cyrilzakka/clinical-trials huggingface dataset:
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity

Recent studies estimated that 15 to 20% of all cancers in humans are associated with viruses. Among oral cancer about 90% are oral squamous cell carcinomas (OSCC). Alcohol and tobacco consumption have been recognized for years as the main risk factors for development of OSCCs. However, 10 to 20% of patients suffering from OSCCs are non-smokers and/ or non-drinkers. Consequently, the hypothesis of another agent responsible has risen. Indeed, several studies have suggested the possibility that a virus could be associated with or be a causal agent of OSCC. The first objective is to detect and characterize the presence of infectious agent (mostly virus) transcripts in pre-malignant or malignant tumours from patients with OSCCs.The secondary objectives are (i) to associate and (ii) if possible define a causality link between these agents and a subset of potentially malignant disorders and/or OSCCs.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years,
* For subgroup "potentially malignant disorder : clinical diagnosis of leukoplakia,
* For subgroup "OSCC" : histological diagnosis of OSCC,
* Patient who never smoked, or light smoker, (≤5 pack-year) or 15 years of cessation,
* Patient who never drank, or light drinker (≤ 20 g/day for men and 10g/day for women) or 15 years of cessation,
* Informed consent signed.

Exclusion Criteria:

• Previous treatment of oral cancer,
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5-55 years (inclusive) of either gender.
* Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
* Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
* Biochemical and haematological test values as follows:

  * Haemoglobin \> 5.0g/100mL
  * White blood cell count \> 1 x109/L
  * Platelet count \> 50 x 109/L
  * AST, ALT and alkaline phosphatase \< 3 times upper normal limit
  * Prothrombin time \< 5 seconds above control
  * Serum creatinine levels within normal limits
  * Serum potassium levels within normal limits
* HIV negative

Exclusion Criteria:

* A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
* Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
* An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
* Proteinuria (\> 2+).
* A history of allergy or hypersensitivity to aminoglycosides.
* A history of major surgery within the last two weeks.
* Pregnancy or lactation. \[Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.\]
* Previous treatment for VL within two weeks of enrolment into the study.
* Prior treatment failures with paromomycin or amphotericin B.
LC-Smart: A Deep Learning-Based Quality Control Model for Laparoscopic Cholecystectomy

Objective: Critical view of safety (CVS) is a successful technique to reduce bile duct injury during laparoscopic cholecystectomy (LC). We aimed to create a deep learning-based quality control model for LC and reduce the learning curve for junior surgeons, which would automatically assess whether surgeons are CVS conscious during procedures.Methods: We retrospectively collected 308 LC videos from public datasets (Cholec80, Endoscapes) and Sun Yat-sen Memorial Hospital. Video frames were labeled using binary classification and feature optimization methods, such as black border clipping and sliding windows. Two neural networks, ResNet-50 and EfficientNetV2-S, were trained and evaluated based on F1 scores and accuracy. Additionally, We created an online CVS recognition system (LC-Smart), tested it using 171 films from two hospitals, and compared the results to two local senior doctors.


Eligibility Criteria:
Inclusion Criteria:

* complete video data with no missing footage;
* surgical procedure identified as laparoscopic cholecystectomy;
* full visibility of the surgical area in the video;
* successful completion of the procedure;
* absence of significant anatomical variations
* video resolution no less than 720×560.

Exclusion Criteria:

* substantial intraoperative adhesions
* a history of previous abdominal or pelvic procedures
* a conversion to open surgery during the procedure
* significant bleeding that obscured structural identification.
Observational of Emergence Time Between Patients Receive General Anesthesia With BIS or Spectrogram EEG Monitor

The bispectral index parameter is used to guide the titration of general anesthesia, however; conflicting results between different studies cannot prove the benefit of EEG monitor on improvement of OR efficiency. Next Generation SedLine features an enhanced signal processing engine, which provides processed EEG parameters. This four channel EEG monitor for the monitoring of perioperative anesthesia depth prevent overdose of medication and may help for individualized anesthetic plan. This research intended to observe the emergence time from end of the surgical wound closure to patient awake (or to extubation) with or without SedLine.

