cyrilzakka/clinical-trials huggingface dataset:
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Men and women \>/=50 years of age.
* Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye.
* ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters.
* Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
* Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Exclusion Criteria:

* Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
* Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
* Any prior treatment with anti-VEGF agents in the study eye.
* Total lesion size \>12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
* Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
* Scar or fibrosis making up \>50% of the total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
* Presence of other causes of CNV in the study eye.
* Prior vitrectomy in the study eye.
* History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
* Any history of macular hole of stage 2 and above in the study eye.
* Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
* History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective

The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
* patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
* patient had demonstated compliance
* patient had given written informed consent.

Exclusion Criteria:

* patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
* patient was pregnant or nursing at the time of entry
* women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment
A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient submitted to bariatric surgery
* All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity

Exclusion Criteria:

•Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
The Effect of Fecal Microbiota Transplantation in Ankylosing Spondylitis (AS) Patients.

Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent Clostridium difficile infection, and the change in gut microbiota is shown to be long lasting. It has led to interest to study its effect on different inflammatory conditions associated with gut dysbiosis.

We hypothesize that dysbiosis in AS leads to inflammasome overactivation on gut mucosa. We aim to study the role of gut inflammation, gut microbiota and inflammasome activation in pathogenesis of AS, and the effect of FMT on these factors, as well as clinical activity, in AS patients.

This is a double-blind placebo- controlled randomized pilot study with 20 patients with active AS from 2 Finnish outpatient clinics. An ileocolonoscopy will be performed to all patients. 10 patients will receive FMT with feces of one of two healthy donors, and 10 patients with their own feces during ileocolonoscopy. Ileal and colonic biopsies will be taken to assess gut wall inflammation and mucosal microbiota composition. Ileocolonoscopy will be controlled in 6 months in patients with macroscopic inflammatory lesions in the first colonoscopy. From mucosal biopsies we will assess intestinal mucosal structure, inflammasome activity, cytokine expression, and the mucin layer thickness and the amount of bacterial LPS (lipopolysaccharide), which are associated with mucosal integrity. Blood levels of zonulin and LPS as indicators of mucosal permeability and bacterial penetrance will be assessed. Fecal samples will be collected repeatedly to measure fecal calprotectin, and to assess the bacterial profile changes. From mucosal biopsies and fecal samples microbial DNA will be segregated and bacterial species sorted by rRNA- based sequence technique. Clinical activity of AS will be assessed in follow-up visits as well as repeated BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index) and MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) evaluations, and measurement of CRP (C-reactive protein) and ESR (erythrocyte sedimentation rate). Follow-up time is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AS by either the 1984 New York criteria or the ASAS (Assessment of SpondyloArthritis International Society) criteria for axial spondyloarthritis.
* Active disease measured by BASDAI \> 4.
* Availability of consecutive fecal samples over 1 year period.
* Compliance to attend ileocolonoscopy and FMT procedure.

Exclusion Criteria:

* Diagnosis of inflammatory bowel disease.
* Antibiotic therapy within the last 3 months.
* Use of any probiotics within the last 3 months.
* Pregnancy.
* Unability to provide a written consent.
* Other reason which by the opinion of the investigator makes patient ineligible for the study.
Physiotherapy in Patients in a Cardiac Intensive Care Unit

Background. Cardiovascular diseases are a major cause of morbidity and mortality. The management of these patients requires multidisciplinary therapeutic approaches. Physiotherapy plays a fundamental role in the postoperative management of patients undergoing cardiac surgery.

Objective: To analyse the relationship between the administration of a physiotherapy intervention and the time spent in the cardiac ICU and on the ward.

Method. Retrospective cohort study. The medical records of 110 patients undergoing cardiac surgery who received a Physiotherapy intervention during their stay in the Intensive Care Unit will be analysed. Data will be collected from patients admitted to the cardiac ICU in 2023. The variables assessed will be: length of stay in ICU and hospital admission (days), age (years completed), weight (kg) and sex. A one-factor analysis of variance will be performed to calculate the association between the variables and a linear regression analysis will be used to describe the hospital stay variables as a function of the other predictor variables.

