cyrilzakka/clinical-trials huggingface dataset:
Benchmarks in Acute Laparoscopic Cholecystectomy

The aim of this observational cohort study is to define peri- and postoperative reference values for acute laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The goal is to spur quality improvement initiatives.

The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. As the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 18 years of age
* laparoscopic acute cholecystectomy

Exclusion Criteria:

* other indications than acute cholecystitis will be excluded
* cholecystectomy due to malignancy
* other organ surgery performed at the same occasion
* previous upper gastrointestinal surgery
* single port access
* robotic surgery
* no data concerning surgical intervention
Effects of Resistance Training in Untrained Older Adults

The latest randomized controlled trials and systematic reviews of resistance training performed by older adults reported that the systematic use of exercise in machines improves muscle strength and power, functional abilities, body mass and body balance. However, the effect of resistance training with elastic tubes exercises have not been studied in all the variables described above. The objective of this study is to analyze the effects of elastic tubes exercises on muscle mass, muscle strength, functional performance and postural control in elderly untrained.

This is a randomized clinical trial study (RCT) with 2 parallel arms. The subjects will be divided in 2 groups with a randomized block technique: Elastic Training Group (ETG) and Machine Training Group (MTG). The subjects will be submitted to a two-week familiarization period and then a sixteen-week of strength training program will be performed twice a week.

This regimen of resistance training in both groups will consist of four exercises for lower limbs and four exercises for upper limbs which will be alternately performed with a one-minute interval between them during familiarization and training periods. Lower limb exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.

Eligibility Criteria:
Inclusion Criteria:

* Convenience sample of forty healthy older adults with a minimum of 55 years of age.

Exclusion Criteria:

* subjects suffering from orthopedic, neurologic, rheumatologic, metabolic or heart conditions, and uncontrolled arterial hypertension. Additional exclusion criteria included undergoing estrogen therapy, use of cardiac pacemaker, knee or hip arthroplasty, the presence of fragments from previous osteosynthesis; orthopedic surgery, fractures, muscle injury or the practice of resistance training within the last 6 months
Intravitreal Celecoxib for Chronic Uveitis

Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.

After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.

Eligibility Criteria:
Inclusion Criteria:

* Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects

Exclusion Criteria:

* 15 years or younger Have active ocular infection Pregnancy Phakic subjects
Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users

This randomized controlled trial will determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional cardiometabolic risk factors in SCI manual wheelchair users.

This randomized controlled trial aims to determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional (insulin resistance, obesity, dyslipidemia (including low HDL-C and elevated TG and blood pressure) and novel (inflammatory status, autonomic nervous system function, vascular structure and function, and cardiorespiratory fitness level) cardiometabolic risk factors in SCI manual wheelchair users. As secondary objectives, this trial will investigate the effects of the exercise intervention on free-living physical activity, shoulder pain, and indices of quality of life.

Men and women, aged 18-65 years; chronic SCI (≥1 year since injury); individuals with sufficient sparing of arm function to participate in upper-body rowing; using a manual wheelchair as a primary tool for mobility will be included in the trial.

The exercise training will be conducted as wheelchair-modified upper-body ergometer rowing. The training will be performed for up to 30 min, 3 times per week with moderate-to-vigorous intensity, with at least one rest day between sessions.

Outcome measurements will be performed immediately before (baseline), after (post) 12 weeks of training, and 6 months after the termination of the intervention period (follow up). This approach allows for assessment of the short term effects of exercise training as well as any residual effects from the training intervention on cardiometabolic risk, shoulder pain, indices of quality of life, and free-living physical activity

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years;
* chronic SCI (≥1 year since injury)
* individuals with sufficient sparing of arm function to participate in upper-body rowing (i.e. as a minimum excluding individuals with complete SCI at or above C5)
* using a manual wheelchair as a primary tool for mobility.

Exclusion Criteria:

* Individuals who regularly engage in \>150 min/week of moderate-to-vigorous intensity physical activity
* have received a cortisone injection in the shoulder within the last four months
* have had shoulder injury within the previous year
* known medical issues (urinary tract infections, cardiovascular contraindications for exercise testing, and pressure sores)
* diagnosed diabetes or any endocrine, heart, kidney, liver disease or any other disease that may limit the ability to perform exercise.
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma

Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated in China.The treatment is being from simplification to diversification,from entirety to individualization.Confronting small hepatocellular carcinoma,we not select simple operation treatment but select a treatment that have more predominance and more fitting with patients in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ? There are many arguments.

randomly put in group standard:

1. via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
2. age: 18-70 years.
3. early hepatocyte cancer，which is single focus of infection diameter ≤ 3 cm.
4. estimate tumor can gain treatment of curing operation or TACE plus PEI.
5. better liver function (Child-Pugh，class A or B).

