cyrilzakka/clinical-trials huggingface dataset:
The All Ireland Infectious Diseases Cohort Project

The All-Ireland Infectious Diseases (AIID) Cohort is a multicentre, prospective, longitudinal observational cohort that enrols consecutive adult subjects attending participating institutions for infectious disease services. This is an ongoing prospective observational cohort of unlimited duration.

The All-Ireland Infectious Diseases cohort study (AIID Cohort) is enrolling patients at a number of Irish Hospitals with infectious diseases, including Covid-19. The AIID Cohort is a multicentre, prospective, longitudinal, observational cohort that enrols consecutive adult subjects (\>18 years old) attending hospitals services for management of infections.

Subjects provide consent for use of routine clinical and laboratory data for research. All data is collected by a combination of retrospective medical note review and extraction of data from electronic health records. At a minimum, the following data items are to be collected at enrolment and subsequent clinic visits:

1. Demography and basic information (e.g. date of birth, gender, country of origin, ethnicity, anthropometric assessments, and reasons for the attendance, date or year for disease diagnosis and transmission risk.
2. Laboratory data: Relevant routine virological (including genotyping) and immunological data for characterisation of the HIV infection, TB, hepatitis C, COVID-19 and other relevant co-infections will also be collected as well as other relevant clinical routine data on tolerability and safety (i.e., renal, liver, lipids)
3. Medical treatment: All medications, including start-and stop dates and reason for discontinuation, adherence. Concomitant medical treatment related to co-infections and co-morbidities.
4. Clinical events: hospitalisation, diseases specific relevant active and previous diagnosis (e.g., AIDS and non-AIDS events, including comorbidities).

In addition, subjects are asked to provide biological samples for up to five occasions every six months for bio-banking for host profiling and pathogen bio-repository. To provide flexibility for participants around requirements for fasting or scheduling, participants may be asked to attend to provide samples for biobanking outside of routine scheduled clinic visits. These stored samples provide the opportunity for future research studies investigating host factors associated with the response to infection.

The AIID Cohort is approved by local institutional review boards and all participants provide written, informed consent. Data and samples within the AIID Cohort are accessed through standardised Data Access Guidelines and all approved Data Access Requests are approved by the local Ethics Committee.

Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years of age patients attending clinical services of participating institutions with issues related to infectious diseases.
* Willing and able to provide informed consent or
* Provide deferred assent if an incapacitated or unconscious patient is unable to provide informed consent

Exclusion criteria:

* Patients under 18 years of age
* Patients with learning disabilities, mental illness, or dementia
Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures

The participant will be trained to self administer the drug and will be supplied with a PENTHROX commercial inhaler kit .The study nurse will train the participant and supervise its use during the procedure.Immediately following the procedure the participant will be asked to fill out two brief questionnaires. The study nurse will assess the participant for adverse event and will follow-up with a phone call 24 hours later.

Many patients with chronic urological conditions require multiple and sometimes painful urological procedures. Ideally these procedures may be done in the cystoscopy suite without a general anesthetic. Low dose methoxyflurane, (MEOF)is a inhaled, self-administered non-opioid analgesic and has been approved by Health Canada's for the short-term relief of moderate to severe acute pain, associated with trauma or international medical procedures, in conscious adult patients. The brand name is PENTHROX.

This study is a single centre, pilot study to assess the feasibility of using a self-administrated, MEOF for pain relief during minor out-patient urological procedures. Eligible participants will receive a one time dose of the the study medication during a planned, outpatient urological procedure done under cystoscopy in the Cystoscopy clinic

Eligibility Criteria:
Inclusion Criteria:

1. Conscious adult patients \>=
2. Patient is scheduled for cystoscopy And:

   * BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity,
   * Diagnostic hydrodistention for painful bladder syndrome
   * Biopsy or cauterization of bladder tumors
   * Biopsy, cauterization and/or injection of Hunner's lesions
   * Visual urethrotomy/bladder neck incision=/- injection of stricture
   * Evaluation of the complex urinary tract problems
3. Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

1. An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
2. Clinically significant renal impairment
3. Women of child bearing potential who are pregnant or peri partum, including labour
4. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
5. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
7. Exacerbation of an underlying condition (i.e., chronic pain)
8. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
9. Clinically evident respiratory impairment as per the opinion of the investigator
10. Prior treatment with PENTHROX within 3 months
Tension Versus no Tension With Foley Bulb Induction

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
* Cephalic presentation
* Intact fetal membranes
* Bishop score less than or equal to 6
* Age greater than or equal to 18 years

Exclusion Criteria:

* Multiparas
* Multiple gestation
* Previous uterine/cervical surgery
* Ruptured fetal membranes
* Fetal malpresentation
* Any contraindication to vaginal delivery at time of admission
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients

Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and molecular techniques, which have limitations including low sensitivity and high cost.Highly sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to the School of Biological and Health Systems Engineering, Arizona State University, for detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations, including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass spectrometry (MS) assay will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 or above,
* Assessed by an Infectious Diseases physician to have clinical and/or radiological suspicion of pulmonary and/or extrapulmonary TB.

