cyrilzakka/clinical-trials huggingface dataset:
Ultrasound in Acute Dyspnea in the Field

Acute heart failure is one of the main causes of acute respiratory distres in prehospital emergency setting. The early and correct diagnosis is important because the misdiagnosis can result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and point-of-care lung ultrasound could be useful methods in field. This study confirmed that the combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh diagnostic accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the field and the tretament possibilities in clinical obscure cases are mainly improved.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criterion for the study was shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea).

Exclusion Criteria:

* Exclusion criteria were age \<18 years, history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: pneumonia, pulmonary embolism, carcinoma, pneumothorax, pleural effusion, intoxications (drugs), anaphylactic reactions, upper airway obstruction, bronchial stenosis, and gastroesophageal reflux disorder
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects

The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function (Part 2) in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \[weight kilogram per meter square (kg/m\^2)\] between 18 and 30 kg/m\^2 (inclusive), and body weight greater than 50 kilogram (kg) but less than 100 kg
* Generally in good health on the basis of physical examination, medical history, vital signs, laboratory tests, and electrocardiogram (ECG) performed at screening and/or prior to administration of the initial dose of study drug
* Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study
* contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
* willing and able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol through the Day 113 visit

Exclusion Criteria:

* Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
* Clinically significant abnormal values for coagulation, hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the clinical research unit) as determined by the investigator or appropriate designee
* Have smoked tobacco or nicotine-related products within 6 months prior to dosing or does not agree to refrain through Day 113
* Donated blood or blood products or had substantial loss of blood \[more than 500 milliliter (mL)\] within 3 months before the first administration of study drug or intends to donate or donates blood or blood products during the study until 30 days after completion
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders
The Alouette Test in Parkinson Disease

Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease
* Montreal Cognitive Assessment (MoCA) test \> 20

Exclusion Criteria:

* Patient's with supranuclear Palsy
* Other neurologic disease
* Any ophthalmologic disease
* Presence of a nystagmus
* Visual acuity \< 0.6
EPLBD With Limited EST vs. EPLBD for Choledocholithiasis

Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (\> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.

ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.

Eligibility Criteria:
Inclusion Criteria:

* large bile duct stones (≥10 mm)

Exclusion Criteria:

* pregnancy
* refusal of written informed consent
* Patients with benign or malignant biliary stricture
* Contraindications to ERCP exist
* Complicated with acute pancreatitis or acute cholangitis
* Coagulation dysfunction，thrombocytopenia
* prior EST or EPBD
* Patients after gastrointestinal reconstruction
Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)

In hospitals, the standard prostate cancer announcement system is based on oral and written information. To improve this system, we have developed animated videos that retrace the patient's care path.

This is an exploratory, controlled, before-and-after, multicenter study designed to assess the effect of a standard announcement system reinforced by animated videos on patients' level of understanding of prostate cancer diagnosis and treatment. Patients' perception of information will be assessed using the EORTC QLQ-INFO25 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Collection of the patient's non-opposition prior to participation in the study.
2. Patient aged ≥ 18 years at inclusion.
3. Patient with newly diagnosed advanced or metastatic prostate cancer.
4. Patients due to start systemic therapy.
5. Patients undergoing consultation.
6. Patient affiliated to a social security scheme.
7. Patient capable, according to the physician-investigator, of communicating well, understanding and complying with the requirements of the study.
8. Patient with a smartphone or computer to review the video at home.

Exclusion Criteria:

1. Patient related to any member of the study staff or having a close relationship or conflict of interest with the sponsor.
2. Patient to receive only local treatment.
3. Patient who does not understand French.
4. Clinical follow-up impossible for psychological, family, social or geographical reasons.
5. Vulnerable patient: deprived of liberty by judicial or administrative decision, adult subject to legal protection or unable to express non-opposition.
Phase II Trial for the Treatment of Relapsed Osteosarcoma

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high grade osteosarcoma recurrence
* Resectable or unresectable recurrence disease within 24 months from the initial diagnosis
* Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis
* Unresectable first relapse within 24 months from the initial diagnosis
* Resectable or unresectable second of further recurrence of high grade osteosarcoma
* Age at diagnosis at least 4years.
* Karnofsky performance status over 60%.
* Renal function and hepatic In normal limits for age.
* L eft ejection ventricular fraction over 50%.
* White blood cells over 3000 million/liter and platelets 100000 million/liter
* Birth potential female must agreed to contraception
* Signed written informed consent

Exclusion Criteria:

* Contraindication to the use of any study drugs
* Mental, social and geographic conditions which fail to ensure adequate adherence to the study
* Hepatitis and human immunodeficiency virus active infection
* Pregnancy or breast-feeding
* Previous treatment with Gemcitabine, Docetaxel and Ifosfamide
Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction

The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)

Intrauterine growth restriction is a major cause of perinatal mortality and morbidity .

It is noted to affect approximately 5-15 % of pregnant women. Egypt has one of the highest incidences of Intrauterine Growth Restriction. The incidence of IUGR varies among countries, populations, races and increases with decreasing gestational age. 14 to 20 million infants have been affected with Intrauterine Growth Restriction cases in the developing countries annually.

A complex and dynamic interaction of maternal, placental and fetal environment is involved in ensuring normal fetal growth. An imbalance or lack of coordination in this complex system may lead to Intrauterine Growth Restriction. Intrauterine Growth Restriction( IUGR) results in significant perinatal and long-term complications, including increased neonatal mortality and morbidity and higher risk for developing metabolic syndrome later in life.

Physiological differences have been noted in growth restricted infants. Intrauterine amino acid disturbances similar to biochemical changes seen in postnatal protein deprived states have been detected. Protein metabolism defect and altered lipid metabolism also have been described.

Undernourishment in utero appears to be associated with persisting changes in the metabolic functions. Birth weight influences the lipoprotein profile and cholesteryl ester transfer protein, which promotes a proatherogenic lipoprotein profile in plasma by determining chemical, physical and biological properties of the respective lipoprotein particle in neonates.

Recent research suggests that several of major disease of later life, including coronary heart disease, hypertension \& type II diabetes originate in impaired intrauterine growth and development. These diseases may be consequence of programming whereby a stimulus or insult at a critical, sensitive period of early life has a permanent effect on structure, physiology and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Any full-term Intrauterine growth restriction (IUGR) neonate

Exclusion Criteria:

* Preterm neonates
* Who died before feeding was established
* Multiple congenital anomalies including GIT anomalies
* Congenital infection
* Cholestasis
* Infant of diabetic mother (IDM)
Exploring the Health Benefits of Sauna Bathing

Cardiovascular disease (CVD) is the leading cause of mortality in Aotearoa New Zealand, with hypertension being a major risk factor that remains difficult to manage with medication. Finnish sauna bathing (FSB), a widely practiced form of heat therapy, has been linked to lower risks of CVD, stroke, and overall mortality. Traditionally, FSB is combined with cold water immersion (CWI), but the combined effects of these therapies remain under explored. While sauna research often focuses on physiological aspects, this study aims to take a holistic approach to understanding its impact on cardiovascular health.

Cardiovascular disease (CVD) remains the leading cause of mortality and morbidity in Aotearoa New Zealand. High blood pressure is a significant risk factor for CVD, with nearly half of older adults in Aotearoa diagnosed with hypertension, and it being relatively intractable to attempts thus far at treatment via antihypertensive medications.

Finnish sauna bathing (FSB) is one form of heat therapy, characterised by the use of a wood-fired sauna in which water is thrown over hot stones to create steam. In Finland, the sauna is not only a common therapy but also deeply ingrained in the cultural fabric, with many households having their own sauna. Traditionally, saunas were communal places where people came together to relax and share experiences thus fostering social connections. Lifelong sauna use is associated with markedly lower risk for chronic diseases such as; CVD, stroke, and all-cause mortality. Integral to the FSB experience is the practice of cold water immersion (CWI) which typically involves a plunge into icy waters, or exposure to freezing temperatures, in between sauna bathing.

