cyrilzakka/clinical-trials huggingface dataset:
Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)

The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.

We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.

We will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.

The objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

The differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.
* patient who has received a complete information about research organization and who is not opposed to the use of his own data.
* patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.

Exclusion Criteria:

* patients with local or general pathology
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)

Adherence to annual follow up is critical to achieving mortality benefits and optimizing cost-effectiveness of lung cancer screening (LCS). However, adherence to LCS follow-up in the real world is suboptimal. Using telehealth, the investigators will co-create Tele-Navigation of Lung Cancer Screening with patients and LCS stakeholders as an intervention to promote adherence of follow-up LCS. The investigators will then implement the Tele-Navi LCS intervention to a pilot sample of patients and evaluate its feasibility in the primary care setting. The investigators will measure the number of patient participants who completed Tele-Navi LCS and follow-up LCS within 180 days from Tele-Navi LCS.


Eligibility Criteria:
Inclusion Criteria:

* Is eligible for LDCT for LCS follow-up
* Has technology to complete study activities (e.g., video call visit)
* English speaker
* Has undergone LCS at UMMH
* Is overdue for LDCT follow-up

Exclusion Criteria:

* Has previous diagnosis of lung cancer
* Has active cancer diagnosis
* Is a nursing home or group care resident
* Is pregnant
Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial

Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.

Eligible: patients \>18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis.

Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy

Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength

Complications are registered.

The patients are observed for two years and the investigators aim to include a total of 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* CMC 1 arthritis
* Pain and dysfunction
* Adult patients
* General good health

Exclusion Criteria:

* Pregnancy
* STT arthritis (CT scan preoperatively for all patients)
* Other injuries in thumb/hand
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory with osteoporosis
* Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture.

Exclusion Criteria:

* Diseases of bone other than osteoporosis
* Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year
* Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment
* Increased risk for the development of osteosarcoma
FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra

Fampridine-SR is registered for the treatment of walking incapacity in MS patients. Two pivotal trials show that app. 40% of MS patients with walking incapacity can improve walking speed averagely 25% when recieving the drug. This has been shown using the Timed 25 Foot Walk Test (T25FW). No effect on cognition and upper limb function has been shown, but this has not been investigated in patients responding to the drug measured by the abovementioned test.

The question is if this will be the case and also if another walking test, termed the Six Spot Step Test (SSST), will be more sensitive to the effect of Fampridine-SR.

Primary outcome measure is the effect measured by SSST. The hypothesis is that SSST is not less sensitive to the effect of Fampridine-SR than T25FW.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria
* EDSS 4-7
* Pyramidal FS \>= 2

Exclusion Criteria:

* History of epileptic seizures
* MS relapse or change in disease modifying treatment (DMT) within 60 days
* cancer within five years
* uncontrolled hypertension
* clinically important cardiac, hepatic, renal or pulmonary disease
* pregnancy
* breast feeding
* concomitant treatment with cimetidine, carvedilol, propranolol and metformin
Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children

Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Children age 6 to 16 years
2. Patients arriving to the immunization clinic for immunization.
3. Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
2. Facial features or injury prohibiting wearing the VR goggles
3. VR system may interfere with immunization
Midwife-led Continuity and Satisfaction With Care - an Observational Case-Control Study in Palestine

This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.

Between 2013 and 2016 a midwife-led continuity model of care was implemented in parts of the Palestinian governmental health system, to improve maternal services to women in rural areas on the occupied West Bank. This study investigated if and how the model influenced women's satisfaction with care, through the continuum of the antenatal-, intrapartum- and postnatal period.

Using an observational case-control design to compare the midwife-led continuity model of care with regular maternity care. Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic, were during the first six months after birth invited to answer a questionnaire containing 60 questions with a 7-points Likert scale, rating different aspects of satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

* Residing in rural village
* Registered for pregnancy care at the villages governmental clinic
* With singleton pregnancy
* Gave birth the last one to six month

Exclusion Criteria:

* Residing in urban areas
* With multiple pregnancy
* Not registered for antenatal care at the local governmental clinic
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults

The purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in Healthy Adults.

This study is seeking healthy adult participants. All the study participants will receive Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site.

We will measure how the phenytoin will be taken up into the blood in Healthy Adults following oral dosing of Phenytoin.

This will help us determine if the Phenytoin 50 mg chewable tablets manufactured at Ascoli and Vega Baja manufacturing site are similar or not.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male participants and female participants of non-childbearing potential aged 18 years or older determined by medical evaluation including detailed medical history, complete physical examination, blood pressure (BP) and pulse rate measurement, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
2. Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb).

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Female participants of childbearing potential; pregnant female participants; breastfeeding female participants; male participants with partners currently pregnant; male participants able to father children who, with their partner(s) are at risk for pregnancy and are unwilling or unable to use a highly effective method of contraception.
3. History of hypersensitivity to phenytoin or its inactive ingredients.
4. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior to the first dose of study intervention.
6. Current use of any prohibited concomitant medication(s).
7. History of febrile illness within 5 days prior to first dose.
Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation

Secondary mitral insufficiency is a common complication of heart failure, aggravating symptoms and prognosis, and may be responsible for worsening dyspnea, pulmonary edema, and excess mortality. It is essentially a ventricular rather than a valvular disease, whose origin may be ischemic or not. It is induced by a geometrical and contractile modification of the left ventricle which causes an imbalance between the tensile and the closing forces of the mitral valve thus causing a defect of coaptation and the increase of the surface between the mitral leaves and the ring in systole (tenting). Dynamic mitral insufficiency is defined by changes in the degree of severity of regurgitation as a function of hemodynamic conditions.

