cyrilzakka/clinical-trials huggingface dataset:
Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff

The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers using objective measures of drowsiness and driving performance in an instrumented research vehicle.

Specific Aim 1. To test the hypothesis that on road (track) driving performance will deteriorate (variation in lateral lane position and the rate of out of lane driving events) and the frequency of episodes of severe sleepiness will increase ("microsleeps" on EEG and Johns' Drowsiness Score \>4) in shift workers following an extended work shift or night shift compared to a rested state, following day shifts.

Specific Aim 2. To test the hypothesis that ocular measures of alertness (percent of time with eyes closed, eye tracking and Johns' Drowsiness Score) are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving.

Specific Aim 2a. To test the hypothesis that autonomic measures, ECG, respiration (measured with the Bioharness), skin conductance level and peripheral blood flow (measured with the Q sensor), are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving

Specific Aim 3. To test the hypothesis that self-reported sleepiness is related to on road (track) driving performance and episodes of severe sleepiness following extended working shifts or night shifts.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be a shift worker who undertakes extended duration shifts (16 hours or longer) or overnight shifts
* Participant must be between the ages of 18-65y
* Participant needs to have held a US driving license for two years previously or an International Driving license for two years with 6-months regular (\>2/week) US driving experience
* Participants who wear corrective eye wear (i.e., glasses) are ONLY eligible to participate if they have a valid prescription so we can fit the Optalert glasses with their prescription lenses
* Resident physicians are only recruited if the combination of their time involvement in the study (i.e., any additional time beyond the time that it would ordinarily take them to commute home from work), together with their scheduled work hours, would fall within ACGME standards for duty hours for resident physicians.

Exclusion Criteria: Exclusion criteria includes all parameters outside the inclusion criteria above.
Oral Fluid vs IV Fluid After Primary TKA

The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.

The main question it aims to answer is:

Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?


Eligibility Criteria:
Inclusion Criteria:

* Age 40-85 years old
* ASA I, II
* Primary osteoarthritis

Exclusion Criteria:

* Diuretics use
* Morbid obesity
* Previous knee surgery
* Cannot undergo spinal anesthesia
Coronary Flow Reserve and Glucometabolic State

Diabetes mellitus is a major risk factor for the development of ischemic heart disease, and patients with diabetes mellitus have a worse outcome following an acute myocardial infarction than non-diabetic patients. Furthermore, abnormal glucose metabolism below the diagnostic threshold of diabetes mellitus is also associated with increased risk of death compared to patients with a normal glucose metabolism. The frequency of abnormal glucose metabolism in acute myocardial infarction is high, and approximately 70% of myocardial infarction patients have diabetes mellitus, newly diagnosed diabetes mellitus or impaired glucose tolerance, leaving only 30% with normal glucose metabolism. The increased mortality among patients with acute myocardial infarction and abnormal glucose metabolism seems mainly related to a higher occurrence of congestive heart failure, suggesting that an abnormal glucose metabolism may play an important role among others in endothelial dysfunction, infarct healing and overall left ventricle function. This raises the question, whether patients with acute myocardial infarction and abnormal glucose metabolism have increased frequency of micro- or macrovascular disease or both.

Coronary flow velocity reserve reflects the patency of the epicardial coronary artery in combination with vasodilator capacity of the microcirculation and may therefore offer a tool for assessment of macro- and microcirculation.

This study will focus on the relation between coronary flow velocity reserve estimated by transthoracal Doppler echocardiography and mortality, risk for heart failure and left ventricle function after acute myocardial infarction stratified according to glycometabolic state


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed first AMI based on characteristic clinical symptoms and/or electrocardiographic signs of AMI and Troponin T or I or CK-MB over diagnostic limits for AMI
2. Referral for coronary arteriography based on the actual myocardial infarction
3. Written informed consent

Exclusion Criteria:

1. Previous myocardial infarction
2. Asthma bronchiale
3. 2 or/and 3 degree atrio-ventricular block and paced rhythm
4. Mental state that makes the patient unavailable in attending the study
5. Use of dipyridamol
6. Sick Sinus Syndrome
Up-Down Oxytocin Infusion

This study is designed to determine the minimum effective dose (ED90) of infusions of oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for additional uterotonics, in low risk parturients presenting for an elective CD.

The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.


Eligibility Criteria:
Inclusion Criteria:

1. Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
2. American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
3. Age ≥ 18 years
4. Term gestational age (≥ 37 weeks)
5. English-speaking

Exclusion Criteria:

1. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
2. Laboring women
3. Urgent or emergency cesarean delivery
4. Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
5. Severe maternal cardiac disease
6. Subjects predisposed to uterine atony and postpartum hemorrhage (i.e. placenta previa, multiple gestation, macrosomia, polyhydramnios, uterine abnormalities, or bleeding diathesis, \> 2 previous CD)
7. Fetal anomalies /Intrauterine Fetal Demise
8. Failed spinal anesthesia
9. Patient enrollment in another study involving a study medication within 30 days of CD
10. Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.

Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus of at least 12 months duration, followed by Rainbow Babies and Children's Pediatric Endocrinology and Diabetes Division
* Most recent HbA1c \>= 8.5%
* Patients must be willing to check their blood sugar at least 4 times daily while wearing the CGM
* Patients and families must be willing to come to diabetes clinic once a month for 4 months

Exclusion Criteria:

* Inability to understand and/or speak the English language
* Pregnancy
* Psychological counseling with Dr. Rebecca Hazen regarding diabetes adherence prior to the study
A UK Multicentre, Health-Related Quality of Life Study for Children and Adolescents With XLH

This study aims to provide Health-related Quality of Life (HRQoL) data from children and adolescents with growing skeletons in the United Kingdom (UK), including those treated with burosumab or alternative XLH treatment, as part of an updated submission to the SMC in early 2023. This study will utilise data from a subset of UK sites already within the XLH Registry (including participating Scottish sites) and collect additional HRQoL data within these sites (that are otherwise not included in the wider XLH Registry protocol). The HRQoL data will enable the calculation of HRQoL to derive the HRQoL utility estimates in children and adolescents with growing skeletons for the RSS health states, hence addressing an area of uncertainty.

This is a multicentre, non-interventional HRQoL study of children and adolescents with growing skeletons using routinely collected XLH Registry data and prospectively collected HRQoL data. This study will aim to enrol approximately 50 patients from approximately 5 UK centres (currently participating in the XLH Registry) over a 6-month period. Each patient will be followed for up to 12 months after enrolment. As stipulated, the data collection should not require additional patient visits or data collection within the health service.

Three types of data will be used in this study:

1. Routinely collected data from the XLH Registry on patient demographics and clinical data, as well as PedsQL HRQoL data.
2. HRQoL data prospectively collected at enrolment, 6-month and 12-month follow-up by the patient and/or their parent / legal guardian.
3. RSS scores within the XLH Registry will be used where available, or RSS will be centrally calculated retrospectively from radiographs of the affected wrist and/or knee. All RSS calculations will be centrally reviewed.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥4 years and \<18 years.
2. Enrolled in the XLH Registry via one of the participating UK centres.
3. Have at least one of the following:

   1. RSS calculated at enrolment during a routine clinic visit. OR
   2. Historical radiographs of the affected wrist and/or knee available in the medical chart within the 6 months prior to enrolment, to allow RSS to be centrally calculated retrospectively.
4. Receiving any XLH treatment (burosumab, oral phosphate and active vitamin D, or other XLH treatment) within 30 days prior to informed consent for this study

Exclusion Criteria:

1. Does not have the cognitive capacity to provide informed consent, or their legally designated representative (i.e. parent / legal guardian) does not have the cognitive capacity to provide informed consent.
2. Is not expected to have open growth plates for the duration of the study.
3. Currently participating in an interventional clinical trial. Participation in a Compassionate Use Programme, Pre-commercial Programme, or Investigator Initiated Study does not preclude a patient from participation in this study.
Level of Knowledge and Habitual Concepts of Turkish Parents on Child Passenger Safety

It is well known that traffic accidents are one of the major reasons for death in childhood. Unfortunately scientific and statistical data usually comes from developed countries. In this study, the investigators will try to evaluate Turkish families' knowledge on Child Passenger Safety, observe how they carry their babies in the car and investigated the reasons behind the undesired behaviors.


Eligibility Criteria:
Inclusion Criteria:

* All families

Exclusion Criteria:

* Families with premature or neurologically disabled babies.
Schizophrenic Patients in Integrated Care

The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month


Eligibility Criteria:
Inclusion Criteria:

* Patients with baseline SWN-K \<=70
* Provision of signed informed consent
* Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

* Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
* Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
* Patients who pose an imminent risk of suicide or danger to self or others
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.


Eligibility Criteria:
Inclusion Criteria:

* Insufficiency of the GSV
* Signed informed consent
* Patient willing to participate in follow-up scheme
* Age \> 18 years
* Ultrasound criteria for endovenous treatment have been met:
* Diameter GSV between 3-12 mm
* No thrombus in the to be treated segment of the GSV

Exclusion Criteria:

* Patient not able to give informed consent
* Patient unable to present at follow-up visits
* Other treatment is more suitable
* Pregnancy and breast feeding
* Known allergy/ contra-indication for sclerotherapy
* Previous ipsilateral surgical treatment of varicose veins
* Deep venous thrombosis or lung emboli in medical history
* Anticoagulant therapy
* C5-C6 varices
* Immobilization
* Fontaine II or IV peripheral arterial disease
* Severe kidney function decline (GFS \< 30 mL/min)
* Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
* Liver diseases accompanied by changes in blood coagulation, livver cirrhosis
Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux

The purpose of this study is to determine whether a specific airway clearance technique, l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in infants under the age of one year. Infants referred to hospital for a multichannel intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is only possible after signing the informal consent by one of the parents.


