cyrilzakka/clinical-trials huggingface dataset:
GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC


Eligibility Criteria:
Key Inclusion Criteria:

1. Signed written informed consent form (ICF).
2. Age of ≥ 18 years at the time of enrollment.
3. Histologically confirmed classic Hodgkin's lymphoma (cHL).
4. Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
5. Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
6. Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. Life expectancy of ≥ 12 weeks.
9. Have adequate hematologic and organ function .

Key Exclusion Criteria:

1. Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
2. Central nervous system lymphoma invasion.
3. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
4. Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways.
5. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
6. Subjects with other malignancy within 5 years prior to the first dose of study treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of the skin.
7. Have received chemotherapy, radiotherapy, molecular-targeted therapy or major surgery within 4 weeks prior to the first dose of study treatmen; Clinically significant AE associated with previous treatment has not returned to baseline or ≤1 (except hair loss).
8. Pregnant or breast-feeding women.
9. Patients are unsuitable for the study evaluated by investigator.
Validity and Reliability of the MAP-Hand Scale in Patients With Carpal Tunnel Syndrome

The primary aim of the study was to determine the validity and reliability of the "MAP-Hand (Measure of Activity Performance of the Hand)" scale in patients with carpal tunnel syndrome. The secondary aim of the study was to evaluate the hand activity performance in patients with carpal tunnel syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and above and able to read and write
2. Diagnosed with mild or moderate unilateral CTS according to electroneuromyography results at least 6 months ago
3. Motor-sensory symptoms such as numbness and loss of strength in the hand for at least three months
4. Volunteers with no history of diabetes, no medical treatment or injections, no surgery, and no cervical radiculopathy or polyneuropathy

Exclusion Criteria:

1. Those with trauma, deformity, fracture, muscle contracture and atrophy in the shoulder, forearm and hand
2. Those who have received corticosteroid injections into the carpal tunnel area within the last three months and have been included in a physiotherapy program
3. Those who have cognitive problems
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer

HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.

HS-10342-201 is a single- arm, open- label, multicenter, phase 2 study in patients with hormone receptor positive (HR positive), human epidermal growth factor receptor 2 negative (HER2 negative) advanced and/or metastatic breast cancer who have had disease progression after endocrine therapy. The efficacy is evaluated as monotherapy, and the primary endpoint is ORR.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of Hormone Receptor Positive(HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
2. Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
3. Prior treatment with chemotherapy regimens, No more than 2 prior chemotherapy regimens in the metastatic setting.
4. At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
5. recovered from the acute effects of therapy with toxicity resolving to baseline or grade 1 except for residual alopecia and peripheral neuropathy.
6. Adequate function of major organs.

Exclusion Criteria:

1. Has received or is undergoing the following treatments:

   1. Currently receiving or have received any CDK4/6 inhibitors;
   2. Receiving/received antitumor therapy within 14 days or 5 half-lives, before the initial dose whichever is the longer;
   3. Radiotherapy with a limited field of radiation for palliation within 14 days of the initial dose of study drug, or received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 28 days of the initial dose.;
   4. Major surgery within 4 weeks of the initial dose of study drug;
   5. Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment. Meningeal or brainstem metastases. Spinal cord compression;
2. Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
3. History of other primary malignancies.
4. Participating in other clinical studies.
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).


Eligibility Criteria:
Inclusion Criteria:

* Heterogeneous emphysema as determined by high-resolution CT scan
* Scheduled for clinically indicated ELVR procedure

Exclusion Criteria:

* Hyperexcretive chronic bronchitis or excessive sputum secretion
* Active pulmonary infection
* Active asthma or lung hyper-responsiveness
Step Up for STEM and Health Careers

The goal of this randomized controlled trial is to evaluate "Step Up for STEM and Health Careers". The "Step Up for STEM and Health Careers" ("Step Up") game is an interactive, digital resource that includes the key elements of a bystander intervention for high school students to understand the importance of diversity in STEM; it also addresses skills, attitudes, and awareness to attain positive STEM identities and mitigate bias and harassment in STEM and health learning environments.

Participants in the intervention arm will be asked to complete the Step Up interactive game; participants in the comparison group will be asked to view a PowerPoint presentation on bias and harassment in STEM/health fields as the control experience. The Step Up game intervention and study outcomes are theory-based (Theory of Planned Behavior, Social Cognitive Career Theory (SCCT)): we will assess the impact of Step Up on attitudes about STEM/health careers, STEM/health career self-efficacy, and bystander behavior.

The goal of this randomized control trial is to evaluate the impact of the "Step Up for STEM and Health Careers" intervention game on STEM/health career and bystander attitudes, as well as self-efficacy. Participants will be randomly assigned to participate in either the Step Up intervention game or the educational PowerPoint presentation.

