cyrilzakka/clinical-trials huggingface dataset:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer

This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer

This patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Skin Ulcer. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Skin Ulcer
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients

Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized.

Design: randomized, open, multicenter and two branches of parallel intervention clinical trial.

Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure.

Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 70 years or more
* Currently receiving eight or more drugs, except ointments and administered via topical nonprescription
* Give their informed written consent to participate in the study.

Exclusion Criteria:

* Estimated life expectancy less than 6 months.
* Active cancer
* Participation in any other clinical trial or program for evaluation of medication in the elderly.
* Institutionalized in nursing homes.
* Surgical intervention scheduled for the next 6 months
Naldebain for Pain Management After Knee Arthroplasty

Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. This study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

Naldebain, a long-acting analgesic injection, obtained a license from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare on March 6, 2017 to approve a sustained-release long-acting analgesic on the market in Taiwan. At present, it is the only analgesic injection that has an efficacy of up to seven days. The currently approved drug indication is to relieve moderate and severe acute pain after surgery. Pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. Because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. Therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic Naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

Eligibility Criteria:
Inclusion Criteria:

* Age at least 50 years old, not exceed 100 years old
* Diagnosed Primary Knee Osteoarthritis accepted Knee Arthroplasty

Exclusion Criteria:

* Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
* Accepted Revision Knee Arthroplasty
* Patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency
* Patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs
The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.

The purpose of this observational study is to prospectively collect data on ROP cases necessitating treatment at a national level. Each and every ROP screening unit in Greece (collaborating centers) report their new TR-ROP cases, their demographics and treatment characteristics, monthly, for a 12-month period. A reminder email is sent to avoid under-reporting due to neglect. Data are collected by the Responsible Party and will be analyzed together with national registry data on all preterm births in the same 12-month period.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants undergoing screening for ROP, who developed TR-ROP and were treated for ROP in one or two eyes.

Exclusion Criteria:

* None.
Survival Rates of Patients With Mobile Bearing Total Knee Arthroplasty After 10 Years

The total knee replacement has become a routine procedure. Survival rate of over 90% after 10 years are generally reported. However, complications and reoperation may still occur for many reasons, and some of them may be related to component design: loosening (tibial above), polyethylene wear, knee stiffness, ligamentous instability, etc ... . Therefore, new designs can, at least in theory, improve the results of conventional models.

In this study, the investigators want to compare retrospectively data concerning survival rates of patients wearing total knee prosthesis with mobile plate for over 10 years, with the ones published in the literature for conventional fixed-bearing prostheses.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients wearing total knee prosthesis with mobile plate for over 10 years

Exclusion Criteria:

* Patients under 18 years
Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice.

The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.

The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.

However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.

The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.

Eligibility Criteria:
Inclusion Criteria:

* Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin
* Patients \> 18 years old
* Obtaining informed consent

Exclusion Criteria:

- Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available \<1 month
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC

Exclusion Criteria:

- Contraindications to rituximab therapy according to the approved SPC
Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block

Tracheal intubation and general anesthesia has been considered a safe and conventional routine methodology for thoracic surgery, include multiple rib fratcure. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. In this study, we decide to perform surgical stabiliazation of rib fractures by paravertebral block surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.

Rib fracture is common in the world,especially in chest trauma. Conservative treatment is used to it for many years but the effect is not well because of continuous pain caused by the dislocation of broken rib. Surgical stabiliazation of rib fractures can relieve the pain rapidly and help patient recover to work early. This kind of surgery is constantly conducted with tracheal intubation and general anesthesia. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. So we think perform surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Simple rib fracutures patients
* No other truama
* Unilatieral rib fractures
* Total number of rib fractures is less than 5
* At least one rib dislocation
* 18-80 years old
* ASA grade I-II
* BMI\<30
* Preoperative arterial partial pressure of oxygen \> 60mmhg
* Partial pressure of carbon dioxide \< 50mmhg

Exclusion Criteria:

* Difficult airway
* History of esophageal reflux
* Myasthenia gravis
* Coagulation disorders
* Gastrointestinal ulcer
* Gastrointestinal bleeding
* Anesthetic drugs allergy history
* Asthma
* Chronic obstructive pulmonary disease
* Pregnant women.
Influence of N-Acetylcysteine on Morbidity, Oxygenation and Cytokine Levels in Partial or Total Esophagectomy for Cancer

The purpose of this study is to evaluate the effect of high-dose n-acetylcysteine on inflammatory reaction, pulmonary morbidity, oxygenation and quality of life in patients undergoing transthoracic, partial or total resection of the esophagus for cancer.

Cancer of the esophagus has a poor long term prognosis as well as high perioperative morbidity. Pulmonary complications play thereby a major role. The standard procedure is either a combined transabdominal/transthoracic approach, which allows better visualisation of the tumor and more radical surgery (which may increase R0 resections and consequently overall survival) or a blunt transhiatal technique. In Zurich, Basel and Lucerne, the combined technique is the standard procedure. The combined surgical approach, pre-existing pulmonary disorders, poor nutritional status and the release of pro-inflammatory cytokines may be important contributing factors to pulmonary complications such as pneumonia, atelectasis, pleural effusions and the Acute Respiratory Distress Syndrome (ARDS). N-Acetylcysteine (NAC) has been shown to have direct and indirect oxygen scavenging abilities. In severe sepsis and acute respiratory distress syndrome, positive effects of NAC on morbidity and mortality were discovered. Aim of this study is to assess the influence of NAC on morbidity, oxygenation parameters and cytokine levels.

