cyrilzakka/clinical-trials huggingface dataset:
Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. As one of the popular urinary tumors, the incidence rate increases by 2-4% per year. Localized RCC is generally cured by surgery, which has achieved good efficacy. However, advanced RCC are still the main factors influencing the survival of RCC patients due to its intrinsic resistance to conventional chemotherapy or radiotherapy. 18F-FDG PET/CT is considered to be a viable tool to assess RCC at initial presentation. However, FDG uptake in RCC is lower than most other solid tumors and is indistinguishable from benign lesions. So, it is necessary to find another effective way to detect RCC and its metastases. As in known, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of RCC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with RCC.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated renal cell carcinoma patients;
* 68Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against PSMA
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects

The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive.
* Body mass index (BMI) should be 18 to 36 kg/m2, inclusive.
* At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements)
* Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator
* Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months
* No clinically relevant abnormalities in laboratory evaluations

Exclusion Criteria:

* History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study.
* Any clinically significant abnormal ECG (electrocardiogram).
* Participation in another clinical trial of an investigational drug or medical device within 60 days.
* Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day.
* Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.
Anesthetizing the Tympanic Membrane in Healthy Volunteers

The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.


Eligibility Criteria:
Inclusion Criteria:

1. \>=18 years of age
2. Both male and female subjects are eligible.

Exclusion Criteria:

1. Pregnant or lactating females
2. Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
3. Markedly atrophic TM
4. Perforated TM
5. Sclerotic TM
6. Otitis externa
7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
8. Damaged or denuded skin in the auditory canal
9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

The study aims are:

1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery.

Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).

There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care.

The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).


Eligibility Criteria:
Inclusion Criteria:

* patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016

Exclusion Criteria:

* age less than 18 years
* parathyroid carcinoma
* secondary or tertiary hyperparathyroidism
Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF

Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.

Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH).

1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors.

2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry

Eligibility Criteria:
Inclusion Criteria:

* SAH patients with modified Fisher Scale 3-4.

Exclusion Criteria:

* Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study
Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them.

Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure.

Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 60 years and undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

* Emergency operation
* Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
* Infectious condition
* Active bleeding
* Hypokalemia
* Severe chronic kidney disease (GFR(CKD-EPI) \<30mL/min/1.73m2) or Dialysis
* Patients taking erythropoietin
* Aplastic anemia, Hemolytic anemia
* Hemochromatosis, Hemosiderosis
* Uncompensated liver cirrhosis, Acute hepatitis, Alcoholism
* Peptic / Duodenal ulcer, Crohn's disease, Ulcerative colitis
* Allergy to iron supplements or vitamin B12
* Symptomatic asthma, eczema
* Immunologic disease (e.g. Rheumatoid arthritis, Systemic lupus erythematosus)
* Malignancy
* Patients being treated in the intensive care unit due to heart failure or other major complications
* Patients who participated in other clinical studies that could affect prognosis
* Patients who cannot understand the informed consent (eg. Foreigner)
Online Chronic Pain Therapy for Adults

This study will evaluate the usefulness of an online, self-directed treatment for chronic pain that has been designed specifically for individuals who are currently or have previously served in the military.

This study will evaluate the efficacy of an eight-module, online, self-directed treatment for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the treatment modality. The online modules are tailored to the unique issues of individuals with a military background. The modules will be delivered via the WebCAPSI Therapy program, an online, password-protected program that allows participants to anonymously progress through all modules at their own pace. ABBT modules cover the following: Introduction, Acceptance, Values, Cognitive Defusion, Mindfulness, Exercise/Pacing/Communication Skills, Self-as-Context, and Willingness. Modules encourage understanding of the information through audio files, military-specific vignettes, written materials, and homework exercises. Modules are designed to be completed in 60 minutes or less. Participants will have access to the online treatment for a three month period and will be encouraged to complete one module per week.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain condition of duration 6 months or longer
* Patient at OSI Clinic in Winnipeg
* Access to a computer with internet at least once per week for 60 minutes

Exclusion Criteria:

* Active psychosis
* Actively suicidal
* Unstable living conditions
* Seriously impaired concentration
* Inability to read and write in English
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.


Eligibility Criteria:
Major Inclusion Criteria:

* Documented laboratory diagnosis of HIV-1 infection
* Plasma HIV-1 RNA \< 400 copies/mL
* Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
* Naive to tenofovir DF

Key Inclusion Criteria for the First 96-Week Extension

* Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
* \<18 years of age (at the start of the extension)
* Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.

Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension

* Completed of treatment with study drug in the first extension phase
* \<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.

Key Exclusion Criteria:

* Participants receiving ongoing therapy with any of the following
* Nephrotoxic agents
* Systemic chemotherapeutic agents
* Systemic corticosteroids
* Interleukin 2 (IL 2) and other immunomodulating agents
* Investigational agents
* Pregnant or lactating participants
* Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
* Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
* Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
* Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis

It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.

The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window.

