cyrilzakka/clinical-trials huggingface dataset:
Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5\~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Age: older than 18 years old，including 18 years old
2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
3. Cancer core: located at lower part of stomach
4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
6. ASA score: ≤ 3;ECOG performance status 0/1
7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
4. Patient who was treated because of systemic inflammatory disease
5. Pregnant patient or lactating women
6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
7. serious mental illness
8. gastric surgery (including for gastric ESD / EMR)
9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
10. other malignant diseases in 5 years
11. have unstable angina or myocardial infarction within six months
12. have cerebral infarction or cerebral hemorrhage within 6 months
13. sustained systemic glucocorticoid treatment history within 1 month
14. have other diseases needed operative treatment at the same time
15. complications (bleeding, perforation, obstruction) required emergency surgery
16. Pulmonary function tests FEV1 \<50% of predicted value.
Sidlenafil in Combination With Oral Anticoagulants in Patients With Intermediate-high Risk of Pulmonary Embolism

Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism


Eligibility Criteria:
Inclusion Criteria:

* pulmonary embolism confirmed by CT scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery.
* Right-left ventricular ratio (RV / LV) ≥1 derived from the apical four-chamber view
* Who gave written informed consent to participate in research

Exclusion Criteria:

* Age \<18 or \>80 years
* Symptoms of pulmonary embolism\> 14 days
* Inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of RV / LV ratio
* A significant risk of bleeding
* The administration of thrombolytic drugs within the previous 4 days
* Active bleeding
* Known coagulopathy
* Thrombocytopenia \<100,10\^9 / l
* Previous use of vitamin K antagonists with an INR\> 2.5 at admission
* History of any intracranial or spinal surgery or trauma or intracranial / spinal bleeding
* Intracranial neoplasm
* Arteriovenous malformations or aneurysms
* GIH \<3 months
* Cataract Surgery
* Obstetrical manipulation
* Cardiopulmonary resuscitation needed.
* Other invasive procedures \<10 days
* Allergy, hypersensitivity, thrombocytopenia to heparin or tissue plasminogen activator
* Allergy to iodine contrast
* A well-known right-left cardiac shunt, for example, a large patent foramen ovale, or atrial septal defect; large (\> 10 mm), or a blood clot in right atrium/right ventricle
* Systolic blood pressure \<90 mm Hg for at least 15 minutes, or fall of systolic blood pressure is not less than 40 mm Hg for at least 15 min., with evidence of organ hypoperfusion (cold extremities or low diuresis \<30 mL / h, or confusion), or the need for administration of catecholamines to maintain adequate perfusion of organs and systolic blood pressure\> 90 mm Hg
* Severe hypertension (systolic\> 180 mm Hg or diastolic\> 105 mm Hg.).
* Pregnancy, lactation, delivery\<30 days
* Participation in any other study (drug or device)
* Life expectancy \<90 days
* Refusal to participate in the study
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.

The duration of the study for a participant will be up to approximately 65 days.

Eligibility Criteria:
Inclusion Criteria:

* Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan.
* Male participants between the ages of 18 and 55 years, inclusive
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests)
* Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness.
* Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study.
* History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2
* Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Medicolegal Aspects of Head Trauma

Trauma is a critical global health problem. It represents the fifth leading cause of significant disability and is one of the most common causes of mortality in youth and adulthood, as one in 10 deaths worldwide occurred due to trauma.

The head is preferred target for criminal acts and is a favorite place for various pathological lesions .Traumatic head injury (THI)is one of the prevalent causes of global death and disability. lately, head injury (HI) cases have increased in both developed and developing nations. Therefore, it is of great value to evaluate the clinical and pathological features of head injury .

Every injury that results in harm to the scalp, skull or brain can be sort out as a HI which can be caused by traffic mishap, falls, sports and gunshot wounds. Vehicle accidents are one of the most prevalence causes of THI as they are deemed to be one of the main causes of fatality due to road-traffic accidents (RTA) .Among different type of the RTA, motorcycle accidents holds the number one cause of accident in most of the country .

Skull fracture and hemorrhage are common association, which may be present with head trauma and affect the outcome of the case.The skull fractures, especially by blunt force offer varying diagnostic and medico- legal problems to the medical jurists as well as to the clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of head trauma

Exclusion Criteria:

* Patients with deficient data i.e. escaped, discharged on demand before period of follow up
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).

Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD.

Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD. We conducted two retrospective studies on patients starting dialysis between 2000 and 2010, and based on two French registries: The French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF).

Eligibility Criteria:
Iinclusion criteria :

* Patients starting dialysis
* Patients included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF) exclusion criteria
* patients without diagnosis of nephropathy
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System

This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.

Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Method comparison study exclusion criteria

   * Female；
   * 18-55 years of age；
   * Voluntary and sign informed consent form.
2. Lay user study inclusion criteria

   * Female；
   * 18-55 years of age；
   * Voluntary and sign informed consent form；
   * Willingness to perform self-test of investigational device；
   * Have the ability to read English.

Exclusion Criteria:

1. Method comparison study exclusion criteria

   * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
   * Within 8 weeks of childbirth or abortion；
   * The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
2. Lay user study inclusion criteria

   * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
   * Within 8 weeks of childbirth or abortion；
   * The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
   * Background in a medical or laboratory testing.
Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)

The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.


Eligibility Criteria:
Inclusion Criteria:

* Patient with either Crohn's disease or ulcerative colitis whose disease is flaring

Exclusion Criteria:

* Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT
Operant Conditioning After ACL Reconstruction

The purpose of this study is to examine if the changes in corticospinal function that accompany ACL reconstruction can be improved through a form of mental coaching and encouragement, known as operant conditioning.

