cyrilzakka/clinical-trials huggingface dataset:
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

see Brief summary

Eligibility Criteria:
Inclusion Criteria:

* Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
* Study site is from 1-15% BSA
* Study site is a single, isolated burn area
* From 2 years and above
* Thermal burn injury
* Signed Informed Consent/Assent Form
* Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.

Exclusion Criteria:

* Completely non-exuding or dry wound bed at study site
* Full thickness \>5%
* Burn greater than 24 hrs old
* Burns to face or neck
* Suspicion of infection of study burn
* Use of chemical/enzymatic and biological debridement within 7 days of investigation start
* Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
* Subject with lung injury or subject being on a ventilator
* Subject with dermatologic skin disorders or necrotizing processes
* Subject with insulin dependent diabetes mellitus
* Electrical, chemical etiology
* Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
* Non-compliant subject
* Subject previously included in this investigation
* Subject included in other ongoing clinical investigation at present or during the past 30 days.
Engaging Church Health Ministries to Decrease Coronavirus Disease-19 Vaccine Hesitancy in Underserved Populations

This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities.

This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities. A total of 98 participants from three-to-five churches will be randomized to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated, boosted, and tested, or to a delayed intervention control group. The effects of the intervention on the primary outcome, change in vaccine/booster hesitancy, will be assessed by a questionnaire that will be administered to both groups at baseline and after three weeks. Following the three-week control period, the delayed intervention control group will also receive the intervention and again be administered the questionnaire. Questionnaires will be used to obtain more granular information on sources of vaccine/booster hesitancy and for their vaccine-related decisions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 y
* Not having received an initial COVID-19 vaccine or a booster vaccine at the recommended interval
* Having vaccine or booster hesitancy
* Able to understand and speak English
* Willing to engage with the church's health ministry via in-person or virtual/phone sessions

Exclusion Criteria:

* None
Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.

The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.

Eligibility Criteria:
Inclusion criteria

* Age \> 18 years
* Metastatic prostate cancer
* Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2)
* Free, informed and signed consent for research

Non inclusion criteria

* Refusal of blood and urine collection
* Patient cognitively incapable of signing consent to participate in this study
* Patient under guardianship or curatorship
Dry Run of the ScreenUrSelf Trial

The proposed study is the Dry Run preceding the ScreenUrSelf trial.

The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practice within the organized cervical cancer screening program in Flanders).

The Dry Run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf trial. The primary outcome of the Dry Run is to check if the flow for data- and sample collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed necessary before start of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for cervical cancer screening within the organized Population-based Screening Program in Flanders:

  * Female
  * Residing in Flanders, Belgium
  * No history of total hysterectomy
  * No (former) diagnosis of cervical or uterine cancer
  * 30 - 64 years old (birth year 1959 - 1992)

Exclusion Criteria:

* Being pregnant or 6 weeks postpartum (self-reported after receiving the study letter/package)
* Participation during menstruation or within the 3 following days is a contraindication
* Not able to understand the study materials and participation form (informed consent form)
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection: Canada

This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages of 3-16 who are failing or intolerant of their current antiretroviral regimen and who are unable to swallow Sustiva capsules.


Eligibility Criteria:
Inclusion Criteria:

* Children 3-16 years of age
* Anti-retroviral naive or experienced
* Failing or intolerant to current anti-retroviral (ARV) regimen
* Limited available viable therapeutic options
* Inability to take capsules/tablets

Exclusion Criteria:

* Weighs less than 10 kg
* Failure on or concomitant use of other non-nucleoside reverse transcriptase inhibitors (NNRTIs)
* An active AIDS-defining opportunistic infection or disease
* More than two episodes of moderate to severe diarrhea or vomiting lasting more than four days within the past three months
Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate

The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, at least 18 years of age
* have stable plaque psoriasis for at least 6 months, psoriasis involving at least 10 percent of the body surface area, had a minimal PASI of 10 at screening
* had previously received phototherapy or systemic psoriasis therapy at least once or candidates for such therapy in the opinion of the investigator

Exclusion Criteria:

* Patients with guttate, erythrodermic, or pustular psoriasis at the time of screening
* recent infection or opportunistic infections, active tuberculosis, hepatitis B and so on
* liver and kidney dysfunction
* those with other serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, liver, lung and kidney), other autoimmune diseases, cancer, HIV infection, which are not suitable for participation in the study of the disease
* history of significant methotrexate toxicity or total cumulative methotrexate exposure \> 1000 mg (unless grade ‡ IIIb liver injury has not occurred)
* use of ultraviolet (UV) B therapy, topical ciclosporin or calcineurin inhibitors, class III through VII topical corticosteroids (permitted on the scalp, axillae, and ⁄or groin), or topical vitamin A or D analogues within 14 days of screening
* and psoralen or UVA therapy, systemic psoriasis therapy (including methotrexate), oral retinoids, class I or II topical corticosteroids, dithranol, cyclophosphamide, sulfasalazine, or intravenous or oral calcineurin inhibitors within 28 days of screening
* Patients were excluded if they had received a tumor necrosis factor (TNF) blocking agent or other biologics within 3 months or interleukin (IL)-12 or IL-23 inhibitors within 6 months of study initiation
Use of TREM-1 Protein to Differentiate Viral and Bacterial Pneumonias in Intubated Children

The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.

Most often, viruses are the cause of pneumonia in children. However, viral pneumonias are frequently associated with secondary bacterial pneumonia. It is important, though difficult, to differentiate patients who only have viral pneumonia from those who have viral pneumonia with secondary bacterial pneumonia. This will help physicians to prescribe antibiotics to only those with bacterial pneumonia and avoid antibiotic use in those with pure viral pneumonia, thus help to limit health-care cost and to decrease emergence of antibiotic resistance. In adult studies, TREM-1 has been shown to be specifically expressed in bacterial infections.

We propose that measuring TREM-1 in the bronchoalveolar lavage (BAL) fluid will help to differentiate these groups. Our hypothesis is that concentration of TREM-1 will be significantly elevated in the BAL fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Children from birth to 18 years intubated for respiratory failure or for surgery as mentioned above within 48 hours of intubation.

Exclusion Criteria:

* Use of antibiotics \>72 hours preceding the study (not applicable to the definite bacterial pneumonia group)
* Use of oral/parenteral glucocorticoid therapy \<2 weeks prior to admission
* Presence of tracheostomy
* Active treatment for pulmonary arterial hypertension
* Mechanical ventilation with FIO2 \>0.6, MAP\>20
* Presence of severe pulmonary interstitial emphysema, pneumothorax, bradycardia (heart rate, \<80 beats/min in neonates, \<70 beats/min in infants), hypotension (mean arterial pressure, \<40 mm Hg in neonates, \<50 mm Hg in infants), and platelet count of \<30,000/mm3.
* Immunodeficient or immunocompromised due to other conditions.
* Enrollment in another interventional study that employs BAL.
A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)

The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Willing and able to provide informed consent
* Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
* Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
* Must submit tumor tissue sample representative of current disease per laboratory manual

Exclusion Criteria:

* Non-squamous histologies (eg, nasopharynx or salivary gland)
* Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
* Tumors that are PD-L1 negative (CPS \<1)
* Clinical evidence of an active second invasive malignancy within \<2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers
* Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)
The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure

The aim of the study is to compare the effects of torasemide and furosemide on clinical and biochemical parameters of hemodynamic and neurohormonal compensation and myocardial remodeling in patients with chronic heart failure with indications for use of loop diuretics.

The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose loop diuretics\]) treated with optimal medical therapy as clinically indicated for use loop diuretics. Patients will be randomized to treatment with furosemide and torasemide (randomization 1 : 1). After randomization, furosemide will continue in its current fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal follow-up of patients in the study will be at least six months.

According to current guidelines, angiotensin converting enzyme inhibitors and beta-adrenolytics are the first-line treatment agents in patients with heart failure. In case of fluid retention, diuretics, as a part of symptomatic treatment, should be administered. In practice, the most common diuretic used in patients with heart failure is loop diuretic - furosemide. What is important, furosemide has no effect on patients' outcomes. Some studies showed unfavourable influence of this drug on rennin-angiotensin-aldosterone system.

