cyrilzakka/clinical-trials huggingface dataset:
Noise-Induced Hearing Loss-Acute Exposure Treatment

The purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.

This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group. After being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.

Participants who meet the eligibility requirements will be randomized in a balanced fashion into one of 3 arms:

Group 1) Zonisamide 100 milligrams (mg) pre-op + Placebo post-op; Group 2) Placebo pre- + placebo post-op; and Group 3) Zonisamide 100 mg post-op + placebo post-op

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo a skull-based surgery that requires at least 45 minutes of surgical-drilling
* At least 18 years of age
* Air conduction thresholds in the non-operated ears are to be no worse than 25 decibel (dB) hearing loss (HL) for pure tone average 0.5, 1, and 2 kilohertz (kHz) with no individual threshold greater than 30 dB HL, and no worse than 45dB HL at 4 kHz at screening.
* Observed air-bone gap \< 10 dB HL at 0.5, 1, 2, and 4 kHz, with normal tympanometry.
* Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.

Exclusion Criteria:

* History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors
* History of moderate-to-severe kidney or liver disease
* Acute viral, bacterial, fungal or parasitic infection
* History of seizures
* Currently pregnant or breast-feeding
* Any current or history of ear disorder and/or central auditory dysfunction in the non-operated ear
* History of ototoxic drug use
* Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice
Call- Associated Acute Fatigue in Surgical Residency

The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep deprivation on surgical residents' technical and cognitive performance in a virtual reality (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were performed on three consecutive mornings- pre- and post-call as after 24 hours resting.

Summary Background Data:

The effect of acute partial sleep deprivation on surgical proficiency is still controversially discussed. The present study is the first to measure objective physiological parameters of fatigue in respect to subjective perceptions of sleepiness in VR- research of surgical performance.

Methods:

38 surgeons were explored on three consecutive mornings: prior to a 24-Hour- Call, post-call and after 24 hours resting. Hours of sleep were recorded. Subjective alertness was assessed using the standardized Stanford-Sleepiness-Scale (SSS). Saliva cortisol concentrations and pupillary activity were measured by ELISA and pupillography. The VR-simulator LapSim® was used to assess technical skills through defined low- fidelity VR-tasks "cutting", "clip applying" and cognitive skills through defined high-fidelity VR-tasks "intracorporal suturing", "VR-cholecystectomy". Objective alertness was measured by the standardized d2-Paper-Pencil-Test.

Eligibility Criteria:
Inclusion Criteria:

* Surgical interns, junior- or senior residents
* Successful completion of a minimum of 10 basic VR- tasks with the VR- simulator LapSim: "camera navigation", "coordination", "clip applying", "Cutting", and "diathermy cutting" and a minimum of 5 sessions of advanced VR- tasks: "fine dissection", "intracorporal suturing" and "VR- cholecystectomy"
* Voluntary participation
* Written informed consent

Exclusion Criteria:

* Lack of required VR- training
* Lack of informed consent
Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System

This is a randomized controlled trial comparing the DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the standard DELTA Xtend Reverse Shoulder System (control group). All Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear indicating a reverse total shoulder arthroplasty referred to the orthopedic department at Herlev and Gentofte Hospital, Copenhagen University Hospital will be considered for participation in the trial. The following exclude from participation in the study: Below 50 years of age; Cognitive or linguistic impairment; insufficient glenoid bone stock; previous fracture in the upper extremities; autoimmune mediated inflammatory arthritis.A total of 122 patients will be included of which 56 will be part of the roentgen radiostereometric analysis. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the glenoid component and functional outcome by Western Ontario Osteoarthritis of the Shoulder Index (WOOS score). The secondary outcomes are position of arthroplasty, loosening, inferior scapular notching, patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density of the proximal humerus assessed by duel energy x-ray absorptiometry and economy (cost utility analysis). The patients are examined before the operation and 1 week and 3, 6, 12 and 24 months after the operation.