Expected outcomes. Physiotherapy treatment in an Intensive Care Unit improves ICU and hospital stay times in patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cardiac pathology
* Undergoing cardiac surgery at the Hospital Universitario Central de Asturias between 1 January and 31 March 2023
* In the postoperative phase in the Intensive Care Unit and subsequently on transfer to the ward, they received physiotherapy treatment or not.
* That the period of stay in the ICU was less than 30 days.

Exclusion Criteria:

* Patients with comorbidities prior to surgery that hindered independence from third parties in the performance of activities of daily living and ambulation; iii) patients with previous cardiac surgeries; and iv) patients whose study variables were not fully recorded in the Medical History.
* Patients with previous cardiac surgeries
* Patients whose study variables were not fully recorded in the Clinical History.
Using Patient Feedback to Improve Communication Regarding Glycemic Control to Patients With Diabetes

In this two-phase mixed methods study, the investigators will first use patient feedback from semi-structured interviews to explore the ways in which patients with diabetes understand their diabetes and assess their disease control. The investigators will also use these interviews to elicit patient feedback on promising alternative communication formats to the hemoglobin A1C (A1C). In the second phase of the study, the investigators will test new formats to communicate information regarding diabetes control to patients with poorly controlled diabetes. This phase will be a three arm RCT comparing the effect of A1C (standard medical information) versus two alternative formats on several participant outcomes, primarily glycemic control at 6 months post-intervention.

The noted importance of understanding glycemic control is concerning given studies estimating that only 25% of patients understand the hemoglobin A1C value (A1C). The A1C is a blood test value reflecting average blood sugars over the previous 3 months and is used as both a clinical indicator of diabetes control with guideline-set targets and as a communication format to express level of disease control to patients.Past work has demonstrated the potential effectiveness of translating poorly understood medical values, like the A1C, into more universally understood forms. We believe applications can be used to address the problem of the poorly understood A1C. This study is two-phase mixed methods approach. We will design alternative communication formats to convey the information provided by the A1C to patients and evaluate the effectiveness of these formats in improving glycemic control, increasing patient understanding of their diabetes control, and altering patient behaviors. In Phase I of the study,we will use patient feedback from semi-structured interviews with 17-25 patients with diabetes to explore the ways in which patients assess and gauge their diabetes control, as well as to elicit patient feedback on promising communication formats. Potential alternative communication formats include categories represented by color-based scales (red/yellow/green), comparisons to averages or norms, trajectories of control over time and modified medical terminology (i.e., changing the name of the test). In phase II, patients with poorly controlled diabetes will be randomized to receive information on their glycemic control through one of three study arms, A1C (control) or one of two experimental format arms (chosen based on phase I results) and the effects of these different communication formats will be evaluated.

Eligibility Criteria:
For Phase I:

Inclusion Criteria:

* Adults who report a diagnosis of diabetes

Exclusion Criteria:

* People without diabetes

For Phase II:

Inclusion Criteria

-Adults seen at University of Pennsylvania primary care practice with a diagnosis of diabetes documented in the electronic health record and a recent hemoglobin A1C \>8 %

Exclusion

* No diabetes
* No A1C or recent A1C \<8%
Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal

Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver babies at home without a skilled birth attendant.

The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and water or an antiseptic solution for the first few days of life can reduce umbilical cord infections.

While significant progress has been made in reducing preschool child mortality in developing countries over the past 20 years, much less progress has been made in reducing neonatal mortality and morbidity. Neonatal mortality rates are high in Nepal; a significant proportion of which are due to sepsis. In addition, the vast majority of women deliver babies at home without a skilled birth attendant and early neonatal care is routinely used in rural areas. Previous hospital-based research in Malawi suggested that newborn cleansing with a dilute chlorhexidine solution could reduce early infant mortality. This project evaluates the use of a simple intervention at the community level and the impact on neonatal mortality.

