cyrilzakka/clinical-trials huggingface dataset:
Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's

Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.

We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol

Exclusion Criteria:

* Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing
Evaluation of the Stinging Potential of Products in Human Eyes

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist. The study design was a three cell, single blind study. Subjects were given the industry standard shampoo mixture in one eye and an exploratory sunscreen in the other as according to the randomization schedule.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
* Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
* Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
* Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
* Subjects should refrain from use of make-up on testing day
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Cancer diagnosis \& stage
* Patients for whom no standard therapy exists
* World Health Organization (WHO) performance status 0-2
* One or more measurable lesions

Exclusion Criteria:

* Prostate cancer
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Pregnant or breast-feeding women
* Any evidence of severe or uncontrolled diseases
* Participation in other trials within 30 days
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

RATIONALE: Diagnostic procedures may improve the ability to detect residual disease.

PURPOSE: Clinical trial to detect the presence of residual disease in children who are receiving therapy for acute myeloid leukemia or myelodysplastic syndrome.

OBJECTIVES: I. Determine the frequency and prognostic significance of persistent abnormal cells with an aberrant phenotype detected by multidimensional flow cytometry (MDF) in bone marrow samples from children who have achieved clinical remission after receiving treatment for acute myeloid leukemia or myelodysplastic syndrome. II. Compare the frequency of persistent abnormal cells obtained by MDF with that of polymerase chain reaction (PCR), morphologic, and cytogenetic analyses of these patient samples. III. Determine the frequency and prognostic significance of persistent abnormal cells with a leukemia-specific molecular marker detected by PCR in samples from these patients.

OUTLINE: Patients have bone marrow samples collected during the course of therapy on the CCG 2961 acute myeloid leukemia treatment protocol. These samples are collected: 1. At the time of diagnosis 2. At the end of induction (within a week of day 35) 3. At the end of consolidation (before bone marrow transplant or Capizzi 2) 4. Before and after interleukin-2 (IL-2) therapy, if applicable 5. At the end of therapy (after transplant with evidence of engraftment for autologous bone marrow transplant patients; after course 2 of intensification for chemotherapy patients; and after IL-2 day 21 for IL-2 patients) 6. At relapse, if applicable. The presence of minimal residual disease in bone marrow is assessed using multidimensional flow cytometry and PCR.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome and enrolled on the CCG 2961 AML treatment protocol Must have one of the following cytogenetic abnormalities t(8;21) inv(16) abnormality of 11q23 OR All patients being enrolled for interleukin-2 therapy or standard care can be enrolled at the time of randomization

PATIENT CHARACTERISTICS: Age: Children Performance status: Specified on the CCG 2961 AML treatment protocol Life expectancy: Specified on the CCG 2961 AML treatment protocol Hematopoietic: Specified on the CCG 2961 AML treatment protocol Hepatic: Specified on the CCG 2961 AML treatment protocol Renal: Specified on the CCG 2961 AML treatment protocol

PRIOR CONCURRENT THERAPY: Specified on the CCG 2961 AML treatment protocols
The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.


Eligibility Criteria:
Inclusion Criteria:

* 9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2).
* 9-18-year-old girls who are on dialysis.
* 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
* Healthy 9-18-year-old girls

Exclusion Criteria:

* Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.
Image-Guided Gynecologic Brachytherapy

This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.

The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases will have lower OAR doses than standard CT-based cases due to more conformal planning. The Investigators will determine dose thresholds for radiation-related toxicity after treatment. The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment, thereby enabling improved recommendations on dose limits to the OAR.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.
* Site/Stage
* Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
* Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
* Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
* Carcinoma of the vagina: Stage I-IVA or vaginal recurrence
* Carcinoma of the vulva: Stage I-IVA or recurrence
* Carcinoma of the urethra based on treating physician's discretion
* Patients who have received prior radiation or chemotherapy may be enrolled on this study.
* Age \> 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
* Life expectancy of greater than 6 months.
* ECOG performance status of \<2 or greater, based on treating physician's discretion
* MRI of the pelvis or PET-CT within 4 months before registration
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Absolute neutrophil count \< 500 at the time of enrollment
* A history of metal in the head or eyes
Effects of Music and Stress Ball Application on Patients During Cataract Surgery

Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Advances in anesthesia and surgical techniques make it possible for most cataract surgery procedures to be performed under topical anesthetic.