Eligibility Criteria:
Inclusion Criteria:

1. Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
2. Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (\>20 degrees posterior wear)
3. Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
4. ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation

Exclusion Criteria:

1. Below 50 years of age
2. Cognitive or linguistic impairment
3. Insufficient glenoid bone-stock
4. Previous fracture in the upper extremities
5. Patients with autoimmune mediated inflammatory arthritis
6. Glenoid border medial to the medial border of the coracoid on a true AP radiograph
Mobile Application for Bariatric Surgery Patients

Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. With the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. Self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life.

Objective: It was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes.

Method: In the first stage;

* Preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content,
* Parallel to this, the adaptation of the "Bariatric Surgery Self-Management Behaviors Scale" into Turkish and the evaluation of its validity and reliability.
* Design of the mobile application, transferring the educational content to the mobile application,
* It is aimed to evaluate the technical suitability and usability of the mobile application.

In the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients.

The developed mobile application will be introduced to patients at discharge after bariatric surgery. Rating scales will be administered to patients at the end of one, three, and six months after surgery. These scales are the Bariatric Surgery Self-Management Behaviors Scale and the Moorehead-Ardelt Quality of Life Scale-II.

Conclusion: It is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Speaking and understanding Turkish,
* Being literate
* Having the ability to use a smartphone,
* Having a mobile phone with IOS or Android software,
* Having internet access,
* Having consented to download the mobile application to the mobile phone,
* Between the ages of 18-65,
* Patients undergoing bariatric surgery for the first time.

Exclusion Criteria:

* Patients with vision or hearing problems
Hepatic Artery Infusion of CD34+ Cells

The primary objective is to determine whether donor stem cells administered via hepatic artery infusion can produce liver cells in patients with severe hepatic dysfunction post stem cell transplantation (SCT) and the safety of this procedure. The secondary objective is to improve liver function and improve survival.

Participants in this study have received stem cell transplantation. As a result of this procedure, participants have developed severe liver dysfunction. Researchers have recently discovered that cells circulating in the blood and bone marrow are capable of forming liver cells. Before taking part in this study, women able to have children must have a negative blood pregnancy test.

Participants in this study will have donor's cells infused directly into their liver through a catheter that will be inserted through the groin. This will be done after liver disease has been diagnosed by liver biopsy. The catheter will stay in the groin for no more than 3 days. During that time, participants will be exposed to repeated x-ray exams to ensure that the catheter stays in place.

During the time that the catheter is in place, the infusion will be repeated as long as donor's cells are available. Participants will receive different drugs by vein to decrease the risk of transfusion reaction. After completing donor cell infusion, the catheter will be removed.

After participants are released from the hospital, they will have periodic evaluation of liver size. About 1 teaspoon of blood will be drawn for standard blood tests to evaluate liver function. Around Days 28 and 90, participants will have liver biopsy.

This is an investigational study. A total of 10 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility Criteria:
Inclusion Criteria:

* SCT recipients with severe hepatic dysfunction (bilirubin equal to or greater than 5mg/dl) and histologically documented VOD.
* The original stem cell donor must be sex-mismatched, willing and able to donate G-CSF-mobilized peripheral blood stem cells.
* The patient must have complete donor chimerism.

Exclusion Criteria:

* Patients who do not have at least 5 x 10\^6 donor CD34+ cells/kg available for infusion.
* Patients with graft versus host disease (GVHD).
* Patients in whom hepatic artery infusion cannot be performed because of anatomical or technical reasons.
* Patients with active hepatitis B or C.
Simvastatin in Uveitis

The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.

3-Hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors (statins) have been shown to reduce local and systemic inflammation in animal models of various autoimmune disorders including uveitis. In this open-label, randomized study clinical efficacy and tolerability of simvastatin 40 mg/day for 8 weeks is evaluated.

Eligibility Criteria:
Inclusion Criteria:

- diagnosis of active non-infectious uveitis

Exclusion Criteria:

* serious liver or kidney disease
* increased transaminase levels of \>1.5 ULN
* planned or active pregnancy
* use of fibrates, nicotinic acid, cyclosporine A, antifungal drugs, macrolide antibiotics, verapamil, and grapefruit juice (\>1 L/day).
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment

Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.

