cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme.

The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).

On a population of patients undergoing minimally invasive lumbar spine surgery divided into two cohorts of equal size according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme:

Primary objective To compare the percentage of therapeutic success achieved in each group one month after surgery.

Secondary objectives: to compare between groups:

* Postoperative pain intensity at D1 and M1
* Analgesic consumption (in stages) at D1 and M1
* Pain-free walking distance at M1
* Surgery conditions (duration of operation, duration of hospitalisation)
* Frequency of adverse events related to surgery (infection rate, 1 month recovery rate, transfusion requirements)
* Emotional impact of the management

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (18 years or older)
* Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
* Patient for whom a minimally invasive spine surgery is planned: (dicectomy, lumbar canal recalibration with or without laminectomy, lumbar arthrodesis by posterior approach limited to one stage)

Exclusion Criteria:

* Patient with a contraindication to spinal anaesthesia
* A bedridden or institutionalised patient
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient not affiliated to the French social security system
* Patient under legal protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol
Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to understand and willing to sign the informed consent form (ICF).
* All patients should aged 14 to75 years,no gender limitation.
* Patients who are newly diagnosed with AML.
* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
* Renal function: creatinine ≤the upper limit of normal;
* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
* Patients without severe allergic constitution.

Exclusion Criteria:

* Patients with allergy or contraindication to the study drug;
* Female patients who are pregnant or breast-feeding.
* Patients with active infection
* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
* Patients with mental illness or other states unable to comply with the protocol;
* Less than 6 weeks after surgical operation of important organs.
* Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal;
* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes

The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.


Eligibility Criteria:
Inclusion Criteria:

* Macular hole with any of following condition

  * High myopia (spherical equivalent ≤ -6.0 Diopters)
  * Large size macular hole (Diameter \> 600 microns)
  * Recurred or failed macular hole from previous surgery
  * Chronic macular hole (symptom duration \> 6 months)

Exclusion Criteria:

* Systemic infection
* Hematologic disease
* Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration
Human Bronchial Microdialysis in Open Aortic Aneurysm Repair

Elective open aortic aneurysm repair has an overall reported 30 day mortality of 2-6 percent, but in patients more than 65-70 years the mortality is reported to be more than 10 percent. The phenomenon of acute lung injury (ALI)/adult respiratory distress syndrome (ARDS) after infra renal abdominal aneurysm repair caused by ischemia-reperfusion is well established. The degree of disability varies from a light degree of acute respiratory failure to mortality for patients with the same profile of risk.

Primary aim is to develop a model that monitors inflammatory marker molecules collected from the bronchial epithelial lining fluid by microdialysis. The method with examination of the bronchial epithelial lining fluid by microdialysis and analysis of multiple inflammation markers as previously done by the investigators group.


Eligibility Criteria:
Inclusion Criteria:

* Patients assigned for elective open aortic surgery

Exclusion Criteria:

* Moderate to severe COPD
Effect of Ivabradine on Exercise Capacity After Heart Transplantation

This study evaluates whether treatment with ivabradine compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest.

Patients will receive treatment with either ivabradin or placebo for a period of 12 weeks.

Elevated resting heart rate (HR) is a normal finding after successful heart transplantation (HTx) due to parasympathetic denervation at the operation.

Elevated resting HR is generally acknowledged as a negative predictor of outcome in heart disease. The impact in heart transplant recipients is not fully understood, however, it has been associated with increased risk of developing cardiac allograft vasculopathy (CAV) or death.

Cardiac allograft vasculopathy is a diffuse vascular disease affecting the entire coronary tree. It is the leading cause of death in patients more than 5 years after HTx and it is well known that patients with CAV have markedly reduced exercise capacity.

The association between elevated HR and CAV raises the question whether an intervention to specifically lower HR could improve symptoms and prognosis in heart transplant recipients with CAV and elevated resting HR.

Small studies have shown that HR reduction using the If channel blocker ivabradine after HTx is safe. However, none of these studies were randomized or blinded, and as such proof of any efficacy (beyond HR reduction) after HTx is non-existing. Clearly, there is a need to determine if such treatment could improve exercise capacity, graft function and prognosis after HTx.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 1 year post heart transplantation
* CAV verified by coronary angiography or intravascular ultrasound
* Resting HR \> 80 bpm
* Age \> 18 years
* Signed informed consent

Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will be required to provide a negative urine human chorionic gonadotropin (hCG) before entering the study and must use a safe birth control method in the total study period.

Exclusion Criteria:

* Rejection (\>H1R) \< 3 months
* Severe renal failure (estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2)
* Inability or contraindication to perform a VO2 max test
* Presence of any condition that might per se influence exercise performance
* Known contraindication for treatment with ivabradine
* Hypersensitivity to the active substance or to any of the excipients of either study drug
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent.


