cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Cluster Trial of Resident Pay for Performance and Cardiovascular Outcomes

The purpose of this study is to determine if a pay for performance model in contrast to the traditional "fee for service" model may improve the number of patients discharged being treated in accordance with Joint Commission on Health Care JCAHO (a non-for profit organization that accredits health care organizations) standards and standard of care for management of hyperlipidemia

In this study the investigators will evaluate these two models by training resident physicians (doctors in training) on JCAHO core measures and specific criteria related to accepted standard of care for acute myocardial infarction and heart failure. The physicians will be randomized to a pay for performance or a fee for service model. Then a medical record review will be performed on patient records that received a discharge diagnosis of myocardial infarction or heart failure and were cared for by the physician subjects


Eligibility Criteria:
Inclusion Criteria:

* Physician inclusion: Resident physician on the Acute Cardiology Service, the Coronary Care Unit, or the General Medicine Service at the University of Virginia
* Patient inclusion: discharge diagnosis of heart failure or myocardial infarction.

Exclusion Criteria:

* Residents that are part of the study team
Comparing Driving Performance Among Trained and Untrained Drivers Using a Driving Simulator

The purpose of this study is to examine differences in driving performance on a simulated driving assessment between novice teen drivers who receive the Risk Anticipation-Perception Training (RAPT) program and novice teen drivers who do not receive the training program.

Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Driving simulators are a safer alternative to on-road assessments that are often affordable and can provide experimental control for research. Though driving simulators have advantages for evaluating driving performance in teens, there are gaps in the literature on the validity of a multidimensional outcome of driving performance in a simulator. To further examine the validity of a multidimensional measure of driving performance in a simulator, we compare simulated driving performance among teens who are trained hazard anticipation-perception training and those who are not.

Eligibility Criteria:
Inclusion Criteria:

* Holds a valid driver's license for less than or equal to 180 days
* 16 - 18 years of age

Exclusion Criteria:

* Self-reports claustrophobia, migraine headaches, and/or motion sickness
* Females who are pregnant
* Previously participated in another CHOP driving simulator study
* Non-English Speaking
Aflibercept or Bevacizumab as Second-line Treatment of RAS Mutated Metastatic Colorectal Cancer

Colorectal cancer is the third most frequent neoplasm after prostate and lung in man and breast and lung cancers in woman from Western Countries. The intensive study of predictive factors has strongly ameliorated the therapeutic flow-chart of metastatic colorectal cancer (mCRC) by allowing the selection of patients who benefit from specific therapies. In this context, the assessment of RAS (N- and K-) oncogene mutations is able to predict the response to anti-EGFR agents being mutated RAS mCRC patients resistant to these drugs. In this group of patients the use of anti-angiogenic drugs (bevacizumab and aflibercept) is predominant. Still to date there are no studies to guide oncologists in the selection of the best anti-angiogenic drug (bevacizumab beyond progression vs aflibercept) after failure of the first-line chemotherapy in RAS-M mCRC patients. The present is the first observational, pragmatic, prospective study aimed to report outcomes of mCRC patients treated with folfiri plus bevacizumab versus folfiri plus aflibercept in second-line treatment of mRAS mCRC. Furthermore, the serum levels of angiopoietin-1 (Ang-1), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A and C (VEGF-A and C), stromal cell-derived factor-1 (SDF-1), platelet-derived growth factor beta (PDGF-β), basic fibroblast growth factor (bFGF), interleukin-8 (IL-8), chemokine (C-C motif) ligand 2 (CCL2), and chemokine (C-C motif) ligand 5 (CCL5) and Placental Growth Factor (PlGF), will be evaluated before starting second-line chemotherapy with bevacizumab or aflibercept in order to evidence any pattern related to response and/or prognosis. The hypothesis is that knowledge of eventual unbalance of these factors could help to select the best anti-angiogenic drug in second-line treatment of mRAS mCRC patients.


Eligibility Criteria:
Inclusion Criteria:

* Cytological or histological diagnosis of RAS mutated mCRC;
* progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab;
* stage IV;
* age \<75 years;
* ECOG Performance Status 0 or 1;
* life expectancy\> 3 months;
* negative pregnancy test for all potentially childbearing women.