Exclusion Criteria:

* Refusal to consent from patients or next of kins for incompetent patients.
Protocol No. 2016 - Calculosis- Endourology;

Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.

Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.

These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.

Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.

All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.

Eligibility Criteria:
Inclusion Criteria:

* subjects suffering from kidney stones or tumors of the upper excretory tract \>= 18 years
* signature of informed consent

Exclusion Criteria:

* subjects \< 18 years
* presence of mental or physical disability that may prevent the patient from answering the questionnaires.
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects

Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects

The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).

Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.

After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.

Eligibility Criteria:
Inclusion Criteria:

1. 21 ≤ Age \<65 years
2. 20 \< BMI ≤ 40 kg/m2
3. Healthy subject
4. Subject is able and willing to give informed consent
5. Subject is able and willing to participate in the study and follow protocol procedures

Exclusion Criteria:

1. Significant swallowing disorders or difficulty swallowing
2. Suspected GI strictures, fistulas or other GI track obstructions
3. Crohn's disease or diverticulosis
4. Recent GI surgery
5. History of long-standing undigested food in the stomach
6. Known ulcer disease
7. Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder
8. Presence of a gastrostomy tube or gastric outlet obstruction
9. History or evidence of any active liver disease
10. Allergy to eggs
11. Treatment with anticholinergic or prokinetic agents
12. Treatment with proton-pump inhibitors
13. Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine)
14. Prediabetes or Diabetes
15. Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
16. Pregnancy or breastfeeding
17. Currently participating in an ongoing clinical study
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.

Amiodarone is very effective to treat cardiac arrhythmias but its use is limited by its toxicity, specially in chronic treatment. Accumulation of the drug in tissues is very probably the cause of the majority of amiodarone delayed adverse effects. However, this has not been proved because obtaining tissue samples is usually difficult and aggressive.

The investigators study, in patients following chronic treatment with amiodarone, if needle aspiration can provide samples of fat tissue useful to accurately determine amiodarone concentrations, how those concentrations in fat tissue correlate with cumulated dose, and how concentrations in fat tissue correlate with concentrations in blood, which is easier to obtain.

The investigators expect this knowledge will help to understand how amiodarone develops its adverse effects and possibly lead to new ways of monitoring treatment with this drug, or to adapt doses in chronic administration.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients taking amiodarone for more than 3 months (any dose, any indication)

Exclusion Criteria:

* Impossibility to perform needle aspiration of abdominal wall (local infection, skin disease)
* Coagulation disorders, INR \> 3.0 if warfarin treatment
* Patient unable to give informed consent
Non-Interventional Study to Capture the Patient Experience on Gene Therapy for Hemophilia Within the AskBio009-101 Study Through Patient and Investigator Interviews

The purpose of this study is to seek to understand the patient's perspective around deciding to participate in a clinical trial for a Hemophilia therapy


Eligibility Criteria:
Inclusion criteria for patients:

* Were screened and consented for the AskBio009-101study at any point in time
* Are able to speak and understand English
* Are between ages of 18 and 75
* Are physically able to participate in a one-hour phone interview
* Consented into this study independently of the AskBio009-101 study

Exclusion criteria for patients:

- N/A

Inclusion criteria for investigators and coordinators:

* Worked at a site as an investigator or study coordinator that consented a patient into the
* AskBio009-101 trial at any point in time, including those that no longer work at a AskBio009-101 site
* Are able to speak and understand English
* Are between ages of 18 and 75
* Are physically able to participate in a one-hour phone interview

Exclusion criteria for investigators and coordinators:

- Not directly involved in the consent process at the gene therapy site
Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least 5 years
* Candidate for islet cell transplantation based upon local accepted practice and guidelines
* Reduced awareness of hypoglycaemia

Exclusion Criteria:

* Treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start
* Any previous organ transplantation
* A history of acute idiopathic or chronic pancreatitis
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification

This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

This study is a phase 2 trial of GC1118, an EGFR monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent
2. 19 years or older
3. patients who experience recurrence following the standard therapy (CCRT, adjuvant temozolomide)
4. high EGFR amplification
5. available archive tumor sample(s)
6. Karnofsky performance status (KPS) \> 70
7. life expectancy \> 3 months
8. adequate end-organ function
9. patients who recovered from previous therapy (NCI CTCAE v4.03 Gr 1)

Exclusion Criteria:

