cyrilzakka/clinical-trials huggingface dataset:
Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19

To examine perceptions and determinants of physical activity during the COVID-19 pandemic among cancer survivors.

This purpose of this study is to examine perceptions and determinants of physical activity during the COVID-19 pandemic in cancer survivors. To test our aim, we will recruit up to 1000 adults diagnosed with cancer within the last five years and ask them to complete an online questionnaire battery assessing their self-reported physical activity habits, psychosocial outcomes (e.g., depression, anxiety, self-efficacy, social support), and perceptions of physical activity engagement during the pandemic. A subsample of participants (n=50) will also be invited to participate in an interview to gain further insights into cancer survivors' physical activity experiences during COVID-19. Analysis of covariance (ANCOVA) will be used to analyze the quantitative survey data, and thematic analysis will be used to analyze the qualitative interview data.

Eligibility Criteria:
Inclusion Criteria:

* Adult with a history of cancer (except non-invasive skin cancer)
* Diagnosed at age 19 or older
* Diagnosed within 5 years of study enrollment
* Access to a computer, tablet, or smartphone with the Internet
* English reading

Exclusion Criteria:

* Unable to read in English
Patient Empowerment With the Patient Perspective

The overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform.

This is a two-stage study design. The first stage consists of focus groups interviews. Three focus groups with 6-8 patients (colorectal cancer patients diagnosed at least one year ago) in each group, will be invited. The focus group interviews will be moderated by one researcher, but accompanied with a second observing researcher. The participants will be identified using the regional Swedish ColoRectal Cancer Registry in Västra Götaland. The participants will be contacted by a short letter (appendix) indicating that we will call them with more information. The participants will by phone be asked to participate in the study and then invited to the focus groups.

The second phase of the project includes a questionnaire, which will be sent to 200 patients from the same population. The questionnaires will be delivered by using the Sunet Survey system, which is a system approved by University of Gothenburg. If the participants prefers a paper copy, or lack the possibility to reply online, a paper copy will be send via mail instead.

At this moment the investigators have developed a questionnaire, which may be refined due to the understating achieved from the focus group interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patient with colorectal cancer

Exclusion Criteria:

* Inability to give informed consent or speaking and reading the Swedish language.
Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention

OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with reteplase infused after coronary reperfusion will reduce the myocardial infarction size.

DESIGN, SETTING, AND PARTICIPANTS: 306 patients presenting at 15 hospitals in China within 12 hours of acute ST-segment elevation myocardial infarction (STEMI) due to a proximal-mid-vessel occlusion of left anterior descending (LAD) coronary artery occlusion will be randomized in a 1:1:1 dose-ranging trial design. Patients will be followed up to 1 month.

INTERVENTIONS: Participants will be randomly assigned to treatment with placebo (n = 102), reteplase 9mg (n = 102), or reteplase 18mg (n = 102) by manual infusion over 2 minutes after reperfusion of the infarct-related coronary artery and before stent implant.

MAIN OUTCOMES AND MEASURES The primary outcomewas the myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Acute STEMI with persistent ST-segment elevation or recent left bundle-branch block with a symptom onset to reperfusion time of 12 hours or less.
2. Angiographic criteria included a proximal-mid coronary artery occlusion (TIMI coronary flow grade 0 or 1) or, impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of large thrombus (TIMI grade ≥2) in left anterior descending (LAD) coronary artery.

Exclusion Criteria:

1. Rescue PCI after thrombolytic therapy.
2. Need for emergency coronary artery bypass grafting.
3. Presence of cardiogenic shock.
4. Life expectancy of \< 6 months.
5. Inability to provide informed consent.
6. Contraindications for the use of thrombolysis, including active internal bleeding, history of intracranial haemorrhage or ischaemic stroke within 6 months, recent major surgery or trauma, severe uncontrolled hypertension, thrombocytopenia and severe liver or kidney failure.
Tumor Grade Determines PD-1/PDL-1 Expression

Endometrial carcinoma is the most common gynecologic cancer in the western world. Two types are usually described. Type I is the endometrioid and is usually estrogen dependent. Type II is usually more aggressive than type I and is estrogen independent. Type II endometrial cancer is usually characterized as high grade while type I as low intermediate and high grade. Ovarian carcinoma as opposed to endometrial carcinoma is not characterized by types but by different histological backgrounds. It is also divided into high and low grade tumors. Ovarian carcinoma is considered to be the most aggressive of all gynecological malignancies resulting in most yearly deaths. Our immune system usually responds to foreign intruders entering our body or formed inside and attacks it in order to destroy it. Cancer cells are considered to be foreign to the body hence the immune system is expected to destroy it . The immune mediated cells which are supposed to attack the cancer are called tumor infiltrating lymphocytes or "TILS". Many different cancers possess the ability to evade TILS in order to survive and grow. Many studies have demonstrated that the presence of large number of TILS improved cancer prognosis. One of these evasive methods is the PD-1/PDL-1 expression. The question whether more aggressive tumors possess better capabilities to evade an immune response via the PD-1/PDL-1 mechanism is currently unknown. All tumor types possess antigens on their cell surface which triggers an immune response to some extent. Even though, the tumor needs different methods in order to be able to avoid the immune system attack. TILS express the PD-1 receptor on their cell surface and when it binds to PDL-1 or PDL-2, the cells which express the ligand deactivate TILS hence deem the lymphocyte incapable of inducing programmed cell death. PDL-1 which is expressed on tumor cells to evade an immune response can be targeted by immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

