cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)

Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.


Eligibility Criteria:
Inclusion criteria:

* Symptoms compatible with COVID-19
* Close exposure to a confirmed COVID-19 index case
* Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus with initial mild disease)

Exclusion criteria:

* known history of smell and taste disorders
* testing inability (cognitive impairment, non native French speakers, test malingering)
* testing contraindication (children, pregnancy, breastfeeding, specific allergies).
Talking Circle for Native American Youth

Native American youth have higher rates of depression and lifetime major depressive episodes, and, by age 11, are more likely to have initiated alcohol and substance use than any other racial/ethnic group. The COVID19 pandemic only compounded this suffering--anxiety, stress, depression, substance use, and suicide related mental health disorders skyrocketed in many Native American communities, especially among youth. Though many are desperate for help, treatment options are scarce to non-existent. To meet this urgent need, our overarching objective is to leverage the empirically proven, highly effective, school based, Talking Circle intervention to promote the mental, emotional, and behavioral (MEB) health of geographically diverse (rural, urban) Native American youth. This study, "Talking Circle for Native American Youth Living Well (A Yo Li)" uses a Community Based Participatory Research (CBPR) approach to evaluate Talking Circle effectiveness, partnering with the United Keetoowah Band (UKB) of Cherokee Indians Tribe in Oklahoma, with members living in two geographically diverse areas, Adair County (rural), and Tulsa City (urban). "A Yo Li" in the UKB tribal language means "youth".

Specific aims for Phase 1 (UG3) include:

UG3 Aim 1. To inform adaptation of the school-based Talking Circle intervention, a Community Partnership Committee (CPC) of UKB members will be developed to conduct a needs/asset mapping process to assess the needs, priorities, and resources for MEB health of UKB youth, paying special attention to the nuances of cultural difference between rural and urban UKB communities in Oklahoma.

UG3 Aim 2. To conduct a Talking Circle intervention Facilitator Training Program with rural and urban UKB tribal community members to catalyze capacity building and sustainability for future intervention.

UG3 Aim 3. To pilot the adapted evidenced-based Talking Circle intervention for the promotion of MEB health among (N=20) 10 to 12 year-olds UKB youth in Oklahoma.

Eligibility Criteria:
Inclusion Criteria:

* Native American students
* English speakers
* Read and write English
* At risk for mental health and behavioral health issues

Exclusion Criteria:

* Not Native American
* Non-English speakers
* Not able to read and write English
* Not at risk for mental health or behavioral health issues
A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)

A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.

Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein grafts (SVGs)

Exclusion Criteria:

* Patient has in-situ Internal Mammary Artery graft(s) (IMA) only, (no SVG or free arterial grafts)
* Patients has had prior CABG or planned concomitant valve surgery or aortic aneurysm repair.
Functional Recovery and Caregiver Burden Following Surgery in the Elderly

The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.

The primary objective of this study is to:

1. Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.

   Secondary objectives are to determine if:
2. Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.
3. Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
4. Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).


Eligibility Criteria:
Inclusion Criteria:

Patients

* aged 65 years and older
* elective surgery with a planned discharge to the community on the day of the surgical procedure.
* Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy.

Caregiver

- spouses, family members, or friends identified as the patient's primary source of support in the community.

Exclusion Criteria:

Patients

* Reside in a nursing home providing professional support services;
* Are unable to complete the study instruments due to cognitive (MMSE \<24) or physical impairment;
* Are unable to speak English or French

Caregiver

* Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient;
* Unable to complete the study instruments due to physical impairment;
* Unable to Speak English or French
Endoscopy for Assessment of Mucosal Healing in IBD

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).

The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* Proctocolectomy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood

The main objective of this trial is to investigate the effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m\^2) (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Relevant chronic or acute infections

Further exclusion criteria may apply.
Walk With a Doc: Enhanced Recovery Walking Program for Surgical Inpatients and Wellness Program for Surgical Residents

Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.

Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Patients receive a pedometer while inpatient to measure their daily steps, which is recorded in the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

* Post-operative surgical patient with an over 24 hour post-operative stay in the hospital
* Safe to ambulate with/without assistance

Exclusion Criteria:

* Unable to ambulate
* Bedbound
Antibiotic Irrigations for Intra-Abdominal Drains

Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.

People with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. Outcomes of interest are duration of systemic antibiotics, and WBC and temperature curve.

Eligibility Criteria:
Inclusion Criteria:

* Intra-abdominal abscess drained with catheter/drain
* Treatment with systemic antibiotics
* Able to consent

Exclusion Criteria:

* Abscess(es) not amendable for an image guided drain placement.
Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia

A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.

