cyrilzakka/clinical-trials huggingface dataset:
Oxytocin Trial in Prader-Willi Syndrome

Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are particularly troublesome for children and their families (the insatiable appetite and social behaviors).

The research questions are:

1. Does intranasal oxytocin cause any side effects in children with PWS?
2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?

This study is to investigate if intranasal oxytocin will improve hyperphagia, social skills, and behaviors in subjects with Prader-Willi syndrome. This will be a randomized placebo controlled pilot study. The primary outcome measure is to determine if intranasal administration of oxytocin will cause any adverse events in subjects with Prader-Willi syndrome. Secondarily, the investigators will also perform evaluations to determine if intranasal oxytocin has any effect on social skills, behaviors, or appetite in children with Prader-Willi syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Children with genetically confirmed PWS
* Ages at ≥ 5 years and ≤ 11 years (must start treatment prior to 11th birthday)
* Child must be in nutritional phase 2b or 3, as determined by the PI at each site.
* Must currently be on growth hormone treatment, and have been receiving growth hormone treatment for at least one year prior to screening date.
* Treatment cannot have been interrupted for more than 1 week within 3 months prior to screening date.
* Priority will be given to children currently enrolled in the RDCRN Natural History study

Exclusion Criteria:

* Inability to tolerate intranasal administration of medication
* Hepatic insufficiency (AST/ALT greater than 3 times the normal levels for age)
* Renal insufficiency (BUN/Creatinine greater than 3 times the normal levels for age)
* History of an abnormal ECG (as determined by a cardiologist). If there is any question about cardiac function, ECG reports will be reviewed with a cardiologist prior to enrollment in the study.
* Child not receiving growth hormone treatment
* Child with hypertension or hypotension for age and sex (blood pressure \>97% for age and sex or blood pressure \<3% for age and sex)
* Diabetes mellitus
* Pregnant or lactating.
* Schizophrenia or psychosis
* Taking any psychotropic medications
Population Pharmacokinetic Modeling to Optimize the Dosage of the Piperacillin / Tazobactam Combination in Patients With Sepsis in Intensive Care

Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum Piperacillin / Tazobactam concentration profiles. optimization of dosing regimens. Indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. They reduce the toxic risk and optimize the effectiveness of these treatments.


Eligibility Criteria:
Inclusion Criteria:

* Major patient (age ≥18 years) male or female.
* Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3".
* Patient with an arterial catheter that can be used for blood sampling by the time the first dose of piperacillin / tazobactam is administered.
* Patient for whom treatment with piperacillin / tazobactam, alone or in combination with another antibiotic, is prescribed according to the following modalities (drug SPC): scheduled antibiotic treatment for at least 48 hours in IV infusion of 4 g of piperacillin and 0.5 g tazobactam over 3 hours, every 6 hours or every 8 hours.
* Patient affiliated to a social security scheme.
* Patient informed and given his non-opposition. If the patient is unable to do so (emergency situations) the non-opposition will be obtained from the patient's representative.

Exclusion Criteria:

* Treatment with piperacillin and / or tazobactam within 7 days prior to evaluation.
* Patient with a history of allergy to penicillins or β-lactams.
* Kidney function of Kdigo score = 3 (3 times baseline plasma creatinine or plasma creatinine ≥ 354μmol / L or extra-renal clearance, or diuresis \<0.3ml / kg / h for ≥ 24h or anuria for ≥ 12h) to not include patients at very high risk of extra-renal clearance within 48 hours.
* Hypersensitivity to the active substances, to any other antibacterial agent of the penicillin class or to any of the excipients.
* History of severe allergic reaction to any other β-lactam.
* Patient being treated with extrarenal treatment.
* Patient being treated with extracorporeal circulation (ECMO).
* Hepatic insufficiency patient with Child C. cirrhosis.
* Patient who refused to participate or refused participation by the representative.
* Person deprived of liberty by an administrative or judicial decision.
* Person under tutorship or curatorship.
* Pregnant or nursing woman.
Imaging of Corneal and Crystalline by Near Infrared Retro-illumination

Retroillumination photography is difficult. The reflections on the cornea and the lens are constant and prevent from obtaining a complete and clear image. Study team have modified a slit lamp intended to photograph the anterior segment of the eye in retroillumination by using a light source in the near infrared (780 nm), and a process which eliminates the reflections.


Eligibility Criteria:
Inclusion Criteria:

* Patient with corneal pathology, crystalline pathology, or pigmentary glaucoma with transilluminable iris. In case of bilateral disease, both eyes will be photographed
* Patient having received an instillation of eye drops to dilate the pupil of the eye to be photographed (or of both eyes).

Exclusion Criteria:

* Major blepharospasm
* Poor or no pupillary dilation: patient with allergy or intolerance to eye drops used for pupillary dilation, refusal of pupillary dilation
* Pregnant or breastfeeding patient
* Person under legal protection
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects

The benefits of microsurgical approaches in periodontal therapy have been described. The main focus of this study is to determine if using microsurgical LMCAF technique would improve the outcomes of the therapy for the Miller Class III isolated recession-type defects.

Six months results of this study showed that LMCAF with microsurgical approach offered better complete and mean root coverage results over macrosurgical LMCAF technique. The superior effect of microsurgical approach on post-operative morbidity can make this technique more preferable for the patients who expected comfortable postoperative period.

This study supports that using the microsurgical aproach with LMCAF procedure significantly affects the clinical and patient-centered success of treating Miller Class III isolated typed defects.