Alternative loop diuretic, which may be administered in patients with heart failure is torasemide. Its longer elimination half-life time, similar diuretic effects, lower influence on electrolyte disorders and additional pleiotropic effects could make torasemide more beneficial than furosemide.

Accordingly, only direct comparison of furosemide and torasemide could present similarities and differences of these two agents.

The hypothesis of this study is that torasemide may present more favourable effects on some clinical parameters in patients with heart failure, than furosemide (e.g. clinical symptoms, biochemical parameters, activity of rennin-angiotensin-aldosterone system, side effects).

Eligibility Criteria:
Inclusion Criteria:

* heart failure NYHA II-IV
* previous treatment with diuretics
* age\>18 years

Exclusion Criteria:

* uncontrolled hypertension
* uncontrolled diabetes
* creatinine \> 2,5 mg/dl
* potassium \> 6 mg/dl
* acute coronary syndrome
* hypertrophic cardiomyopathy
Radiotherapy Treatment Planning Comparison Using SBRT-PATHY (Photons) Versus CARBON-PATHY for Unresectable Bulky Tumors

This study uses a novel unconventional radiotherapy technique, consisting of high dose PArtial Tumor irradiation targeting exclusively the HYpoxic segment of unresectable bulky tumors delivered either with photons (SBRT-PATHY) or with carbon-ions (CARBON-PATHY) while sparing the peritumoral immune microenvironment (PIM).

This study will be conducted as a two phase study. Phase A is a retrospective study. Up to 10 patients with bulky (\>6cm tumors) previous planned with planning CT with IV contrast will be selected for planning and dosimetry comparison. This is performed to optimize the contouring and planning procedures. Phase B is a prospective study. Ten patients with bulky (\>6cm tumor) requiring radiotherapy, with planning CT and MR with IV contrast will be accrued. Every effort will be made to include equal numbers of patients (2-3) from head and neck, thorax, abdomen and pelvis. Their images will be used for planning and dosimetry comparison.

Patients will be treated according to clinical plans. The study plans will not be used for treatment. Treatment plans for Photon delivery (SBRT-PATHY) and Carbon delivery (CARBON-PATHY) to deliver 30 Gy in three fractions will be planned to be delivered to the BTV will be performed. SBRT-PATHY plans will be generated at the Princess Margaret Cancer Center (PMCC, Toronto, Canada) while CARBON-PATHY plans will be generated at the MedAustron Center for Particle Therapy and Research (W. Neustadt, Austria).

The objective is to compare the dosimetric profile achievable using SBRT-PATHY (using photons) and CARBON-PATHY (using carbon-ions) for unresectable bulky tumors and surrounding tissues.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (for use their planning CT and MR data for study specific planning)
2. Malignant solid bulky primary or recurrent tumor with diameter of ≥6 cm
3. Age \> 18 years
4. Radiation planning CT (with IV contrast) and MRI (with or without IV contrast) is planned

Exclusion Criteria:

1. Patients without bulky lesions,
2. Contraindication to i.v. CT and MRT contrast medium administration, particularly estimated glomerular filtration rate (GFR) less than 45 mL/min/1.73 m².
3. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control,
4. Any condition that, in the opinion of the investigators, would interfere with treatment planning or interpretation of study results

Note (1): criterion n°4 will be evaluated on the four eyes principle, evaluated by both Principle Investigator and Sub-Investigators.
Percutaneous Microwave Ablation Under Ultrasound Guidance for Liver Cancer: a Multicenter Analysis

Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. This study is designed to investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA as a primary treatment will be enrolled from at least ten Chinese institutions with different levels of MWA experience. All the patients will be closely followed up until June 2019. Clinicopathologic data, recurrence and survival estimates, complications and prognosis-relative factors will be measured.


Eligibility Criteria:
Inclusion Criteria:

* absence of ascites or the depth of ascites on US detection less than 4 cm;
* a normal serum total bilirubin level or less than 60 µmol/L;
* a normal albumin level or not less than 30 g/L;
* for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
* for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.

Exclusion Criteria:

Contraindications include patients who have

1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state;
2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L);
3. high intrahepatic tumor burden (tumor volume \>70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden;
4. acute or active inflammatory and infectious lesions at any organ;
5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction;
6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.