cyrilzakka/clinical-trials huggingface dataset:
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma

To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.

The participants will be divided into two groups (the experimental group and control group). Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy. Participants in the control group will receive radical cystectomy alone.

After follow-up, the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial.
* 18-75 years of age on day of signing informed consent.
* Have histologically confirmed muscle invasive disease of the urinary bladder.
* Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
* Clinical stage II-III and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
* Eastern Cooperative Oncology Group 0-1 and good organ function.

Exclusion Criteria:

* A non-surgical approach recommended by the treating urologist due to any reason.
* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration.
* Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
* Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease requiring systemic treatment.
* Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-programmed cell death 1, anti-programmed cell death-Ligand 1 antibody.
* Has a known history of Human Immunodeficiency Virus.
* Has known active Hepatitis B or Hepatitis C.
Non-invasive Measurement of Hemoglobin in Infants and Neonates

Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere).

Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere). Data collection whenever an arterial blood gas analysis is indicated by the experienced attending anesthetist - before and after cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective congenital heart surgery
* routine use of an arterial line
* weight \>= 3000g

Exclusion Criteria:

* urgent surgery
* premature birth
* parents refuse
Subacromial Corticosteroid Injections and tDCS in Rotator Cuff Tendinopathy

This study evaluates the effects of corticosteroid injections over time, as well as the additional effect provided by subsequent transcranial direct current stimulation (tDCS) of the motor cortex on patients with rotator cuff tendinopathy of the shoulder. All patients will receive a subacromial corticosteroid injection. Two weeks later, a third will receive a treatment of tDCS, a third will receive a placebo a-tDCS treatment, and the last third will not receive any additional treatment.

Corticosteroid injections (CSI) are often used by physicians in the treatment of rotator cuff tendinopathy, a painful chronic degeneration of the tendons in the shoulder. However, the effect of CSI in comparison with placebo is disputed in the scientific literature, with most studies only showing mild short-term effect (less than six weeks) on pain compared to placebo injections.

Transcranial direct current stimulation (tDCS) is a non-invasive technique allowing to stimulate areas of the brain in order to change the excitability of the neurons. When the negative electrode is applied on the motor cortex of the brain, it increases the excitability of the neurons in that area, which in turns inhibits the activity of the thalamus, an area of the brain linked with the perception of pain. Some studies have shown that tDCS can improve chronic pain of different origins, such as lower back pain, fibromyalgia, stroke, osteoarthritis, and post-operative pain.

We tested whether applying tDCS following a CSI would have more effect on patient's pain, function, and activity, than CSI alone.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain for at least 9 months
* Trial of conservative treatment prior to inclusion
* Positive painful arc sign
* At least one positive impingement test (Neer or Hawkin's impingement sign)
* Written and oral comprehension of French and/or English

Exclusion Criteria specific to rotator cuff tendinopathy and CSI:

* Traumatic origin
* Diagnosis of a systemic inflammatory joint disease
* Complete rotator cuff tear on physical examination or MRI
* Diagnosis of acromio-clavicular syndrome
* Presence of cervical nerve root pain or symptoms
* Other confounding pathologies seen clinically or radiographically
* History of previous fracture or surgery at the shoulder
* Contraindication to CSI
* CSI received in the last three months
* Planned or ongoing pregnancy
* Receiving worker's compensation or being involved in litigation relating to the shoulder pathology.
* Inability to follow protocol instructions

Exclusion Criteria specific to tDCS and transcranial magnetic stimulation:

* History of epilepsy or convulsions
* Brain metallic implants or fragments
* Brain lesions or tumors
* Use of a pacemaker or ICD
* Use of an intravenous medication pump
* Severe cardiac disease, or recent cardiac event
* Consumption of medications known to lower the seizure threshold
* Alcoholism
* Severe sleep deprivation
* Eczema or skin lesions at the area of electrode application
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy

Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.


Eligibility Criteria:
Inclusion Criteria:

* proximal tibial osteotomy

Exclusion Criteria:

* femoral or sciatic nerve deficit,
* pre-existing peripheral neuropathy,
* chronic pain diagnosis,
* pregnancy,
* identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).
Caffeine and Sodium Citrate Ingestion

A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term, high-intensity exercise task was shown by several studies. These studies were conducted with healthy, able-bodied subjects.

The aim of the study is to investigate whether caffeine or sodium citrate ingestion could enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo controlled and randomized study.

The athletes have to complete four 1500m tests on a training roller. Before each treatment they get different supplementations. Once they get sodium citrate and a placebo, once caffeine and a placebo, once sodium citrate and caffeine and for the fourth treatment they get twice a placebo. Two hours after starting with the supplementation they have to complete the 1500m as fast as possible. Time to complete 1500m, blood pH, plasma bicarbonate, sodium concentration, heart rate, oxygen consumption, blood lactate concentration and rate of perceived exertion (RPE) were measured.