This success greatly reduces the duration of surgery, and the side effects associated with local or general anesthesia. However, despite the sedation that can be administered before and during surgery (e.g. benzodiazepines and opioids), patients can experience significant anxiety along with a certain degree of pain and discomfort during surgery. Anxiety causes stress that causes the cardiovascular system to respond by activating the sympathetic nervous system, which causes an increase in heart rate and blood pressure (BP) levels. These mechanisms can complicate the surgical procedure due to increased intraocular pressure. Hypertension and tachycardia above 85 discharges per minute represent an increased risk of orbital bleeding during local anesthetic injection and potential perioperative supracoroidal expulsive bleeding. The sequence and pre-operative music intervention is to be an inexpensive, easy-to-implement technique that has no side effects, has no significant beneficial effects on the anxiety of patients in different surgical populations. Also, music intervention allows for better patient co-operation during surgery under topical anesthesia and a drop in intraoperative blood pressure. Another method that is effective in reducing anxiety and pain is the stress ball. The stress ball is usually a soft toy that is not greater than 7 cm, gets stuck, relieving stress and muscle tension, or manipulated with fingers for exercising the muscles. One of the methods of distracting attention, the stress ball is an effective way of ensuring cognitive focus. The stress ball method has been used to reduce patients' anxiety and pain. Stretching the stress ball during surgery increases the feeling of strength, allowing patients to have direct control over the object. In this way, surgical intervention has a positive effect on anxiety and patient satisfaction without intervention. While the literature includes studies involving the combination of stress ball use and music intervention on surgical patients, there is no research involving combined use of music and stress ball application in cataract surgery in a single study. The investigators work therefore contributes to literature.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older and undergoing PHACO surgery,
* Not having any hearing or perception problems,
* Not having any physical problems to squeeze a stress ball,
* Having undergone cataract surgery for the first time,
* Being willing to participate in the research.

Exclusion Criteria:

* Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
* Transition from topical to general anesthesia during surgery,
* A psychiatric diagnosis.
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive adolescents confirmed by medical report
* Prescribed antiretroviral therapy
* Enrolled in care at one of 40 medical clinics within study region
* 10-16 years of age at the time of enrollment
* Living within a family (not necessarily with biological parent(s))

Exclusion Criteria:

* Not HIV-positive
* HIV-positive but not prescribed antiretroviral therapy
* Not enrolled in care at one of 40 medical clinics within study region
* Younger than 10 years and older than 16 years
* Not living within a family
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.

We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.

Eligibility Criteria:
Inclusion Criteria:

* Normal and obese (\>95th BMI%) females
* Weight of 24 kg or more
* Early to late puberty (expected age range 7-18)
* Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

* Screening labs outside of age-appropriate normal range
* Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
* Morning Cortisol \<5 g/dL
* 17-hydroxyprogesterone \>295 ng/dL
* Weight\<24 kg
* History of Cushing's syndrome or adrenal insufficiency
* Pregnant (self reported)
A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults

The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.


Eligibility Criteria:
Inclusion Criteria:

1. History of regular caffeine consumption.
2. Body mass index (BMI) of ≥18.5 and \<25.00 kg/m2.
3. Fasting blood glucose \< 126 mg/dl
4. Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
5. Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit.

Exclusion Criteria:

1. Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit.
2. Known cases of type II Diabetes Mellitus.
3. Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication.
4. Participants suffering from primary or secondary insomnia with/ without active treatment.
Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease

Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory properties, can play an important role in the control of metabolic disorders associated with CKD, since it can modulate the mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of promoting the activation of the transcription-related factor-2 nuclear factor erythroid factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein also associated with the reduction of inflammation. These two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription factor that participates in the inflammatory response. Although it is a promising treatment, there are no studies evaluating the effects of resveratrol supplementation in patients with CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on inflammation and oxidative stress in patients undergoing conservative treatment of CKD.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment

Exclusion Criteria:

* Patients with diabetes mellitus, AIDS, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements
Evaluation of the Impact of a Coordinating Nurse in a Personalized Care Program on Quality of Care, Coordination of the Actors and on Quality of Life for Patients With Lung Cancer

The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV. Controlling the timelines in a care program seems crucial to improve prognosis of lung cancer.

The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care program for patients of thoracic oncology.

New strategies therapeutics result in a longer survival rate. However their side effects affect the patient's quality of life. Even if these side effects are ambulatory manageable, they require to be treated promptly and tends to increase the active list of patients of the thoracic oncology.

Due to the alteration in the care provided to lung cancer patient, there is a need to coordinate the available means, inside and outside the hospital, to improve the quality of care and the quality of life of the patient.

Every patient of the thoracic oncology department receives a personalized care program as a routine practice. In this study, a coordinating nurse (CN) will be added to the personalized care program. Patients newly diagnosed with a lung cancer will be randomized either in the group with a CN or in the group without a CN.

The study will last one year maximum for each participant. Their quality of life, their satisfaction of the quality of the personalized care program - and their general practitioner's satisfaction - will be evaluated throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient of the thoracic oncology ward between April and November 2016
* Newly diagnosed lung cancer
* Treated in the pneumology ward of the Mulhouse Hospital (France)
* Patient enrolled in another clinical trial can also be enrolled in this study
* Patients who have not disagreed to participate to the study

Exclusion Criteria:

* Secondary cancer in lung
* Relapse of primary cancer in lung of the same histological type
* Previous enrollment in this study
* Uncontrolled psychological problem