cyrilzakka/clinical-trials huggingface dataset:
ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients

Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor for later major adverse coronary events. Diagnosis of coronary arterial disease would thus be desirable for obese patients, however percutaneous angiography is an invasive procedure and associated with a certain morbidity in obese patients. In this study the investigators would like to assess whether dual source CT angiography can be used for diagnosis of coronary arterial disease in severely obese patients and which settings yield the best image quality.

Obesity is a major health problem in many countries and a major risk factor for cardiovascular disease. Extreme obesity can be treated with surgery, however these procedures are associated with a certain surgery-related morbidity which increases with comorbidities, in particular coronary diseases. Thus, preoperative cardiac risk assessment would be desirable, however percutaneous coronary angiography is an invasive procedure with problems and complications in obese patients. A non-invasive alternative would be coronary dual-.source CT angiography (CCTA), however little experience exists in the application of CCTA in morbid obese patients. This study would like to address the following issues:

1. Comparison of image quality of coronary CT angiography using a dual source CT from obese patients using a special protocol (140 kV, 350 mAs) with images from historical controls from normal weight patients with a standard protocol (120 kV, 330 mAs).
2. Prediction of major adverse coronary events. Patients with a coronary stenosis in CCTA will be followed for any major adverse coronary events (details see Outcomes)
3. Is it possible to detect myocardial fat by a reduced CT density. Images from obese patients will be compared to historical controls from normal patients. Furthermore, is the myocardial CT density correlated with the BMI of obese patients?
4. Optimisation of scan protocol. Increasing the scanning angle beyond the standard 90° will reduce the signal noise at the cost of temporal resolution. Various scanning angles with be tested for an optimal combination of signal noise and temporal resolution.
5. Does the long QT-syndrome improve after bariatric surgery? It is assumed that the long QT-syndrome is a consequence of fattening of the myocardia. Is it possible to see a reduction of myocardial fattening and thus an improvement of the long QT-syndrome with CT during the follow-up after bariatric surgery?

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity (BMI \>35 kg/m²)
* intention to undergo bariatric surgery
* increased risk for coronary artery disease (based on PROCAM score)

Exclusion Criteria:

* kidney insufficiency (serum creatinine \>100 µmol/l, creatinine clearance \<50 ml/min)
* allergy to iodine containing contrast agents
* hyperthyroidism
* metformin medication
* pregnancy
Serum 1,25-dihydroxyvitamin D Levels in Type 2 Diabetes Mellitus Patients With Different Levels of Albuminuria

Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be presented with the characteristics of albuminuria, and its main pathological change is glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1 and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular injury may be the primary pathological change in diabetic renal injury not only the secondary change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM patients, the tubular injury may be severe already. An index which is predominant, sensitive and convenient to be measured should be purposed.It is predicted that insufficient renal 1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators present the presumption that the activity of renal 1-alpha hydroxylase could reflect the degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years, DM duration \>1 year, all of the patients were predialysis

Exclusion Criteria:

* history of liver or kidney disease, malignancy, current pregnancy, extensive dermatologic disease, evidence of metabolic bone disease and hyper-/hypo- thyroidism that would affect mineral metabolism. Patients who were taking native or active vitamin D, steroids, phosphate binders, or medications that affect vitamin D metabolism were also excluded.
Quality of Life in Food Allergic Families

Food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. Food allergies place a tremendous burden not just on the patient but on his/her family as well. In an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.

We intend to show a difference between the intervention group, who will receive a food allergy packet, along with three follow up phone calls from our trained allergy nurse, and the control group, will be given the food allergy packet only. We expect the intervention group to score higher on the quality of life survey, showing that the support and education of our allergy nurse has a positive effect on quality of life of our patients and their families.

Eligibility Criteria:
Inclusion Criteria:

* IgE mediated food allergy
* Ages 0-17
* Willing to participate

Exclusion Criteria:

* Food sensitivities
* Unable to understand or read survey
* Unable to be available for follow up survey and nurse phone calls.
Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)

"To evaluate the use of the Dexcom CGM System when used according to approved commercial labeling during standard clinical use and its impact on intended users in a real-world setting"

"The Dexcom Global Registry is a non-randomized, open-label, multi-center registry with the goal of collecting Dexcom CGM System data in a real world setting.The registry study involves retrospective and/or prospective data collection associated with Dexcom CGM System use."

