cyrilzakka/clinical-trials huggingface dataset:
An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator's judgment.
* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
* Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.

Exclusion Criteria:

* Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
* Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator's clinical judgment.
* Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
* Subjects who require immunization with live/live attenuated vaccine.
* Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren's syndrome.
* Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634- CL-224 study.
* Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
* Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
* Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.
A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
* Treatment with Xeomin® and BOTOX® for at least 2 years each.

Exclusion Criteria:

* Having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
* Previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm.
Tadalafil-Delivra and Raynaud's Phenomenon

A 4-8 week observational feasibility study of the use of the use of Tadalafil-Delivra in the treatment of Reynaud's Phenomena (RP).

To determine if the feasibility of conducting a future RCT using the chosen outcome assessments in RP patients at 2 Rheumatology clinics.

Study Design:

Observation of patients prescribed Tadalafil-Delivra 2% (Tad-Del) for the treatment of RP with defined feasibility objectives and data collection through efficacy and safety assessments. Study objectives are:

* At least 70% recruitment of eligible participants.
* 100% data collection from at least 70% of all enrolled subjects.
* Estimate the standard deviation(s) of all outcome assessments.

Setting/Participants:

Patients prescribed Tad-Del will be screened for study enrollment at 2 participating rheumatology clinics by the local research team. Participants that meet all the eligibility criteria will be enrolled in the study as subjects. Subjects will self-administer the medication as prescribed and return to the clinic for follow-up. Data will be collected on outcome assessments at: baseline, 1 week and at 4 to 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults of both genders, Age 18 to 75 years.
2. Patients with a confirmed diagnosis of Raynaud's Phenomenon (RP).
3. Written informed consent.
4. The presence of 1 or more digital ulcers (DU), that is not related to calcinosis, anywhere on a finger that is symptomatic for RP- defined as a VAS pain score of ≥25mm of 100mm Or 1 -3 fingers that are symptomatic for RP under standard of care treatment (SoC). Symptomatic is defined as a VAS pain score of ≥ 25mm of 100mm.
5. Prescribed, but not currently being treated with Tad-Del.
6. Maintenance of a stable background of prescribed treatment for RP including vasodilators, orally administered PDE5i and pain medication. Changes to administration of this concomitant medication will be documented in the case report form (CRF).

Exclusion Criteria:

1. Unwilling and/or incapable of adhering to the study procedures and follow-up schedule.
2. Use of other prescribed topical treatment for RP, such as nitrates.
3. Active infection of the index ulcer
4. Calcinosis at the site of the index ulcer
5. Received Iloprost or other prostacyclin treatment in the last 4 months.
6. Unsuitable for study participation as determined by the clinical investigator.
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).

Eligibility Criteria:
Inclusion Criteria:

* pathology of the head of pancreas requiring surgery

Exclusion Criteria:

* pathology of the head of pancreas not requiring surgery
Totally Endoscopic Ablation of Atrial Fibrillation

Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.

Secondary Objectives

Does totally endoscopic ablation:

* reduce atrial fibrillation symptoms?
* increase working capacity and improve quality of life?
* improve atrial function?
* reduce the risk for stroke?

This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.

After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.

The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 50 years
2. Longstanding persistent AF of \> 1 year duration
3. Severe symptoms related to AF
4. Have signed and dated Informed Consent.
5. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

1. Severe ischemic heart disease or heart valve disease
2. Thrombus formation in left atrial appendage
3. Intolerance to warfarin medication
4. Advanced pulmonary disease, FEV 1 \< 1.5 litre
5. Left atrial diameter \> 60 mm
6. Body Mass Index (BMI) \> 35 kg/m2
7. Previous pulmonary or heart surgery
8. Participation in another clinical trial within the last 30 days prior to enrollment
Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults

Due to demographic changes that have resulted in an aging population, the role of caregiver of an older adult has become very important in recent years. While numerous programs have been designed to lighten the caregiver's physical and emotional burden, fewer programs train caregivers to improve skills and level of independence in the person they care for. The objectives of this research study were to assess the benefits of a caregiver training program on the cognitive and functional status of older adults, as well as to compare the effects of this program according to type of caregiver (professional caregiver vs. family caregiver). Methods: The sample was composed of 160 older adults: a) 100 received care from caregivers who had taken the training program (treatment group), of which 60 were professional caregivers and 40 were family caregivers; and b) 60 received care from caregivers who had not taken the program (control group). In order to evaluate program effects on cognitive and functional status, we used both direct measures (MMSE, CAPE and EuroQol) and caregiver reports (Barthel and RMPBC).