Eligibility Criteria:
Inclusion Criteria:

* wheelchair athletes
* national team
* category T53 and T54

Exclusion Criteria:

* medicated
* pregnant (for women)
* cardiovascular and respiratory diseases
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)

This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes or hypertension requiring therapy
* EF \>/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'\>/= 12 determined by echo within 1 year
* previous hospitalization for heart failure or previous BNP \>100 pg/mL.

Exclusion Criteria:

* Clinically significant valvular disease
* history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
* history of acute MI within 6 months
* severe COPD
* active or treated malignancies (except basal cell carcinoma)
* significant systemic illnesses that would prohibit completion of the study or compliance
Intraocular Pressure Versus Optic Nerve Sheath Diameter

This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath Diameter in steep trendelenburg position. Both observations will be done in same patient over the surgical duration.

Steep trendelenburg position is required for various robotic surgical procedures like hysterectomy, radical prostatectomy etc. Both Intraocular Pressure and Optic Nerve Sheath Diameter are found to get increased while in this position.

Intraocular Pressure will be measured by schiotz tonometer over an hourly interval whereas Optic nerve sheath diameter will be measured with use of ultrasound using a probe of 7.5 Mega hertz. Both values will be measured in both the eyes and will be compared statistically to find any correlation which may exist between the two.

Eligibility Criteria:
Inclusion Criteria:

* robotic surgeries
* surgical duration upto 4 hours
* american society of anaesthesiologists 1 to 3

Exclusion Criteria:

* any history of opthalmic intervention
* patient suffering from glaucoma
* patients taking any diuretics for cardiac problems
Remote Ischemia Precondition (RIPC) for Hepatic Protection in Patients Undergoing Hepatectomy

Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.

Remote ischemia precondition (RIPC) had been proofed beneficial to ischemia reperfusion injury of heart, kidney, liver, brain and spinal cord in experimentation on animals. And the clinical studies of RIPC were mainly focused on heart, RIPC's protection effect on hepatic ischemia reperfusion injury in patients undergoing hepatectomy still remains unknown, So we designed this study to demonstrate the hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
* Selective hepatectomy, one time hepatic portal occlusion
* Child-Pugh A

Exclusion Criteria:

* Peripheral vessels diseases
* Not the same surgical procedure as expected
* Administered anti-inflammatory drugs as glucocorticoid etc
* Diagnosed of diabetes
* History of liver surgery
* History of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy
* Refuse to join the research
* Patients with psychopathy
* Acute infection need antibiotic therapy
* Hepatic artery or portal vein embolism
Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular Edema

Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically significant diabetic macular edema which targets the retinal pigment epithelium while sparing the neurosensory retina.

Abstract:

OBJECTIVE: To evaluate effectivity and safety of Selective Retina Therapy (SRT) for diabetic macular edema (DME).

DESIGN: Prospective two-center interventional uncontrolled case series. PARTICIPANTS: 39 eyes of 39 patients with previously untreated non-ischemic DME.

INTERVENTION: Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer. The pulse energy was individually adjusted to achieve angiographically visible but funduscopically invisible effects. Optoacoustic measurements were performed to detect the individual threshold of RPE damage during laser treatment and correlated with funduscopy and fundus fluorescein angiography (FFA) or indocyanine green angiography. Follow-up at 3 and 6 months post treatment included best-corrected ETDRS visual acuity (BCVA), FFA, fundus photography, and retinal thickness measured by optical coherence tomography (OCT).

MAIN OUTCOME MEASURES: Change of BCVA, change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements.

RESULTS: Mean BCVA improved from 43.7 letters (standard deviation, SD=9.1) at baseline to 46.1 letters (SD=10.5) at 6 months follow-up (p=0.02). BCVA improved (\> 5 letters) or remained stable (+/- 5 letters) in 84% of eyes. 13% of eyes improved by ≥ 10 letters while 16% of eyes lost more than 5 letters. There was no severe loss of vision (loss of ≥ 15 letters). Overall, mean central retinal thickness, hard exsudates and leakage in FFA did not change significantly (p\>0.05) while improvement of BCVA correlated with a reduction of hard exsudates and central retinal thickness. Specificity and sensitivity of detecting the angiographic visible threshold of RPE damage by optoacoustic measurements were 86% and 70%, respectively. No adverse effects or pain were noted during or after treatment.

CONCLUSION: SRT is an effective and safe treatment of DME with functional and anatomical improvement or stabilization in most patients. Optoacoustic measurements are suitable to detect the individual threshold of RPE damage.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study

Exclusion Criteria:

* Ischemic diabetic macular edema, significant media opacity compromising the interpretation of fluorescein angiography and fundus photography, previous intraocular surgery, previous macular laser treatment, other retinal or ocular diseases, and known allergic hypersensitivity to fluorescein, indocyanine green, or iodine. General exclusion criteria included pregnancy or breast-feeding and significant medical conditions such as renal failure.
Sleep Apnea in Patients with MGUS and MM

This study involves patients with plasma cell dyscrasia including monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma (MM), with and without sleep apnea, who are providing bone marrow specimens. Specimens will be obtained at the time that patients undergo a standard-of-care procedure in order to minimize discomfort and reduce any risk.

