cyrilzakka/clinical-trials huggingface dataset:
Adaptation Of An HPV Education Resource To Promote HPV Vaccination

The purpose of the study is to assess Human Papillomavirus (HPV) and HPV vaccination knowledge, awareness, attitudes, health beliefs, and behaviors as well as educational preferences for learning more about HPV and HPV vaccination and to receive feedback on and adapt HPV educational materials for Young Latino Men who have Sex with Men (YLMSM).

To assess HPV and HPV vaccination knowledge, awareness, attitudes, health beliefs, and behaviors as well as educational preferences among 260 Spanish-speaking YLMSM ages 18-26 in Florida and Puerto Rico. To conduct 20 in-depth interviews with key stakeholders (10 in PR and 10 in FL) eliciting feedback to inform intervention content and delivery methods and identify potential facilitators and barriers to intervention implementation. To culturally adapt an existing Cancer 101 educational resource in English and Spanish for YLMSM ages 18-26 and to conduct focus groups or individual interviews with 24 YLMSM in PR (n=12) and FL (n=12) to gain feedback on the acceptability, accessibility, content, delivery preferences, and aesthetics of the theoretically informed, HPV educational intervention targeted for English and/or Spanish-speaking YLMSM.

Eligibility Criteria:
Inclusion Criteria for Aim 1 \& 3:

* Men who have had sex with a man and/or are attracted to men
* Hispanic/Latino ethnicity
* Able to read, write and understand Spanish (for Aim 1) and Spanish or English (for Aim 3)
* Aged 18-26 years
* Primary residence in either Puerto Rico or Florida
* Has access to the internet (Aim 1 only)

Additional criteria for Aim 3:

* Has regular access to a working telephone or be able to attend an in-person focus group (modifications related to COVID-19 situation will allow virtual modality to complete the focus groups or individual interviews).
* Able to read, write and understand Spanish or English

Inclusion Criteria for Aim 2:

* Individuals with a current or prior role (within last twelve months) in a community-based organization, private or public healthcare clinic, health department, college/university organization, or interest group that provides services to sexual minorities in FL or PR as a healthcare provider, staff member, group member, or in a leadership role
* Age 21 or older
* Able to understand, read and speak either Spanish or English
* Access to a working telephone or computer

Exclusion Criteria for Aim 1 \& 3:

* Self identifies as either transman or transwoman
* aged \<18 years or \>27 years
* Individuals who contact the research team about interest in participating on Aims 1 or 3 (when recruitment cap has been completed for that aim) can be directed to Aims 1 or 3 for possible recruitment. Individuals can participate in more than 1 aim, but not more than one time in a single aim.
Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

For patients who survive allogeneic bone marrow transplants greater than 100 days, chronic GvHD is a major cause of non-relapse morbidity and mortality. Depending on the presence of known associated risk factors, chronic GvHD will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%.

Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD, suppression of these cells by means other than medications could have benefit in the GvHD population.

ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations.

The purpose of this study is to determine whether ECP, in conjunction with standard therapy, is effective in the treatment of chronic GvHD. Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.

Eligibility Criteria:
Inclusion Criteria:

* Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
* Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
* Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
* Patients must weight at least 40 kg (88 lbs.)

Exclusion Criteria:

* Active gastrointestinal bleeding
* Previous treatment with ECP
* Females who are pregnant and/or lactating
Online HOPE Intervention on Mental Health Literacy Among Youths in Singapore: An RCT Protocol

The author developed the HOPE intervention based on a systematic review (Tay, Tay, \& Klainin-Yobas, 2018). The overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.

The study will be a two-group, parallel randomized control trial (RCT), with a pre-test, post-test and repeated, control group design.

he overall aim of the study is to test the effectiveness of the online HOPE intervention in enhancing mental health literacy, on depression literacy, psychological well-being and in reducing stress among youths aged 18 - 24 living in Singapore.

Eligibility Criteria:
Inclusion Criteria:

* : a) students of a particular University in Singapore, b) aged between 18 to 24 years old, c) had internet access and d) could read, write and understand the English language.

Exclusion Criteria:

* Exclusion criteria were reading or hearing disabilities. This was because the online HOPE intervention consists of written words and videos that require visual and auditory abilities, respectively.
A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* rheumatoid arthritis, functional status I-III;
* SJC\>=4 (28 joint count) and TJC\>=4 (28 joint count) at screening and baseline;
* RF and/or anti-CCP positive;
* may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);
* inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;
* history of, or current, inflammatory joint disease other than rheumatoid arthritis;
* diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
* significant cardiac or pulmonary disease;
* previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).
Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache

Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years, pain in any tooth

Exclusion Criteria:

* duration of pain \> 96 hours
* oral trauma within 96 hours of presentation
* facial or neck swelling
* pericoronitis
* visual impairment to less than finger counting within three feet
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish

This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal infections in patients who wear polish compared to those who do not.

Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely affected by the application of nail polish.

Eligibility Criteria:
Inclusion Criteria:

* Female age 19-70, as 19 is the legal age in Alabama
* DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide microscopy and culture of a dermatophyte
* Suitable for application of topical antifungal therapy, in the opinion of the investigator
* Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this was the criteria used in the pivotal trial using topical efinaconazole for onychomycosis
* Women of childbearing potential will be required to use birth control and a negative urine pregnancy test must be documented prior to initiating treatment

Exclusion Criteria:

* History of immunosuppression or concurrent use of immunosuppressant drugs
* History of uncontrolled diabetes mellitus
* History of psoriasis or any other condition that might interfere with the toenail evaluation
* Three or more dermatophytomas (streaks) on the target nail
* Severe DLSO of the target nail
* Patients who cannot refrain from wearing gel or plastic based polishes that are used in salons and that require curing
Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative

This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.

