cyrilzakka/clinical-trials huggingface dataset:
Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Age more than 50 years
* Prostate size of more than 80 ml
* IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
* Indications for surgery

  * Refractory retention (failed ≥1 trial of voiding).
  * Associated bladder Stones.
  * Associated recurrent gross Hematuria.
  * Associated with recurrent Infections.
  * Associated renal insufficiency.
  * Bother symptoms refractory to medical treatment.

Exclusion Criteria:

* Uncorrectable coagulopathy.
* Patient with active UTI.
* Prostate less than 80 ml.
* Severe associated comorbidities.
* Previous urethral, prostate, and bladder surgeries,
* Patients diagnosed with neurogenic bladder.
* Patients diagnosed with prostate cancer.
The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes

The study RADAR aims at developing a wearable based dysglycemia detection and warning system for patients with diabetes mellitus using artificial intelligence.

Prior research has investigated the general potential of data analytics and artificial intelligence to infer blood glucose levels from a variety of data sources. In this study patients with insulin-dependent diabetes mellitus will be wearing a continuous glucose meter (CGM) and a smartwatch for a maximum duration of 3 months in an outpatient setting. The gathered data will be used to develop a non-invasive and wearable based dysglycemia detection and warning system using artificial intelligence.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age ≥ 18 years
* Diabetes mellitus treated with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

Exclusion Criteria:

* Smartwatch cannot be attached around the wrist of the patient
* Known allergies to components of the Garmin smartwatch or the Dexcom G6 system
* Pregnancy, intention to become pregnant or breast feeding
* Cardiac arrhythmia (e.g. atrial flutter or fibrillation, AV-reentry tachycardia, AV-block \> grade 1)
* Pacemaker or ICD (implantable cardioverter defibrillator)
* Treatment with antiarrhythmic drugs or beta-blockers
* Drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction.

This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* subjects with age \> 18 years
* in good health status (assessed in occasion of enrollment visit) without any major systemic illness
* candidate to third molar extraction and presenting local pain within 2 hours after dental extraction

Exclusion Criteria:

* patients with any major systemic illness
* patients with a clinical history of drug abuse
* patients with hypertension and/or a condition of increased cardiovascular risk
* pregnant or lactating women
* patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
* patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval)
* patients with either a history of peptic ulcer or of haemorrhagic diathesis
* patients who can not ensure an adequate compliance for the study
Endoprosthesis Metal Toxicity Study

The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.

At your first visit you will be asked to do the following:

1. Sign the consent document.
2. Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
3. Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
4. Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
5. Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.

6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.

Eligibility Criteria:
Inclusion Criteria:

* Patient has an endoprosthesis after extremity malignancy

Exclusion Criteria:

* Current fracture or infection around the endoprosthesis
* Patient is pregnant
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging

A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).

Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging catheters. The images will be collected into a library and independent readers will rank each image on the quality of vessel morphology and disease.

Eligibility Criteria:
Inclusion Criteria:

* adult
* suspected vascular disease that might be a candidate for IVUS
* reference vessel can accommodate imaging catheters
* successful diagnostic imaging and removal of IVUS catheter with no adverse events

Exclusion Criteria:

* if female, pregnant or breast-feeding
* unwilling to give informed consent
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II

Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:

1. To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above.
2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
3. Examine mechanisms by which components are hypothesized to work.

In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in MMT or BUP treatment for \> 3 months
* Plan to continue treatment for next 6 months
* Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
* Aged \> 18
* Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
* Available at least one of the times study classes are offered.

Exclusion Criteria:

* Currently taking yoga classes or practicing yoga at home once per week or more often.
* Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
* Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
* Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
* Surgery requiring overnight hospitalization planned in the next 3 months
* Pregnancy
* No access to a reasonably safe, reliable place to engage in personal yoga practice and a private space to participate in online yoga classes
Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Receiving chronic maintenance hemodialysis for end-stage kidney disease
* Currently receiving epoetin alfa for anemia
* Hb between 8.5 and 10.0 g/dL during screening

Exclusion Criteria:

* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
taVNS for Upper Limb Rehabilitation

This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.

Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Ischemic or hemorrhagic stroke that occurred at least 6 months prior
* Completed conventional rehabilitation therapy at least one month prior
* Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than or equal to 58 (out of 66)

Exclusion Criteria:

* Primary intracerebral hematoma, or subarachnoid hemorrhage
* Bilateral upper extremity weakness
* Other concomitant neurological disorders affecting upper extremity motor function
* Documented history of dementia before or after stroke
* Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment
* Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) \>=180/100mmHg at baseline
* Contraindicated for MRI scanning.
Genome-wide Analysis of Lipid-lowering Efficacy and Drug Level of Simvastatin and Rosuvastatin

This study will perform a genome-wide association study (GWAS) of the lipid responses to rosuvastatin and simvastatin and plasma concentrations of these two statins in a homogeneous group of Han Chinese patients.

