cyrilzakka/clinical-trials huggingface dataset:
Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.

Total thyroidectomy (TT) is responsible for postoperative hypocalcemia in 20-30% of patients, which is definitive in 1-4% of operated patients (1). This complication is mainly due to surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative identification of the parathyroids. Intraoperative parathyroid auto-fluorescence visualization (without any dye injection) using near infrared light (NIR) is an emerging technique, which allows correct identification of normal parathyroids in almost all cases (2), but the clinical impact of NIR is unknown.

The aim of this prospective, comparative randomized study, is to compare 2 groups of patients: patients operated with NIR (NIR+) vs patients operated without NIR (NIR-).

The main objective of this study is to assess the impact of intraoperative use of NIR camera on postoperative hypocalcemia. Secondary objectives are to assess the impact of NIR on the visualization, autotransplantation and inadvertent resection rates during TT.

Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND).

Exclusion Criteria:

* Combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)
Markers in the Diagnosis of TIA

MIND-TIA is primarily an observational diagnostic study that aims to evaluate the role of novel biomarkers in the diagnosis of Transient Ischemic Attack (TIA)in primary care.

Rapid and adequate diagnosis of TIA is of great importance to enable a rapid start of treatment, and thereby decrease the risk of subsequent ischemic stroke.

Rationale:

A Transient Ischaemic Attack (TIA) does not cause permanent damage of brain tissue, but the risk of a subsequent ischemic stroke in the short term is high. Timely recognition of TIA would result in early treatment and reduce the risk of ischaemic stroke, and other adverse cardiovascular events.

To improve the management of TIA adequate diagnosis is of imminent importance. However the diagnosis is notoriously difficult, for both GP and neurologist.

Adequate biomarkers for brain ischaemia could improve the early diagnosis and thus the subsequent management of TIA.

Objectives:

1. To assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of TIA.

   Secondary objectives
2. To assess the prognostic value of biomarkers in patients with an established diagnosis of TIA.
3. To assess the time delay and factors related to delay in patients suspected of TIA.

Study population:

350 adult persons suspected of TIA from primary care.

Methods:

Recruitment of patients will be performed at the general practices of 200 GPs in the vicinity of 4 to 5 participating hospitals. During a home visit a research nurse collects a blood sample, and takes two health-related questionnaires. Participants will be referred by their GP to the regional TIA outpatient clinic for additional investigations, including brain imaging. The diagnostic accuracy of a set of biomarkers will be assessed with the 'definite' diagnosis of TIA by a panel of neurologists as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Being adult (18 years and older)
* Presenting to the GP with a new episode of symptoms suspected of TIA and the GP considering further investigations to confirm or exclude TIA at the TIA outpatient clinic.
* A blood sample can be collected within 72 hours after onset of symptoms.

Exclusion Criteria:

* The patient still has active symptoms or signs suspected of an ongoing ischemic stroke and immediate referral to the neurologist seems indicated.
* Valid history taking is impossible because of severe cognitive impairment or insufficient knowledge of the Dutch language.
* Patient with a life expectancy of \< 6 months.
* Patient is not willing or able to give written informed consent
Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin

This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.

Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress.

General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures.

Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.

Eligibility Criteria:
Inclusion Criteria:

* patients under 18 years of age sedated with DEX IN prior to MRI.

Exclusion Criteria:

* incomplete or missing medical records
Empathy in Frames: Animated Cartoons To Reduce HIV Stigma Among South African Young Adults

This study looks at whether using cartoons that reflect the culture of South Africa can help change how young adults there think about HIV/AIDS. This study will test two types of cartoons in a two-arm (treatment, comparator) randomized controlled trial design-one with Black characters and one with White characters-to see how they affect people's attitudes and knowledge about HIV/AIDS. Randomly allocated participants will be Black seronegative South African adults between 18 and 35 years old. This group was chosen because they're a demographic disproportionately affected by HIV, they're at a high point in their lives for shaping and sharing beliefs, and they're also highly active online, which is where this study takes place.

The cartoons will show the daily struggles of the protagonist living with HIV/AIDS, and end with a call to action. The study aims to highlight how the characters' ethnicity influences how viewers feel about and remember the message. The investigators want to understand if seeing characters who look like them helps people understand and empathize more. The aim of this study is to learn how cultural representation can improve health communication and guide future efforts to reduce stigma in different communities. Ultimately, the investigators hope this study will contribute to better public health messages and create a more accepting environment for people with HIV/AIDS.


Eligibility Criteria:
Inclusion Criteria:

* Must self-identify as Black South African
* Must be HIV seronegative
* Age range: 18-35 years
* Must currently reside in South Africa
* Must have basic English language comprehension
* Must have internet access to view video content

Exclusion Criteria:

* Prior participation in HIV stigma reduction interventions
* HIV seropositive status
* Non-Black South African identity
* Outside target age range (18-35)
Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. This proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy. This same regimen has been described by a leader in the field of gynecology in his text - TeLinde's Operative Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

Eligibility Criteria:
Inclusion Criteria:

* All female patients 18 years of age or older undergoing surgery for vulvar carcinoma (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy without groin node dissection, and partial vulvectomy)
* Disease State will not affect inclusion in the study. Women with previous surgery for vulvar carcinoma will be included as will those undergoing initial operation.
* Number of subjects: 160

Exclusion Criteria:

* Women simultaneously undergoing treatment for other forms of cancer
* Women under the age of 18
* Pregnant patients
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures.
* The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
* Out-patient status at enrollment and randomization.

