cyrilzakka/clinical-trials huggingface dataset:
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
* A male or female of 4 to 5 years of age at the time of enrolment.
* With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.
* Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
* Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
* History of or intercurrent hepatitis B disease.
* Hepatitis B vaccination at birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
* Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.
Novel Gallium 68 Citrate in Orthopedic Infections

In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months after hip replacement with complaint of joint pain.
* Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening).
* Pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening.

Exclusion Criteria:

* Inability to consent
* Pregnancy or known or suspected hypersensitivity to metals or gallium
* Joint replacement for any reason other than primary or secondary osteoarthritis
* Prior surgical therapy for prosthesis failure after initial hospital discharge
* Active inflammatory/infectious process at any location other than prosthetic joint (Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)
Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution

Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.


Eligibility Criteria:
Inclusion Criteria:

* Children between 0 and 18 years old
* Followed in the dermatology department of CHRU de Nancy between January 2014 and December 2020
* Presenting with one or more infantile hemangioma

Exclusion Criteria:

- Those whoes guardian does not want his data to be collected in this study
Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus

The purpose of this study is to determine which surgical method makes less corneal haze

Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea. The investigators evaluate whether partial removal versus total removal of the corneal epithelium can lead to less corneal haze and better visual outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16-40 years
* axial topography consistent with keratoconus
* minimum corneal thickness more than 400 µm and a progression of keratoconus in past 12 months

Exclusion Criteria:

* history of ocular herpes or non-healing corneal ulcers
* subjects with current ocular infection
* severe preoperative corneal haze or scar
* severe ocular surface disease
* autoimmune diseases
* pregnant women
MBSR for Work Active Seniors

Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.

Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* psychosis
New York City Eye Study (NYCES)

Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New York City Eye Study (NYCES) to promote eye and vision health by conducting eye health screenings in adults age 21+ (PAR-23-009/NOT-EY-22-004).

The proposed innovative clinical trial will be a hybrid 2, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.(Curran 2012) A total of 14 NYCHA developments confirm access to 43,273 residents living at or below the NYC.gov poverty measure.(NYC Mayor Clinical measures (visual acuity, intraocular pressure, and fundus images), and quality-of-life will be assessed. To ensure that all community members receive the basic level of service, all participants who fail the eye health screening will be seen the same day by the study optometrist and eye glasses will be provided at no charge. All participant referred to ophthalmology will be assisted with scheduling their initial in-office eye exam appointment. Participants referred in the 9 developments randomized to the Intervention Arm will receive ongoing support from a patient navigator to assist with follow-up eye care; those referred in the 5 developments randomized to the Usual Care Arm + Automated Reminders, but will not receive support from patient navigators. The aims of the study are:

Aim 1) Using a type 2 hybrid design, evaluate the Effectiveness of a community-based intervention that begins with eye health screenings conducted at NYCHA affordable housing developments, followed by a 2:1 cluster-randomized clinical trial using Patient Navigators to increase: (a) Adherence to in-office eye exams for those referred to ophthalmology (Implementation outcome) and (b) Detection of eye disease(s) (glaucoma, retina, other) confirmed by the in-office eye exams (Clinical effectiveness outcome).

Aim 2: Assess Reach, Adoption, and Implementation using a mixed-methods study for those screened and referred to ophthalmology. Hypothesis: Assessing implementation outcomes and comparing among developments using a type 2 hybrid design will inform future intervention implementation.

Aim 3: Focusing on the Maintenance portion of RE-AIM, determine the costs and cost-effectiveness of eye health screenings and intervention, defined as cost per case detected, cost per participant achieving adherence, and sustainability at 1-4 years.

Impact: This community-based intervention addresses vision and eye health disparities by providing a basic level of services to all participants and addresses a structural issue of access to eye care by partnering with NYCHA. The evidence generated from this RCT has the potential to provide a roadmap for policy change.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age 21 and older.
* Living independently in an affordable housing development and surrounding neighborhoods.

Exclusion Criteria:

* Self-reported terminal illness with life expectancy less than 1 year.
* Inability to provide informed consent due to dementia or other reasons.
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation.

This is a double-blind, randomized, placebo-controlled, multicenter, sequential dose-escalation study which will occur in two parts. All selection criteria, assessments and procedures described in this protocol will be applied to both parts. Up to 5 cohorts will be studied with a total of 67 patients at approximately 18 clinical sites in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous for F508del-CFTR gene
* Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis
* Body weight ≥ 40 kg
* FEV1 ≥ 40% predicted
* Oxygen saturation ≥ 90% breathing ambient air
* Hematology and clinical chemistry of blood and urine results with no clinically significant abnormalities that would interfere with the study assessments
* Negative pregnancy test for women of child bearing potential
* Sexually active subjects of child bearing potential willing to follow contraception requirements

Exclusion Criteria:

* Previous enrollment in another cohort for this study.
* Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment within 4 weeks of Study Day 1.
* Any change in chronic therapies for CF lung disease within 4 weeks of Study Day 1.
* Blood hemoglobin \<10 g/dL at screening.
* Serum albumin \<2.5 g/dL at screening.
* Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN) in three or more of the following: AST, ALT, GGT, ALP, total bilirubin at screening.
* History of abnormal renal function (creatinine clearance \< 50 mL/min using Cockcroft-Gault equation) within a year at screening.
* History, including the screening assessment, of ventricular tachycardia or other ventricular arrhythmias.
* History, including the screening assessment, of prolonged QT and/or QTcF interval (\> 450 msec).
* History of solid organ or hematological transplantation.
* Intranasal medication changes within 14 days prior to Study Day 1
* Required Use of continuous (24 hr/d) or nocturnal supplemental oxygen.
* Concomitant use of any inhibitors or inducers of CYP3A4.
Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation

The rhythm disorders of Atrial Fibrillation (AF) require continuous treatment with anticoagulants to prevent stroke. The introduction of direct oral anticoagulants (DOACs) quickly supplanted the administration of anti-vitamin K (AVK) which presented an elevated risk of hemorrhage.

However, the adherence of the treatments by the OAD is very poor, several studies show that 30 to 50% of the patients fail to adhere to their treatment very soon after starting it. In a recent study, in the United States, using data collected between 2010 and 2014 in more than 60,000 patients with AF, Yao et al show that less than 50% of patients can be considered "adherent".

They conclude in this study that adherence to anticoagulation is low in practice, although it may be slightly improved with DOACs. More recently a meta-analysis shows that 66% of patient treated by DOACs were considered adherent (PDC \> 80 %). In addition, therapeutic adherence seems to be essential in patients with a CHA2DS2-VASc score ≥2. Indeed improving adherence reduces the risk of stroke occurrence. The investigators propose to evaluate during an interview in the pharmacy, the adherence of ambulatory patients (at the time of their renewal of treatment at the pharmacy) by the "Proportion of Days Covered" (PDC) of the treatment by AOD, and by a simplified questionnaire and to define a profile of patients treated for AF at risk of nonadherence to AOD (PDC adherence prediction score). The investigators perform an observational, prospective multicenter study , in which patients adherence will be quantified in a standardized method.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Consultation in the community pharmacy
* long-term treatment for at least six months with an DOACs.
* Patients able and agreeing to participate in the evaluation of their adherence

Exclusion Criteria:

* Treatment by DOACs limited in the duration
* Contra-indications of DOACs
Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia

In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.

August-2 is a trial embedded in the August-1 registry study. All patients enrolled in August-2 are also part of August-1, but there will be patients who are documented in the register, but will not take part in August-2. The investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* angiopathic or angioneuropathic critical limb ischemia (at least Wagner-Armstrong stadium II)
* participation in the August-1 Register
* revascularization not possible or residual ischemia after revascularization
* persisting ulcerations despite antibiosis, adjustment of blood glucose levels and debridement
* expected further hospitalization for at least 3 weeks (pressure relief and antibiosis)
* fibrinogen \>= 4g/l
* signed informed consent

Exclusion Criteria:

* life expectancy \< 1 year
* prior major amputation
* planned major amputation
* prior therapy of the current episode of diabetic foot syndrome with urokinase (except in cases of revascularization when the duration between the intervention and randomization must not exceed 7 days)
* mechanical heart valve substitute
* cerebral event with CT-detectable changes in the last 3 months
* non-remediated proliferation retinopathy
* uncontrolled hypertension (systolic \>180 mmg, diastolic \>100 mmHg)
* hemorrhagic diathesis (spontaneous quick \< 50%, spontaneous PTT \> 40 s, thrombocytes \< 100 Gpt/l)
* gastrointestinal bleeding or ulcers in the last 4 weeks
* prior reverse bypass operation
* contraindications against therapy with urokinase acc. to the SMPc
* concurrent participation in another clinical trial
* insufficient compliance
* pregnancy
Transition in Transgender

The aim of this longitudinal, observational study is to investigate the effects of gender-affirming hormone treatment in FTM (female to male) and MTF (male to female) transgender (TG) people with regard to changes in brain structure and function as well as psychological and behavioral consequences. Methodological problems and missing studies in this area were mentioned several times with an emphasis on the need for longitudinal research.

Transgender (TG) is still a polarizing issue today. The lack of acceptance in society and often even in one's own family, the feeling of a lack of identity and connection with one's own body and the experienced discrimination all lead to a considerable degree of suffering in TG and elevated levels of psychiatric symptoms as well as a reduced quality of life. Many TG people seek hormonal treatment. Physical and psychological consequences of this treatment still need to be revealed.

To this aim, the investigators recruit TG people (MTF and FTM) who intend to seek gender-affirming hormonal treatment. Before treatment, various measures will be taken, including a semi-structured interview to assess psychiatric symptoms, self-ratings, behavioral experiments (to assess male/female face recognition and male/female voice perception), while functional MRI scans are taken to assess respective neural correlates. In addition, resting-state scans as well as anatomic images will be taken.

Six months after having started gender-affirming hormone treatment, participants will be reinvited to undergo the same study protocol.

In between testing sessions, patients will perform several online surveys regarding their psychological well-being.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosed gender dysphoria (DSM 5) or gender incongruence (ICD-11)
2. the pursuit of hormone therapy
3. native German speakers
4. age: 18-55
5. written informed consent following oral and written information
6. persons who are legally competent and mentally able to follow the instructions of the staff

Exclusion Criteria:

1. drug abuse/addiction
2. first-degree relatives with psychotic disorders
3. pregnant or breastfeeding
4. traumatic brain injuries
5. neurological diseases
6. known internal, e.g. metabolic, endocrine or cardiac disorders
7. magnetic metal implants
8. hearing disorders, voice disorders and pronounced hoarseness
9. shift workers or irregular day-night rhythm
10. persons placed in an institution by order of the authorities or courts
11. persons who are in a dependent or employment relationship with the auditor
12. simultaneous participation in a clinical trial
13. hormone treatment already started
Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias

Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.

This is a prospective, observational, single center, pilot study. Data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions)
* Indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization

Exclusion Criteria:

* Platelet count \< 100,000 cells/mm3
* BMI \> 45 kg/m2 or \< 18 kg/m2
Implementation of New Trauma Triage Criteria and Implications on Under- and Overtriage.

New trauma alert criteria has been introduced in Sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. The Swedish trauma registry is used to identify eligible patients.

The Swedish trauma registry (SweTrau) was initiated in 2011, and has up to date 40.000 registered patients. In order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the Uppsala/Örebro region. These hospitals register in SweTrau and all had the same alert criteria prior to the implementation of new alert criteria.

A power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% CI.

The including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000.

The registry has information about time of trauma, initiated alerts, Injury Severity Score and mechanism of injury suitable for analysis for our hypothesis.

Eligibility Criteria:
Inclusion Criteria:

- All patients registered in SweTrau at all including sites between 1 June 2016 and 1 November 2017

Exclusion Criteria:

* Patients registered due to secondary referral where the initial assessment was performed at another hospital