cyrilzakka/clinical-trials huggingface dataset:
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants

Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.

PRIMARY OBJECTIVES:

I. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose.

SECONDARY OBJECTIVES:

I. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose.

II. To assess safety and reactogenicity to each vaccine dose.

OUTLINE:

Participants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline (priming injection) and at 24 and 30 months (booster injections).

After completion of study, participants are followed up for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, medically well girls and boys
* Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
* Ability to understand and the willingness to sign a written assent document by the participant

Exclusion Criteria:

* Previous vaccination against HPV
* The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
* Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
* Receiving active treatment for cancer or an autoimmune condition
* Confirmed or suspected immunosuppressive or immunodeficient condition
* Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
* History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy
* Are pregnant
Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation.
* Patient who agreed to participate in the study.

Exclusion Criteria:

* Patient under the age of 18.
SMBG Protocols Predicting Glucose Levels in Senior Diabetes Mellitus With CAD

Self-monitoring of blood glucose (SMBG) is a common way to assess glycemic control in diabetes management. Multiple times of blood glucose measurements by fingerstick in the same day are of tough challenge to it. The changes and variations of glucose excursion in senior diabetics with Coronary Artery Disease (CAD)involve a safety issue besides glycated hemoglobin (GHb) value. The goal of this study is to explore modified SMBG protocols for precisely monitoring and predicting glycemic excursion, variability in senior type 2 diabetics with CAD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Clinical diagnosis of coronary artery disease
* Age ≥65 years
* The blood glucose is controlled by diets and (or) oral hypoglycemic drugs
* BMI≤28 kg/m²
* Being able to monitor and record capillary glucose value by themselves at home

Exclusion Criteria:

* Diabetic ketoacidosis (DKA)
* Acute cardiovascular events
* Anemia
* Insulin treatment
* Incapable to perform SMBG at home
Randomized Controlled Trial of ImmuKnow in Liver Transplantation

ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events

We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the Control group was managed by the Standard of Care at our institution. ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.

Eligibility Criteria:
Inclusion Criteria:

* consecutive adult liver transplant recipients at our center;
* patients not entered into other studies;
* provided consent.

Exclusion Criteria:

* available follow-up;
* consent removed.
PDA for Antidepressant Use in Pregnancy

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created and piloted with positive results an online patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this study is to conduct a Randomized Controlled Trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy.

A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting women with depression will be randomized in a 1:1 ratio to either online PDA or a control condition comprising an online set of publicly available standard resources. The study will be stratified by preconception vs. pregnant, and by province.

The study is based at Women's College Hospital (Toronto) but participants will be recruited from across Canada, as the online intervention does not require any in-person study visits. Participants will be recruited via social media (ex. Facebook, Twitter, mommy/baby blogs) and by provider referrals.

Participants will be given a series of online questionnaires with various measures collected at baseline, 4 weeks post-randomization, in each trimester of pregnancy, and at 1, 3, 6 and 12 months postpartum. Participants who are planning pregnancy will enter the longer-term (pregnancy and postpartum) follow-up phase once they become pregnant; those who do not conceive by one year post-randomization will be sent a final set of questionnaires and exit the study. A process evaluation will also be conducted to gain insights around trial conduct, and perspectives on potential for (or barriers to) scale-up. This, along with the planned economic evaluation, will inform clinical and policy decisions around adopting the PDA into real-world practice.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥ 18 years old; and
2. Diagnosed with major depressive disorder (current or in remission); and
3. Planning conception in the next 12 months or \< 30 weeks gestational age; and
4. Deciding whether to start or continue a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in pregnancy; and
5. Have moderate-to-high decisional conflict regarding the decision to start or continue an SSRI/SNRI in pregnancy; and
6. Live in Canada

Exclusion Criteria:

1. Have had alcohol or substance use disorder in prior 12 months; or
2. Have active suicide ideation or psychosis; or
3. Have past/current major obstetrical or fetal complications; or
4. Are unable to complete relevant study procedures online; or
5. Are unable to complete study procedures in English
Mind Programme for Women With Breast Cancer (Nationwide Coverage)

The purpose of this research project is to optimize the Mind programme for women with breast cancer, taking into consideration the results from its pilot study, and to testits efficacy and cost-effectiveness through a 3-arm randomized controlled trial


Eligibility Criteria:
Inclusion criteria:

1. age between 18-70;
2. primary diagnosis of BC (stages between I and III);
3. having a scheduled radiotherapy treatment starting within 2 months, currently undergoing radiotherapy treatment, or having finished radiotherapy treatment no more than 6 months prior, at any hospital in Portugal;
4. able to understand and answer to self-report questionnaires in Portuguese;
5. having access to a computer or tablet with internet.

Exclusion criteria:

1. currently undergoing any form of psychological intervention;
2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
3. diagnosis of neurological disease.
Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)

The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Deep Brian Stimulation surgery

Exclusion Criteria:

* DBS treatment stopped before 12 month followup
Assisted Partner Services and HIVST in Western Kenya

This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.


Eligibility Criteria:
Inclusion Criteria:

Aim 1:

* Men and women
* Tests HIV positive and is not in care or on treatment
* ≥18 years old
* Willing and able to provide informed consent
* Able to provide locator information for sexual partners

Aim 2:

* ≥18 years old
* Willing and able to provide informed consent

Exclusion Criteria:

Aim 1:

* Pregnancy
* Reports intimate partner violence during last month
* \<18 years old

Aim 2:

• \<18 years old
A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃.

