cyrilzakka/clinical-trials huggingface dataset:
Combined Triple Therapy in Diabetic Retinopathy (DRP)

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetic retinopathy

  * macular edema more than 200 micron
  * vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

Exclusion Criteria:

* Prior intraocular injection within 4 months
* Core or complete vitrectomy
* History of glaucoma or ocular hypertension
* Presence of iris neovascularization
* Significant media opacity
* Monocularity and pregnancy
Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant

Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF) implant. AcF is unique in that it delivers intravitreal corticosteroids for 2 to 3 years, whereas DXM only releases them for 3 to 6 months. After 6 months for AcF and 1 month for DXM, full therapeutic efficacy is attained.

AcF's safety and efficacy have now been confirmed in the FAME originator studies as well as other phase IV investigations. However, in the FAME princeps trials and numerous phase IV trials where patients got AcF more than 6 months after DXM, up to 40% of patients required laser, anti-VEGF, and/or DXM retreatment within the AcF active period. This high rate could be attributed to AcF's 6-month delay in reaching full efficacy.

This is why the investigators intended to replicate the previous Iluvi1-month research, which shown that injecting DXM at 1 month preserved visual acuity and central retinal thickness for the first 6 months without increasing intraocular pressure significantly. The study, however, was unable to determine the long-term impact on the rate of relapses requiring additional therapy as well as tolerance with the development of long-term cortisone-induced glaucoma.

In light of this, the investigators should like to gather new data for a 3-year follow-up after AcF injection, including measurements of optic nerve fibre thickness (OCT RNFL). This is an essential safety data point because it assesses the long-term effects of ocular hypertension, which is a well-known side effect of intravitreal corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Patient (Male, Female)°≥ 18 years old
* Having received an AcF injection 1 month after a DXM injection
* For diabetic macular edema or uveitic macular edema

Exclusion Criteria:

* Patient's refusal to allow his or her medical data to be used for research purposes
Effect of Adipose Derived Stem Cells on Survival of Fat as Filler

this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler

Skin aging is a complex biological process.The physiological changes associated with aging of the skin are manifested in xerosis, dramatic loss of skin elasticity due to damage to collagen and elastin fibers; as well as barrier function, modification of rhytides and deficiencies in the regenerative property of the skin. All of which ultimately result in thinning of the skin, malar fat atrophy and pigmentary changes. Autologous fat grafting or lipo injection containing stromal vascular fraction (SVF) acts like ideal soft tissue filler for facial filling and rejuvenation. It leads to progressive improvement of the skin texture, elasticity, and color over a few months, therefore adipose tissue seems to be not only a simple filler but also a dynamic filler with two types of different and supplementary effects, the volumetric effect and the regenerative effect.Cell assisted lipotransfer (CAL) is a technique that combines aspirated fat with concentrated ADSCs in the stromal vascular fraction (SVF) of the lipoaspirate. This technique could enhance the survival rate of the transplanted fat and leads to better cosmetic improvement

Eligibility Criteria:
Inclusion Criteria

1. Clinically diagnosed facial skin aging.
2. Glogau photoaging score II and III.
3. Body mass index ≥20 with adequate abdominal or other subcutaneous adipose tissue accessible for lipoaspiration.

Exclusion Criteria:

1. History of keloid formation.
2. Any coincidental chronic illness (e.g. metabolic, autoimmune or endocrinal) or malignancy.
3. Any bleeding or coagulation disorder or recent use of anticoagulant therapy.
4. Active infection.
5. History of any previous aesthetic procedure on the face within the past 6 months.
6. History of intake of anti-aging systemic or topical medications within the previous 3 months
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma

The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma.

Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A better understanding of PD-L1 expression in a "real world" setting could help understand its clinical utility in the management and decision making in advanced UC and clinical trial design

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Age ≥18 years old
* Patient must have advanced UC confirmed by their HCP; histologically- confirmed diagnosis of UC an dHCP-confirmed advanced UC.
* Patient must be either currently receiving 1L systemic treatment for their advanced UC or will be starting 1L systemic treatment (i.e. "newly diagnosed" advanced UC; 1L therapy is defined as the first systemic therapy given for advanced UC).
* Patient remains eligible for the study if they received neoadjuvant or adjuvant platinum-based chemotherapy if their recurrence was more than 12 months after their last chemotherapy dose.
* Radio-sensitizing chemotherapy as part of chemoradiation is NOT counted as neoadjuvant or adjuvant chemotherapy; thus, the 12-month interval mention above does not apply, and the patient would be eligible
* Patients with available tumor tissue sample (fresh or archival - up to 3 years old) that was collected as part of SoC any time prior to 1L treatment for advanced UC with a target of 18 slides (7 minimum) available for biomarker testing (PD-L1 and tTMB). Already prepared slides must have been cut within 6 months prior to PD-L1 testing.

