cyrilzakka/clinical-trials huggingface dataset:
Study of Aortic Root Reimplantation Procedure

Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.

A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.

Eligibility Criteria:
Inclusion Criteria:

* Aortic insufficiency 2+
* Ascending aorta or aortic root of greater than 4.5 cm (\> 4.0 cm in Marfan syndrome)
* Good conditions of aortic cusps

Exclusion Criteria:

* Aortic annulus more than 32 mm
* Aortic cusps destruction
* Critical aortic cusps elongation
* Aortic root dissection
Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation test

Exclusion Criteria:

* serious disease
* other perennial allergies
Increasing Family Engagement in Critical Care

The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients.

The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. "Engage" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. "Learn" contains educational capsules about the ICU environment and information about care participation. "Report" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult family members (age ≥ 18 years) of ICU patients
* Expected ICU stay ≥ 48 hours
* Able to participate in English or French

Exclusion Criteria:

* Family members who do not wish to participate in care
* Repeat admissions within the study period
* Another family member has already participated in the study
Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement

The aim of this study is to evaluate the accuracy and implications of the diagnoses and treatment determined by bedside ultrasonography (b-US) of the kidneys compared to current clinical assessment. Potentially diagnosing patients faster and avoiding missing conditions leading to readmission or unnecessary radiation from computed tomography (CT).

This study evaluates the use of b-US as a supplement to clinical evaluation, in an unselected group of patients in the emergency department (ED) with signs of kidney involvement. The b-US of the kidneys is performed by a medical student certified in this technique. The evaluation will be based on data collected from a Danish hospital (Odense University Hospital, OUH) in autumn 2018.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of urinary tract infection and one or more of the following:
* Flank pain
* Fever
* Symptoms when voiding
* Creatinine elevation or 20% elevation from known creatinine level elevation

Exclusion Criteria:

* Age \< 18 years
* Radiological ultrasonographic examination already performed
* Patients who are not able to consent
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score.

We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon.

However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions.

The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.


Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years of age
* Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies
* PSA ≤ 30 ng / ml
* Clinical stage ≤ T2c
* Affiliation or beneficiary of a social security scheme

Exclusion Criteria:

* Men over 80 years of age
* PSA\> 30 ng / ml
* Stage T3 or T4 on digital rectal examination
* Previous prostate biopsy performed within 12 months
* History of prostate cancer diagnosed by biopsy or endourethral resection.
* History of pelvic radiotherapy regardless of the cause.
* History of total or focal treatment for prostate cancer.
* History of hormone therapy
* MRI performed more than 3 months before biopsy
* Prostate MRI performed on a machine other than the center's machines accredited for the study.
* Presence of a hip prosthesis
* Contraindication to performing an MRI
* Contraindication to performing prostate biopsy
* Patient subject to a legal protection measure or deprived of liberty
* Subject participating or having participated in interventional medical research with an exclusion period still in progress
* Misunderstanding of the French language
Skin Sensitization Test (Modified Draize-95 Test)

Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be aged 18 to 65 years, inclusive;
* Subjects who have not participated in other voluntary testing for at least 30 days;
* Subjects must execute an Informed Consent Form that includes a HIPAA statement; and
* Subjects must be capable of understanding and following directions.
* Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial.

Exclusion Criteria:

* Subjects who are in ill health, as determined by the PI;
* Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
* Subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial;
* Female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial;
* Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
* Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
* Subjects with any visible skin disease that might be confused with skin reactions caused by the test material;
* Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
* Subjects with any indication of existing Type I allergy (immediate hypersensitivity) to natural rubber proteins;
* Subjects with a history of frequent irritation; or
* Subjects who have received endogenous or exogenous immunosuppressive treatment (or prolonged exposure to sun).
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children

Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children


Eligibility Criteria:
Inclusion Criteria:

* Aged 4 to 6 years on the day of enrolment.
* Have received, on the day of enrolment, immunisation with Triaxis as a 5th dose for diphtheria, tetanus, pertussis vaccination in routine practice in accordance with the Spanish version of the EU SmPC and the Spanish immunisation recommendations.
* Have received a complete course of immunisation with diphtheria, tetanus and pertussis (4 doses).
* Participant and participant´s parent/legal representative are able to comply with all study procedures.
* Written informed consent obtained from at least one parent/legal representative of the participant before the participant is enrolled in the study

Exclusion Criteria:

* Have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis.
* Presence of a contra-indication or cautions to vaccination in accordance with the Spanish version of the EU SmPC:

  1. Hypersensitivity to vaccines of diphtheria, tetanus or pertussis, any component of the vaccine and any residual component of the manufacturing process such as formaldehyde and glutaraldehyde that may be present in trace amounts.
  2. Encephalopathy of unknown origin within 7 days after a prior immunisation with a vaccine against pertussis.
  3. Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy if no treatment has been established and the condition is not stable.
  4. Acute severe febrile illness or acute infection.
Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients

Steroids are one of the pillars of immunosuppression for kidney transplant patients but their use is associated with a high rate of complications. Withdrawal of steroids reduces some metabolic and cardiovascular complications, but it may increase the risk of acute rejection. However, little is known about whether steroid withdrawal is associated with the generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months after the transplantation as compared with patients who continue with steroids. The hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney transplant patients


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged over 18 years with no immunological risk (PRA \<25% and no DSA) who are receiving their first cadaveric or living kidney transplant.
2. Patients who, three months after the transplantation, are receiving tacrolimus in combination with mycophenolic acid (MPA) or mycophenolate mofetil (MMF) plus steroids, with stable plasma levels of tacrolimus.
3. No clinical or histological immunological dysfunction before randomization
4. No de novo anti-HLA DSA at the time of randomization.
5. Patients who wish to and are able to give written informed consent to participate in the study.
6. For women, agreeing to use efficient contraception during the study.