1. Etiological study of Non-immune fetal hydrops(NIFH):

   1. Etiological study of NIFH in mid-pregnancy period;
   2. Etiological study of NIFH and hygroma colli in first trimester;
   3. Value assessment of technology for exome sequencing in diagnosis of NIFH;
2. The accuracy of NIFH intrauterine intervention and its effect assessment:

   1. Perinatal outcomes of NIFH ;
   2. The effect of intrauterine treatments.

Eligibility Criteria:
Inclusion Criteria:

* Cases corresponding to diagnosis standards
* Willing to accept the regular follow-up

Exclusion Criteria:

* Immune hydrops fetalis
* Multiple pregnancy, except for twin-to-twin transfusion syndrome IV
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
2. Patient's IA will be treated using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the CAR study and prior to enrollment.

   Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
3. Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm.
4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.

Exclusion Criteria:

1. Target aneurysm has been previously treated via surgical or endovascular means.
2. Patient is enrolled in another device or drug study in which participation could confound study results.
3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
4. Patient has been previously enrolled into this study.
A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face other than acne that could interfere with clinical evaluations
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial

This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study.

Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men \> 18 years and women \> 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized.

Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control).

Primary outcome is survival at 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized men \> 18 years and hospitalized women \> 50 years.

Exclusion Criteria:

* Patients not capable to comprehend information to decide about participation in the study
* Women considered of childbearing potential (WOCBP) i. e. premenopausal women
* Patients with do not resuscitate (DNR) descision
* Prior enrollment and randomization in the trial
A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN ≥ 3 months before screening.
* Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
* Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
* IGA-CPG-S score of ≥ 2 at screening and baseline.
* Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).

Exclusion Criteria:

* Chronic or acute pruritus due to a condition other than PN.
* Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
* Acute or chronic active HBV or HCV infection.
* Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
The Cognitive and Cerebral Blood Flow Effects of Resveratrol

Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.


Eligibility Criteria:
Inclusion Criteria:

* Male/female,
* Healthy
* Age 18-35 years old
* Non smoker
* Proficient in English
* Not taking any herbal or prescription medications
* Not pregnant
* Does not drink more than 6 cups of coffee per day

Exclusion Criteria:

* Suffered a head injury, neurological disorder or neuro-developmental disorder
* Food allergies/intolerances
Study on Mechanical and Electrical Alternans

The main objective is to investigate mechanical alternans and MTWA in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.

In patients with severe heart failure and aortic valve disease mechanical alternans or pulsus alternans (a condition in which there is a beat-to-beat oscillation in the strength of cardiac muscle at a constant heart rate) is observed.

The mechanisms linking mechanical to electrophysiological dysfunction in heart failure are still under investigation, but impaired calcium cycling is the most striking abnormality of failing myocytes, and is most responsible for contractile dysfunction. Yet it remains unclear how this influences susceptibility to arrhythmias.

The MTWA is suggested as a risk marker to identify high risk patients for potential VTEs but the underlying mechanism is not completely understood. The aim of this study is to investigate this in a clinical setting by measuring LV parameters using a PV loop conductance catheter and generate TWA recording simultaneously to demonstrate a possible correlation between these two phenomena in patients with ischemic heart failure and find out if MTWA could turn into a more valuable risk factor.

Our hypothesis is that alternating changes in LV filling explains the electrocardiogenesis of TWA by changing the position of the heart relative to the body surface electrodes in an alternating way.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure caused by coronary artery disease
* Indication for left ventricular radiofrequency (LV RF) ablation
* LVEF ≤ 35% measured by echocardiogram or MRI

Exclusion Criteria:

* hemodynamically instable patients
* age under 18 and over 85 years,
* heart failure not caused by coronary artery disease
* Severe co-morbidity
Tobacco's Impact on Postoperative Complications in Acute Surgery

The purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.


Eligibility Criteria:
Inclusion Criteria:

* acute admittance in a vascular department
* current smoker
* surgery within 7 days
* informed/written consent

Exclusion Criteria:

* alcohol intake \> 35 units pr. week
* dementia or mental disease
* \> 90 years