cyrilzakka/clinical-trials huggingface dataset:
Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors

The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.

The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors. Participants will undergo baseline testing at Dana-Farber or Yale, including administration of questionnaires to assess quality of life and the presence of cancer and treatment-related symptoms, fasting blood draw, and evaluation of body composition (using dual energy X-ray absorptiometry (DEXA). Participants will then take part in the 12-week LIVESTRONG Program or will be assigned to a wait-list control group. All measurements will be repeated at Dana-Farber or Yale after the 12-week exercise program or control period.

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis excluding non-melanoma skin cancer
* Physically able to exercise
* Able to complete forms and understand instructions in English
* Agrees to be randomly assigned to either exercise or wait-list control group
* Willing and able to attend one of the LIVESTRONG at the YMCA programs for 12 weeks
* Willing and able to complete the baseline and 3-month clinic visits

Exclusion Criteria:

* \> 80 years of age
* \< 18 years of age
* Recent (past 6 months) stroke/myocardial infarction or congestive heart failure/documented ejection fraction \< 40%
* Plans to undergo a major surgical procedure in the next 6 months
* Presence of dementia or major psychiatric disease that would preclude participation in a group-based exercise program
* Pregnant women or women intending to become pregnant
The Individualized Stepwise Treatment Mode of Adolescent Idiopathic Scoliosis

Based on the risk factors affecting adolescent scoliosis found in the previous social survey, this project adopts the paradigm based on transfer learning and semi-supervised learning, and uses mathematical methods such as multiple learning methods and Transformer image classification algorithms to develop and verify the early warning model and stepped treatment model of adolescent scoliosis, and conducts cost-effect analysis.

This study intends to build a standard system for the prevention and treatment of scoliosis in adolescents, do a good job in school health education and prevention and control work in school, comprehensively strengthen the construction of the prevention and control system of spondylosis, improve the ability of professionals in medical institutions, and give full play to the role of home-school-medical in the prevention and control of abnormal spinal curvature in children Firstly, relying on the investigation report, we independently develop the software platform and physical device for measuring, preventing and correcting scoliosis. Secondly, we use a series of prevention and control advantages to change from passive to active. Based on the Internet and big data technology, we integrate Western medicine data management and monitoring technology to establish the characteristics of the disease General disease information (personal history, family history, solar terms, climate and environment detection indicators, etc.) as one of the health management platform, the management platform set up health archives disease risk early warning health intervention and health promotion education follow-up management system management data quality control review data analysis and visualization 9 modules, respectively set up a management platform patient-side physician side and management background 3 parts through sampling investigation clinical research, break the medical school barriers, to build a personalized step treatment model for adolescent scoliosis.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of moderate and mild AIS, with a Cobb angle measuring less than 45°;
2. The age range of 12 to 16 years old;
3. Participants are required to have no history of mental illness, possess normal communication skills, and be proficient in reading and writing;
4. Signed informed consent by the patient or their family.

Exclusion Criteria:

Patients who fulfill any of the following conditions will be excluded a clear history of inducement, such as diseases caused by trauma, surgery, cognitive impairment, severe dysfunction of heart, liver, kidney and other organs, and malignant tumors, immune diseases and other malignant diseases.
Assessment of a New Goldmann Applanation Tonometer

The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.

The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.

The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.

The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.

Patients at the Department of Ophthalmology, University of Bern, will be included after informed consent. The study has been approved by the local ethical committee. Routine ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements will be taken with the two tonometers in random order. Prior to pressure measurement, central corneal thickness will be measured with a non-contact method (Optical Low Coherence Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* patient willing to participate and signed informed consent

Exclusion Criteria:

* patient under 18 y of age
* patient pregnant
* not steady fixation, nystagm
* corneal scars or corneal disease
* astigmatism higher than 2.5 diopters
* corneal surgery in the past
* microphthalmos or buphthalmos
* contact lens wear
* dry eye syndrome
* blepharospasm
* active inflammation of conjunctiva, cornea or uvea
* known allergy to topical oxybuprocain for topical anaesthesia
* known allergy to fluorescein solution (used for applanation tonometry)
Cancer Related Fatigue in Patients Receiving Chemotherapy

The purpose of this study is to examine the degree of fatigue in patients receiving chemotherapy. Special interest goes out to the course of fatigue throughout five treatments and the actions taken by patients to reduce this fatigue.The correlation between fatigue and haemoglobin will also be subject of study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer requiring chemotherapy treatment

Exclusion Criteria:

* Pregnancy
* Psychological illness
* Life expectancy less than three months
* Lack of basic proficiency in Dutch
A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
* Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
* No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).

Exclusion Criteria:

* Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
* Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

This trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

The orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. Most patients are diagnosed between the age of 20-40 years. In sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. Sarcoidosis invalidates the lives of most patient for many years.

Although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. These symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. However, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. This wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking.

This project examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis, confirmed by histology or cytology
* Age 18-60 years
* No affected organ requiring high dose immunosuppressive therapy
* Short Form - 36 subscale physical functioning score \< 70 points

Exclusion Criteria:

* Allergy to corticosteroids
* Diagnosis of glaucoma, osteoporosis, history of fractures
* History of gastric ulcera in the past 12 months
* Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor
* Current use of carbamazepin, fenytoin, rifampicin
* Obesity (BMI \> 30)
* Pregnancy of lactation
Metal Ion Concentration Between Coated and Uncoated TKA

Metal ion release from metal implants may have side effects. It can be reduced by coating of the implant. This study compares coated and uncoated TKA.

Patients are randomized to receive a coated or uncoated TKA. Patients are assessed before surgery, after 3 month, 1 year and 5 years.

