cyrilzakka/clinical-trials huggingface dataset:
MIRODERM H2H DFU Study

This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.

The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life.

The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%.

This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history.

Outcome assessments:

* proportion of subjects with 100% epithelialization of wound
* SF-36
* Adverse events

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older at time of initial visit
* Have Type I or Type II diabetes
* Have a neuropathic diabetic foot ulcer with the following characteristics:

  * Is greater than 1 cm2 and less than or equal to 12 cm2
  * Has failed to close following at least 2 treatments with a biologic
  * Has been present for 90 days or longer
  * Does not show signs of infection
  * Is full thickness (Wagner Grade I or II)
  * Located distal to the malleolus
  * Depth of less than or equal to 5 mm
  * No exposed capsule, tendon or bone
  * No tunneling, undermining or sinus tracts
  * Not between the toes
* Be willing and able to maintain required off-loading of affected limb
* Be willing and able to perform necessary dressing changes
* Have at least one of the following:

  * An Ankle-brachial index (ABI) ≥ 0.8
  * TcPO2 of ≥ 30 mmHg
  * A toe pressure of ≥ 50 mmHg

Exclusion Criteria:

* Be pregnant or be planning to become pregnant during the study
* Have had a Chopart's Amputation (or higher)
* Have a history of bone cancer of the affected limb
* Be undergoing dialysis
* Have active osteomyelitis or be receiving treatment for osteomyelitis
* Be diagnosed with unstable Charcot Foot on the affected side
* Have an HbA1c level of ≥ 12% within the past 90 days
* Have another ulcer within 2 cm of the study ulcer
* Be immunocompromised or at risk of immunosuppression as determined by the treating investigator
* Have a known collagen vascular disease or connective tissue disease
* Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks
* Be participating in another medical research study
* Have a sensitivity to porcine material
A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Must have adequate coagulation, hematology, kidney, and liver function, per protocol.
* Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML)
* Meet the following disease activity criteria:
* an established, confirmed diagnosis of AML by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3; and
* an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* If male participant is sexually active, he must agree from day 1 through 6 months after the last dose of alvocidib or 90 days after the last dose of venetoclax, whichever is longer, to practice the protocol-specified protection.

Exclusion Criteria:

* History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
* History of previous enrollment in Studies NCT02993523 or NCT03069352.
* History of exposure to alvocidib or any other cyclin-dependent kinase 9 (CDK9) inhibitor.
* History of Tumor Lysis Syndrome (TLS) due to previous exposure to venetoclax.
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Optimal Timing for Repair of Left to Right Shunt Lesions

The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.

In the past, children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band. This prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements. The primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals. The secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy. This study will be conducted through a retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the congenital surgery database
* Patients who have undergone repair of ventricular septal defects
* Patients who have undergone repair of atrioventricular canal defects
Improving Pain Management and Opioid Safety for Patients With Cirrhosis

This project aims to test a behavioral intervention in patients with liver cirrhosis and chronic pain and teach self pain-management skills.

Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with cirrhosis of the liver, which affects 4 million people in the US. In this population, prescription opioids are associated with complications of liver disease, decreased access to life-saving transplantation, and increased hospitalization, post-transplant mortality, and all-cause mortality. Moreover, most patients with cirrhosis have underlying alcohol and/or substance use disorders (SUDs), which increase the risk of opioid-related complications and misuse. Despite these risks, our pilot work found that nearly half of all patients with cirrhosis are prescribed opioid medications each year and that these prescriptions are often inconsistent with opioid prescribing safety guidelines. One potential reason for this may be the lack of safe, evidence-based, alternative pain management strategies for this patient population. Indeed, existing opioid safety and pain management interventions designed for general populations do not address many of the specific issues facing patients with cirrhosis.

