cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks

Background: Sixty million American adults suffer from moderate to severe chronic pain. Of these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a large nonprofit health plan, developed and implemented opioid risk reduction strategies for doctors and patients in some, but not all, of its clinics. The risk reduction initiative achieved large opioid dose reductions, near universal documentation of care plans, and marked increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the opioid risk reduction initiative, incorporating patient perspectives, is needed to guide health care improvement efforts to reduce opioid risks regionally and nationally.

Research goal: The investigators will evaluate a major health plan initiative to reduce risks of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced prescribing of high opioid doses. In 2010 the same clinics increased care planning and monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects of this initiative on health and safety outcomes of COT patients. We will test whether the initiative influenced pain outcomes; patient-reported opioid benefits and problems; and opioid-related adverse events.

Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction initiative among COT patients using opioids long-term. The investigators will compare COT patients from clinics that implemented the initiative with COT patients from care settings that did not implement the initiative. The investigators will use survey data to assess patient-reported outcomes including pain severity, depressive symptoms, and patient perceptions of opioid benefits and problems, including validated measures of prescription opioid use disorder. They will interview and compare 800 COT patients using opioids long-term from clinics that implemented the risk reduction initiative and 800 COT patients from care settings that did not.

Impact: This research will provide an urgently needed, rigorous evaluation of a major risk reduction initiative among COT patients. Evaluation results will guide efforts of health plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic pain care.

Detailed description not provided

Eligibility Criteria:
Inclusion Criteria:

* Enrolled for at least one year prior to sampling for survey
* Received 70+ days supply of opioids in 2 of 4 quarters, including the most recent 90 days
* Received 45+ days supply of opioids in the other 2 quarters

Exclusion Criteria:

* Received cancer diagnoses, other than non-melanoma skin cancer, at least twice in the prior year
* Received any skilled nursing facility care in the prior year
* Received any hospice care or
* Received any opioids from an oncologist
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children

Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic \[hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)\], HIV-infected Ugandan children between the ages of 6 mos and 12 years.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of HIV (based JCRC clinic records);
2. On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
3. Age 6 months - 12 years at the time of screening
4. Hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)by CBC at time of screening

Exclusion Criteria:

1. Acute illness or current opportunistic infection
2. Temperature \>= 38.0°C at the time of screening
3. Known sickle cell disease
4. Acute malnutrition (bilateral pitting edema or extreme wasting)
5. Any chronic illness requiring regular medical attention
6. Residence \> 50 km from JCRC hospital
7. Non-English or Luganda speaking
8. Currently taking iron supplements
Risk Literacy Among Portuguese Medical and Dentistry Students

This study is an online survey to assess risk literacy among students of the medical and dentistry faculties in Portugal. Risk literacy is the capability to understand and interpret statistical information, based on simple rules of thumb.

The investigators assess the level of "medical risk literacy" among Portuguese medical and dentistry students with the Quick Risk Test (QRT) and the multiple choice version of the Berlin Numeracy Test (BNT).

This study is an online survey to assess risk literacy among students of the medical and dentistry faculties in Portugal.

The primary outcome is the measurement of "medical risk literacy" among Portuguese medical and dentistry students as assessed with the Quick Risk Test (QRT) and the multiple choice version of the Berlin Numeracy Test (BNT).

Secondary outcomes is to investigate whether study year, faculty, and prior statistical education have an impact on the level of risk literacy. Participants will be invited via email through established faculty mailing lists or established social media channels. For the survey, an online-survey tool (Unipark, academic program or Questback) will be used. Participation is voluntary and can be withdrawn at any time by aborting the survey (e.g. via closing the browser). Informed consent will be acquired at the beginning of the survey. English and Portuguese versions will be available to the participant.

As incentive to participate, participants completing the brief (ca.15 minutes) online-questionnaire will be granted a free subscriptions to the AMBOSS medical learning platform (2 weeks) and have the option to be entered into a lottery with the possibility of winning one of 3 free 6 month subscriptions.