Eligibility Criteria:
Inclusion Criteria:

* Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling
* Has at least one HbA1C (Hemoglobin a1c) measurement within three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use
* Subject is willing and able to use Dexcom CGM System according to approved product labeling
* Subject is willing and able to complete applicable patient reported outcome assessments/ surveys
* Subject is willing and able to comply with the protocol
* Subject is willing and able to comply with provider requirements for at least two provider encounters per year according to applicable clinical practice guidelines
* Subject or the subject's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB/EC approved waiver of consent

Exclusion Criteria:

* Is contraindicated for a Dexcom CGM System per approved commercial labeling
* In the Investigator's opinion, the subject is not considered to be a suitable candidate
Comparison Four Intubation Devices

Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics
* no clinical experience in infant intubation

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy.
Prestilol(Perindopril+Bisoprolol) in Therapy of Patients With Atrial Fibrilation

The study aims to evaluate the effectiveness and safety of oral fixed-dose combination of bisoprolol/perindopril in patients with permanent atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:permanent atrial fibrillation with normal EF -

Exclusion Criteria:AF with decreased EF

-
Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone.

Opiate analgesics remain the most popular option following outpatient hand surgery despite growing evidence that non-opiate analgesics may provide equivalent pain relief with fewer adverse effects and greater overall satisfaction. The purpose of this randomized trial is to compare the efficacy, side effect profiles and satisfaction associated with Ibuprofen plus Acetaminophen versus Oxycodone alone following outpatient hand surgery. No previous studies have compared the use of opiate analgesics with acetaminophen/ibuprofen following outpatient hand surgery. Patients will be randomized to receive either oxycodone alone or acetaminophen and ibuprofen following outpatient soft tissue hand surgery. Patients will be randomized to receive one of the two aforementioned pain regimens. Patients will be given a booklet in which to record pain level by visual analog scale (VAS), satisfaction with pain control, brief pain inventory and any side effects. Patients will be seen in clinic 1 week after surgery to review symptoms. Patients may also be contacted by phone to review daily log of symptoms. Patients will be seen in clinic 1 week after surgery per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: Carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, de Quervain's release.
* primary language is English or Spanish

Exclusion Criteria:

* any pre-existing condition requiring preoperative opiate analgesia, eg chronic pain syndrome
* allergy to acetaminophen, ibuprofen, or oxycodone
* renal impairment or liver disease either documented based on history or when preoperative creatinine, BUN, or liver function tests are outside the normal range provided by the lab
* peptic ulcer disease or any history of gastrointestinal bleeding
* coagulopathy documented on history, review of systems, or based on preoperative lab testing where PT, PTT, or INR are outside the normal range provided by the lab
* pregnancy based on positive beta-HCG test which is performed on the day of the surgical procedure as is standard protocol
Relationship of Position Sense With Gait and Balance in Patients With Multiple Sclerosis

Balance and gait disturbances are among the most common problems in patients with Multiple Sclerosis (MS). There is evidence of decreased foot sole sensation in MS patients. Studies conducted in healthy individuals have revealed the relationship between balance and foot sole sensation. These studies have demonstrated that sensory feedback from the cutaneous receptors of the foot sole plays an important role in maintaining balance. However, it is not yet known clearly to what extent the sensory impairment seen in MS patients affects balance and gait disorders.

The aim of this study is to examine the relationship between lower extremity position sense and foot sole sense with gait and balance in MS patients.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The balance, gait, lower extremity position sense, and foot sole sense will be evaluated.

The researchers will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. In addition, the researchers will examine the correlations between balance, gait, lower extremity position sense, and foot sole using by Pearson bivariate correlations.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age Having a diagnosis of "Multiple Sclerosis" by a specialist physician Relapse free in the last 3 mounts Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 ) No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research
Pilot Trial: Postoperative Opioid-free Analgesia

North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.

This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (\>18 yo) undergoing outpatient surgery

* Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
* Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)

Exclusion Criteria:

All patients

* Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
* Contraindications to any of the drugs used in the trial
* Difficult to be reached after surgery
* Inability to provide written informed consent
The National Lipedema Study

Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction.

Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking.

