cyrilzakka/clinical-trials huggingface dataset:
Esmolol Versus Dexmedetomidine During Intracranial Procedures

Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA physical status 1-3
* Glasgow Coma Scale:13-15
* Hunt-Hess: 0-3

Exclusion Criteria:

* Patients with ASA physical status \>3,
* Body Mass Index (BMI) over 30,
* indication for rapid sequence induction,
* any contraindication for receiving b-blocker,
* Glasgow Coma Scale (GCS) \<13,
* history of drug abuse,
* neurologic deficit or preoperatively foreseen delayed extubation,
* preoperative heart rate\<45.
Study on Effect of Robotic Versus Laparoscopic Surgical Technology on Genitourinary Function After Total Mesorectal Excision for Rectal Cancer

Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.


Eligibility Criteria:
Inclusion Criteria: (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3

Exclusion Criteria: Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score \<10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.
Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial

Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.


Eligibility Criteria:
Inclusion Criteria:

* Having a plasma tHcy \>10 micromol/L
* Not suffering from conditions as described in exclusion criteria.
* Vegetarian for at least one year.
* Not participating in a weight reducing diet.
* Not consuming regularly vitamin B12 supplements.
* Give written consent to participate in clinical trial and be fluent in English language.

Exclusion Criteria:

* Having a plasma tHcy less or equal to 10 micromol/L.
* Suffering from pernicious anemia or other vitamin B12 deficiency disease.
* Undergone bowel surgery or suffer from gastrointestinal disease.
* Pregnant, lactating or trying to conceive.
* Smoker.
* Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male).
* Consume large amounts of caffeine (regular consumption of \>4 cups of strong tea or coffee per day).
* Use of medications known to influence nutritional status.
* Have genetic metabolic disease.
* Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer.
* Have a known blood-borne infection (e.g. Hepatitis or HIV).
Comparing Patient Satisfaction With Pataday or Bepreve

The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).

5 week randomized study with 15 subjects using Pataday qd for 2 weeks, and the other 15 subjects using Bepreve BID for 2 weeks. Following a one-week washout period, the two groups are given the opposite test article (TA) for 2 weeks. Subjects to complete daily diary regarding effects of drug and are seen in clinic for 3 exams.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female subjects of any racial/ethnic group.
* Be at least 18 years of age or older.
* Have a diagnosis of allergic conjunctivitis with active symptoms, with no concurrent ocular allergy associated conditions and no plans to have ocular surgery during study period.
* Willing and able to return for all required visits and follow instructions from investigator and staff.
* Able to self-administer test article (TA) or have a caregiver available to instill all doses of TA.
* If a woman, capable of becoming pregnant, agrees to have pregnancy testing performed at screening (must be negative) and agrees to use a medically acceptable form of birth control (intrauterine device, birth control pill, patch or subcutaneous implant, condoms, diaphragm, and abstinence) throughout the study duration and for at least one week prior to and one week after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
* Sign and date the informed consent form approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
* Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff, and to complete and return the Screening and Subject Diaries.

Exclusion Criteria:

* Have known hypersensitivity to BEPREVE or PATADAY or any of their components.
* Are actively taking steroids or antihistamines during the study or within 7 days prior to enrolling in the study.
* Are pregnant, planning to become pregnant, or nursing/lactating.
* Have a known history of alcohol or drug abuse.
* Participated in a study of an investigational drug or device within the past 30 days prior to enrolling in the study.
* Have a presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit.
* Have any significant illness {eg: any autoimmune disease, or severe cardiovascular disease (including arrhythmias)}that the Investigator feels could be expected to interfere with the subject's safety or study parameters and/or put the subject at anyh unnecessary risk.
Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years
* Eligibility for intravenous thrombolytic treatment (National Institute of Neurological Disorders and Stroke criteria)
* Permanent ischemic stroke confirm with encephalic MRI (Magnetic Resonance Imaging)
* Patient able of accepting protocol information
* Patient who received information about the protocol and had not expressed its opposition to participate

Exclusion Criteria:

* Pacemaker
* Surgical ferromagnetic clips
* Cochlear implants
* Intraocular metallic foreign body
* Iron implants or objects likely to concentrate the Radio Frequency field
* Claustrophobia
* Known intolerance to contrast media (DOTAREM)
* Pregnant women (Beta Human Chorionic gonadotrophin performed for biological assessment of thrombolysis)
* Patient with severe kidney with Glomerular Filtration rate \< 30 ml/min
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma

Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

Melanoma is a cutaneous cancer due to a proliferation of melanocytes. For metastatic cases the prognostic is poor (18% survival at 5 years). Few factors predict metastasis. Sleep Apnea Syndrome is involved in mechanism of carcinogenesis and aggressiveness markers of malignant cutaneous melanoma.

Hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tIIaN0M0 Study design: Adult patients with a Breslow's Thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. Patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. Patients with sleep apnea will be treated.

Standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral CT-scan and a lymph-node ultrasound every 6 months will be performed.

Sample size: based on previous data from the investigators showing that 25% of patients with a Breslow's Thickness ≥ 1mm will have node or visceral metastasis. For an alpha threshold of 5% and a study power of 80%, with 5% of dropouts, with the hypothesis that 40% of apnea syndrome patients will metastasis versus 20% in the control group the study should include 83 patients in each group.

