cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Norspan Patch and Oral Tramadol

This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR (slow release) Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged more than 18 years.
* Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
* Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.

Exclusion Criteria:

* Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
* Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
* Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.
GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways.

The use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway.

Worldwide, up to 600 patients are estimated to die annually as a result of the complications that occur during tracheal intubation The GlideScope® (videolaryngoscope) is used for endotracheal intubation in patients with difficult airway predictors, in this patients overall success intubation rate is 96%. but success intubation rate at first attempt is only 86%.

Despite this positive rates, due to high comorbidity when intubation fails, both failure rates (inverse of success rate) are impermissible. 14% failure at the first attempt intubation as well as 4% overall intubation failure.

in this study the investigators try to show that new procedure associating aScope® (disposable fiberscope) together with GlideScope® increases the success intubation rate of both ( overall and first attempt).

Eligibility Criteria:
Inclusion Criteria:

* Patients programed for general anesthesia with endotracheal intubation required that presents one or both criteria of difficult airway predictors:
* criteria 1: Arne test \>10 (Arne J,1998)
* criteria 2: Ratio between neck circumference and thyromental distance \> 4. (Kim WH, 2011)

Exclusion Criteria:

* Patients with mouth opening which does not allow the introduction of video laryngoscope.
* Patients with indication of flexible fiberoptic intubation with awake patient.
Effect of Sarcopenic Obesity on Weight Loss Outcomes and Quality of Life After Laparoscopic Sleeve Gastrectomy

The purpose of this study is to assess the impact of sarcopenic obesity (SO) on weight loss outcomes and improvement of quality of life after laparoscopic sleeve gastrectomy.

Sarcopenic obesity is a state in which a lack of muscle mass and strength coexists with an increase in fat mass, and it may affect the health outcome of people with obesity after laparoscopic sleeve gastrectomy (LSG).No studies have reported differences in weight loss outcomes between patients with SO and those with non-sarcopenic obesity (NSO) after LSG. Therefore, this study aimed to systematically evaluate the differences in weight loss and quality of life (QOL) evaluation between patients with SO and NSO after LSG and provide high-level evidence-based medical evidence for the impact of SO on weight loss in the obese population and refinement of follow-up strategies.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients who met the indications for LSG and were followed up regularly as planned after surgery.

Exclusion Criteria:

1. incomplete critical clinical data;
2. incomplete imaging data;
3. insufficient follow-up data.
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).


Eligibility Criteria:
Inclusion Criteria:

* Metastatic disease or locally advanced, unresectable disease.

  * Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
  * Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
  * Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
  * Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
* Availability of tumor tissue for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC participants only, PD-L1 expression should be 1% or higher.
* Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Has adequate organ function.
* Have an anticipated life expectancy of ≥3 months.

Exclusion Criteria:

* Have known brain metastases.
* Has received ≥3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ≥4 lines for NSCLC or urothelial cancer.
* Has active autoimmune disease.
* Known human immunodeficiency virus (HIV) infection.
* Known active hepatitis B or hepatitis C infection.
* Has received any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling pathways.
* Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
* Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
* Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment.
VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators

ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. The aim is to test whether a novel adaptation to a handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment and has implications in the prevention of infection.

The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part

Exclusion Criteria:

* Patients who are unable or refuse to consent
The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly

The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.


Eligibility Criteria:
Inclusion Criteria:

* (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia

Exclusion Criteria:

* (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension
FLEX®-DCB Dialysis ACCESS Stenosis Study

This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.


Eligibility Criteria:
Inclusion Criteria:

* Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
* Arteriovenous fistula is located in the arm.
* Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
* Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
* Patients with a dysfunctional or thrombosed hemodialysis access and a \>50% stenosis, regardless of prior treatment (All types of lesion and access failure)
* If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus.
* Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length.

Exclusion Criteria:

* Life expectancy \< 9 months
* Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
* The hemodialysis access is located in the leg.
* Patient has more than two lesions in the access circuit.
* Patient has a secondary non-target lesion that cannot be successfully treated
* Target lesion is located central to the axillosubclavian junction.
* Surgical revision of the access site planned.
* Recent surgical interventions of the access site.
* Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication.
* Known allergy or sensitivity to paclitaxel.
* Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day.
* Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data.
* Patients anticipating a kidney transplant.
* Patients anticipating a conversion to peritoneal dialysis.
* The patient has a stent located in the target or secondary non-target lesion.
* Patient has an active infection in the AV access or a systemic infection.
* Known hyper-coagulable state
* Currently participating in an investigational drug, biologic, or device study.
* Previously enrolled in this study.
The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical -7 Pulse CO-Oximeter in Intraoperative Blood Transfusion Practice During Obstetric Procedures

The principle aim of this study is to detect the accurracy of Masimo Radical-7¿ Pulse CO-Oximeter in relation to laboratory hemoglobin and estimated blood loss in intraoperative blood transfusion practice during obstetric procedures with high risk of bleeding.

Photoplethysmography of peripheral perfusion can be displayed by pulse oximeters. While the pulse oximeterplethysmogram represents a volume change and the arterial line blood pressure tracing represents a pressure change, it has been demonstrated that cyclical shifts in the plethysmogram reflect similar cyclic changes in the blood pressure tracing and that these changes reflect changes in the intravascular volume status of patients.Plethysmography Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle . PVI = ﴾PI Max - PI Min﴿ ÷ PI Maxx 100 %.

