cyrilzakka/clinical-trials huggingface dataset:
the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain

1. To establish doctor-nurse-patient cooperative analgesic linkage program.
2. Evaluate the effect of doctor-nurse-patient cooperative analgesic linkage program on movement evoked pain after laparotomy for patients with hepatobiliary and pancreatic disease through quasi-experimental study.

Part I The establishment of doctor-nurse-patient cooperative analgesic linkage program

1. Based on literature review and clinical investigation results, initially make a doctor-nurse-patient cooperative analgesic linkage program through discussion in experts consensus meeting.
2. Using Delphi method, determine the doctor-nurse-patient cooperative analgesic linkage program after two rounds consultation.

Part II Clinical application study of doctor-nurse-patient cooperative analgesic linkage program.

Conduct non-randomized control study in corresponding period. 80 patients from two wards which managed by the same medical and nursing team were divided into experimental and control group. Patients in the control group were received routine post-operative analgesia pump and analgesics, and functional rehabilitation, while ones in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program. Evaluate the effect of pain control during rehabilitation, adverse events during rehabilitation, patients' satisfaction of pain control.

Eligibility Criteria:
Inclusion Criteria:

* Consent to the study.
* Normal cognitive ability and speak Chinese
* Patients received selective laparotomy under general anesthesia.
* Length of stay is longer than three days.
* Patients who are allowed to do rehabilitation.

Exclusion Criteria:

* Patients with Severe organic disease, chronic pain, history of brain injury, history of drug or alcohol addiction.
* Psychiatric patients
* Consciousness disorder
* Patients contradict to opioid medications
Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities

The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.


Eligibility Criteria:
Inclusion Criteria:

* Any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromats, car service provider \[e.g. gas station, mechanic, car wash\]) in predominantly Black communities in Miami where HIV prevalence is high.
* Pre- and Post-assessment: Individuals are only eligible to complete the survey one time during the Pre-Intervention and during the Post-Intervention phases.
* Intervention: Individuals are only eligible to participate in the Intervention phase of this study once every 6 months.

Exclusion Criteria:

* Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures.
* Individuals who have previously completed the survey during the Pre-Intervention and Post-Intervention phases.
* Individuals who have participated in the Intervention phase of this study within less than 6 months.
Hydrocortisone for Prevention of Septic Shock

Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis according to ACCP/CCM criteria
* Onset of severe sepsis \< 48 hours
* Informed consent
* Effective contraception in fertile women

Exclusion Criteria:

* Septic shock
* Known hypersensitivity to hydrocortisone and additives
* Glucocorticoid history which warrants continuation of glucocorticoid administration
* Other indication for systemic glucocorticoid therapy
* DNR-order
* Moribund patient
* Pregnancy
* Breast feeding women
* Age \< 18 years
* Other interventional study
* Relationship to investigator
Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.

Participants with historical diagnosis of CD and UC who were naïve to anti-TNF therapy were observed in this retrospective study. The study will look to identify the local barriers in prescribing anti-TNF therapy, treatment patterns and indicators of sub-optimal response to anti-TNF therapy in UC and CD participants in real-world clinical practice in the EM countries, along with the associated incidence of sub-optimal response and impact on health care resource utilization (HCRU). The will enroll approximately 2000 participants.

The study consists of two periods, eligibility period followed by a data abstraction period. During the eligibility period participants who had initiated first anti-TNF therapy during 01 March 2010 up to 01 March 2015 will be recruited and observed. Participants will be followed up for a period of minimum 2 years (other than death) and a maximum of 5 years from the date of first treatment of anti-TNF therapy for CD and UC (Index date). During the data abstraction period participants who have eligible medical charts will be identified and all retrospective data will be collected.

This multi-center trial will be conducted in Argentina, China, Colombia, Mexico, Russia, Saudi Arabia, Singapore, South Korea, Taiwan and Turkey. The overall time to abstract data during the data extraction period from the web-based electronic data capture (EDC) system will be approximately 1 year from March 2017 to February 2018.

Eligibility Criteria:
Inclusion Criteria:

1. Who are 18 years or older at Index Date and diagnosed with UC or CD.
2. Who were naive to anti-TNF therapy and received their first dose of any anti-TNF therapy (index date) for UC or CD within the Eligibility Period from 01 March 2010 through 01 March 2015.

Exclusion Criteria:

1. Diagnosed with indeterminate/unspecified type of IBD.
2. Were part of an IBD-related clinical trial during the observational period should be excluded (that is, index date up to the date of chart abstraction).
3. Who received an anti-TNF therapy for any non-UC or non-CD conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer).
4. Who received an anti-TNF/biologic therapy at any point that was administered outside of the labelled dosing regimen (example, episodic use of anti-TNF therapy).
5. With UC who had a total colectomy prior to their first anti-TNF therapy.
6. Charts not available.
Supporting the Wellness of Ontario Physicians During COVID-19

In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency. Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19. There are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied. The evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms. Researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Active membership to the Ontario Medical Association (OMA). Up-to-date cell phone information registered to the OMA.

Exclusion Criteria:

* Participation in the OMA Physician Burnout Task Force. Opt-out from the intervention.
Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.

The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and treatment options are limited. Fructose overconsumption has been associated with gut permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis of intestinal biopsies. Findings in volunteers will be compared with liver patients undergoing study procedures without fructose challenge. Translational in vitro experiments will explore cellular responses to fructose and endotoxin. This project should provide novel insights into dietary induced alterations of the gut integrity in progression of NAFLD to NASH.


Eligibility Criteria:
1. Healthy men and women from 18 to 85, no disease history, no intake of regular medication.
2. Patients with confirmed (at least one imaging positive) intrahepatic fat accumulation (NAFL), male and female
3. Patients with confirmed NASH (biopsy within 6 months prior to study), male and female
4. Diagnosed HCV, genotype 1, male and female

Signed informed consent

General exclusion criteria (for all groups)

1. Pregnancy and lactation
2. Imprisoned persons
3. Inflammatory bowel conditions (celiac disease, Crohn's disease, ulcerative colitis)
4. Prior bariatric surgery
5. Alcoholic steatohepatitis and/or alcohol consumption \> 140 gramms per week (or \> 30g/day)
6. Other liver diseases (autoimmune, genetic, cholestatic, Wilson disease, Weber-Christian disease, partial lipodystrophy of the face sparing type, abetalipoproteinemia, and jejunal diverticulosis with bacterial overgrowth.)
7. Virus hepatitis (A, B, C) (except for group (4): defined as HCV, genotype 1)
8. Known allergic reaction to the drugs used (see material and methods)
9. Intake of drugs known to accumulate intrahepatic lipids (e.g. steroids/glucocorticoids, tamoxifen, amiodarone, perhexiline maleate, synthetic estrogens, antiretroviral agents, tetracycline, minocycline, certain pesticides, methotrexate)
10. Intake of drugs known to drive fibrosis/cirrhosis (e.g. azathioprine, oral contraceptive pills)
11. Inability or contraindications to perform study procedures
12. General and absolute endoscopy contraindications
Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer

The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Women who have Her-2 positive and ER- negative or ER-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study.
* Participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy.
* Participants may not have had a BRCA mutation found on genetic testing.
* Participants should have not yet received treatment for their breast cancer, including:

  * chemotherapy,
  * hormonal therapy,
  * trastuzumab.
Comaprison Between QLB and ESPB in Patients for PCNL Operation

comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.

Here the investigators are going to compare between the Anterior approach for the subcostal oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Percutaneous Nephrolithotomy surgery. We hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Age: 18-60
* ASA (American Society of Anesthesiologists) class I and II
* Elective surgery
* Patients undergoing PNL surgery

Exclusion Criteria:

* Patient's refusal
* Allergy or contraindications to drugs used in the study
* Emergency surgery
* Psychiatric disorders
* Severely co-morbid patients
* Inflammation or infection over injection site
* Bleeding diathesis; INR more than 1.5 and Platelet count less than 100,000/mm3
* Peripheral neuropathy
* Obese patients BMI ≥35
* Patients on previous opioid therapy
* Pre-operative haemoglobin \<10 mg/dl
* Inability to properly describe postoperative pain to investigators
* Coagulation abnormalities
* History of drug addiction or alcohol abuse
* History of Previous renal surgery
Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

* The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
* Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
* Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.


Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand and provide written Informed Consent;
2. Healthy adult, male or female, 18 years of age or older with skin type I-IV;
3. Having a suitable treatment area for hair removal;
4. Able and willing to comply with the treatment/follow-up schedule and requirements;
5. Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.