After completion of the questionnaire, participants will be re-directed to a dedicated AMBOSS website where they can enter their email-address to take part in the lottery. This assures strict separation of the anonymous experimental data and the AMBOSS subscription data. Prior to initiation of the questionnaire, in the invitation email, participants will be provided the full participant information and made aware that, due to anonymity, it will not be possible to retrospectively delete their responses once the survey has been completed.

As the primary outcome is a baseline assessment and the secondary outcomes are exploratory analyses, no hypotheses will be tested in this survey.

Eligibility Criteria:
Inclusion Criteria:

* medical and dentistry students of Portuguese faculties
* active matriculation at a Portuguese faculty
* completion of the questionnaire

Exclusion Criteria:

* no active matriculation at a Portuguese faculty
Implantation of Olfactory Ensheathing Cells (OECs)

Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The Olfactory Ensheathing Cells (OECs) will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain.

(1)Recruited patients should receive the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Then, quality control of OECs should be done by immunohistochemical staining positive for GFAP, S100, and P75. Finally, the investigators will transplanted the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain. (2) Combination with traditional drug therapy (such as used the anti-thrombosis reagent or anti-platelet aggregation reagent). (3) NIH-stroke scale (NIHSS), European stroke scale (ESS), European stroke motor subscale (EMS), Barthel Index(BI) and MMSE will be performed for each patient to evaluate the therapeutic effect as the primary end points. (4) In addition, MRI(DTI) \& TMS(MEP) will be also checked for each recruitment patient as the secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* Aged 35-70 year old Chronic Stroke Adult Patients,
* With Stroke History of More Than 6 Months, Less Than 60 Months,
* With Stable Hemiplegia Condition,
* NIHSS Score Is Between 5\~15.

Exclusion Criteria:

* Patients Aged Less Than 35 or More Than 70,
* Hemorrhage Stroke or MRI Show The Occlusion Is Not In The Middle Cerebral Artery Territory,
* NIHSS Is Not In The Range of 5\~15,
* Pregnant Women,
* Impaired Liver Function, Abnormal Blood Coagulation, AIDS Carrier, Tumors, Other Special Conditions, etc.
Study Of Sunitinib With FOLFIRI In Colorectal Cancer

To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
* Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.

Exclusion Criteria:

* History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
* Current, recent, or planned participation in an experimental treatment drug study other than this protocol.
Bacterial Colonization of Suction Drains Following Spine Surgery

Closed suction drains are commonly used following surgery, if the wound is expected to discharge significant amounts of fluid. To this date, no evidence base exists as to the exact post operative time period or discharge volume necessitating presence of a drain. In orthopedic common practice, drains are removed on the second post operative day, fearing the drain will serve as a point of entry for nosocomial infection. In this study, drains will be left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of days following surgery. Daily cultures and antibiotic levels will be taken from the drains receptacle, to determine if and when the drains is colonized by aerobic bacteria.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study.

Exclusion Criteria:

* Known active infection in the spine or elsewhere.
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia

Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Patients seen in first trimester with low or high risk pregnancy

Exclusion Criteria:

* Pregnant patients first seen after the first trimester
* Unlikely to continue care in our system
* Unwilling to comply with rigor of taking food supplements throughout gestation
Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates

This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.

There is very little data on drug metabolism during pregnancy, and how it may differ from the non-pregnant woman. There is even less data on placental transfer of drug to the neonate when medications are given prior to delivery. This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.

The investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the profile of neonatal metabolism of the drug that crosses the placental barrier.

Eligibility Criteria:
Inclusion Criteria:

Adult participant:

* Age 18-45 years old
* Term pregnancy (37-42 weeks)
* Delivers by planned cesarean section, or unplanned, non-urgent cesarean section.
* Generally healthy
* Able and willing to sign informed consent

Neonatal participant:

* Male of female
* 37-42 weeks gestation

Exclusion Criteria:

* Adult:Medical condition that would effect metabolism of the study drugs
* Known allergy to either study medication
* Use of medications in the last 48 hours that might induce or inhibit metabolism of ondansetron (e.g. barbiturates, fluconazole, erythromycin, etc.)
Transfusing Neonates Based on Platelet Mass

Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed.

This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.

The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.

The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.


