cyrilzakka/clinical-trials huggingface dataset:
Polidocanol Versus Glucose Treatment of Telangiectasia Trial

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.

Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.

Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.

Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis.

Eligibility Criteria:
Inclusion Criteria:

* females
* with telangiectasis on thigh side
* clinical classification of chronic venous disease C1(mild venous disease),
* minimum age of 18 year-old and maximum age 65 year-old
* agreement with the study
* signing the free and informed consent ( IC)
* not use anticoagulant drugs .

Exclusion Criteria:

* male
* varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
* restrict mobility
* arterial insufficiency
* be allergic to any substance that may be related to the study drugs
* any cause of dermatitis on application site
* don´t be free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
* pregnancy
* previous deep vein thrombosis (DVT)
* family history of DVT
* thrombophilia
* do not agree with the search terms
Coagulation Parameters in IBD Patients

1. to assess the incidence of coagulation disorders in IBD patients in comparison with another normal controlled group
2. risk factors that contribute to development of thrombosis in IBD patients
3. to determine the effectiveness of prophlactive anticoagulant measures
4. to determine the association between disease activity and coagulation parameters

Inflammatory bowel disease is a group of disorders associated with chronic, recurrent, and immune system-mediated inflammation of The bowel mucosa . The reported global incidence and prevalence rates for ulcerative colitis vary between 1.2-20.3 and 6-246 per 100000 persons, respectively, and the corresponding figures for Crohns disease are 0.03-15.6 and 3.6-214 \[2 In a population based cohort study involving 1160 patients with ulcerative colitis, the complication-related mortality rate was 9.6% during follow-up period of 35 years, in another study, 221 patients with Crohns disease were followed up for 33 years, with an overall complication-related mortality rate of Of the extra-intestinal manifestations of inflammatory bowel disease (IBD), thromboembolic events represent a major cause of morbidity and mortality with a 3.6 times increased risk in comparison with the general population .

Although clinical observations suggest an incidence rate between 1 and 8% for thromboembolic events in subjects with IBD, postmortem studies point out to a much higher occurrence rate around 41% . As a matter of fact, these and similar findings have led to an increased interest in the search for the association between IBD and hypercoagulable states as a potential cause of increased morbidity and mortality due to thromboembolic events in IBD . For instance, the existence of documentable prothrombotic abnormalities and a positive history for thromboembolic complications were demonstrated in at least one third of the subjects with IBD in a study by Solem et al Inflammation and coagulation are two crucial systems that are in balance and constantly influence each other. The impact of inflammation on coagulation has been confirmed by several experimental studies showing that inflammatory mechanism shift the hemostatic balance to favor the activation of coagulation which, in turn, can also sustain inflammation promoting a vicious circle between chronic inflammation and thrombosis

Eligibility Criteria:
Inclusion Criteria:

All patients of IBD more than 18 years

Exclusion Criteria:

-All IBD patients less than 18 years-all diseases that cause coagulation disorders all diseases that cause coagulation disorders ( liver diseases , collagen diseases, other auto immune disease
The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy

This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy

This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time

Eligibility Criteria:
Inclusion Criteria:

Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria:

Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
Nitric Oxide During CPB to Reduce AKI in Neonates

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

Screening: All patients undergoing either elective or emergency cardiac surgery will be screened against the eligibility criteria.

Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively.

Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure.

Participants will be randomly allocated to the NO or control group in a 1:1 ratio.

This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age: \</= 30 days
* Gestational age: 38 weeks
* Diagnosis: Congenital Heart Disease (CHD)
* Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD
* Consent of parent/guardian

Exclusion Criteria:

* Currently receiving or has received inhaled nitric oxide (NO) or other nitrogen donors such as sildenafil or nitroprusside
* Pre-existing acute kidney injury (AKI) as per the AKIN criteria;
* Cardiac arrest within one week prior consent;
* Prior cardiac surgery with CPB procedure;
* Prior history of Extra Corporeal Membrane Oxygenation (ECMO)
* Use of another investigational drug.
A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)

This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.

Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab product label and local standard of care. AxSpA patients who responded to newly initialized adalimumab treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. Although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group.

Participants who consented to participate in the study were observed for up to 12 months from Baseline (defined as the Randomization visit where participants were assigned to one of the two physiotherapy options).

