cyrilzakka/clinical-trials huggingface dataset:
G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.

The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Eligibility Criteria:
Inclusion Criteria:

* 55 to 80 years of age, inclusive
* Skeletally mature
* Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
* Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion Criteria:

* Is septic, has an active infection or has osteomyelitis at the affected joint
* Has significant osteoporosis as defined by treating surgeon
* Has metabolic disorder(s) which may impair bone formation
* Has osteomalacia
* Has distant foci of infections which may spread to the implant site
* Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
* Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
* Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
* Is known to be pregnant
* Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
* Has a known sensitively or allergy to one or more of
Characterization of Brain Metastases

The purpose is to characterize tumour biological markers in brain metastases tissue from patients with different primary tumour by using ex vivo techniques as high-resolution magic angle spinning MR spectroscopy and micro array.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of brain metastases

Exclusion Criteria:

* children
* pregnancy
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.

By the end of 2012 40 patients have been enrolled and passed the one year follow up.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Typical achalasia according to manometry
* Eckhardt score \>3
* Informed consent

Exclusion Criteria:

* Severe comorbidity precluding surgery
* Pseudo achalasia
* Inability to participate in follow-up
Macula Evolution in Patients With AMD Taking Oral Food Supplementation

LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations .

The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Age ≥ 50 years old
* At least one Eligible Eye, defined by following conditions :

  1. Far Best Corrected Visual Acuity (BCVA) ≥ 75 ETDRS letters (or ≥ 20/32 Snellen equivalent)
  2. At least one drusen with a minimal diameter of 125 µM assessed by SD-OCT / intermediate age-related macular degeneration
  3. Macula sparing
  4. Clear ocular media
  5. Adequate pupillary dilation

Exclusion Criteria:

* Presence of other macular disease such as epiretinal membrane or macular telangiectasia.
* Presence of any geographic atrophy including macular region
* Any history of retina neovascularization
* Macula or retinal diseases other than age-related macular degeneration
* A concurrent ocular pathology that may contribute to vision loss (eg, choroidal neovascularization, glaucoma, visually significant cataract, optic neuropathy, history of retinal surgery) or interfere with acquisition of high-quality images
* Ocular or periocular infections
* Presence of congenital retinal pathologies that may impact data collection
* Exudative AMD
Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women

We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms

Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another.

Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 40-65 years old
* Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
* Serum 25(OH)vitamin D level ≥ 30 ng/ml.

Exclusion Criteria:

* The use of any medications and/or disease that affect bone metabolism
* Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
* Presence of an osteoporotic fracture
* Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
* Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
* Body mass index ≥35 kg/m²
* Thrombosis history
Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography

This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial.

The purpose of this study is to determine the effects of abdominal muscle activation training, using pressure biofeedback in comparison with surface electromyography biofeedback, in management of non-specific low back pain: a randomized control trial.

Pain and disability are the primary outcomes which will be determined using:

1. Numeric pain rating scale (NPRS)
2. Oswestry disability index (ODI) Data will be taken before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age (adults 19 - 44 years)
* Non-specific LBP with NPRS \> 3
* Negative SLR test in prone and supine
* Painless extremity movement and activity
* Manual muscle testing of abdominal muscles between grade 2 - 4
* Sedentary individuals (no exercise plan followed in last 3 months)

Exclusion Criteria:

* History of any spinal surgery
* Degenerative disc disorder, facet joint syndrome, spinal stenosis, myelopathy, lumbar syringomyelia
* Sensory disturbances due to neurological causes, lumbar radiculopathy, fibromyalgia, myofascial pain syndrome
* Sacroiliac joint dysfunction
* Pregnancy
* Medical conditions; Hypertension, Diabetes mellites
* Work disability greater than 6 months
* Not able to attend regular therapy appointments
Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams

The main objective of this pilot study is to implement an awareness campaign for colorectal cancer screening in the workplace, in partnership with the staff of the occupational health service of one of the largest companies in Maine-Loire , and to evaluate the impact of this action on the participation rate of colorectal cancer screening among employees.


Eligibility Criteria:
Inclusion Criteria:

* The study population is made up of the employees of the CHU d'Angers included in the target population of organized colorectal cancer screening in the Maine-et-Loire so employees aged 50 and over.

Exclusion Criteria:

* The criteria for non-inclusion are those of organized screening for colorectal cancer taking into account the active population:
* Age \<50 years and\> 67 years
* Personal or family history of polyps or colorectal cancer
* Personal history of intestinal disease already undergoing colonoscopy surveillance (chronic inflammatory bowel disease, HNPCC syndrome, familial adenomatous polyposis)
* Known genetic disease with risk of developing colorectal cancer.
Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events


Eligibility Criteria:
Inclusion Criteria:

* Male and female neonates meeting the criteria for induced hypothermia:

  * Gestational age ≥ 36 weeks and birth weight ≥ 1800 g;
  * Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤ 7.0 or base deficit ≤ - 16 mEq/L;
  * Evidence of neonatal distress, such as an Apgar score ≤ 5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes;
  * Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG).
* Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.

Exclusion Criteria:

* Neonates with complex congenital heart disease
* Neonates with cerebral malformations
* Neonates with genetic syndrome
* Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life
The Effect Of Interactive Robot on Children's After The Surgery

This project will be conducted with 5-10-year-old children who will undergo an outpatient surgery in Trakya University Health Research and Application Center at Pediatric Surgery Clinic and their parents. It is reported in the literature that technology-based applications and robot use are promising innovations in reducing pain, anxiety, and fear in children. This was the main starting point in the planning of the study. In this study, by using interactive robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency / duration of the mobilization and to increase parental satisfaction of the children undergoing outpatient surgery.

