cyrilzakka/clinical-trials huggingface dataset:
Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography

The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.

Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.

This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.

* The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.
* A baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.
* Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.
* The standard angiogram/ PCI will be performed as per usual practice.
* Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
* At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiography and/or PCI via transradial approach
* Informed consent
* Documented normal Allen's test

Exclusion Criteria:

* Patient who had a previous angiogram using the same radial artery
* Abnormal Allen's test
* Previous failed radial access.
* Known bleeding disorder or hypercoagulable condition
* Cardiogenic shock
Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.

Amyotrophic lateral sclerosis is one of the most serious neurodegenerative disease, leading to death in 3 years by progressive paralysis of 4 limbs, speech, swallowing and breathing, and due to a progressive death of central and peripheral neurons. The cause of the disease is unknown, but an immunologically factor is more precisely suspected in ALS. Since 2008, the work of Immunology have shown that vitamin D was a major regulator of immunity. It regulates particularly the function of dendritic cells and regulates the immune response in macrophages. A vitamin D deficiency will induce activation of microglia. In neurology, vitamin D deficiency is associated with a greater impairment in neuronal function. This deficit is associated with a faster alteration of the microvasculature, alteration known to increase neuronal suffering and to enhance the neurodegenerative processes. The investigators postulate that ALS patients have a more severe prognosis if their vitamin D levels at the time of diagnosis is lower. The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.

Eligibility Criteria:
Inclusion Criteria:

* Subject with possible, probable or definite Amyotrophic Lateral Sclerosis (ALS).
* ALS operating for less than three years at dosage of vitamin D time.
* Subject monitored in the center ALS of Montpellier for 6 months.
* Subject agreeing to give his consent in writing or orally if the patient SLA is unable to write

Exclusion Criteria:

* Subject has received a Vitamine D treatment in the six months preceding the inclusion
* Subject with a clinical condition on the inclusion day that makes it highly probable death in the year (quadriplegic patient, subject ventilated for respiratory failure in ALS, major malnutrition) or with ALSFRS-R score \<20.
* Pregnant or breastfeeding women
* Subject not covered by a social security scheme.
* Subject under guardianship
* Adult protected by the law
Dexamethasone for Postoperative Nausea and Vomiting

The investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy.

More than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (PONV). PONV is related to surgical, anesthetic and patient factors.

We want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of PONV in patients undergoing laparoscopic cholecystectomy.

Three groups to be studied : (Group O) will receive 4 mg ondansetron, (Group D) will receive 8 mg dexamethasone and (Group P) will receive normal saline .

Eligibility Criteria:
Inclusion Criteria:

* (ASA) grade I and II, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of Anesthesia and Intensive Care, University of Jordan, Amman, Jordan between November 2007 and March 2008

Exclusion Criteria:

* All patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries
* Pregnant, breast feeding ladies
* Any patient with BMI (Body Mass Index) \> 34 kg/m²
* Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol
Utility of 2- Octyl Cyanoacrylate (2-OCA)

Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations.

Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations. It has also been used for treatment of ascites fluid leaks following paracentesis with success in case reports. While the initial FDA approval included a contraindication for use on mucosal surfaces, some evidence in literature suggests that use on mucosal surfaces might warrant further investigation. For example, 2-OCA has been used for repair of a lacerated tongue of a pediatric patient and for closure of congenital cleft lips

Eligibility Criteria:
Inclusion Criteria:

* Inpatients at Methodist Dallas Medical Center (MDMC) ≥18 years of age with ascites requiring therapeutic paracentesis performed by the procedure team at the bedside.

Exclusion Criteria:

* Paracentesis procedures performed in the interventional radiology department or by physicians outside of the procedure team.
* Patients who undergo a liver transplant surgery or other abdominal surgeries within 48 hours from the paracentesis procedure.
* Patients that undergo paracentesis using a device or kit other than the 18 gauge Safe-T-Centesis kit
A Study of DF6002 Alone and in Combination With Nivolumab

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.

Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV) administration of DF6002, as monotherapy and in combination with nivolumab, and to determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED) of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients with advanced (unresectable, recurrent, or metastatic) solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
* ECOG performance status of 0 or 1
* Clinical or radiological evidence of disease
* Adequate hematological, hepatic and renal function
* Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment

Exclusion Criteria:

* Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment
* Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety
* Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
* Rapidly progressive disease
* Serious cardiac illness or medical conditions
* Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Other protocol-defined inclusion/exclusion criteria apply
Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .

The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.


Eligibility Criteria:
Inclusion Criteria:

* pregnant female with preeclampsia
* age 18-40

Exclusion Criteria:

* age less than 18
* age above 40
* patient refusal of spinal anesthesia
* patient with eclampsia
* patient allergy to anesthesia drugs or to NE
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a BMI ≥27 kg/m² and \<35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants).
* Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
* Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* No male contraception is required except in compliance with specific local government study requirements.

Exclusion Criteria:

* For participants with Type 2 Diabetes (T2D):

  * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening.
* Have a known clinically significant gastric emptying abnormality.
* For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.
* Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have chronic kidney disease.
* Have lupus or rheumatoid arthritis.
* Have the following cardiovascular conditions within 90 days prior to screening.
* Have acute or chronic hepatitis.
Bioequivalence Study Of Verapamil

The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screen
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.

This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years.
* Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
* ECOG performance status of 0 or 1.
* ASA (American Society of Anesthesiologists) classification of I-III.
* Voluntary signed informed consent from the participant or their legal representative.

Exclusion Criteria:

* Evidence of potential distant metastasis found preoperatively.
* History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
* Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
* Participation in any other clinical trial within the last 6 months.
* Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus

Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.

Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.

Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.

The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.

Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.

Eligibility Criteria:
Inclusion Criteria:

* Previous caesarean section
* Complete 37 week calculated from the first day of the last menstrual period.

Exclusion Criteria:

* Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
* Hypertensive patients.
* Chronic disease e.g. diabetes mellitus.
* Known renal disease.
* Pre-operative infection.
Whole Body Vibration in Chronic Obstructive Pulmonary Disease

The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.


Eligibility Criteria:
Inclusion Criteria:

* severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) \< 0.7 and FEV1 \< 50% predicted,
* stable disease defined as no exacerbation,
* hospital admission or change in treatment in the previous 3 months.

Exclusion Criteria:

* other significant respiratory disease (bronchiectasis,
* lung fibrosis, asthma, etc),
* active smoking,
* severe cardiovascular,
* neurological, and/or metabolic pathology that could interfere with the results,
* total hip, knee or ankle arthroplasty,
* previous vitreous haemorrhage,
* severe alcoholism (\> 80 g/day) and
* severe malnutrition (BMI \< 19 Kg/m2) to reduce the risk of falling and dropouts.
Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration

The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.


Eligibility Criteria:
Inclusion Criteria:

* elective primary shoulder arthroplasty

Exclusion Criteria:

* reverse or delta prosthesis
* recent fracture near the shoulder
* allergic to amid-type local analgesics
* operation not under general anaesthesia
* incompetent, pregnant, below 18 or above 90 years old
* severe chronic neurogenic pain or sensory disturbances in the shoulder
Clinical Trial on Harmonic Focus Shears

The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.

According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique.

In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.

Eligibility Criteria:
Inclusion Criteria:

* Total thyroidectomy for multinodular goiter in adults patients

Exclusion Criteria:

* Redo surgery, malignancy.
The BASA Study: Breath Analysis for Severe Asthma Patients

This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Severe asthma diagnosis according to the latest recommendation
* Eligible or in treatment with a biologic treatment for severe asthma
* Able to follow istructions
* Able and willing to sign the informed consent

Exclusion Criteria:

* Not able to perform lung function measurements and the procedures of the study
* Acute respiratory or non respiratory infection (\<4 weeks)
* Not willing to continue the study
Study of Minirin Melt® in Adult Patients With Nocturia

Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia


Eligibility Criteria:
Inclusion Criteria:

* Adult aged between 19 and 65 years
* Patients having nocturia
* Decision made to prescribe Minirin Melt according to prescription information
* Willingness and ability to provide written informed consent

Exclusion Criteria:

* When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
* When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
* When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
* When patients have known hyponatremia
* When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
* When patients have hypersensitivity to the active substances or to any of the excipients