During exercise, the course of mitral insufficiency is variable and is not predicted by the degree of regurgitation at rest. The worsening of the leak is also well correlated with the onset of dyspnea on exertion in patients with left Ventricular Ejection Fraction heart failure (LVEF reduced). Nevertheless, there is little data available in the literature on the factors predisposing to the development of stress-related mitral insufficiency, as well as its clinical and echocardiographic impact in the cardiac insufficiency patient, particularly in the case of preserved LVEF (6.7%).

The identification of echocardiographic data at rest to predict and anticipate the behavior of mitral insufficiency in the effort (aggravation or stability / disappearance), would allow a simplified evaluation and a better management in this population of patients for which the evaluation in echography of effort can be technically complex and limited (difficulty of quantification of the mitral leak, time of effort sometimes too short ...).


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient who received a stress echocardiography performed by an experienced operator in the evaluation of mitral insufficiency at the Paris Saint-Joseph Hospital Group between March 2016 and February 2019
* Patient presenting during this ultrasound a mitral insufficiency secondary to rest and effort
* Francophone patient

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients who oppose the use of their data for this research
* Patient with primary mitral insufficiency, structural abnormality of valvular leaflets
* Patient with valvular or valvular calcification
* Patient with other significant associated valvulopathy (grade\> II / IV: corresponds to the severity of mitral leak quantified on cardiac ultrasound)
* Patient with cardiac valve prosthesis
* Hypertrophic or restrictive cardiomyopathy
* Patient with congenital heart disease
Effect of Topical Fluoroquinolones on Epithelial Wound Healing After PRK

The prescribed antibiotic for prophylaxis of infection following PRK should be effective at eradicating a potential infection. In addition, the antibiotic should have a rapid onset of action, effectively penetrate the target tissue, and be safe and not toxic to any layer of the healing cornea, especially the epithelium. Several studies have investigated the toxicity of the fourth generation fluoroquinolones on the corneal epithelium and studies have demonstrated that gatifloxacin is less deleterious to the healing cornea than moxifloxacin. Most of these studies, however, have been conducted in animals. This was a retrospective chart review.

Prior generation fluoroquinolones predominantly either inhibit topoisomerase II (DNA Gyrase) or topoisomerase IV and therefore only require one genetic mutation for bacteria to develop resistance. Fourth-generation fluoroquinolones are equally effective against topoisomerase II and IV, which significantly expands their spectrum of action against gram-positive agents and atypical mycobacteria and Nocardia . This duality of action of the fourth generation fluoroquinolones requires that for bacteria to become resistant to these agents, the bacteria must undergo two genetic mutations resulting in a significantly decreased chance of an organism developing resistance.Minimum inhibitory concentrations determined in vitro suggest that fourth-generation fluoroquinolones are more effective than second- and third-generation fluoroquinolones against gram-positive bacteria including Staphylococcal species found in endophthalmitis and bacterial keratitis cultures. The increased efficacy of fourth-generation fluoroquinolones make these antibiotics important agents to evaluate for prophylaxis against post-PRK infections. This was a retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for inclusion if they were a healthy male or female 18 years of age or older and were candidates for bilateral PRK.
* Eligible patients had a best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score equivalent to a Snellen score of 20/30 or better in each eye, had a stable prescription for 1 year, were willing to participate in the study, and were able to comprehend and sign the informed consent form.
* All subjects were instructed that if they decide not to participate they could withdraw from the study at any time.

Exclusion Criteria:

* Patients were excluded from the study if they had a history of refractive or other ocular surgery in either eye.
* Patients with any condition which could delay wound healing were not eligible to participate.
* They were excluded if they had poor tolerance to any component of the masked study fluoroquinolones, Acular® LS (Allergan) or Pred Forte® (Allergan).
* Patients were also excluded if they required the use of a systemic antibiotic during the study period, were involved in another investigational study or had participated in a study within 30 days prior to the start of this study.
Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery

Exclusion Criteria:

* Previous Anterior cruciate ligament injury
* Other knee injury with restrictions that could interfere with rehabilitation
* Other injury or disease that could interfere with rehabilitation
* Inability to understand the information
A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)

This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>= 18 years of age at screening
* Diagnosis of diabetes mellitus Type 2
* Glycosylated hemoglobin A1C (HbA1C) \< 10% at screening
* Estimated glomerular filtration rate (eGFR) \>=30 and \< 60 mL/min/1.73 m2
* Urinary albumin-to-creatinine ratio (UACR) \>=500 and \< 5000 mg/g
* Treatment with either angiotensin converting enzyme inhibitor or angiotensin II receptor blocker for at least three months prior to screening
* Women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study

Exclusion Criteria:

* Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening
* Prior intolerance to a TDZ or fibrate
* Previous participation in a trial with aleglitazar
* Diagnosis or history of other types of diabetes
* Diagnosis or history of acute metabolic diabetic complications within the past 6 months
* Known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease
* Diagnosed acute kidney injury or dialysis within 12 weeks prior to screening
* Poorly controlled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at baseline)
* Known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma
* History of myocardial infarction or stroke in the past 12 weeks prior to screening
* Symptomatic congestive heart failure NYHA class II-IV at baseline or heart failure leading to hospitalization within the 12 months prior to screening
* Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
* Inadequate liver and hematological function
* Chronic treatment with immunosuppressive therapy
* Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods