cyrilzakka/clinical-trials huggingface dataset:
Blood-brain Barrier Leakage in Dementia. A Dynamic Contrast-enhanced MRI Study

Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of dementia. Yet, the cause of these diseases is still unknown. A potentially important initiating factor is a disrupted blood-brain barrier. This can initiate cerebral microangiopathy, which has frequently been associated with VaD. Nevertheless, also in most AD patients a substantial increase of vascular damage has been observed. The present study investigates the correlation between blood-brain-barrier breakdown and cognitive decline in AD and VaD. An innovative dynamic contrast-enhanced MRI scan that has recently been developed and tested at our institute, will be used to measure blood-brain barrier permeability.

Objective: We will investigate the relationship between this permeability measure and (i) cognitive performance and (ii) the status of MRI visible cerebrovascular pathology (i.e. white matter hyperintensities, lacunar infarctions, microbleeds) in the most common forms of dementia.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Informed consent before participation in the study
* Age of 55 and older
* Diagnosed with AD, VaD, mixed AD and VaD, mild cognitive impairment, vascular cognitive impairment and subjective cognitive impairment
* MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥18 are considered mentally competent)

Healthy participants:

* Informed consent before participation in the study
* Age of 55 and older
* No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
* MMSE ≥ 26
* No substantial memory complaints (according to participant)
* Average age, gender and education is similar to the patient groups.

Exclusion Criteria:

* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
* Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR \< 30 mL/min; or known allergy to Gadovist. If participants have a low renal function as determined by \<30 GFR \<60, the PI will contact a radiologist (Paul Hofman). The radiologist will decide if this patient should be excluded.
* Major vascular disorders (e.g. stroke, heart disease)
* Psychiatric or neurological disorders: Major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.
* Structural abnormalities of the brain
* Cognitive impairment due to alcohol/drug abuse or abuse of other substances.
* Absence of reliable informant (for patient groups)
Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* The patient is admitted to the trauma service.
* The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF
* The patient is not being treated for chronic pain
* The patient is \>18 years of age.
* Surgery anticipated \<120 hours from injury

Exclusion Criteria:

* Age \< 18 years or ≥ 80 years
* Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
* Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment \< 12)
* Prior or expected emergency exploratory laparotomy during this admission
* Prior or expected emergency thoracotomy during this admission
* Prior or expected emergency craniotomy during this admission
* Spinal cord injury
* Pelvic fracture that has required, or is expected to require, operative intervention during this admission
* The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)
* The patient is incarcerated
* The patient is known to be pregnant
* Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine the efficacy of the combination of cisplatin and gemcitabine in terms of response rate and progression free survival in patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate this treatment regimen in terms of toxicity and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression following 6 courses of therapy receive an additional 6 courses of therapy. Quality of life is assessed prior to each course and then every 3 months. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Locally advanced Stage IIIB (T4, Nx, M0, or Tx, N3, M0) OR Metastatic disease Stage IV unresectable disease Following cell types eligible: Epidermoid cell Large cell Adenocarcinoma Bidimensionally measurable disease Unresectable recurrence after primary surgery allowed No brain metastasis

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.10 mg/dL Cardiovascular: No uncontrolled cardiac disease Other: No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior experimental therapy No other concurrent experimental drugs
A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
* Willing to stay awake for at least 2 hours after taking study drug
* Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

* Breast-feeding, pregnant, or plan to become pregnant during the study
* Not able to tell migraine attack from other headaches
* Older than 50 years of age at migraine onset
* Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
* History of gastric or small intestinal surgery
* History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
* Currently participating or have participated in a study with in investigational compound or device in the last 30 days
Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus

This study aims to integrate clinical indicators and features of fundus images, combined with metabolomics, to construct an early warning model for diabetic retinopathy (DR) in type 2 diabetes. By combining clinical indicators with metabolomics, the investigators aim to establish a precise DR typing model based on the age of diabetes onset (early-onset diabetes, late-onset diabetes) and based on the coexistence with two types of diabetic macrovascular complications. A multidisciplinary collaboration will be conducted for comprehensive management of DR to control the progression of moderate-stage DR. Cloud-based patient rooms combined with continuous glucose monitoring (CGM) will further explore the role of integrated diabetes retinopathy ward management models in the management of patients undergoing diabetes retinopathy surgery, pioneering a new model for the management of advanced DR.


Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for type 2 diabetes in the "China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)";

  * Aged between 20 and 79 years old, without other severe underlying diseases; ③ Possesses full cognitive and literacy abilities; ④ Volunteers to participate in this study and are willing to sign an informed consent form.

