cyrilzakka/clinical-trials huggingface dataset:
Immunopathology of Loeys-Dietz Syndrome

Loeys-Dietz syndrome (LDS) is a rare vascular genetic disorder (estimated prevalence 1/25,000-1/100,000) due primarily to mutations in the Transforming growth factor beta (TGF-β) cytokine receptor 1 and 2 genes. In addition to a common vascular phenotype with Marfan syndrome (dilatation of the ascending aorta, arachnodactyly, lens dislocation), patients present specific malformations (bifid uvula, hypertelorism, tortuous arteries) and immuno-allergic manifestations (asthma, eczema, food allergy, eosinophilic esophagitis, chronic inflammatory bowel disease).

Pathophysiologically, LDS appears to be associated with hyperactivation of the intracellular TGF-β signaling pathway in a manner similar to Marfan syndrome, as evidenced by increased intracellular phosphorylated Smad2/3 (pSmad2/3) in lymphocytes. The immuno-allergic complications appear paradoxical because of the major immunosuppressive role of this cytokine on lymphoid and myeloid immune lineages.

The biological description of immunological abnormalities associated with LDS is based on a single 2013 study that found increased regulatory T (Treg) and Th2 lymphocyte polarizations, as well as increased circulating eosinophil and total IgE levels.

In order to better understand the underlying mechanisms, the investigators propose to perform a descriptive clinical-biological study to identify and study the immune subpopulations most impacted by the causative mutations of LDS.


Eligibility Criteria:
Inclusion Criteria:

For patients with Loeys-Dietz syndrome:

* Patients aged ≥ 5 years with Loeys-Dietz syndrome with a diagnosis confirmed by the presence of a TGF-βR 1 or R2 mutation known to be pathogenic to patients.
* Free, informed and signed consent from the patient or both parents or legal guardians for minor patients.
* Patient affiliated to a social security system or similar.

For healthy volunteers:

* Subjects aged ≥ 5 years.
* Free, informed and signed consent of the witness, or if applicable of both parents or legal representatives for minors.
* Patient affiliated to a social security system or similar.

Exclusion Criteria:

For patients with Loeys-Dietz syndrome:

* Patient with an evolving or recently healed (\< 3 months) cancer that could alter the immunologic profile.
* Patient with an evolving or recently healed (\< 3 months) infection that could alter the immunologic profile.
* Patient with a weight of less than 20 kg.
* Pregnant woman.
* Patient participating in another research study with an exclusion period exclusion period still in progress.

For healthy volunteers:

* Subject with an active or recently cured (\< 3 months) cancer that could alter the immunologic profile.
* Subject with an active or recently healed (\< 3 months) infection that could alter the immunological profile.
* Patient with a weight of less than 20 kg.
* Pregnant woman.
* Subject participating in another research study with an exclusion period exclusion period still in progress.
* Persons under court protection.
A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.


Eligibility Criteria:
Inclusion Criteria:

1. Age less than one year
2. Requiring general anesthesia and orotracheal intubation
3. Weight less than 10 kg
4. ASA class 1-3

Exclusion Criteria:

1. Documented difficult airway
2. Facial deformities
Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA treatment according to the last version of the Cochrane review. Nowadays the best dose regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen treatment versus standard treatment could reduce the number of doses of ibuprofen without increasing the reopening rate and reducing the side effects associated to this medication.

Patent ductus arteriosus (PDA) is presented in 55 to 70% of the preterm infants with a gestational age lower than 30 weeks or a birth weight lower than 1000 grams. PDA has being associated to mortality or morbidity such as ischemic or hemorrhagic cerebral events, necrotising enterocolitis, renal disfunction or poor pulmonary outcome; however, it is not clear whether these are a consequence of the PDA presence, the treatment implemented for closing it, or the immaturity of these population. PDA standard treatment (ST) consists on three doses of indomethacin or ibuprofen (10-5-5mg/kg) given 24 hours apart, being the surgical closure a second line therapeutic option. In spite of ibuprofen has been pointed as the drug of choice for PDA treatment by the last version of the Cochrane review, side effects have been associated to both medication. Standard ibuprofen treatment is based on a clinical trial where the three-dose protocol seemed to be more effective than one-dose scheme for PDA closure; however, the sample size was not powered to find differences statistically significant, so nowadays the best dose regimen for ibuprofen remains uncertain. Functional echocardiographic assessment is spreading to all over the world. In this scenario, it has been proposed its implementation to guide PDA treatment in order to individualize the number of doses of indomethacin administered as a function of patient's response, limiting the doses and side effects in those where PDA presented an early constriction. The investigators hypothesized whether echocardiographically guided PDA ibuprofen treatment could reduce the number of doses of ibuprofen without increasing the reopening rate and reducing the side effects associated to this medication.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with a gestational age lower than 37 weeks of gestational age
* PDA ≥ 1.5 mm
* No contraindication to receive ibuprofen
* Informed consent signed.