All ages Endometrial carcinoma Ovarian carcinoma All grades All stages All races Female patients PD-1/PDL-1 staining positive -

Exclusion Criteria:

Any cancer which is not endometrial or ovarian Cancer which do not stain positive for PD-1/PDL-1

-
Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

The purpose of the investigators' study was to evaluate whether misoprostol will improve pain scores .

an intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the intrauterine device insertion tube, and removing the tube; and placement of the device in the uterus.

Eligibility Criteria:
Inclusion Criteria:

* • Women not taken analgesics or anxiolytics in the 24 hours prior insertion

  * Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to IUD placement
Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer

Researchers from Memorial Sloan-Kettering Cancer Center are conducting a research study on a Chinese herbal medicine known as "Jin Fu Kang". We want to see if this can help patients with advanced lung cancer. Jin Fu Kang might reduce the growth of cancer or improve quality of life. You are eligible for this trial because your cancer has progressed after prior chemotherapy and your doctor has recommended further chemotherapy treatment.

Lung cancer that has been confirmed and that has spread is called advanced cancer. There is no known permanent cure for advanced lung cancer, but chemotherapy may temporarily shrink the cancer and improve the quality of patients' lives.

Jin Fu Kang is a herbal medicine specially developed in China for the treatment of lung cancer. It is based on a traditional medicine that is widely used and appears to be safe. Although clinical trials in China suggest that Jin Fu Kang may be of benefit, it has never been researched in patients with lung cancer in the United States. As such, its risks and benefits are not fully understood.

The scientific aims are to determine the toxicity of Jin Fu Kang/docetaxel combination treatment in patients with non-small cell lung cancer, to determine whether Jin Fu Kang alters the pharmacokinetics of docetaxel and to provide preliminary efficacy and survival data for Jin Fu Kang/docetaxel combination treatment in patients with non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

-Patients must meet all of the following inclusion criteria:

* Pathologic confirmation of stage III or IV NSCLC.
* Docetaxel therapy for cancer is clinically indicated.
* KPS\>=60% \*ANC\<1,000/mcl and Platelets\<100/mcl

Exclusion Criteria:

-Patients must meet none of the following exclusion criteria:

* WBC\< 4,000/µl, hemoglobin \< 10 g/dl, platelet count \< 100,000/µl, total bilirubin \> ULN, AST \>1.5 x ULN, alkaline phosphatase \> 2.5 x ULN, creatinine \> 1.5 mg/dl or creatinine clearance \< 50 ml/min/1.7 m2), (ANC \> 10,000/µl)
* Prior docetaxel
* Patient must have recovered from all previous treatment-related toxicity
* Concurrent use of any botanicals for anticancer intent
* Use of Jin Fu Kang or any of its constituent botanicals in the previous three weeks.
* History of allergy to any of the constituent botanicals in Jin Fu Kang.
* Pregnant or lactating women or women of childbearing potential not using effective contraception. A negative pregnancy test must be documented during the screening period for women of childbearing potential.
* Concurrent active cancer.
* Concurrent use of immunosuppressives: as an immunostimulant, astragalus-containing products are contraindicated for patients on immunosuppressive therapy.
Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-30, weight 60-100 kg
* Non/ex-smokers, Non/ex-nicotine users

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examinations
* Use of any prescribed or non-prescribed medication
Vitamin D Supplementation in Older Adults With Urinary Incontinence

Urinary incontinence (UI) is a common disorder among older women that greatly affects quality of life. Emerging evidence from observational studies links vitamin D insufficiency with UI. Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be assessed by a 7-day bladder diary and other validated symptom measures administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D supplementation on UI symptom improvement and inform a larger, randomized controlled clinical trial involving vitamin D supplementation.


Eligibility Criteria:
Inclusion Criteria:

(1) Post-menopausal women (age ≥50 years of age); (2)Urine leakage for 3 or more months; (3) at least 3 urinary urgency incontinence episodes on a 7-day bladder diary; and (4) serum 25(OH)D level (vitamin D) is \<30 ng/mL. Women who currently take a bladder medications (anticholinergic) for UI symptom control may enroll into the study if they agree to (1) cease taking these medications at least two weeks before the pre-intervention assessment and (2) not take these medications during the study's treatment and assessment period.

Exclusion Criteria:

(1) neurologic diseases known to affect UI; (2) Diseases known to affect vitamin D absorption and metabolism; (3) Prior pelvic floor radiation; (4) Obstructive causes of UI;(6)Current use of medications known to affect vitamin D levels; (7) Uncontrolled diabetes (Hemoglobin A1C\>9%); (8) albumin corrected serum Calcium \> 11.0 mg/dL; (9)history of hyperparathyroidism; (10) currently untreated kidney stones; (11) post void residual urine volume \>200 ml; and, (12) current treatment with vitamin D \>=1000IU/day (if not willing to stop taking).
68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma

This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT.

