cyrilzakka/clinical-trials huggingface dataset:
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer

1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
2. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.

Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.

The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.

Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.

Exclusion Criteria:

* Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST \>50% over the normal range), and sepsis), morbid obesity (BMI \>40), anemia (hematocrit \< 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
* Patients will be excluded if they have poor English or French comprehension.
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions

The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.

First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.

Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.

All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.

CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* patients suspected to suffer from LPR
* Patients with laryngeal/hypopharyngeal lesions.

Exclusion Criteria:

* Patient refusal
* Patients with anatomical variants which precludes biopsy taking.
* Patients with allergy to lidocain-based local anesthesia agents.
Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer

The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.

Gastric cancer, as the second common malignant tumors in china, is marked by its poor prognosis and high recurrent rate. Although R0 resection could be achieved in most advanced gastric cancer(AGC) patients without metastasis, age-standardized 5-years survival rate was no more than 27.4%. Peritoneal metastasis accounts for 50% of the recurrent case and remain to be the most fatal recurrence pattern.

Hyperthermic intraperitoneal perfusion chemotherapy ( HIPEC ), has been proved as one of the most efficient approach against peritoneal carcinomatosis from gastric cancer and recommended in the guideline for gastric cancer published by the health committee of china. However, its role as prophylactic treatment after curative has never been determined. HIPEC works by delivering heat and cytotoxic drug to the cancer cell and is more effective on the tumor with small size. As present study suggest that Peritoneal metastasis is related to lymph node dissection during surgery while opening lymphatic channels and spreading viable cancer cells into the peritoneal cavity, HIPEC might be a reasonable approach to destroy the remaining cancer cells after curative surgery. Thus this research aim to explore the efficacy and safety of combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection.

Eligibility Criteria:
Inclusion Criteria:

1. First diagnosed as gastric cancer by pathological examination;
2. No previous chemotherapy or radiotherapy;
3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope;
4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1;
5. Informed consent signed;

Exclusion Criteria:

1. Other malignancy within 5 years.
2. Peritoneal metastasis detected during surgery.
3. Pregnant or lactating women;
4. Patients with conditions requiring emergency surgery;
5. Tumor progress during neo-adjuvant chemotherapy
6. Severe, uncontrolled physical or metal disease.
7. Poor compliance.
8. Uncontrolled infection
Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle

Over the last few years, it has been suggested that Knee Ostheoarthritis (KOA) incidence and progression could potentially be related to skeletal muscle characteristics. In particular, weakness of the quadriceps muscle would be a key determinant of KOA. However the mechanisms underpinning the influence of skeletal muscle in the pathophysiology of ostheoarthritis (OA) are poorly understood.

Crosstalk between skeletal muscle and structures around and in the joint is of interest. In physical deconditioning and aging, it has been reported that skeletal muscle can be replaced by adipose tissue. Several factors involved in the development of OA but also of adipose tissue may be involved in these muscular changes. Of interest, in patients with KOA, quadriceps weakness is an ubiquitous clinical finding. Infiltration of adipose tissue in skeletal muscle has been shown to affect muscle strength and mobility and be linked to cartilage volume loss and the occurrence/progression of KOA.

The main objective of this study is to compare the characteristics of the Hoffa tissus and the intamuscular fat (IMF) tissus in the quadriceps muscle in patients with gonarthrosis requiring total knee prosthesis.

This is a single-centre study based on a collection of surgical waste and is categorized as Research Not Involving Human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, aged between 40 and 85 years
* Patient having a confirmed diagnosis of knee ostheoarthritis
* Patient undergoing a surgery for a total knee prosthesis for knee ostheoarthritis

Exclusion Criteria:

-
Ultrasound Guided Epidural Block in Axial SPA

Study Design: A randomized, prospective, pilot, controlled trial. Setting: Rheumatology and rehabilitation department Minia University and Sohag University Objectives: To evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial SPA.

Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip), whereas Group II patients did not receive. Both groups were age and sex matched and both were under treatment with anti TNF and NSAIDs with or without sDMARDs.


Eligibility Criteria:
Inclusion Criteria:

* all participants fulfilled the ASAS criteria for axial SPA
* all participants under treatment including bDMARDS and sDMARDs beside NSAIDs

Exclusion Criteria:

* Naive patients not under treatment
* limitation of spine flexion due to non inflammatory causes
A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain

The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled.

Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre.

Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling.

All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women between 18 and 80 years old.
2. Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
3. Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
4. Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
5. Expected to stay at the hospital for at least 24 h.
6. Providing written informed consent for participating in this study.

Exclusion Criteria:

1. Use of NSAID within 12 hours prior to the first planned dose.
2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
3. Anaemia (haemoglobin \<10 g/dl) and/or history or evidence of asthma or heart failure.
4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
5. Pregnant or nursing.
6. Weight less than 40 kg.
7. History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
8. History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
9. Gastrointestinal bleeding that required medical intervention.
10. Platelet count less than 80.000 determined within the 28 days prior to surgery.
11. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
12. Severe renal failure (calculated creatinine clearance \< 60 ml/min).
13. Liver failure, ALAT or ASAT \>3 times upper limit of normality, or bilirubin \>2 g/dl.
14. Diagnosed of Bowel Inflammatory Disease.
15. Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects

This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) from ≥ 19 to ≤ 30 kg/m2
* Normal ECG, with no history or evidence of myocardial infarction, QT prolongation, or ventricular arrhythmias
* Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR)
* History of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to Screening
* Negative screening tests for drugs of abuse (including alcohol)
* Hepatitis B (HBV) surface antigen negative
* Hepatitis C (HCV) antibody negative
* HIV-1, 2 antibody negative
* Male subjects who are sexually active must be willing to use highly effective contraception from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
* Male subjects must refrain from sperm donation from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
* Females of childbearing potential must have a negative serum pregnancy test
* Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study treatment and for 30 days following the last dose of study drug

Exclusion Criteria:

* Female subjects who are pregnant or lactating
* History of anaphylactic reaction to any drug
* Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing
* Presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months
* Have donated blood within 56 days of study dosing
* Presence or history of any pulmonary diseases (ie, asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis, interstitial lung disease)
* Major surgery within 6 months of Screening
* Experienced symptoms of recent acute upper or lower respiratory tract infection requiring treatment within the 2 weeks prior to Screening
* Have had any radiation in the past year that would cause the subject exceed recommended limits by participating in this study protocol
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
* Previously diagnosed as having type 2 diabetes
* HbA1c ≥7.0% and ≤10.5%
* Body weight ≥ 30 kg
* Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
* Women must have a negative serum or urine pregnancy test
* Women must not be breastfeeding

Exclusion Criteria:

* Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
* Fasting plasma glucose (FPG) \> 255 mg/dL
* Diabetic ketoacidosis (DKA) within 6 months of study entry
* Abnormal renal function
* Active liver disease
* Anemia
* An abnormal Thyroid Stimulating Hormone (TSH)
* Creatinine kinase (CK) ≥ 3X ULN
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.


Eligibility Criteria:
Inclusion Criteria:

* Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day.

Exclusion Criteria:

* Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
* Patient has a known neurological disease influencing bladder function.
* Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Combined Anesthesia for Laparoscopy Surgery in Gynecology

The purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.

Following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia.

During the postoperative period data regarding pain level as evaluated by visual analogue scale (VAS), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiology (ASA) physical status classification system:ASA I-III.
2. Benign Gynecological Laparoscopy surgery

Exclusion Criteria:

1. Patients who are not capable to sign the consent form.
2. Women with known allergy to the medication used in spinal analgesia.
3. Patients who are pregnant or lactating.
4. Patients with contraindication to spinal analgesia.
5. Patients who use opioid on a regular base.
Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction

The purpose of this investigator-initiated study is to determine whether a single-step session that combines endoscopic ultrasound (which may further include liver biopsy and needle-guided cholangiography) with endoscopic cholangiopancreatography (ERCP) can facilitate in the management of liver graft dysfunction. All patients will undergo the same procedural protocol.

Liver graft dysfunction can arise from many disease processes, which include biliary obstruction, rejection, infection and ischemia. Battery of tests, and at times empiric therapy, is necessary to obtain final diagnosis. This results in waste of time and medical resources that can lead to delay in care, which may ultimately translate to increase morbidity and mortality, as well as increase in cost.

In this protocol, the investigators propose utilization of interventional endoscopy for the diagnosis and treatment of liver graft dysfunction. Use of endoscopic ultrasound (EUS) with possible liver biopsy and cholangiography, and endoscopic retrograde cholangiopancreatography in one session may facilitate diagnosis and treatment. All patients enrolled in this protocol will undergo the same procedural protocol. The quality of care metrics in these patients (such as length of stay, cost, mortality, etc), will be compared to that of historical controls.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized patients with liver graft dysfunction

Exclusion Criteria:

* Thrombocytopenia (platelets \<50.000/mL) until corrected
* Coagulopathy (international normalized ratio (INR) \>1.5) until corrrected
* Use of thrombolytic or anti-platelet agents within 5-7 days of the procedure.
* Any with known bleeding diathesis will be excluded. (e.g. disseminated intravascular coagulation (DIC), von-Willebrand disease, hemophilia).
* Those who had recent prior liver biopsy or EUS/ERCP will be excluded.
* Those with active bacteremia will be excluded, at least until treated.
* For this initial study, those with altered GI tract anatomy (e.g. those with hepaticojejunostomy or gastro-jejunostomy) will be excluded
Evaluation of Chronic Liver Disease Condition and Transplant Prognosis Assisted by Eye Biological Parameters

This study investigates the correlation between ocular biological characteristics and overall conditions before and after liver transplantation by collecting ocular biological characteristics. Explore whether it is possible to construct a clinical prediction model for liver transplantation by incorporating ocular biometric features, in order to optimize disease management before and after liver transplantation.

This study is a bidirectional cohort study, which retrospectively analysed data from a prospective database to construct a model, and prospectively collected patient information from preoperative to postoperative for model improvement and validation.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years old;
2. Late stage liver disease patients waiting for liver transplantation treatment, as well as patients with varying degrees of cirrhosis;
3. Can collect complete basic demographic information, liver function blood test indicators, liver pathology and imaging examination results;
4. Can cooperate with eye OCT, OCTA and other examinations, and obtain qualified examination parameters;
5. Voluntarily follow the clinical trial protocol and sign the informed consent form.

Exclusion Criteria:

1. History of other organ transplant surgeries;
2. History of intraocular laser treatment, medication injection, and surgery;
3. History of high myopia, glaucoma, and retinal choroidal related eye diseases;
4. History of major systemic diseases other than liver disease;
5. Individuals whose overall body and eye conditions cannot cooperate with eye examinations.