It is theorized reduced corticospinal excitability contributes to quadriceps dysfunction after knee injury and joint disease. Current rehabilitation does not directly target the alterations in corticospinal excitability, which may limit recovery. Operant conditioning is an emerging approach capable of increasing corticospinal excitability by directly targeting the corticospinal pathways. However, it remains to be determined whether operant conditioning of the corticospinal pathway may improve corticospinal function after knee trauma. Therefore, this study will evaluate the ability of operant up-conditioning of the corticospinal pathway to improve corticospinal function after ACL reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* aged 14-45 years
* suffered an acute, complete ACL rupture
* have undergone ACL reconstructive surgery
* willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria:

* have suffered a previous ACL injury on the contralateral leg
* have undergone previous major surgery to the contralateral knee
* have a history of recent significant knee injury (other than ACL) or lower-extremity fracture
* have a history of uncontrolled diabetes or hypertension
* be pregnant or plan to become pregnant
* have metal implants in the head
* have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers)
* have unexplained recurrent headaches
* have a recent history of seizure
* have a history of repeated fainting spells
Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity

This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. Participants, divided in six groups, will receive one of these breakfast integrations for 14 days:

group 1) 30 g peeled hazelnuts;

group 2) 30 g unpeeled hazelnuts;

group 3) snack with 30 g peeled hazelnuts;

group 4) snack with 2.5 g cocoa powder;

group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;

group 6) empty snack, control group.

In the last few years, the prevalence of overweight and obesity has increased in all age groups. The European Food Safety Authority stated "cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". Several studies reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease. The hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet integrations on vascular reactivity and endocrine-metabolic parameters.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-24.9 kg/m2

Exclusion Criteria:

* diabetes mellitus
* glucose intolerance
* dyslipidemia
* metabolic syndrome
* allergies
Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies

prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be divided into two groups, the first group will undergo early chest tube removal - after three hours, the second group will have late chest tube removal according to the department's protocol.

the study aims to prove the possibility and non inferiority for early chest tube removal for thoracoscopic surgeries with non complicated surgical course.

Presence of chest tube post thoracoscopic surgery is associated with increased morbidities like wound infection, pain, and prolong the hospital admission Corse, in the other hand, early chest tube removal is associated with increased the need for recurrent active intervention like pleural tapping for re-accumulated pleural effusion.

Method: randomized prospective study includes 60 patients who underwent thoracoscopic lobectomy/segmentectomy/ thoracoscopic mediastinal biopsy.

The study will exclude patients with difficult operative course ( intraoperative finding of significant adhesions/ intraoperative injury of the lung parenchyma/ intraoperative bleeding/failure of extubation ) and patient with post operative findings of ( bleeding in the chest tube more than 100 ml in the first hour, persistent air leak, non expanded lung on chest x-ray ) The patients will be divided into two groups, the first group - 30 patients - will undergo chest tube removal after three hours, and the second group will undergo chest tube removal according to the treating department protocol.

All patients will be evaluated regarding the pain level - subjective and objective -, admission period, infection, and the need for invasive intervention.

The patients will be evaluated during the admission, after one week and after two weeks.

Eligibility Criteria:
Inclusion Criteria:

* patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy.
* post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation.
* patients with who read and signed informed consent regarding the participation of the study.

Exclusion Criteria:

* Patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax.
* patients who underwent thoracoscopic pleural biopsy for possible malignancy.
* patients under 18 year old.
Development of a Novel Convolution Neural Network for Arrhythmia Classification

Identifying the correct arrhythmia at the time of a clinic event including cardiac arrest is of high priority to patients, healthcare organizations, and to public health. Recent developments in artificial intelligence and machine learning are providing new opportunities to rapidly and accurately diagnose cardiac arrhythmias and for how new mobile health and cardiac telemetry devices are used in patient care. The current investigation aims to validate a new artificial intelligence statistical approach called 'convolution neural network classifier' and its performance to different arrhythmias diagnosed on 12-lead ECGs and single-lead Holter/event monitoring. These arrhythmias include; atrial fibrillation, supraventricular tachycardia, AV-block, asystole, ventricular tachycardia and ventricular fibrillation, and will be benchmarked to the American Heart Association performance criteria (95% one-sided confidence interval of 67-92% based on arrhythmia type). In order to do so, the study approach is to create a large ECG database of de-identified raw ECG data, and to train the neural network on the ECG data in order to improve the diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

* All ECG data compiled from 12-lead ECG, single, and multiple lead databases

Exclusion Criteria:

* None
An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections

The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections (\[IPFI\]; lung diseases caused by fungal infection).

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be divided into the intravenous (into a vein) injection period and the oral solution administration (giving) period. During the intravenous injection period 200 milligram (mg) twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice daily will be given as maintenance therapy (treatment designed to help the original primary treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Probable or proven invasive pulmonary infectious participants (IPFI) - Hospitalized participants (at least hospitalized treatment and observation could be ensured during the intravenous injection period) - The participants (or legal representatives) have signed the informed consent forms.

Exclusion Criteria:

* Currently taking taboo drugs, such as terfenadine, astemizole, cisapride and HMG CoA reductase inhibitors (for example simvastatin, lovastatin, oral or intravenous midazolam or triazolam) - History of allergy or intolerance to imidazoles or pyrrole drugs (for example fluconazole, itraconazole, ketoconazole, miconazole, clotrimazole) - Pregnant and breast feeding women, or women of child bearing age not taking effective contraception measures - Participants with pure oral, urinary tract, and vaginal candidiasis (yeast infection) - Participants with fungal meningitis (inflammation of the meninges), active liver disease, renal insufficiency with the serum creatinine clearance rate less than 30 milliliter per minute (ml/min), and current abnormal cardiac function such as congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body), or participants with history of congestive heart failure