Exclusion Criteria:

1. Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months);
2. Hormonal disorders that may affect hair growth;
3. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
4. Livedo reticularis;
5. Uncontrolled systemic diseases such as diabetes;
6. Active infections in the treated area;
7. Dysplastic nevi;
8. Significant concurrent skin conditions or any inflammatory skin conditions;
9. Active cold sores, open lacerations or abrasions;
10. Chronic or cutaneous viral, fungal, or bacterial diseases;
11. Current cancer;
12. History of skin cancer or pre-cancerous lesions at the treatment areas;
13. Use of Accutane™ (Isotretinoin) within the past six month;
14. Keloid formation in the treatment area;
15. Tattoos in the treatment area;
16. Bleeding coagulopathies or use of anticoagulants;
17. Auto-immune disorders;
18. Erythema ab igne, when identified treatments should be discontinued;
19. Photosensitivity disorder that can be exacerbated by laser or intense light;
20. Herpes simplex in the treatment area;
21. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
22. Poor wound healing;
23. Sunburns;
24. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;
25. Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.
Bone Mass and Strength After Kidney Transplantation

The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18
* Self-describes as White race

Exclusion Criteria:

* Lower extremity amputations
* Non-ambulatory
* Paget´s disease of bone
* Current hyperthyroidism, untreated hypothyroidism
* Medical diseases (end stage liver, intestinal malabsorption)
* Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
* Weight \>300 pounds
* Dual organ transplant
* Myocardial infarction or stroke
* Tobacco use within the past year
Understanding Immunity Persistence After Adolescent MenC Vaccination

The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed clinical study M14P2E1
* Participant who are willing to participate and who would be expected to comply with the requirements of the protocol
* Participants who have given informed consent for participation in the study

Exclusion Criteria:

* History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)
* Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
* Severe blood clotting disorders
Natural History Study of Patients With VCP-related Disease

A natural history study to understand the expected progression of disease in patients with confirmed mutations in the VCP gene over 1 year.

This is a single site, prospective natural history study to evaluate the utility of strength, functional, and patient reported outcomes in quantifying disease progression over 1 year in patients with mutations in the VCP gene.

Patients will complete a remote and onsite visits at baseline, a remote visit at 6 months, and then a final remote and onsite visit at 12 months. All strength, functional, and patient reported measures will be completed at each visit to assess reliability, consistency of results across testing environments, and sensitivity to change over time.

Additionally, patients may opt in to provide blood, serum, and urine samples for biobanking.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed mutation in the VCP gene
* Age ≥18 years
* Willing and able to provide informed consent and follow all study procedures

Exclusion Criteria:

* Participation in an interventional clinical trial
* Any concomitant illness or comorbid condition that would interfere with a patient's ability to complete study procedures safely at the discretion of the site PI.
Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.

The investigators are conducting this research study to find better ways of treating pain following knee surgery like the one the participant will be having. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control. This type of nerve block is commonly used to treat other knee pains, like that associated with arthritis, after knee replacements, and after repairs of the knee ligaments; however, it is considered experimental in your case, as its effects (good or bad) are unknown in the type of knee surgery the participant are undergoing.

The investigators plan is to decide at random, like the flip of a coin, whether to give numbing medication (0.25% bupivacaine) around the incision like the investigators normally would or give it instead to block the pain sensors around the knee. The participant would get medication either at the incision (shin) or the knee, depending on which arm the participant are in (research). The participant will also be given pain medication pills by your surgeon as part of the participant normal postoperative care (not research).

Eligibility Criteria:
Inclusion Criteria:

• Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture

Exclusion Criteria:

* Subjects younger than 18
* Polytraumatized Subjects
* Subjects with pathologic fractures
* Subjects with tibial plateau fractures treated nonoperatively
* Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
* Subjects with open fractures
* Subjects with fracture-dislocations
* Subjects with active or history of anxiety
* Subjects with visual analog scale anxiety score ≥ 7 measured preoperatively
* Subjects with chronic pain syndromes
* Subjects with chronic opioid use
* Subjects with illicit drug use disorder
* Subjects with alcohol abuse disorder
* Subjects with kidney disease precluding use of ketorolac
* Subjects with liver disease precluding the use of acetaminophen
* Subjects with allergy to acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opiates or local anesthesia
* Subjects with inability to provide a visual analog scale score postoperatively
* Subjects with contraindications to receiving peripheral nerve blocks, including relevant neurologic deficits, active infection at sites of injections - re-operation at the same site