Exclusion Criteria:

* presence of primary non-treated stenosing colorectal neoplasm;
* active or uncontrolled infections or bleedings;
* other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation;
* presence of brain metastases;
* refusal or inability to provide informed consent;
* impossibility to guarantee follow-up.
Nutrition Supplementation in Cardiovascular Surgery Patients

This randomized controlled pilot study evaluates the use of oral nutritional supplementation in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is given for 30 days prior to surgery, continuing throughout their surgical hospitalization and ends at hospital discharge. Half of the participants will receive the oral nutritional supplement and the other half will not.

Cardiovascular surgery (CVS) is a resource intensive modality in the treatment of coronary artery disease and valvular heart disease. CVS patients who are malnourished experience increased duration of cardiopulmonary bypass, post-operative infections, impaired wound healing, muscle wasting, longer lengths of intensive care unit (ICU) and hospital stay, higher readmission rates, higher treatment costs and marked increases in mortality. Despite the devastating effects of malnutrition in these patients, physicians and health care practitioners are poor in respect to identification, monitoring and treatment of malnutrition.

In two large tertiary hospitals in Ontario, this will be a randomized trial of a novel nutritional pathway to rapidly identify at-risk CVS patients pre-operatively, and then provide oral nutritional supplementation (ONS) during the 30 days prior to surgery, then continue supplementation throughout hospitalization until discharge. Meaningful patient-centered and economic outcomes will be examined.

Eligibility Criteria:
Inclusion Criteria:

1. Require cardiovascular surgery
2. Have been assessed in a pre-operative clinic
3. Have an intermediate or high risk Society of Thoracic Surgeons (STS) score
4. Malnutrition Universal Screening Tool (MUST) score of \>1.

Exclusion Criteria:

1. Require urgent/emergent cardiovascular surgery
2. Have advanced symptomatic angina or heart failure
3. Are designated palliative care
4. Are currently suffering from refeeding syndrome
5. Have a pre-existing medical condition that prevents oral intake of full fluids
6. Are on a fluid restricted diet
7. Are unable to walk prior to current illness
8. Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
9. Are pregnant or currently breastfeeding.
Posterior Cervical Fixation Study

The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo posterior occipito-cervico-thoracic fixation surgery using one of the NuVasive posterior fixation systems (Vuepoint II OCT or Reline-C) based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 in each implant arm) will be enrolled and will be followed for 24 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent
2. Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions:

   1. traumatic spinal fractures and/or traumatic dislocations
   2. instability or deformity
   3. failed previous fusions (e.g., pseudoarthrosis)
   4. tumors involving the cervical spine
   5. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability
3. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):

   1. Vuepoint II OCT
   2. Reline-C
4. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
5. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested)
2. Use of bone growth stimulators postoperatively
3. Active smoking within 6 weeks of surgery
4. Patient has known sensitivity to materials implanted
5. Systemic or local infection (latent or active) or signs of local inflammation
6. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
7. Pregnant, or plans to become pregnant
8. Patient is a prisoner
9. Patient is participating in another clinical study that would confound study data
Economic Evaluation of Innovative Molecular Analyses in Onco-haematology

To evaluate the impact of innovative molecular diagnostics on the clinical management of patients with haematological malignancies via updated Appropriate-Prescribing-Guides including Next-Generation Sequencing (NGS) panels, facilitated therapeutic orientation, and optimised use of costly novel therapeutics and risk-adapted treatment. A micro-costing approach will be used to develop flat fee tarifs for NGS analyses.

The 12 somatic genetic cancer tests that have received temporary authorisation in France form the basis of this study. These tests are not yet in the national biology reimbursement nomenclature but are supported by the ministry of health in a temporary list "Le référentiel des actes innovants hors nomenclature de biologie et d'anatomocytopathologie" (RIHN).

