cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma

Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial.

Background: Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.

Methods: This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial. Twenty hospitals are selected based on specific eligibility criteria. After the baseline period, 5 randomization steps with 4 hospitals per step will be conducted. Each hospital will gradually enter intervention period in the randomized order for the implementation of regional trauma care system. The initial 1-month is considered as the intervention transition period, during which hospitals are modified and healthcare workers are trained according to the requirements of the regional trauma care system.

Conclusion: This is the first study assessing the effectiveness of the regional trauma care system on the treatment of patients with severe trauma with the conduction a prospective study in China.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-60 years old, with no restriction on gender;
2. Severe trauma, including trauma patients with ISS score ≥ 16;
3. Time from trauma to admission \<24h.

Exclusion Criteria:

1. Patients who complicated with underlying diseases, such as malignant tumor and diabetes mellitus;
2. Patients with important organ dysfunction before trauma;
3. The investigator considers not appropriate for enrollment. -
Risk Factors of Depression, Anxiety and Eating Disorder After Bariatric Surgery

the goal of this observational study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery.

participants will undergo psychometric tests.

the aim of this study is to Investigate and determine rate of occurrence and associated risk factors of depression , anxiety , eating disorder after bariatric surgery .

and its correlation to postoperative changes in weight .

All data from the subjects will be obtained through direct interviews of postoperative patients

All subjects will be submitted to :

1. Obtaining detailed history of

Age , sex , socioeconomic level , work , educational level , marital status , functionality of the patient , special habits (smoking index , alchohol and substance abuse , feeding habits , exercise ).

Evaluating the family history of obesity , psychiatric disorder , Bariatric surgery

Searching for early and late complications of Bariatric surgery : Dumping syndrome , malnutrition , vomiting , hernias , redundant ght loss (by wieght skin , skin infection , vomiting .

Determining the type of surgery. degree of obesity of postoperative patients

evaluated by body mass index

Medical comorbidities Hypertension , diabetes , chronic kidney disease , chronic liver disease , ischemic heart disease , obstructive sleep apnea , gastric reflux , dermatological disorders

Psychometric evaluation

Hamilton Anxiety Rating Scale

Hamilton Depression Rating Scale

Eating disorder evaluation. Eating Attitudes Test-26

Eligibility Criteria:
Inclusion Criteria:

* study sample of humans who had bariatric surgery.
* Subjects with postoperative time of ≥ 3 months
* Male or female aged between 18:60 years.

Exclusion Criteria:

* Illiterate patients.
* Patients have dementia or psychosis.
* Age below 18 or above 60 years.
* Patients refused to give written informed consent
Artificial Intelligence Versus Expert Endoscopists for Diagnosis of Gastric Cancer

Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy.

Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists.

Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists.

Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer.

Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan.

Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images.

Study Duration: 3 months.

Prior to Study: Total 500: Screen potential subjects by inclusion and exclusion criteria; obtain endoscopy images.

Randomization was performed.

Intervention: AI diagnosis was performed for 250 patients using upper gastrointestinal endoscopy images, and Expert endoscopists diagnosis was performed for 250 patients by same methods.

Primary analysis: Perform primary analysis of primary and secondary endpoints for 250 patients in each group

Cross over diagnosis between AI and expert endoscopists was performed.

Perform secondary analysis of agreement of gastric cancer diagnosis per images and IOU between AI and expert endoscopists for 500 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥ 20 years who underwent upper gastrointestinal endoscopy at Tokyo University Hospital during 2018.
2. Informed optout consent, obtained from each patient before completion of the study.

Exclusion Criteria:

1. Patients who underwent gastrectomy.
2. Patients who underwent transnasal upper gastrointestinal endoscopy.
Evaluation of Oral Needs of Children With Disorder Attention Deficit/Hyperactivity Disorder

There is little accurate data in the literature at present on oral problems of hyperactive children, especially regarding care needs that would justify an assumption oral specific. The purpose of this study is therefore to have accurate data regarding the risk of caries, other oral diseases like periodontal disease, trauma, and assess the needs dental care and problems in cooperation for dental care in a population of children and adolescents with hyperactivity disorder with attention deficit. Finally, it has recently been described as the sleep disordered breathing was not uncommon in disorder attention deficit/hyperactivity disorder, whether snoring and/or apnea. But it is now accepted that some features of facial morphology favoring pharyngeal congestion occur in individuals with obstructive sleep apnea (hyperdivergent typology with increased anterior facial height and decreased posterior facial height, becoming the facial retrognathia, pharyngeal congestion, elongation and thickening of the soft palate, low position of the hyoid bone). A cephalometric analysis of craniofacial architecture and relationships with the soft tissue surrounding skeletal structures will detect if any of these specific characteristics that could promote sleep disordered breathing are found in disorder attention deficit/hyperactivity disorder prevalence with a particular.