The research team plans to recruit patients at UPMC for participation in the Liver Education About Pain (LEAP) intervention program. LEAP is a modular 12-week pain self-management intervention with individual and group sessions. Individual sessions serve the purpose of individualizing the program to the needs of the patients. Group sessions allow participants to practice skills, set goals with the group, seek social support, and learn together. The purpose of the LEAP program is to make pain better, help patients reach their personal goals (things that may be hard to do because of pain), and add to the care patients' medical team is providing.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be over 18 years of age and fluent in English
* Must have a diagnosis of cirrhosis
* Must be receiving care at UPMC hepatology clinics
* Must have chronic pain lasting at least 3 months

Exclusion Criteria:

* Participants will be excluded if they are younger than 18 years of age or are unable to provide informed consent for any reason
* Participants will be excluded if they had a prior liver transplantation or have a limited life expectancy of less than 6 months
Functional Residual Capacity Measured by Capnography in Ventilated Patients

Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. The present study was designed to determine if volumetric capnography can detect changes in the functional residual capacity during surgery.

This is a prospective and observational study designed to test the reliability of the capnodynamic equation to determine changes in functional residual capacity measured during anesthesia. The investigators will studied 40 mechanically ventilated patients undergoing general anesthesia. Functional residual capacity will be continuously measured in a non invasive way using expired carbon dioxide. Changes in functional residual capacity with standard modification in body positioning (Trendelenburg or anti-Trendelenburg position) and ventilatory settings wiil be tested.

Eligibility Criteria:
Inclusion Criteria:

* Written Inform Consent
* Programmed surgery
* Laparoscopic surgery
* Supine position

Exclusion Criteria:

* Emergency surgery
* Chronic respiratory disease
* Active smoking
Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor

The purpose of this investigation is to see if the newly developed "iKOs™ microcatheter" can safely and accurately measure flow and pressure within the heart arteries of 10 patients undergoing angiogram and pressure wire tests.

After being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. Those who are assessed as eligible will undergo baseline assessments and preparation for their angiogram.

Once enrolled they will undergo coronary angiography at the start of their clinical procedure. The angiogram will be examined by the Investigator and a decision made if the target vessel is suitable for a pressure wire study and insertion of the investigational device. If the investigator confirms that the participant remains eligible and the study part can go ahead, the participant will proceed to undergo the investigation with the iKOs microcatheter.

The study assessments will be performed through the right radial artery (preference) under local anaesthesia. A sheath will be inserted and a pre-procedure blood sample taken for Troponin T level. A pressure study will then be performed, initially with a pressure wire before using the iKOs™ microcatheter. Both will be performed before and after hyperaemia. Following withdrawal of the iKOs™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn. The case will then proceed as clinically indicated. The whole procedure should take about 30-45 minutes. Post-procedure the participant will be managed according to standard clinical practice.

The participant will be discharged home, usually about 4 hours after the end of the procedure. A troponin blood test and ECG will be repeated before they are discharged.

Follow up telephone calls to assess for any complications of the procedure will be made within the first 7 days and again between 6 and 8 weeks after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent
* \>18 years old
* Have a clinical diagnosis of coronary artery disease
* Undergoing further assessment of a coronary artery with a pressure wire study

Exclusion Criteria:

General

* Previous coronary artery bypass grafting.
* Non/ST-elevation myocardial infarction as indication for angiography.
* Ongoing evidence of ischaemia at rest.
* Severe renal impairment (GFR \<25).
* Severe anaemia (Hb \<10).
* Heparin allergy.
* Atrial fibrillation.
* Contraindication to adenosine.
* Pregnant or lactating; or female of childbearing potential.
* Participation in other interventional studies.

Additional exclusion criteria at Angiogram:

* Critical coronary artery stenosis in the vessel which is to be studied (\>90%).
* Left main stem coronary disease causing a \>50% stenosis.
* Triple vessel coronary disease.
Telemedical Interventional Monitoring in Heart Failure

Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:

* reduction of mortality rate
* reduction of hospitalizations
* increasement of patients' quality of life

The clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring which will measure various parameters on a daily basis (e.g., weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory CHF NYHA II or III
2. LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months
3. Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
4. Age ≥ 18 years
5. Informed consent

Exclusion Criteria:

1. Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
2. Insufficient compliance to telemonitoring or study visits
3. Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
4. Pregnancy
5. Concurrent participation in other therapy trials
6. Hospitalization for cardiac decompensation within 7 days before inclusion in trial
7. Implanted cardiac assist system
8. Unstable angina pectoris
9. Congenital heart defect
10. Primary heart valve disease
11. Hypertrophic or restrictive cardiomyopathy
12. Arrhythmogenic right ventricular cardiomyopathy
13. Acute myocarditis diagnosis ,1 year
14. Actively listed for heart transplantation
15. Planned revascularization or CRT implantation
16. Chronic renal insufficiency with creatinine .2.5 mg/dl
17. Liver cirrhosis
18. Known alcohol or drug abuse
Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19

Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to participate in the pilot study. Nasopharyngeal swabs were obtained three times per week for two consecutive weeks and tested with a point-of-care rapid antigen test and reverse transcription polymerase chain reaction (RT-PCR). In addition, serum samples were obtained at the beginning of the study and 2 weeks after last swab was obtained in order to evaluate the serological status of participating health care workers.

Health care workers (HCW) currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study. HCW directly involved in COVID-19 patient care and those who had a previous laboratory confirmed SARS-CoV-2 infection were not eligible for inclusion in the study. For each participating HCW, nasopharyngeal swabs were obtained. Swabs were collected on Mondays, Wednesdays and Fridays for two consecutive weeks with a maximum of six samplings per person scheduled.

Swabs were inserted into universal transport medium (UTM) and tested with SARS-CoV-2 Rapid Antigen test (Roche Diagnostics GmbH, Mannheim, Germany), in accordance with the manufacturer's instructions. Briefly, samples were thoroughly vortexed and 350 μL of UTM were mixed with the extraction buffer included in the testing kit. Three drops of the mixture were applied to the specimen well of the lateral flow test device and results were visually read after a 15 min incubation at room temperature.

Nasopharyngeal swab samples were subsequently tested for the presence of SARS-CoV-2 RNA without intermitting freeze-thaw cycle. Viral RNA was isolated from the specimens using the QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, Germany). PCR amplification was set up on CFX96 Touch Real-Time PCR Detection System (Bio-Rad Laboratories - Dubai Branch, Dubai, United Arab Emirates) and a commercially available PCR kit Allplex™2019-nCoV (Seegene, Seoul, South Korea) was used. Allplex™2019-nCoV assay enables simultaneous detection and identification of three target genes, specific for SARS-CoV-2 (e.g. the E, RdRp, and N gene). Samples were considered positive for SARS-CoV-2 only if all three targeted genes were amplified.

In addition, serum samples were collected at the beginning of the study and 14 days after the last nasopharyngeal swab was obtained. The presence of antibodies against SARS-CoV-2 were evaluated using IDK anti-SARS-CoV-2 IgM and IgG ELISA Kit (Immundiagnostik AG, Bensheim, Germany), following manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* health care worker

Exclusion Criteria:

* previous known COVID 19 infection
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).

This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.


Eligibility Criteria:
Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA \<32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a Japanese male.
* The subject is able to read and understand the informed consent form (ICF).
* The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit.
* The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100 bpm at the screening visit.

Exclusion Criteria:

* The subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1.
* The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.)
* The subject has taken any investigational products within 4 months prior to Day 1.
Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK

The primary objective of the study is the descriptive analysis of incidence \& severity of side effects \& reasons for discontinuation of the treatment of chronic pain with transdermal analgesic Buprenorphine patches.

750 patients that are treated with transdermal Buprenorphine patches for chronic pain will be included in the study. About 20% of patients are aimed to be patch-naive, ie have received their first prescription of transdermal analgesic patches within 1 month before inclusion in this observational study. Furthermore the study should not include more than 25% of cancer patients that are treated for chronic pain in order to ensure an appropriate mix of patient population.

Eligibility Criteria:
Inclusion Criteria

* Patient age \> 18
* Patient is treated with transdermal Buprenorphine
* The patient is able to answer the patient's survey \& has an estimated overall survival of minimum 6 months
* The patient gives his/her informed, written consent to participate in the study

Exclusion Criteria

* Patient Age \< 18
* Patient has less than 6 months survival expectancy
* Patient is unable to answer the patient survey for whatever reason in any feasible form