovascularization caused by age-related macula degeneration
* no previous treatment
* a follow-up at least 12 months
* a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

* choroidal neovascularization caused by other eye diseases
* ocular surgery within the past 3 mouths
* history of uveitis
* intraocular pressure higher than 25 mmHg, or glaucoma
* history of systemic or ocular thromboembolic events.