Exclusion Criteria:

* Life-threatening congenital defects
* Congenital heart disease
* Contraindication for ibuprofen administration such as oligoanuria \< 1cc/kg/h or recent severe intraventricular bleeding (IVH grade III) or creatinine serum level \> 1.5 mg/dl or potential intestinal ischemia.
* Informed consent refused
Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder

Using a virtual reality program in screening and treatment of ADHD.

Virtual Reality is a novel program designed to imitate a real classroom environment including various distractions. It includes a head monitor to track eye movements Children aged 10-20 years with ADHD will use the program with and without methylphenidate(1 mg/kg). Their results will be compared to a control group.

Parental consent will be obtained.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of ADHD-DSM4 criteria AGE 10-20 YEARS normal neurological examination IQ\>80

Exclusion Criteria:

ABNORMAL NEUROLOGICAL STATUS
Putting CDSMP to Work

This project is the test of the effectiveness of the Chronic Disease Self-Management Program which will be translated to a worksite setting.

This project will test adaptations of the Chronic Disease Self-Management Program (CDSMP) designed to increase the likelihood of widespread use in workplace settings. CDSMP, which has been proven efficacious in community trials, is a six-week program that is designed to help individuals better manage their chronic disease and its many complications. Although there is considerable interest among worksite health promotion practitioners for a chronic disease program, CDSMP has not been adapted and tested in workplace settings. In this study, we will determine a) if the CDSMP program tailored to worksites can be efficacious, b) the comparative effectiveness of the worksite tailored CDSMP when compared to the original CDSMP and c) the cost-effectiveness (average and incremental) and return on investment of the two interventions. The participating sites are seven organizations from a rural county in Southwest Georgia. Our partner for the project is the local YMCA. YMCA staff will be trained to implement the program which will foster sustainability. Participants will be randomly assigned to 1) workplace-tailored CDSMP, 2) 'usual care' CDSMP, and 3) control group. Data will collected at baseline, 6-month follow-up and 12-months follow-up. The control group will be a delayed intervention group that will be randomly assigned to an intervention group after taking the 6 month survey. The primary outcome measures include blood pressure, cholesterol, blood glucose, BMI, diet, physical activity and tobacco use and the secondary measures including patient-provider communication, quality of life, medical adherence, and work performance and productivity. An average cost-effectiveness analysis will compare interventions to control and an incremental cost-effectiveness analysis will be conducted comparing each intervention to one another. The hypotheses will be tested using a growth modeling approach examining changes over time. This will enable us to maximize the dissemination and implementation of CDSMP across worksite populations by using approaches which are realistic for most work organizations.

Eligibility Criteria:
Inclusion Criteria:

* The primary target is all employees 45 years or above with levels of gender and ethnicity similar to those found in the workplaces with which we will work.
* If younger individuals wish to participate, we will not turn them away but the program is designed for older adults. It is unlikely we will get a substantial number of participants over 45.

Exclusion Criteria:

* None
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.

This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18 years and older.
* Male or female patients are eligible.
* Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
* Patients with mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
* Patients must have a MSDBP \>= 90 mmHg and \< 110 mmHg at Visit 1 (week -2 to -4), and a MSDBP \>= 95 mmHg and \< 110 mmHg at Visit 2 (week 0).
* Patients must have an absolute difference of =\< 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

* Severe hypertension (grade 3 WHO classification; MSDBP \>=110 mmHg diastolic and/or MSSBP \>= 180 mmHg systolic).
* Inability to discontinue all prior anti-hypertensive medications safely for a period of 14 weeks).
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1 (week -2 to -4).
* Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 to -4).
* Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, etc.
* Type 1 Diabetes Mellitus.
* Type 2 Diabetes Mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) \>8% at Visit 1 (week -2 to -4).
* Administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 0 (week -4 to -6).
* Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
* Other protocol-defined inclusion/exclusion criteria may apply
Safety Study of F2695 SR in Major Depressive Disorder

