cyrilzakka/clinical-trials huggingface dataset:
The VIBLOK SAfety and perFormancE Trial

Genital herpes has a high prevalence in industrialized as well as developing countries.

Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with possible serious consequences.

Medical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. Genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin.

VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin. Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over 80%.

The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults with HSV-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is male or female and at least 18 years of age
2. HSV-2 seropositive by the UW Western blot or Alegria assay
3. History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).
4. General good health at the discretion of the investigator.
5. Willing to not use any topical genital therapy aside from the study device for the duration of the trial.
6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.
7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.
8. Willing to keep a daily trial diary during the treatment period.
9. Negative pregnancy test for women at screening.
10. Willing to use contraceptives for the duration of the study.
11. Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.
12. Subject must be willing to give written informed consent.

Exclusion Criteria:

1. Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes
2. Treatment with systemic steroids or other immune-modulating agents
3. Participation in any investigational drug or device trial within 30 days prior to screening.
4. Pregnancy or breastfeeding, in case of women.
5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
Alberta Cancer Exercise Hybrid Effectiveness-Implementation Study

The primary purpose of this proposed 5-year hybrid effectiveness and implementation study is to evaluate the relative benefit from, and implementation of an Alberta wide clinic-to-community-based cancer and exercise model of care - the Alberta Cancer Exercise (ACE) Program. The investigators hypothesize that the strategy will improve the physical well-being and QoL of survivors (on and off cancer treatment) while preventing the development of secondary cancers.

A total of 2500 adult cancer survivors will be enrolled in the 5-year study. The investigators will build capacity by expanding ACE training and programming to sites beyond the large urban centers. The investigators plan for implementation in 7 Alberta YMCAs and/or City Recreation facilities within 3 years, as well as to formally establish partnerships within AHS to build further capacity across the province within existing AHS programming (e.g., CancerControl Rehab Services, Alberta Healthy Living Program and Primary Care Network). Virtual and supported home-based options will be available as an alternative.

Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming in their home or community. The exercise intervention will take place at the survivor's home, YMCAs and municipal fitness centres across the province. The supported home-based and community-based exercise program will be administered by exercise specialists who have undergone the ACE Cancer and Exercise: Training for Fitness Professionals course. Survivors will take part in a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for an 8-to-12-week period.

Effectiveness outcomes include physical fitness, physical activity, quality of life, and healthcare utilization. These outcomes are known factors associated with the secondary prevention of cancer. The RE-AIM framework will be used to evaluate program reach, effectiveness, adoption, implementation and maintenance. The Alberta Quality Matrix for Health will serve as a framework to inform program sustainability beyond the funding period. Through this research, the investigators will better understand the effectiveness of the ACE program, and evaluate processes to support future implementation and sustainability.

Eligibility Criteria:
Inclusion Criteria:

1. have a diagnosis of cancer;
2. be over the age of 18 years;
3. be able to participate in low-intensity levels of activity at minimum;
4. be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), or have received cancer treatment within the past 3 years; or have ongoing significant cancer or treatment-related impairments (requiring supportive exercise intervention);
5. be able to provide informed written consent in English.

Exclusion criteria:

1) Inability or deemed unsafe to participate in physical activity program

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A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water


Eligibility Criteria:
Inclusion Criteria:

* The informed consent must be signed before any study specific tests or procedures are done
* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Ethnicity: White
* Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²
* Confirmation of the subject's health insurance coverage prior to the first screening examination / visit
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
* States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
* Fasting blood glucose level outside normal range
* Impaired glucose tolerance in glucose tolerance test
Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study

The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models, featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in association with poor prognosis, but the biological and genetic factors that cause VTE are still obscure.

The Investigators propose to study whether in patients harboring a surgically resectable colorectal cancer the MET oncogene is expressed and may be associated with a blood thrombophilic condition that favors the onset of VTE.

These data would have two main implications: (i) for the first time, a direct genetic link between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii) the procoagulant alterations would have diagnostic/prognostic significance for the identification of patients at risk for poor outcome, and implementation of appropriate therapeutic protocols.


Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18;
* age \< or = 80;
* Clinical diagnosis of colorectal tumor by CT, MRI or endoscopy;
* surgically resectable tumor;

Exclusion Criteria:

* Inclusion in other clinical protocols requiring administration of anticoagulant drugs;
* Life expectancy \< 6 month;
* Clinical diagnosis of thrombophilic condition by laboratory analysis;
* Previously implanted Central Venous Catheter;
* Previous or concomitant second neoplasia;
* Clinical diagnosis of kidney, liver or heart failure;
* Inflammatory markers alteration associated with disease unrelated to neoplasia (infection, connective tissue disease etc);
* Severe hemostasis disorder;
First in Human Study of TORL-3-600 in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-3-600
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer requiring surgical intervention-elective

   a)Benign or Malignant
2. Inflammatory colorectal conditions requiring surgical intervention-elective

   1. Diverticulitis
   2. Ulcerative Colitis
   3. Crohn's Disease

Exclusion Criteria:

* Pregnancy
* Emergency procedures
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.