Exclusion Criteria:

1. Patients who receive a multiorgan transplant.
2. Retransplants.
3. Presence of DSA before the transplant or at the time of randomization.
4. Cold ischemia time \>30 hours
5. Patients with serum creatinine \>2 mg/dL or proteinuria \>1g/day at the time of randomization
6. Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization.
7. Presence of subclinical rejection on the protocol biopsy prior to randomization
8. Patients with BK-polyomavirus nephropathy at the time of randomization.
9. Patients with recurrent or de novo glomerulonephritis.
10. Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question.
11. Patients who are positive for the human immunodeficiency virus (HIV) or those who have a severe systemic infection that, in the investigator's judgment, will require continued treatment.
12. Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised.
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma

This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed soft tissue sarcoma
* Locally advanced, recurrent, or metastatic, unresectable disease
* Measurable disease according to modified RECIST
* ECOG performance status of 0 or 1
* Men or women at least 18 years of age
* Adequate hematological, renal, hepatic, and coagulation function

Exclusion Criteria:

* Prior treatment with anthracyclines
* Uncontrolled cardiovascular disease
SGLT2 Inhibitors and Effects on Hematopoiesis, Inflammation and Metabolic Markers

Study of the response to SGLT2 inhibitors in type 2 diabetic patients with relevance to the erythropoesis and indexes of cardiorenal function.

The study enrolls type 2 diabetic patients in whom the introduction of a SGLT2 inhibitor is deemed necessary as part of their routine treatment during their visit to our outpatient diabetes unit.

A whole blood, a serum and a urine sample is obtained before and one month after the initiation of treatment with a SGLT2 inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* Hba1C\>7% on their current treatment
* introduction of SGLT2 inhibitor as part of their routine care

Exclusion Criteria:

* eGFR\<60 ml/min
Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application

Aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8% patch ("Qutenza").

Secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.

According to literature, one of the most common adverse events of capsaicin 8% patch is a burning pain and a reversible erythema at the application site. In general it is recommended to apply a topical anesthetic one hour before capsaicin 8% patch application, or to treat the pain with cooling, NSAIDs or even opioids. Nevertheless, there is still only limited data available on the effects and side-effects. In this study it shall be tested if cooling the skin down for about 5-10 Celsius, immediately before Qutenza is applied, and continuing the cooling during the whole application time, results in a reliable prevention of the burning pain compared to pretreatment with topical anesthesia applied one hour in advance. This would lead to the assumption that the application pain is predominantly caused by a decrease of the threshold for heat pain beyond skin temperature and can therefore be prevented by a lowering of the skin temperature.

By ascertaining pain 24 hours after capsaicin 8% patch application and epidermal nerve fiber density (ENFD) 1 week after capsaicin 8% patch application it shall be proved if the different pretreatment methods do not change the secondary effects of capsaicin application.

If results turn out to be positive, it would be a massive relief with regard to time management and rescue medication.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers 18 ore more years old

Exclusion Criteria:

* dermatologic or neurologic injuries on both thighs
Epidural Catheter Location by Epidural Pressure Waveform

The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows pulsatile waveform recordings.

30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal. The epidural catheter was marked at the skin level to record the distance between the skin at the time of measurements. The power analysis required a sample of 30 observations to set 80% test power and 95% significance level.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients
* Must have an epidural catheter

Exclusion criteria

• Non-obstetric patients
The EMERGE Project: Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Messages in Young Adults

As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages. The team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged survey each week for 5 weeks. The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response. As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain qualitative feedback from participants regarding text messages they most and least liked. The survey is not designed to evaluate the effectiveness of the text message intervention.

As part of the development of the Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) Project, the study team will conduct a single-group study to examine the feasibility of assessing economic and sexual risk behaviors using text messages. The study team will enroll approximately 20 young adults, aged 18 to 24, who are African-American, homeless, out-of-school, and un/under-employed. Participants will complete a text-messaged survey each week for 5 weeks. The study team will collect information about the number of participants who respond to the weekly survey, the number of questions to which they respond in each survey, and the number of hours from sending a survey to participants to receiving their response. As an exploratory aim, participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment. The study team will obtain qualitative feedback from participants regarding text messages they most and least liked. The survey is not designed to evaluate the effectiveness of the text message intervention. The single-group study is anticipated to start in August 2017.

Eligibility Criteria:
Inclusion Criteria:

* Individuals will be included in the study if, at the time of enrollment, they are:
* African American
* Aged 18-24
* Living in Baltimore City
* Experiencing homelessness in the past 12 months
* Employed fewer than 10 hours per week
* Not enrolled in school
* Ownership of a mobile phone with text-messaging capacity
* Reporting at least one episode of unprotected sex in prior 6 months or one other personal or sexual partner HIV risk factor within prior 6 months (STI diagnosis, sex while high or drunk, sex exchange, illicit drug use, alcohol dependence).

Exclusion Criteria:

* Aged 17 or younger.
* Older than 24 years
* Unwilling to provide consent for study participation