Obesity is a risk factor for the development of MM, although the mechanisms that link obesity and MM are unclear. Obesity, in turn, is closely associated with obstructive sleep apnea. Interestingly, the key risk factors for both sleep apnea and MM are overlapping (age, sex, race and body mass index). During the apnea, or cessation of normal breathing, arterial oxygen saturation falls. This can occur as often as 60 times per hour, resulting in chronic intermittent hypoxia (CIH). In preliminary studies, investigators exposed C57BL/6 mice, that are typically resistant to engraftment of malignant plasma cells to CIH, followed by injection of malignant 5TGM1 cells. With CIH, 5TGM1 cells homed to bone marrow, and engrafted and expanded, resulting in lethal disease. These mice had key features of the myeloma phenotype, including bone damage and gammopathy. Investigators explored potential mechanisms by which CIH promote MM progression by performing whole bone marrow RNASeq analysis. They found pathways relevant to angiogenesis, cell adhesion, and stromal cell development (including dendritic cells and eosinophils) to be upregulated. This is an exciting and potentially translational finding because these elements are also upregulated in the bone marrow of human myeloma patients. Investigators also found upregulation of B cell and plasma cell development and differentiation pathway, and downregulation of B-cell apoptosis pathways. Taking these preliminary findings together, the overarching hypothesis is that CIH increases oxidative stress, thereby supporting B cell maturation and changing the bone marrow stromal microenvironment to drive the progression to MM.

Eligibility Criteria:
Patients diagnosed with MGUS or MM who will be receiving a bone marrow biopsy as part of their standard of care are eligible to participate in this study
Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning

This study measures the utility of a novel artificial intelligence (AI) algorithm for performing auto-segmentation of computed tomography (CT) scans for radiation therapy planning.

PRIMARY OBJECTIVE:

I. To measure the observed utility of an AI algorithm for normal segmentation by recording study subjects' observations of its function.

OUTLINE: This is an observational study.

Participants complete surveys about the performance/functionality of the auto-segmentation algorithm on study.

Eligibility Criteria:
Inclusion Criteria:

* Employment at Mayo Clinic Arizona, Florida, or Rochester (which includes Regional Practice sites located at Mayo Clinic Health System locations) as train clinical staff that participate in normal tissue segmentation

Exclusion Criteria:

* Inability to complete study surveys
Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women \>= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
* Women \>=15 years of age attending a clinic for routine cervical screening,
* Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit,
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
* No cervical sample provided,
* History of hysterectomy,
* Known diagnosis of immunosuppression, or patient on immunosuppressives,
* Pregnant female \>=25 years of age.
Analyzes of Hemorrhagic Obstetric Patients Whose Were Used Fibrinogen

The files of hemorrhagic obstetric patients undergoing surgery and followed in the intensive care unit and using Fibrinogen and blood products were included in the study between January 2015- September 2018 at the Anesthesiology and Reanimation Clinic of SBU Kanuni Sultan Süleyman Training and Research Hospital. Patients under 18 years of age were excluded from the study. In this study, ages, operation types, number of blood and products, the amount of fibrinogen, the results of the hemogram and bleeding parameters, the levels of fibrinogen, the duration of hospital stay and the intensive care unit were recorded.

Bleeding is an important event that threatens the patient's life. Too much blood and blood products can be used in massive bleeding. However, unwanted allergic reactions may occur in blood and blood product transfusions. Fibrinogen is the first coagulation factor in coagulopathy. Some studies have shown that when the fibrinogen level falls to \<150-200 mg / dl, the bleeding increases dramatically.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric patients, underwent surgery and followed in ICU
* Used Fibrinogen and Blood products
* Over 18 years age

Exclusion Criteria:

* Under 18 years age
* Obstetric patients, underwent surgery but not used Fibrinogen and Blood products
Oral Contraceptives and Economic Behaviour

The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Before and at the end of treatment, mood and sexuality will be assessed by validated instruments. At the end of treatment, each woman will participate in behavioral experiments testing self-confidence, risk taking and altruism. The current project could fill the gap of ignorance about causal effects of OCs on mood, sexuality and behavior. The results might improve current practice as regards information about OCs, choice of hormonal contraceptive, regimen and duration of use. As a consequence, this could lead to reduced discontinuation rate, fewer unintended pregnancies and abortions. The project will contribute to an overall improvement in women's reproductive health.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young women, aged 18-35 years, BMI 19-30

Exclusion Criteria:

* Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months