Eligibility Criteria:
Inclusion Criteria:

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion Criteria:

* patients under 18 years
* pregnant women
Long- Term Follow-up of Extraction Socket Management

Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Good general health (ASA 1, 2)
* Controlled periodontitis
* \>18 years of age or signed consent by the parents
* Smoking history of\<10 cigarettes per day
* Signed informed consent.

Exclusion Criteria:

* Pregnancy or lactation
* Concurrent participation in another trial
* Bone disease or the use of medications that interfered with bone metabolism
* History of head and neck radio- therapy
* Presence of dehiscence or fenestration on bone wall of the socket.
OCS Liver Perfusion (OLP) Post-Approval Registry

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Eligibility Criteria:
Inclusion Criteria:

* Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System

Donor Exclusion Criteria:

* Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or
* Split donor liver; or
* DCD donor liver with \>30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or
* DCD donors age \>55 years; or
* DCD donor liver with macrosteatosis of \>15%
* Living donors
* Donors with positive serology for HIV, Hep B and C
* Donors with macrosteatosis of ≥40%

Recipient Exclusion Criteria:

* Fulminant liver failure; or
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* Chronic renal dialysis at time of transplant; or
* Dependency on more than 1 inotropic agent to maintain hemodynamics; or
* Ventilator dependent at time of transplant.
Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease

Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.


Eligibility Criteria:
Inclusion Criteria:

* Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
* Adult non-Parkinsonian patients undergoing intracranial surgery

Exclusion Criteria:

* ASA score higher than Class II
* predicted difficult airway
* alcohol or drug abuser
* informed consent was not provided
Human Prostate Tissue Model to Maintain and Study Prostate Cancer Stem Cells

This pilot research trial studies the use of a human prostate tissue model to maintain and study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was removed during surgery from patients with non-cancerous enlargement of the prostate (benign prostatic hyperplasia) and may create an environment similar to the natural environment of the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real tissue to create an environment to study stem cells may help doctors learn more about how they work and how they respond to treatments.

PRIMARY OBJECTIVES:

I. To optimize a decellularized prostate tissue model for the maintenance of prostate cancer stem cells.

SECONDARY OBJECTIVES:

I. To investigate the self-renewal and differentiation ability of human prostate cancer stem cells (CSCs) (tumor-associated calcium signal transducer 2 \[TROP2\]+ cells) in the above mentioned decellularized prostate tissue model.

II. To compare the number of CSCs according to key patient characteristics, including race, age, Gleason, metastasis status, and previous cancer treatment(s).

OUTLINE:

Tissue samples are collected from patients with benign prostatic hyperplasia for decellularization and preparation as human extracellular matrix for growing human prostate CSCs. Tissue samples are also collected from patients with prostate cancer for the analysis of TROP2+ cells by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Male patients scheduled for a prostatectomy
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs
Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients

The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.

Two postoperative transfusion strategies:

1. Liberal - transfused when Hgb is \<100g/L
2. Restrictive - transfused when Hgb is \<70g/L


Eligibility Criteria:
Inclusion Criteria:

* Patients \>=70 years of age undergoing non-emergency coronary artery bypass surgery
* Initial postoperative hemoglobin level 70-90g/L

Exclusion Criteria:

* Patients who are unable to provide informed consent in English
* Patients with preoperative hemoglobin concentrations \<100g/L
* Patients who require emergency re-operation
* Patients with intraoperative or postoperative bleeding diathesis
* Patients with postoperative clinical instability (eg. low output state)
* Patients in whom insertion of an intra-aortic balloon pump is required
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitizone added onto their blinded study medication

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
* HbA1c \>= 7.0% and \<= 10.0 %
* Body mass index \<= 40 kg/m2
* Fasting C-peptide \>= 1 ng/dL

Exclusion Criteria:

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for females
Post Facilitation Stretch Versus Active Isolated Stretching Along With Deep Friction Massage in Wallet Sciatica.

To compare the effects of post facilitation stretch and active isolated stretch along with deep friction massage on pain pressure threshold of trigger points, disability, muscle length, and hip joint range of motion in wallet sciatica.

Literature shows the effectiveness of both techniques post facilitation stretch and active isolated stretch but didn't report any comparison. In this study, investigator diagnosed the patients with wallet sciatica who came with the complaint of low back pain. Both techniques were compared to determine the effectiveness in patients with wallet sciatica having trigger points.

Eligibility Criteria:
Inclusion Criteria:

* Pain (Grade greater than 3)
* Chronic pain (greater than 3 months) buttock pain.
* Patients with piriformis tightness less than 40 degrees.
* Patients with active trigger points of the piriformis.

Exclusion Criteria:

* Patient with tumor
* Patients with cognitive problems.
* Recent or history of hip trauma or injury.
* Recent abdominal surgery.
* Any other orthopedic or neurological condition of hip and lumbar spine