The PRME RuBIH2 will focus on 5 clinical situations in onco-haematology:

1. Myelodysplasia (MDS)
2. Acute lymphocytic leukemia (T) (ALL)
3. Lymphoproliferative disorders (LPD)
4. Acute myeloblastic leukemia (AML)
5. Myeloproliferative disorders (MPD)

The project is organised in 4 complementary work packages (WP): WP1 Cost evaluation, WP2 Prescription Guidelines, WP3 Clinical Validation and WP4 Budget Impact and Organisation.

WP1 will provide costing information on molecular tests and will build on previous studies conducted in France.

WP2 will update existing prescription guidelines based on evidence from the literature and evidence from the WP3. These prescription guidelines will in turn be valued and provide recommendations for a flat fee bundle for pre-specified clinical situations.

WP3 will provide evidence on the clinical impact of molecular diagnosis (in particular NGS) in the 5 pre-specified conditions. Changes in patient management will be measured using a prospective questionnaire for an estimated 3960 molecular tests. The impact of the test on the patient clinical pathway will be analysed. The impact of molecular tests on patient outcome will not be measured.

WP4 will use information from WP1 and WP2 to estimate the budget impact and to provide scenario analyses on the territorial organisation of molecular biology platforms. Based on the estimation of the national activity of molecular onco-haematology platforms the annual functioning budget required to implement molecular diagnosis in France will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological malignancies referred for molecular diagnosis workup. RuBIH2 will focus on 5 clinical situations in onco-haematology:

  1. Myelodysplasia (MDS)
  2. Acute lymphocytic leukemia (T) (ALL)
  3. Lymphoproliferative disorders (LPD)
  4. Acute myeloblastic leukemia (AML)
  5. Myeloproliferative disorders (MPD)

Exclusion Criteria:

* Other haematological diseases not included in the list above.
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)

Main objective: Safety and tolerability of Antistax® film coated tablets

Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of chronic venous insufficiency


Eligibility Criteria:
Inclusion Criteria:

* Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
* Male or female out-patients of any ethnic origin
* Age ranging from 25 to 75 years

Exclusion Criteria:

* Known hypersensitivity to any ingredients of the study medication
* Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
* Florid venous ulcers
* Arterial occlusive disease, irrespective of the severity
* Phlebitis or thrombophlebitis
* Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.
* Evidence of diabetic micro-angiopathy or polyneuropathy in medical history
* Poor general health (based on the investigator's judgement)
* Addiction to alcohol abuse
* Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial
* Women of child-bearing age not using any reliable contraceptive methods
* Pregnant or lactating women
* Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days
* Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.
The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception

This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment.

Tinnitus refers to persistent "ringing in the ears" in absence of external sound. For some individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. Existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. Newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. While these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient.

Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). For tinnitus however this treatment modality has only been tested in isolation. The purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tDCS.

There is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing loss. Our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. In this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.This is consistent with the reported benefits of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-80 years of age
* No history of otological disease
* Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate

Exclusion Criteria:

* hearing loss greater than 50 dB HL
* Shows signs of depression or anxiety (Zung self-rating Depression Scale \> 50; Beck Anxiety Inventory \> 36)
Quadratus Lumborum Block for Post-Cesarean Analgesia

Most women having planned cesarean section receive spinal anesthetic for the procedure.

Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression.

The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section.

If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block.

We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.

This will be a randomized controlled double blinded trial.

Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study.

After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group).

Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture.

Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side.

All patients will receive routine postoperative analgesia, including analgesics and oral morphine.

All patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean delivery
* American Society of Anesthesiologists Physical Status 1-3
* Suitable for procedure to be carried out under spinal anesthesia

Exclusion Criteria:

* Inability to give informed consent or to co-operate with post-operative evaluation
* Allergy to local anesthetics, morphine, fentanyl, ropivacaine
* Ongoing major medical or psychiatric problems
* Chronic opioid use
* Major coagulopathy
* BMI\>35 on first ante natal visit
* Pre-eclampsia
* Contraindication to neuraxial anesthesia
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis

Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this. Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-45 years old
* Right upper extremity dominant
* No upper extremity limitation in activities of daily living
* Volunteer individuals

Exclusion Criteria:

* With orthopedic, neurological and rheumatological problems in the upper extremity
* Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation
* History of upper extremity injury or surgery in the last 6 months