cyrilzakka/clinical-trials huggingface dataset:
PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors

The purpose of this study is to assess the awareness of eligibility of lung cancer screening in Hispanic/LatinX Head and Neck Cancer (HNC) survivors using a survey questionnaire; and to understand the barriers to screening using qualitative interviews.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to understand, and sign informed consent form.
* Age ≥ 18 years.
* Participants must self-identify as Hispanic/LatinX.
* Individuals must be head and neck cancer survivors (treated locally with surgery, radiation alone, or definitive chemoradiation ≥ 5 years earlier and have no signs/symptoms to suggest recurrence of disease).
* Subjects that meet lung cancer (LC) screening eligibility according to United States Preventive Services Task Force (USPSTF21) and/or National Comprehensive Cancer Network (NCCN). For patients with a history of head and neck cancers, the NCCN recommends annual screening with low dose computerized tomography (LDCT) in those who have had a history of 20 pack years of smoking or more. USPSTF21 LC screening eligibility includes adults ages 50-80 that are current smoker or former smokers that quit within 15 years and have a 20 pack-year history or more of smoking.

Exclusion Criteria:

* Individuals with pre-established diagnosis of lung cancer.
* Participants with current diagnosis of any active malignancy.
* Subjects that had undergone lung imaging within previous 3 years.
* Pregnant or nursing mothers.
* Individuals that received head and neck related treatment less than 5 years before screening.
* Individuals with \< 20 pack year history of smoking.
* Subjects with previous history of distant metastatic head and neck cancer.
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC


Eligibility Criteria:
1.18\~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values:

* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception
BFR in Overweight Sedentary Subjects

This project should allow the investigators to observe the effects of low load training under partial vascular occlusion (BFR) in comparison with resistance training at low load without partial vascular occlusion in sedentary people overweight on parameters : decrease in fat mass; increase in muscle mass 79; muscle strength; decrease in the energy cost of walking; increase in preferred walking speed; improvement in walking pattern in patients overweight. Training under partial vascular occlusion should facilitate physical activity in overweight people as it can be just as effective as a "classic" type training with heavy loads. Thus, this device could allow people for who wear heavy loads can present an obstacle to physical activity to feel more involved in the physical activity programs offered in medical or sports centers.

The main objective of this study is to observe the effects of low load training under vascular occlusion (BFR) compared with low load resistance training without vascular occlusion in overweight sedentary people on parameters such as: decrease in fat mass; lower blood sugar levels as well as lower blood triglycerides and cholesterol levels; increased muscle mass; muscle strength; the reduction of the energy cost of walking; increasing the preferred walking speed; improving the walking pattern in overweight patients.

3.2 Primary and secondary endpoints

The first hypothesis is that the BFR drive will be effective in improving walking economy (thus reducing the energy cost of walking) and increasing the preferred walking speed, by improving walking patterns.

The second hypothesis is that BFR training makes it possible to modify the body composition in a slight way and to promote the gain of muscle strength in overweight individuals who do not practice physical activity beforehand. In addition, blood tests will show a decrease in blood sugar, blood triglyceride levels and cholesterol.

3.3 Study design

This single-center project aims to test the effects of low-load training under partial vascular occlusion (BFR) compared to low-load resistance training without vascular occlusion in overweight sedentary people. The main expected effects are a decrease in fat mass, an increase in muscle mass and strength, a decrease in the energy cost of walking as well as an increase in preferential walking speed. This project is part of a continuity of research in a public health context in order to propose adapted and effective physical activity programs for an overweight population unable to train with heavy loads.

Eligibility Criteria:
Inclusion Criteria:

* IMC between 25 and 35
* vaccin against Covid-19

Exclusion Criteria:

hypertension diabete
IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate-risk AML
* Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
* With negative MRD before mobilization and collect of peripheral blood stem cells
* Without HLA-matched donors (related and unrelated)
* Refusal of haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Pelvic Floor Disorder Education in Prenatal Care

Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population.

Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.

Once verbal consent is obtained, participants will be randomly assigned in a 1:1 ratio to the intervention (video education) or control group (routine prenatal visit only). Group assignments will be performed using computer-generated randomization. All participants will complete a paper questionnaire including basic demographic information, prior history of pelvic floor disorders, and current PFD symptoms. Participants assigned to the routine prenatal visit only will be instructed to complete the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). The PIKQ is a validated 24-item questionnaire designed to assess knowledge of PFDs, including two 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP).

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
* English-speaking

Exclusion Criteria:

* Non-English-speaking patients
* Gestational age \< 37 weeks
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-80 years)
* active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
* patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) \> 8,
* faecal calprotectin above 250 µg/g.

Exclusion Criteria:

* Abcess,
* Bowel resection within 6 months before enrolment,
* Ostomy,
* Short-bowel syndrome,
* Clinically significant stricture that could require surgery,
* Pregnant,
* Lactating woman or desire to become pregnant during the study,
* Unwilling or unable to follow the study diet.
A Self-Management Intervention for Youth With Sickle Cell Disease and Their Families: Phase I

This study is being conducted to test an intervention for children and adolescents ages 8-17 years with sickle cell disease and their families. In the first phase of this study, key informant interviews are being conducted with health care providers and children ages 8-17 with sickle cell disease and their primary caregivers. Participants are asked to review the intervention and provide feedback that will inform revision to the intervention.