Statistical analysis: an intermediate analysis after 80 included patients will be performed. Peto method will be followed, results will be considered significant with a p≤0.001 and the study will be stopped.

Normality of data will be checked by Kurtosis and Skewness tests, variance equality will be tested with the Leven test. The significance level will be set at 5%.

Eligibility Criteria:
Inclusion Criteria:

* adults hospitalized in the dermatological unit for the initial consult for a melanoma with a Breslow's Thickness ≥ 1mm

Exclusion Criteria:

* pregnant women
* Institutionalized patient
* patients with metastasis in the lymph node or any organ at the time of the first consult
* patients with another neoplasia requiring treatment other than surgery in the last 5 years
* patients with creatinine above 200µmol/ml or clearance below 30ml/min
Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Clinical Early Stages of Non-small Cell Lung Cancer

Randomized Phase III trial of surgery alone or surgery plus preoperative Gemcitabine-Cisplatin in clinical early stages of non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with early stage NSCLC
Difference Between Patient Vaccine Hesitancy and Perception by Their Family Physician of Their Vaccine Hesitancy

The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation:

* for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale)
* for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other.

The investigators will ask to a patient and his/her family physician to complete in parallel a brief questionnaire at the beginning of the consultation:

* for the patient: self-evaluation of his/her vaccine hesitancy (with a 0-100 scale)
* for the physician: evaluation of this patient vaccine hesitancy (on the same 0-100 scale) Each of these 2 questionnaires should be filled blindly from the other.

The investigators will recruit 400 to 500 patients in 20 medical practices of general practioners.

Eligibility Criteria:
Inclusion Criteria:

* visiting the family physician
* accepting the study after information

Exclusion Criteria:

* none apart from the reverse of inclusion criteria
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.

The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.

Eligibility Criteria:
Inclusion Criteria Summary:

* Be between 18 and 60 years of age
* Have evidence of degenerative disc disease (DDD)
* History of back and/or radicular pain which is severe, ongoing and recurrent
* Minimum 6 month period of prior conservative care
* Moderate Oswestry Disability Index score
* Moderate pain score
* Be likely to return for all follow-up visits
* Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria Summary:

* Any back or leg pain of unknown origin
* Foot drop
* Previous trauma to the study treatment level with compression or bursting
* Previous retroperitoneal surgery
* Other spinal surgery at affected level except IDET, laminotomy
* Previous thoracic or lumbar fusion
* Documented abnormal abdominal vessel or muscular/fascial pathology or morphology
* Degenerative spondylolisthesis
* Ischemic (spondylolytic) spondylolisthesis
* Spondylitis
* Documented significant spinal, foraminal or lateral stenosis
* Severely reduced disc space height
* Documented presence of free nuclear fragment
* Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
* Scoliosis of the lumbar spine
* Metabolic bone disease
* Active systemic infection
* Hepatitis
* Active malignancy or history of metastatic malignancy
* Any terminal or autoimmune disease
* Any other disease, condition or surgery which might impair healing
* Recent history of chemical or alcohol dependence
* Current or extended use of any drug known to interfere with bone or soft tissue healing
* Known metal allergy
* Morbid obesity
* Transitional vertebrae at level to be treated that has not clearly fused
* Currently a prisoner
* Currently involved in spinal litigation
* Currently experiencing an episode of major mental illness
* Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
* Participation in another drug, diologic or medical trial within 30 days of study surgery
* Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.
Preoperative Strength-resistance Training in Valvular Heart Disease Patients

Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. CVD is the leading cause of mortality worldwide, representing 31% of deaths. In Spain, CVD caused 24% of all deaths in 2020. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay.

The purpose of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce ICU length of stay, postoperative complications, and hospital length of stay (LOS). Additionally, the secondary objective is to determine whether a program that includes RT in addition to respiratory and aerobic training can have better effects on ventilatory variables.

This study follows the protocol of a prospective, parallel, non-randomized clinical trial. Ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. The control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. The experimental group, in addition, will receive RT targeting peripheral muscles. Variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. Quantitative variables will be analyzed using a t-test or ANOVA, or Mann-Whitney test if the distribution is non-parametric.


Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with valvular pathology who have been admitted as candidates for cardiac surgery for the first time, and who have been scheduled for surgery

Exclusion Criteria:

* stage 4 or 5 renal failure, low ejection fraction, Euroscore greater than 15 (Nashef et al., 2012) , non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary artery disease, or need for urgent intervention
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 6 months to 18 years.
* Those who was born after normal pregnancy period(37 weeks) for aged 6 months to \< 1 year
* Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Exclusion Criteria:

* Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
* Subjects with immune deficiency disorder or malignant cancer.
* History of Guillain-Barre syndrome.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day.
* Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
* Subjects who had received blood products or immunoglobulin within 3 months before screening.
* Subjects who had received influenza vaccination within 6 months prior to the screening.
* Subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination.
* Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
* Subjects with clinically significant chronic disease.
* Pregnant women, breast-feeding women.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.