cyrilzakka/clinical-trials huggingface dataset:
Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer

The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma.

The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan, endoscopic ultrasonography (EUS), endoscopy and esophagography.

Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin.

Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed cases histologically as squamous cell carcinoma,
* a performance status 0 to 2,
* white blood cells \>3,000/microL,
* platelets \>100,000/microL,
* serum total bilirubin \<2.0 mg/dl,
* serum transaminase \<3 times the upper normal limit,
* serum creatinine \<1.5 mg/dl,
* creatinine clearance \>60 ml/min

Exclusion Criteria:

* serious cardiac disease
* prior chemotherapy and radiotherapy
The Efficiency of the Central Venous Catheter Care Protocol

The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, which was created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

Hematopoietic stem cell transplantation (HSCT) is one of the important treatment approaches that prolongs survival in patients with hematological malignancies, immunodeficiency and some solid tumors. Despite advances in the treatment process, reasons such as recurrence of the underlying disease, organ toxicities and infectious complications adversely affect treatment success. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and useful in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications.

Central venous catheters (CVC) are one of the main applications of modern clinical treatment. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and valuable in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications. The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

This research is a pretest-posttest quasi-experimental clinical study. It is conducted with 60 patients between January 2022 and December 2023. The data is collected with Patient Information Form and Daily Patient Evaluation Chart. No application will be made to 30 patients in the control group, and catheter care will be provided to the patients of the intervention group in line with the CVC Care Protocol created by the researchers.

Eligibility Criteria:
Inclusion Criteria:

* Being hospitalized by the Medical Oncology Clinic at in a training and research hospital to become an Autologous HSCT,
* The patient has an 8F-size, two-lumen temporary CVC,
* Over 18 years of age
* There is no communication problem,
* Agreeing to participate in the research voluntarily after being informed about the study,

Exclusion Criteria:

* Using a vascular access method other than an 8F size two-lumen temporary CVC in the patient,
* Refusal to participate in the research voluntarily after being informed about the study,
* Identification of a different focus of infection in the patient.
Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle

The menstrual cycle is governed by hormonal changes. Each cycle can be divided into three phases based on events in the ovary (ovarian cycle) or in the uterus (uterine cycle).

H0: There will be no correlation between pelvic pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between low back pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between pelvic pain and low back pain in healthy young women during the menstrual cycle

Thirty-five female patients participated in this study. They were randomly assigned to the study. The outcome measures were pelvic pain assessed using the functional pelvic pain scale, low back pain assessed using the back pain functional scale, and postural stability assessed using the Biodex balance system.

Eligibility Criteria:
Inclusion Criteria:

1. All young females will suffer from pelvic pain, low back pain, and postural instability during the menstrual cycle
2. Age will range from 18 to 22 years
3. All young females will have a BMI range from 25-30

Exclusion Criteria:

1. Lumbar spondylosis
2. Lumbar disc prolapse
3. Sacroiliac joint arthritis
4. Low back trauma
5. BMI more than 30
Centralized Pan-Middle East Survey on the Under-treatment of Hypercholesterolemia, Sub-study for the Gulf States

The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country, to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III in the following sub-populations:

* Primary/secondary prevention patients.
* Patients with metabolic syndrome (according to NCEP III definition). And to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in the following sub-populations:

  * Primary/secondary prevention patients.
  * Patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Race
* On lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
* Subject must sign informed consent

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).

This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of breast malignancy, stage T1
2. Surgical treatment with lumpectomy
3. age 60 or older
4. resection margins negative by at least 2mm
5. any grade
6. ER positive
7. unicentric
8. invasive ductal
9. pathologic free of nodal metastases (N0, i- or i+)
10. Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%

Exclusion criteria

1. Prior radiotherapy to the breast
2. Neoadjuvant chemotherapy
3. multicentric disease
4. Pure DCIS histology
5. Presence of extensive intraductal component
6. Node positive disease (N1 or greater)
Efficiency in 4-week Plyometric Training: Lower Limb Improvement in Sedentary Adults

The goal of this clinical trial is to compare the effects of different volumes of plyometric training on lower limb muscle strength, power, and muscle activity in sedentary individuals. The main question\[s\] it aims to answer are:

* What is the minimum volume of plyometric training that can induce changes in lower limb strength and power variables?
* How does muscle activity in the lower limbs vary with different volumes of plyometric training?

Participants will be asked to:

* Complete questionnaires to determine their level of physical activity.
* Attend pre and post-evaluations of lower limb muscle activity, strength, and power during an instrumented sit-to-stand test.
* Perform lower limb plyometric exercises, such as jumps, hops, and bounds.
* Attend supervised training sessions three times a week for a duration of 4 weeks.

Researchers will compare three groups to see if the minimum volume of plyometric training can be identified.


Eligibility Criteria:
Inclusion Criteria:

* Subjects without lower limb musculoskeletal injuries in the past six months.
* Without previous lower limb surgery in the past two years
* Being sedentary

Exclusion Criteria:

* Medical conditions that could compromise their participation (including cardiovascular disease).
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
3. Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
4. At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm).
5. ECOG PS score of 0 to 2.

