cyrilzakka/clinical-trials huggingface dataset:
Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery

Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. Pericapsular nerve group (PENG) block has been recently recommended for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia method based on blocking the articular branches of femoral nerve (FN) and accessory obturator nerve (AON) in the region between the anterior inferior iliac spine (AIIS) and iliopubic eminence (IPE).The aim of this study was to evaluate the analgesic effect of ultrasound guided pediatric pericapsular nerve group (PENG) block in pediatric patients undergoing CHD surgery.


Eligibility Criteria:
Inclusion Criteria:

-American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* Incomplete patient forms
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* American Society of Anesthesiologist's III-IV
Evaluation of Clot Stability Induced by Solulin: Evaluation of New Solulin Mutants Lacking Protein C Activation Capacity

Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves the administration of exogenous human FVIII to restore normal hemostasis. The main complication of the substitutive treatment of hemophilia A is the development, in 15 to 30% of the cases, of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant activity of therapeutically administered FVIII. In 2003, the average annual cost of care for a patient with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France (6000 patients), represents an annual budget of 378 million euros.

In order to reduce the cost of treatment and to bypass this complication, different therapeutic strategies (new products or adjunctive therapeutic options) have been explored, including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and antibodies directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble thrombomodulin (Solulin) have been developed. This molecule may be used to partially correct the premature lysis defect in Factor VIII deficient plasma through an activated TAFI - dependent mechanism.

With a long half-life (15- to 30-hour) and effective dose range estimated to range from the sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly basis and provide the basis for a factor-sparing regime that would cut costs and make therapy more widely available. However, before proceeding to advanced trials, safety concerns stemming from the anticoagulant properties of Solulin must be addressed. The development of Solulin mutants lacking protein C activation capacity would make this concern redundant. At the same time, such mutant molecules are likely to possess an effective dose range.

Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking protein C activation capacity with respect to their ability to stabilize fibrin clots in whole blood of humans with different coagulation factor deficiencies (hemophilia A, hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).


Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital blood disorder (hemophilia A and B),
* Inform consent

Exclusion Criteria:

* Patients with acquired blood disorder.
* Allo-immunisation against blood coagulation factor concentrates (FVIII inhibitor)
Permeability Map to Distinguish Progression From Pseudoprogression in High-Grade Glioma

The aim of the present study is to assess whether a new method of quantifying therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish pseudoprogression from true progression in patients with high grade glioma, who received CCRT.

Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for glioblastoma multiforme (GBM). Response assessment in GBM is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated. The incidence of pseudoprogression after concurrent chemoradiation is15%to 30%. A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement. Dynamic contrast-enhanced (DCE) MR imaging provides a noninvasive means for quantifying tumor vascular properties.

Eligibility Criteria:
Inclusion Criteria:

* Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Exclusion Criteria:

* Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.
RCT to Evaluate Biocompatibility of Resin-based Dental Materials

In this randomized clinical trial, the bio-compatibility of 2 materials used for dental restorations will be compared: glass-ionomer vs resin-based composites.

Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.

Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. Global alterations in DNA methylation and DNA hydroxymethylation levels will be determined using UPLC-MS/MS.


Eligibility Criteria:
Inclusion Criteria:

* one or more carious lesions in primary molars that require treatment

Exclusion Criteria:

* carious lesions that already affected the dental pulp, large lesions requiring cusp replacement, presence of oral inflammatory conditions during the previous 2 weeks, carriage of a fixed or removable prosthesis/orthodontic appliance, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in previous 2 months, previous dental restorations
Counterfactual Thinking and Decision-making in Parkinson's Disease

The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals affected by Parkinson's Disease when compared to healthy individuals.


Eligibility Criteria:
Inclusion criteria:

• Diagnosis of Parkinson's disease, according to the medical assessment performed by trained neurologists.

Exclusion Criteria:

* Diagnosis of Obstructive Sleep Apnea Syndrome, according to the clinical assessment;
* Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders;
* Dementia, according to the clinical/neuropsychological assessment.
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation

Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.

Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)


Eligibility Criteria:
Inclusion Criteria:

* admitted to hospital for worsening HF
* age ≥ 70 years
* LVEF \< 50% and need of diuretics
* NYHA II or III
* living alone
* willing to participate with informed consent.

Exclusion Criteria:

* Major depression (PHQ 9-score \>9)
* being on hemodialysis
* had been admitted to hospital for any reason within 7 days before HF decompensation.
* patients with a left ventricular assist device
* coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes

This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.

Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
* tested positive for urine cotinine (≥ 200 ng/mL) at Screening
* exhaled carbon monoxide \> 10 ppm (parts per million) at Screening

Exclusion Criteria:

* relevant illness history
* relevant medication use
* body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
* allergy to propylene glycol or glycerin
* use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
* use of any prescription smoking cessation treatments within 3 months prior to Check-in
* smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
* planning to quit smoking during the study
* female subjects who are pregnant, lactating, or intend to become pregnant
A Study of Viracept in HIV-Positive Women

The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count \<= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 T cell count \<= 400 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
* Prior protease inhibitor therapy.
STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE

OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in second-line treatment in patients with lung cancer advanced non-small of histology predominantly flaky by assessing the survival free of progression (SLP).

Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP) type.

DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to study the drug under study is erlotinib.

-Dose and treatment guidelines follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.

POPULATION in study and number TOTAL of subjects population under study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib.

-Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.

STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected.


Eligibility Criteria:
Inclusion Criteria:

-• Age ≥ 18 years.

* Histological or cytologic diagnosis of cancer (NSCLC) with predominantly squamous histology stage IV non-small-cell lung.
* ECOG performance status between 0 and 2.
* Patients who have progressed to a first line of advanced disease and are eligible for a second line with Erlotinib.
* Patients that grant informed, preferably in writing, or oral consent before witnesses independent of the research team.

Exclusion Criteria:

-• Patients with uncontrolled or severe systemic disease, an active infection, neoplasia concomitant or secondary neoplasia to primary disease, except for carcinoma in situ of cervix or adequately treated skin carcinoma.

* Disease with mutated EGFR, according to local laboratory. The determination of the EGFR is not mandatory. Those patients from centers where there is the determination of the EGFR or those patients that the EGFR is unknown may be included in.
* Inability to take oral medication or previous surgical procedures that affect the absorption and imply the need for intravenous or parenteral feeding.
* Interstitial lung disease clinically active.
* Unstable angina or recent myocardial infarction.
* Brain metastasis uncontrolled and progressive.
* Patients who are participating in a clinical trial.
* Use of an inhibitor of tyrosine kinase in first line of treatment.
* Patients whose estimated life expectancy does not reach the 2 months.
* Any condition, situation which, in the opinion of the investigator, may endanger the safety of the patient, or could interfere significantly with the involvement of the subject in the study or evaluation of the results of the study.
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation

Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).


Eligibility Criteria:
Inclusion Criteria:

* Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
* Unstable Angina/NSTEMI patients who completed PCI for main lesions
* Either systolic \> 130mmHg or diastolic \> 80mmHg, or patients with anti-hypertensive drugs

Exclusion Criteria:

* STEMI patients within one month
* Variant Angina
* Liver function abnormality or renal failure
* History of Hypersensitivity to testing drugs
* Severe heart failure(NYHA class\>3) or uncorrectable hematologic disease
* Woman possible to be pregnant
* Uncontrolled diabetes
* Expected life span \< one year
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).


Eligibility Criteria:
Inclusion Criteria:

* Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
* T-ALL or T-LBL participants with relapsed/refractory disease.
* Have had at least 60 days between prior hematopoietic stem cell transplantation (SCT) and first dose of study drug.
* Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale for adults.
* Lansky score \>50% for participants \<16 years old.
* Have adequate organ function.
* Are at least:

  * adult Phase 1 Part A and Phase 2: ≥16 years old at the time of screening
  * pediatric Phase 1 Part B: 2 to \<16 years old
* Men and women with reproductive potential: Must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer.
* Females with childbearing potential: Have had a negative serum pregnancy test ≤7 days before the first dose of study drug and also must not be breastfeeding.
* Are able to swallow capsules and tablets.

Exclusion Criteria:

* Have previously completed or withdrawn from this study or any other study investigating LY3039478 or other Notch inhibitors.
* Have evidence of uncontrolled, active infection \<7 days prior to administration of study medication.
* Have current or recent gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
* Have active leukemic involvement of the central nervous system (CNS).
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function

A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.


Eligibility Criteria:
Inclusion Criteria:

* Weighs at least 45 kg
* Body mass index between 18 and 40 kg/m2 inclusive
* Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
* Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
* Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal

Exclusion Criteria:

* Subject is known to be HIV positive or has HIV antibodies
* Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
* Is Hepatitis positive
* Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
* History of substance abuse within 6 months prior to screening
* Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
* Has abnormal liver function tests (ALT, AST, and/or bilirubin)
* Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers

This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging.

The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation.

Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years.

They can be summarized as follows:

1. to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation.
2. to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level.
3. to determine the clinical impact of new or worsening TR after CIED implantation.
4. to explore the treatment strategies for lead-related TR (observational).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient able and willing to give informed consent in written form before the index procedure
* Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
* Patients undergoing any new CIED implantation with or without transvalvular lead
* Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers

Exclusion Criteria:

* Previous or present CIED
* Life expectancy \< 12 months due to non-cardiac condition
* Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
* Previous tricuspid valve intervention (transcatheter, surgical)
* Participation in another study, which would lead to deviations from this trial protocol
Feasibility of Targeted Bronchial Washing for Molecular Testing by Next Generation Sequencing in Early-stage Lung Cancer

This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients suspicious of early-stage lung cancer.

Eligibility Criteria:
1. Inclusion Criteria:

   * Age ≥ 20 years
   * Obtained written informed consent
   * Subjects suspected of having resectable lung cancer on computed tomography
   * Subjects without contraindication to brochoscopy
   * Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing
2. Exclusion Criteria:

   * Subjects who withdraw informed consent
   * Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy - for genetic alteration with Next Generation Sequencing based on the investigator's judgement
   * Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
   * Subjects diagnosed with a benign lesion from the lung tissue lesion