Exclusion Criteria:

* Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
* Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
* History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
Causes Of End Stage Renal Disease In Patients Undergoing Regular Hemodialysis

CKD is defined as kidney damage for ≥3 months, as defined by structural and or functional abnormalities of the kidney, with or without decreased GFR or GFR \<60 mL/min/1.73m2 for ≥3 months, with or without kidney damage. CKD is classified based on cause, GFR category, and albuminuria category (CGA). ESRD has become a public health problem worldwide, with recent reports showing that the total number of ESRD patients has been growing dramatically.

The prevalence ESRD undergoing maintenance dialysis in 2010 was 284 individuals per million population (pmp) worldwide, which has increased 1.7 times from 165 pmp patients in 1990.

In Egypt, the prevalence of dialysis patients has increased from 225 pmp in 1996 to 483 pmp in 2008(according to last Egyptian renal registry) and the main causes of ESKD in Egypt, other than diabetic nephropathy, included hypertensive kidney disease, chronic glomerulonephritis, unknown etiology, chronic pyelonephritis, schistosomal obstructive uropathy, and schistosomal nephropathy .

It is well established that diabetic kidney disease is the most common cause or in combination with hypertensive nephropathy are the most common causes of end-stage renal disease (ESRD) in developed and developing countries. Patient survival in diabetics on maintenance renal replacement therapy including hemodialysis (HD), peritoneal dialysis (PD) and kidney transplantation is significantly lower than that seen in nondiabetics with ESRD. The poor prognosis of diabetic patients with ESRD is partly due to presence of significant cardiovascular disease, problems with vascular access, more susceptible to infections, foot ulcer, and hemodynamic instability during HD.

Hemodialysis (HD) is the first line of renal replacement therapy in the investigator's country. It is well known that patients on RRT are of greater risk for complications and worse prognosis in comparison to patients with the same co-morbidities but not on RRT.

The most common complicatons of hemodialysis are hypotensive episodes, muscular cramps, itching, arrhythmias,and anaphylactic responses during the sessions.

Eligibility Criteria:
Inclusion Criteria:

* All ESRD patients \>18years old in Assuit University Hospital dialysis unit .
* Patients on regular haemodialysis for more than six months.

Exclusion Criteria:

* ESRD patients\<18years old .
* patients with acute kidney injury .
* patients on haemodialysis for less than six months.
"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"

The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.

We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary pressures, endothelial function, etc. We will also assess the reversibility of these changes after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore changes in coronary flow response after 12 weeks of CPAP use compared with baseline.

Eligibility Criteria:
Inclusion Criteria:

* subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) \>15 events/hour and Epworth score \>10, or an AHI \>20 events/hour
* either sex
* any race
* between 21-50 years old.

Exclusion Criteria:

* Systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg
* Changes in antihypertensive medications in the last 6 weeks
* Restless leg syndrome
* Average overnight oxygen saturation below 80%
* Current use of beta-blockers
* History of coronary artery disease
* History of Stroke
* Atrial fibrillation
* Peripheral vascular disease
* Suspected cardiac valve abnormality
* Ejection fraction \<50%
* Type I and type II Diabetes Mellitus (DM)
* Asthma or confirmed Chronic Obstructive Pulmonary Disease
* Cigarette smoking in the last 6 months
* Raynaud's disease
* Pregnancy (the normal hormonal changes that occur in pregnancy affect greatly arterial stiffness parameters) If a subject becomes pregnant we will discontinue data collection.
* Physically incapable of resting on left lateral decubitus for 40 minutes.
* Mastectomy with lymph node removal that might preclude us to monitor blood pressures on both arms
Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation

A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.

The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.

Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .

The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.

After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.

The participating patients will receive postoperative questionnaires following the first year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective, inguinal hernia repair
* 18 years or older
* Male gender
* ASA physical classification system 1-3
* Informed consent

Exclusion Criteria:

* Patients with recurrent hernia, except patients operated in childhood without mesh application.
* Patients with bilateral hernia
* Patients with chronic pain
* Patients in anticoagulation therapy
* Previous major surgery in lower abdomen
Shockwave Treatment for Advanced Angina in Maastricht

There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
* Patients demonstrates exercise tolerance test (ETT) duration \< 10 minutes on a modified Bruce protocol
* No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
* Patient's conditions stable for at least 3 months
* Life expectancy of \> 12 months.

Exclusion Criteria:

* Unstable angina pectoris
* Haemodynamically significant valvular heart disease
* Myocardial infarction \<3 month prior randomization
* Evidence of intracardiac thrombus
* Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
* Patients who are unwilling or unable to cooperate with the study procedure.
* Age \< 18 years
* Cardiac or pulmonary malignancy
* No informed consent
* Known depression
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.

Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

Study design Prospective, observational multi-center trial with 2 cohorts.

Study population

1. Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
2. Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.

Main Endpoints

1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of \> trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker

Eligibility Criteria:
Inclusion Criteria:

* Cohort A:

  1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
  2. Patients with a severely calcified aortic valve (Agatston score \> 3000 for men, and \> 1600 for women)
  3. Patients with small anatomy defined by mean aortic annulus diameter \< 20mm
* Cohort B:

  1. every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.

Exclusion Criteria:

* poor CT quality
* previous aortic valve replacement
* Permanent pacemaker at baseline