cyrilzakka/clinical-trials huggingface dataset:
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response

The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer.

Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group.

Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.

Chronic stress can impair immune function, including immune response to vaccines. This has important implications for cancer control and prevention because tumor vaccines are emerging as tools for cancer treatment and prevention, and the cohort that would benefit from the vaccines is likely to be stressed. Women at elevated risk for breast cancer experience significant levels of distress that have been associated with immune function decrements. Interventions to treat distress-related immune decrements among these women are needed because these women will be among the first candidates for breast cancer vaccines. In theory, stress-management interventions should improve immune function and response to vaccines, but the findings to date are mixed, in part because most intervention studies have been done with medical patients who by nature have immune confounds. Thus, it is unknown how stress management interventions affect immune function in stressed but otherwise healthy people, such as women at elevated risk for breast cancer.

Comparison: Women will be randomly assigned to a 10-week structured, CBSM intervention or a wait-list comparison group with delay participation in the intervention. The comparison group will be offered the full CBSM intervention after all assessment time points have been completed.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-60 years
* Family history of breast cancer
* Fluent in English
* Working phone
* Working address
* Plan to live in the area for one year

Exclusion Criteria:

* Prior cancer diagnosis (except non-melanoma skin cancer)
* Current major depressive episode
* History of Bipolar Disorder or Schizophrenia
* History of autoimmune disease
* History of Hepatitis A or HA vaccination
* Current infectious disease
* Use of immune modulating drugs
Pilates Exercises v/s Yoga on Rounded Shoulders

To Compare the effects of Pilates exercises an yoga on rounded shoulders

Pilates exercises and Yoga are two effective treatments for correcting RSP. In Pilates each exercise is conducted in more than one times usually three to five hence exposing the body to different and new muscular and kinesthetic challenges. On the other hand Yoga is a process in which the joints and muscles operate together in a systematic and automatic manner where each pose is sustained for a period of time. Several literatures support the belief that Pilates exercises and Yoga are effective treatments for RSP correction, as well as improving sleep quality, heart rate and SpO2 First, The participants will be divided into two groups, for Pilates exercises and Yoga. Honor wristbands will be distributed and Exercises will be demonstrated to each group. Explanation of using Honor band will be given. Measurements will be taken before the intervention including cervical ROM. shoulder ROM at baseline, 2nd week and 4th week. while heart rate, SpO2 immediately after the session. Sleep quality prior the intervention, 2nd and 4th week. Patients will do the exercises 3 times per week for 4 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rounded shoulders who achieve more than 2.5 cm in table top test.

Exclusion Criteria:

* Patients with a positive history of trauma, fracture or surgery of the cervical spine or shoulder.
* Neck pain with radiation to the arm and upper extremity.
* Diagnosed cases of torticollis and scoliosis.
* Patient with any serious underlying pathology that influence the mobility of upper limb
* History of osteoporosis, any heart disease
The EASE Study - Human Factor and Usability Testing of a Binocular OCT System

Ophthalmology is among the most technology driven of all medical specialties, with advanced medical imaging devices - and specialised computer software - increasingly adopted for routine clinical use. While many such devices are capable of completing specific tasks, lack of "usability" prevents their widespread adoption (i.e., such devices are not easy to learn and remember, or are not efficient or subjectively pleasing to use). Moreover, devices that are difficult to use expose patients to clinical risk as a result of human error during usage.

With the introduction of a new medical technology, it is essential, therefore, to have a deep understanding of patients, what they need, what they value, their abilities, and also their limitations.

Human factor and usability testing, also known as "human factor engineering", deals with the formal study of people's interaction with their environment (in this case, the binocular optical coherence tomography (OCT) device). Structured, patient-centred, usability testing is essential to the design, clinical validation, regulatory approval, and widespread implementation, of all new medical devices. This is particularly the case for a putative binocular OCT system - a device intended for automated use in visually impaired, often elderly, populations. Although the binocular OCT is already at an advanced stage of hardware development, the EASE study will facilitate an iterative process of operating software and workflow modifications to optimize the device for use in these populations.


Eligibility Criteria:
Inclusion criteria for participants with chronic eye disease will include:

* Presence of retinal disease, glaucoma or strabismus
* Male or female, aged 18 years or older
* Ability to understand nature/purpose of the study and to provide informed consent
* Ability to undergo binocular OCT imaging
* Ability to follow instructions and complete the study
* Ability to speak English

Exclusion criteria for participants with chronic eye disease will include:

* Optical media opacity sufficient to preclude adequate ocular imaging with OCT
* Hearing impairment sufficient to interfere with hearing instructions
* Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.

Inclusion criteria for healthy subjects will include:

* No self-reported ocular history (although wearing corrective prescription glasses is permitted)
* Male or female, aged 18 years or older
* Ability to understand nature/purpose of the study and to provide informed consent
* Ability to undergo binocular OCT imaging
* Ability to follow instructions and complete the study
* Ability to speak English

Exclusion criteria for healthy subjects will include:

* Presence of ocular pathology
* Hearing impairment sufficient to interfere with hearing instructions
* Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
VircapSeq Virus Detection in Sézary Syndrome

This study will be using this technique, called "VirCapSeq-VERT" to analyze the white blood cells of patients with Sézary syndrome. This could provide the foundation for future studies looking to understand the role that viruses play in the origin of Sézary syndrome. This could have important implications for the future development of new and effective therapies for the disease.

