cyrilzakka/clinical-trials huggingface dataset:
Copperhead Envenomation Observational Study

The primary objective of the study is to evaluate the responsiveness and utility of several clinical outcome assessments in the setting of copperhead snakebite. The secondary objective is to characterize the clinical course of signs, symptoms and impairment during the recovery phase of copperhead snakebite.

This observational study will document the patient's recovery from copperhead snakebite. All care provided will be at the discretion of the treating physician in accordance with the local standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Envenomation by a copperhead snake
* Presentation for care at a health care facility within 24 hrs of envenomation
* Envenomation on an extremity distal to the knee or elbow
* Clinical evidence of venom effect (limb swelling and/or tenderness)
* Enrollment can be completed within 48 hrs of envenomation prior to discharge
* Patient is willing and able to complete follow-up schedule of assessments
* Patient is able to read, comprehend and sign IRB approved informed consent
* Patient is able to read and comprehend written assessment tools
* Patient is at least 18 yrs old
* Patient is sober, competent and able to complete verbal and written informed consent

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is a prisoner
* Patient has distracting injury, condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of status
* Patient has had previous snake envenomation to any body area within 30 days prior to screening/enrollment, regardless of whether antivenom was administered
* Patient had an acute traumatic or medical event, surgery, or exacerbation of pre-existing medical or surgical condition effecting the envenomated extremity within 30 days prior to screening/enrollment
* Patient has participated in a clinical study involving and investigational pharmaceutical product or device within 3 months prior to screening that may have impact on clinical outcomes of snakebite
* Patient has previously participated in this study
* Patient is, in the investigator's opinion, otherwise unsuitable for participation. Note: Treatment with antivenom prior to eligibility evaluation is not an exclusion criterion
Individual Blood Pressure Optimization Based on Cerebral Autoregulation After Implantation of Continuous-flow LVAD

This study will collect retrospective and prospective clinical data regarding the Principal Investigator's patient population to allow for data analysis seeking basic trends and to prepare academic reports, including journal manuscripts and presentations for scientific organizations.

Preoperative data will be collected as the baseline information through chart review and patient interview before the surgery as follows: patient demographics, co-morbidities, medication, preoperative laboratory results, and preoperative vital signs.

Intraoperative data will be collected by chart review or monitor review as follows: type of implant device, concomitant procedures, length of surgery, duration of cardiopulmonary bypass and aortic cross clamp, blood products administered hemodynamic variables, and NIRS signals.

Postoperative data will be collected by chart review or monitor review as follows: medications, blood products administered, postoperative laboratory results, adverse events and operative mortality\*, length of mechanical ventilation, length of inotrope administered, hemodynamic variables, length of intensive care unit and hospital stay, mortality, and NIRS signals.

Participants will receive routine standard institutional perioperative care that included invasive radial artery blood pressure monitoring. Participants will be connected to the NIRS monitor using sensor probes placed on the right and left sides of the forehead per routine clinical application. NIRS signal monitoring will be initiated before induction of general anesthesia in the operation room for collecting baseline data, and continued during LVAD implantation procedure. After implantation of LVAD, continuous NIRS monitoring will be carried out in the ICU until termination of the invasive arterial blood pressure monitoring.

For all participants enrolled in this study, all medical treatment which is provided will not deviate from the standard of clinical care, including surgery and other procedures as well as blood sample collection. The data will be reviewed routinely to seek trends. When needed to examine specific clinical issues, such as risk factors for a given complication, additional clinical data will be retrieved from the medical records. All data sets analyzed and used for presentations or publication will be anonymized to protect patient confidentiality. This study will be conducted indefinitely.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients greater than or equal to 18 years old undergoing continuous-flow left ventricular assist device implantation for the clinical indications of bridge to transplant or destination therapy.

Exclusion Criteria:

* Patients \< 18 years of age will be ineligible for this study.
Master Preceptor Fellowship Program: A Pilot Study

The Master Preceptor Fellowship Pilot Study is a prospective cohort study that is being conducted to measure changes in participant knowledge, teaching efficacy, leadership skills, job satisfaction and quality of life.

The Master Preceptor Fellows are physicians or physician assistants who have worked in primary care setting for a minimum of one year. The participants agree to participate in a 52-week (1-year) program designed to enhance the primary care physician's knowledge and skills via self-directed and didactic coursework along with a transformational community-based project. The culmination of the mentorship, leadership, and educational experiences gained in the Master Preceptor Fellowship (MPF) will allow the primary care physician champion to apply his or her innovative response to an identified need in their community.