Key informant, semi-structured interviews are conducted using an interview guide to obtain expert provider (healthcare providers of children with SCD) and end-user (children and parents/caregivers) feedback on the intervention. Interview questions are designed to solicit information on advantages and disadvantages, perceived usefulness, and recommendations for improvement on the intervention. The interviews will last approximately 1 hour and are audio recorded. Recordings are transcribed for analysis. Data are analyzed using a deductive-inductive approach with the intervention as a framework for initial categories. Findings will inform revisions to the intervention. Feasibility testing of the revised intervention will be conducted in the next phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-17 years and their primary caregiver
* Child with SCD as indicated by self/parent report or report from MUSC Pediatric Sickle Cell clinic staff
* Child has been seen at the MUSC Pediatric Sickle Cell clinic for at least 6 months
* MUSC Pediatric Sickle Cell clinic staff report preventive recommendations are followed by child/caregiver

Health care providers:

* Age 18 years or older
* Healthcare professional with at least 6 months' experience caring for children with SCD

Exclusion Criteria:

* Non-English speaking
* Inability or unwillingness to participate in a one-on-one interview
* Inability or unwillingness of parent/caregiver or health care provider to give informed consent and of child to give assent
Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests

ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. This led to an over-selection of patients and a significant reduction in the number of eligible patients. A balance needed to be struck between over-selecting patients and maintaining the expertise of medical and paramedical teams in the field. In addition, it has also been shown that ECPR also increases the number of organs and transplants.

In February 2024, the criteria for inclusion in the protocol were redefined to include any witnessed non-traumatic cardiac arrest, whatever the initial rhythm. This simplification should enable more patients to be included in the procedure.

The aim of the study is to assess the patient's outcome


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest
* enrolled in the ECPR program
* 18 years old or more
* Low-flow estimated \<60minutes

Exclusion Criteria:

* traumatic cardiac arrest
* major comorbidities
Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser

This is an investigator-sponsored trial (IST), an open-label pilot study, assessing the safety and biologic activity of bromfenac in subjects with diffuse DME refractory to laser.

Ten subjects will be enrolled in this study, which will be conducted at Ophthalmic Consultants of Boston, Boston, MA. All subjects must be diagnosed with diffuse DME that is either refractory to laser photocoagulation or in patients who have refused laser.

Consented subjects will be screened to determine eligibility. Eligibility will be determined by the Investigator, a retinal specialist. Only one eye will be chosen as the "study eye." Only the study eye will receive bromfenac drops during the study.

Eligible subjects will self-administer bromfenac two times per day (BID) for three months (treatment period). Subjects will have monthly examinations during the treatment period, followed by follow up visits at Month 4 and Month 6.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Center-involved macular edema secondary to diabetes mellitus

Exclusion Criteria:

* Study eye with edema amenable to focal laser
* Treatment with laser, intraocular steroids, and anti-VEGF agents within 90 days
* Current eye infections
Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART

More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).

The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens.

This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.

This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study discontinuation. Participants must meet enrollment criteria for P1060 as well as additional criteria for this study. Study visits will occur as a part of P1060 study visits, all of which include a physical exam, blood collection, and assessments of HIV-related symptoms.

Participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.

Eligibility Criteria:
Inclusion Criteria:

* Enrolling in study IMPAACT P1060
* Parent/legal guardian agrees to seek medical care for intercurrent illness at the study site, whenever possible, and agree to not use at-home remedies for febrile illness in the child

Exclusion Criteria:

None.
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers

This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of 18.0-30.0 kg/m2 at screening
* Is physically healthy
* Agree to abide by the contraception requirements for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Have a positive pregnancy test and/or be currently breastfeeding
* Have a history of or current infection with Hepatitis B virus, Hepatitis C virus, or human immunodeficiency virus (HIV)
* Have current evidence of or history of any clinically significant medical or psychiatric condition or observed abnormality
* Have any skin condition likely to interfere with ECG electrode placement or adhesion
* Have current abuse or dependence (within the past 5 years) on any drugs (exclusive of nicotine or caffeine)
* Have used any prescription or over-the-counter (OTC) medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins), or have consumed grapefruit or any grapefruit products within 14 days prior to the first study drug dose
* Have consumed alcohol-, caffeine-, or xanthine-containing products within 24 hours prior to the first study drug dose
* Have used nicotine within 90 days prior to the first study drug dose
* Have used opioids 30 days prior to screening, or have an anticipated need for opioid medication during the study
* Additional criteria may apply
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
* History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
* Gleason score less than or equal to 7
* Clinical Stage T1-T2c
* PSA
* less than or = 15 ng/ml prior to start of therapy if Gleason \< or = 6 or
* less than or = 10 ng/ml prior to start of therapy if Gleason = 7
* Zubrod Performance Status 0-1
* Age \> 40

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
* Evidence of distant metastases
* Regional lymph node involvement
* Significant urinary obstruction
* Estimated prostate gland \> 100 grams
* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
* Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
* Severe, active comorbidity
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions

This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.

All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

Eligibility Criteria:
Inclusion Criteria:

* Women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use

Exclusion Criteria:

* Cannot read, speak and understand English
* Cannot see well enough to read information on the label