cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Imaging at Different Levels of Magnetic Intensity

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by brightening areas of the magnetic resonance image, thereby improving the contrast.

In this study researchers will use magnetic resonance imaging and contrast substances, like gadolinium, on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI.

Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the MRI systems located at the NIH. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols.

Eligibility Criteria:
* INCLUSION CRITERIA:

Any normal volunteer greater than or equal to 18 who is capable of giving informed consent.

EXCLUSION CRITERIA:

A subject will be excluded if he/she has a contraindication to MR scanning such as:

1. Brain aneurysm clip
2. Implanted neural stimulator
3. Implanted cardiac pacemaker or defibrillator
4. Cochlear or ear implant
5. Ocular foreign body (e.g. metal shavings)
6. Insulin pump
7. Pregnant women (when uncertain, subject will undergo urine or blood testing).
8. Claustrophobia
9. Any condition in the Principal Investigator's judgement which present unnecessary risk

EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:

1. Lactating Women
2. Renal or hepatic disease
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤age≤65 years of age,male.
* Hemophilia A or B patients with inhibitors.
* Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
* Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
* Establish proper venous access.
* Agree to use adequate contraception to avoid pregnancy.
* Provide signed informed consent.

Exclusion Criteria:

* Have any coagulation disorder other than hemophilia A or B.
* Treat with prophylactic treatment of coagulation factor.
* Treat with anticoagulant within 7d of the time of study drug administration.
* Have a history of arterial and/or venous thromboembolic events.
* Have platelet \<100,000/mL,hemoglobin\<90g/L.
* Severe liver or kidney disease.
* Bleeding in the central nervous system or throat before screening.
* Accept major operation or blood transfusion within 1 month of the time of screening.
* HIV positive with current CD4+ count of less than 200/μl.
* Have a known allergy to Blood product.
* Participate in other clinical research within 1 month of the time of study drug administration.
* Treat with coagulant within 7d of the time of study drug administration.
Tumor Collection From Routine Nephrectomy for Subjects With Advanced Stage RCC

Standard treatment for kidney cancer is to remove the tumors from the body with surgery. The purpose of this clinical trial is to collect, preserve, and store excess kidney cancer tumor specimens that would normally be discarded after surgery.

The purpose of this non-treatment, non-interventional protocol is to collect, preserve, and store excess tumor specimens, which would otherwise be discarded, following routine nephrectomy for subjects with advanced renal cell carcinoma (RCC). The collected tumor specimen will be preserved under current Good Manufacturing Practice conditions and will not be used for any other research or therapeutic purpose without a separate consent from the subject, specific to the intended use on a separate Institutional Review Board or Institutional Ethics Committee approved Argos sponsored study.

Following routine nephrectomy (partial or cytoreductive) as indicated for subjects with advanced RCC, small samples of the excised tumor will be sectioned and placed into an RNA preservative solution as supplied by the sponsor. After collection, this preserved tumor specimen will be shipped to a repository operating under current Good Manufacturing Practice conditions. The tumor specimen will be stored for no longer than five years unless subsequent consent is obtained for extended storage or other use.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years
* 2. Diagnosis or clinical signs of advanced RCC (Stage III or IV RCC; Refer to Appendix A)
* 3. Scheduled for cytoreductive or partial (unilateral or bilateral) nephrectomy
* 4. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of tumor specimen collection prior to enrollment

Exclusion Criteria:

* 1. Evidence of brain metastases prior to nephrectomy
* 2. Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids, for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
* 3. History of HIV infection, or history of chronic infection with Hepatitis B or Hepatitis C
Taping for Children With and Without Movement Clumsiness

To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).


Eligibility Criteria:
Inclusion Criteria:

* Children with DCD and typically developing children will need to score \<16 percentile and \>25 percentile, respectively, on MABC-2
* Study in mainstream schools
* No intellectual disabilities

Exclusion Criteria:

* Subjects who are receiving regular treatments
* Demonstrate excessive disruptive behaviour
* Unable to follow instructions
* Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance
Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization

Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.

A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.

In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score \[DASH\], MEPS \[Mayo Elbow Performance Score\], Oxford Elbow Score \[OES\], Pain, Subjective Elbow Score) and functionality (range of motion \[ROM\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
* understanding of German language (written and oral)
* informed consent

Exclusion Criteria:

* Patients not meeting the above criteria
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living with HIV

There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally.

This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time.

This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.


Eligibility Criteria:
Inclusion Criteria:

* Living with HIV
* Has a uterine cervix

Exclusion Criteria:

* Unable to give fully informed consent
* Pregnant or unwilling to avoid pregnancy during vaccination
* Allergy to the vaccine or its components
* Prior receipt of any HPV vaccine
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected obstructive sleep apnea

Exclusion Criteria:

* Lung infection
* Insomnia
Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection

Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has been recommended to prevent HAV infection in male homosexuals. HIV infection may impair serological responses to HAV vaccination in HIV-infected patients. The investigators hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in HIV-infected patients.

In this study, we aim to compare the serological responses to HAV vaccination between HIV-infected patients who receive 2 doses or 3 doses of HAV vaccine and HIV-uninfected persons who receive 2 doses of HAV vaccine. Persons who identify themselves as male homosexuals aged younger than 40 years and are seronegative for hepatitis A virus will be enrolled. HAV vaccination will be provided free-of-charge. HIV-uninfected persons will receive 2 doses of HAV vaccine that will be administered at baseline and 6 months after the first dose, while HIV-infected patients will be given 2 doses or 3 doses of HAV vaccine; for those who choose to receive 3 doses, a second dose will be given 1 month after the first dose. A longitudinal follow-up of serological responses will be conducted to assess the effectiveness of HAV vaccination; HAV IgG will be determined at 6 months after the first dose of HAV vaccination(before the administration of the second dose), 12 months and 18 months after the first dose of HAV vaccination .