1. patients who had EGFR target agent(s) before screening
2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (\> 2grade, NYHA), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease)
3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks
4. patients who had investigation drug(s) within previous 4 weeks
5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer)
6. patients who had severe infection within previous 4 weeks
7. HIV infection
8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks
9. clinically significant liver disease (active hepatitis B viral (HBV) or hepatitis C viral (HCV) infection, alcoholic liver disease etc)
10. pregnancy or breast-feeding
The Beat Pain Better Trial

The Beat Pain Better study examines strategies to increase the reach of evidence-based interventions for persons with osteoarthritis (OA) in communities that experience disparities. The study is a hybrid type 3 effectiveness-imple-mentation trial using sequential, multiple assignment, ran¬domi¬zation to evaluate 1) two text mes¬saging strat¬egies to reach persons with OA and enroll them in physical activity counseling provided by physical therapists; and 2) two strat¬egies to engage enrolled persons in the Walk with Ease (WWE) intervention for sustained self-management.

We will conduct a hybrid type 3 effectiveness-imple¬mentation trial with a sequential, multiple assignment, ran¬domi¬zed design. Primary outcome is physical activity (PA) counseling reach (Aim 1). Secondary outcomes evaluate reach of WWE (Aim 2) and outcomes across RE-AIM domains (Aim 3). Persons with ICD-10 diagnosis codes indicating OA will be identified from EHRs in partnering clinics and sent text message (TM) invitations to participate in PA counseling. Phase I randomization will test two TM strategies: weekly TMs over 4 weeks with or without motiva¬tional messages. Phase II randomization for those who enroll in PA counseling and provide consent will test two formats for the WWE AAEBI; self-directed or enhanced self-directed delivery.

Participants will be randomized with 1:1 distribution at each randomization. Participants may consent and enroll for randomization to a WWE format even if they did not receive the TM intervention. The first randomization is performed using the TM platform (Azara or similar), stratified by site. The second randomization is performed using the REDCap randomization module, also stratified by site and by baseline PA level. Randomization schemas will be developed before enrollment. Randomization errors will be recorded as protocol deviations.

Eligibility Criteria:
Inclusion Criteria:

1. Age 45 or older;
2. Visit in participating medical clinic within the past 6 months
3. OA diagnosis code related to lower extremity and/or spine on the problem list or associ¬ated with an encounter in the past 6 months
4. Has functioning cell phone able to receive calls and texts

Exclusion Criteria:

1. Unable to participate in a regular walking program defined as the ability to walk for at least five minutes with or without the use of an assistive device.
2. Medical contraindication to participation in physical activity
3. Unable to communicate in either Spanish or English
Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

The optimum segment of No-Touch veins for bypassing is still undefined. The purpose of this study is to assess the incidence of leg wound complication after No-Touch harvesting of proximal segment of saphenous veins compared to distal segment of veins in the leg. Graft occlusion rates between the two segments of veins for bypassing will also be compared during follow-up.

This is a prospective, single-center, open-label, randomized within-subject-controlled trial. We aim to randomize 100 patients undergoing isolated coronary artery bypass graft (CABG). We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. In each patient, one saphenous vein graft (SVG) will be randomized to be the proximal segment, while another will be the distal segment as control. Healing of leg wounds will be assessed on day 6 post-operatively. Follow-up will be performed via face-to-face interview until at least 1 year after the operation by CT angiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older who undergo primary isolated open-chest CABG with two vein grafts, one to the left coronary territory and the other to the right, with or without cardiopulmonary bypass

Exclusion Criteria:

* Concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
* Redo CABG
* Emergent CABG (cardiogenic shock, inotropic pressure support, IABP)
* Severe vein varicosity as assessed after vein harvesting and before randomization
* Use of vascular stapler for anastomosis
* Endarterectomy of coronary artery during surgery
* Left ventricular repair due to ventricular aneurysm
* Concomitant life-threatening disease likely to limit life expectancy to less than two years
* Severe renal insufficiency (i.e. creatinine \>200 μmol/L)
* Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
* Participant of other ongoing clinical trials
Association Between Light Spectrum and Survival After Cataract Surgery

This study was a retrospective observational cohort analysis of subjects aged 65 years and older, who underwent bilateral cataract surgery within a single (15 hospital) healthcare system, to determine the association between type (conventional or blue-light filtering) of implanted intraocular lens and survival.


Eligibility Criteria:
Inclusion Criteria:

* The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system. To be considered bilateral and concomitant, cataract surgery had to be performed on both the left and the right eye within a 365-day period.

Exclusion Criteria:

* We excluded patients undergoing unilateral cataract surgery, surgery to replace or repair a previously implanted IOL, or bilateral implantation with one Blue-IOL and one Natural-IOL (i.e., mixed IOL transmission properties).