Sauna bathing is typically researched with a physiological / biomedical lens and in isolation, that is, the additive effects of sauna bathing and cold-induced adaptations from cold-water immersion are not well understood, highlighting a gap in this research area. Additionally, the health benefits of sauna are wide ranging, therefore our focus is to use a holistic lens to explore the impact of sauna bathing cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

* SBP: 110-179 mmHg; DBP 60-99 mmHg)
* 18 - 70 y old.
* Participants who are prescribed anti-hypertensive or dyslipidaemia medications will be included but must be on a stable dose for at least 30 days.

Exclusion Criteria:

* stable or unstable angina
* recent myocardial infarction (\<3 months)
* orthostatic hypotension
* severe aortic stenosis
* pregnancy
* acute infectious diseases
* rheumatoid arthritis in the acute inflammatory phase
* fever for any reason
* any other medical condition deemed a risk.
A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms

In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech

3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database.

The data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices.

Mobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them.

MMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information

Eligibility Criteria:
Inclusion Criteria:

* Older patients who are willing to wear a smart wristband and have an Android smart phone

Exclusion Criteria:

-
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus
* either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
* HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
* HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
* Age between 18 and 80 years
* BMI less than 40 kg/m2
* Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria:

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
9. Treatment with anti obesity drugs
10. Current treatment with systemic steroids
11. Alcohol abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. known intolerance to metformin
14. Dehydration
15. Unstable or acute CHF
16. Acute or chronic acidosis
17. Hereditary galactose intolerance
18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.


Eligibility Criteria:
Limited inclusion criteria:

* Documented symptomatic deep venous reflux in one limb
* Deep venous reflux in the region of interest

Limited exclusion criteria:

General:

* Age \< 18 years
* BMI ≥ 40
* Cultural objections to porcine materials
* Unwillingness or inability to comply with the follow-up
* Unwillingness to provide study data for duration of study
* Simultaneous participation in another device or drug study
* Inability or refusal to give informed consent

Medical:

* Pregnant, or planning to become pregnant
* Diagnosis of terminal illness with life expectancy less than 12 months
* Complete symptom resolution with compliant compression therapy for three months
* Untreated superficial venous disease
* Medical interventions including any of the following: planned procedure of any leg, vascular intervention or major surgery within the last three months, implanted inferior vena cava filter
* Medical history of any of the following: anticoagulation treatment for pulmonary embolism (within the last six months or ongoing), insulin dependent diabetes, chronic obstructive pulmonary disease, renal dysfunction requiring dialysis, leg amputation, bleeding diathesis, untreated or unresolved systemic infection or local infection, active malignancy except non-melanoma skin cancer, other acute or chronic medical condition that may cause noncompliance with the protocol or confound the study results, documented history of significant untreated stenosis within the arterial system
* Positive coronavirus (COVID-19) test six days prior to implant procedure

Anatomical:

* Inability to clearly visualize target implantation site
* Tortuous target implantation site
* Inadequate inflow and/or outflow to the target region

Procedural:

* Inability to gain access to the access site vein
* Untreated focal or diffuse stenosis
Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.

Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity

Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features.
* Age \>18 years.
* Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET imaging+/- confirmatory nodal biopsy.
* No evidence of paraaortic nodal metastasis.

Exclusion Criteria:

* History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder.
* Rectal Polyps or extensive hemorrhoids.
Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks

The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..


Eligibility Criteria:
Inclusion Criteria:

* A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
* Fasting LDL-C concentrations at Visit 1 as defined in the protocol.

Exclusion Criteria:

* History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
* Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
* Severe congestive cardiac failure (as defined by the protocol - Appendix I).
* Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).