Eligibility Criteria:
Inclusion Criteria:

* Have a medicine or physician assistant degree (MD/DO or PA)
* Be board certified or board eligible in family medicine, general internal medicine, or general -pediatrics; or be certified as a physician assistant
* Have a position in a community-based primary care site
* Have a record of practice in a primary care discipline field for at least two years
* Be at least 18 years of age

Exclusion Criteria:

* Unable to adequately speak and comprehend English
* Less than 18 years of age
Comparison of the Effects of Erector Spinae Area (ESP) Block and Thoracic Paravertebral Block (TPVB) on Acute Pain, Postoperative Persistent Pain and Neuropathic Pain in Video-Assisted Thoracoscopic Surgery

VATS is a minimally invasive approach that allows the introduction of a video camera and surgical instruments into the thoracic cavity through small incisions made in the chest wall. The first thoracoscopy was performed by Jacobeus in 1910, and a cystoscope was used in this procedure. Over the years, with the development of surgical techniques and technology, the procedures performed using VATS have diversified. Today, it is used for the diagnosis of pleural diseases and effusions, the staging of lung cancer, lung lobectomies, and the determination of parenchymal diseases.

Respiratory therapy and pain management after extubation are important issues in postoperative care. Adequate postoperative pain control is necessary for a good respiratory effort. The use of intravenous opioids has become the standard in pain management for years. Opioids administered to adequately control pain can cause sedation and respiratory depression. Due to the large number of opioid-related side effects, alternative pain relief methods are being sought. Erector spinae area (ESP) block and thoracic paravertebral block (TPVB) have recently been described for the treatment of pain after thoracic surgery. Although these blocks have been shown to be effective in the treatment of pain after thoracotomy when compared with systemically administered opioids, they have not been compared in terms of the quality of recovery and postoperative pain after minimally invasive thoracic surgery.

The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Thoracic Paravertebral Block (TPVB) on postoperative acute pain in patients scheduled for VATS surgery. The effects of the 2 blocks on postoperative chronic pain and neuropathic pain will also be compared.

Participants:

Their pain status will be recorded for 24 hours after spinal surgery When they come for a follow-up visit 3 months after surgery, 2 tests will be performed to check their pain status.


Eligibility Criteria:
Inclusion Criteria:

* Elective VATS surgery performed
* ASA I-III
* 18-75 years old

Exclusion Criteria:

* 1. Refusal at enrollment 2. Request for withdrawal from the study 3. Inability to give informed consent 4. Emergency surgery 5. Bleeding diathesis 6. Presence of contraindications to the LA agents used in this study 7. Use of chronic opioids 8. Psychiatric disorders 9. Presence of infection at the injection site
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis

This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.


Eligibility Criteria:
Inclusion Criteria:

* CKD participants undergoing dialysis
* Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
* Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Exclusion Criteria:

* Conditions known to cause inadequate response to ESA treatment
* Anemia other than symptomatic anemia associated with CKD
A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Primary Objective(s):

* To describe the demographic characteristics of people living with FOP
* To describe the prevalence of clinical characteristics of interest in people living with FOP
* To describe the use of key medications in people living with FOP
* To estimate the crude mortality rate among people with FOP


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed FOP diagnosis
2. Members from the International Fibrodysplasia Ossificans Progressiva Association (iFOPA) cohort who have opted-in to be tokenized by Health Verity Marketplace
3. Must be enrolled in the closed medical claims data source for any duration of time between January 1, 2018 and December 31, 2022

Exclusion Criteria:

1. Failure to meet inclusion criteria
Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA.

Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path

Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone
* Primary liver cancer: up to three liver nodules ≤ 3 cm
* Secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance Renal tumours: single or multiple (von Hippel Lindau syndrome), \< 4 cm

Exclusion Criteria:

* pregnant women
* non-manageable coagulopathies
* Extended extrahepatic or extrarenal disease
* for liver ablation: presence of bilio-digestive anastomosis
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients can be receive drug treatment within 24 hours after stroke onset
2. Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale
3. Patients with motor dysfunction of upper and/or lower extremities
4. Patients aged 20 years or older when giving informed consent

Exclusion Criteria:

1. Serum creatinine of \>1.5 mg/dL
2. Embolic infarction
3. Intracranial haemorrhage
4. Large infarction with severe consciousness
5. Transient ischemic attack (TIA)
6. A modified Rankin Scale score of ≥2 before stroke onset
7. Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset
8. Patients were receive surgical treatment or intravascular treatment
9. With severe complications (cirrhosis, heart failure, etc.)
10. Treating malignant tumor
11. Pregnant or possibly pregnant women, nursing mothers
12. History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity
13. Less than 3 months since any other clinical trial or postmarketing study
A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists

Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis


Eligibility Criteria:
Inclusion Criteria:

* Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
* At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)

Exclusion Criteria:

* At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)

  * During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).
Combining Virtual Reality and Hypnosis to Alleviate Chronic Pain in Elderly Patients with Hand Arthritis

The goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. The main questions it aims to answer are:

* Does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life?
* Does the intervention allow for an improvement of physiological variables related to pain? Researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual).

Participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in French
* Being diagnosed with hand arthrisis
* Reporting an invalidating chronic pain in hand related to the condition

Exclusion Criteria:

* Experiencing a medical condition altering the ability to consent or participate in the study
* Experiencing cognitive disorders; Experiencing sensory disorders (deafness, blindness)
Two Different Exercise Training in Frozen Shoulder Treatment

The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>60 years
* Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
* Patients with ability to follow simple orders; iii)
* Patients with ability to sign to provide informed consent

Exclusion Criteria:

* Normal passive ROM
* External ROM \< 30
* To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
* Pain \< 3 according to the numbered pain assessment scale
The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD

Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.


Eligibility Criteria:
Inclusion/exclusion criteria for Healthy Subjects

Inclusion criteria

* Male or female, age ≥ 50 years old
* Non-smoker

Exclusion criteria

* Presence of peripheral artery disease
* History of a heart attack or stroke
* Diabetes
* Active cancer
* Severe renal disease (CrCl \< 60)
* Severe liver disease
* Active rheumatological diseases

Inclusion/exclusion criteria for PAD Subjects

Inclusion criteria

* Male or female, age 50 years or older
* Atherosclerotic PAD, ABI ≤0.85
* Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
* For Aim 3, subjects will have Rutherford stage 4 or 5 disease
* For Aim 3, subjects will be undergoing revascularization as standard of care

Exclusion criteria

* Presence of a femoral, popliteal or tibial aneurysm of the index limb
* Life expectancy less than 2 years
* A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
* Renal dysfunction defined as MDRD eGFR ≤ 20ml/min/173 m2 at the time of screening
* Currently on dialysis or history of a renal transplant
* Cirrhosis or active hepatitis
* A documented hypercoagulable state
* Myocardial infarction within 6 months
* Stroke within 6 months
* Nonatherosclerotic occlusive disease of the lower extremity
* Any prior infrainguinal revascularization on index limb
* Current immunosuppressive medication, chemotherapy or radiation therapy
* Inability to have an MRI
* Exercise limitation aside from that due to PAD (i.e. COPD, degenerative joint disease, etc.)
* Women who are pregnant
* Women who are nursing
* Primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.
Knowledge Translation Intervention for ACL Injury Prevention Program in Youth Soccer

Anterior cruciate ligament (ACL) injuries of the knee are common in youth soccer players, and show an even higher prevalence in female soccer players. Clinical practice guidelines recommend ACL injury prevention programs (ACL-IPP) to reduce injury risk, yet implementation in amateur youth soccer is low, reducing actual real-world effectiveness. This trial is a pragmatic effectiveness trial for ACL injury prevention for amateur youth soccer players, using a knowledge translation intervention with the Knowledge-to-Action Framework.

ACL injury prevention programs (ACL-IPP) are exercise programs recommended by clinical practice guidelines that have been shown to reduce the risk of an ACL injury. However, implementation of these programs is low, which reduces the real-world effectiveness of these programs. This project will assess a knowledge translation intervention with youth soccer programs for implementation of ACL-IPPs utilizing the Knowledge-to-Action Framework. The main educational intervention will be a knowledge translation (KT) intervention between the researchers, and coaches/players of youth soccer programs within the state of Michigan. Specifics of the knowledge translation intervention will or may include focus groups, surveys, in-person training, video handouts, and paper handouts. This will be compared to coaches/teams that are offered a handout that describes an evidence-based ACL-IPP.

Eligibility Criteria:
Inclusion Criteria:

* Amateur youth soccer organizations within southern Michigan.

Exclusion Criteria:

* Players above the age of 19 or below the age of 14
* Teams that have dedicated medical staffing
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer

This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic axillary node clearance can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50


Eligibility Criteria:
Inclusion criteria:

Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)

Exclusion criteria:

Previous cancer history life expectancy \< 10 years Metastasis