The "Step Up for STEM and Health Careers" intervention consists of students playing a "Step Up" game to help them understand the importance of diversity in STEM and health careers, attain STEM/health career self-efficacy, and create an inclusive learning environment for others. The control group consists of an educational PowerPoint presentation on the importance of diversity in STEM and health careers, STEM/health career self-efficacy, and creating an inclusive learning environment for others.

The Step Up intervention game (created by Resilient Games Studio (RGS)) consists of six digital episodes that focus on a specific topic: importance of diversity in STEM careers, heuristics and biases, structural biases and intersectionality, harassment, sexual harassment, and bystander behaviors. Each episode includes interactive mini-games to teach theory-based skills and lessons. Adult characters, who serve as "in-game" STEM/health role models, are integrated throughout the game. The game was built based on the Theory of Planned Behavior (TPB) and the Social Cognitive Career Theory (SCCT) to improve STEM/health career and bystander attitudes, as well as self-efficacy.

The educational PowerPoint presentation on bias and harassment in STEM/health fields was also created by RGS and will be used as a control experience for adolescent participants. The PowerPoint presentation will contain sections that correspond to each of the episode topics of the Step Up intervention game.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Access to a computer and internet connection
* Live in Chicago Metropolitan Area
* Current high school student (enrolled in grade 9-12); or in 12th grade in 2023-2024 school year

Exclusion Criteria:

-
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer

Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.


Eligibility Criteria:
Inclusion Criteria:

* Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion Criteria:

* Manifestation of hypersensitivity to any component of the product
* Uncooperative patients
* Severe infection
* Debilitating diseases
* Steroid treatment
* Pregnancy
The Role of Licensing in Early Care and Education: Licensed Providers

Child Trends, funded by the Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for The Role of Licensing in Early Care and Education (TRLECE): Licensed Child Care Providers project. The goal of this information collection is to deepen the field's understanding of child care and early education licensing systems, which play a critical role in supporting positive outcomes for providers, families, and children. The investigators will conduct one round of survey data collection with a nationwide survey of licensed child care providers from all states.

This study aims to advance understanding of the landscape of child care and early education licensing systems. State/territory child care and early education licensing agencies establish and monitor regulations that child care programs serving young children must meet to operate legally. These regulations and monitoring practices play a large role in the operations of child care programs but have received relatively little research attention. The field has limited information about features of state/territory licensing units and limited information about child care and early education providers' experiences and perceptions of licensing (i.e., there are a few findings from individual states but no national survey). Ultimately, TRLECE: Licensed Child Care Providers findings can inform changes to licensing policies and practices in the child care and early education field, guidance and technical assistance to state leaders, and future research.

The investigators will gather information for this descriptive study through a survey of licensed child care provider. This survey is designed to collect information about licensed child care and early education providers' experiences with child care licensing, including regulations and inspections; perceptions of the burden, value, and fairness of the licensing system; and perceived strengths of and challenges with the licensing system. The investigators intend to invite a stratified random sample of directors of center-based programs and family child care providers from all 50 states and the DC to participate and will aim to have 1,000 participants from each group.

Eligibility Criteria:
Inclusion Criteria:

* A randomly selected group of directors/owners/managers of licensed child care programs (providers) in all U.S. states and DC

Exclusion Criteria:

* Individuals who are not directors/owners/managers of licensed child care programs (providers) in all U.S. states and DC
A Comparison of European and Chinese Blood Sugar Responses

This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow European parents and likewise for the Chinese participants).

100 participants (50 European and 50 Chinese) will attend a lab after an overnight fast and have a capillary finger-prick blood test to assess fasted blood glucose levels and then consume a 50 gram glucose solution. Blood test will be repeated at 15, 30, 45, 60, 90 and 120 minutes post consumption of the glucose solution. This test will be repeated on a spate occasion at least a week later than the first test. Participants will only take part in the experiment after singing informed consent and agreeing to take part in the study and after a medical screening questionnaire assessing that they are non-diabetic or haemophiliac or have blood born infections.

Eligibility Criteria:
Inclusion Criteria:

* European ethnicity
* Chinese ethnicity
* age 19-59 years

Exclusion Criteria:

* diabetics
* serious blood born infection
* haemophilia
Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction

Observational study of preterm infant with a gestational age \< 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Gestacional Age \< 30 weeks

Exclusion Criteria:

* Brain malformation
* Genetic syndrome
* Metabolic disorders
* Chromosomal abnormality
* None cranial ultrasound
A Study on the Effects on Glucose Regulation, Inflammation and Serum Lipids After Fish Protein Supplementation in Elderly (GRIPE)

The elderly population have and increased risk of loss of both muscle mass and function and is therefore recommended a higher protein intake than the healthy adult population. These age-related changes in muscle function may be explained by chronic low-grade inflammation and insulin resistance. Despite the recommendation of a higher protein intake, little is known about how different protein sources may affect the metabolic health in this population. Analysis of amino acid composition show that fish can be a good protein source for humans. Many fish species are today used as feed ingredients, rather than a protein source for humans. A few studies conducted in humans and rats show that proteins from fish may improve glucose tolerance, reduce inflammation and improve lipid metabolism, indicating that proteins from fish may not only serve as a valuable nutrient but could also hold specific health promoting properties.

The present study will investigate the effects of a protein hydrolysate from blue whiting, a fish species normally used to produce fish meal for aquaculture industry, on glucose homeostasis, inflammation and serum lipids in elderly nursing home residents.

Participants receive 6g per day of protein hydrolysate from blue whiting as protein powder mixed with a non-caloric juice for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* \>60 years
* both genders
* nursing home resident

Exclusion Criteria:

* life expectancy \< 6 months
* severe cognitive impairment
* allergies towards fish, milk, egg
* weight loss \>5% last 3 months
Phase I/II Study of Retroviral-Mediated Transfer of Iduronate-2-Sulfatase Gene Into Lymphocytes of Patients With Mucopolysaccharidosis II (Mild Hunter Syndrome)

OBJECTIVES: I. Evaluate the safety and feasibility of treating mucopolysaccharidosis II (mild Hunter syndrome) by lymphocyte gene therapy.

II. Determine the levels of iduronate-2-sulfatase enzyme in these patients attained by infusing increasing doses of lymphocytes transduced with a retroviral vector designed for insertion and expression of this iduronate-2-sulfatase gene (L2SN).

III. Determine the duration of survival of these transduced cells in these patients.

IV. Determine whether monthly infusion of L2SN-transduced lymphocytes accomplishes metabolic correction (as measured by glycosaminoglycan excretion), decrease in liver or spleen volume, any therapeutic effect upon cardiac and pulmonary dysfunction, or any other effects from treatment.

PROTOCOL OUTLINE: Peripheral blood lymphocytes are harvested from patient by apheresis, stimulated to initiate the growth of T-lymphocytes, transduced with retrovirus L2SN containing iduronate-2-sulfatase, and reinfused into the patient.

Patients receive 12 monthly infusions of these retroviral-mediated gene transduced lymphocytes with the first three infusions in a dose escalation format.

Patients are monitored for at least 2 hours after completion of each infusion. Patients are followed at 1 year after treatment, and then until death.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Mucopolysaccharidosis II (mild Hunter syndrome) as defined by the following:

* Characteristic coarse facial features, hepatosplenomegaly, and radiographic evidence of dysostosis multiplex
* Elevated urinary excretion of glycosaminoglycans in 3 urine specimens
* Deficient iduronate-2-sulfatase enzyme activity as measured in plasma and leukocytes
* Mutation consistent with mild Hunter syndrome must have either: A single base substitution of the coding sequence not previously associated with severe Hunter syndrome phenotype OR An exon-skipping mutation that would allow for occasional production of (minimal amounts of) normal protein

--Patient Characteristics--

Cardiovascular: No severe cardiac disease

Pulmonary: No severe respiratory disease

Other:

* Must have IQ score of 80 or higher
* Effective contraception required of all fertile patients
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care

The main objective of the proposed study is to assess the effectiveness, feasibility and costs of a tailored strategy (developed in accordance with the barriers found and current practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a common strategy of 'audit \& feedback'.

In a previous study among 22 Dutch hospitals many gaps in the care for patients with non-Hodgkin's lymphomas (NHL) were found, compared to best evidence as described in guidelines. In a problem analysis study, barriers and facilitators for good quality of NHL-care were assessed and a tailored implementation strategy was developed, based on these findings. The proposed study aims at the effectiveness, feasibility and costs of this tailored strategy to improve quality of care for patients with an NHL in a clustered randomized controlled trial in 19 Dutch hospitals.

Multilevel regression analyses will be performed to evaluate the effectiveness of both strategies. Exposure to and experiences with the strategy elements will be analysed descriptively.

Regarding the costs, the two strategies are compared with a health care perspective. The input of resources will be assessed by collecting volumes of consumed resources and multiplying these by the price of each resource unit; the implementation process and consequently costs will be estimated by an Activity Based Costing (ABC) approach. The output will be determined by the level of adherence to the NHL quality indicators.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-Hodgkin lymphoma
* Diagnosed in one of the participating hospitals
* Able to read and understand Dutch
BIOSTREAM.HF HeartInsight

The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.


Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to give consent
* Participation in BIO\|STREAM.HF
* HeartInsight-capable CRT-D device implanted or planned to be implanted
* Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment
* HeartInsight score available or planned use of HeartInsight
* History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure
* Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage

Exclusion Criteria:

* Patient with permanent atrial fibrillation or 100% atrial pacing
* Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
* History of patient incompliance