46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent provided for participation in the trial
2. Age ≥ 18 y
3. at least one of the following indications should be applied

   1. Scheduled for surgical resection of renal mass
   2. confirmed recurrent/metastatic clear cell renal cell carcinoma
   3. suspicion for recurrent/metastatic clear cell renal cell carcinoma

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
2. Pregnancy or lactation
3. Severe claustrophobia.
Communicating Multiple Disease Risks: A Translation of Risk Prediction Science

Epidemiology seeks to improve public health by identifying risk factors for cancer and other diseases and conveying that information to relevant audiences (e.g., physicians, the public). The audience is presumed to understand and use that information to make appropriate decisions about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can affect the risk of multiple health outcomes, this information is seldom communicated to people in a way that optimizes their understanding of the importance of engaging in a single healthy behavior. Providing individuals with the ability to understand how a single behavior (obtaining sufficient physical activity) could affect their risk of developing multiple diseases could foster a more coherent and meaningful picture of the behavior's importance in reducing health risks, increase motivation and intentions to engage in the behavior, and over time improve public health.

The proposed study translates epidemiological data about five diseases that cause significant morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes, and stroke) into a visual display that conveys individualized risk estimates in a comprehensible, meaningful, and useful way to diverse lay audiences.


Eligibility Criteria:
Inclusion Criteria:

* 30-64 years of age
* Less than (3) relevant comorbidities (diabetes, heart disease, stroke, and cancer, where cancer counts as (2) comorbidities for women but (1) for men)
* Having a SMS capable mobile phone that is not shared with anyone else

Exclusion Criteria:

* Not meeting national guidelines for aerobic physical activity (i.e., at least 150 minutes per week of moderate intensity aerobic physical activity)
* Participants from HRPO# 201501028 will be ineligible for this study
* Uses text messaging less than once per month
Vision In Preschoolers Study (VIP Study)

To identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia, strabismus, and/or significant refractive error.

The Vision In Preschoolers (VIP) Study is a multi-center, multidisciplinary, prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. The primary goal of the VIP Study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia, strabismus and/or significant refractive error.

The VIP Study is designed in three-phases.

Phase I activities will establish which screening tests perform well when administered by licensed eye care professionals (pediatric optometrists and pediatric ophthalmologists) in a population of 1000 Head Start preschoolers at high risk for the targeted vision disorders.

Phase II activities will provide evaluation of the tests' performance when administered by pediatric nurses and lay people on a high risk population of 1000 Head Start preschoolers. Each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener. Tests selected for Phase II will be determined by the outcome of Phase I.

Phase III activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of (6400) Head Start preschoolers. The category of screening personnel and the specific screening tests used in Phase III will be determined by the outcome of Phases I and II.

Eligibility Criteria:
Children enrolled in Head Start who are between the ages of 3 years 0 months and 4 years 11 months of age.
Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly

The overall objective of the research is to identify the prevalence and incidence of BPPV and the impact on balance problems, fall risk and inactivity in frail elderly. The investigators will demonstrate the importance of early diagnosis and treatment in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized in a nursing home for at least 3 months
* Able to understand and follow simple instructions
* Able to stand independently for 30 seconds
* Willing to participate in the study

Exclusion Criteria:

* diagnosis of progressive neurological diseases (such as Amyotrophic Lateral Sclerosis) resulting in a fast decline within 3 months
* Rehabilitating for a neurological or orthopaedic incident such as knee prosthesis, stroke,... )
* Contra-indication for Hallpike and Epley maneuver
Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma

A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA

Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. PCI-32765 is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of PCI-32765 in combination with carfilzomib (Kyprolis™) with and without dexamethasone in subjects with relapsed or relapsed and refractory multiple myeloma (MM).

Eligibility Criteria:
Inclusion Criteria:

* Measurable disease of MM as defined by at least ONE of the following:

  1. Serum monoclonal protein (SPEP) ≥1 g/dL
  2. Urine M-protein ≥200 mg/24 hrs
  3. Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio
* Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen
* Adequate hematologic, hepatic, and renal function
* ECOG performance status of 0-2

Inclusion Criteria for Phase 2 Sub-study Cohort:

* Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:
* Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:

  1. Achieved less than a partial response (\<PR) following at least 4 cycles and are without evidence of progression disease (PD).

     OR
  2. Disease progression following an initial confirmed response of MR or better to the combination (according to IMWG response criteria).

Exclusion Criteria:

* Subject must not have primary refractory disease
* Plasma cell leukemia, primary amyloidosis or POEMS syndrome
* Unable to swallow capsules or disease significantly affecting gastrointestinal function
* Requires anti-coagulation with warfarin or a vitamin K antagonist
* Requires treatment with strong CYP3A inhibitors

Exclusion Criteria for Phase 2 Sub-study Cohort:

* Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib