cyrilzakka/clinical-trials huggingface dataset:
A Study of Preferences of Participants and Oncologists for the Characteristics of the Treatment for Renal Cell Carcinoma (RCC) In Spain And Portugal

The purpose of this observational study is to determine patients' and professionals' preferences for the characteristics (attributes) of the treatment for Renal cell carcinoma (RCC) in Spain and Portugal.

This study uses a literature review, qualitative (focus groups) and quantitative methods (discrete-choice experiment, DCE) to determine renal cell carcinoma (RCC) participants and oncologists' preferences. In this clinical trial, the study team will develop a survey consisting of comparisons of hypothetical treatment profiles (scenarios). Scenarios are presented to participants, and each participant chooses the most preferable.

Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Oncologists from Spain and Portugal will be identified by the promoter and invited to participate in the study in accordance with the inclusion criteria described below.

* The oncologist is currently working in a Spanish or Portuguese public hospital.
* The oncologist has at least 2 years of experience in the management of participants with Renal Cell Carcinoma (RCC).
* The oncologist has agreed to participate in the study.

Participants with a diagnosis of RCC will be identified and recruited by the Principal Investigators of the study, taking into account the inclusion criteria described below.

* The participant has been diagnosed with RCC for a minimum of 2 months before study inclusion.
* The participant has received or is currently receiving pharmacological treatment for RCC;
* The participant has provided the informed consent to participate in the study.
* The participant must be able to read, understand and complete the survey instrument according to the judgment of the responsible physician.

Exclusion Criteria:

• Not applicable
One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab.

Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.


Eligibility Criteria:
Inclusion Criteria:

* diabetic patients, older than 18years,
* center-involving DME, central macular thickness (CMT) \>300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection.
* The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included.

Exclusion Criteria:

* Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy.
* uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery \>6 months prior to conversion).
* Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging

\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.

This Phase II study will investigate the utility of \[18F\] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined \[18F\]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that \[18F\] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \[18F\] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years of age) patients with documented HCC tumor mass \>3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
* The appropriate criteria for inclusion for this patient population are:
* Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN\*) Category 5 lesion either on CT or MRI)
* Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
* Willingness to undergo PET/CT
* Able to lie on the imaging table for up to 1 hour.
* Able to provide signed informed consent.
* Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure

Exclusion Criteria:

* Estimated life expectancy \<12 months or serious medical co-morbidities that would preclude definitive local therapy
* Unable to lie on the imaging table
* Age less than 18 years.
* Pregnancy or lactation
* Inability or unwillingness to provide informed consent.
* Weight \>500 lbs (the weight limit of the tomograph gantry table)
PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency

The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13) in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the antibody response will be impaired in patients as compared with controls. In contrast, we postulate that the cellular immune response will be intact.

Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency \< 2,8 g/L and/or Immunoglobulin gamma 2-deficiency \< 1,15 g/L
* Age 18-65

Exclusion Criteria:

* Immunoglobulin gamma-substitution for 6 months prior to study inclusion
* Prevenar7 or Prevenar13 given prior to study inclusion.
* Pneumovax given during a 2 year period prior to study inclusion
* Pregnancy or planning to become pregnant during the study period (4 weeks)
* Taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks).
* Taking systemic steroids, Non steroidal anti inflammatory drugs (NSAID) or immunosuppressive drugs.
* Being allergic to any substance in the vaccine.
* Acute and ongoing disease with high fever.
* Thrombocytopenia (\< 100x109/L).
* Coagulopathy
* Breastfeeding a baby
* The healthy controls should not have any disease with effects on the immune-system
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

OBJECTIVES:

* Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
* Determine the safety and long-term side effects of this drug in this population.

OUTLINE: Patients receive oral celecoxib twice daily for 6 months.