This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy. The primary endpoint is 12-month progression-free-survival (PFS) rate assessed by investigators. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), progression free survival (PFS), overall survival (OS), and safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
* PD-L1 TPS\<1%
* Life expectancy more than 3 months
* Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
* Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
* ECOG score 0-1
* Patients must have at least one measurable lesion according to RECIST 1.1
* Has adequate organ function
* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
* Voluntarily sign a written informed consent form

Exclusion Criteria:

* Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
* With active central nervous system (CNS) metastases confirmed by CT or MRI
* With other malignancy within 3 years before enrollment
* With severe infections within 4 weeks of the first dose of study treatment
* Women who are pregnant or lactating
* History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
* History of myocarditis, cardiomyopathy, and malignant arrhythmia
* Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
* Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
* Active autoimmune diseases that require systematic treatment within 2 years before enrollment
* History of Human Immunodeficiency Virus (HIV)
* With active hepatitis B infection
* With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Zeiss RESIGHT Disposable Lenses Evaluation Study

To evaluate the intra-operative efficacy of a new intra-operative viewing device.

This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.

Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
* Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction).
* Both vitrectomy-only and combined phaco-vitrectomy surgeries
* General or local anesthesia, or combination

Exclusion Criteria:

* Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
* Repeat vitrectomy surgery
A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects

This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that has resolved at least 3 months prior to first dosing of the IP.

This list only contains the key exclusion criteria.
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.

Background: Bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case.

Objectives:

The aim of this study was to investigate the safety and efficacy of an elective Bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with Bikini line laparoscopic cholecystectomy as minimal invasive scarless technique.

We issued a modifications in order to minimize the number of ports (Brief ports) and modify port sites, using the Bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. Aiming at faster recovery, decrease pain and improve cosmoses.

Bikini Line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. Obesity, intended as BMI 40, does not have any obstacle on the technical feasibility of BLLC.

Thoroughly, BLLC is a novel technique aimed at solving the issue of cosmoses that is always presented as a main complaint from morbid obese patients. The main concern to use Brief ports laparoscopy or hidden scar laparoscopy to reduce incisions and change sites. The study designed to identify superiority of technique regarding success as a day case surgery, better cosmoses and lesser pain.

We tried to wear off the port sites scar and kept our stabs in the suprapubic Bikin line. We kept camera port in the navel's natural scar and used the other ports in lower abdominal crease at Bikini line. Cosmosis has been and still the reason among patient population to accept the laparoscopic surgery, many synonyms can be applied here, as Cosmotic,Hidden scar, Scarless, Non-visualized or Scarless Bikini cholecystectomy.

BLLC is performed under general anesthesia. Patient placed in the supine position with patient's legs apart and arms are rolled in, patient strapped to table at the mid-thigh. Surgeon stood between patient's legs, the camera man stood on the right side of patient, monitor placed near patient head to the right side. Three ports were used, 12 mm visiport (....) umbilical, with A 30 degree camera used, 5mm in Bikini line at Right mid-clavicular line and third port 5mm in Bikini line at left mid-clavicular line (Figure) Patient kept in reverse Trendlenburg position with maximum degree 20. But to lesser degree than done in classic LC,

Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3.

Exclusion Criteria:

* Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day.

Patients required additional trocars for patient safety, readmission,
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Moderate to severe COVID-19 associated disease as defined by the WHO
* Willing and able to provide informed consent prior to performing study procedures
* Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay
* Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.
* Normal potassium, magnesium, and calcium levels pre-therapy when used in agents at risk of QT prolongation

Patients will be further distinguished based on their disease severity into one of two categories:

* Moderate and severe, not critical disease: patients with SpO2 ≤ 94% on room air, and those who require supplemental oxygen
* Severe, critical disease: patients with critical illness requiring ICU-level care including requiring mechanical ventilation or ECMO, and/or end organ dysfunction as seen in sepsis/septic shock.

Exclusion Criteria:

* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment Medication specific Exclusion

Baricitinib:

1. Contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients.
2. Prior untreated latent tuberculosis
3. Any individuals with TB risk factors will not be enrolled in the baricitinib arm of the study.
4. Presence of active viral hepatitis C or B
5. People with a clinical history of invasive or active fungal infection
6. People with a clinical history of active CMV disease in the last year
7. Patients who are pregnant or breastfeeding
8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<15)

Tocilizumab:

1. Known hypersensitivity to tocilizumab or any of its components
2. Prior untreated latent tuberculosis
3. Any individuals with TB risk factors will not be enrolled in the tocilizumab arm of the study.
4. Presence of active viral hepatitis C or B
5. People with a clinical history of invasive or active fungal infection
6. People with a clinical history of active CMV disease in the last year
7. CRP\<75 mg/L
8. SpO2 ≥ 92% on room air

Remdesivir:

1. Known hypersensitivity to remdesivir or any of its components
2. Weight below 40 kg
3. SpO2 ≥ 94% on room air
4. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30)