cyrilzakka/clinical-trials huggingface dataset:
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

This is a multicenter, open-label, single arm study. The primary objective is to assess the long-term safety and tolerability of OMS906 in patients with PNH. Secondary objectives of this study include assessment of the long-term efficacy of OMS906 in patients with PNH. Patients will receive OMS906 5 mg/kg administered as intravenous (IV) injections at 8-week intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Have completed the last dosing visit of the prior OMS906 PNH study.
2. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906.
3. Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug.
4. Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug.
5. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study.
6. Have provided informed consent

Exclusion Criteria:

1. Platelet count \<30,000/µL or absolute neutrophil count \<500 cells/µL at the start of the Evaluation Period.
2. Elevation of liver function tests, defined as total bilirubin \> 2 x ULN, direct bilirubin \> 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), \> 2 X ULN unless due to PNH-related hemolysis.
3. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.
4. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis.
5. Pregnant, planning to become pregnant, or nursing female patients.
6. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension.
7. Unable or unwilling to comply with the requirements of the study.
Fractional Flow Reserve and Intravascular Ultrasound in Evaluating Intermediate Coronary Lesions

Recent studies have shown that optimal IVUS criteria defining the functional significance (FFR \< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate these results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Both physiologic information from fractional flow reserve (FFR) and anatomical information from intravascular ultrasound (IVUS) in assessing intermediate coronary stenotic lesions are useful. Functional significance of a coronary stenosis is determined by both the severity of a stenosis and the amount of myocardium supplied. Therefore, when the functional significance of a lesion is assessed by lumen area measured by IVUS, different criteria should be applied according to lesion location and anatomical variations of the coronary artery. However, previous studies included only patients with proximal lesions or small vessel disease, and the sample sizes were too small to assess these differences. In a recent study, the investigators have shown that optimal IVUS criteria defining the functional significance (FFR \< 0.8) of intermediate coronary stenoses is different according to their locations of the coronary tree. Herein, the investigators performed this study to validate the our results and to generalize the IVUS criteria defining functional significance of intermediate coronary stenosis in a different location of coronary tree in a larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate coronary stenosis by visual estimation

Exclusion Criteria:

* history of coronary artery bypass graft surgery
* previously revascularized lesion
* creatinine \> 1.6 mg/dL or eGFR \< 30 ml/min/1.73m2 pre-procedure per institutional standards
* known pregnancy
* contrast agent allergy that cannot be adequately premedicated
* severe PVD precluding cardiac catheterization
* patient not a candidate for IVUS and FFR
* inability or unwillingness to provide informed consent
* inability or unwillingness to perform required follow up procedures
Geographic Atrophy Long-Terms Outcomes Study

The purpose of this study is to describe functional and long-term clinical outcomes of patients with a diagnosis of Geographic Athrophy secondary to Age related Macular Degenaration in Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients:

* Aged 60 years or over at the time of GA diagnosis
* Patients providing informed consent to participate in the study; if the patient is physically incapable of completing the electronic consent form, the form can be completed by a legally acceptable representative of the patient (including an impartial witness, where required)
* Patients first diagnosed with GA in at least 1 eye between 3 and 10 years prior to index date
* For patients with unilateral GA, the other eye should show signs of AMD (i.e., the non-GA eye should present with at least drusen, reticular pseudodrusen, or wet-AMD)

Inclusion criteria for caregivers:

* Aged 18 years or over at the time of consent
* Caregivers who self-identify as the primary caregiver for a patient for whom documented informed consent for inclusion in the study has been obtained

Exclusion Criteria:

Exclusion criteria for patients:

* Patients diagnosed with GA due to causes other than AMD (e.g., monogenetic macular dystrophies \[Stargardt disease, other\], toxic maculopathies) in either eye
* GA with any concurrent intraocular condition that in the opinion of the treating physician would require surgical or intravitreal intervention (for the prevention or treatment of visual loss) during the study or might impact the interpretation of routine clinical assessments e.g., glaucoma, cataract, proliferative diabetic retinopathy. Patients first diagnosed with GA less than 3 years prior to the date of consent
* Patients who have not attended a healthcare institution for the management of GA following diagnosis of GA (a minimum of 2 routine clinical visits for monitoring of GA that included assessment of at least BCVA should be documented in the medical records)
* Patients who have been enrolled in an interventional clinical trial in which they received medication for any retinal condition (note: patients with bilateral GA should be excluded only if both eyes received the pharmacological intervention)

Exclusion criteria for caregivers:

* Caregivers for whom documented informed consent has not been obtained for participation in the GALTOS survey
* Caregivers with any significant mental incapacity that would prevent them from participating in the survey
* Paid caregivers
Application of the 24-hour Recall Methodology Assisted by Digital Photographs for the Analysis of Dietary Intake

With this project, the investigators expect to standardize a reliable and optimized methodology based on a 24-hour recall tool assisted by digital photographs with a complete output of foods and nutritional information for the Colombian population.

After recruitment, participants (20) will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent. Dietary intake assessments will be conducted using 24-hour dietary recalls, assisted with digital photographs registry of the food and beverages consumed, and a brief description (the two 24 dietary recalls will be applied on different and non-consecutive days). Simultaneously, food weighing using a home kitchen scale and drink volume measurements will be used as a reference. For the analysis of nutritional information, the daily food intake extracted from food photologs will be entered into the automated Self-Administered Dietary Assessment Tool (ASA24®). Macro- and micronutrient intake using the actual food weights recorded by the participants, will be estimated from the USDA FNDDS 2017-2018 database, and polyphenols composition from a phenol database.

On the day of each 24-h dietary recall, participants will collect a 24-h urine sample to assess their protein, sodium, and potassium intake. Additionally, the day after each 24 dietary recall, participants will also provide blood samples to determine circulating levels of vitamin C, vitamin B1, vitamin K1, folate, zinc, copper, and beta-carotene; and fecal samples to identify vegetable species in feces.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 18 years
* Who owns a smartphone.
* Autonomous in the use of a smartphone.
* With internet access.

Exclusion Criteria:

* Subjects who do not photograph the food and/or do not record them.
* Subjects that do not accept the interview for the clarification of doubts related to the food after the photographic report.
* People who can not stay at home for at least the evaluation days to facilitate the weighing of food.
RGD PET/CT Imaging in COVID-19 Patients

Aim: We aim to evaluate αvβ3 integrin expression in proven COVID-19 infected patients with indicative findings on routine contrast-enhanced CT using \[68Ga\]Ga-DOTA-(RGD)2. If activated vascular endothelium in the lung parenchyma proceeds ARDS, as frequently observed during COVID-19 infection, imaging αvβ3 integrin expression using PET/CT could have potential as a clinical tool to characterize patients at early stages during disease and guide development of novel treatments targeting the vascular endothelium.

Study design: This is a prospective, observational non-randomized pilot study. Maximum 10 patients will undergo a \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scan and CT-subtraction scan in the same procedure. 10-minutes/bed position static \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scans of the thorax will be acquired starting at 60 minutes post injection.

Study population: Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and indicative pulmonary abnormalities on contrast-enhanced CT (CORADS 4-5) undergo PET/CT scans after injection of 70 μg (200 MBq) \[68Ga\]Ga-DOTA-(RGD)2 and CT-subtraction.

Intervention: All patients will undergo a \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scan, and in the same procedure, a CT-subtraction scan.

Primary study objective: The primary objective of this study is to demonstrate and quantitate activation of the endothelium in the lung vasculature using \[68Ga\]Ga-DOTA-(RGD)2 PET/CT.

Secondary study objectives:

1. To assess the spatial correlation between \[68Ga\]Ga-DOTA-(RGD)2 uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
2. To assess the spatial correlation between \[68Ga\]Ga-DOTA-(RGD)2 and CTS of the lung parenchyma
3. To assess the correlation between \[68Ga\]Ga-DOTA-(RGD)2 and laboratory results
4. To explore the correlation between \[68Ga\]Ga-DOTA-(RGD)2 uptake and clinical course of disease


Eligibility Criteria:
Inclusion Criteria:

* a microbiologically proven SARS-CoV-19 infection
* pulmonary involvement as demonstrated on recent (\<1 week) chest CT, classified as CORADS 4 or 5, with indicative findings such as ill-demarcated multifocal ground glass opacities, mixed ground glass and consolidations, predominant peripheral and basal distribution, vascular thickening, round shaped and/or (reversed) halo
* More than or equal to 18 years of age;
* Ability to provide written informed consent.

Exclusion Criteria:

• Contra-indication for PET: Pregnancy; Breast-feeding; Severe claustrophobia.

* Contra-indication for administration of iodine-containing contrast agents.
* Saturation \<94% at room air (without need of additional oxygen)
* Previously documented lung abnormalities that can interfere with interpretation of research scans, e.g. extensive fibrosis, known interstitial lung disease, pulmonary metastases, known pulmonary involvement of granulomatous diseases.
* Oth Estimated creatinine clearance \< 30mL/min according to the Cockcroft-Gault formula (or local institutional standard method) OR oligo-uric patients (\<400mL/24hr)
Preoperative Cisplatin in Early Stage Breast Cancer

The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.

Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery.

Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment.

After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast.

Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation.

Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.

Eligibility Criteria:
Inclusion Criteria:

* All tumors must be ER-, PR- and HER-2 negative.
* Age \> 18 years
* ECOG performance status of less than or equal to 1
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Hemoglobin \> 9mm/dl
* Platelets \> 100,000/mm3
* Creatinine \< 1.5mg/dl
* Glucose \< 200mg/dl
* Bilirubin \< 1.5 x upper limit of normal (ULN)
* SGOT \< 3.0 x ULN

Exclusion Criteria:

* Prior chemotherapy treatment
* Pregnant or breast-feeding women
* History of serious illness, medical or psychiatric condition requiring medical management
* Uncontrolled infection
* Renal dysfunction
* Active or severe cardiovascular or pulmonary disease
* Peripheral neuropathy of any etiology that exceeds grade 1
* Prior history of malignancy
* Uncontrolled diabetes
Immune Response in Lung Cancer

This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of 0-1
* Patients with histologically documented non-small cell lung cancer
* Control group - patients without non-small cell lung cancer
* Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

* Any other malignancies within 5 years
* Any unstable systemic disease (including active infections, significant cardiovascular disease)
* Prior chemotherapy or radiotherapy
* Autoimmune disease
* Nursing or pregnant women
Chest Wall Deformities in Children - Epidemiological Data

Pectus excavatum (PE) or funnel breast is the most common congenital deformity of the chest wall, which occurs in about 1 in 400 births with a boy to girl ratio of 4: 1 to 3: 1. The etiology of PE is largely undefined, but there are numerous indications that genetic factors play a role in the development of PE. Up to 40% of patients report affected family members with similar congenital deformities. In many families, PE follows a pattern that would be compatible with an autosomal dominant or recessive pattern of inheritance. The data on the frequent occurrence of PE in family members fluctuate greatly and only a few genes associated with a PE have been identified so far.

Previous studies suggest that sulfation of proteoglycans plays a crucial role in the normal development of cartilage and bone and could therefore be crucial in the genesis of the disease. The main catalytic machinery responsible for the biosynthesis and breakage of sulfate esters in the proteoglycans consists of various enzymes and transporters. Mutations in Sphingosine Kinase 1 (SK1) and Sphingosine Kinase 2 (SK2) genes that encode the transmembrane transporters of sulfate or enzymes that are involved in 3'-phosphoadenosine 5'-phosphosulfate (PAPS) synthesis have been identified as the cause of several inherited diseases that all have skeletal system deformities.

Connections between chest wall deformities with syndromes (e.g. Marfan, Noonan), anomalies (e.g. Poland, Moebius) or associations (e.g. Cantrell Pentalogy, PHACE) are well known. In contrast, there have so far been hardly any genetic studies of the isolated congenital chest wall deformities. Epidemiological data are insufficient and only a few groups deal with the inheritance and the incidence of this disease when it occurs in isolation.