Cutaneous T-cell lymphoma (CTCL) is a rare lymphoproliferative disorder characterized by malignant CD4+ T-cells that infiltrate the skin. While most cases are confined to skin, CTCL is also capable of affecting the blood, lymph nodes, and visceral organs. Sézary Syndrome (SS) is a leukemic variant of the disease with a poor prognosis and can arise with or without cutaneous involvement. The pathogenesis of CTCL is poorly understood, but chronic antigen stimulation possibly due to a bacterial or viral infection or colonization of the skin may lead to malignant transformation of the skin resident T cells. Colonization of the skin of CTCL patients with Staphylococcus aureus is common and can lead to the clonal expansion of malignant T cells in the skin. However, its role as an etiological agent is unlikely, considering commonality of S.aureus and rarity of the skin T-cell lymphomas. Mounting evidence suggests that oncogenic viral pathogen may play a role, but all efforts to implicate certain viruses, such as retroviruses or herpesviruses have yielded inconsistent results. This study will use the most sensitive method to date, a novel viral detection technique capable of detecting every known vertebrate virus in tissue samples, called "Virome Capture Sequencing Platform for Vertebrate Viruses (VirCapSeq-VERT)." This allows it to detect previously undiscovered viruses that diverge from known sequences by as much as 40%.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Sézary syndrome diagnosed according to the WHO-EORTC classification.

Exclusion Criteria:

* Pregnant patients.
* Patients with known anemia with documented \<7.5 mg/dL.
* Patients who are unable to give informed consent.
A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.


Eligibility Criteria:
Inclusion Criteria:

* Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available
* Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
* Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Subject has adequate hematologic, hepatic, renal, and coagulation function
* Subject has a life expectancy greater than 3 months
* Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy
* Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure

Exclusion Criteria:

* Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
* Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS4.
* Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
* Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment
* Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
* Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
* Subject has known or suspected primary brain or leptomeningeal metastases
* Subject has leukemia or lymphoma
* Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
* Subjects with known history, or clinical or laboratory evidence of liver disease
* Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* Subject if female, is pregnant or breastfeeding
* Subject has received an organ transplant
Improving the Hospital-to-Home Transition Through Post-Discharge Virtual Visits in Primary Care

The purpose of this study is to test a new process for having a virtual visit with a primary care doctor after discharge from the hospital, instead of an in-person visit.

The goal of this project is to fully develop the protocol for identifying patients who would benefit from a virtual visit and develop the protocol for implementing the virtual visit. The value of this project is that the results will provide ample preliminary data for a future randomized controlled trial to determine the effectiveness of the intervention. This project will have an intervention group only. The hypothesis is that the intervention can be implemented in a way that is feasible and acceptable to providers and patients.

Eligibility Criteria:
Inclusion Criteria:

* Medical inpatients, age \>=18, with an existing WCIMA attending as his or her PCP
* Patients with disposition to home
* Medically appropriate for a video visit (as determined by inpatient attending)
* Patients or caregivers must be able to enroll in MyChart before discharge, must be capable of using the Weill Cornell Connect app to do a video visit at home using broadband access or the equivalent (must own a device compatible with the app, e.g.

smartphone or tablet)

* English speaking
* Cognitively able to participate or Caregiver must be able to participate
Screening of Biomarkers on Endometrial Cancers

Ovarian cancer is the first mortality rate of gynecologic malignancies. The incidence of ovarian cancer increased in recent 10 years and it has become the ninth cause of malignancies in the women in Taiwan. From the above-mentioned data, ovarian cancer indeed is a disease that should be respected, however, there were only few of research work focusing on it in Taiwan. Despite the widespread use of aggressive cytoreductive surgery and the introduction of chemotherapy regimens, the overall survival has changed little over the last two decades. The basic problem in treating epithelial ovarian cancer is that once it has spread beyond the ovary, it is exceedingly difficult to control and ultimately to cure. More than 70% of ovarian cancer patients were advanced stage when diagnosed. To study the mechanisms of carcinogenesis, progression, and metastasis of ovarian cancer will help us understand this disease and develop new treatment strategies for ovarian cancer in the future.

We have established an ascitogenic itnraperitoneal tumor cell line-WF3 in the mouse model in our previous two-year project of NSC grant (grant number (NSC90-2314-B-002-457 and NSC91-2341-B-002-315). Our group found that, mesothelin, this molecule is highly related with the carcinogenesis, tumor progression and tumor metastasis in our animal model and human cancer tissues. To further evaluate the role of mesothelin in ovarian cancer and elucidate the potential of mesothelin as a target antigen for immunotherapy,


Eligibility Criteria:
Inclusion Criteria:

* Patients with endometrial cancers who undergo hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital. All of the patients received four to six courses of adjuvant platinum-containing chemotherapy.Histologic grading was according to International Union against Cancer criteria (28). The stage of disease was classified according to the International Federation of Gynecology and Obstetrics (FIGO, 1987). Pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. The histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. The maximal diameter of the residual tumor after surgery will be also recorded. All patients will be followed up at 3-month intervals.
High Body Mass Index and Severity of Coronavirus

A cohort study included 114 adult patients with confirmed COVID-19 were categorized by BMI levels on admission: overweight (25-29.9 kg/m2), and obesity (four categories: 30-34.9 kg/m2, 35-39.9 kg/m2, 40-44.9 kg/m2, and ≥45 kg/m2).


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* confirmed COVUID 19 infection
* body mass index more than 25kg/m2

Exclusion Criteria:

-
Extended Half-Life (EHL) Clotting Factor for Improving the Musculoskeletal Health of Patients With Hemophilia

Background. Hemophiliac arthropathy is the main long-term physical damage in patients with hemophilia, causing disability and functional limitations.

Objective. Assessment of the efficacy of a prophylactic treatment with EHL products for improving the musculoskeletal health of adult patients with hemophilia.

Study Design. Multicenter observational clinical study. Method. 40 patients with hemophilia A will be included in this study. Patients will be recruited from 5 centers located in various regions of Spain (Community of Madrid, Galicia, Community of Valenciana, Málaga and Vizcaya). The dependent variables will be: bleeding frequency (self-report of bleeding), changes in the dosage of factor VIII with EHL products (rFVIIIFc), pain (measured with the visual analog scale and a pressure Algometer), degree of kinesiophobia (Tampa Scale of Kinesiophobia), degree of adherence to treatment (Veritas-Pro scale), joint health (using the Hemophilia Joint Health Score), muscle strength (using a dynamometer) and functionality (using the 6-Minute Walking Test). Three evaluations will be carried out: baseline, at 6 months, and at the end of the study period, at 12 months. The evolution of quantitative variables shall be analyzed by parametric tests (t-student test) or non-parametric tests (Wilcoxon test). Pearson's correlation coefficient shall be used to obtain the correlation between the dependent and independent variables. By means of a linear regression analysis we will record the percentage influence of the clinical variables relative to the dependent variables measured in this study Expected results. The aim is to establish the effectiveness of the prophylactic treatment in the improvement of the state health, joint pain, muscle strength and functionality in patients with hemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A
* Patients over 18 years
* Patients under prophylactic treatment with rFVIIIFc concentrates.

Exclusion Criteria:

* Patients with neurological or cognitive disorders preventing the understanding of the various measuring instruments
* Patients who are scheduled for major orthopedic surgery (total arthroplasty)
* Not signed the Informed Consent Document
SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH 66336 before surgery in treating patients who have colorectal cancer that has metastasized to the liver.

OBJECTIVES: I. Determine the biologic activity and safety of preoperative SCH 66336 in patients with colorectal carcinoma metastatic to the liver.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four doses of preoperative SCH 66336 (no treatment, 100 mg, 200 mg, or 300 mg). Patients receive oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.

PROJECTED ACCRUAL: A total of 40 patients (10 per arm) will be accrued for this study within 10 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer with radiologically documented liver metastases Meet institutional criteria for exploratory laparotomy and/or resection of hepatic metastasis No central nervous system (CNS) metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: white blood count (WBC) greater than 3,000/mm3 Platelet count greater than 150,000/mm3 Hemoglobin at least 10 g/dL (transfusions and/or epoetin alfa allowed if stable without treatment for at least 1 week) Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 5 times ULN Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No poor medical risks because of nonmalignant systemic disease No active uncontrolled infection No intractable vomiting (e.g., grade 2 or higher despite antiemetics) or any medical condition that could preclude taking oral medication and gastrointestinal absorption No AIDS related illness HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No more than 2 prior chemotherapy regimens for systemic disease At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy, including oral contraceptives No concurrent systemic corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to greater than 30% of bone marrow Whole pelvic radiation alone is not exclusionary No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 4 weeks since other prior investigational therapy and recovered No prior farnesyl protein transferase inhibitor
Voluntary Interruption of Pregnancy on Women's Sexuality

The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.

The aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after abortion.

The medical consequences of abortion are low. However, there is an undeniable emotional and psychological impact on these women (40-45% of anxiety-type symptoms, approximately 20% of depressive symptoms after the discovery of the pregnancy and 30% of emotional disorders, particularly anxiety, in the month following the abortion).

The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.

The aim of this study is to evaluate the impact of voluntary termination of pregnancy (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after a termination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years)
* Patient performing a medical or surgical abortion
* Patient with health insurance
* No opposition to participation in the study

Exclusion Criteria:

* Patient who does not speak French and/or is illiterate
* Patient under legal protection
* Patient unable to complete the study procedures (no internet connection, no smart phone or tablet)
* Patient with diagnosed psychiatric comorbidities.