This is a clinical observation study. Inclusion criteria are patients with ASA 1-3, age over 20 who need general anesthesia surgery without other neurologic disease. All inclusions will receive the general anesthesia with SedLine monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG monitor signal. The Controls were patients with same criteria without BIS monitor. Sample size was decided if the estimated difference between SedLine group and BIS group are 1 minute and the average estimated as 2 minute. With 80% desired power and default is .05, each group will need 63 cases.

Eligibility Criteria:
Inclusion Criteria:

* patients who need routine general anesthesia
* have no neurological problem
* have no dermo issue over forehead area
* not allergic to the patch

Exclusion Criteria:

* patients who is not agreed
Predictors of Bariatric Surgery Weight Loss

The aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort.

The study aims to answer the following question on whether the prevalence of disordered eating is higher in individuals that are candidates of bariatric surgery compared to the general population with obesity.

Participants referred to Jaber Al Ahmad Al Sabah Hospital, Hawalli, Kuwait, for bariatric surgery were consecutively screened for the study.

A cross-sectional analysis was performed on a subgroup of this cohort with complete baseline data. The analysis investigates the influence of psychological factors associated with obesity before bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Obesity BMI \> 30 kg/m2
* 18 years and older

Exclusion Criteria:

* BMI \< 30 kg/m2
Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes

The purposes of the study are

* to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients
* to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life
* to assess what kind of intervention induces highest effects in long term persistence of these positive changes

Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69).

Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions.

Eligibility Criteria:
Inclusion Criteria:

* diagnoses of type 2 diabetes (ADA criteria)
* admitted diabetes treatments will be diet and oral hypoglycemic agents

Exclusion Criteria:

* sports intervention \>60 minutes per week
* medical conditions
* preproliferative or proliferative retinopathy
* instable coronary heart disease
* inability to perform the scheduled physical activity programs
* acute clinically significant intercurrent diseases
Organ Protective Effect of Cetirizine In Patients With Severe Burns

This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.

This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Commitment to comply with the procedures and cooperation during the course
* TBSA \>30% and admitted within the first day after burns
* No severe compound injuries

Exclusion Criteria:

* History of allergy to drugs in the trial
* Postoperative complications that would interfere with the observation
* Mental illness and severe heart disease, hypertension
* Serious genetic diseases
* Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.)
* Pregnancy/lactation
* Malignant tumors
* Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors
* Serious adverse reactions
* Self-requested withdrawal
Chronic Sleep Restriction

Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index ≤ 25 kg/m2
* Physically active individuals
* 8 years of school education.

Exclusion Criteria:

* High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35
* High level of anxiety - Beck Depression Inventory ≥ 19
* PSQI - Pittsburgh Sleep Quality Index ≥ 11
* ESS - Epworth Sleepiness Scale ≥ 15
* Irregular rhythm of sleep identified by actigraphy
* Sleep disturbance by polysomnography
* Shift worker or nocturnal worker;
* Obesity;
* Smoker;
* Alcohol Intake of more than 3 drinks per day;
* Taking sleep medications or illicit drugs.
Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures

Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. This study will use magnetic resonance imaging (MRI) procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure.

CAD is the most common type of heart disease in the United States. It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries. Over time, less blood is able to flow through the arteries, depriving the heart of the blood and oxygen it needs. If left untreated, CAD can lead to heart failure, heart attack, and arrhythmias. Someone with plaque build-up may undergo a percutaneous coronary intervention (PCI) to unblock the narrowed arteries and increase blood flow. PCI encompasses a variety of procedures, including balloon angioplasty and stent placement. In balloon angioplasty, a small balloon is inserted into the heart artery and then inflated. This pushes the plaque against the artery walls and widens the artery. Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open. Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart, the tiny vessels of the heart may become blocked after these procedures, which may affect how the heart heals. This study will use MRI to examine heart function in people who have undergone PCI procedures. Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures, the factors that lead to the blockages, and how often blockages affect healing of the heart.