Case loads: 160 residents with small hepatocellular carcinoma in China

Therapeutic regimen: under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.

Research end-point:

1. ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and TACE plus PEI for small hepatocellular carcinoma
2. intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor life span

Telephone call at any time

Eligibility Criteria:
Inclusion Criteria:

1. via clinical diagnosis and confirm it is primary liver cancer, and not accept any anticancer treatment.
2. age:18-70years
3. early hepatocyte cancer，which is single focus of infection diameter ≤3cm.
4. estimate tumor can gain treatment of curing operation or micro-create treatment combineation
5. better liver function (Child-Pugh，class A or B)

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance;
5. serious heart、lung、kidney disease.
Sophrology and Congenital Heart Disease

The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease.

Investigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.

Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population.

Our recent randomized trial in a population of children and adolescents with asthma showed that sophrology improve lung function (NCT02114398). Sophrology, from the Greek "study of consciousness in harmony", is an adjuvant therapy, considered in healthcare as a relaxation technique, mainly based on breathing.

Investigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate in a program of sophrology with structured group sessions will improve their exercise capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 13 to 25 years old
* With a congenital heart disease (CHD) as defined in the international anatomic and clinical classification (ACC) - CHD classification.
* Informed consent from adult patients or parents/legal guardians for minor patients

Exclusion Criteria:

* Medical contraindication to perform an exercise test.
* Patient already included in a clinical trial.
* Cardiac surgery planned during the study
* Severe intellectual disability that does not allow practice of sophrology exercise or questionnaires to be completed .
The Study of Genes Localization for Female Pelvic Floor Dysfunction

Female pelvic floor dysfunction (FPD) is due to defects in the pelvic support structures, degradation, damage or dysfunction. The main problem of which is pelvic organ prolapse(POP), urinary incontinence(UI) and genital tract injury. Although it does not pose a serious threat to life, but affect the patient's quality of life seriously in the physical, psychological, social behavior and other aspects. With the growing aging population, the incidence rate has gradually increased, and increasing demands for people's quality of life simultaneously, more and more attention was raised to PFD as common chronic diseases.

In recent years, the basic research, epidemiology, prevention, diagnosis and treatment of PFD have made great progress, especially in developing gynecological urology theory and reconstructive pelvic surgery. But overall the basic research of PFD is lagging behind, especially susceptibility gene localization and functional studies did not get enough attention.


Eligibility Criteria:
Inclusion Criteria:

1. female aging from 30 to 70-year old;
2. preoperative diagnosis of gynecologic malignancies;
3. have the ability to comply with Research programs;
4. voluntarily participate in the study and signed an informed consent form

Exclusion Criteria:

1. patients with severe cardiovascular diseases, kidney, liver and other vital organs diseases, bone marrow disease and mental illness;
2. patients suffering from autoimmune diseases;
3. patients with acute infectious disease or infection early phase of infection;
4. patients with urinary tract infection;
5. patients with infection or erosion of ano-genital skin;
6. for any other reason, the researchers considered unsuitable for inclusion.
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

This is a multi-center, international study designed to collect clinical, genetic and quality of life information on females with hemophilia, an inherited bleeding disorder. The study is designed to determine whether there are problems and issues unique to females with hemophilia.

The study involves two questionnaires: one on the diagnosis, symptoms, complications and treatment of each participant to be completed by a staff member; the other is a questionnaire to be completed by the participant on how the disease has affected her life. Finally, for those participants who have not previously had genetic testing, the third part of the study is an optional blood test to determine the genetic cause, what change in the factor VIII or factor IX gene, caused the hemophilia. The test results will be available to those participants who wish to learn their results. With the data we collect we will compile a database to examine the connection between the genetic cause of hemophilia and the course and symptoms of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Females with severe (FVIII\<0.01u/ml) or moderate (FVIII 0.01≤0.05 u/ml) hemophilia A
* Females with severe (FIX\<0.01u/ml) or moderate (FIX 0.01≤0.05u/ml) hemophilia B
* Willingness to participate in the study.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.
Homocyst(e)Ine, Vitamin Status, and CVD Risk