The use of interactive robots is expected to reduce the child's anxiety by ensuring that the child is physically, psychologically, and socially optimal. It is foreseen that the child with reduced anxiety will be willing to mobilize with the interactive robot and it will increase the mobilization time and the frequency of the mobilization during the day. Decreasing the anxiety of children and increasing the desire for mobilization will increase the satisfaction of the families.

The study will be conducted with 84 children (42 Experiment + 42 Control) aged 5-10 years. The study was planned as a randomized controlled study. Data will be collected by "Questionnaire Form" and "Child Anxiety Scale-State Anxiety" and Parental Satisfaction Scoring-Visual Analog Scale" and "Mobilization Chart". Families will be informed about the research and before the surgery, families, and children in both groups will be informed about the benefits of mobilization. Two hours after the operation, just before the mobilization, the children in the experimental group will be introduced to the robot, and the children in the control group will be asked to mobilize with their parents.

When the child is first mobilized at the time recommended by the physician for all groups after the surgery, the child's anxiety for mobilization will be assessed using the Child Anxiety Scale (State Anxiety). The mobilization time of the children will be measured by stopwatch and recorded in the Mobilization Schedule together with the frequency of mobilization. Parental Satisfaction Scale- Visual Analogue Scale will be applied to evaluate the satisfaction of the parents towards the application.

Eligibility Criteria:
Inclusion Criteria:

* Undergo day surgery,
* Speaking Turkish,
* Being a volunteer to participate in the study,
* Being 5-10 aged,
* Do not have a visual, auditory, or mental problem and their parents will be included in the research.

Exclusion Criteria:

* No undergo day surgery,
* No Speaking Turkish,
* Not being a volunteer to participate in the study,
* Not being 5-10 aged,
* Have a visual, auditory, or mental problem and their parents will be included in the research.
Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease

Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease
* Exist non-motor symptoms
* Undergoing selective DBS.
* Age ≥60 years.
* Obtain written informed consent.

Exclusion Criteria:

* preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18)
* history of psychoactive
* allergic or intolerant to dexmedetomidine
* severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block
* severe hepatic dysfunction (Child-Pugh class C)
* severe renal dysfunction requiring renal replacement therapy before the surgery
* medical records documented inability to communicate in the preoperative period due to language barrier or other situations.
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis
2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected
2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
3. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

Exclusion Criteria:

1. Patients under 2 years of age.
2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
4. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
Effect of aPDT on Deep Caries in Permanent Tooth

The aim of this study is to assess the clinical effect of aPDT on deep caries in permanent teeth. Half of the deep caries will receive aPDT disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure.

The aim of the proposed study is to assess the clinical effect of antimicrobial photodynamic therapy (aPDT) using LED on dentin with deep caries in permanent teeth. Permanent teeth with deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: Group 1 -Control after incomplete caries removal, washed with sodium 0.9% saline; Group 2 - PDT + CH after incomplete caries removal, disinfect the residual dentin with PDT(LED + O-Toluidine Blue). Dentin samples will be collected before and after disinfect for microbiological analysis. Then the teeth will be capped with CH and restored using resin with clinical and radiographic follow up at 6, 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Good general health, without syndromes or chronic systemic diseases
* Permanent tooth with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits

Exclusion Criteria:

* Refused to sign the informed consent document
* Allergic to photosensitizer
* Unlikely to be able to comply with the study procedures
PIPAF Platelets in the Pathogenesis of Ageing Associated Frailty

This is a prospective observational study aimed at testing the existence of an association between frailty, inflammatory status, and degree of platelet activation and reactivity in elderly subjects with type 2 diabetes or coronary artery disease or Alzheimer's disease.

Frailty in the elderly is a syndrome that strongly affects quality of life and represents a major social and economic challenge. Frailty often, and more frequently, occurs in individuals with aging-related diseases including type 2 diabetes, cardiovascular disease, and Alzheimer's disease. All of these diseases are associated with a state of weak chronic inflammation. Studies in recent years have pointed out that platelets can directly contribute to inflammatory processes. Due to of this ability to act as proinflammatory cells and of their strong involvement in various metabolic, cardiovascular, and neurodegenerative disorders, platelets appear to have key roles in the physio-pathological mechanisms that predispose to frailty.

In the present study, it is planned to recruit 4 cohorts of elderly patients, each of 40 patients, divided by pathology ( frail elderly, diabetic elderly, elderly with stable atherosclerotic coronary artery disease, elderly with early-stage Alzheimer's disease) and a cohort of 40 healthy elderly subjects. All subjects will perform a blood draw at enrollment and after 24 months of follow up in order to evaluate: the state of platelet activation; the aggregating response of platelets to stimuli such as thrombin, Adenosine DiPhosphate (ADP), and collagen; the state of chronic inflammation and oxidative stress; the procoagulant profile of platelets; presence of platelet subpopulations characterized by RNA, microRNA and/or protein profiling. Each subject will also be given a questionnaire to assess frailty status (according to Fried's criteria) and urine samples will be collected to perform the assay of metabolites such as 11dh-TXB, 8-hydroxy-2-deoxyguanosine (8-OHdG) and 8-epiPGF2a (8-isoprostane).

Eligibility Criteria:
Inclusion Criteria:

* age \> 65 years
* low-dose aspirin therapy (100 mg)
* belonging to each of the cohorts indicated

Exclusion Criteria:

* Lack of inclusion criteria and/or consent to the study