Patients are followed at 2 weeks and then at 6 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 45
* Smoked \> 20 pack years

Exclusion Criteria:

* Concurrent use of NSAIDs
* Hypersensitivity to celecoxib
* Documented allergic-type reaction to sulfonamides
* History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
* History of liver dysfunction
* Hypertension or cardiac conditions aggravated by fluid retention and edema
* Previous history of gastrointestinal ulceration, bleeding, or perforation
* Renal dysfunction
* End stage respiratory disease
* Unstable angina
* Other malignancy
* Pregnancy
* Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
* Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
SUSTAIN: Behavior Change and Nutrition Security for CKMS

To determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be Medicaid enrolled, and/or dual enrolled in Medicaid
* Patients must be diagnosed with at least one of the following diseases: hypertension, type 2 diabetes mellitus, hyperlipidemia, chronic kidney disease and/or metabolic syndrome
* Patients must at least 18 years of age or older at the time of signing consent
* Patient must have access to internet-enabled device
* Patient has no objections to online grocery shopping, home food deliveries, or nutrition counseling
* Patient lives in setting able to receive Instacart deliveries (e.g., non-institutionalized)
* Patient is willing to use a credit card for Instacart back-up payments

Exclusion Criteria:

* Have any condition that impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.)
* Have active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption)
* Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator
* Any other factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study
* Recent (e.g., 6 months) participation in other behavioral nutrition trials
* Are currently pregnant or are planning to become pregnant during the study
Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC

This study aims to see if there's a link between a substance called phosphatidylethanol (PEth) and how patients who have surgery at University Hospitals do after surgery. PEth levels reflect the amount of alcohol use by someone over the past few weeks. This study is checking PEth levels on all patients who are planned to stay in the hospital for three or more days after surgery regardless if they drink alcohol. Specifically, it will look at if PEth levels are connected to problems that might come up during and after surgery, like confusion, lung or heart issues, needing blood transfusions, infections, unexpected intensive care unit (ICU) stays, and longer hospital stays. While there are reports of moderate alcohol consumption being good for the heart, there are other data that alcohol consumption can be harmful. Since there's not much information on how drinking alcohol affects health outcomes during and after surgery, especially for patients who are planned to be admitted to the hospital ward or ICU after surgery, this study will hopefully see if PEth levels before surgery can predict how patients do after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age range: 21-79
* 2. Patients undergoing elective surgery at UHCMC with planned ICU admission
* 3. Patients undergoing elective surgery at UHCMC with expected in-hospital admission for three or more days

Exclusion Criteria:

* 1. Patients undergoing same day outpatient surgeries or expected to be admitted less than three days post-operatively
* 2. Subjects who have received a blood transfusion within the past month before surgery
* 3. Pregnant subjects
Influencer Marketing: a Survey-based Experiment

Young adults (N = 1,500) will participate in the online survey-based experiment. They will be randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or a healthy lifestyle activity alone (control). After watching each video, participants will rate perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge, attractiveness, intelligence, and popularity) on the scale of 0 (e.g., dishonest) to 100 (honest).

Among all participants, harm perceptions of e-cigarettes will be assessed. Susceptibility to use e-cigarettes will be assessed among never users. These outcomes will then be compared among participants who perceived influencers as credible and those who perceived influencers as non-credible.

Young adults (18-24 years of age) living in California were recruited by YouGov marketing research panel to participate in a survey on tobacco-related attitudes and behaviors. YouGov, a research panel agency, has been used in prior research to survey young adults about their tobacco-related attitudes and behaviors. Respondents (N=1,500) were matched to a sampling frame based on gender, age, race, and education. The sampling frame was a politically representative modeled frame of United States (U.S.) adults based on the American Community Survey. The matched cases were weighted to the sampling frame using a propensity score matching procedure. Participants were provided with a survey URL link. After completing informed consent, participants completed the survey online. The study was approved by the University of Southern California Institutional Review Board (UP-21-00135). Respondents were randomly assigned to watch 10 10-second long TikTok videos in either experimental (influencers promoting e-cigarettes alongside healthy lifestyle activities ) or control group (influencers showing healthy lifestyle activity alone).

Eligibility Criteria:
Inclusion Criteria:

* 18-24 years of age,
* English fluency,
* Current California resident.

The survey was sampled to be representative by age group (18 to 24) and gender, and was weighted to be representative by age, gender, race, and educational attainment using propensity score weighting.

