cyrilzakka/clinical-trials huggingface dataset:
Utilization of Hepatitis C Positive Kidneys in Negative Recipients

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

Eligibility Criteria:
Recipient Inclusion/Exclusion Criteria:

Inclusion Criteria:

* Adult age \>18 years able to provide consent
* Lack of available living donor
* Calculated pre-transplant reactive panel (cPRA) of \<80%
* Estimated post-transplant survival (EPTS) index \>20% and \<80%
* Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
* No clinically significant pre-transplant liver disease

Exclusion Criteria:

* Living donor available
* Dialysis time \>5 years
* Listing for multi-organ transplantation
* Active or recent history (\<6 months) of alcohol abuse or substance abuse
* Clinically significant liver disease as determined by principal investigator
* History of hepatocarcinoma
* Pregnancy or lactation
* Refusal to accept blood transfusion
* HIV infection
* HCV pcr or antibody positive
* HBV infection

Donor Inclusion Criteria:

* Positive HCV PCR at time of donation
* Kidney donor profile index (KDPI)\<85%
Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.

The main question it aims to answer are:

* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.

Participants will perform:

* walking tests inside parallel bars on flat and/or inclined terrain;
* walking tests on treadmill;
* stair climbing/descent tests.


Eligibility Criteria:
Inclusion Criteria:

* trans femoural amputation
* Medicare Functional Classification Levels k3-k4
* expert prosthesis wearer (more than one year)
* electronic knee prostheses user
* energy-release prosthetic foot user

Exclusion Criteria:

* Relevant medical comorbidities
* heart device wearers (PMK or AICD)
* cognitive impairment
* anxious or depressed illness
The Evaluation of Postoperative Pain After Caesarean Section

The aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Patients will invite to complete the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. After caesarean section, patient controlled analgesia is used for pain relief. And the intensity of pain will be measured by using numerical rating scale.

Pain is the main problem of postoperative period. Postoperative analgesic consumption can be associated with physical and psychological condition of the individual. This study is aimed to investigate the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations.

Patients are invited to complete the pain catastrophizing scale questionnaire in preoperative period.

A total of 100 patients will be included into the study. Patients are divided into two groups in terms of surgical priority whether emergency or elective. Spinal or general anesthesia will be performed to the patients. In postoperative period, patient controlled analgesia will be applied for pain relief and numerical rating scale is used to determine the pain intensity in 1st, 2nd, 6th, 12th, 24th hours. The analgesic consumption in 24 hours will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score of 1 or 3 and 1-Emergency or 3-Emergency

Exclusion Criteria:

* Patients whose not to participate
* Patients whose have communication problems
* Patients whose have been using antipsychotic or antidepressant drugs
Timing of HCG Administration in IUI Cycles

Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.

Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.

Eligibility Criteria:
Inclusion Criteria:

* Mild male factor infertility or unexplained infertility.

Exclusion Criteria:

* Advanced male factor infertility.
* Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
* Endometriosis.
* Tubal disease.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
* Metabolic or hormonal abnormalities.
Study of DTRI-031 in Healthy Volunteers

A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031

Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort.

Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28.

A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Ability to provide written consent
* Weight 50-110 kg with BMI 18.5-32 kg/m2
* Willingness to use contraceptives
* Negative COVID-19 test
* Negative results for alcohol and drugs of abuse

Exclusion Criteria:

* Pregnant or lactating females
* Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
* Females with active menstruation on day of dosing
* Use of prescription medications known to affect platelet function
* Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
* Contraindication to anticoagulation or increased bleeding risks
* History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
* History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
* Planned surgery during the study
* Any clinical significant abnormality at screening
* Use of investigational drug in past 30 days or 5 half lives
* Concurrent enrollment in another clinical study or more than 3 clinical studies in past 12 months
* Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test
Stress and CKD Among African Americans

The goal of this study is to determine whether experiencing stress from discrimination may increase chronic kidney disease (CKD) progression in African Americans. Study participation occurs over the course of 2 days, and participant time burden is expected to be about 4.5 hours, plus a 24-hour period of wearing a blood pressure monitor.

On Day 1, the project coordinator will explain the study to participants and answer any questions he/she may have. Those who agree to participate in the study will provide consent at the clinic and will also be asked to complete a questionnaire on an iPad in a small, private room at the clinic. The participant will complete the questionnaire alone, however, the project coordinator will read questions aloud if the participant chooses. Before leaving on Day 1, participants will fitted with a blood pressure monitor to be worn for the next 24 hours.

The clinical intervention portion of the study occurs during the morning of Day 2 (between 9:00 AM and 11:00 AM). Participants will be instructed to bring the blood pressure monitor and a list of current medications (or the actual medications) with them. First, participants will provide a urine sample and undergo blood pressure testing. A research nurse will insert a catheter (a small thin tube) into the participant's vein, and allow a 30-minute resting period so that the participant gets used to the catheter, and then take a baseline blood draw. Participants will judge how distressed they feel in that moment using a standard scale and tell the project coordinator his/her rating. Next, participants will be randomized to one of two study arms such that half will recall the racial experience and half will recall the non-racialized stressful event. An audience of two observers of same race will wear white coats and watch as the participants recall the stressful events. The research nurse will draw blood and take blood pressure measurements at multiple time points during both recall experiences. Immediately before and after each recall task, the participant will again judge how distressed he/she is feeling in that moment using the same scale as before. The project coordinator will explain the purpose of the story recall and common ways that individuals may respond to the task (such as feeling anxious after the task). A total of 100 people will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Emory University Hospital Midtown
* Self-identify as African American or Black
* Estimated glomerular filtration rate (eGFR) ≥ 15, or \<90

Exclusion Criteria:

* Mental disorder that prevents the completion of the Computer Assisted Personal Interview (CAPI) and the stressful recall manipulation
* Currently on maintenance dialysis
* Unable or unwilling to undergo intravenous catheterization
Plethysmography as a Useful Intraoperative Monitor

Data from both the traditional invasive cardiac monitors and the Nonin will be collected simultaneously. The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

After obtaining written consent to participate, the standard of care arterial line and PA catheter will be placed pre-operatively. The investigators will attach the Nonin pulse oximeter, as a second pulse oximeter probe, to patients undergoing surgical procedures which already require invasive cardiac monitors (arterial line, pulmonary artery catheter, etc). Data from both the traditional invasive cardiac monitors and the Nonin pulse oximeter will be collected as electronic files. Once both files are compiled they will be de-identified.