The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
* Have normal examination findings at the final visit of the lead-in study
* Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential

Exclusion Criteria:

* Any exclusionary psychiatric or medical condition that developed during the lead in study
* Patients considered a suicide risk
* Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception
CARS: Cannabis and Alcohol Reduction Study

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 13 and 17
* be seeking treatment for either cannabis or alcohol use;
* report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous)
* have a caregiver willing to participate and provide consent.
Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

1. Comparison between the duration of time from the beginning of cervical preparation until abortion, between sublingual misoprostol and the combination of sublingual misoprostol with laminaria for second trimester medical termination of pregnancy (TOP).
2. Comparison between the adverse event rate following Sublingual misoprostol only vs. Sublingual misoprostol and laminaria given for pregnancy termination.
3. Comparison between the levels of satisfaction rate of women who underwent pregnancy termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.

A prospective randomized control trial; 50 women undergoing pregnancy termination in the second trimester (14-28 weeks)in each group.

Following receiving an ethical approval by the local institutional review board (IRB), committee, consecutively all women in between 14 weeks to 28 weeks; that have a reason for termination of pregnancy like: intrauterine fetal death or medical or genetic indications for termination of pregnancy or socioeconomic termination of pregnancy will be offered to take part in the study. If eligible according to the inclusion and exclusion criteria, women will be asked to sign a consent form.

All participants will undergo blood exams (CBC, Prothrombin time, Partial thromboplastin time , and BLOOD TYPING) and ultrasound exam for Confirmation of diagnosis as routinely indicated for missed abortion at our department

Eligibility Criteria:
Inclusion Criteria:

Second trimester pregnancy No evidence of chorioamnionitis

Exclusion Criteria:

Allergy to misoprostol. Evidence for infection. Asthma
Prehospital COOLing 1 (PreCOOL 1)

Elevated body temperature was shown to be associated with worse outcome in acute stroke patients. PreCOOL 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Suspected stroke
* Symptom onset ≤ 7 days
* Tympanic temperature ≥ 36.7°C
* Informed consent by the patient
* Age ≥ 18 years

Exclusion Criteria:

* Severe cardiac insufficiency (NYHA ≥ III)
* New anisocoria, severe nausea, vomiting or headache
* High-grade heart valve stenosis or insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* Threatening ventricular dysrhythmia
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Severe renal insufficiency with reduced diuresis
* Pregnancy
Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.

A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.

The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria:

Severe new trauma after the treatment
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Eligibility Criteria:
Inclusion Criteria:

Subjects must have history of dry eye as determined by:

1. Questionnaire
2. Tear Film Break Up Time less than or equal to 10 seconds
3. Schirmer's score of less than or equal to 5 mm
4. Corneal staining greater than or equal to 3 in either eye, and
5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

* Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.

This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 through 49 years and in good health by history, physical exam, and labs
* Weight greater than or equal to (\>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at Screening
* Written informed consent prior to performing any protocol related procedures, including Screening evaluations
* Ability to complete the Follow-up period of 360 days

Key Exclusion Criteria:

* Acute illness including fever \>= 99.5 Fahrenheit (°F) on day of dosing
* Any drug therapy within 7 days prior to Day 1 (except contraceptives)
* Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
* Previous receipt of a monoclonal antibody (mAb)
* Pregnant or nursing mother
* Concurrent enrollment in another interventional study
Cryoablation of Venous Vascular Malformations

To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations.

Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years,
* Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI,
* Recurrence of symptoms after initial treatment,
* Symptomatic deformation :pain, tangible mass,functional discomfort
* Recurrence after treatment by surgery or sclerosis
* Cryotherapy considered technically feasible after discussion in multidisciplinary committee,
* Localization at distance from the skin and major neurovascular structures,
* Absence of contra-indication of anaesthesia,
* Signed informed consent,
* Coverage by French social security

Exclusion Criteria:

* Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve),
* TP \<50% TCA\> 1.5 x control, anticoagulation
* Platelets \<90000/mm3,
* Progressive infection
* Patient included in another clinical study,
* Unable to undergo medical tests for geographical, social or psychological,
* Adult under a legal guardianship or unable to consent,
* Pregnancy and breastfeeding.