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification, aged at least 18 years
* Prescription of Humira® (adalimumab) for treating axSpA according to the local product label
* Eligibility for active physiotherapy according to the rheumatologist and physiotherapist
* Participants must have signed written informed consent before starting any study related assessments or procedures.

Exclusion Criteria:

* Participants with total spinal ankylosis based on the investigators' assessments of available radiographs
* Participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist
* Participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol
* Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is prohibited.
Study Comparing Satisfaction of Hospitalized Patients Receiving Invasive Care for Cancer Treatment, With Snoezelen Session Versus Standard Care

This is a monocentric, comparative, open-label, randomized, crossover study enrolling patients hospitalized in Strasbourg Europe Cancerology Institute, receiving repeated invasive care for cancer treatment.

The purpose of this study is to compare the satisfaction of patients, regarding their perception of care, with or without Snoezelen session.

Patients will followed during two visits for a repeated invasive care. They will be randomized to two groups in a 1:1 ratio.

Crossover plan and arms are described as follow:

Arm A : Visit 1 with Snoezelen session before invasive care and Visit 2 without Snoezelen session before invasive care (standard care)

Arm B : Visit 1 without Snoezelen session before invasive care (standard care) and Visit 2 with Snoezelen session before invasive care

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for cancer and hospitalized for invasive care
* Two programmed hospitalization for repeated care
* Patients receiving one of the following invasive care: Huber needle application (transfusion, parenteral nutrition), complex wound dressing, intrathecal chemotherapy, ascites fluid or pleural puncture
* Patients must be ≥ 18 years old
* Performance Status ≤ 3
* Absence of psychiatric disorder impairing follow-up
* Ability to speak, understand, write and read French
* Signed informed consent from the patient
* Affiliation to social security system

Exclusion Criteria:

* Patients presenting infectious symptoms requiring isolation
* Patients \< 18 years old or patients ≥ 18 years old under supervision
* Patients placed under judicial protection or guardianship
* Women that are pregnant or breast-feeding
MASCOT Registry of Patients With Myeloproliferative Neoplasms Associated Splanchnic Vein Thrombosis

A registry of UK patients diagnosed to have splanchnic vein thrombosis and myeloproliferative neoplasm, including isolated mutation of JAK2V617f. The purpose of the registry is to understand outcomes, treatment variations and data to inform and enable future clinical trial design and facilitate regulatory approval decision-making.

Splanchnic or abdominal vein thrombosis (SVT) comprises thrombosis of hepatic, portal, superior mesenteric, splenic vein in isolation or combination. It has a prevalence of 1-2% in the general population based on autopsy reports. However, 40-50% of patients with hepatic vein thrombosis and about 25-30% of patients with PVT have an underlying myeloproliferative disease that is the cause of the thrombosis. Although some data on MPN-SVT have been published from European registries, the lack of sufficient clinical and scientific data in these patients has led to variation in treatment patterns with regard to timing, choice and duration of anticoagulation, the use of cytotoxic or biologic agents and interventions with thrombolysis and stenting with TIPSS in the acute stage. Data on the patterns of treatment of these patients in U.K and their outcomes with regard to morbidity and mortality are lacking. Availability of such data in U.K. will lead to the design of good quality prospective interventional studies.

PROJECT DESIGN This registry is designed for longitudinal real-world data collection on UK patients with MPN-SVT who are managed at tertiary liver centres in U.K. A pre-defined data set, built by a committee of specialist clinicians from the Mascot registry investigators will be collected and entered into the electronic web-based database built by Dendrite Clinical Systems Ltd.

The data captured includes demographic information linked to the NHS number, which will enable linked-anonymous data accrual and analysis as well as correlation with the Systemic Anti-Cancer Therapy Data Set (SACT) via the National Cancer Registration and Analysis Service (NCRAS) and Cancer Drug Fund (CDF) database. It will also allow interrogation of the national registries for stroke (SSNAP) and cardiac surgery (NACSA) as co-morbidities involving arterial circulation are prevalent in 30% of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Myeloproliferative neoplasm (MPN, WHO 2008, WHO 2016, BCSH) and splanchnic vein thrombosis
* Isolated Jak2v617f allele and splanchnic vein thrombosis
* MPN and portal cavernoma

Exclusion Criteria:

-
Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients

Studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. The trial test the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome. Prospective randomised controlled trial in adult patients admitted for burns \> 15% body surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study endpoints: mechanical ventilation time, inflammation (CRP), infectious and other complications, mortality until discharge.