Eligibility Criteria:
Inclusion Criteria:

* Presence of Miller Class III isolated gingival recessions located at upper and lower incisors and canines (Miller 1985)
* Presence of identifiable cementoenamel junction (CEJ)
* Presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ
* Lateral keratinized tissue width at least 6 mm greater than the width of the recession measured at the level of the cemento-enamel junction (CEJ)
* Lateral keratinized tissue height at least 2 mm greater than the buccal probing depth of the adjacent tooth/teeth
* Full-mouth plaque score and full-mouth bleeding score of \< 15% (four sites/tooth) -No occlusal interferences; all patients were nonsmokers

Exclusion Criteria:

* Tooth with a prosthetic crown or restoration involving CEJ
* Patients with a history of destructive periodontal disease (o zaman class 3 nasıl oluştu demiş adam) or repeated abscess formation
* Presence of systemic disease or taking medications known to interfere with periodontal tissue health or healing (patients with insulin-dependent diabetes
* History of malignancy, radiotherapy, or chemotherapy for malignancy
* Disease affecting connective tissue metabolism)
* Patient pregnant or nursing during the past 5 months
* Patients who participated in a clinical trial within the past 6 months
Pulmonary Hypertension in Lymphangioleiomyomatosis

This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.

Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests

Eligibility Criteria:
Inclusion Criteria:

* Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis
* Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units)

Exclusion Criteria:

* Post capillary pulmonary hypertension
* Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease)
* Not willing to participate
Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and/or diagnosis of TMD
* With complaints of muscle disorders and / or joint pain, pain symptoms
* Presence of occlusal interferences
* Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion

Exclusion Criteria:

* Individuals with extensive dental flaws
* Orthodontic treatment in progress
* History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended
Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method

The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".

The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".

the study will compare the "fabrique à histoire"(Lunii(R)) with the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Children 3 to 6 years in pediatric emergency needing to venous puncture
* Oral consent by children
* Informed and signed consent by tenured of parent authority
* To have Anaesthetic patch 45 minutes or more before the venous puncture

Exclusion Criteria:

* To have Anaesthetic patch less than 45 minutes before the venous puncture because of necessity to blood test or an other emergency
* Necessity to analgesic 3 emergency
* Necessity to MEOPA
* Minor parents
* Assessment of anxiety is not possible because of comorbidity
* Anterior participation to these study
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder

The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans who served in Iraq and Afghanistan provided through telemedicine which connects patients to doctors in different locations using the internet. In this study, Veterans will receive prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. To this end, the investigators propose to enroll up to 20 individuals who will access the investigators services through the GA telehealth network who has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites to access the investigators therapists using GA telehealth equipment. The investigators hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms of PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Participants must meet DSM-IV criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom, Operation Enduring Freedom-Afghanistan, and/or Operation New Dawn.
* Patients must be literate in English.
* Patients must be medically healthy or medically stable such that the stress of the therapy is not contraindicated.
* Participants must comprehend his or her role in treatment and the risks involved in order to be entered.

Exclusion Criteria:

* Patients with a history of mania, schizophrenia, or other psychoses
* Patients with prominent suicidal ideation
* Patients with current alcohol or drug dependence
* Patients with special medical conditions such as pregnancy, renal insufficiency, those with various chronic diseases or a history of significant head injury
(Peak) a Phase 3 Randomized Trial of CGT9486+Sunitinib Vs. Sunitinib in Subjects with Gastrointestinal Stromal Tumors

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 442 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Additionally, a drug-drug interactions substudy will investigate the potential for CGT9486 to be a CYP3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
2. Documented disease progression on or intolerance to imatinib
3. Subjects must have received the following treatment:

   DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST Part 1b: Treatment with ≥2 prior TKI for GISTs Part 2: Prior treatment with imatinib only
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key Exclusion Criteria:

1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
2. Clinically significant cardiac disease
3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
5. Any active bleeding excluding hemorrhoidal or gum bleeding
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8. Received strong CYP3A4 inhibitors or inducers
9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy

A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors

Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old;
2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma);
3. Confirmed as adenocarcinoma by histology;
4. Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled);
5. At least one measurable lesion according to RECIST 1.1 standard;
6. Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment;
7. Sign informed consent, has good compliance and can cooperate with follow-up.

Exclusion Criteria:

1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population

The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease.

The analyses conducted by Viome will include, but are not limited to: genetic, transcriptomic, metabolomic, physiological, and physical. The samples collected from participants may include any of these: stool, blood, saliva, cheek swab, vaginal, breast milk/colostrum, nasal swabs or washes, and urine.

Study participants will collect the clinical samples and ship them to Viome labs or CROs (Contract Research Organizations), where they will be analyzed.

The objective of the study is to establish which foods correspond with increased wellness, and which foods correspond to decreased wellness.

The study hypothesis is that by monitoring the patterns of food intake and lifestyle parameters, in conjunction with non-invasive sample testing, personalized diet and lifestyle recommendations can be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Anyone that resides in the US at the time of enrollment.

Exclusion Criteria:

* None
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* biopsy-confirmed IgA nephropathy
* proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l

Exclusion Criteria:

* pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
* history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
* evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
* history of malignancy, drug or alcohol abuse
* participation in any previous trial on ACE inhibitor
* taking other investigational drugs within the past 30 days
* known history of sensitivity / allergy to ACE inhibitor

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.