cyrilzakka/clinical-trials huggingface dataset:
Pain, Inflammation, and Cannabis in HIV

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.

This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. We will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD product, and a low THC:high CBD product). Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* Diagnosis of HIV
* Fluency in English
* Active certification for medical cannabis
* No medical cannabis dispensed or used within the previous 30 days
* Intends to purchase soft-gel capsule medical cannabis at Vireo
* ICD-10 diagnosis code for neuropathic pain, OR
* Neuropathic pain in problem list of electronic medical record, OR
* Neuropathic pain questionnaire-short form\>0

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete 14 weeks of study visits
* Medical cannabis use within 30 days prior to enrollment
* Unique pain symptoms (e.g. multiple sclerosis, rheumatoid arthritis)
* Terminal illness
* Current or prior psychotic disorder
* Street cannabis, opioid, cocaine, or benzodiazepine use in the past 30 days
* Dispensed opioids of benzodiazepines within 60 days
* Non-steroidal anti-inflammatory use within 7 days prior to enrollment
* Steroid use within the past 14 days with duration of therapy \>=21 days
Comparing Concussion Education Types

The purpose of this study is to determine if there are differences in knowledge, self-efficacy, and empathy surrounding concussions, as well as intent to report a concussion, after viewing concussion education (CrashCourse and Brain Fly-Through) in 2D versus in 3D.

In this randomized study, all participants will receive two types of concussion education (CrashCourse and Brain Fly-Through). Participants will be randomized to the 2D or 3D (Virtual Reality) group, and will experience both concussion educations in that modality (either 2D or 3D).

In this randomized study, all participants will receive two types of concussion education (CrashCourse and Brain Fly-Through). Participants will be randomized to the 2D or 3D (Virtual Reality) group, and will experience both concussion educations in that modality (either 2D or 3D).

During their in person study visit, participants will complete a brief ( \~5 minute) pre-survey before viewing the CrashCourse and Brain Fly-Through concussion educations. Participants will then be asked to complete a brief ( \~2 minute) survey to assess their knowledge, self-efficacy, and empathy surrounding concussions.

Two months later, participants will receive a brief ( \~5 minute) follow-up survey via email, assessing the same constructs.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* health professions student (ex: Nursing, PT, OT, Pharmacy, Athletic Training) and/or a student-athlete at Concordia University (Ann Arbor or Mequon campus)

Exclusion Criteria:

- have previously viewed the TeachAids CrashCourse concussion education
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function

In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.


Eligibility Criteria:
Inclusion Criteria:

* Partially or fully edentulous jaw
* Written informed consent

Exclusion Criteria:

* Pregnant women/lactating women
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and sexual problems.

Eligibility Criteria:
Inclusion Criteria:

* Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
* Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
* Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
* Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)

Exclusion

* Implanted materials that prohibit magnetic imaging
* Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
* Areflexive or atonic bladder
* Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
* Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
* Unwilling to allow de-identified data to be stored for future use or shared with other researchers.
Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma

Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function.

We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.

Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.

Patients will be randomized and blinded to a treatment regimen.

Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.

To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.

Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.

Post injection activity: All patients will use crutches for 24-48 hours after injection. All patients will have physical therapy two times a week according to a standardized protocol.

Follow up at the clinic for all patients will be every 3 weeks from weeks 1-12. All patients will fill out an injury location specific questionnaire, Tegner Activity Scale, short form-12, and visual analog scale for pain, among others. Additional follow-up will be done at 6 months, 1 year and 2 years. All radiographic studies will be read by a radiologist blinded to the study groups.

The primary endpoint for all patients in the study will be twelve weeks. Secondary enpoints are 6 months, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

-Acute or chronic ligament or tendon injuries

Exclusion Criteria:

* Pregnant women,
* children,
* other injuries that require surgical intervention,
* associated fractures,
* systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues
PBC Induced Fatigue Treated With Thiamine

Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease characterised by destruction of the intrahepatic bile ducts leading to liver inflammation and fibrosis, and ultimately liver cirrhosis and end-stage liver disease. More than 50% of patients with PBC suffer from chronic fatigue, and approximately 20% suffer from severe fatigue with negative impact on their quality of life. Although fatigue is a large problem in patients with PBC, no effective treatments are available.

A Danish intervention study have shown that high dose oral thiamine (Vitamin B1) were effective in treating chronic fatigue in patients with inflammatory bowel disease. In this study, only few and minor adverse events to thiamine treatment were observed. Although the precise mechanism of work remains unknown, the investigators see no reason that this cannot be transferred topatients with PBC. Hence, the investigators aim to conduct a study investigating the use of oral thiamine in chronic fatigued patients with PBC.

The study will be conducted as a double-blinded, placebo-controlled, randomised, crossover trial including 36 patients with PBC and with a higher fatigue level than in the general population for more than six months. The patients will be randomised into one of two 3x4 weeks setups; 1) thiamine for four weeks followed by four weeks washout and finally four weeks of placebo or 2) placebo for four weeks followed by four weeks washout and finally four weeks of thiamine. The primary endpoint is to investigate the fatigue-level before and after treatment with thiamine and placebo using every patient as their own control. Fatigue-level will be measured using international validated questionnaires. The doses of thiamine are calculated based on the patient gender and weight. All patients will be included in the outpatient clinic at the Department of Hepatology and Gastroenterology at Aarhus University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* PBC for more than 3 months
* PBC-40 fatigue score \>32
* Fatigued for at least 6 months

Exclusion Criteria:

* Comorbidity that can explain fatigue
* Non-compliant patients
* Pregnancy
* Expected surgical interventions during the study period
* Chronic kidney disease (eGFR\<60)
Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applied

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied
Activity and Metformin Intervention in Obese Adolescents

The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.

Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.

This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Obese adolescents defined as BMI greater than the 95th percentile for age and gender
* Metformin naive subjects

Exclusion Criteria:

* Elevated fasting plasma glucose ≥ 6.0 mmol/L
* 2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
* A1C \> 6.0%
* Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
* Smoking
* Pregnancy
* Renal insufficiency (serum creatinine \> the upper limit of normal)
* Hepatic dysfunction (\> 1.5 times the upper limit of normal for AST and ALT)
* Latex Allergy
* Hypersensitivity to metformin or its ingredients
* Breast feeding
* Subjects with a history of lactic acidosis
* Abnormal creatinine clearance
* HIV, HBV, and HCV infections
* Drug and alcohol abuse
* Severe mental disorders
* Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials
* Participation in another clinical trial
* Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders
* Malignant diseases
* Previous exposure to any pharmaceutical antidiabetic agent
TICACOS International

The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections.

Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.

Study objectives

To evaluate the effect of tight caloric control in critical patients on:

* The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter related infections, Urinary tract infections)
* Mortality rates, length of stay in the ICU and in hospital, length of ventilation and incidence of non-infectious complications.

Primary endpoint:

Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.

Secondary endpoints

* Metabolic control: glucose concentration, insulin administration, rate of hypoglycemic events.
* Success of tight caloric control: accumulative and maximum negative energy balance.
* Organ function: SOFA score.
* Rate of non-infectious complications: requirement for surgery or occurrence of pressure sores.
* Length of ICU stay and of assisted ventilation (LOS and LOV)
* ICU survival rate.
* Patient status and disposition on day 28 or at hospital discharge.
* 3 \& 6 months survival.

Eligibility Criteria:
Inclusion Criteria:

1. Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
2. Age ≥ 18 years;no upper age limit.
3. Expected stay in ICU\> 3 days: \[SAPS II (18) \> ICU median or high-level of nursing care implemented or per clinical impression of attending physician\]
4. Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.

Exclusion Criteria:

1. Pregnancy.
2. DNR order.
3. Readmission in the ICU during the same hospitalization/transfer from other ICU.
4. Admission for postoperative monitoring.
5. Respiratory instability: SpO2 \<90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate \> 35/min)
6. Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration).
7. Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system.
8. FiO2 80% or patients requiring prone position
9. Chronic/acute liver failure:Child-Pugh class C
10. Brain injury for various reasons with Glasgow Coma Scale below 10.
11. Cardiac surgery patients.
12. Patients in the hospital for more than 7 days.
13. Contra indication to use enteral nutrition.
14. Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial.
15. Ethical issues that will influence subject eligibility.
EEG@HOME (Phase 3b of the Project, Interviews)

The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

Phase 3 of this Project will be divided into Phase 3a and Phase 3b.

In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.

Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.

The results of the interviews will be analysed by the design company pilipili nv.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy patient

Exclusion Criteria:

* No experience with EEG
Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

Surgical site infection (SSI) is the commonest hospital-acquired infection globally, and prevalence is much higher in the low-income countries. Caesarean delivery carries a 5-20 fold risk for developing postpartum sepsis. SSIs cause significant morbidity, prolonged hospitalization and mortality. Simple and inexpensive interventions like preoperative bathing need to be studied, to assess their impact on surgical site infection rates.

Caesarean delivery is the single-most important risk factor for postpartum pregnancy associated infections carrying a 5 to 20-fold increase in the risk of developing sepsis. Research done in MRRH showed a post-surgery wound sepsis prevalence of 82% on all surgical wards in the hospital and the prevalence of post caesarean section wound infection at MRRH is 15.5%. At MRRH, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization and mortality. SSI is associated with a mortality rate of 3%, and 75% of SSI associated deaths are directly attributable to the SSIs. Universal practices like preoperative bathing of patients are currently not being practiced at MRRH and thus their impact on reducing the burden can only be speculated upon. The aim of this study was to assess the impact of preoperative bathing with chloroxylenol antiseptic on the incidence of post caesarean section surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* All mother scheduled for delivery by emergency C/S at MRRH during the study period.

Exclusion Criteria:

* Women who declined to consent.
* Women with obvious evidence of infection, like fever, foul-smelling liquor, or those already on antibiotics for reasons other than preoperative prophylaxis.
* Women in whom delivery was indicated to occur within less than 30 minutes, like in fetal distress, obstructed labor, pulsatile cord prolapse, or ruptured uterus.
* Women who could not communicate and give information for the study and those who do not have a working telephone contact.
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

PRIMARY OBJECTIVES:

I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.

SECONDARY OBJECTIVES:

I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization.

IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms.

OUTLINE: Patients are randomized into 1 of 4 arms.

ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit.

ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit.

ARM D: Patients undergo usual care.

After completion of study, patients are followed up at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
* Prostate-specific antigen (PSA) \< 50 ng/mL
* Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
* Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
* Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures