cyrilzakka/clinical-trials huggingface dataset:
Input of a Multidisciplinary Device to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families

Severe forms of hemophilia and other constitutional bleeding disorders represent a group of rare diseases. In last decades, news therapies have dramatically increased life expectancy and joint's protection.

The investigators propose to set up a single-centre, descriptive, transversal pilot study, designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the totality or part of the device accompanying the diagnostic announcement in the past 10 years.

Severe forms of hemophilia and other constitutional bleeding disorders represent a group of rare diseases. In last decades, news therapies have dramatically increased life expectancy and joint's protection. The recurrence of joint bleedings is responsive of multifocal arthropathy in the natural history, but nowadays, the orthopedic outcome is good thanks to prophylactic treatments.

However, the announcement of the diagnosis of such hereditary bleeding disorders at a very young age represents a real psychological trauma for parents. Such an announcement may induce some psycho-developmental impairment.

An innovative support has been implemented at the Hemophilia Treatment Center in Marseille, in conjunction with the French Hemophilia Society. This program is based on a multidisciplinary partnership that favors the psychological support and the reinsurance of the parents.

With Rare Diseases Foundation support, the investigators have initiated this pilot study that will include more than 20 patients with severe hemophilia or constitutional bleeding disorder, who benefit from the device. This descriptive, monocentric, interventional study will permit to describe the psychological status, the quality of life of patients and their parents, but also to evaluate the impact of the device on initiation and observance of treatments like Long Term Prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 3 and 12 years
* Patients diagnosed and treated at the Center until inclusion
* Patients with FVIII :C \< 2% or with FIX :C \<2% or with FVII:C \<2% or with FXIII:C \<2% or fibrinogen \<0,2 g/l, or with type 3 von Willebrand diseases or Thrombasthenia of Glanzmann diseases.
* Patient who participate to multidisciplinary support and announcement of diagnosis device
* Voluntarily given fully informed written and signed consents obtained before any study-related procedures are conducted

Exclusion Criteria:

* Patient with other clotting disorder or disease.
* Patient diagnosed or treated in other centre
* Patient with psychiatric disorder or disease
* Patient with other severe chronic disease
The Effects of Periodic Training on Physical and Motor Performance in Wrestlers

The aim of this study was to investigate the effects of 12 weeks wrestling training on the physical and motor performance parameters of wrestlers in athlete training centers. The effect of 12 weeks of intensive training was investigated in 33 wrestlers aged 12-14 years in athlete training centers in Çorum province. Paired samples t-test was used in the statistical procedures.


Eligibility Criteria:
Inclusion Criteria:

Male wrestlers aged 12-14 years. Participants enrolled in athlete training centers in Çorum province. Those who have given informed consent and whose legal guardians have also provided consent.

Participants who have no physical or medical conditions preventing them from performing intense physical activity.

Participants who are actively attending training sessions during the study period.

Exclusion Criteria:

Wrestlers with chronic illnesses or injuries that could interfere with physical training.

Participants who do not regularly attend the training program. Individuals who did not provide informed consent or whose guardians did not consent.
To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia

This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.

This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19
* Patients with Essential Hypertension and Primary Hypercholesterolemia

Exclusion Criteria:

* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
* Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
Mechanisms Mediating Cardiovascular Disease in Children With Obstructive Sleep Apnea

To identify the early effects of obstructive sleep apnea on the cardiovascular system of children.

BACKGROUND:

Obstructive sleep apnea (OSA) is an important clinical disorder occurring in men, women, and children with a prevalence of 4 percent, 2 percent and 1-3 percent, respectively. OSA is under active study in adults and is definitely linked with increased cardiovascular morbidity, even in its mild to moderate clinical forms. In contrast, OSA has not been well studied in children and the potential deleterious consequences on cardiovascular function have received little or no attention.