Eligibility Criteria:
Inclusion Criteria:

* Age between 18\~40-years-old
* Homosexuals

Exclusion Criteria:

* Presence of symptoms or signs suggestive of active infection
* Allergy to vaccination
* Failure to provide written informed consent
* Use of immunosuppressive or immunomodulating agents or chemotherapy
Desflurane-induced Myocardial Protection

This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

Exclusion Criteria:

* Patients younger than 20 years old.
* Recent myocardial infarction (within 1 year).
* Renal dysfunction (GFR less than 50ml/min).
* Known allergy to study drugs including propofol.
Maternal Abdominal Morphology Assessment

Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes.

The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.

As pancreas size is thought to reflect pancreatic insulin production and/or islet mass, monitoring pancreas size during and after pregnancy may advance the investigators' understanding of gestational diabetes mellitus (GDM) incidence and progression. Information on pancreas size changes during pregnancy, typical fetal pancreatic development, the relationship between pancreas size and GDM risk, and the relationship between pancreas size and neonatal hypoglycemia are largely unknown. Through this project, magnetic resonance imaging (MRI) will be used to measure changes in pancreas size during pregnancy and the effect of maternal diabetes on these measures.

This prospective cohort study is observational and will include up to 87 pregnant women who are between 18-54 years old. Study visits will take place at approximately 15-18 weeks gestation, 24-28 weeks gestation, 34-38 weeks gestation, and 1 year-1 year and 2 months postpartum. At each study visit, participants will self-report their height and weight, have their blood pressure measured, have their blood drawn, have an HbA1c finger stick test, participate in oral glucose tolerance testing (OGTT), complete an MRI scan, and undergo continuous glucose monitoring (CGM).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, with a singleton gestation
* Age 18 - 54 years at screening
* Gestational age \< 14 weeks
* Willing to commit to 1 year postpartum follow up
* Planning to remain in geographical vicinity of Austin for 1 year after delivery

Exclusion Criteria:

* Presence of any mechanically or magnetically activated implants
* Claustrophobia
* Other contraindication for MRI
* BMI ≥ 35.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)
Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

The goal of the study is to determine if the addition of a superficial cervical plexus block to a traditional interscalene plexus block will provide superior perioperative analgesia to an interscalene brachial plexus blockade alone for repair of clavicle fractures and non-/malunions.

When patients that are possible participants in the study present for surgery, they will be offered the opportunity to participate in the trial as part of the informed consent process. Should they agree to participate, they will be randomized to receive either an interscalene + "sham" superficial cervical plexus block or an interscalene + superficial cervical plexus block. The randomization will have already been predetermined based off of envelopes that will have been created by a research assistant. Within the envelopes the proper paperwork needed to consent a participant along with a label that will be labeled either interscalene + sham superficial cervical plexus block or interscalene + superficial cervical plexus block. This will assign the randomization of each participant (this will be unknown to all study personnel until identified by the label). Their pain scores will be assessed pre-operatively as well as post-operatively .. If they are admitted to the hospital, the PI and/or Co-Investigators will assess their pain scores on a daily basis and follow-up with a phone call to assess their satisfaction with the block. Numerical pain scores (scale of 0-10) will be used to assess post-operative pain with 0 indicating no pain and 10 indicating severe pain. Post-operative pain will be assessed by compiling pain scores from 2 different sources: Numerical pain scores recorded by nursing staff (vitals section of EMR) and also pain scores ascertained by residents during rounds (progress notes). For each pain score, we will record the date and time it was obtained. If they are discharged the same day as surgery, they will receive a phone call within 48 hours to assess their pain scale and satisfaction. We will also assess nausea and vomiting, the amount and type of pain medicine they are taking, and assess if they could tell when their block wore off.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present for repair of isolated clavicle fractures and non-/malunions that consent to regional anesthesia and to be a part of the study.

Exclusion Criteria:

* Polytraumatized patients with multiple confounding injuries, patients who are not candidates for either block at the discretion of the Anesthesia Attending, patient refusal to participate in study, patient refusal of regional technique, patients with significant pulmonary disease that will not tolerate possible hemi-diaphragmatic paralysis at the discretion of the attending anesthesiologist.
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation

HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic HCV or NASH
* Liver biopsy within 2 years of enrollment
* Compensated liver disease

Exclusion Criteria:

* Decompensated liver disease
* Currently being treated with beta blockers, ACE inhibitors, or other agents affecting FMD
* Malignancy diagnosed within 5 years of study enrollment without demonstrated clearance
* History of congestive heart failure
* Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR \< 30 mL/min/1.73m2)
* Crohn's disease or any active intestinal inflammatory condition
* Having an ileal resection
* Diabetic Gastroparesis
* Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed at each visit.
* Inability to consent for one's self
Satisfaction and Compliance of Risedronate in PMO

Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure compliance (50 % drug taken), and persistence.


Eligibility Criteria:
Inclusion Criteria:

* Five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
* Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (\> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Risedronate.
* Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the Investigator.

Exclusion Criteria:

* Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment.
* Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.
* History of alcohol and/or drug abuse.
* Subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication.
* Subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial.
* Excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months.
* Known hypersensitivity to bisphosphonates and/or excipients.
* Abnormal laboratory parameters, which are clinically relevant according to the Investigator (including renal insufficiency; creatinine clearance \< 30 mL/min)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.