According to power analysis, 90 patients have to be included in the trial. A multicenter approach was chosen to finish the study within 3 years. Respective to the average number of operations per institution and year, the following distribution is planned: Triemli Hospital 40, University Hospital Basel 30, Kantonsspital Lucerne 20. Inclusion criteria for this trial are patients undergoing thoraco-abdomino-cervical or abdomino-thoracic esophagectomy for cancer between 20 and 90 years and given informed consent. Exclusion criteria are known allergy or hypersensitivity to NAC and pregnancy. Patients are randomised to receive either high dose N-Acetylcysteine administered perioperatively and postoperatively for three days (150mg/kg perioperatively and 50mg/kg days 1-3) or placebo (glucose 5%).

Pre-, peri- and postoperatively cytokines (IL-1, IL-1ra, IL-6, IL-8, IL-10, TNF-α), are quantified by enzyme-linked immuno assay (ELISA) from blood, broncho-alveolar lavage and lavage of pleural space. Leucocytes, C-reactive protein, Procalcitonin and oxygenation parameters (arterial blood gas analyses = ABGA) are regularly measured. Morbidity and mortality is assessed. Furthermore, all patients are asked to complete a quality of life questionnaire (EORTC QLQ-OES18 and 30, SF-36) before and after the operation (12, 24, 36 months post-op).

Eligibility Criteria:
Inclusion Criteria:

* elective, abdomino-thoracic esophagectomy
* elective, thoraco-abdomino-cervical esophagectomy
* age 20-90 years
* informed consent given

Exclusion Criteria:

* emergency procedures
* patients with increased bronchorrhoea
* hypersensitivity against n-acetylcysteine
* pregnancy
* lactation
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments.

Eligibility Criteria:
Inclusion Criteria:

- Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Virtual Therapy as a Method Supporting the Cardiac Rehabilitation

This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing second stage of cardiac rehabilitation. Half of the study group will receive VR therapy (VR group) as an addition to cardiologically monitored physical training. The other half of the group (control group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.

Cardiologically monitored physical training in second stage of cardiac rehabilitation leads to the improvement in the physical capacity and overall fitness of the patients with Coronary Artery Disease, allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the heart disease itself and the cardiac surgery performed. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training).

Thanks to using head mounted display and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms.

The goals of the project:

1. The evaluation of the influence of VR therapy on the depressive symptoms and the anxiety level of the patients undergoing second stage of cardiac rehabilitation.
2. The evaluation of the influence of VR therapy on the stress level of the patients undergoing second stage of cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Disease;
* the second stage of cardiac rehabilitation conducted in outpatient settings;
* anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.

Exclusion Criteria:

* cognitive impairment (MMSE\<24);
* inability to self-complete the research questionnaires;
* presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
* initiation of psychiatric treatment during the research project;
* contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
* the patient's refusal at any stage of the research project.
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement

Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.

The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.


Eligibility Criteria:
Inclusion Criteria:

* Aortic stenosis
* Indication of Aortic Valve Replacement (Surgery or TAVI)

Exclusion Criteria:

* Rheumatismal or congenital aortic stenosis
* Aortic insufficiency (grade \>= 2/4)
* Associated valvulopathy (grade \>= 2/4)
* Myocardial infarction antecedent
* Severe renal failure
* Cardiac surgery (Aorta abdominal) antecedent
* Complex congenital cardiopathy
A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine

The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are:

* To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects
* To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects
* To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects
* To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects

Participants for Phase I will be randomized to either JCXH-221 or placebo.

This is a phase 1 study looking to enroll a total of 72 patients.

For phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. The subjects will be enrolled and randomized to either placebo or JCXH-221. A low dose of JCXH-221 will be explored vs placebo for each age group first.

Eligibility Criteria:
Main Inclusion Criteria

* Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Age: 18 years of age or older, at screening.
* Status: Healthy subjects.
* Subjects must have completed the full doses for primary vaccination with an approved SARS-CoV-2 vaccine and may have received booster dose(s), with the last vaccination (can be 2nd dose of primary vaccination or booster dose) having occurred at least 4 months prior to enrollment.

Main Exclusion Criteria

* Current or prior symptomatic or asymptomatic SARS-CoV-2 infection confirmed by an approved or authorized rapid antigen test on Day 1 or within 4 months prior to Day 1.
* Subjects with significant exposure (as defined by current CDC guidance) to someone with laboratory confirmed SARS-CoV-2 infection or COVID-19 with the past 14 days prior to the Screening visit.
* Subjects with fever or signs of acute infection at the time of enrollment and vaccination.
* Subjects who are taking medications that may prevent or treat COVID-19.
* Subjects who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 within 4 months before Day 1.
* Subjects with history of myocarditis or pericarditis, or with AEs after mRNA vaccination that are in nature and severity beyond the common AEs expected and necessitating medical intervention.
* Subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes \>6 months
* stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0%

Exclusion Criteria:

* prior treatment with exenatide
* history of pancreatitis
* history of medullary thyroid cancer or multiple endocrine neoplasia 2