Eligibility Criteria:
Inclusion Criteria:

* Consent signed by parents before the examination
* With of a social security scheme
* Age greater than or equal to 5 years and less than 15 years, Children with a diagnosis of attention deficit / hyperactivity confirmed or made by a physician specialists co-investigators of the study, diagnosis defined according to precise criteria for a disorder attention deficit/hyperactivity disorder as specified in DSM-IV with a normal IQ, ie higher than 80, and without other neurological or psychiatric
* Child consultant in a hospital or doctors' offices

Exclusion Criteria:

* Refusal of consent of the parents
* No affiliation to a social security scheme
* Age below 5 years or more than 15 years
* Diagnosis of a disorder attention deficit/hyperactivity disorder not confirmed by a physician , IQ \<80, Pathology associated neurological or psychiatric
Intra-arterial Chemotherapy(Chemosurgery) for Retinoblastoma

Conventional treatments of retinoblastoma involves laser photocoagulation, cryotherapy (freezing of the tumor), plaque radiotherapy,external beam radiotherapy, and intravenous chemotherapy. Enucleation (removing of the eye)is the last option when the tumor cannot be controlled otherwise. However,many children with retinoblastoma present with advanced intraocular disease for which enucleation is the only option. Intra-arterial chemotherapy (Chemosurgery)delivers anti-tumor drug directly into the ophthalmic artery (the artery feeding the eye) in order to increase the dose of drug reaching the tumor while minimizing toxicity to the rest of the body.

Present treatments for intraocular retinoblastoma cure 99% of children but have significant toxicity. Enucleation of the eye is effective but blinds the eye and leaves a lifelong cosmetic deformity. Radiation is associated with the subsequent development of fatal cancers. Systemic (intravenous)chemotherapy is used worldwide but experience with it has shown that the majority of eyes initially treated with chemotherapy still require additional treatments, such as radiation, laser, cryotherapy or even enucleation. In addition blood transfusions, secondary infections, insertion of ports and permanent hearing loss are now well reported. Three years ago we developed this technique of Chemosurgery for significantly increasing the dose of drug to the cancer while decreasing the dose of drug administered to children. This approach has decreased the need for enucleation in advanced eyes scheduled for enucleation with minimal systemic toxicity. We now offer treatment of both eyes simultaneously (in bilateral cases) and to eyes with less advanced disease and normal vision as an alternative to toxic systemic chemotherapy. In cases of very advanced ocular disease we will be using multiple drugs infused at the same session to increase tumor kill.

Chemosurgery interventions are performed under general anesthesia. The femoral artery (artery at the groin) is punctured and a catheter (a small plastic tube)is advanced into the opthalmic artery (the artery of the eye)using fluoroscopic (X-ray) guidance. The drugs are injected directly into the opthalmic artery over a period of 30-45 min.The catheter is then removed, manual compression exerted to the femoral artery, the child is awaken and goes to recovery for 6 hours. The procedure is repeated every 3-4 weeks for a total of 2 to 6 sessions according to tumor response. Since April 2006, our center has treated by chemosurgery 60 eyes in 52 patients with advanced intra-ocular retinoblastoma for which enucleation was considered.

Eligibility Criteria:
Inclusion Criteria:

* advanced retinoblastoma in one or both eyes
* recurrent retinoblastoma after failure of conventional methods

Exclusion Criteria:

* retinoblastoma judged curable by conventional methods
* patient judged unable to undergo the procedure
Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease

A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.