Exclusion Criteria:

* Those who have been diagnosed with type 1 or other types of diabetes;

  * Those with severe cardiac, pulmonary, hepatic, or renal insufficiency;

    * Those with mental confusion, speech disorders, or dementia, etc.;

      * Those who are unable to take care of themselves, bedridden, or have mobility impairments; ⑤ Women who are breastfeeding or pregnant;

        * Those with a recent history of surgery, trauma, acute major vascular complications, or infectious diseases.
Factors Associated With the Complexity of Dental Implant Surgery After Alveolar Ridge Preservation: A Retrospective Cross-sectional Study

Alcohol consumption, tooth position, and periodontitis-related tooth extraction affect the complexity of subsequent implant surgery after alveolar ridge preservation.

Materials and methods We retrospectively analyzed the dentition of 165 alveolar ridge preservation sites in 116 patients. The bone width at three different vertical levels was measured on cone beam computed tomography images, and a comparison of bone regeneration requirements for subsequent dental implant surgery was performed for different socket types.

Eligibility Criteria:
Inclusion Criteria:

* teeth extraction in the premolar and molar regions, who underwent flapless tooth extraction with alveolat ridge preservation (ARP) and filling with freeze-dried bone allograft (FDBA) and platelet-rich fibrin (PRF), who underwent cone beam computed tomography (CBCT) followed by dental implant surgery after tooth extraction, and with adequate oral hygiene

Exclusion Criteria:

* untreated periodontitis, systemic disease, or the of medication that influences bone metabolism
Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

The purpose of this study is to determine the effect a morning light treatment has on improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia syndrome (FMS).


Eligibility Criteria:
Inclusion Criteria:

• Meet criteria for Fibromyalgia syndrome (FMS)

Exclusion Criteria:

* Significant chronic disease
* Severe hearing or memory problems
* Pending medical leave applications at workplace
* Current pregnancy, breastfeeding, or actively trying to get pregnant
* Night work or travel outside the eastern time zone within 1 month of the study
* Other research participation
* Frequent number of special events during study period (weddings, concerts, exams, etc).
Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast

The purpose of this study is to compare fat graft retention over time from lipoaspirate processed using two FDA-cleared devices: the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433).

This is a single-center, prospective, randomized study enrolling patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. A total of 20 patients will be enrolled in the study. Ten patients will receive lipoaspirate processed with the Revolve and ten patients will have lipoaspirate processed with the AuraGen 1-2-3 with AuraClens.

Patients will be followed on post-procedure months 3, 6, and 12. Fat graft retention will be evaluated by photographic assessment by blinded reviewers, and 3D imaging. Patient satisfaction will be measured using the Breast-Q - Augmentation survey.

Eligibility Criteria:
Inclusion Criteria:

* Female patients \> 18 years and \< 65 years of age
* Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) without a breast implant.
* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
* Patients must be non-smokers.
* Patients with available/adequate harvest sites for fat grafting.
* Anticipated harvested fat volume between 400 and 1400 cc
* Anticipated fat injection volume 150-350 cc per breast
* Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in their diet or lifestyle during the study.

Exclusion Criteria:

* Skin rash in the treatment area.
* Patients who smoke or use nicotine products.
* Patients with bleeding disorders or currently taking anticoagulants.
* Patients with a history of trauma or surgery to the treatment area.
* Patients with a history of breast cancer.
* Active, chronic, or recurrent infection.
* Compromised immune system (e.g. diabetes).
* Hypersensitivity to analgesic agents.
* Co-morbid conditions that could limit their ability to participate in the study or to comply with follow-up requirements.
* Untreated drug and/or alcohol abuse.
* Pregnant or breastfeeding.
* Any issue that, at the discretion of the investigator, would contraindicate the patient's participation.
* Patients who do not wish to have the study area (breast) photographed

NOTE Please note that there is no remuneration for participation in this study.
Improved Sitting Balance: Body Functions to Participation

The aim of this study is to evaluate the changes in activity and participation domains of International Classification of Functioning, Disability and Health (ICF) in children with cerebral palsy (CP) who received integrated Botulinum Toxin-A (BoNT-A) injections into the lower limb(s) with a treatment goal of improved sitting balance.

Postural problems play a substantial role in activities of daily living in children with CP having Gross Motor Function Classification System (GMFCS) levels IV or V. Improvement in sitting balance may positively effect the performance and caregiving of vital tasks of daily life in these children and may furtherly improve the quality of life of both the child and family. BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment. In the current literature its efficacy on body functions and structures by hypertonia management is well known. However there is inconclusive evidence for improvement in activity and participation domains of ICF with BoNT-A. CP is a very heterogenous population and in most of the studies the inclusion criteria do not adress level of underlying motor control and the primary efficacy assessment methods were usually chosen to cover hypertonia. Besides generally the efficacy endpoints were so soon to detect changes in activity or participation domains of ICF. Lack of association of rehabilitation programs is another important concern for the current clinical studies.

In this present study a well defined subpopulation of CP children having GMFCS levels of IV or V who each received integrated BoNT-A treatment with a primary goal of improved sitting balance will be recruited to identify the probable changes in activity and participation domains of ICF as well as changes in quality of life of the family and the child.