Eligibility Criteria:
Inclusion Criteria:

* . All patients who are in the Altona Children's Hospital or in the University Hospital Hamburg. Funnel breast, keel breast, sternal cleft
* . A signed declaration of consent from the parents or legal guardians is available
* . The patient has given a declaration of consent

Exclusion Criteria:

* Confirmation of another diagnosis associated with chest wall deformities:

  1. Marfan syndrome
  2. Noonan syndrome
  3. Poland syndrome
  4. Moebius syndrome
  5. Cantrell Pentalogy
  6. PHACE association
Creation of a Database of Images of the Eye with the Holographic Doppler Laser

Many retinal pathologies are of vascular origin. In order to better understand their pathophysiology and make an accurate diagnosis, it is essential to visualise and quantify blood flow. The holographic Doppler laser (LDH) is a new medical device currently being developed by physics researchers at the Institut Langevin. The 1st prototype of this device is currently being used as part of research involving humans with minimal risks and constraints at the Hôpital National de la Vision des Quinze-Vingts (NCT04129021).

In order to better visualise, understand and quantify the vascular anomalies suspected in the fundus of patients undergoing ophthalmology treatment , we would like to acquire images/videos with a 2nd LDH prototype, within the ophthalmology clinical investigation platform at the Hôpital Fondation Adolphe de Rothschild.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Age ≥ 18 years
* Having received informed information about the study and having signed a consent to participate in the study
* Affiliated or beneficiary of social insurance

For participants with no known ocular pathology:

- No known ocular pathology other than a refractive disorder

For patients with optic nerve pathology:

- Patient undergoing ophthalmology consultation for optic nerve pathology in at least one eye (examples: glaucoma, optic neuritis, hereditary optic nerve diseases)

For patients with retinal and/or choroidal pathology:

- Patients undergoing ophthalmology consultations for retinal and/or choroidal pathology in at least one eye (examples: diabetic retinopathy, age-related macular degeneration).

For patients with retinal vascular pathology:

- Patient undergoing ophthalmology consultation for retinal vascular pathology in at least one eye (e.g. central retinal artery occlusion, central retinal vein occlusion, ocular ischemia syndrome).

Exclusion Criteria:

* Inability to maintain a stable sitting position
* Contraindications to holographic doppler laser :

  * implanted medical electronic device (pacemaker or other)
  * history of photosensitivity.
  * received photo-dynamic therapy (PDT) within the last 3 months.
  * viral conjunctivitis or any other infectious disease.
  * skin lesions on the neck or forehead, not allowing contact with a chin strap
  * patients at high risk of damage from optical radiation (e.g. aphakic patients, or patients with reduced sensitivity to light due to disease of the back of the eye).
3D HD Versus 2D HD in Laparoscopic Inguinal Hernia Repair: a Randomized Controlled Trial

The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.

Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective inguinal hernia repair (out-patient treatment)

Exclusion Criteria:

* Previous lower abdominal surgery
* ASA-score 3 or above
Study Comparing Two Different Tablet Formulations Of Bosutinib

This study is comparing 2 formulations of bosutinib in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of non-childbearing potential, age 18 to 50 years.

Exclusion Criteria:

* Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Eating Disorders Programs: An Indicated Trial

The purpose of this study is to assess the effectiveness of two body acceptance programs for women. Participants may experience reduction of eating pathology and prevention of future obesity and eating disorders; may derive a sense of altruism and contribution to furthering understanding of a public health problem.


Eligibility Criteria:
Inclusion Criteria:

* Participant indicates sub-threshold or threshold eating disorder.
* Participant is available to participate in the intervention sessions.
* Participants must be MRI eligible.

Exclusion Criteria:

* Participant does not indicate sub-threshold or threshold eating disorder.
* Participant is unable to attend intervention sessions.
* Participant cannot participate if MRI ineligible.