Exclusion Criteria:

* Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study
* Patient has resectable localized UC and has refused surgery
* Patients with history of non-urothelial active malignancy that completed therapy within 2 years from study enrollment except:

  * Any resected in situ carcinoma or non-melanoma skin cancer
  * Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy) and in which no systemic therapy was indicated
FFP Usage in Pediatric CV Surgery

When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.

This will be a single center, retrospective study. Our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between January 2019 and January 2023. Patients will be divided into two groups: FFP given at onset of CPB and no FFP given intraoperatively. Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded. Patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using REDCAP and via chart review using Connect Care.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded
Study of GDX012 in Patients With MRD Positive AML

The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry.

The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Weight ≥ 40 kg
* Anticipated life expectancy \> 3 months prior to lymphodepletion
* Karnofsky Performance Score ≥ 70%
* Histologically confirmed diagnosis of AML
* In complete response (CR) (including CRi/CRp); patients in first, second or subsequent CR (including CRi/CRp) are permitted
* MRD detected in bone marrow by MFC
* Negative pregnancy test (females of childbearing potential only)
* Agree to use effective birth control
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Platelet Count ≥ 20 x 109/L
* Prothrombin Time or INR ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
* Partial Thromboplastin Time ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
* Hemoglobin ≥ 8.0 g/dL
* Creatinine Clearance ≥ 40mL/min
* Serum Total Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's Syndrome with Direct Bilirubin \< 35% of Total Bilirubin)
* ALT ≤ 2.5 x ULN

Exclusion Criteria:

* Cytotoxic chemotherapy within 3 weeks
* Immune therapy within 4 weeks
* Immunosuppressive therapy within 2 weeks (with exceptions)
* Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
* Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
* Known hypersensitivity to chemotherapy, other agents, or excipients used in this study
* Female patient that is pregnant or lactating/breastfeeding
* Ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ Grade 1 (with exceptions)
* History of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents)
* Active CNS involvement (i.e. leukemic infiltration)
* Any other malignancy that requires active therapy
* Uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months)
* Active infection with HIV, Hepatitis B or Hepatitis C

NOTE: other protocol defined inclusion/exclusion criteria may apply.
Impaired Decision-making in Adolescents

There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. It is likely that a biopsychological vulnerability in some aggressive children and children with DBD makes them liable to substance use and abuse. The investigators hypothesize that deficient decision making is such a biopsychological factor. In this study the investigators aim to test the latter hypothesis by investigating the decision making ability in a group of adolescents with DBD with and without substance use disorders. Decision-making is assessed with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty, reward and punishment. The GT is specifically designed to assess impaired decision-making in individuals who are unable to learn from their mistakes and make decisions that repeatedly lead to negative consequences. This characteristic may be common to individuals with externalizing disorders such as DBD, psychopathy, and substance use disorders.

This study consists of two substudies with adolescents in the age of 14-21 years. The first study group consist of adolescents with DBD with (n=30) and without (n=30) substance use disorders. These adolescents are recruited from orthopsychiatric, forensic psychiatric, and judicial institutions.

The second study group consists of a) ex-patients of the Utrecht Coping Power Program (UCPP)who previously participated to a follow-up study, and b) ex-patients who were treated as a child at an outpatient clinic of the UMC Utrecht. These latter groups were taken together and subdivided into a group with (n=30) and without (n=30) substance use problems.

For both studies healthy controls (n=80) are recruited. The investigators will start with healthy controls from earlier studies, and those are extented and will serve as control group for both studies.

Eligibility Criteria:
Inclusion Criteria:

* Having a DISC diagnosis DBD

Exclusion Criteria:

* Having the DISC diagnosis Schizophrenia
WelChol® and Insulin in Treating Patients With Type 2 Diabetes

The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable insulin therapy for 6 weeks
* Stable dose of any other antidiabetic medications for 90 days
* Hemoglobin A1c value between 7.5% to 9.5%
* C peptide greater than 0.5 ng/mL
* Prescribed ADA diet

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C less than 60 mg/dL
* Serum TG greater than 500 mg/dL
* Body mass index (BMI) greater than 45 kg/m2-
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Restricted to 18 to 80 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas
* Absolute neutrophil count \>= 1,500 / uL
* Platelets \>= 50,000 / Ul
* Serum creatinine \<= 1.5 mg / dL
* Adequate nutritional status (Albumin \>= 3.5)
* Metastasis confined to the peritoneum:

  * Positive peritoneal cytology
  * Peritoneal metastasis on diagnostic laparoscopy
  * Peritoneal metastasis on imaging
* Response to systemic chemotherapy defined as at least one of the following:

  * Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\]
  * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\>= 20% decrease in the longest diameter of target lesion) RECIST criteria
  * Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology
  * Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9
* Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction
* Body Mass Index (BMI) =\< 35 kg/m\^2

Exclusion Criteria:

* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)
* Malignant ascites at time of study enrollment
* Comorbidities that would preclude protocol therapy
* Subjects deemed unable to comply with study and/or follow-up procedures
* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients

The primary purpose of this study is to demonstrate that a continuous infusion of intravenous (IV) heparin (UFH) for Venous thromboembolism (VTE) prophylaxis will restore prophylactic levels of heparin in high-risk critically ill medical patients as compared with guideline recommended subcutaneous heparin. Antifactor Xa assay, a laboratory test to measure the anticoagulant activity of heparin, or the ability of heparin to thin the blood, will be used to demonstrate that Intravenous administration is more effective.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the medical ICU (MICU)
* High-risk for Venous Thromboembolism (VTE) ≥ 1 of the following:
* Body Mass Index (BMI) ≥ 30 kg/m2
* Personal or family history of VTE
* Receiving vasopressors

Exclusion Criteria:

* Indication for therapeutic anticoagulation
* Evidence of deep vein thrombosis (DVT) on ultrasonography at admission
* Indwelling intrathecal, epidural, or other indwelling deep catheters
* Recent (\< 3 months) International Society of Thrombosis and Haemostasis (ISTH) major bleeding13
* Recent (\< 3 months) major trauma
* Recent (\< 3 months) neurosurgery or orthopedic surgery Pregnancy
* Contraindication to heparin or heparin products
Functional Characterization of CD8+ T Cells After Supramaximal Exercise

Healthy human subjects perform supramaximal exercise with venous blood samples obtained before and up to 60 minutes after the exercise bout.

Healthy, human subjects perform 3 x 30 seconds of supramaximal exercise. Venous blood samples were obtained before and up to 60 minutes after the exercise bout. The blood was used for absolute count of lymphocytes and monocytes per volume blood, and for isolation of CD8+ T cells. It was also used for blood gas analysis. The CD8+ T cells were characterized using flow cytometry, and then cultured for 7 days with CD8+ activation beads. The cells were counted and analyzed for viability at day4 and day8. RNAseq was performed on CD8+ cells isolated before and directly after exercise. CD8+ T cells from Day 1 pre and post exercise and then after 7 days of culture, were analyzed for IFNgamma release using Elispot, and for cytotoxicity against HEK cancer cells in vitro. Flow cytometry of CD8+ T cells was performed on fresh CD8 T cells pre and post exercise, and then on day4 and day8 after culture. SeaHorse metabolic assay was done on Day1 CD8 T cells obtained pre and post exercise.

Eligibility Criteria:
Inclusion Criteria:

* Be used to physical exercise and be able to perform strenous exercise Be able to attend the experimental procedure for the 90 minute duration of the study

Exclusion Criteria:

* Smoking Pregnant Have any medical condition requiring medical treatment
Coffee for Optimal Metabolite Profile

The aim of this project is to evaluate metabolite profile after consumption of three types of coffee differing in type of bean, degree of roasting and preparation method. Metabolite profiles will be evaluated after a) a single dose b) 3-day consumption. The study will be carried out as a three-way cross-over design with three different types of coffee. Wash-out periods where participants consume their habitual diet are implemented between all intervention periods. The first day of intervention (single dose) includes postprandial measurements during 13 hours.


Eligibility Criteria:
Inclusion Criteria:

* Females and males
* 18 to 80 years of age
* Body mass index (BMI) 18.5-30.0 kg/m2
* Fasting glucose ≤ 6.1 mmol/l
* Low density lipoprotein (LDL) cholesterol ≤ 5.30 mmol/l
* Triglycerides ≤ 2.60 mmol/l
* Signed informed consent

Exclusion Criteria:

* Food allergies or intolerances preventing consumption of any products included in the study.
* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personnel.
* Pregnant, lactating or planning a pregnancy during the study period.
* Antibiotic use for the last 3 months.
* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Chron's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* Previous major gastrointestinal surgery
* Have type I diabetes
* Thyroid disorder