DESIGN NARRATIVE:

The study will examine in children 1) The interaction between OSA and baroreflex dysfunction, 2) The relation of OSA severity and baroreflex dysfunction to abnormalities in blood pressure control during wakefulness and sleep, 3) The association of the diminished baroreflex gain and impaired blood pressure control with an index of end organ damage, the left ventricular mass index, and 4) Whether effective treatment of OSA results in significant improvement in baroreceptor function, blood pressure control and a decrease in left ventricular mass index. A cross-sectional study will be conducted in 8-12 year old children with OSA and a matched group of normal children. Studies include baroreceptor function, 24-hour ambulatory blood pressure and left ventricular mass index. Baroreceptor function will be measured by non-invasive techniques based on combined computer analysis of heart rate and blood pressure measured by portapres. 24-hour ambulatory blood pressure will be measured by a Spacelab monitor and left ventricular mass index will be measured by direct M-mode echocardiogram. A longitudinal study will be conducted on the effect of adequate treatment of OSA on baroreceptor function, daytime and nocturnal blood pressure and left ventricular mass index. A cohort of children with OSA and a matched group of normal controls will be followed for a period of 12 months after treatment of the disorder. Results are expected to show that children with OSA have decreased baroreceptor sensitivity, elevated nocturnal blood pressure and increased left ventricular mass index and that effective therapy for OSA, as determined by polysomnography, will improve or normalize baroreceptor sensitivity as well as nocturnal blood pressures and will lead to a decrease in left ventricular mass index.

Eligibility Criteria:
No eligibility criteria
Fatty Acid Supplementation in Children With ASD

The purpose of this study is to examine how fatty acid supplementation alters biological signatures in children with ASD

Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms that affect their quality of life and severely disrupt family well-being. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses were formulated based on data from the investigators previous studies and other published data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently elevated in children with ASD and decreases in these markers correlate with ASD symptom improvement. The investigators long-term goal is to identify effective treatments for ASD.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-6 years old
* ASD diagnosis at Nationwide Children's Hospital within the prior 6 months
* ADOS-2 score in "autism" (severe) range
* English is primary language

Exclusion Criteria:

* Fatty acid supplementation in the past 6 months
* Consumes fatty fish more than 3 times per week
* Still breastfeeding or formula feeding
* Quadriparesis
* Deafness
* Blindness
* Seizure disorder diagnosis
* Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angleman Syndromes, Tuberous Schlerosis
* Feeding problems precluding consumption of the supplement
* Ingredient allergy (canola, fish, or borage seed)
* Planned surgeries scheduled within the time frame of trial participation
Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator

This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.

All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.

Eligibility Criteria:
Inclusion Criteria:

* The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
* The vertebral fracture sites where are located in T11-L2
* No clinical neurological symptoms and signs
* The patients who have complete preoperative X-ray, CT, MRI and other imaging data

Exclusion Criteria:

* Vertebral burst fracture with spinal canal occupation
* Fracture caused by severe osteoporosis or tumor and other pathological factors
* Moderate and severe scoliosis
* Patients with pedicle dysplasia
* Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
* Coagulation dysfunction or surgical site of the skin infection
Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy

Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.

The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures.

EUS is an operator dependent procedure where accuracy depends on experience and skills. Nowadays, EUS-training can be achieved by a formal fellowship training in a center for 6-24 months or an informal training through didactic sessions with a short hands-on experience. However, parameters for a correct and complete learning experience measurement are yet to be defined. The implementation of artificial intelligence on EUS can potentially mitigate the operator-dependent variable and improve diagnostic accuracy.

Therefore, detection of normal anatomical structures on a separate basis using an AI-based model, expert and non-expert endoscopists to determine where the AI would be most helpful.

The investigators aim to compare the diagnostic accuracy of the AI-based model with the endoscopists identification of normal anatomical structures in EUS procedures.

Eligibility Criteria:
Inclusion Criteria:

* Expert gastrointestinal EUS-endoscopists.
* Non-expert gastrointestinal endoscopists training for EUS.
* Patients with chronic dyspepsia without other findings.
* Patients with previous CT images or upper digestive endoscopy reporting no other findings.
* Patients requiring EUS for surveillance due to family history of pancreatic cancer without findings on MRI.

Exclusion Criteria:

* Internet connection less than 100 MBs per second.
* Patients with abnormal structures or with visible lesions.
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor

Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.

This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence.
* ECOG-performance status ≤ 3.
* Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500 / mm3, platelets \> 150 000/μl, creatinine clearance \> 60 mL / min according to Cockroft formula).
* Patient-compliant and psychologically able to follow the trial procedures.

Exclusion Criteria:

* Non-epithelial ovarian cancer or borderline ovarian tumor.
* Pregnancy or breastfeeding.
* Patients affected by major depressive disorder even in treatment or minor mood disorders.
* Patients with severe impairment of respiratory, hepatic or renal function.
* Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
* Patients with bowel obstruction.
* Inadequate bone marrow, liver, kidney function.
* No clear-peritoneal disease at surgical exploration.
* Patients with ascites \>2000 cc (CT-Scan)
* Patients who have already made third line chemotherapy.
The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation

The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III.
* Scheduled for DBS.