This study will enroll people who are undergoing a PCI procedure. Participants will undergo an MRI scan of the heart before and after the PCI procedure. During the 72 hours after the procedure, electrocardiogram (EKG) will be used to monitor heart electrical activity. At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later, participants will undergo an MRI, EKG, and blood collection. Study staff will call participants every 6 months for 5 years to collect medical information.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing diagnostic coronary angiography
* Undergoing percutaneous coronary intervention

Exclusion Criteria:

* Clinically unstable (i.e., demonstrates unstable cardiac rhythm or hemodynamics, supported on vasopressors or an intra-aortic balloon pump, and/or is actively ischemic) at the time of the MRI procedure
* Unable to undergo MRI procedure (e.g., has non-MRI compatible implanted metallic objects, including cardiac pacemakers or cerebral aneurysm clips that are not MRI compatible)
* Current glomerular filtration rate of less than 60mL/min/1.73m2
* Pregnant
Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

As docetaxel is proven to be effective in late stages of prostate cancer with a large tumour burden it should be effective in primarily treated intermediate and high risk prostate cancer as an adjuvant treatment after radiotherapy to prevent early relapse. This will therefore be tested in a randomised phase III trial where patients will be randomized either to docetaxel or surveillance

Primary endpoint:

* PSA progression rate, ASTRO guidelines.

Secondary endpoints:

* PSA doubling time after progression
* Quality of Life (QoL)
* Safety
* Metastases free survival
* Overall survival

Eligibility Criteria:
Inclusion Criteria:

* Men \> 18 and ≤75 years of age.
* WHO/ECOG performance status 0 - 1.
* Histological proven adenocarcinoma of the prostate within 12 months prior to randomisation
* One of the following:

  * T2 with Gleason score 7(4+3 ) and PSA \>10 ng/ml to \< 70 ng/ml
  * T2 with Gleason 8-10, any PSA \< 70 ng/ml
  * any T3 tumour
* Prior neoadjuvant hormone therapy is mandatory for all patients
* Adequate haematological-, liver- and kidney function. (Hemoglobin \> 110 g/l, neutrophils \> 1.5 x 109/ l, platelets \> 150 x 109/ l, ASAT and ALAT \< 1.5 x ULN, ALP \< 1.5 x ULN, creatinine \< 1.5 x ULN)
* Written informed consent

Exclusion Criteria:

* M+
* N+ clinical or pathological
* Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past five years.
* Previous radiotherapy to the pelvic region.
* Previous chemotherapy within 5 years.
* Systemic corticosteroids within 6 months prior to randomisation.
* Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
* Active untreated infectious disease, including tuberculosis, MRSA.
* Active gastric ulcer.
* Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
* Other serious illness or medical condition
Beverages and Societal Health

The overall aim of the study is to compare the effects of three types of beverages - sugar-sweetened (SSB), artificially sweetened (ASB), and unsweetened (USB) - on cardiovascular disease (CVD) risk factors and body weight among young adults.

Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of body weight, risk for diabetes and cardiovascular disease. With rising public health awareness of these potential adverse effects, consumption of artificially sweetened beverages (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the implication that they promote weight loss and improved health. However, there are no long-term experimental studies of ASB and body weight or any other health outcome. Several recent prospective observational studies have linked intake of ASB to increased risk of the metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage for 1 year, using methods that build upon previous successful work. Careful attention will be given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of experimental confounders. The primary study endpoint will be the ratio of serum triglyceride to HDL-cholesterol concentrations. Secondary endpoints will include changes in other cardiovascular disease risk factors, body weight, dietary quality, and taste preferences.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 40 years
* Consumption of at least 12 fluid ounces of sugar-sweetened beverage per day
* Willingness to consume types of beverages consistent with group assignment
* Body mass index (BMI) ranging from 18.5 - 40 kg/m2, and body weight ≤275 pounds
* Access to a working telephone or cell phone

Exclusion Criteria:

* Intention to move away from the greater Boston area during the projected period of study enrollment (i.e., 1 year post-randomization)
* Plans to be away from home for 5 weeks or longer during the study period (e.g., moving away from the greater Boston area during the summer)
* Physician diagnosis of a major medical illness, eating disorder, or phenylketonuria (PKU)
* Chronic use of any medication that may affect one or more study endpoints
* Impaired fasting glucose (IFG, fasting blood glucose ≥110 mg/dL)
* Current moderate or heavy smoker (\>10 cigarettes per day)
* Another member of the family (i.e., first degree relative) or household participating in the study If female,
* Pregnant in the past 12 months or planning to become pregnant during the study period
* Lactating in the preceding 3 months
* Change in birth control medication in previous 3 months or plans to change during the study period