Blood samples are collected in 7.5 ml S-Monovette® tubes (for trace metal analysis, Sarstedt AG, Germany) using a specific steel needle for trace metal analysis (Sarstedt AG, Germany). Within one hour, plasma was separated by centrifugation at 2500g for ten minutes. Samples were stored at -20°C before being analysed for chromium, cobalt, molybdenum and nickel content using a graphite furnace atomic absorption spectrometer Z-8270 with Polarisation-Zeeman-Absorption (Hitachi Ltd., Japan). The accuracy and precision of the method is validated to \< 10% using the control materials SeronormTM Trace Elements Serum (SERO AS, Norway). The detection limit of the method is estimated at 0.5µg/l for chromium, cobalt and molybdenum, 1.0µg/l for nickel (mean + 3 standard deviations from buffer). All probes having ion levels below the detection limit were adjusted to 0.25µg/l for chromium, cobalt and molybdenum and 0.5µg/l for nickel.

Clinical outcome is measured with the Knee Society Score, Oxford Knee Score, Short-Form 36 and University of Los Angeles Activity Score.

Eligibility Criteria:
Inclusion Criteria:

* indication to TKA
* no other metal implant

Exclusion Criteria:

* no informed consent
* not able to understand study and/or questionnaires
* Need of a higher constrained implant
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer

The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
2. Age ≥ 18 years at the time of informed consent signing.
3. Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
4. ECOG PS: 0-2 points;
5. The expected survival time was more than 3 months;
6. Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:

   1. Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
   2. Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
   3. Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
   4. Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
7. Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.
8. Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.

Exclusion Criteria:

1. Prior TROP2-targeted treatment was administered.
2. Patients with active oral mucositis or oral ulcers were excluded.
3. Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
4. Other conditions where the investigator determines the patient is unsuitable for study participation.
Expression of VEGF-C and VEGF-CR in Oral Cancers and Premalignant Lesions

The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and premalignant lesions

The role of vascular endothelial growth factor-C (VEGF-C) and its receptors induced lymphangiogenesis and host inflammatory responses on the carcinogenesis of oral cancers and premalignant lesions

Eligibility Criteria:
Inclusion Criteria:

* oral cancer and oral precancer specimens

Exclusion Criteria:

* other diseases
The Impact of Rehabilitation on Quality of Life in Visually Impaired

The project has four primary objectives: 1) Determine if blind rehabilitation improves the quality of life of legally blind veterans; 2) Determine the relationship between quality of life and visual function; 3) Determine if factors, such as cognitive status, level of depression, age and the presence of additional medical conditions besides vision loss, intervention of blind rehabilitation extends beyond the visually impaired individual and improve the quality of life of their primary caregiver (e.g. spouse, partner, family member or friend.)


Eligibility Criteria:
Visually impaired
Citicoline & Antioxidants in Glaucoma

To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of POAG
* aged between 18 and 75 years
* Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
* myopia less than 5 diopters (D) were considered eligible for inclusion.

Exclusion Criteria:

* IOP levels exceeding 21 mmHg,
* hyper-sensitivity to citicoline,
* a history of optic neuritis,
* previous glaucoma or retinal surgery,
* prior cataract or refractive surgery,
* macular degeneration or other retinal disorders,
* any systemic diseases that could potentially lead to neurodegeneration (e.g., multiple sclerosis, diabetes)
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

This study included a randomized treatment phase, followed by an extension phase. The treatment phase lasted from Study Day 1 (day of randomization) to the occurrence of a protocol-specified progressive disease event or study conclusion, whichever came first. The extension phase (including crossover of control group patients) lasted from the progressive disease event until the earliest of the following events: a) the patient was no longer receiving clinical benefit, b) the patient chose to withdraw from the study, or c) the study ended. All patients received ruxolitinib in the extension phase of the study. Maximum individual patient duration was 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World Health Organization criteria
* Subjects with MF requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an ECOG performance status of 0, 1, 2 or 3
* Subjects with peripheral blood blast count of \< 10%.
* Subjects who have not previously received treatment with a JAK inhibitor

Exclusion Criteria:

* Subjects with a life expectancy of less than 6 months
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with any history of platelet counts \< 50,000/µL or ANC \< 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months
Study of Chidamide, Decitabine and Immune Checkpoint Inhibitors in R/R NHL and Advanced Solid Tumors

This phase I/II trial aims to evaluate safety and efficacy of Chidamide, Decitabine and Immune checkpoint inhibitors in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.

Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Low-dose decitabine inhibits the activity of DNA methyltransferase, which can increase the expression of tumor antigens and HLA molecules, enhance antigen processing, promote T cell infiltration, and boost effector T cell function. Immune checkpoint inhibitors (ICIs) have emerged as effective therapies for many cancers by promoting the reactivation and restoring function of T cells. In conclusion, we speculate that the chemotherapy free regimen of Chidamide, Decitabine and Immune checkpoint inhibitors may explore a new avenue for therapeutic intervention in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. 16 to 80 years of age.
2. ECOG performance of less than 3.
3. Life expectancy of at least 3 months.
4. Histopathological confirmed Non-Hodgkin Lymphoma and solid tumors.
5. Patients are relapsed/refractory Non-Hodgkin Lymphoma with ineligible for autologous hematopoietic stem cell transplantation.
6. The guidelines（ASCO/CSCO）recommend patients to participate in clinical trials.
7. Subjects must have at least one measureable target lesion.
8. Willingness to provide written informed consent for the study.

Exclusion Criteria:

1. Active, known or suspected autoimmune diseases.
2. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
3. History of severe hypersensitive reactions to other monoclonal antibodies.
4. History of allergy or intolerance to study drug components.
5. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
6. History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
7. Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
8. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
9. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
10. Vaccination within 30 days of study enrollment.
11. Active bleeding or known hemorrhagic tendency.