Comparisons: Two nested community-based randomized trials are being conducted. The first compares the neonatal mortality rates between newborn infants randomized to receive a whole body skin cleansing soon after birth with baby wipes impregnated with 0.25% chlorhexidine compared with newborns cleaned with baby wipes with a placebo solution. The second trial compares the rates of umbilical cord infections among children assigned to three groups:

* education of the mother on clean cord care alone;
* education of the mother plus routine washing of the cord and stump with soap and water solution for the first 10 days of life; -OR-
* education of the mother plus routine washing of the cord and stump with a 4% chlorhexidine solution.

Enrolled infants are visited on a regular basis during the first month of life to record vital status and grade the cord for signs of infection.

Eligibility Criteria:
Inclusion Criteria:

* All liveborn infants born in the study area

Exclusion Criteria:

* Newborn infants who died prior to study staff arriving to conduct the interventions
A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening
* Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening
* Mean blood pressure \>90/60 millimeters of mercury (mmHg) and \<140/90 mmHg at screening
* If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening
* Stable weight for 3 months prior to screening
* Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m\^2)
* Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions
* Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control
* Male participants must use a reliable method of birth control

Exclusion Criteria:

* Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening
* Ongoing or history of frequent intermittent tachyarrhythmia
* Resting heart rate \<60 beats per minute (bpm) or \>100 bpm at screening
* Work rotating shifts or work during the hours of 2200 to 0700
* Chronic insulin therapy
* Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
* Nondominant arm circumference \>42 centimeter (cm)
* Use of drugs to promote weight loss
* Chronic use of systemic steroids
* Gastric emptying abnormality or bariatric surgery
* Hepatitis, other liver disease, or alanine transaminase (ALT) \>3 times the upper limit of normal
* Acute or chronic pancreatitis
* Severe renal impairment
* Active autoimmune disease or uncontrolled endocrine abnormality
* Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia
* Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening
* Transplanted organ except corneal transplants
* Active or untreated cancer or in remission \<5 years, except skin, in situ cervical, or prostate cancer
* Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing
The Use of Voice-Based AI in 988 Crisis Counseling

Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. This research study's goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.


Eligibility Criteria:
Inclusion Criteria:

Must be employed at Protocall Services, Inc.

Exclusion Criteria:

Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research.
Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation

Prospective cohort study evaluating the electrophysiologic and biochemical effects of stellate ganglion block in patients with ventricular tachycardia.


Eligibility Criteria:
Inclusion Criteria:

* Planned catheter based VT ablation
* Age at least 18 years

Exclusion Criteria:

* Pregnancy
* Contraindication to SGB or VT ablation
* Hypersensitivity of local anesthetic of amide type
* Hemodynamic instability during the procedure prior to the study protocol
Elastography as Gouty Arthropathy Outcome (EGO)

Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.

Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are at least 18 years of age but younger than or equal to 99 years of age.
2. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis.
3. Subjects with one palpable tophus detectable by one of the three clinical parameters described.

   -

Exclusion Criteria:

1. Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds.
2. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial.
3. Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated.

   -
Geniculate Artery Embolization for the Treatment of Knee Pain

This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce the severity of pain and disability caused by knee osteoarthritis.

Purpose: The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee OA and if it can be performed safely. The secondary aim is to determine if GAE can result in the decreased necessity for ongoing conservative OA therapies such as medication therapy and joint injections.

Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.

Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing GAE to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 1, 3 \& 6 months. An MRI will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe knee pain (visual analog scale (VAS) \> 50 mm), and
* Pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
* Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.

Exclusion Criteria:

* Current local infection, or
* Life expectancy less than 6 months, or
* Known advanced atherosclerosis, or
* Rheumatoid or infectious arthritis, or
* Prior knee surgery, or
* Uncorrectable coagulopathy including international normalized ratio (INR) \> 2.5 or platelets \< 30,000, or
* Iodine allergy resulting in anaphylaxis, or
* Renal dysfunction as defined by serum creatinine \>1.6 dl/mg obtained within the past 30 days.