Eligibility Criteria:
* Be between 40 - 90 years of age
* Have a diagnosis of Parkinson's disease
* Be able to walk for 10 min without an aid
* Be able to follow and understand the oral instructions of the investigator
* Have a disease stage of I to IV (while ON-medication)
* Have had no change in your Parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months
* Have at least about 1 "freezing" episode per day (based on the New Freezing of Gait Questionnaire: N-FOG)
* Not participating in another clinical trial
* Have no acute joint disease
* Not have any other condition that affects your walking pattern or prevents you from completing all study tasks
* Have not undergone major surgery or hospitalization in the last 3 months
* No substance abuse
* No depressive disorder or other apathetic disorder that precludes daily exercise
Comparison of PVI-guided Fluid Management With Traditional Fluid Management in Colorectal Surgery

The first objective of this study was to compare the traditional fluid management (TFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels. ASA I-II 70 patients included in this prospective study.

Objectives: The first objective of our study was to compare the traditional fluid management (TFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels. Our secondary purpose was to compare the effects of different fluid regimens on the return of bowel function and the duration of hospital stay. Methods: The study included 70 American Society of Anesthesiologists (ASA) grade I and II patients, aged above 18 and undergoing elective colorectal surgery. After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.

After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus gelatin injection (Gelofusine®, Barun) was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in TFM group, a 250-ml bolus gelatin injection (Gelofusine®, Barun) was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.

In the first 24 hours after surgery, oliguria (\<0.5 ml / kg urine output), need for blood transfusion and the time of first bowel movement (depending on the days after surgery), length of hospital stay were recorded.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 age
* elective colorectal suregry
* ASA 1-2

Exclusion Criteria:

* Chronic renal disease
* Ejection fraction \< 30
* arthmia
Using Three Different Doses of Hyperbaric Prilocaine 2% Local Anaesthetic ( 40,50 and 60mg ),Through Spinal Anaesthesia in Knee Arthroscopy Patients to Compare Time to Void

The goal of this randomised trial is to use a short acting local anaesthetic drug (hyperbaric prilocaine 2%) which is beneficial in short operations which are performed as a day case surgery.

in this study the investigators will use 3 different doses of prilocaine 2% (40,50 or 60 mg ) intrathecal (in spinal anaesthesia) in participants undergoing arthroscopy on the knee.

the primary outcome is to compare time to micturate (go to the bathroom) between the three groups .

the secondary outcomes are:

* time to recovery of the motor and sensory block
* time to discharge from post anesthesia care unit
* any complications ; itching, lowered blood pressure, nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing knee arthroscopy will be eligible for the study. -

Exclusion Criteria:

1. Coagulopathy and other bleeding disorders (INR more than 1.4 and platelet less than 80000)
2. Patient refusal.
3. Infection at the site of injection.
4. Allergies against prilocaine.
5. Increased intracranial pressure.
6. Severe MS and AS.
7. Sever hypovolemia.
A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.


Eligibility Criteria:
Inclusion Criteria (those who meet all of the following are eligible)

1. Patients requiring diagnostic colonoscopy with an estimated examination time ≤ 30 min; males and females, ASA grade I-II, between 18 and 65 years old (inclusive);
2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
3. Respiratory rate between ≥ 10 and ≤ 24 breaths per minute; SpO2 when inhaling \> 95%; SBP ≥ 90 mmHg; DBP ≥ 60 mmHg; heart rate between ≥ 50 and ≤ 100 beats per minute;
4. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria (those who meet any one of the following are ineligible):

1. Patients having contraindications to general anesthesia or previous history of anesthesia accidents;
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;
3. Patient received any of the following drugs or therapies prior to screening:

   1. Participated in other drug clinical trials within 3 month prior to screening;
   2. In receipt of propofol and/or opioid analgesics within 1 month prior to screening;
4. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.
5. Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:

   1. ANC ≤ 1.5 x 109/L;
   2. PLT ≤ 80 x 109/L;
   3. Hb ≤ 90 g/L (no blood transfusion within the last 14 days);
   4. AST and ALT ≥ 2.5 x ULN;
   5. TBIL ≥ 1.5 x ULN;
   6. Creatinine ≥ 1.5 x ULN.
6. History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);
7. History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);
8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Patients who are planning pregnancy within 1 month after the completion of the trial (including male patients);
9. Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;
10. Patients determined by the investigator to be unsuitable for participating in this trial for any reason.
InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.

When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).

Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.

Exclusion Criteria:

* Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync Registry