cyrilzakka/clinical-trials huggingface dataset:
Comparison of Different Feeding Appliances for Cleft Palate Babies

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

Eligibility Criteria:
Inclusion Criteria:

* Infants with age range from 1-15 days.
* Unilateral cleft palate.
* Medically free subjects.
* Both males and females.

Exclusion Criteria:

* Patients older than 15 days.
* Syndromic patients with other defects in addition to cleft lip and palate.
* Patients with bilateral cleft lip and palate.
* Patients with previous presurgical infant orthopedic treatment.
* Medically compromised patients.-
Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures

Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.


Eligibility Criteria:
Inclusion Criteria:

* Obtaining a written informed consent of the patient,
* Affiliated with a Medicare (or rightful beneficiary),
* Disponibility of the patient,
* Patients ≥ 18 ans,
* Anterior cruciate ligament rupture concerned only one knee of the patient.

Exclusion Criteria:

* Patient is in the exclusion period for another study,
* Patient is under judicial protection, guardianship, or curators,
* Eligible patients who are refused to sign consent,
* It is impossible to give clear informations to the patient,
* Pregnant women,
* Nursing mother,
* Patient which has been already operate of the other knee,
* Patient present ligament lesions associated.
Study of Tolerant Kidney Transplant Recipients

The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.

Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the body's immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or "anti-rejection" drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to "tolerate" the transplanted kidney, and this condition is referred to as "tolerance".

In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance.

Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010).

Eligibility Criteria:
Inclusion Criteria:

* Must be a renal transplant recipient or living donor
* Meet the criteria for inclusion in one of the study enrollment groups
* Provide informed consent

Exclusion Criteria:

* AIDS \[includes all HIV-infected persons who have less than 200 cells/mm(3) CD4+ T-lymphocytes/microL, or a CD4+ T-lymphocyte/micro liter or a CD4+ T-lymphocyte percent of total lymphocytes less than 14, or who have been diagnosed with an AIDS-defining condition as defined by the Centers for Disease Control and Prevention (CDC)
* Current malignancy requiring recent surgery, ongoing chemotherapy or radiation
* Acute systemic infections within 30 days prior to enrollment
* Pregnancy
* Transplant of another organ

Note: Patients meeting any of the exclusion criteria, if identified to have been clinically tolerant prior to the occurrence of the excluding condition, will be enrolled and demographic data collected for the registry; however, the decision as to whether or not to collect blood, urine, and tissue samples will be deferred until the participant's condition improves and the clinically tolerant state persists.
Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure

Background Clonidine, a derivate of Imidazol, is an antihypertensive drug. It acts by stimulating adrenergic receptors on nerves in the brain and Imidazol-receptors. As a result, clonidine slows the heart rate and reduces blood pressure. Clonidine was approved by the FDA in 1974 and is registered in Austria with the brand name "Catapresan".

Alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. In addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists are neuroprotective. Brimonidine, which is the most commonly used topical alpha-2 agonist, is currently on the market for treatment of glaucoma and is effective in reducing intraocular pressure. It has, however, been shown that brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is, however, known about potential vasoconstrictor effects of brimonidine in the posterior pole of the eye. This is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology. Direct investigation of the ocular hemodynamic effects of brimonidine is, however, difficult, because lowering intraocular pressure with brimonidine may confound the results due to the concomitant change in ocular perfusion pressure.

The aim of the present study is to assess the effect of intravenous clonidine as model drug of alpha agonists on ocular blood flow and IOP in healthy humans.

Study objectives:

To investigate effects of clonidine on ocular blood flow and intraocular pressure.


Eligibility Criteria:
Inclusion Criteria:

Men aged between 19 and 35 years, nonsmokers

Body mass index between 15th and 85th percentile

Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion Criteria:

Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

Treatment in the previous 3 weeks with any drug

Symptoms of a clinically relevant illness in the 3 weeks before the first study day

History of hypersensitivity to the trial drug or to drugs with a similar chemical structure

History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs

Blood donation during the previous 3 weeks

History or family history of epilepsy
Remote Video Consultation for Quality of Life Assessment in Patients Hospitalised After COVID-19 Infection

Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities.

This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* COVID-19 hospitalisation at Le Havre hospital between March 1st and May 11th
* Non-opposition during first phone contact

Exclusion Criteria:

* Guardianship
* Juvenile patients
* Pregnancy
* Inability to communicate
* Cognitive disorders
* Deceased patient
PIM 2.0: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project

Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.

Goal:

* Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
* Improve Veteran and staff satisfaction

Objectives:

* Maintain the patient in the home setting as much as possible
* Secure appropriate home environment to facilitate health and well-being
* Utilize comprehensive team-based care
* Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues


Eligibility Criteria:
Inclusion Criteria:

* Refered for intensive management

Exclusion Criteria:

* None
Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV) infections are more prevalent in systemic lupus erythematosus (SLE) patients or other auto-immune diseases when compared to the healthy population. In France, despite a vaccination available since 2007, rate of vaccination remain low. Although little is known about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response in this group of patients. To date, available data suggest that HPV vaccines can be given safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in SLE patients, this vaccination should be encouraged.

The aim of this study was to assess the vaccination coverage rate in chronically ill girls with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.