Eligibility Criteria:
Inclusion Criteria:

* All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
* Gross Motor Functional Classification Scale level of IV-V
* Being scheduled for BoNT-A treatment to lower extremity
* Primary goal of treatment selected as improved sitting balance

Exclusion Criteria:

* Severe cognitive or behavioural problems
* Severe dystonia
Comparative Evaluation of the Evolution of Emerging Biological Markers in Patients Hospitalized for Acute Heart Failure According to Conventional Management or Therapeutic Adjustment Via Daily Ultrasound.

This is a bi-centric, prospective randomized study to evaluate the contribution of rapid echocardioscopy at the patient's bedside to improving the prognosis of patients hospitalized for acute heart failure. The following markers will be evaluated: sST2, Copeptin, chromogranin, NGAL, suPAR and cystatin.

The JECICA study is the first prospective randomized study to evaluate the contribution of rapid echocardioscopy at the patient's bedside to improving the prognosis of patients hospitalized for acute heart failure (paper submitted to the American Heart Journal, Impact Factor 4.15). The serum library set up to consider this ancillary study can now be used.

With it, a comparative analysis of the expression profiles of emerging biological markers will be made according to whether patients received standard management or the "Jet Echo" strategy. The following markers will be evaluated: sST2, Copeptin, chromogranin, NGAL, suPAR and cystatin. This study should help to explain any differences in results observed, consider the development of multiparametric prognostic scores and explore the correlation between biological markers and the evaluation of echocardiographic congestion from a pathophysiological viewpoint.

The results obtained should lead us to improve our usual practices for the management of heart failure patients.

Eligibility Criteria:
Inclusion Criteria: (General inclusion criteria)

* The patient or his representative must have given free and informed consent and signed the consent form.
* The patient must be affiliated to or beneficiary of a health insurance plan.
* The patient must have been available for 6 months of follow-up.
* The patient is at least (\>) 18 years of age.

Inclusion criteria for target population:

* Patient hospitalized for acute heart failure who received at least 40mg of IV furosemide.
* Patient with impaired Left Ventricle Ejection Fraction \<50%.
* Patient with an Nt-ProBNP value \>1200pg/ml.

Exclusion Criteria : (General non-inclusion criteria)

* Subject is participating in another study.
* Subject is in an exclusion period determined by a previous study.
* Subject is under court protection.
* Subject or subject's representative refuses to sign consent.
* It is not possible to provide the subject or the subject's representative with informed information.

Criteria for non-inclusion regarding associated interfering diseases or conditions:

* Patient is pregnant or breastfeeding.
* Patient is already included in a surveillance program (PRADO, OSICAT).
* Patient has a mechanical or biological mitral prosthesis.
* History of mitral narrowing.
* Severe valve disease with a surgical deadline within a month (\<30 days).
* Chronic renal failure on dialysis.
* High grade BAV (BAV 2/1 and BAV3).
* Hypertrophic cardiomyopathy.
* Cardiogenic shock.
* Contraindication to furosemide.
* Anechoic patient.

Exclusion criteria:

- Patient hospitalized for more than (\>) 1 month.
Pediatric Kidney Transplant

End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric kidney transplants are performed each year. The aim was to evaluate the surgical management of TR and the long-term results.

End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment is a kidney transplant. In France, around 100 pediatric kidney transplants are performed every year.

Although the first adult kidney transplants were performed in 1954, pediatric renal transplantation was considered unsafe compared with dialysis, which was preferred. In the 1980s, improved graft selection, optimized pre-transplant management and a better understanding of the immune system led to the development of pediatric kidney transplantation.

Despite considerable progress, graft survival in these long-lived patients remains a major challenge.

The aim of this study is to evaluate surgical practices in the four French pediatric transplant centers, and to define risk factors for surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients who underwent renal transplantation in one of the 4 centers

Exclusion Criteria:

* Multi organ transplant
Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn

The purpose of the current study was to evaluate the effect of physical therapy rehabilitation program combined with music therapy on pediatric with lower limb burn. Methods. A twelve-week randomized controlled study including thirty lower limb pediatric burned patients who randomly divided into two groups, Group(A) received physical therapy rehabilitation program combined with music therapy in addition to routine medical care while Group (B) received physical therapy rehabilitation program without music therapy. Pain was assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer, and gait assessed by GAIT Rite. Assessment was carried before and after treatment


Eligibility Criteria:
Inclusion Criteria:

* Lower limb 2nd degree burn since 6 weeks
* Burn affect skin around ankle and knee joint,
* Both sex, age ranged between 10 to 15 years old
* Patients have sufficient cognition and education enough to understand the requirements of this study

Exclusion Criteria:

* All patients with age more than 15 years or less than 10 years
* Patients with hearing problems
* Acute viral diseases, acute tuberculosis, mental disorders
* Those with pace makers, diabetics, cardiac, renal patients
* Patients with genetic disease
* 3rd degree burn and 1st degree bum
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-01-70

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility Criteria:
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.