cyrilzakka/clinical-trials huggingface dataset:
Femoral Nerve Block vs Peri-capsular Nerve Group Block for Hip Fracture Analgesia

The purpose of the study is to compare the analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia

Spinal anesthesia is commonly used in patients undergoing hip fracture surgery. However the procedure of patient positioning to perform a spinal block is painful and may require the administration of IV analgesics or some regional anesthesia techniques such as femoral nerve block, fascia-iliaca compartment block, peri-capsular nerve group block. At the study, the investigators aimed to compare analgesic efficacy of femoral nerve block and peri-capsular nerve group block administered before spinal anesthesia for positioning to spinal anaesthesia in patients undergoing surgery for hip fracture and to evaluate the efficacy for postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* patients with hip fracture scheduled for surgery under spinal anesthesia.

Exclusion Criteria:

* hemorrhagic diathesis,
* peripheral neuropathy,
* allergy to local anesthetics,
* mental disorders,
* use of analgesics for 8 h before the performance of spinal block
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
* Fluent in English

Exclusion Criteria:

* Unable to understand the study objectives, procedures, risks, and benefits
* Unable to consent for themselves
Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery

The deep brain stimulation is surgical technique used for the Parkinson's disease, essential tremor, dystonia, epilepsy, and psychiatric diseases. A pulse generator or battery (implanted pulse generator, IPG) is a need for replacement every few years. In general, electric cautery(BOVIE), which is commonly used in surgery, cannot be used when the deep brain stimulation machine is inserted, so conventional tools such as scissors and knives are used for replacement surgery. However, in the process, damage to the machine may be inflicted by knives, scissors, etc., and in the worst case, the machine may be unusable, resulting in financial and human consumption.

Plasma Blade is currently used for tissue incision and coagulation in Korea, and is the only insurance-recognized tool in Korea for the replacement surgery of a cardiovascular implantable electronic device (CIED). The deep brain stimulation machine has a structure very similar to that of the heart electronics. In addition, the plasma blade was used to replace the deep brain stimulation machine overseas.The safety is reported in the surgery, so the plasma blade deep brain stimulation machine has been replaced in Korea. The investigators would like to check the safety and effectiveness for use in surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 19
* Those who voluntarily agree to participate in this clinical trial and are willing to comply with the clinical trial protocol
* Persons who have previously undergone deep brain stimulation for Parkinson's disease, essential tremor, dystonia, epilepsy, etc.
* Those who need replacement of deep brain stimulation machine

Exclusion Criteria:

* Those who cannot be under general anesthesia
Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies

The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. The investigators will also look at the safety of the combination treatment, and see which treatment is better. In either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with any tumor obstructing the distal bile duct and causing an indwelling biliary SEMS
* Patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia)
* Age ≥ 18 years

Exclusion Criteria:

* Have altered gastro-duodenal or hepatobiliary anatomy such that ERCP is felt to be unacceptably technically difficult or unsafe
* Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP stenting is felt to be unlikely to provide adequate clinical benefit
* Have cardiac pacemakers
* Have Child B/C cirrhosis
* Are pregnant
* Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory distress or unsafe hematological parameters such as refractory anemia \<7g/dL, thrombocytopenia \<50K/mcL, or coagulopathy with INR \>2.0)
* Have biliary strictures not technically amenable to endoscopic therapy
Micronutrient Levels and Nutritional Status in Critical Illness

Rationale: A significant proportion of patients admitted to the Intensive Care Unit (ICU) is unable to fully recover, even when the initial cause of their illness has been treated. Inadequate dietary intake prior to admission and during the recovery phase may leave patients in a frail physical state, limiting rehabilitation potential. Commonly used methods to assess nutritional intake and nutritional status are highly impacted by various disease-related confounders and reporting bias. We hypothesise that a combined assessment of biomarkers in plasma and urine may provide a more accurate overview of nutritional status at ICU-admission.

