cyrilzakka/clinical-trials huggingface dataset:
Prehospital Evaluation and Economic Analysis of Different Coronary Syndrome Treatment Strategies - PREDICT

Despite remarkable gains in treatment over the last decade short-term mortality for those who survive to hospital with AT-elevation acute myocardial infarction (STEMI) remains high (5%-10%). Different studies have pointed out that reperfusion (intravenous fibrinolysis or percutaneous coronary interventions (PCI) and its timing are critical in decreasing STEMI patients' mortality. Studies of prehospital 12 lead electrocardiograms (12 lead PHECG) with advance emergency department (ED) notification suggest that there is a time to treatment advantage with this intervention. The use of 12 lead PHECG is not currently universal and part of standard treatment throughout the province. The purpose of the study is to follow STEMI study subjects during standard treatments and to compare the outcomes of subjects that received 12 lead PHECG with advanced ED notification in mixed rural/urban areas with outcomes of subjects treated in areas with only 3 lead PHECG monitoring and indirect ED notification. The investigators hypothesize that there will be a survival benefit for study subjects with 12 lead PHECG and advance ED notification in rural and urban environments through a reduction in door-to-reperfusion time and that 12 lead PHECG will be a cost-saving technology for the province of Ontario.

Many studies have established that reperfusion reduces mortality in ST-elevation acute myocardial infarction (STEMI) patients; the earlier reperfusion therapy is delivered, the greater the mortality reduction. Most STEMI patient in Ontario still do not receive reperfusion therapy within established target times of \<30 minutes for fibrinolysis or \<90 minutes for PCI. 12 lead PHECG with advance ED notification may have a time to treatment impact in STEMI patients. However studies, investigating this intervention were all small, largely urban trials, and were carried out with advanced care paramedics. In Ontario, many emergency medical services (EMS) systems cover large rural regions, and are frequently staffed by primary care paramedics with only basic life support training. Thus, the benefit of 12 lead PHECG in these settings is unclear. In addition, no study has assessed the cost-effectiveness of 12 lead PHECG compared to 3 lead PHECG.

Eligibility Criteria:
Inclusion Criteria:

* Call 911 for assistance
* Are suspected by the paramedics of having ischemic chest pain for greater than 30 minutes but less than 6 hours
* Be greater than or equal to 18 years of age
* Experience chest pain that fails to completely respond to nitrates as per standard provincial chest pain protocol.

Exclusion Criteria:

* Subjects less than 18 years of age
Acute Hemodynamic and Biological Effects of ECP and Exercise

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, written informed consent to participate in the study

Exclusion Criteria:

* 1. Pregnancy (serum β-HCG\<2 IU/l for all female volunteers)

Baseline History:

1. Endurance exercise 5 days before and the days between the exams
2. History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder
3. History of metabolic disorder, particularly diabetes mellitus
4. History of respiratory, renal, hepatic or cerebral disease
5. Allergic reactions to Luminity or its components
6. Cardiovascular medication
7. Illness characterized by acute phase response
8. Anaemia with haemoglobin levels \< 110 g/L

Baseline Physical Examination:

1. Peripheral artery disease

Baseline Echocardiogram:

1. Valvular heart disease
2. Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta)
3. Intra- or extracardiac shunt
4. Systolic or diastolic left ventricular (LV) dysfunction
5. LV-hypertrophy
6. Pulmonary arterial hypertension
The Effect of Combined General/Epidural Anesthesia Versus General Anesthesia on Diaphragmatic Function

The aim of this study was to investigate whether robot assisted laparoscopic radical prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and whether combined general/epidural anesthesia could provide better postoperative diaphragmatic function.

Diaphragmatic dysfunction after abdominal surgery can result in extended hospital stay and increased medical costs, because it is related with atelectasis, lung collapse or pneumonia. The mechanism of diaphragm dysfunction is thought to be from not only direct injury to abdominal wall and viscera but inhibitory reflexes of phrenic activity. Thoracic or upper abdominal surgery is suggested as a risk factor of postoperative diaphragm dysfunction, and perioperative analgesic modality is also known to affect diaphragm movements. But there has been no trial to investigate the effect of laparoscopic pelvic surgery such as prostatectomy on diaphragm movement. Moreover, it is not clear if minimally invasive Robot-assisted laparoscopic radical prostatectomy (RALRP) has any influence on respiratory and diaphragm functions.

