cyrilzakka/clinical-trials huggingface dataset:
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers

This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.

The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction \>20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.

Eligibility Criteria:
Inclusion Criteria

1. Subjects are male or female, 18 years of age or older.
2. Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
3. Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit.
4. Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
5. The subject is able and willing to follow the protocol requirements.
6. Subject has signed informed consent.

Exclusion Criteria

1. Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
2. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
3. The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
4. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
5. Subject is pregnant or breast feeding.
6. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
7. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit.
8. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
9. Known HbA1C \>12%.
10. Mini-nutritional assessment Malnutrition Indication score \<17.
A Study of Inhaler Use in the Community

This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).

Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Known history of Respiratory Illness
* Prescribed salmeterol/fluticasone Diskus Inhaler

Exclusion Criteria:

* Unable to understand study protocol
* Refusal to sign consent form
Rapamycin for Prevention of Chronic Graft-Versus-Host Disease

The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.

Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Received an allogeneic MSD or MUD PBSCT
* 24 weeks post SCT
* Currently on Tacrolimus for GVHD prophylaxis
* Deemed eligible for tapering off of Tacrolimus by primary BMT physician

Exclusion Criteria:

* Relapsed Disease
* Ongoing GVHD
* Patients whose immunosuppression is being stopped early to treat or prevent relapse
* Patients with pure red cell aplasia due to ABO mismatched donor
* Ongoing thrombotic microangiopathy
* Allergy to rapamycin
* Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment
Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED

The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED.

Approximately 90 participants diagnosed with persistent corneal epithelial defect (PCED) will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy. After an initial cohort of at least 2 participants to evaluate the safety of the high strength product, participants in the second cohort will be randomized to treatment with either the product or vehicle (placebo) for 8 weeks. The percentage of healing will be compared between groups treated with product and vehicle. Total length of study participation will be approximately 34 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Have PCED for at least 7 days prior due to an underlying condition such as diabetic keratopathy, herpetic eye disease, severe dry eye disease, limbal stem cell deficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery, medical trauma, chemical burn, etc.
2. PCED measurements meet study criteria.

Exclusion Criteria:

1. Any active ocular infection or any active infectious disease that could impact the PCED.
2. Severe corneal burns in the Study Eye.
3. Severe limbal stem cell deficiency in either eye.
4. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.
5. Severe blepharitis or severe meibomian gland disease.
6. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.
7. Evidence of corneal ulceration.
8. Anticipated need for punctal occlusion.
9. Use of Oxervate in the Study Eye within past 30 days.
10. History of any surgical procedure for treatment of the study PCED.
11. History of any other ocular surgery in the Study Eye within 90 days prior to screening.
12. Not willing to suspend use of contact lens in the Study Eye.
13. Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.
14. Expected use of systemic doxycycline.
15. Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.
16. History of current drug or alcohol abuse or addiction.
17. Use of another investigational agent within 30 days.
18. Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.
A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care

Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. A new home care model using a telemedicine system (Virtual Hospital) was developed.

Stable HIV-infected patients with access to a computer and broadband were randomized to: arm I, patients monitored by Virtual Hospital the first year and arm II patients monitored in the hospital the first year (standard of care). After 1 year of follow up, patients were crossed into the other arm. A "Virtual Hospital" was developed to integrate the control of patient in a multidisciplinary telecare team, allowing the patient to be remotely followed-up by the healthcare professionals through Internet. Virtual Hospital had four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and a clinical evaluation of Virtual Hospital were made.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients (CD4 \>250 cells/mm3 during at least the 3 months before inclusion to the study)
* Having access to a computer and to a broadband

Exclusion Criteria:

* HIV infected adults with current therapy failure (defined by detectable viral load on treatment or CD4 cell count \< 250 cells/ml)
* Tumors
* Opportunistic infections
* Pregnant women
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial

The purpose of this clinical trial was to systematically study the clinical performance and accuracy of the human DAB2IP, CHFR and GRASP gene methylation combined test kit (PCR-fluorescent probe method) produced by Jiangsu Kunyuan Biotechnology Co., LTD. The test reagent was compared with the clinical reference standard (pathological diagnosis and/or imaging diagnosis) to verify the clinical performance of the product. At the same time, for each gene that can be detected by the assessment reagent, the digital PCR method is used as a comparison method to verify the accuracy of the assessment reagent detection. The validity of the assessment reagent can meet the requirements of its intended use from the above two aspects, and provide sufficient clinical evaluation data for the registration and application of the product in China.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, gender unlimited;
2. Subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 mL);
3. Subjects who meet one of the following conditions:

   (i) Initial treatment subjects with symptoms and/or signs suspected of hepatocellular carcinoma as determined by the clinician;

   People with HBV or HCV infection, excessive alcohol consumption, non-alcoholic steatohepatitis, cirrhosis of the liver from other causes (LC), benign hepatopathy (BHL), and a family history of liver cancer;

   iii Subjects with other tumors, including but not limited to esophageal, stomach, colorectal, pancreatic, lung, breast, prostate, etc.;
4. Voluntarily participate in the experiment and sign the informed consent.

Exclusion Criteria:

1. Liver cancer subjects who have received previous treatment, such as radiotherapy and chemotherapy, surgery, etc.;
2. Subjects with other malignant tumors;
3. Subjects with recurrent liver cancer confirmed or suspected by the investigator;
4. Subjects whose information is missing or untraceable;
5. The researcher believes that the subjects should not be included in this study for other reasons.
Allopurinol and Quality of Life in Liver Cirrhosis

The study aims to evaluate the impact of allopurinol on patients' related quality of life.

Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers

Eligibility Criteria:
Inclusion Criteria:

cirrhosis adult both sex

Exclusion Criteria:

* renal insufficiency
Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.


Eligibility Criteria:
Inclusion Criteria:

(For prospective subjects diagnosed with stroke)

* Confirmed diagnosis of a single stroke at least six months prior to participation

Exclusion Criteria:

* History of vestibular disorders or dizziness
* Diagnosis of neurological disorders affecting movement
* Ocular disease and/or impairment in more than one eye
* Pregnant or expecting to become pregnant
* Difficulty maintaining alertness and/or remaining still
Familial Form of Carotid Web: a Doppler Ultrasound Study

There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound.

Carotid web are rare, focal dysplasia of the internal carotid artery and a high risk causes of stroke in young adult. Natural history of these dysplasia remains poorly understood. High prevalence of carotid web among Afro-Caribbean population and the similarity between carotid web and fibromuscular dysplasia, suggest existence of genetic factors. But there has been to our knowledge no familial form of carotid web reported. The aim of this study is to determine the prevalence of carotid web among relatives of patients with carotid web using carotid duplex doppler ultrasound.

Researchers aim to test whether carotid web could be detected in relatives of patients with known carotid web, using duplex doppler ultrasound.

This is a pilot, transversal, single-center study performed at Toulouse University Hospital, France. From 30 carotid web cases aged under 65 (patients with previously known Carotid web, symptomatic or not) followed in neurology department, investigators aim to include 60 first-degree relatives younger than 65 years old. Included relatives will underwent carotid duplex doppler ultrasound to detect carotid web. The primary outcome is the prevalence of carotid web among relatives. Secondary outcomes include : Number of families with at least one relative who has been diagnosed with carotid web, number of relatives who has been diagnosed with carotid web per family, clinical characteristics of patients and morphological characteristics of carotid web.

Eligibility Criteria:
Inclusion Criteria:

Carotid Web index patients:

* Patients with carotid web confirmed by CT angiogram (CTA) of cervical arteries or digital substraction angiogram (DSA).
* At least one first degree relative aged younger than 65 years old.

Relatives patients :

- First degree relatives of patient with diagnosed carotid web.

Exclusion Criteria:

* Persons placed under judicial protection or under another protection status
* Pregnant or breastfeeding woman.
Troponin I Level and Mortality in Acute Abdominal Surgery

The goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery.

MINS is defined as at least one increased single measurement of plasma troponin I (TnI). TnI-dynamic is defined as either two succeeding measurements of TnI \> 59 ng/l with an increase/fall of more than 20%, or by one measurements of TnI \> 59 ng/l with a succeeding measurement of TnI \< 59 ng/l and a decrease of more than 50%.

Participants will have plasma TnI measured 6-12 hours postoperatively and on each of the following four postoperative days. Follow-up will be minimum one year after surgery.

The aim of the study is to determine:

* The incidence of MINS within the first four postoperative days
* The incidence of dynamic TnI changes
* The association between MINS and dynamic TnI changes respectively and all-course short-term mortality

Gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. Myocardial injury after non-cardiac surgery (MINS) is a frequent but often unrecognized postoperative complication. MINS is associated with an increased risk of other cardiac complications and 30-day mortality. However, the literature on MINS is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic TnI-criteria used for acute myocardial injury has any association with mortality in patients with MINS.

This study aims to estimate the incidence of MINS in patients undergoing AHA surgery, and the association between the short-term mortality and MINS defined as a single increased measurement of TnI and as TnI dynamics respectively.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients undergoing acute high-risk abdominal surgery

Exclusion Criteria:

* Patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage
* If further treatment postoperatively was assessed as futile and terminated immediately after surgery
Emergency Management of Minor Blunt Thoracic Trauma

Thoracic traumas are frequent causes of emergency department admissions and the third most common cause of death from trauma. Although emergency management of major thoracic traumas that have high mortality and morbidity were discussed and well-understood in detail in the literature, there are limited information regarding diagnosis, emergency management, treatment and follow-up after discharge of patients with minor blunt thoracic traumas.

The investigators aimed to investigate demographic data, physical examination findings, and the relationship between lung injury, emergency department final diagnosis, hospitalization, discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale (GCS) of 15
* stable vital signs
* admitted within the first 6 hours after injury

Exclusion Criteria:

* urgent and urgent triage category
Examining the Impact of Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males

This crossover study investigates the effects of restricting arterial blood flow during cycling exercise on PGC-1α and its upstream signalling pathways. In a randomized order, participants will exercise once for 30 minutes with restricted blood flow and then will exercise once for 30 minutes with no blood flow restriction.


Eligibility Criteria:
Inclusion Criteria:

* 3 hours of physical activity per week
* No previous cycling training
* No concurrent involvement in another training program
* Body mass index \< 30 kg/m2

Exclusion Criteria:

* Presence of cardiovascular disease
* Presence of metabolic disease
* Taking regular oral medication
* Current smoker
Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination

The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.

The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros

Eligibility Criteria:
Inclusion Criteria:

* Subject over 18 years old
* Consent to participate in the study
* Member of or beneficiary of a social security scheme
* For patients: benefiting from an MRI examination as part of their care
* For volunteers: Consent to be informed if an unexpected anomaly is revealed by the imaging.

Exclusion Criteria:

* Subject benefiting from a measure of legal protection
* Pregnant or breastfeeding women
* For volunteers: Contraindication to MRI (detailed contraindications questionnaire, THI score \>28 questionnaire, hearing sensitivity questionnaire grade \>1)
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation
* Candidate for cardioversion

Exclusion Criteria:

* Colchicine allergy
* Hepatic or renal failure
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma

To evaluate the difference in the incidence of febrile episodes in patients undergoing stem cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim.

A febrile episode will be considered as: body temperature \> 38°C for two measurements in the 24 hours with an interval of 6 hours at least between the two measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 and \< 70 years
2. Diagnosis of multiple myeloma
3. ECOG \< 2 to be evaluated at baseline, after the induction chemotherapy
4. Indication to the mobilization with high dose cyclophosphamide chemotherapy
5. Normal blood counts: neutrophils \> 1500/μl; platelets \> 100.000/μl; hemoglobin \> 10 g/dl.
6. Liver and renal function: SGOT/AST, SGPT/ALT; bilirubin \< 1.5 times the upper limit of the normal ranges; creatinine \< 2 times the upper limit of the normal ranges.
7. Interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days
8. ECG e/o Echocardiogram within age related normal range
9. Negative HCV and HbsAg
10. Must be willing and able to fill in the patient's diary
11. Written informed consent

Exclusion Criteria:

1. Documented and/or suspected infections
2. Uncontrolled concurrent illness
3. Documented cardiac dysfunction