The investigators will also record medications and IV fluids given during surgery.

The Nonin Pulse Oximeter is clinically marketed for this indication

The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older Patient scheduled for surgery that will have both an arterial catheter and a pulmonary artery catheter as standard of care Informed consent

Exclusion Criteria:

* Only the above inclusion criteria apply
Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)

The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.

Some of the current thinking in regards to the pathophysiology of AD involves the production of amyloid Beta protein (AB) by secretase processing of amyloid precursor protein (APP). While AB is thought to be toxic to neurons its role leading to AD pathogenesis, this is not without debate. In any case, it appears that AB forms amyloid plaques that are largely ubiquitous in AD. Neuronal cell death as a result of the disease is another clear pathophysiologic finding. Because of the importance of these findings in the development of AD, targeted therapies are being investigated to selectively inhibit AB production and/or manipulate amyloid load.

Positron emission tomography (PET) is a molecular imaging modality used to noninvasively measure functional processes of the body. A trace amount of a radiopharmaceutical is injected into a patient and the radiopharmaceutical will be taken up or localized in the body as a function of certain biological processes. The detectors of a PET scanner then measure the radiopharmaceutical distribution externally and the reconstructed PET images should represent the true distribution of the radiopharmaceutical within the body.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 30 years of age or older.
2. Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR), cognitive normal elderly (30) age \>60 and cognitive normal young subjects (30) ages 30-60.
3. Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of 0.5 or greater.

Exclusion Criteria:

1. Subjects unable to lie down without moving for 30 minutes.
2. Women who are pregnant or who cannot stop breast feeding for 24 hours.
3. Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc,.
4. Subjects who are too claustrophobic to perform the tests.
5. Subject who have had previous brain irradiation, stroke or brain tumor(s)
Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy

Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestational age 12-32 weeks
* diagnosis of bacterial vaginosis
* treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days

Exclusion Criteria:

* multiple pregnancy
* allergy to clindamycin
Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in SNAC Wrist

The investigator compare two types of limited wrist arthrodesis used for management of cases with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most suitable technique

There is a controversy regarding the suitable limited wrist arthrodesis technique for SNAC wrist grade II and III . For several decades , scaphoid excision and four corner fusion (between lunate , capitate , hamate and triquetrum) was the gold standard with good functional outcomes . Later on , a more limited fusion technique was described , three corner fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to improve ulnar deviation range . On the other hand , biomechanical studies mentioned that the triquetrum had a certain proprioceptive function that could be affected when it was included in the fusion process .Furthermore , if the triquetrum was excised the radiolunate contact pressure would increase with higher risk of development of arthritis. The aim of the study to compare the conventional four corner fusion with three corner fusion with triquetrum excision

Eligibility Criteria:
Inclusion Criteria:

* SNAC wrist G II , III

Exclusion Criteria:

* cases with radiolunate arthritis
* Scapholunate advanced collapse
* Grade 1 Scaphoid non union advanced collapse
* Kienbock disease
* Skeletally immature patients
Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.

The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective CABG surgery

Exclusion Criteria:

* Patient refusal

  * Dementia patients
  * Poor ventricular function with ejection fraction below 40%
  * Asthmatic patients
  * Uncontrolled diabetic patients with HbA1c above 8
  * Combined surgeries (CABG+ valves)
  * Emergency surgeries.
  * Pre-existing arrhythmia
  * Patients with renal impairment
  * Patients with hepatic impairment
  * Patients with heart block
  * Off-pump CABG
Time Course of Procalcitonin and C Reactive Protein in Septic Patients Under Treatment With Corticosteroids

A systemic treatment with corticosteroids has been advocated for various bacterial infectious diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller increase or a more rapid decrease of this acute phase protein will:

1. suggest attenuated systemic inflammation, but
2. does not necessarily reflect adequate therapy of the infection.

For several reasons (good diagnostic tool for sepsis, induction not decreased by immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in patients under corticosteroids. As this issue has not yet been examined the investigators will prospectively study the time-course of PTC and CRP in a well-defined septic patient group, that in adjunction to antibiotic therapy also received systemic corticosteroid treatment and compare it to a similar group without corticosteroid treatment.


Eligibility Criteria:
Inclusion Criteria:

* Acute exacerbation of chronic obstructive pulmonary disease (COPD) due to bacterial pneumonia

Exclusion Criteria:

* Chronic systemic use of corticosteroids
Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke

In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.

This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.

Eligibility Criteria:
Inclusion Criteria:

* History of subacute-chronic ischemic stroke (3-12 months)

Exclusion Criteria:

* Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
* Severe depression (Beck Depression Scale \> 29)
* Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
* Pregnancy or planning to become pregnant or breastfeed during the study period.
* Botox injections or hemiplegia rehabilitation within 6 months before treatment.
* Having a history of hemorrhagic stroke
* Presence of ongoing dysphagia or aspiration difficulties.