Exclusion Criteria:

* History of dystonia.
* Severe heart failure with ejection fraction less than 30%.
* History of obstructive sleep apnea.
* History of renal failure with creatinine level \> 2 mg/dl.
* Allergies to α-2 agonists and propofol.
* Current use of α-2 agonist medications such as clonidine.
Utility Study in Diffuse Large B-Cell Lymphoma (DLBCL)

This study is a prospective, cross-sectional survey to be administered to real patients in remission from DLBCL using a 15-minute postal or online survey. The project is designed to describe the impact of DLBCL remission on health utility and quality of life. Data collection will occur over a 4-month period.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (\>/=) 18 years of age
* Diagnosis of DLBCL and currently in first remission
* Prior drug treatment for DLBCL

Exclusion Criteria:

* Receiving active treatment for DLBCL
* Relapsed following any treatment for DLBCL
Supportive Treatment of Severe Heart Failure by Renal Denervation

The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* NYHA III-IV
* ejection fraction \<45 %
* 6-minute walking test under 440m

Exclusion Criteria:

* Unstable hemodynamic state
* uncooperation
Detection of Circulating Tumor Cells in Peripheral Blood From Healthy Volunteers and Patients With Cancer

To address the challenges of isolating and analyzing rare cells, this study aims to validate technical diagnostic instrumentation, tests, protocols and analysis to correlate the number of circulating tumor cells present in whole blood for predicting cancer prognosis and treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients. Blood samples will be collected from these patients at regular intervals as determined by their doctors. The patient's disease progression will be monitored over the lifetime of this study. The specific aims are to isolate, enumerate and analyze the number of circulating tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging techniques. Investigators will also use this study to optimize diagnostic instrumentation, test protocols and downstream CTC analysis. Investigators may also correlate the results of these tests with the prognosis of the patients as well as any clinical evidence (e.g. from radiological imaging scans). While investigators focus on prognosis in this study, these correlated tests potentially may also be valuable in future studies for early diagnosis and monitoring of cancer.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in the first stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with stage 4 breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

For inclusion in the second stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

Exclusion Criteria:

The following is regarded as a criterion for exclusion from the study and applicable to both 2 stages :

1. Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the study.
Impact of the COVID-19 Pandemic and HRQOL in Cancer Patients and Survivors

This study uses questionnaires to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted health-related quality of life (HRQOL) and other areas such as COVID-19-specific psychological distress, disruptions to health care, finances and social interactions in cancer patients. The coronavirus disease 2019 (COVID-19) is an infectious disease that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The information learned from this study will guide the development of psychosocial programs to improve patient care and outcomes in cancer patients and survivors in the context of facing a global pandemic.

PRIMARY OBJECTIVES:

I. Assess experiences during the coronavirus disease-2019 (COVID-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and HRQoL and other psychosocial and behavioral factors in cancer survivors who participated in one of three prior clinical trials.

II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19 specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL.

III. Evaluate the extent to which resiliency factors such as social support and perceived benefits assessed concurrently and other psychosocial measures assessed in the prior trials moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

IV. Examine group differences in the outcomes assessed in the protocol relative to prior group assignment in the behavioral clinical trials.

OUTLINE:

Participants complete a survey online over 35-45 minutes about their experiences regarding the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Prior patients who participated in one of the following protocols: 2012-0112, 2009-0976, or 2005-0035
* Has an active email address or can be contacted via MyChart or personal email

Exclusion Criteria:

* No evidence of consent from prior clinical trials
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure

Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.

Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.

The purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Previous MitraClip implantation
* Persistent relevant iASD 30 days after MitraClip intervention

Exclusion Criteria:

* Unsuccessful MitraClip implantation
* No relevant iASD 30 days after MitraClip intervention
* Unstable angina in the previous 4 weeks
* Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy
* Constrictive pericarditis / restrictive cardiomyopathies
* Pericardial effusion planed for surgery or interventional therapy
* Coagulation disorders
* Malignant disease with a life expectance \< 12 months
* Pregnancy
* Participation in another study
* iASD diameter \> 38 mm
* Aortic minimum distance of the iASD \< 5 mm
* Thrombus in left atrial appendage
* Venous access impossible with a 24 French catheter system
* Presence of an inferior vena cava filter