The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.

Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing solution.

The patients are fed as long as clinically required with the initial solution.

Eligibility Criteria:
Inclusion Criteria:

- adult \>16 years, burns \> 15% BSA, mechanical ventilation, next of kin consent

Exclusion Criteria:

* absence of the above, absence of commitment to full treatment
* comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
* pregnancy
Healthy Planet Hepatitis B

This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.


Eligibility Criteria:
Inclusion Criteria:

- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record

Exclusion Criteria:

- previously completed hepatitis B screening tests
Role of Stress Cardiac MRI in Predicting Adverse Clinical Events in Patients With Known or Suspected Ischemic Heart Disease

The investigators plan to use retrospective data to assess heart function and structure abnormalities through the use of an approved vasodilating agent for stress cardiac MRI tests. The investigators are interested in how these MRI findings relate to long-term prognosis in people who are at risk for cardiac disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 21 years old
* No contraindications for cardiac MRI (by renal function or metallic hazards)
Serious Games for Training in Oral Rehabilitation

Coronavirus disease-19 (COVID-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. The "Playdent" project proposed the integration of serious games (SGs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.

Three Serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. However, in order to assess the influence of SGs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. The null hypothesis was that SGs had no impact on the learning outcomes of undergraduate students.

Eligibility Criteria:
Inclusion Criteria:

* adult students (aged at least 18)
* enrolled in the third-year at the faculty of dental surgery of the University of Paris,
* agreeing to participate in the study

Exclusion Criteria:

* Third-year students who had repeated their courses
Intracranial Stimulation Mapping In Epilepsy

This is a single group prospective study to determine the feasibility for generating brain maps that localize cerebral functions and inter-regional information flow in partial epilepsy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years and older at screening.
* Written informed consent is obtained from the participant to comply with the requirements of the study.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Currently undergoing clinically indicated intracranial EEG monitoring for planning of epilepsy surgery in the University of Minnesota/MINCEP program.

Exclusion Criteria:

* Pregnancy ruled out prior to approval for intracranial EG monitoring.
* Persons who are rendered temporarily or permanently invulnerable by inability to understand the research due to study complexity, cognitive impairment, or by inability to make independent decisions owing to University of Minnesota or to Fairview health services.
Smartphone App for Cancer Medication Adherence

For this current proposal, the investigator will conduct a single-center prospective non-randomized pilot interventional study in patients with any stage and type of cancer who are either taking at least one OACD or are taking at least one oral medication for chronic condition management in conjunction with any cancer treatment.

Primary Objective: To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients either receiving oral anticancer agents (OACDs) or receiving oral medications for chronic disease management (non-OACDs) in conjunction with non-oral cancer treatment.

Secondary Objectives: To compare and characterize medication adherence before and after the 12-week intervention using the Voils Extent of Adherence Scale and the Medisafe App. Also to determine the acceptability, utility and patient engagement with the App, to evaluate changes in healthcare related quality of life before and after the intervention, and to explore behaviors, knowledge, attitudes and beliefs related to medication adherence using a semi-structured interview delivered over the telephone.

Many patients with cancer experience frustration with the large number and complex scheduling of their medications. This study will help find out how much "pill burden" exists in patients with cancer, and how a smartphone app can help patients take medications as providers prescribe. Results of this study may help figure out the best way to help patients manage medications in the future.

Eligibility Criteria:
Inclusion Criteria:

* Any type/stage cancer
* Patients must be taking either:

  * at least one oral anti-cancer drug (OACD) or
  * at least one oral medication (non-OACD) for management of a chronic condition in addition to receiving non-oral cancer treatment
* Patients must have access to a mobile phone or tablet that can download the Medisafe App. (ie apple/android)
* Subjects must be able to complete self-administered questionnaires in English or Spanish.
* Co-enrollment in trials involving pharmacologic therapy is allowed.

Exclusion Criteria:

* Inability to provide informed consent