Eligibility Criteria:
Inclusion Criteria:

* Patients of over 18 years of age undergoing elective Robot-assisted laparoscopic radical prostatectomy

Exclusion Criteria:

* Patients with previous history of smoking, cardiopulmonary or neuromuscular disease or obesity (body mass index \> 30 kg.m-2)
Diabetes Nutrition Education for American Indian and Alaska Native Communities

This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

This study involves pilot testing a newly developed diabetes nutrition education program for American Indian and Alaska Native adults with T2D. The first phase of this study (COMIRB Protocol 18-006) included a qualitative needs assessment to inform the development of this program. The second phase involves pilot testing the study at 6 collaborating AI/AN sites across the US. The Study Aims include: piloting the newly adapted program at 6 AI/AN collaborating sites to gain feedback on satisfaction, likability, usability and clinical outcomes such as HgA1C (measure of blood sugar control), blood pressure, and body mass index (BMI).

Eligibility Criteria:
Inclusion Criteria:

* AI/AN status (self-reported)
* age \> 18 years
* fluent in English
* a current diagnosis of T2DM.

Exclusion Criteria:

* a major medical issue that may interfere with participation (e.g., prior cardio- or cerebrovascular disease including a recent myocardial infarction or major stroke; cancer not in remission; dialysis; active alcohol and/or substance abuse.)
* a planned move from the area within the 3 to 6 month data collection time period that would not allow completion of all the study visits
Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia

For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :

1. Patient survival probability at 100 days, 1 year and 2 years.
2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic GVHD within 6 months and 2 years.
3. Engraftment at 6 months, 1 year and 2 years

The objective of this trial is to make an initial assessment for this new treatment regimen and to show it is equal or superior to the current standard practice. With this initial assessment be hope to gain information suggesting further study of this regimen or discontinuation of this regimen before exposing large numbers of patients to this new treatment option. We also will gain experience with this new regimen giving insights as to possible modifications in dosing and monitoring and selection of patients for future treatment in case of positive results. For this initial study we plan to enroll up to 24 patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SAA based on bone marrow aspirate and biopsy results. Failure to respond to immunosuppressive therapy and/or lack of an HLA identical family member.
* A 10/10 or 9/10 HLA matched unrelated donor or a 9/10 matched related donor available after high resolution typing.

Exclusion Criteria:

* Patients with Aplastic anemia and active infection must be treated to maximally resolve this problem before beginning the conditioning regimen.
* HIV seropositive patients
* Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
* Patient greater than 60 years of age.
* Women who are pregnant or nursing.
* Patients with active hepatitis
* Patients with severe cardiac dysfunction defined as shortening fraction \<25%.
* Patients with severe renal dysfunction defined as creatinine clearance \<40ml/mim/1.73m2.
* Patient with severe pulmonary dysfunction with FEV1, FVC and DLCO 40% of predicted or 3 SD below normal.
Low-dose Contrast Media for Low-kVp Abdomen CT

The purpose of this clinical study is to test the performance of low radiation dose abdominal CT combined with low dose contrast media for the diagnosis of acute appendicitis in young patients. The main questions to be answered are:

1, Can low-dose contrast media paired with low-dose radiation CT of the abdomen provide acceptable diagnostic accuracy in acute appendicitis? 2. How much radiation dose can be saved by using low radiation dose abdominal CT in combination with low dose contrast media?


Eligibility Criteria:
Inclusion criteria:

* Patients in the emergency department with suspected acute appendicitis based on clinical examination
* Patients scheduled for contrast-enhanced CT of the abdomen and pelvis for diagnosis of suspected acute appendicitis.

Exclusion criteria:

* Patients who decline to participate
* Contraindications to contrast-enhanced CT (eGFR \< 30 mL/min/173 m\^2 or pregnant)
* BMI \>= 30.
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.

children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility Criteria:
Inclusion Criteria:

* both-bone forearm fracture
* age \< 16 years
* dislocation
* stable

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
Marker Driven Selection of Patients for Prostate Biopsy and Management

The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).


Eligibility Criteria:
Inclusion Criteria:

1. Male participant, aged 40-85 years.
2. In good general health as evidenced by medical history.
3. Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
4. Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.

Exclusion Criteria:

1. Previous or current history of prostate cancer or treatment for prostate cancer.
2. Previous history of pelvic radiation.
3. Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
4. Inability to undergo blood draw or biopsy of the prostate as per protocol.
5. Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
6. Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
7. Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs.
8. Patients with impaired decision-making capacity.
The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).

Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.

Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
* Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
* BMI (Body Mass Index) more than or equal to 27 kg/m\^2

Exclusion Criteria:

* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
* Impaired liver function
* Impaired renal function
* Screening calcitonin equal to or above 50 ng/l
* Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
* Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
* Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
* History of chronic pancreatitis or idiopathic acute pancreatitis
IDDSI Nutritional Drink for Dysphagia Study

This study will evaluate the gastrointestinal (GI) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.

Dysphagia is a complex condition common in a number of diagnoses including stroke, Parkinson's disease, head and neck cancer, dementia, learning disabilities and gastric/oesophageal motility disorders.

A modified textured diet and/or fluid is considered as an effective intervention in management of dysphagia. The International Dysphagia Diet Standardisation Initiative (IDDSI) have developed a new framework around the terms and descriptors used in the management of individuals with dysphagia. Malnutrition is very common in patients with dysphagia and the use of pre-thickened oral nutritional supplements (ONS) has been found as an effective way to manage this. However, due to impairment in the swallow process, dysphagic patients require pre-thickened oral nutritional supplement to ensure safe consumption of these nutritional supplements.

40 participants, requiring a new pre-thickened oral nutritional supplement in line with the new IDDSI framework recruited from hospitals, outpatients clinics, care homes, community hospitals, community dietetic/speech and language therapy services or stroke rehabilitation units will receive the ready-to-use oral nutritional supplement for a 4 week intervention period. This study aims to primarily evaluate gastro-intestinal tolerance, with secondary outcomes including compliance, acceptability, nutrient intake, anthropometry and safety.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥ 18 years
* Patients with a requirement for ≥ 250kcal/day from a milkshake style ONS for ≥ 4 weeks or current users of ONS
* Patients identified to require mildly thick (IDDSI level 2) fluids.
* Patients competent to provide written informed consent and able to answer questions
* Patients able to take study ONS orally

Exclusion Criteria:

* Patients that lack capacity to provide informed consent
* Patients that are unable to take study ONS orally
* Participants with chronic renal disease requiring dialysis
* Participants with liver failure
* Participants that are pregnant or lactating
* Participation in other studies that may interfere with this study
* Participants receiving 100% total nutritional requirements from tube feeding or parenteral nutrition
* Patients with galactosaemia or lactose intolerance
* Patients receiving palliative or end of life care
UNC Metastatic Cancer Radiation Therapy Registry

The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.


Eligibility Criteria:
Inclusion Criteria:

Written informed consent was obtained to participate in the study and HIPAA

Authorization for release of personal health information. Ability to understand and willingness to sign informed consent

Diagnosed with or is suspected to have metastatic cancer.

Age ≥ 18 years at the time of consent.

Evaluated to receive radiation therapy as part of their standard-of-care treatment plan.

Exclusion Criteria:

All participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

Any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent.
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2

The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Eligibility Criteria:
Inclusion Criteria:

* Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older.
* The study will include patients with and without a Hepatitis C diagnosis.
* Patients will be recruited at their routine office visits and/or during any admissions to the hospital.

Exclusion Criteria:

* Patients who do not speak and understand English.
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation

Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.

The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.

For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.

A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
* Informed Consent: Patient has signed a "Patient Informed Consent.
* Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
* Able and willing to follow instructions and complete follow-up
* Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)

Exclusion Criteria:

* Patient is skeletally immature
* Active Infection (including septic knee, distant infection, or osteomyelitis)
* Severe hip arthrosis
* Neurological disorders (including, but not limited to Parkinson's disease)
* Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
* Hip or knee ankylosis
* Either rheumatoid or post-traumatic knee arthritis
* Scheduled for simultaneous bilateral TKA
* Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
* Any metal within 150 mm of the joint line for the operative-side knee
* Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
* An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
* A female who is pregnant or lactating
* Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
* Arterial disease or stents that would exclude the use of a tourniquet