Objective:

Main: Assess nutrition-related biomarkers in plasma and urine samples at ICU admission

Secondary:

Identify the number of micronutrient deficiencies at ICU admission Compare biomarker profile and dietary intake of short and long-stay ICU patients at baseline Compare subjective dietary intake, nutritional status and muscle thickness between patients with and without micronutrient deficiencies at baseline Study design: Observational study

Study population: Adult patients admitted to the ICU. Two groups will be recruited: patients with a short length of stay (\<48 hours) and patients with a longer length of stay (≥48 hours).

Main study parameters: Biomarker status in blood and urine at ICU admission.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to standard care ICU treatment, the following measurements will be performed:

* Within 24 hours after admission blood and urine samples will be collected from existing venous line and urinary catheter
* Within 72 hours an ultrasound measurement of the upper leg will be performed.
* During ICU stay, when the patient is capable to do so, they will be asked to complete a retrospective dietary intake assessment.

The risks and negative effects of these tests are limited. However, this study asks for a time investment and physical and mental effort of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and above.

Exclusion Criteria:

* Not proficient in speaking and/or understanding Dutch
* Comorbidity highly affecting gut absorption (e.g. post-bariatric surgery)
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
* Will maintain their implant during the study without modifications.

Exclusion Criteria:

* Women who are taking any medications or supplements known to be

  1. Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
  2. are not willing to abstain from any of these medications or supplements during the entire course of the study.
* Women with liver disease (i.e. hepatitis, fatty liver disease), and
* Women with abnormal liver or renal function, or
* Women with abnormal electrolytes on their screening blood work.
Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate

Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate.

Sexual functions remain very important in men with prostate cancer. However sexual functions are deteriorating fast with course of the disease. The influence of CPA on sexual functions remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5 scored erectile dysfunction within the use of its indication in prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Males \> 18 years previously untreated with Androcur.
* No contraindication to Androcur.

Exclusion Criteria:

* Liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of the prostate). A history of or existing thrombosis or embolism. Severe chronic depression. Hypersensitivity to cyproterone. Cyproterone acetate in previous therapy.
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
* HCV RNA \> 1 x 10\^4 IU/mL at screening
* Infection with HCV genotype 1, 2 or 3 as determined at screening
* HIV-1 infection confirmed with positive ELISA or Western blot at screening
* Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
* Confirmation of chronic HCV infection
* Ability to determine presence/absence of cirrhosis.
* HIV antiretroviral therapy (ARV) criteria of one of the following:

  * ARV untreated with a CD4 T-cell count \> 500 cells/mm\^3
  * On a stable, protocol-approved, ARV for \> 8 weeks prior to screening with a CD4 T-cell count \> 200 cells/mm\^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
* Approved HIV antiretroviral medications based on drug interaction studies
* Not been treated with any investigational drug or device within 30 days of the screening visit
* Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
* Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
* Must be of generally good health as determined by the investigator.
* Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

Exclusion Criteria:

* Non-genotype 1/2/3 or mixed genotype at screening
* Genotype 1 with prior treatment for HCV
* Poor control with ARV regimen
* Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
* Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
* A new AIDS-defining condition diagnosed within 30 days prior to screening
* Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
* Infection with hepatitis B virus (HBV)
* Contraindication to RBV therapy
* Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day)
* History of solid organ transplantation or malignancy diagnosed or treated within 5 years
* Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)

The primary purpose of this study is to compare the incidence of

residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of

\< 0.90.

Undetected residual neuromuscular blockade is common in the post-anesthesia care

unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle

relaxants in the operating room have T4/T1 ratios \<0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.

Eligibility Criteria:
Inclusion Criteria:

* male or females who are \>= 18 and \<= 65 years of age
* classified by the American Society of Anesthesiologists (ASA) as Class 1 or 2 or 3;
* Body Mass Index (BMI) of \<35 kg/m\^2;
* is scheduled to undergo an elective open abdominal surgical procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of neuromuscular blockade if required) for endotracheal intubation and requiring neuromuscular blockade reversal;
* is scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch® SX;
* is scheduled to undergo an elective open abdominal procedure expected to last \<=4 hours (from start of skin incision to end of last stitch of the skin);
* have given written informed consent.