Eligibility Criteria:
Inclusion Criteria:

* Older adults: age 65 or older, receiving care, no diagnosis of dementia, and their informed consent.

Exclusion Criteria:

-
Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)

A variety of in vivo experimental models have been established for the studies of human cancer using both cancer cell lines and patient-derived xenografts (PDXs). In order to meet the aspiration of precision medicine, the in vivo murine models have been widely adopted. However, common constraints such as high cost, long duration of experiments, and low engraftment efficiency remained to be resolved. The chick embryo chorioallantoic membrane (CAM) is an alternative model to overcome some of these limitations. The chick CAM is shown to be a robust model for both the inoculation of cell lines and grafting of patient tumors for drug therapy evaluations and target genes/pathways analysis.

The start-up INOVOTION has developed a unique, highly sensitive and reproducible CAM assay to graft human cancer cells/tumors in the chicken egg environment. INOVOTION's technology was validated for over 55 human tumor cell lines, including carcinomas, gliomas and melanomas, as well as over 30 reference drugs currently on the market.

At INOVOTION, the graft of human cancer cells on the chicken CAM is currently conducted manually. To scale-up, the process was recently automated. The automation performance was assessed on cancer cells lines. The objective of this study is to demonstrate that the automation of the INOVOTION process enables tumors' proliferation using patient samples (from tumor samples or circulating tumor cells) as grafting material.


Eligibility Criteria:
* Inclusion Criteria for all cohorts \* :

  * Age \> 18
  * Signed consent
  * Inclusion criteria for the "Prostate" cohort:
  * prostate adenocarcinoma histologically proven
  * metastatic situation
  * at least 2 metastatic sites
  * Evolutionary disease that requires a new treatment
  * Inclusion criteria for the "Breast" cohort:
  * HER2+ or RH+ breast adenocarcinoma histologically proven
  * metastatic situation
  * at least 2 metastatic sites
  * Evolutionary disease that requires a new treatment
  * Inclusion criteria for the "Lung" cohort:
  * Non Small Lung cancer histologically proven
  * metastatic situation
  * at least 2 metastatic sites
  * Evolutionary disease that requires a new treatment
  * Inclusion criteria for "Ovarian" cohort:
  * Ovarian cancer histologically proven
  * Presence of peritoneal carcinomatosis (stage IIIC or IV); with or without presence of peritoneal fluid
  * Inclusion criteria for "Colo-Rectal" cohort:
  * Colo-rectal cancer histologically proven
  * Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid
  * Evolutionary disease that requires a new treatment
  * Inclusion criteria for "Gastric" cohort:
  * Gastric cancer histologically proven
  * Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid
* Exclusion Criteria for all cohorts \* :

  * Weight \<50kg
  * Parallel participation in a doubled blinded study
  * Brain or ganglionary metastasis only
Topical IL-1-Ra for Treatment of Corneal Neovascularization

The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.

Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patients with superficial or deep corneal NV that extends farther than 1 mm from the limbus
* Patients are in generally good stable overall healthExclusion Criteria: • Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 30 days of study entry
* Corneal or ocular surface infection within 30 days prior to study entry• Ocular or periocular malignancy
* Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
* Persistent epithelial defect (\>1mm and ≥14 days duration) within 2 weeks prior to study entry
* Intravitreal or periocular steroids within 2 weeks prior to study entry
* Change in dose/frequency of topical steroids and/or NSAIDs within 2 weeks prior to study entry
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using contraception
* Signs of current infection, including fever and current treatment with antibiotics
* Participation in another simultaneous medical investigation or trial
Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients

The purpose of this study is to estimate how quickly cognitive status and functional status in older patients on hemodialysis declines.

Dialysis outcome measures, which predict morbidity and mortality of younger patients on renal replacement therapy, such as dialysis clearance, do not correlate with survival of the elderly patients on hemodialysis. Survival of older patients on hemodialysis is significantly worse when compared to that of the younger patients. Conditions commonly affecting older adults, such as functional decline, cognitive impairment, depression and declining quality of life have not been well studied in hemodialysis population. There may be an important relationship between these measurements and outcomes in older dialysis patients. Institution of appropriate age-specific interventions could result in improved health status and mortality of older patients on hemodialysis. Our broad objective is to better understand global functioning of the elderly dialysis patients and its possible impact on dialysis outcomes in attempt to improve health care of the older patients receiving hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program.

Exclusion Criteria:

* Patients 59 and younger, and patients with the following medical conditions: malignancies currently requiring chemotherapy or radiation therapy, severe heart failure (NYHA class IV), known HIV infection, or currently active hepatic encephalopathy.
Sodium Fluorescein-Guided Resection of Pediatric Neurosurgical Tumors

Sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.

This study will be a prospective non-randomized cohort study with patients presenting to Children's Hospital Colorado for resection of a central nervous system tumor. This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. Fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.

Eligibility Criteria:
Inclusion Criteria:

* Age 31 days through 21 years on date of surgery
* Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
* Parent/legal guardian (or adult subject) willing and able to complete the informed consent process

Exclusion Criteria:

* Tumor in functionally eloquent cortex that precludes maximal surgical resection
* Severe renal dysfunction
* Preoperative serum creatinine level \> than normal range and GFR \< 30.
* Severe liver dysfunction
* History of asthma or pulmonary spasm
* Known allergy to sodium fluorescein or any other contrast dye
* Previous administration of sodium fluorescein within the last 72 hours
* Pregnant or nursing mother
* Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
Smartphone and Posture Control In Healthy Adolescents

This is a study to determine if smartphone use affect posture control in adolescents.

It is within subject repeated measure study to determine if touch screen use affect posture control in healthy adolescents.

200 normal adolescents between 14 and 18 years old will be included.

1st they will be assessed for posture control to determine normal values for their ages, then each child will be given smartphone to play a game while the sound is muted for 15 min then their balance will be re-assessed, finally they will use the phone for another 15 min but the children will use headphone piece this time then re-assess balance.

Eligibility Criteria:
Inclusion Criteria:

* Children age from 14 to 18 years old.
* Both genders will be included.
* Normal Body mass index (BMI) for age.
* Children using smartphone for at least 1 year.

Exclusion Criteria:

* Obese children.
* children with vestibular or visual problems.
* Children with neurological disorders.
* Children with congenital deformities or musculoskeletal disorders.
* Children with cognitive impairment.
* Injuries or inflammatory conditions involving the extremities.
A Study of Retrograde Reperfusion of Renal Graft to Reduce Ischemic-reperfusion Injury

To evaluate whether retrograde venous reperfusion of a renal graft before antegrade arterial reperfusion can reduce ischemic-reperfusion injury.

All registered eligible candidates for kidney transplant will be randomized to receive either:

* retrograde venous, then arterial reperfusion or
* antegrade arterial reperfusion.

According to our hypothesis, retrograde venous reperfusion prevents and reduces the immediate and long-term effects of renal allograft ischemic-reperfusion injury.

For the study Chi-square method of sample size estimation with a=0,05, b=0,20 required a 14 subject per group.

The study will include 30 potential kidney recipients for both group aged 18-60 years who will receive kidney transplants. Only adult patients undergoing primary living donor kidney transplantation with standard three-component immunosuppression will be enrolled to the study.The main study group will consist of 15 patients with retrograde graft reperfusion, and control group - will include 15 kidney recipients with only conventional antegrade arterial reperfusion (without retrograde reperfusion).

Patients of the study group with standard kidney implantation surgery will undergo retrograde reperfusion through the renal vein after venous anastomosis. After the venous anastomosis of the graft, an arterial anastomosis is applied with the renal artery without tightening the suture to leave a lumen sufficient for the outflow of retrograde blood. Then the retrograde blood flow through the renal vein is started, venous blood fills the graft and flows through the renal artery through the lumen of the anastomosis in a volume of 80-100 ml. Retrograde blood collected for gas and lactate analysis at the beginning of reperfusion, at the first minute and at the fifth minute. Further, the sutures of the arterial anastomosis are tightened, and after tying, a typical antegrade reperfusion of the graft through the renal artery is performed.

Patients in the control group will undergo standard kidney implantation surgery with typical antegrade arterial reperfusion.

T-test and Mann-Whitney test will be used to compare the median of urea, creatinine levels in serum and glomerular filtration rate (GFR) on the 1st, 7th, 14th, 30th, 60th postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* patients with end-stage kidney disease who are ready for kidney transplantation;
* Panel reactive antibodies (PRA) less than 20%.
* informed consent to participate in the study.

Exclusion Criteria:

* recipients preparing for combined organ transplantation;
* recipients with previously performed transplantation of another organ;
* recipients preparing for transplantation with a different immunosuppressive regimen;
* upcoming blood group incompatibility (AB0-i) transplant;
* PRA antibodies more than 20%;