The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Aged subject from 9 months and over
* Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018
* Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

Exclusion Criteria:

* Refusal of the patient to participate in the study
* CROP does not make it possible to evaluate the visibility of the FR
* Preoperative or uninterpretable scanner
* Major anatomical malformation
* Subject under the protection of justice
* Subject under guardianship or curatorship
SIMOX - Induction of Oxidative Stress

The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* healthy men
* 18-50 years
* BMI: 18-30

Exclusion Criteria:

* Total cholesterol less than 3 mmol/L
* Use of natural and herbal medicines that is affected/affects simvastatin:

anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole

* following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder
* allergies towards any of the tested medicine
* intake of narcotics within 2 months prior to trial
* intake of supplements within 2 months prior to trial
The Relationship Between Disability, Fear Avoidance Beliefs, Physical Performance and Quality of Life in Chronic Low Back Pain

The aim of this study was to determine the multidimensional profile of individuals with chronic low back pain (CLBP) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. Individuals with chronic low back pain between the ages of 18-50 will be included in the study. Disability level of the participants will be assessed with Oswestry Disability Index (ODI), fear avoidance attitudes with Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA), and quality of life with Short Form-12 (SF-12). Trunk endurance, functional mobility and static-dynamic balance will be assessed for physical performance. Trunk endurance will be assessed with McGill endurance tests, functional mobility with Timed Up and Go Test (TUG), dynamic balance with Y-balance test, and static balance with single leg stance test.


Eligibility Criteria:
Inclusion Criteria:

* Back pain for at least 3 months
* Pain intensity ≥ 3 on the Visual Analog Scale

Exclusion Criteria:

* History of spinal surgery/trauma
* Other back pain (associated with rheumatic diseases, multiple sclerosis, malignancy, etc.) instability conditions such as spondylolysis and spondylolisthesis
* Pregnancy
* Obesity (BMI ≥ 30 kg/m²)
* Presence of orthopedic problems or chronic diseases that may interfere with testing
The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.

This will be an open study conducted in healthy male subjects at a single centre. Each subject will participate in a screening visit and 2 study periods. At the first study period, all subjects will receive a single dose of BCT197 and at study period 2, all subjects will receive 3 daily doses of azithromycin and a single dose of BCT197.

Eligibility Criteria:
Inclusion Criteria

* Healthy male subjects.
* Non-smokers (including e-cigarettes).
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
* Willing to use highly effective barrier contraception methods.
* Male subjects must not donate sperm during the study.

Exclusion Criteria

* Any subjects with pre-existing active skin disease.
* Laboratory values at screening which are deemed to be clinically significant.
* Volunteers with abnormal liver function tests.
* 12 Lead ECG with QTcF \>450 msec.
* Allergy to any of BCT197 excipients.
* Known hypersensitivity or intolerance to azithromycin.
* Taking medications known to cause QTc prolongation.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
* Any clinically significant illness within 30 days prior to study drug administration.
* Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
Nursing Care in Threat of Preterm Birth

Relaxation-Focused Nursing Care which is formed by using these two models is composed of; positive language, positive environment and reducing stressors. Relaxation-Focused Nursing Care, which is thought to have an effect on delaying birth, consists of four stages as a two-day program.In this study, it is aimed to determine the effect of Relaxation-Focused Nursing Care on stress level, cortisol level and birth week.

Preterm birth is seen in 7-12% of all pregnant women and according to estimations about 15 million infants are delivered each year. Preterm birth is an extremely important problem in terms of its effects on newborn's health, mother's health, community and economy. Preterm birth causes the newborn chronic pulmonary disease; gastrointestinal, immunologic, central nervous system, auditory and visual problems; long-term motor and cardiovascular system diseases; and cognitive, visual, behavioral disorders. While preterm birth causes the women postpartum anxiety, stress and depression; it also leads to newborn intensive care costs, long-term complex health care needs for families and community and has serious consequences for public service sector such as health insurance, education, other social support systems and economy. Some factors initiate preterm birth, whereas 70-80% of them start spontaneously, remaining 20-30% has iatrogenic origin. It is reported that there is no known and effective treatment for preterm birth. It is reported in literature that stress which is one of the risk factors of preterm birth, causes preterm birth. If stress causes threat of preterm delivery, reducing stress may delay preterm birth and the complications of preterm birth on newborn and mother's health and also its economic and social burden can be reduced. National and international studies related to the effect of coping with stress on threat of preterm birth are lacking. It is thought that preterm birth can be prevented in women with threat of preterm birth through developing mechanisms to cope with stress and reducing stressors. Since nurse provides 24-hour care for woman diagnosed with the threat of preterm birth, the nursing care may be effective in this aspect.

Eligibility Criteria:
Inclusion Criteria:

* to be diagnosed with TPB,
* to be over 18 years of age,
* to know Turkish and
* to agree to participate in the research.

Exclusion Criteria:

* diagnosis of EMR,
* multiple pregnancy,
* admission to hospital with vaginal bleeding,
* psychiatric, chronic and pregnancy-related disease developing,
* to want to quit the study at any stage after agreeing to participate in the study, and
* delivery at any stage after the data collection process has been completed after agreeing to participate in the trial.