Exclusion Criteria:

* participants for whom a difficult intubation is expected because of anatomical malformations;
* is known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;
* is known or suspected to have significant renal dysfunction (e.g., creatinine clearance \< 30 mL/min) ;
* is known or suspected to have significant hepatic dysfunction;
* is known or suspected to have a (family) history of malignant hyperthermia;
* is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;
* participants for whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* participants for whom a pre-established need for postoperative intensive care admission is expected;
* pregnant or breast-feeding females;
* have participated in a previous sugammadex clinical trial;
Large-scale Brain Organization During Cognitive Control in ADHD

The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dynamics resulting from stimulant administration in children with ADHD, and how those changes relate to behavioral and symptom improvements. Subjects will be children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and, if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant medication, counterbalanced and double-blind. Functional connectivity will be measured using functional MRI and innovative graph theoretical analytic tools will be implemented. Network metrics will be related to symptomatology and behavioral testing measures. It is hypothesized that stimulant administration in children with ADHD will increase flexibility in network reconfiguration in response to changing cognitive control demands as compared to when they are on placebo. It is further hypothesized that the degree to which brain network organization is changed will be related to the degree of improvement in cognitive control performance.


Eligibility Criteria:
Inclusion Criteria:

* Between 8-12 years old
* Diagnosis of ADHD (for ADHD group); ADHD group only can have comorbid Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses of oppositional defiant disorder, conduct disorder, depressive disorders, or anxiety disorders
* ADHD subjects must never have been treated with medication for their ADHD

Exclusion Criteria:

* Wechsler Intelligence Scale for Children-Fifth Edition Full-Scale Intelligence Quotient (IQ) \< 80
* Wechsler Individual Achievement Test-Third Edition Word Reading \< 85
* Any neurologic or developmental disabilities
* Any reading or learning disabilities
* Visual impairment that cannot be corrected-to-normal
* Color blindness
* Documented hearing impairment greater than 25 decibels (dB) loss in either year
* Have already gone through puberty (Tanner Stage II or higher)
* Medical contraindication to MRI
* Any psychoactive medication
MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer

Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.

Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven diagnosis of prostate adenocarcinoma
2. NCCN defined low-, intermediate- and high-risk prostate cancer
3. Age ≥ 18
4. Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion

Exclusion Criteria:

1. History of prior pelvic radiation (external beam or brachytherapy)
2. Inability to undergo MRI
3. Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
4. American Urological Association (AUA) score \>17 - AUA score \>17
Implant for Walking After Stroke

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.

The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.

Eligibility Criteria:
Inclusion Criteria:

* At least 6-months post stroke
* Age 21 to 75 years old
* Able to ambulate, but does not require the assistance of more than one person
* Walk slower than 0.8m/s during a 10m walk test
* Lower extremity Fugl-Meyer Motor Assessment (FMA) \<= 20
* Reduced peak hip, knee and/or ankle range of motion during stance or swing phases
* Modified Ashworth Scale (MAS) \<= 2 at the above joints during passive flexion and extension
* Innervated and excitable lower extremity and trunk musculature
* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
* Adequate social support and stability
* Willingness to comply with follow-up procedures
* Neurologically stable as determined by a physician

Exclusion Criteria:

* Non-English speaking
* Significant range of motion limitations (lacking hip extension, etc.)
* History of spontaneous fractures or other evidence of excessively low bone density
* Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)
* Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.)
* Cardiovascular or pulmonary disease
* Uncontrolled diabetes or hypertension
* Presence of a demand pacemaker or cardiac defibrillator
* Pregnancy
* Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)
* Significant history of repeated falls
* Severely impaired cognition and communication
* Any other medical or psychological condition that would be a contraindication