To test the hypotheses that the risk of myocardial infarction and/or stroke is associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

BACKGROUND:

Elevated plasma homocyst(e)ine is a risk factor for vascular disease in middle-aged men. Supplementation with folate, and to some extent vitamins B12 and B6, can reduce plasma homocyst(e)ine levels. There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lp(a) may be greatly enhanced by homocyst(e)ine. The high prevalence of low levels of folate and vitamins B12 and B6 among the elderly in the United States has led to the hypothesis that a substantial portion of cardiovascular morbidity and mortality among older persons could be prevented by increasing intake of these nutrients to reduce plasma levels of homocysteine. Little is known, however, regarding the relationship of homocysteine, folate, B vitamins, and Lp(a) to cardiovascular disease among the elderly, among whom CVD represents the leading cause of morbidity and mortality.

DESIGN NARRATIVE:

In this ancillary study to the prospective Cardiovascular Health Study (CHS), a case-cohort design was used to test hypotheses that the risk of myocardial infarction and/or stoke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6. Further, a determination was made whether elevated plasma levels of homocysteine and Lp(a) interacted to increase substantially the risk of myocardial infarction and/or stroke above that due to either factor alone. The sub-cohort was used to study the relationship between the factors under study and progression of sub-clinical atherosclerosis. For each case and sub-cohort member, an aliquot of fasting plasma drawn at baseline was analyzed for homocysteine, folate B12, and B6 concentrations. \[Values of plasma Lp(a) were determined at baseline.\] Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction and/or stroke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

Eligibility Criteria:
No eligibility criteria
Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects

This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
* Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
* A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry)
* Not able or willing to refrain from smoking during the inpatient period
Artificial Intelligence as a Decision Making Tool in Neurology

Background: The establishment of neuroinformatics as a distinct field has enabled the integration of computational biology and informatics to improve neurological research. This interdisciplinary approach enhances the capacity to integrate diverse datasets, unravel complex neural networks, and develop computational models that can improve clinical management. The investigators aim to evaluate whether an artificial-intelligence-based tool is effective in non-English-speaking regions.

Hypothesis: Integrating a language model-based clinical assistance system within the neurology ward will significantly enhance the efficiency and accuracy of patient care by leveraging neuroinformatics principles. The investigators hypothesize that combining natural language processing and data analytics will improve diagnostic and treatment processes.

Research Design:

A pre-post-intervention design will be used, measuring outcomes before and after the implementation of a neuroinformatics-driven clinical assistance system. Changes in diagnostic accuracy, treatment decisions, and workflow efficiency will be quantified.

Workflow:

1. A neurologist evaluates each patient, and the patient signs informed consent.
2. A medical student manually uploads de-identified clinical information to a secure interface.
3. Data are analyzed by a large language model (LLM) system through a hospital-approved application.
4. A senior physician must approve any decision based on the LLM's recommendation.
5. For half of the prospectively enrolled participants, the LLM's recommendation is presented to the resident.

Retrospective Data:

1. The investigators will extract data from 10,000 patients who were evaluated by a neurologist in the Emergency Department.
2. Clinical information (without patient identifiers) will be uploaded to a secure, hospital-approved LLM with a security key.
3. The model's output will be compared with actual clinical decisions and patient outcomes (e.g., mortality, discharge status).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* Unable to give informed consent
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 20 and 80 years
* having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach
* having Barrett's Esophagus proven by histology confirmation
* length of esophageal metaplastic mucosa equal to or longer than 1 centimeter

Exclusion Criteria:

* pregnancy,
* coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia)
* previous gastric surgery,
* allergic to esomeprazole,
* presence of dysplastic esophageal mucosa
* equivocal endoscopic diagnosis of Barrett's esophagus
A Clinical Study of Tobradex AF

The purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring cataract surgery

Exclusion Criteria:

* Age related
High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study

The investigators hypothesize that while the extremely low birthweight (ELBW) infants (\<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with HFNC while getting coparable respiratory support to NIMV.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight \>1000 g for the initial treatment of RDS or \<35 weeks post extubation or for apnea of prematurity
2. Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.

Exclusion Criteria:

1. Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus \[PDA\]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH),
2. Parents refuse consent.
3. Unavailability of suitable ventilator.