Exclusion Criteria:

1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
5. Known central nervous system lymphoma.
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients with Advanced Solid Tumors

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.

Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.

Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.


Eligibility Criteria:
Inclusion Criteria:

1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
2. Aged ≥18 years.
3. Be able and willing to comply with protocol visits and procedures.
4. History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Adequate organ and bone marrow function.
7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

1. Inadequate washout period for prior anticancer treatment before the first dose of study drug.
2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
3. Clinically significant concomitant pulmonary disease.
4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose.
5. Unresolved toxicities from previous anticancer therapy.
6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.
Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19

This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10\^9 exosome particles (per dose) versus Dose 2 - 10\^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19 infection.

The study population will include patients with moderate or severe COVID-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent.

90 patients will be randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients).

The exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (QD) for 5 days.

Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

Eligibility Criteria:
Inclusion Criteria:

1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) within 30 days of screening.
2. Age 18-80 years.
3. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):

   a. Clinical and Imaging-based evaluation i. Respiratory rate \> 23/min and \< 30/min ii. SpO2 at room air ≤94% and ≥90% iii. Bilateral pulmonary infiltrates \>25% within 24-48 hours or a severe deterioration compared to imaging at admission.

   b. Evidence of an exacerbated inflammatory process i. LDH \> 300 U/L or what is the upper limit for normal per age ii. CRP \>25 mg/L iii. Ferritin \>500 ng/ml iv. Lymphocytes \<800 cells/mm3 v. D-dimers \> 500ng/ml
4. Willing and able to sign an informed consent.

Exclusion Criteria:

1. Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
2. Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator's judgment.
3. Previous complete or partial vaccination for SARS-CoV-2.
4. Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding.
5. Participation in any other Interventional study in the last 30 days
6. Active cancer.
T-Cell PET Imaging With [18F]F-AraG in Lung Cancer

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single \[18F\]F-AraG PET exam as part of this study. \[18F\]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of \[18F\]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.

A total of 20 patients will be enrolled over an accrual period of approximately 12 months. Approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort.

Patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Histologically or cytologically documented stage I-IIIA non-small cell lung cancer (NSCLC)
3. Eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of NCT03217071
4. In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study
5. Able to provide informed consent and follow the study guidelines

Exclusion Criteria:

1. Female patients who are pregnant or breastfeeding
Increasing Physical Activity in Older Adults With Osteoarthritis Pain: Examining a Brief Behavioral Intervention

The purpose of this study is to evaluate how older adults might benefit from sessions that teach behavioral coping skills for increasing physical activity and reducing interference from arthritis pain. This study will randomize individuals to receive Engage-PA, or continue to receive treatment as usual. Engage-PA involves two sessions (about 45 minutes each) with a study therapist that teaches individuals behavioral skills for increasing daily steps. These behavioral skills include identifying their personal values and instructions on how to pace their daily physical activity to avoid creating severe pain when walking. All participants in the study will wear small devices that track physical activity such as daily steps throughout the study, which also allow participants to see their daily step counts and overall level of activity. All participants will answer a set of questions about how much arthritis gets the way of many important life activities, their success at living in line with their personal values, and how much thoughts, feelings and body sensations get in the way of living a satisfying life. These questions will be asked at the beginning of the study and 6 weeks into the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* English speaking
* Diagnosis of osteoarthritis in knee or hip
* Able to ambulate even if assisted with ambulatory device such as walker or cane
* Endorse worst pain and pain interference as ≥ 3 out of 10 within the last week

Exclusion Criteria:

* Planned surgery during study duration that would limit mobility (e.g., due to recommended rehabilitation or recovery period) for more than 3 weeks
* Current enrollment in cardiac rehabilitation
* Myocardial infarction in the past 3 months
* Major surgery requiring limited movement or mobility for recovery within the past 3 months
* Presence of a serious psychiatric condition (e.g., schizophrenia, suicidal intent) indicated by medical chart, treating medical provider or other staff, or study staff interactions that would contraindicate safe study participation
* Medical provider indicating that exercise (even walking) should only be medically supervised; as determined by medical record review or patient reported
* Fall or falls within the last 3 months that led to immediate medical treatment/hospitalization
* Reported or suspected moderate or severe cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \<19
Perioperative Management of DIEP Flaps

By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure \> 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.


Eligibility Criteria:
Inclusion criteria:

* Informed consent for study participation
* Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study

Exclusion criteria:

* No informed consent for study participation
* Patients with a high thromboembolic risk profile
* During pregnancy and breastfeeding
* Minors
* Patients with a health care proxy
Test Catheter Pilot Study in Healthy Volunteers

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Male
* Signed informed consent
* Negative urine multistix

Exclusion Criteria:

* Abnormalities, diseases or surgical procedures performed in the lower urinary tract