Eligibility Criteria:
Inclusion Criteria:

1. Audlt patients ( ≥ 18 years old);
2. elective valve surgery under cardiopulmonary bypass;
3. Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).

Exclusion Criteria:

（1）Low body weight (male: \<50 kg;Female: \< 45kg);（2）preoperative shock；（3）myocardial infarction within 3 months before surgery；（4）ischemic heart disease;Left main coronary artery stenosis \>70%;Severe aortic stenosis (area \< 0.7cm2);Severe changes in left ventricular function (ejection fraction \<30%, requiring vasoactive agents to assist circulation);（5）uncontrolled hypertension;（6） severe carotid artery stenosis (\>70% or with symptoms);（7） kidney failure (blood creatinine level \>442 mmol/L) or dialysis treatment;（8） serum albumin level (ALB) is less than 25 g/L.（9） international standardized ratio (INR) \>1.5 or platelet count \<100 103/mm3;（10）Inherited/acquired coagulation function defect;（11）preoperative preparation platelet;（12） contagious or infectious diseases;（13） patient or family members refused to participate in research;（14）refused to infusion of autologous blood or allogeneic blood products
Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma

This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.

The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumors or relapses/refractory non-Hodgkin's lymphoma confirmed by histology or cytology
* Has at least one measurable lesion (solid tumor according to RECIST v1.1 criteria, non-Hodgkin's lymphoma according to Lugnao criteria)
* ECOG score of 0 or 1;
* Expected survival time ≥ 3 months (at the discretion of the investigator);
* Adequate organ and bone marrow function;
* Voluntarily sign the informed consent form;

Exclusion Criteria:

* Has central nervous system primary malignant tumor, active epileptic seizure, spinal cord compression or carcinomatous meningitis
* The previous anti-tumor treatment has not passed the prescribed washout period
* HIV antibody is positive, or with other acquired/congenital immunodeficiency disease, or with history of organ transplantation;
* Active hepatitis B or hepatitis C virus (HCV) antibody was positive;
* Patients who are pregnant or lactating;
* Known or suspected hypersensitivity to the study drug or its pharmaceutical excipients (including mono-hydrate citric acid, sodium di-hydrate citric acid, mannitol, polysorbate, arginine, succinic acid);
* Any active autoimmune disease, or known history of autoimmune disease, or syndrome requiring systemic steroids or immunosuppressive medications (other than controlled thyroid disease with alternative therapy/non-immunosuppressive therapy);
* Participation in another therapeutic or interventional clinical study in the meantime;
* Other circumstances where the investigator considers it is not appropriate to participate in the study.
Exeantide in Type 2 Diabetes on Insulin

Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.

The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 20-75 years of age inclusive.
* Type 2 diabetes
* On insulin therapy
* HbA1c ≥7.5% and ≤ 9%
* BMI ≥ 30 kg/m2
* Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.

Exclusion Criteria:

* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
* Pregnancy
* Hepatic disease (abnormal LFT's)
* Use of DPP4 inhibitors.
* Renal impairment (serum creatinine \> 1.5)
* Participation in any other concurrent clinical trial
* Any other life-threatening, non-cardiac disease
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure.
* Use of an investigational agent or therapeutic regimen within 30 days of study
Study of Biological Effect of Tarceva (OSI-774) for Patients Stricken by ENT Epidermoid Carcinoma

The purpose of this study is to evaluate the biological effect of Tarceva (OSI-774) from an inhibition of EGF tumor receptor tyrosine kinase activity's point of view, for patients who are carriers of head and neck epidermoid carcinoma.

Patients will receive Tarceva in continuous between 18 and 28 days after pan-endoscopy exam until surgery

Eligibility Criteria:
Inclusion Criteria:

* Neck and head epidermoid carcinoma histologically proved. Patient with an ENT epidermoid tumor can be included in the study if this relapse is located in an area not irradiated yet.
* At least tumor classified T2NXM0
* Patient who can be picked up in a first surgery with a curative purpose or who must have a necessity's surgery (cervical curettage for voluminous adenopathies before radiotherapy)
* Patient without clinical or radiological sign of metastatic disease
* Good general status (OMS ≤ 2)
* Patient able to ingest food.
* Age ≥ 18 years
* Well-informed written consent, signed by the patient.
* Patient with sickness benefit

Exclusion Criteria:

* Patient with relapse ever treated by radiotherapy
* Other prospective study's participation
* Recent and massive digestive haemorrhage
* Medical contra-indication like main general status alteration, uncontrolled serious infectious disease, main uncontrolled metabolic anomaly ongoing.
* Pre-existent pulmonary pathology (BPCO, pleurisy, lymphangitis, interstitial syndrome)
* Severe cardiac pathology (stage 3 or 4 cardiac insufficiency, unstable angina pectoris, uncontrolled arrhythmia, myocardium's infarction antecedent during the year that precede the inclusion.
* Ophthalmic pathology antecedent concerning the ocular surface or lens-carrier
* Concomitant administration, by local or general tract, of drug responsible for ocular drought or which could delay the epithelial cicatrization
* Less than 1000 polynuclear neutrophil leucocytes or less than 75000 blood-platelets at inclusion
* Bilirubin at higher concentration than one point five times the normal
* Renal insufficiency (glomerular filtration flow ≤ 40 ml/min)calculated in accordance with Cockroft's formula
* Tacking of Beta blockers, amiodarone, NSAIDs, bleomycin, just before or during the study
* Pregnant or nursing women
* Patient under guardianship or trusteeship.
Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
* Sexual abstinence or use of safe contraceptive methods i.e. intrauterine devices, hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long acting injections), or surgically sterilized partner throughout the course of the study and until six days after the study has ended for the subject. Women who are postmenopausal (defined as no menstrual periods for 12 months or more prior to enrolment) can be included without use of contraceptive methods.
* Presentation of a negative urine human chorionic gonadotropin (hCG) urine pregnancy test prior to dosing (on both study days)

Exclusion Criteria:

* History of clinically significant urinary incontinence.
* Current acute or chronic condition, unless considered clinically irrelevant and stable by the investigator.
* Average systolic blood pressure \<100 mmHg or \>140 mmHg and/or average diastolic blood pressure \<60 mmHg or \>90 mmHg (average of three measurements performed at screening).
* Average pulse \< 40 or \> 100 beats/minute (average of three measurements performed at screening).
* Pregnancy within 6 months before screening and throughout the study period.
* Breastfeeding throughout the study period and 6 days after study day 2.
* Any systemic drug use within 2 weeks before first study drug administration (prescription drugs, over-the-counter drugs, herbal drugs and illicit drugs), except for occasional use of paracetamol (up to 4 g/day), hormonal contraceptives and hormone replacement therapy.
* Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months.
* Alcohol consume 24 hours prior to dosing.
* Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Implemented as a Special Investigation by Central Registration System

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered etanercept in order to be enrolled in the survey
* Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion Criteria:

* Patients who have been administered etanercept 50mg once a week
* Patients who have been administered etanercept 25mg once a week
Lidocaine Infusion for Postthoracotomy Pain Syndrome

This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery

Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases

Exclusion Criteria:

* (1)ASA classification status III or above
* (2)Body weight\<35kg
* (3)Liver cirrhosis
* (4)A history of previous thoracotomy
* (5)Pregnancy
* (6)Severe arrhythmia
* (7)Congestive heart failure
* (8)Opioid or steroid use 6 months before surgery
* (9)Allergy to lidocaine
* (10)Chronic pain syndrome (any type)
* (11)Emergency surgery
* (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders
The Necessity of Preoperative Bowel Preparation

Hemorrhoidectomy is an common treatment for high-grade hemorrhoids. The necessity of preoperative bowel preparation (PBP) in hemorrhoidectomy is inconclusive. This study aims to evaluate the benefit and safety of PBP in hemorrhoidectomy.

Hemorrhoidectomy is an effective treatment for high-grade hemorrhoids and is recommended in patients with grade III-IV hemorrhoids. Common hemorrhoidectomy approaches include stapled hemorrhoidopexy and conventional procedures, such as Ferguson hemorrhoidectomy and Milligan-Morgan hemorrhoidectomy. Conventional techniques produce a lower recurrence rate, whereas stapled hemorrhoidopexy is associated with fewer postoperative complications and shorter recovery time.

Common complications after hemorrhoidectomy include urinary retention, pain, and delayed hemorrhage. Surgical site infection is a rare complication after hemorrhoid excision. Traditional opinions held that preoperative bowel preparation (PBP) reduces fecal mass and bacterial count in the bowel lumen, minimizing the risk of infective and anastomotic complications. However, a study that evaluated intramucosal bacterial count demonstrated that PBP does not reduce the colon bacterial count. A randomized control trial (RCT) evaluating the effect of PBP before colorectal surgery suggested that the procedure can be omitted. However, another RCT with 79 participants revealed that bowel preparation before anorectal surgery can result in less pain during the first postoperative defecation. A meta-analysis with 36 studies concluded that PBP before elective colorectal surgery does not affect the postoperative complication rate. On the contrary, the necessity of PBP before anorectal surgeries remains unreported. The choice of whether PBP has to be performed is often the surgeon's preference. It may be challenging for physicians to determine the appropriate decision of PBP before hemorrhoidectomy to reduce postoperative complications while minimizing patient discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent hemorrhoidectomy

Exclusion Criteria:

* Patients who had received emergent or other anorectal surgery, such as fistulectomy, were excluded.