cyrilzakka/clinical-trials huggingface dataset:
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.

Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.

It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.

Eligibility Criteria:
Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Area(s) requiring skin grafting at least 320 square centimeters.
4. The subject is at least 5 years of age.
5. The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
5. Pregnant or lactating women.
Inter-Hospital Transfer to a Vascular Neurology Unit After Telethrombolysis

Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.

In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.

The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.

It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France).

Stroke is a major health problem with increasing incidence. It represents the leading cause of disability and the third cause of death in France. There are two main types of stroke: ischemic (80%) or hemorrhagic (20%).

Early thrombolysis is essential in treating ischemic strokes. The time window for thrombolysis is limited to 4,5 hours after symptoms onset.

In the French region of Franche Comté, in order to reduce the thrombolytic delay, a telemedicine network was developed between the neurovascular reference unit (NVU) localised in the University Hospital of Besançon and the peripheral hospital centres. Patients may then be transported to the NVU immediately after the thrombolysis initiation.

The aim of our study was to assess the relevance of a systematic medicalization of transfer to the NVU of patients with stroke who were telethrombolyzed before.

It was a retrospective, monocentric and observational study conducted over 24 months, in Franche-Comte (France). Evaluation of neurological status was made with the Glasgow score (GCS) and National Institute of Health Stroke Score (NIHSS). The respiratory (SpO2; needs O2) and hemodynamic status (arterial blood pressure, heart rate) were assessed as well as the need for medical resuscitation at different times of the transport (thrombolysis, transfer, arrival at the Regional University Hospital Centre).

Eligibility Criteria:
Inclusion Criteria:

* Patient with ischaemic stroke
* Emergency department admission between 01/01/2012 and 12/31/2013
* Telemedicine stroke consult
* Thrombolysis therapy
* Patient transfered to NVU after thrombolysis initiation
* Transfer staffed by a qualified physician

Exclusion Criteria:

* Transfer non staffed by a qualified physician
Evaluation of Plasma Renin Concentrations in Cardiac Surgery

The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. This study will evaluate blood samples for renin concentration throughout the course of open heart surgery.

The investigator hypothesizes that renin concentrations will increase with exposure to cardiopulmonary bypass and that increased renin concentrations will be associated with the development of vasoplegia.

Specific Aim 1. To characterize the effects of cardiopulmonary bypass on plasma renin concentrations in adults undergoing cardiac surgery.

Specific Aim 2. To test the prognostic value of plasma renin concentrations on outcomes following cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult persons 18 years of age or greater.
* Scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass.

Exclusion Criteria:

* Surgery involving heart or lung transplantation or implant of a durable left ventricular assist device.
* Emergency cardiac surgery.
* Established diagnosis of any congenital heart disease.
* End-stage kidney disease receiving kidney replacement therapy before surgery.
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia

This study was designed is to examine the idea that GW679769 has an effect on three of the pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to distension.

An exploratory study to investigate the effects of the NK1 antagonist GW679769, 120 mg once daily for 4 days, on gastric accommodation, gastric emptying and gastric distension-induced perception and discomfort in adult male and female patients with functional dyspepsia, in a single-centre, placebo-controlled, double-blind, randomised, two-period crossover study

Eligibility Criteria:
Inclusion criteria:

* Functional dyspepsia as diagnosed according to the Rome II criteria
* Must had a one month trial (full dose) of proton pump inhibitor treatment within the last 6 months, during a symptomatic period, that produced no lasting response, although this may not be required for those patients who have no symptoms of heartburn and do not present pain-predominant dyspepsia symptoms. Such decision will be left to the Principal Investigator's discretion.
* Patients who are non-smokers or smokers who smoke up to 20 cigarettes per day

Exclusion criteria:

* Active or history of peptic ulcer disorder
* History of major abdominal surgery
* History of underlying psychiatric illness, or current active psychiatric morbidity
* Pregnant or nursing women
Study to Evaluate Potential Food Effects

Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and surgically sterile or post-menopausal (last menstrual period \> 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
* Who have not used tobacco or nicotine-containing products within the past 3 months;
* Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
* Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.

Exclusion Criteria:

* History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
* History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
* History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
* History of autoimmune disease;
* History of immunodeficiency or of unusual susceptibility to infectious diseases;
* History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
* Any history of hypersensitivity or clinically significant allergy to any drug;
* Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
* Family history of sudden death;
* History of uveitis or inflammatory ocular disease;
* History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
* History of autoimmune disease;
* History of immunodeficiency or of unusual susceptibility to infectious diseases;
* History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
* Any history of hypersensitivity or clinically significant allergy to any drug;
* Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
* Family history of sudden death;
* History of uveitis or inflammatory ocular disease.
Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults

To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

Eligibility Criteria:
Inclusion Criteria:

* Healthy HIV-infected adults
* Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

Exclusion Criteria:

* Have any active opportunistic infections
* Received blood or blood product within 3 months
* Received anti-malarial drugs
* Received rabies vaccination in a previous year.
Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism

* Pulmonary embolism (PE) is a diagnostic and therapeutic challenge. The risk of death of untreated PE is approximately 25%. On the other hand, anticoagulant treatment is associated with a haemorrhagic risk (2% of major haemorrhagic accidents per year, of which 10% are fatal). A diagnostic accuracy is therefore necessary.
* Two approaches are available to diagnose PE:

  1. A functional approach, represented by pulmonary ventilation / perfusion scintigraphy (V / P), which looks for the functional consequences of PE. The main disadvantage of this approach is that there is a high rate of non-diagnostic examinations. On the other hand, it allows a mapping of pulmonary perfusion at the microcapillary scale, and thus allows the quantification of the vascular obstruction index, which would be an independent risk factor of PE recurrence.
  2. A morphological approach, represented by CT pulmonary angiography (CTPA), which allows the visualisation of the clot itself. This approach is currently the most used but has some limitations, including a risk of over-diagnosis of pulmonary embolism and the inability to reliably quantify the index of vascular obstruction.

Lung subtraction iodine mapping CT is a new technique allowing, during the realization of a CTPA, without additional irradiation, to provide a mapping of the iodine. This mapping of iodine could potentially be used to evaluate pulmonary perfusion.

It would then be possible to obtain, during a single examination, in addition to the anatomical information of the thoracic angioscan, information on the pulmonary perfusion and thus to assess the functional consequences of PE.

No study to date has evaluated the performance of the pulmonary subtraction CT for the evaluation of pulmonary perfusion in the context of acute pulmonary embolism suspicion.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have been diagnosed with acute pulmonary embolism on the Aquilion One Genesis scan (Toshiba, Medical System, Tokyo, Japan) at the Brest University Hospital, and who have had a mapping of the iodine derived from the subtraction images.

Exclusion Criteria:

* Tomoscintigraphy not feasible within 24 hours.
* Massive pulmonary embolism or with signs of gravity
* Pregnant or lactating women
* Minor patient
* Protected adults
* Incapacity / refusal to give consent
* Hypersensitivity to pertechnetate (99m Tc)
* Hypersensitivity to human albumin
Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Eligibility Criteria:
Inclusion Criteria:

* At least 22 years of age at time of consent
* Clinically indicated for a Holter monitor test
* Able to wear the HeartWatch on the left bicep for the study duration
* Able to follow the protocol
* No functional implantable pacemaker or defibrillator
* Left bicep circumference \>/= 22 cm and \</= 45 cm
* Provision of written-informed consent

Exclusion Criteria:

* Known allergy to any component of the Holter monitor
* Known allergy to any component of the HeartWatch
* Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
* Dextrocardia
* Implanted functional Pacemaker or Defibrillator
* Left bicep circumference \< 22 cm
* Left bicep circumference \< 45 cm
Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer

The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.

Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.

Eligibility Criteria:
Inclusion Criteria:

Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy.

Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment

Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study.

Participants must have a baseline WBMRI and CT-guided bone marrow biopsy.

Exclusion Criteria:

Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).
Rate of Leg Curl to Leg Press During Isokinetic Testing

The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have established themselves as the gold standard in competitive football. In this context, however, force tests in the open kinetic chain (OKC) have almost exclusively been used so far. Especially force measurements in the closed kinetic chain (CKC) could have a higher relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio in the CKC due to the involvement of the hip muscles. There is little data in the literature on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data for isokinetic measurement systems in the CKC. Using a cross over design and randomly allocating 28 competitive football players into two groups (n=14 each) that either started tests with the leg press or legcurl device, the investigators assumed (1) a significantly lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg press to predict functional performance of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* male elite soccer players (5th-6th German soccer division)

Exclusion Criteria:

* no acute injuries
Evaluation of Bowel Cleansing Using the Pure-Vu System in Patients With History of Inadequate Bowel Preparation

The study aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

The study is planned as a single arm, open trial will include up to 30 patients, aim to evaluate the performance of Pure-Vu System in cleansing patients' colon with history of inadequate bowel preparation who are indicated for a colonoscopy procedure.

Subjects will be enrolled at up to 3 clinical sites in Israel. Subjects who meet the eligibility criteria will be required to follow a standard bowel preparation instruction. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix C) and to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.

Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with history of inadequate bowel preparation.
2. Subjects in the age range of 22-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria:

1. Patients with active Inflammatory Bowel Disease
2. Patients with previous history of acute diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Patients with known bowel obstruction / strictures
4. History of prior surgery to colon and/or rectum
5. ASA ≥ III
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
9. Patients with known coagulation disorder (INR \>1.5).
10. Patients at risk of hypokalemia or hyponatremia
11. Patients with congestive cardiac failure
12. Pregnancy (as stated by patient) or breast feeding
13. Patients with altered mental status/inability to provide informed consent
14. Patients who have participated in another interventional clinical study in the last 2 months
The Food Effect on the Pharmacokinetics of NVP-1402

The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.

This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* No history of clinically significant medical disorder
* Capable of consent to participate in the study

Exclusion Criteria:

* History of hypersensitive reactions to study drug or other related drugs
* Any significant abnormality found during screening
* Any significant medical history
* History of alcohol abuse, smoking continuously
* History of drug abuse
* Clinically significant surgery within 4 weeks prior to administration of the study drug
* Participation in another clinical trial within 3 months prior to administration of the study drug