This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years.
* Able to understand the content of informed consent and willing to sign the informed consent
* Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
* A body mass index (BMI) \<35
* Hemoglobin 110-150g/L for female, and 120-160g/L for male.
* White blood cells (WBC) 4.0-10.0×109 cells/L
* Total lymphocyte Count 0.8-4.5×109 cells/L
* Platelets 100-300×109 cells/L
* Alanine aminotransferase (ALT) 0-40U/L
* Serum creatinine 44-106μmol/L
* Partial thromboplastin time (PTT) 20-40 seconds
* Prothrombin time (PT) 10-14 seconds
* Negative in HIV diagnostic blood test
* Axillary temperature ≤37.0°C on the day of enrollment
* General good health as established by medical history and physical examination.

Exclusion Criteria:

* Family history of seizure, epilepsy, brain or mental disease
* Subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV vaccine, such as mannitol
* Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
* Any acute fever disease or infections in last 7 days
* Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
* Hereditary angioneurotic edema or acquired angioneurotic edema
* Urticaria in last one year
* Asplenia or functional asplenia
* Platelet disorder or other bleeding disorder may cause injection contraindication
* Faint at the sight of blood or needles.
* Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
* Prior administration of blood products in last 4 months
* Prior administration of other research medicines in last 1 month
* Prior administration of attenuated vaccine in last 1 month
* Prior administration of inactivated vaccine in last 14 days
* Current anti-tuberculosis prophylaxis or therapy
* Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
Expressive Writing for Co-Occurring Depression and Alcohol Misuse

\*\*\*Please note that this study does not offer comprehensive treatment program for alcohol abuse or depression. Please do not contact the study staff if you are seeking psychological treatment. Further, this study is only enrolling people who are clients at Career and Recovery Resources, Inc., in Houston.

The hypothesis is that writing about feelings and thoughts will help people who are in group treatment feel less depressed and abuse alcohol less.

Expressive writing applied to a variety of populations (e.g., HIV, cancer, PTSD, depression) has been associated with health improvements, reductions in symptoms of emotional distress, and one preliminary study found reductions in alcohol misuse among college students. Data suggest that expressive writing is a technique to facilitate emotional processing that can influence a number of clinical outcomes by facilitating cognitive restructuring (Hunt, 1998; Pennebaker, 2004). In addition to examining cognitive content change following expressive writing, we believe the effects of emotional writing on mood and drinking may involve two additional processes that have been found significant for both depression and alcohol misuse, namely experiential avoidance and ruminative thinking. We hypothesize that expressive writing will lead to less drinking and enhanced mood by reducing: (1) negative thought content, (2) experiential avoidance of unpleasant private events (e.g., negative thoughts, feelings, bodily sensations), and (3) ruminative thinking.

Eligibility Criteria:
\*\*\*Please note that this study does not offer comprehensive treatment program for alcohol abuse or depression. Please do not contact the study staff if you are seeking psychological treatment. Further, this study is only enrolling people who are clients at Career and Recovery Resources, Inc., in Houston.

Inclusion Criteria:

* Enrolled in group therapy program at Career and Recovery Resources, Inc.
* Must be at least 18.
* Willing and able to participate in the study through the one month follow up.
* Able to provide the contact information of at least two people who can generally locate their whereabouts.
* Speak English fluently.

Exclusion Criteria:

* Inability to read, write, speak English.
* History of bipolar or psychotic disorders.
* Severe medical, cognitive and /or psychiatric impairment that precludes cooperation with study protocol.
* Substance withdrawal symptoms requiring medical attention.
* Currently receiving other individual psychosocial therapy outside of C\&R for substance abuse or other psychiatric conditions with the exception of AA, NA or CA.
* Impending incarceration or other factor that would create inability or unwillingness to participate in the 6 week long study period (e.g., halfway house or other aftercare program restrictions).
The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes

Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.

The investigators hypothesize that RAI absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the "Quick Bolus" feature as compared to the "Standard Bolus".

Outcomes were updated at time of results entry.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 30 (inclusive)
2. Clinical diagnosis of T1D of at least one year's duration
3. On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
4. HbA1c \<10%
5. Minimum weight requirement of at least 37.9 kg
6. Ability to comprehend written and spoken English
7. Total daily requirement of insulin between 0.6 and1.2 U/kg/day
8. Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism

Exclusion Criteria:

1. Medication besides insulin known to alter blood glucose or insulin action
2. Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception.
3. Inability to comprehend written and spoken English
4. Any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study
5. Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
Online Health Survey of Patients With Vitiligo Vulgaris/ Online Survey of Pediatric Patients With Vitiligo

The study is an on-line survey posted on survey monkey that addresses some demographic and environmental issues that could potentially relate to vitiligo vulgaris onset or disease exacerbation.

The survey is designed to look at some issues that are pertinent to individuals with vitiligo, including access to care, severity of disease, under-reported disease activity, causative and exacerbating factors and co-morbid illnesses.

Eligibility Criteria:
Inclusion Criteria:

* Ability to complete survey

Exclusion Criteria:

* Inability to complete survey
PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.

The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.

Eligibility Criteria:
Inclusion Criteria:

* DLBCL Lymphoma subtype --No comorbid disease

Exclusion Criteria:

* Pregnancy
* Peptic ulcer
* Severe cardiac disease
* Osteoporosis
Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
* Best Corrected Visual Acuity less than 0.1
* Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane

At least 6 months follow-up

Exclusion Criteria:

* Eyes with diffuse chorioretinal macular atrophy
* Concomitant presence of a choroidal neovascular membrane
* Young patients less than 21 years old.
* History of trauma
* Dense media opacity (corneal/ lenticular)