Exclusion Criteria:

Not meeting these criteria:

* 18-24 years of age,
* English fluency,
* Current California resident.
Change Physical Activity and School Play Space. Randomized Study Protocol.

Physical activity is a factor that contributes to a motor and cognitive development in early childhood. Currently, childhood obesity has grown steadily in Chile. This study aims to evaluate the impact of a school environmental intervention on the physical activity and cognitive functions in 1st-grade schoolchildren during the COVID-19 pandemic. The study will use a randomized experimental design with a sample of 300 schoolchildren divided into a control and an intervention group (n=150 each group). Sociodemographic characteristics and lifestyle of the schoolchildren will be obtained through a questionnaire answered by parents/guardians. Cognitive function will be evaluated using the TENI test by tablet and physical activity will be measured during 7 consecutive days using accelerometers (Actigraph GT3X and wGT3X-BT). Both groups will receive a lecture aimed at schoolchildren. Teachers of the intervention group will also receive a talk regarding the intervention that will take place in their school environment, which includes a circuit of psychomotor games painted on the recess playground floor. ANCOVA analysis will be performed, adjusted for age and sex; then, a multivariate linear regression model will be applied considering the significant variables and adjustment. The significance level will be p\<.05. SPSSv25 and R version 3.14 will be used for the analyses. The intervention is expected to contribute to the increase of physical activity favoring the school environment within a context of vulnerability and with a low-cost initiative


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the participating students are a) children enrolled in 1st-grade in municipal schools in the city of Talca; b) without impediments to physical activity; c) able to understand an order considering their age; d) residents in the commune of Talca; and e) with a commitment not to change school or residence during the duration of the project.

Exclusion Criteria:

* The exclusion criteria are presenting any medical condition that prevents the development of the evaluations and/or presenting any behavioral disorder condition.
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed IgAN, with biopsy confirmation
* 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
* Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification

Key Exclusion Criteria:

* Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
* Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.
Video-stylet for Nasotracheal Intubation in Limited Mouth Opening Patient

The aim of the study is to investigate the efficiency of the Video-stylet (Trachway ®) and the fiberoptic bronchoscopy in facilitation of nasotracheal intubation in limited mouth opening patients.


Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring Nasotracheal Intubation under general anesthesia
4. limited mouth open ,mouth open \< 3 cm
5. unlimited neck motion

Exclusion Criteria:

1. Ankylosing arthritis patients.
2. BMI≧35 kg/m2
Pilot Study of Varenicline to Treat Opioid Dependence

The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.


Eligibility Criteria:
Inclusion criteria

* Age\>=21 years
* Use of opioids at admission to PRC, with daily morphine equivalent dose\>=60mg
* Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC
* Ability to provide informed consent

Exclusion criteria

* Currently using varenicline or other pharmacotherapy for nicotine dependence
* Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;
* History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;
* Known varenicline allergy
* Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction
* Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen
Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.


Eligibility Criteria:
Inclusion Criteria:

* relapsed or refractory disease
* histologically or cytologically confirmed disease
* characteristic immunophenotypic profiles
* measurable disease (for lymphoma patients)
* ECOG performance status of 0-2
* adequate liver and kidney function
* adequate bone marrow reserves
* ineligible or unwilling to undergo autologous stem cell transplantation

Exclusion Criteria:

* failure to recover from any major surgery within 4 weeks of study entry
* pregnant or lactating women
* women of child-bearing potential not using reliable and appropriate contraception
* routine prophylactic use of G-CSF required within 2 weeks of study entry
* Grade 3 or higher peripheral neuropathy
* history of hepatitis B virus or HIV
* central nervous system or meningeal involvement by lymphoma or multiple myeloma
Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls


Eligibility Criteria:
Inclusion Criteria:

1. RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
2. Age≥18 years

Exclusion Criteria:

* History of hepatitis B and C virus infection.
* Receiving hepatotoxic drugs other than RA-specific drugs.
* Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).
* Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.
* Autoimmune liver disease.
* Cancer.
* Pregnancy.