The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* female
* age 20-65 years
* significant pain from lipedema
* lipedema stage 1-2 or localized stage 3

Exclusion Criteria:

* Non-fluency in the Norwegian language
* pregnancy
* current malignancy
* previous surgical treatment for lipedema
* smoking
* BMI \> 28
* serious comorbidities such as cardiac-, pulmonary-, renal disease
* unwillingness to wear compression garments
A Neurocognitive Model of Anorexia Nervosa

The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.

Patients with Anorexia Nervosa (AN) have extreme difficulty changing their eating behavior, even when they express desire for change. These behaviors seem to override all other potential responses, and can appear perseverative, or habitual. The purpose of this study is to investigate thought processes and neural mechanisms that may contribute to the development of habitual behaviors. The investigators hypothesize that patients with AN will perform differently than people without eating disorders on a series of neuropsychological tasks and will show different neural activation patterns in functional neuroimaging scans.

Eligibility Criteria:
Inclusion:

* DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), current or prior;
* Age 16-45;
* Inpatient on GCRU
* Medically stable.

Exclusion:

* Any other current major Axis I disorder (including current bulimia nervosa), except major depression;
* History of concussion, seizure disorder, or other neurological illness;
* History of learning disability;
* Acute Suicidality

Healthy comparison group:

Inclusion:

* No current or past psychiatric illness;
* Age 16-45
* No history of binge eating or vomiting;
* Normal weight (80%-120% ideal body weight)

Exclusion:

* Significant medical or neurologic illness(concussion, seizure disorder, learning disability, other neurological illness)
* Current psychotropic medication or medications known to impact cognition

Additional Exclusion Criteria for fMRI:

* Significant Claustrophobia
* Pregnancy
* Indwelling metallic object, non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
* For patients, current psychotropic medications (antidepressants for 2 week (prozac and antipsychotics for 4 weeks)
* For patients, any other current Axis I diagnosis
Evaluation of Oral Midazolam in First-trimester Surgical Abortions

The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.

Women in the study will be randomized to receive either midazolam or placebo. Every participant will still receive the standard oral medications for pain (ibuprofen) as well as an injection of numbing medicine (lidocaine) near the cervix (PCB). The co-primary outcomes are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time points before, during, and after the procedure, as well as subject satisfaction with anxiety and pain control and overall abortion experience. Due to the dose-dependent anterograde amnesic effect of midazolam, we will also investigate the effects on memory and recall, which has not previously been studied. In addition, we will also collect data on side effects frequently associated with oral midazolam such as nausea and sleepiness. Women will also be responsible for completing a one-page survey 1-3 days after the procedure visit and return it by mail using a pre-addressed and stamped envelope.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Voluntarily requesting surgical pregnancy termination
* Pregnancy with intrauterine gestational sac between 6 0/7 and 10 6/7 weeks gestation, dated by ultrasound
* Eligible for suction aspiration
* English or Spanish speaking
* Good general health
* Able and willing to give informed consent and agree to terms of the study
* Have assistance home; no driving for 24 hours

Exclusion Criteria:

* - Gestational ages 11 0/7 weeks or more
* Gestational age less than 6 0/7 weeks
* Incomplete abortion
* Premedication with misoprostol
* Use of narcotic pain or anti-anxiety medication within past 24 hours
* Use of heroin or methadone within last 3 months
* Chronic alcoholism or alcohol intoxication within past 24 hours
* Requested narcotics or Intravenous sedation (prior to randomization)
* Allergic reaction or allergy to cherry/cherry flavoring or lidocaine or non-steroidal anti-inflammatory drugs (NSAIDs)
* Allergic reaction or sensitivity to benzodiazepines including hyperactive or aggressive behavior (paradoxical reaction)
* Medical problem necessitating inpatient procedure
* Untreated acute cervicitis or pelvic inflammatory disease
* Known acute narrow-angle glaucoma
* Weighing less than 100 lb (45 kg)
* Use of potent medications interfering with microsomal metabolism within past 48 hours (carbamazepine (Tegretol), cimetidine (Tagamet), diltiazem (Cardizem), erythromycin, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), nelfinavir, ranitidine (Zantac), rifampin (Rifadin), ritonavir (Norvir), saquinavir, verapamil (Calan))