cyrilzakka/clinical-trials huggingface dataset:
Detection of Early Esophageal Cancer by NIR-FME.

To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The phase I study, named VICE, completed within the UMCG, showed that synchronal use of VEGFA-guided near-infrared fluorescence molecular endoscopy (NIR-FME) and high-definition white light endoscopy (HD-WLE), following topical or systemic tracer administration, could be practiced to recognize dysplastic and early EAC lesions in patients with BE. Furthermore, early lesion detection was improved by \~33% using the topically applied tracer approach compared with HD-WL/NBI endoscopy. With this phase 2 intervention study the investigators aim to statistically confirm previous pilot (Phase I) clinical data showing that the combination of HD-WLE and FME using labelled bevacizumab improves early EC detection over the current clinical standard.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy.
* Age: 18 years or older.
* Written informed consent.

Exclusion Criteria:

* Patients younger than 18 years old
* Submucosal and invasive EAC; EAC with TNM-classification other than T1.
* Radiation therapy for esophageal cancer
* Immunoglobulin allergy
* Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer
* Prior Bevacizumab treatment
* Non-adjustable hypertension
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
* Pregnancy or breast feeding.
Clinical Implication CMR in AMI Registry

1. To evaluate the clinical implication of cardiac magnetic resonance imaging in patients with acute myocardial infarction
2. To determine factors affecting the 6-month remodeling index assessed by cardiac magnetic resonance imaging

To date, advances in medical treatment and reperfusion therapy led to markedly decreased morbidity and mortality rate in patients with acute myocardial infarction (AMI). Nevertheless, there is a deterioration of left ventricular systolic function or development of heart failure in 40-50% of surviving patients with AMI after the percutaneous coronary intervention (PCI), and it is related to infarct size at the index procedure. Conventional methods of measuring the infarct size included electrocardiogram, peak cardiac enzyme, and echocardiography, but these do not indicate the exact irreversible tissue damage and only suggest indirect parameters. However, cardiac magnetic resonance imaging (CMR) provides information on infarct size, microvascular obstruction, transmurality, and salvage index, and discriminative function between viable and non-viable myocardium with high spatial resolution. Also, magnetic resonance imaging is used as a gold standard for the evaluation of the myocardial remodeling index. However, it is not well known in which patients occur adverse remodeling for the myocardium and in which patients occur reverse remodeling. Therefore, the investigators sought to evaluate the clinical implication of CMR and to determine factors affecting the 6-month remodeling index assessed by cardiac magnetic resonance imaging through the current registry.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed as type 1 myocardial infarction the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia.

Exclusion Criteria:

* Patients who cannot perform cardiac magnetic resonance imaging
* Target vessel is not suitable for coronary intervention
Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.

the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors

Eligibility Criteria:
Inclusion Criteria:

* perimenopausal women With FD symptoms

Exclusion Criteria:

* other gastrointestinal disease
* Cardiovascular, metabolic, respiratory, renal complaints
* Pregnancy
* Women in Lactation
* neurological / Psychic Women
Assessement of Capacity to Consent

Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory.

Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode.

This is a Social and Human Sciences study which does not aim to modify the usual management of patients.


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 75
* Ability to understand and participate in the interview
* French-speaking
* Presence of a current characterized depressive episode according to DSM-5 diagnostic criteria

Exclusion criteria:

- Refusal to participate
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients

This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.

This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).

The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.

Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with anidulafungin or caspofungin
* Admitted to an ICU ward

Exclusion Criteria:

* \< 18 years
* DNR 2 or 3
Quality and Independence of Gait Classification Scale for DMD (QIGS-DMD)

The aim of this study was to develop a reliable and valid gait classification scale for Duchenne Muscular Dystrophy (QIGS-DMD). The items of the QIGS-DMD were designed based on the literature review considering existing functional classification scales, gait scales, and the opinions of the physiotherapists who were expertized in rehabilitation of patients with DMD. Content validity was determined based on the opinions of a total of ten expert physiotherapists. Videos were recorded during gait of 69 children with DMD and inter- and intra-rater reliability were examined. Criterion validity was determined according to the relationship between QIGS-DMD and Motor Function Measure (MFM) and Vignos Lower Extremity Rating Scale (VLERS).


Eligibility Criteria:
Inclusion Criteria:

* being 5 years old or above, and
* having a confirmed diagnosis of Duchenne Muscular Dystrophy.

Exclusion Criteria:

* having other coexisting medical or psychiatric diseases or injury and/or surgery related to the lower extremities within the last 6 months
Epidemiology of Bacteremia at Two Tertiary ICUs in Switzerland

The objectives of the retrospective cohort study is to describe the actual current practice of antibiotic treatment duration for bloodstream infections in critically ill patients at two tertiary hospitals (ICU Inselspital Bern and ICU CHUV Lausanne), to examine patient, pathogen and infectious syndrome factors associated with selection of shortened treatment duration, and to describe the expected time course of clinical resolution among bacteremic patients.


Eligibility Criteria:
Inclusion Criteria:

Patient has a positive blood culture with a pathogenic organism Patient is critically ill at the time the blood culture was collected as defined by the following:

1. was treated at the ICU/IMC at the time of blood culture collection;
2. or has been admitted to ICU/IMC in the 48 hours after blood culture collection

Exclusion Criteria:

1. Patient has a single positive blood culture with a common contaminant organism:

   * coagulase negative staphylococci;
   * Bacillus spp.;
   * Corynebacterium spp.;
   * Propionibacterium spp.;
   * Aerococcus spp.;
   * Micrococcus spp.
2. Explicit documentation that the patient does not want to participate in any study
Acupuncture - a Treatment for Children With Headache

Acupuncture as a treatment for headache in children

A randomised controlled study in the effect of acupuncture as a treatment for headache in children.

The children are randomised for training or for training and acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by pediatrician-
* Age-9-17 years
* Min. headache 8 times within the last month

Exclusion Criteria:

* Mentally illness
* Fear of needles
Urogynecological and Sexual Functions After Vecchietti Operation

The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation.

Thirteen patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty were included. A control group of 13 age-matched, childless, sexually active women were examined during the same period. All patients underwent the basic evaluation of anatomical outcomes. Sexual outcomes were established by polish validated FSFI questionnaire. Continence status was assessed by polish validated UDI-6 and IIQ-7 questionnaires. The UDI-6 is subdivided in three domains: stress incontinence, irritative and obstructive discomfort. The IIQ-7 measures the implications of urinary incontinence for normal daily functioning.

Eligibility Criteria:
Inclusion Criteria:

* patients with MRKHS who underwent laparoscopic Vecchietti vaginoplasty
* control group of 13 age-matched, childless, sexually active women

Exclusion Criteria:

* unability to understand informed consent
Enhancing Self-Understanding and Social Integration of Middle School Students With Learning Disabilities

Research and intervention programs for students with learning disabilities (LD) typically address child and family characteristics without examining the school context and conditions that affect adjustment. Focusing on the student with LD can highlight the child and family's deficits. An ecological theoretical framework guides this research project, a collaboration of the University of Toronto, Faculty of Social Work and Ontario Institute for Studies in Education of the University of Toronto (OISE/UT), Integra and the Toronto Catholic District School Board. This framework is based on the assumption that people are very much part of and affected by social and environmental settings. Accordingly, it is important not to see the adjustment problems of children with LD as being caused only by their LD. Instead, their academic and social problems are seen as unfolding in larger circumstances that include other children, the classroom, the school, the family and the community. These many factors act together to influence the child with LD and must be taken into account along with individual characteristics of the child.

Objectives

1. Deliver an ecologically informed school-based intervention that addresses individual, social and environmental factors, to improve the adjustment of students with LD
2. Examine the efficacy of the intervention
3. Contribute to knowledge of the factors that influence the adjustment of students with LD
4. Circulate this information to those who live and work with students with LD in order to offer understanding and direction for programs and interventions and to facilitate cross-sector collaboration

The research will utilize both quantitative and qualitative methodologies. 6 schools will be selected. 3 will receive the intervention in year 1 (2004-2005 school year), comprising 1) group treatment, 2) workshops, and 3) consultation. The other 3 schools will be controls in year 1 and receive the intervention in year 2 (2005-2006 school year).

Students in grades 6-8, identified as having LD will be offered the opportunity to participate in the project (with parental consent). This project comprises 3 components:

1. School-based group treatment for students in grades 6-8 with LD and psychosocial problems. Group treatment will focus on assisting participants to understand the impact of their LD as well as on development of self-advocacy skills.
2. Workshops on understanding LD for teachers, parents, and students without LD (grades 6-8).

Eligibility Criteria:
Inclusion Criteria:

* Grades 6-8 with identified LD
* Must demonstrate need for psychosocial intervention based on results on measures

Exclusion Criteria:

* Cannot meet criteria for conduct disorder on the Teacher Report Form
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients with GI Malignancies

This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patient with GI malignancy
* Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.

Exclusion Criteria:

* Patients not meeting standard hematologic parameters for chemotherapy administration as follows:

  * Absolute neutrophil count (ANC) ≥ 1500
  * Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:
  * AST ≤ 5x ULN
  * ALT ≤ 5X ULN
  * Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:
  * Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.
Pipeline Embolization for Intracranial Aneurysms

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.

Eligibility Criteria:
Inclusion criteria:

1. Aged 22 to 75 years old, male or non-pregnant female;
2. UIA was diagnosed by CTA, MRA, or DSA;
3. The size of aneurysms is between 3 to 25mm;
4. Understands the nature of the procedure and provision of written informed consent;
5. Indications for FD implantation with or without adjunctive coiling;
6. Is willing to return to the investigational site for follow-up according to our protocol.

Exclusion criteria:

1. With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
2. Pregnancy or lactation;
3. Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
4. Parent vessel with a diameter \<2.0 mm or ≥5.0 mm.;
5. Unwilling to be followed up or likely to have poor treatment compliance;
6. Life expectancy less than 3 years;
7. Inability to receive anti-platelet or anticoagulant medication;
8. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);
9. Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.
Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
* Non-smoker
* Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous participation in this trial
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
* The receipt of any investigational drug within the last 3 months prior to this trial
Longitudinal Cardiac Outcomes and Body Composition

To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition.

BACKGROUND:

To describe growth events adequately, long-term serial data with frequent measurements at appropriate ages are necessary. The study uses the Fels Longitudinal Study. In the Fels Longitudinal Study, data collection begins at birth, and all children are scheduled for measurements semiannually, on their birthdays and half birthdays, until the age of 18 years, after which they are scheduled every 2 years. The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood.

DESIGN NARRATIVE:

The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size, body composition and blood pressure. To address this goal, 685 adult white active participants in the Fels Longitudinal Study, 352 men and 333 women 20 to 70 years of age, will be studied. These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years. Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program. The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure. The innovative longitudinal statistical analysis used will include covariates such as age, gender, birth year for secular trend, adulthood lifestyle (smoking, alcohol consumption, and physical activity), adult body size and composition, menopause, and medical condition and medication use. The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition. Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood. Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index (BMI). Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease. This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters.

Eligibility Criteria:
No eligibility criteria
Endoscopic Subsurface Optical Imaging for Cancer Detection

The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.

This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center.

Exclusion Criteria:

* Non bladder surgical procedures at University of California Davis Medical Center.
Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis

PENG neurolysis in advanced osteoarthritis of the hip joint.

The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the hip joint.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
* patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgetics
* Age of patients: from 18 to 110 years of age.
* Caucasian patients can give informed, complete, written consent.

Exclusion Criteria:

* suspected or diagnosed opioid dependence syndrome
* active cancer
* dementia