LINK (Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care is a 6-month pragmatic randomized controlled trial (pRCT) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. The four study arms are: 1) Mid-Ohio Farmacy (receiving weekly produce through a consortium of local food banks); 2) Mid-Ohio Farmacy + Cooking for Diabetes (Cooking for Diabetes is a 6-week diabetes and culinary education intervention); 3) Mid-Ohio Farmacy + Health Impact Ohio Pathways Hub (The Pathways Hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) Mid-Ohio Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub). Participants will be enter

Participants will be randomized using a 1:1:1:1 stratified randomization scheme built into Research Electronic Data Capture (REDCap) at the participant level.

Primary and secondary outcomes will be collected at baseline, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes based on American Diabetes Association Criteria
* Hemoglobin A1c ≥ 7.5%
* Screen Positive on 2-item Food Security Screener

Exclusion Criteria:

* Unwilling to Attest to Release of Information to Mid-Ohio Food Collective
Liver Safety Under Upfront Arimidex vs Tamoxifen

The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven HR+ invasive breast cancer
* Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
* Postmenopausal woman

Exclusion Criteria:

* clinical evidence of metastatic disease
* previous adjuvant hormonal therapy for breast cancer
* liver diseases
The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma

The purpose of this study is to determine the type and degree of inflammatory parameters in peripheral blood of asthma patients compared to analysis of induced sputum.

115 asthma patients visiting the outpatient clinic of the University Medical Center will be included. Blood samples are obtained and sputum induction is performed.

Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained from induced sputum

Asthma is a heterogeneous disease and can be classified by level of control, disease severity and the inflammatory phenotype. However, these different domains overlap and classification of patients according to these characteristics has caused confusion in the literature. Concerning the inflammatory phenotype international consensus is present regarding the diagnostic power of induced sputum. This methodology is, however, difficult to implement in general practice. Local inflammation is associated with a complex combination of systemic pro- and anti-inflammatory signals that induce changes in responsive leukocytes. These changes can be used as read-out for type and degree of inflammatory disease. Hypothesis: This will facilitate the diagnosis of inflammatory phenotypes in asthma, as general application of induced sputum is not feasible.

Goals

1. To investigate whether analysis of antibodies directed against active Beta-1 and Beta-2-integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the diagnosis of eosinophilic asthma as compared to analysis of sputum eosinophilia.
2. To evaluate the applicability of antibodies against active β1/β2-integrins and FcγRII in symptomatic asthma patients as a test to diagnose eosinophilic and neutrophilic asthma.
3. To determine specific protein profiles in serum of asthma patients by proteomics for the development of a diagnostic test.
4. To evaluate the effectiveness of this new test in comparison with FeNO.

Eligibility Criteria:
Inclusion Criteria:

* Adult asthma
* Aged 18-75 years
* Visiting the outpatient clinic of the UMCU

Exclusion Criteria:

* Smoking at present or in the last 12 months
* Past smoking history of \> 10 Pack years
* AB treatment for RTI in past 4 weeks
* ABPA
Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.

This is a randomized, double-blind, parallel-group, dose-escalation investigation. Participants ("children" defined as ages 3 - \< 12 years and "adolescents" defined as ages 12 - 17 years) will be randomized 2:1 to either methadone or short-acting opioid. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. The trial will include 2 periods in 3 parallel age groups. In the first period, each age cohort will recruit 66 patients (44 methadone, 22 control). Children will be randomized to methadone 0.15 mg/kg age-ideal body weight and adolescents to 0.2 mg/kg age-ideal body weight. When an age cohort reaches 66 patients, this is the end of the first period. At that time, an unblinded interim analysis will be conducted in that cohort to determine if dose escalation to 0.2 mg/kg dose in children and the 0.25 mg/kg dose in adolescents are met. Methadone dose escalation will be based on clinically meaningful differences in need for rescue opioid in the PACU and the absence of well-defined opioid adverse events. Outcomes data will be collected in hospital and after discharge. With daily surveys for 7 days, and 3 phone calls on day 30, 3 months and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 3 and \< 18 years
2. Elective tonsillectomy +/- adenoidectomy
3. Signed informed consent by parent or legal guardian
4. Children \>= 12 years must provide signed written consent, Children \>= 7 years must provide verbal assent
5. Negative pregnancy test within 48 hours for post pubescent females

Exclusion Criteria:

1. History of chronic kidney or liver disease
2. Current diagnosis of a chronic pain disorder
3. Severe sleep apnea: Apnea Hypopnea Index \> 10
4. Planned admission to the Pediatric Intensive Care Unit (PICU)
5. Additional procedures under general anesthesia for which opioids would be prescribed
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)

A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).


Eligibility Criteria:
INCLUSION CRITERIA:

1. Male or female between the ages of 21and 64 years, inclusive;
2. Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization;
3. Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
4. Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
5. Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
6. Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
7. Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.

EXCLUSION

1. History of Post-Traumatic Stress Disorder;
2. Concomitant Major Depressive Disorder or Bipolar Disorder;
3. Any abnormal pre-study laboratory values that require clinical intervention
4. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
5. Pregnant or breastfeeding
6. History of drug addiction, alcoholism, or drug abuse
7. Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
8. A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
9. Use of prescription and non-prescription sedative drugs;
10. Prior failure to respond to escitalopram therapy for anxiety
11. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
12. History of sleep apnea
13. History of myasthenia gravis
14. Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
15. Subject is currently participating in another clinical trial (or within 28 days of screening).