Eligibility Criteria:
Inclusion Criteria:

* Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study.

Exclusion Criteria:

* prematurity (gestational age less than 37 weeks),
* the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Self-assessment Triage in Inflammatory Arthritis

There are benefits to early, intensive treatment of IA. But getting to treatment depends on timeline and accurate case identification. The longest delays occur in persons self-identifying the need to see care for IA, recognition of these cases by primary care providers (PCPs), and appropriate, timely referral to rheumatology. Current methods of improving time to referral and consultation are effective, but costly and unsustainable, so there is need to look for alternatives. One solutions may be the use of patient self-administered tools.

In this study, we will test whether the use of validated, self-administered patient questionnaires (self-assessment) can advance the urgency rating of referrals for people with inflammatory arthritis (IA). If urgency ratings can be advanced then self-assessment may have the potential to reduce wait times to see a rheumatologist.

In Canada, one in every hundred people has IA and hundreds of new patients are diagnosed each year. Wait times to see a rheumatologist are long, so anything that has the potential to reduce these wait times would have a significant impact.


Eligibility Criteria:
Inclusion Criteria:

* new patient referral

Exclusion Criteria:

* under 18 years of age
* confirmed diagnosis of inflammatory condition
* seen/managed by another rheumatologist within the last five years
* unable to speak English
* on disease modifying antirheumatic drugs.
* referrals from the Emergency Department
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.

Intracranial aneurysm (IA) is a common cerebrovascular disease and the main cause of nontraumatic subarachnoid hemorrhage. Once ruptured, it will cause a high mortality rate, and nearly half of the survivors will also have disabilities. After comparing surgical risk and rupture risk, a significant proportion of patients with intracranial aneurysms choose conservative observation.

Previous studies suggest that inflammation of aneurysmal wall is a high-risk factor of rupture. Dimethyl fumarate (DMF) acts as an anti-inflammatory agent by activating nuclear factor erythroid 2-related factor 2(Nrf2) and other pathways. Animal experiments found dimethyl fumarate reduces the formation and rupture of intracranial aneurysms.

MRI High-resolution vessel wall imaging (HR-VWI) has become a valuable method to assess the Wall of unruptured intracranial aneurysms. Using HR-VWI, it may be possible to detect smaller or more subtle areas of signal enhancement and change, which may give a more precise understanding of the pathology.

In this study, DMF was evaluated for its ability to reduce inflammation of the aneurysm wall measured with High-resolution Vessel Wall Imaging (HR-VWI).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years.
2. Unruptured IA of ≥3mm identified on imaging (CT, MRI or digital subtraction angiography).
3. Aneurysm wall enhancement identified by HR-VWI before treatment.
4. Ability to understand the objective of the trial with provision of written informed consent.

Exclusion Criteria:

1. MRI contraindications (metallic implant, contrast allergy, claustrophobia, etc).
2. Planned treatment of the aneurysm within 12 months.
3. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, etc.).
4. Severely impaired liver or renal function.
5. Retreatment of recurrent aneurysm.
6. Pregnant or lactating women.
7. Malignant diseases (liver disease, kidney disease, congestive heart failure, malignant tumours, etc.).
8. Poor compliance.
Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)

To Compare between outcomes of Antibiotic Prophylaxis and No antibiotic prophylaxis in non-complicated low risk laparoscopic cholecystectomy

There is no doubt that Laparoscopic cholecystectomy (LC) is the surgery of choice in cholelithiasis \[1\].

Routine antibiotic prophylaxis in LC decreases the rate of intra and post operative infections specifically the Surgical site infection (SSI) \[2\]. However, the rate of antibiotic side effects remains considerable, mainly antibiotic resistance to the commonly used antibiotics as Cefoperazone and other antibiotics used in routine prophylaxis \[3\]. So Some studies proved that No need for antibiotic prophylaxis \[4\]. In spite, no antibiotic prophylaxis may lead to infections mainly SSI and prolongation of hospitalization time \[5\]. However None of these studies has proved Superiority over the other and stills a matter of controversy \[6\]. For this reason more efforts are directed to limit the use of antibiotic in non complicated low risk laparoscopic cholecystectomy. Prophylaxis in this study is directed to start from time of admission till 1 month post operative. In our study we Follow both outcomes to compare between both techniques

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female at the Age of 18 years or above.
* Symptomatic gall bladder stones.
* Ultrasonography shows gall bladder stones.
* Uncomplicated chronic calculous cholecystitis

Exclusion Criteria:

* Complicated gall bladder stones.
* Malignant gall bladder mass
* Laparoscopic cholecystectomy with Common Bile Duct (CBD) exploration.
* Absolute contraindications to LC like cardiovascular, pulmonary disease, coagulopathies and end stage liver disease.
* The cases of Laparoscopic Cholecystectomy conversion to Open Cholecystectomy due to equipment failure.
* Immunocompromised patients as Uncontrolled DM, HIV and patients on certain medications as corticosteroids and chemotherapy.