Eligibility Criteria:
Inclusion Criteria:

* Thrombocytopenic infants

Exclusion Criteria:

* Major congenital anomalies
Cognitive Exergame Training on Dual-Task Cost and Balance Stability in Older Adults

Balance stability requires both motor and cognitive (mental) functions working together. Balance stability may decrease when performing two tasks at the same time (dual task), as cognitive and motor tasks compete for performing a higher task. Meanwhile, social distance and remote working become a necessity due to Covid-19. The primary aim is to evaluate the feasibility of cognitive exergame training in reducing dual-task costs and improve the balance performance among individuals between 65 and 85 years. The secondary aim is to observe the effectiveness of virtual home exercise on adherence and interactive rate of the population between 65 and 85 years.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between 65-85 years
* Individuals with no sign of aphasia
* Individuals with a manual muscle test score of ≤5/5
* Individuals who can perform a full range of movement (ROM) against gravity
* Individuals who can stand for five minutes without the use of an assistive device

Exclusion Criteria:

* Individuals with a neurological condition (e.g. vestibular deficit, stroke, Parkinson's disease, epilepsy or peripheral neuropathy) o Individuals with a cardiovascular or musculoskeletal disorder
* Individuals with any lower limb injury or balance disorder within the last 12 months that has affected their physical activity
* Individuals with cognitive impairment such as dementia
* Individuals who score over 13 points on the Short FES-I
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.

This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).

Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.


Eligibility Criteria:
Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
2. Feasibility to undergo all procedures listed in protocol
3. Ability to provide written informed consent

Exclusion Criteria:

1. Prior diagnosis of prostate cancer
2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
3. Contraindication to prostate biopsy
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation

Hyperosmotic solutions of 1.5% and 3% NaCl are equally effective for brain relaxation and microcirculation during brain surgery. The effect of 1.5% NaCl on postoperative natremia and natriuresis is less pronounced.

All the patients meeting the study criteria will be randomized into two groups. After standardized induction to general anesthesia all patients will be given the infusion of hyperosmotic NaCl 5 ml/kg/BW during 30 min, group A 1.5% NaCl, group B 3% NaCl. Corticosteroids will be administered as usually. After dura opening the brain relaxation score will be assessed by surgeon (1 = completely relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain), and the first measurement of the brain microcirculation provided by use of SDF probe in the area of the healthy brain, and of perifocal oedema. Both sites of investigation will be marked for the second measurement, which will be done after the end of tumor resection. Laboratory examinations: natremia preoperatively, natremia and osmolarity peroperatively 1 hour after NaCl infusion and at the end of surgery. Concentration of natrium will be examined in CSF after dura opening. Anesthesia management will be according to the standardised protocol, the patients will be awaken and extubated after the end of the procedure at the operating theatre.

Eligibility Criteria:
Inclusion Criteria:

* peripheral supratentorial brain tumors or metastasis
* indication for osmotherapy
* ASA status I-III

Exclusion Criteria:

* reoperation
* osmotherapy prior to surgery
* preoperative natremia less than 135 mmol/l and more than 140 mmol/l
* GCS less than 14
* obstructive hydrocephalus
Reduction of Exit Site Infection in Peritoneal Dialysis Patients

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.

This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.

The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure.

Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.

This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.

The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).

Eligibility Criteria:
Inclusion Criteria:

* peritoneal dialysis patients capable to sign an informed consent or have an official guardian

Exclusion Criteria:

* patient's refusal
On-Premise and Remote Robotic Neurointervention

This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.

This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.

Eligibility Criteria:
Inclusion criteria

* The patient is ≥ 18 years of age
* The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention.
* The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria:

* Patients currently pregnant or breastfeeding.
* People with any of the following vascular history:
* Known congenital aortopathy, connective tissue disorder or vasculopathy
* Known arterial dissection of any kind
* Bleeding diathesis
* Use of Warfarin, IV Heparin, Clexane, Fondaparinux or any new oral anticoagulants (NOACs) or direct oral anticoagulants (DOACs)

People with any of the following medical history:

* Active malignancy
* Known contrast allergy
* Height \> 190cm