PVI has the potential to provide useful information concerning changes in the balance between intrathoracic airway pressure and intravascular fluid volume. Trending of PVI may be useful in monitoring surgical patients, both intraoperatively and postoperatively, for appropriate hydration states. For example, a rising PVI may indicate developing hypovolemia and gives an alarm for the need of appropriate fluid and or blood products transfusion supported by the patient hemoglobin level.

Continuous Hb monitoring may allow a more rapid detection of clinically significant blood loss, and has the potential to significantly improve perioperative transfusion practices, may enable a more rapid assessment of a patient's condition and more appropriate blood management and even perhaps reduce needless transfusions.

Eligibility Criteria:
Inclusion Criteria:

1. All adult high risk patients (ASA 1-2)
2. Age group (16-44 years old)
3. Obtetric surgery with high risk of bleeding in early and late pregnancy e.g Disturbed ectopic pregnancy ,Vesicular mole , Abortion , Placenta accrete , Rupture uterus and placenta previa

Exclusion Criteria:

1. Significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase \>2.5 times normal).
2. Significant renal disease defined as (serum creatinine \>1.5 mg/dl or creatinine clearance \<40 ml/min).
3. Significant coagulopathy defined as (INR \>1.5).
4. Use of antiplatlets or anticoagulants.
5. Anemic patients with Hb% less than 8 gm/dl
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV

This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the new liver caused by HCV.

There are data to suggest that with eradication of the HCV virus, improvements in liver fibrosis can be seen in the post-transplant population. However, amelioration of inflammatory activity, and deceleration of fibrosis progression is a gradual process over the course of many years. This placebo-controlled study is designed to evaluate the effects of IDN-6556, compared to placebo, on markers of apoptosis and inflammation, and liver histology.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
* History of orthotopic liver transplantation for HCV-induced liver disease
* Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1
* Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be enrolled)
* Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug

Exclusion Criteria:

* Known infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
* History of renal transplant and/or severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min/1.73 m2
* Evidence of tumor burden \>Milan criteria, or evidence of micro- or macrovascular invasion in explanted liver
* Hepatocellular carcinoma (HCC) at entry into the study
* Concurrent sirolimus (rapamycin) use
* History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of \> 480 milliseconds (msec)
* Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
* If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
Impact of "Teaching the Teachers" Concept on Global Education and Application of Hepatocellular Carcinoma Diagnosis Guidelines

This study evaluates a concept called 'Teaching the Teachers' and whether it is helpful in disseminating guidelines on the national and international levels. "Teaching the Teachers" involves teaching the guidelines to experts who later teach the same guidelines to other radiologists, trainees, and physicians to assume the teacher's role and disseminate the guidelines and so on.

PRIMARY OBJECTIVES:

I. Evaluate the magnitude of teaching of hepatocellular carcinoma (HCC) diagnostic guidelines after applying "Teaching the Teachers" concept.

II. Assess the effect of "Teaching the Teachers" concept on application of guidelines in clinical practice.

OUTLINE:

Participants complete surveys immediately after completion of a HCC diagnostic guideline webinar, monthly thereafter, and again at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Physicians who finished radiology residency
* Radiologists with current or completed specialized training in abdominal imaging
* Radiologists with expertise in liver imaging with no minimum number of years of experience
* Radiologists working in academic, community, and governmental practices
* Radiologists with current practice in any country around the globe
* Radiologists with and without previous knowledge of HCC diagnosis guidelines (Liver Imaging Reporting and Data System \[LI-RADS\])
* Radiologists with interest in education and/or teaching

Exclusion Criteria:

* Physicians with no formal training in radiology
* Radiologists with no expertise in abdominal/liver imaging
* Current radiology residents
* Radiologists with no interest in education and/or teaching
J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer

Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection


Eligibility Criteria:
Inclusion Criteria:

* patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope

Exclusion Criteria:

* refusal of the patient to participate
* pregnancy,
* previous radiation therapy,
* those have cancers other than adenocarcinoma,
* those planned to have local excision or abdominoperineal resection
TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma

The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.

This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of HCC confirmed by radiology, histology, or cytology

  -≥18 years
* China liver cancer staging: Ib-IIIa
* Child-Pugh score ≤6 point
* Previous TACE treatment(≤2 times) is permitted
* Adequate organ and marrow function

Exclusion Criteria:

* Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated \>5 years prior to enrolment with no recurrence
* Participants who have severe allergy to iodine, and unable to receive TACE
* Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
* Participants who had congenital or acquired immune deficiency, such as HIV infection
* Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
* Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism
Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial

Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.

Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).


Eligibility Criteria:
Inclusion Criteria:

Age \>18 years Single Pregnancy \<7 weeks of gestation

Exclusion Criteria:

Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo


Eligibility Criteria:
Inclusion Criteria:

Additional criteria check may apply for qualification:

* Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%
* eGFR of ≥30 mL/min/1.73m2 and \<90 mL/min/1.73m2
* The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr
* Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
* Patients who are under dietary management and taking therapeutic exercise for diabetes

Exclusion Criteria:

Additional criteria check may apply for qualification:

* Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* A diagnosis of non-diabetic renal disease
* Hereditary glucose-galactose malabsorption or primary renal glucosuria
* Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Severe hepatic disorder or severe renal disorder
* Blood potassium level \>5.5 mmoL/L
* Stable blood pressure (diastolic blood pressure (DBP) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)