A GWAS will be performed on about 360 Han Chinese patients with hypercholesterolaemia (which may be familial or non-familial) who have previously participated in a research project on the pharmacogenetics of statins and who have been treated with rosuvastatin and simvastatin to determine the genetic factors that may be related to the reduction in plasma low-density lipoprotein cholesterol (LDL-C) and plasma concentrations of these two statins. The lipid profiles were measured at baseline on no lipid-lowering treatment and after 4-6 week treatment of rosuvastatin 10 mg daily and after treatment with simvastatin 40 mg daily for at least 6 weeks with at least a 4-week washout period between the two treatments. Plasma concentrations of these two statins and their active metabolites about 12 hours after administration of statins have been measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Genotyping for the whole-genome scan will be carried out on the Illumina OminiExpress beadchip (Illumina, San Diego, CA). The samples will be processed using the Illumina iScan platform at the Li Ka Shing Institute of Health Science, The Chinese University of Hong Kong (CUHK).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypercholesterolemia (familial or non-familial)
* Eligible for statin treatment according to local guidelines in the Hong Kong Public Hospital system.

Exclusion Criteria:

* Taking other medication which may interact with the pharmacokinetics or lipid response to statins.
* Not willing to cooperate with study requirements.
AGRA Before and After Liver Transplantation

The immune system is impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients at risk. It is still unclear, how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections. Therefore, AGRA will be measured before and after liver transplantation and predictive merit of AGRA for post-transplant infections will be tested.

Cirrhosis-associated immune dysfunction syndrome (CAIDS) is a well-recognized phenomenon. It affects all immune cells as well as the humoral immune system. Because of this deficiency patients with liver cirrhosis often suffer from severe infections that can be complicated by sepsis, acute renal or liver failure, and lead to prolonged hospitalization and ultimately to the death of the patient. The humoral immune system is a first-line defence mechanism and consists of cell-free molecules that are partly produced by the liver and target pathogens through opsonisation, growth inhibition and lysis. A cirrhotic liver cannot reach its full protein expression capacity and consequently, quantitative and qualitative changes of complement factors and immunoglobulins have been observed in liver disease patients before.

Liver transplantation remains the only curative option to treat liver cirrhosis and its extrahepatic manifestations; however due to limited organ supply this option is not applicable in all cases. Therefore, liver cirrhosis and its complications (eg. infections) need to be managed by health care professionals, who often lack appropriate tools for risk assessment. To meet this clinical need, a novel biomarker was recently established (Acellular Growth Retardation Ability, short AGRA) that uses the state of the humoral immune system to predict the future occurrence of severe infection in liver disease patients. However, it is still unclear how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections.

Therefore, patients scheduled for liver transplantation will be included in the trial. AGRA measurements before and after the transplant (1, 7, 90 days after the end of antibiotic treatment) will be performed. Additionally outcome data regarding severe infections are collected for one year before and after transplantation. The respective organ donors are included as a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-80 years
* Listed for liver transplantation (for recipients)
* Liver recipient is included in the study (for donors)
* Informed consent

Exclusion Criteria:

* Antibiotic therapy with substances active against E. coli at the scheduled blood sampling
Validation of a Mouse Model of Pancreatic Carcinogenesis

The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in our validated mouse model. Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic resection for PDAC, intraductal papillary mucinous neoplasm (IPMN) or mucinous cystic neoplasm (MCN). Tissue will be examined for the three most common founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are found, heterozygote normal and abnormal tissue will be examined to look for mutations in the other BRCA1 or BRCA2 allele. The interaction between other cancer causing genes with BRCA1/2 will also be evaluated by comparing the sequences of the other genes in pre-cancerous lesions.

We hypothesize that BRCA1- and BRCA2-mediated pancreatic ductal adenocarcinoma progresses through the PanIN route, as seen in both BRCA1 and BRCA2 murine models of pancreatic cancer. We further hypothesize that BRCA1 mutations may enable an additional pre- neoplastic pathway through MCN, and that IPMN may embody yet another pre- neoplastic pathway.

Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of death from malignancy in the United States. Several gene mutations and cancer syndromes have been identified that are found in greater frequency in individuals with PDAC, including the breast ovary cancer syndrome (BRCA1 and BRCA2 mutations). We have recently generated mouse models of pancreatic cancer in which we found that deletions of either BRCA1 or BRCA2 cooperate with K-ras activation and p53 mutations to increase the rate of tumorigenesis via accelerated progression of Pancreatic Intraepithelial Neoplasia (PanIN). However, only BRCA1 deletions were associated with the development of concomitant Mucinous Cystic Neoplasms (MCNs), suggesting potentially distinct pathways for BRCA1- and BRCA2-mediated tumorigenesis in the pancreas. Our primary aim is to determine if germline mutations of BRCA1 and BRCA2 result in different pre-neoplastic pathways to pancreatic cancer, as in our murine model. Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic resection for pancreatic cancer, IPMN or MCN. Tissue will be genotyped for the three most common founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are found, heterozygote normal and abnormal tissue will be microdissected to look for loss of heterozygosity at the BRCA1 or BRCA2 allele. Our secondary aim is to evaluate the interaction of p53 and Kras with BRCA1 and BRCA2 by sequencing p53 and Kras in PanIN as compared to IPMN and MCN lesions.

Eligibility Criteria:
Inclusion Criteria:

* Tissue-confirmed diagnosis of pancreatic adenocarcinoma, MCN, or IPMN.
* Underwent surgical resection for pancreatic adenocarcinoma, MCN, or IPMN.

Exclusion Criteria:

* Unwilling to provide informed consent.
* Under the age of 18.