cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.

The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.

Eligibility Criteria:
Inclusion Criteria:

1. Age range: ≥18 years of age
2. Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
3. Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
4. IRB written informed consent obtained and signed Exclusion Criteria
5. Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.

Exclusion Criteria:

1. Unable to provide consent
2. Pregnant or lactating
3. BMI \> 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
4. Previous history of MI or thoracic surgery.
5. Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
6. Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in patients with bacterial infection.

Primary objective:

• To assess clinical and microbiological efficacy of FOM in patients with bacterial infection.

Secondary objectives:

* To determine the rate and severity of unexpected adverse events.
* To determine the mean duration of therapy with FOM in patients with bacterial infection.

Study design:

Multi-center, non-interventional study

Please note that InfectoPharm Arzneimittel und Consilium GmbH has taken over sponsor responsibilities for all German sites of this clinical trial with Jannuary 2016 from J\&P MEDICAL RESEARCH LTD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bacterial infection receiving FOM for clinical purposes will be included into the analysis.

Exclusion Criteria:

-
Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence

Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.

Early metastases of hepatocellular carcinoma (HCC) may be detected by the isolation of circulating tumor cells (CTCs) in the bloodstream. During the course of therapeutic attempts, monitoring CTC changes in patients with HCC is helpful for the efficacy assessment. Nevertheless, the markers used for the detection, such as a-feto protein, asialoglycoprotein receptor or epithelial cell adhesion molecule, CD133 or CD90, are not specific for HCC CTCs. In spite of these limitations, a timely determination of the existence of CTCs will be beneficial for the monitoring of distant metastases, the evaluation of therapeutic attempts, and the prediction of prognosis.

Eligibility Criteria:
Inclusion Criteria:

* definitive pathological diagnosis of HCC based on World Health Organization (WHO) criteria;
* underwent curative resection one month ago, CT or MRI detecting no new lesions when recruited;
* CTC counts≥2 after resection;
* age between 18 and 75 years;
* adequate hematologic function (platelet count: \>60 × 109 platelets/L; hemoglobin: \>90g/L; and prothrombin time: \<3 seconds above control);
* adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
* Child-Pugh classification A or B grade

Exclusion Criteria:

* a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
* diffuse-type HCC;
* evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
* severe underlying cardiac or renal diseases;
* color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation;
* obstructive jaundice
Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.


Eligibility Criteria:
Inclusion Criteria:

- Women undergoing embryo transfer in either fresh or frozen cycles

Exclusion Criteria:

* Women aged \> 42 years old
* Women with factors which will affect uterine contractility
* congenital uterine anomaly
* acquired uterine pathology such as myoma \>5cm, adenomyosis \>5cm or endometrial polyp
* Women with presence of hydrosalpinx
* Women undergoing pre-implantation genetic test in IVF cycles
* History of allergy to misoprostol , Buscopan® or same group of drug
* Contraindication to the use of Buscopan® e.g. glaucoma, myasthenia gravis, tachycardia, megacolon
* Women who are on other smooth muscle relaxant other than Buscopan®
NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens

The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.

Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to medical services
* Persistent blood glucose level \> 140 mg/dL
* With an expected stay ≥ 48 hours

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus
* Parenteral nutrition
* Glucose levels ≥ 400 mg/dL at screening
* Diabetic ketoacidosis or non-ketosis hyperosmolar state
* Clinically relevant hepatic disease
* Glomerular filtration rate ≤ 30 ml/min
* Pregnancy
* Terminal disease
* Inability to provide informed consent
Safety and Tolerability of GX-P1 in Healthy Male Volunteers

This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1


Eligibility Criteria:
Inclusion Criteria:

1. Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
2. Healthy male volunteers aged 19-45 years within screening periods
3. Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
4. Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

Exclusion Criteria:

1. Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
2. History of or current disease evidence including malignant tumor
3. History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
4. Have participated in another clinical trial with investigational drug within 180 days prior to screening period
5. Positive for HCV antibody, HBsAg, or HIV antibody at screening period
6. Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator
Self and Body-esteem in Socio-professional Rehabilitation

The body esteem influences the physical appearance, which can be a social brake. To enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. The study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center

Our hypothesis is that a group program centered on the image and the presentation of the self, with the intervention of professionals of the image of the body, such as socio-hairdresser, socio-beautician, allows a better socio-professional inclusion, through an improvement in body self-esteem. Taking care of yourself will require different approaches such as advice on hygiene, becoming aware of your body, experimenting with beauty treatments and having the means to reproduce them at home. We will compare our IPS program (Image and Presentation of Self), with the usual management in the care center (TAU = "Treatment As Usual")

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65.
* Speaking French.
* Diagnosis of severe mental disorders (MSD) established according to the criteria of the DSM-V (Diagnostic and Statistical Manual of Mental Disorders) such as: Schizophrenia, Bipolar Disorders, Serious Personality Disorders, Severe Anxiety Disorders, Depressive Disorders; with a clinical stability of more than 3 months.
* Supported at SUR/CL3R with an application for socio-professional reintegration.
* Guardian agreement (for persons under guardianship);
* Information given to the curator (for persons under curatorship);
* Member of the social security scheme.

Exclusion Criteria:

* Diagnosis of Autism Spectrum Disorder (ASD) or Eating Behaviour Disorder.
* Clinical status incompatible with group activity.
* Acute episode in progress.
* Refusal to participate.
* Simultaneous participation in a psycho-social rehabilitation program targeting image or self-esteem (general and/or body).
The Therapeutics Effects of Yoga in Individuals With Parkinson's Disease

To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease

This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease
* Stage 1-3 Hoehn \& Yahr

Exclusion Criteria:

* Decline in immune function
* 6 month joint surgery
* spinal fusions
* decline in mental status measured by Folstein Mini Mental Status Exam
Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury

Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial urethral realignment after PFUI decreases rates of urethral obstruction and the need for subsequent urethral procedures.

The retrospective record review should determine the utility of acute urethral realignment after PFUI.

A retrospective chart review to compare outcomes between urethral realignment (group 1) and suprapubic tube (SPT) placement (group 2). The comparison will be between two routinely practiced management approaches of urethral injury after pelvic fracture.

Prior studies demonstrate urethral realignment is associated with a 15% to 50% reduction in urethral obstruction, however, it has also been associated with higher rates of incontinence and erectile dysfunction. Our hypothesis is that early realignment of traumatic urethral injuries after pelvic fracture lowers the incidence of complications like urethral strictures and subsequent need for surgeries.

Eligibility Criteria:
Inclusion Criteria:

Men \> 18 years old Blunt force trauma Presence of pelvic fracture Urethral injury Inability to pass a Foley catheter retrograde through the injury into the bladder

Exclusion Criteria:

Straddle type urethral injuries without a pelvic fracture Passage of a catheter successfully in a retrograde fashion
Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity

The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.

The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age
* Preoperative diagnosis of Invasive breast cancer
* Patient deemed for total mastectomy with axillary lymph node dissection (ALND)
* Subject capable of giving informed consent and participating in the process of consent
* Affiliated to the french social security

Exclusion Criteria:

* Mastectomy without ALND
* Previous ipsilateral axillary radiotherapy
* Previous axillary surgery
* Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
* Breastfeeding
* Allergy to indocyanine green
* Patients with a known history of reaction to iodine or iodine-containing compounds.
* No consent
* Impaired capacity to make informed medical decisions
* Patient on guardianship
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children

Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. In adults, esophageal pressure (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical studies suggest that PES may be useful to guide the management of mechanical ventilation. In children, the PES measurement could have similar potential benefits, but beforehand the reliability of PES to estimate PPL needs to be assessed.

Objective The primary objective of this study is to validate the reliability of PES directly monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate PPL, when compared to a gold standard, i.e the direct PPL measurement in situ.

Method This is a prospective single center study. Children \<18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included.

Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously recorded.

Expected results We expect that the PES-based methods will provide an accurate estimation of PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.


Eligibility Criteria:
Inclusion Criteria:

* Children \<18 years old, hospitalized in the pediatric intensive care unit;
* Requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician;
* With at least one chest tube.

Exclusion Criteria:

* Contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder);
* Hemodynamic instability, as defined by the treating team, and the absence of recent (\<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine;
* Respiratory instability defined as a severe respiratory failure requiring FiO2 \> 60%, or PaCO2 \> 80 mmHg on blood gas in the last hour;
* Persistent pleural effusion or pneumothorax despite the chest-tube;
* Bronchopleural fistula;
* Recent (\<12 hours) thoracic hemorrhage;
* Delayed sternal closure at the time of study;
* Significant pericardial effusion;
* Absence of parental or tutor consent;
* Patient for whom a limitation of life support treatments is discussed or decided.
Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic

Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.

We propose to determine the more relevant marker combination in this case.

In urgence of a severe acute respiratory insufficiency,for thanks to an approach diagnostic, therapeutic and prognostic we propose to determine the more relevant biomarker combination.

An expert committee will compare the biomarker diagnostic and prognostic relevance thanks to all elements clinico-biological and patient monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Oxygen saturation below or equal to 92% in ambient air.
* Respiratory frequence above 25 cycle per minute

Exclusion Criteria:

* Minors
* Pregnant or lactating women
* Patient without social security
* Patient hospitalize without consent
* Chest pain with acute coronary electro-cardiographic change leading immediate achievement of a diagnostic coronary angiography and/or therapeutic
* Pneumothorax
3M Study - Maria Malmö Mobile Telephone Study

The present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. Subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.


Eligibility Criteria:
Inclusion Criteria:

* Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.
Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
* Bone marrow aspirate or biopsy must contain \>= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where \>= 30% of non-erythroid cells must be leukemic blasts
* Age \>= 61 years
* Informed consent, personally signed and dated to participate in the study
* Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib

Exclusion Criteria:

* Central nervous system manifestation of AML
* Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Chronically impaired renal function (creatinin clearance \< 30 ml/min)
* Chronic pulmonary disease with relevant hypoxia
* Inadequate liver function (ALT and AST \>= 2.5 x ULN)
* Total bilirubin \>= 1.5 x ULN
* Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
* Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
* Uncontrolled active infection
* Concurrent malignancies other than AML
* Previous treatment of AML except hydroxyurea and up to 2 days \<= 100 mg/m²/d cytarabine
* Known HIV and/or hepatitis C infection
* Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
* Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
* Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
* History of organ allograft
* Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
* Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
* Serious, non-healing wound, ulcer or bone fracture
* Allergy to study medication or excipients in study medication
* Investigational drug therapy outside of this trial during or within 4 weeks of study entry
* Patients who are not eligible for standard chemotherapy
Prospective Study on COVID -19 Reinfection on Vaccinated and Non-vaccinated Outpatients

the aim of the study is to compare the severity of symptoms in case of reinfection with COVID-19. the study will compare between two groups; vaccinated and non vaccinated. the side effects from vaccination and symptoms of infection and reinfection will be reprted.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed with COVID infection
* take any type of vaccines

Exclusion Criteria:

* no accept sharing
* not vaccinated with COVID vaccine