Eligibility Criteria:
Inclusion Criteria:

* Young girls older than 11 years old until adult transition
* Follow-up for systemic lupus erythematosus (American college of rheumatology classification) or idiopathic juvenile arthritis (International League of Associations for Rheumatology classification)
* Follow-up in a Childen's hospital of Lyon (Hopital Femme Mère Enfant) and Paris (Hospital Necker-Enfants Malades, Hôpital Robert Debré)
* With no parental opposition to participate

Exclusion Criteria:

* Refusing to participate
* Age \< 11 years old
A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.


Eligibility Criteria:
Inclusion Criteria:

1. Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
2. According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
3. Patients who have not received disease-related anti-tumor system therapy;
4. Age 18\~70 years;
5. Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
6. Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
7. Cartesian score ≥70; or ECOG PS 0 or 1
8. Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
9. Sign the informed consent.

Exclusion Criteria:

1. Patients with distant metastases were identified at the time of diagnosis;
2. Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
3. Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
4. Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
5. A woman who is pregnant or lactating;
6. Known active HIV or HBV, HCV infection;
7. Known to be allergic to drugs that may be used;
8. The researchers did not consider participants to be eligible for this study.
Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

The purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria.

The overall description of the Steno-2 Study is stated in four protocols approved by the regulatory authorities in Denmark. The protocol identification numbers are KA 92071gm (4 years intervention ), KA-99035g (8 years intervention ), KA-99035-GS (13 years follow-up since intervention start) and H-KA-99035-GS (21 year follow-up since intervention start).

The aim of the study was to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria. The primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points. The primary end point after eight years of intervention was a composite CVD endpoint with microvascular complications as secondary end points.

The interventional part of the study was ended in December 2001 after a total of eight years of intervention. From that time on, all patients were followed in a post-trial study. Also, during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study. The aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i) mortality and ii) years of life gained, respectively, with such an interventional approach.

Endpoints in the two parts of the post-trial follow-up:

Part one at 13 years since start of intervention:

Primary endpoint: Total mortality. Secondary endpoints: Cardiovascular endpoints as defined previously; Microvascular disease.

Part two at 21 years since start of intervention:

Primary endpoint: Difference in median time to 50% mortality in each of the two original treatment groups Secondary endpoints: Cardiovascular endpoints as defined previously; Recurrent cardiovascular events; Microvascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Microalbuminuria

Exclusion Criteria:

* Stimulated serum C-peptide concentration less than 600 pmol/L
* Pancreatic insufficiency or diabetes secondary to pancreatitis
* Alcohol abuse
* Non-diabetic kidney disease
* Life-threatening disease with death probable within 4 years of study start
Melatonin and Coronary Artery Calcification

The investigators planned to research the association between plasma melatonin and coronary artery calcification in a Chinese population.

Coronary artery calcification (CAC) is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. However, no study has evaluated whether melatonin is associated with CAC in patients with coronary atherosclerosis. The investigators planned to research the association between plasma melatonin and coronary artery calcification.

Eligibility Criteria:
Inclusion Criteria:

Patients with angina-like chest pain, were included in this study. All subjects had blood samples collected and all underwent a coronary CTA scan.

Exclusion Criteria:

1. melatonin treatment
2. coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
3. heart failure or cardiomyopathies
4. hepatic failure
5. renal dysfunction
6. haemolytic disorders
7. thyroid disease
8. neoplastic diseases
9. acute infectious or inflammatory conditions.
EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia

The objective is to determine if a set of clinical supports that includes computer-assisted identification, an EHR registry, facilitated GI referral, and an EHR tool for documentation improves the timely referral and completion of bidirectional endoscopy in men aged 18 years and older and women aged 40 years and older with iron deficiency anemia.


Eligibility Criteria:
Inclusion Criteria:

Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)

Exclusion Criteria:

No primary care office practice within Northwestern Medical Group
Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.

This study will evaluate the effects of a 6-weeks strengthening PF program by using tele-rehabilitation, with or without intracavitary biofeedback, in the PF anatomo-functional characteristics, quality of life and sports performance of female athletes with PFD.

To this end, 45 female athletes with self-reported PFD who train and compete in athletic in Spain will be recruited and randomly distributed in three groups of the experimental study. During 6 weeks, all participants will use an specifically developed Smartphone application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a strengthening program for PF, which will be instructed by 3D avatars, while using an intracavitary biofeedback device that will inform about vaginal pressure; the experimental group 2 (EG2) will be similar to EG1, but they will not use the intracavitary biofeedback device.

Before and after these 6 weeks, anatomo-functional PF characteristics, quality of life, PFD symptoms and sports performance of all participants will be evaluated. As an additional outcome, the level of engagement of the athletes from experimental groups to complete the training program will be registered.

Female athletes from EG1 and EG2 will complete the strengthening program for PF three times per week, during six weeks. Each session will last about 20 minutes and exercises will be modified every two weeks to meet the principle of training progression and avoid athletes become bored.

Eligibility Criteria:
Inclusion Criteria:

* To train and compete in any of the Track and Field modalities
* To have sports license from regional or national Track and Field Federation in the season when study starts.
* To have a self-reported pelvic floor disorder (urinary incontinence, fecal incontinence, sexual dysfunction or pelvic organ prolapse).

Exclusion Criteria:

* To have pelvic pain during the last three months.
* To have recurrent infections of urinary tract during the last three months.
* To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
* To have been pregnant during the year prior to the start of the study.