cyrilzakka/clinical-trials huggingface dataset:
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 (inclusive), male or female;
* Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition);
* At least one measurable lesion (according to RECIST v1.1)
* ECOG performance status score of 0 -1;
* Life expectancy ≥ 12 weeks;
* Fully understand this research and voluntarily sign the ICF.

Exclusion Criteria:

* Diffuse liver cancer；
* Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
* Pregnancy or lactation；
* Patients with extrahepatic diffusion；
* Spontaneous tumor rupture；
* Expected non-compliance.
Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain

The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.

Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life.

Physical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain.

Thus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach.

The study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.

Eligibility Criteria:
Inclusion Criteria:

* chronic neck pain for at least 6 months
* reduced physical neck function (NDI minimum 10)
* pain primarily in the neck region,
* finished any medical /radiological examinations
* able to read and understand Danish and
* able to participate in the exercise program.

Exclusion Criteria:

* radiculopathies upper extremity
* neurological deficits
* in a process of examining for unknown pathology,
* experimental medical treatment,
* being in a unstable social situation
* pregnancy
* fractures
* suffering from depression
* other known coexisting medical conditions which would severely restrict participation in the exercise program
Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease

The aim of the study will be to evaluate shear stress and blood flow parameters in lower limb arteries during arm cycle ergometer exercise in participants with peripheral artery disease. Twenty patients participants with peripheral artery disease and claudication symptoms will be recruited. Participants will perform 3 experimental sessions in random order. Iarm-cranking (15 sets of two minutes exercise), warm water foot immersion, and control. During the interventions, blood pressure and heart rate will be assessed every 6 minutes. Measurements of arterial diameter, blood flow, anterograde and retrograde shear stress of the femoral artery will be evaluated using a two-dimensional ultrasound device with spectral Doppler.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of peripheral artery disease or ankle-brachial index less than 0.90 in one or both limbs
* do not present peripheral neuropathy;
* be able to exercise after medical approval
* aged 50 or over.

Exclusion Criteria:

* Medication change during the study
* Health problems that contraindicates the practice of physical exercise.
Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer

Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.

A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mGC and predict atypical tumor responses. Molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort B, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level.

In addition, CSCs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
* Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria;
* Written informed consent.

Exclusion Criteria:

* Previous chemotherapy for metastatic disease;
* Comorbidities not controlled with adequate medical therapy;
* Brain metastases;
* Patient unable to give adequate consent to the study.
Efficacy of Trans Abdominis Plane Block for Post Cesarean Delivery Analgesia

Relief from pain is part of the fundamental human right to health. (1) However, available evidence indicates an increasingly detailed understanding of the pathophysiology of pain and general inadequacy of its treatment.

Background: Relief from pain is part of the fundamental human right to health. (1) However, available evidence indicates an increasingly detailed understanding of the pathophysiology of pain and general inadequacy of its treatment.

Rationale: Assessment and Improving the Pain Management Modality

Study objectives: In this study, determined the efficacy of TAP block in patients undergoing cesarean section.

Methods:

This study is a cross-sectional study. It is a multi-centric study as it was conducted in different Governmental hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-50 years
2. Patients of \>50 kg or \<100 kg weight.
3. Urgency: Elective, Emergent and Urgent cases

Exclusion Criteria:

1. Patients of \<50 kg or \>100 kg weight
2. Any contraindication to any of anesthesia medications
3. Patient unable to understand numeric rating scale (NRS)
Effect of Kangaroo Care on Heart Rate Variability

Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants between 32 t0 35 weeks old
* After 7 days of extra-uterine life

Exclusion Criteria:

* Sepsis, infection
* Cardiac disease
* Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis
Dietary Fiber for Fecal Incontinence

The primary aim of this study was to compare the effects of supplementation with one of three dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal incontinence (FI), symptom intolerance, and quality of life in community-living individuals who have incontinence of loose or liquid feces. A secondary aim was to explore the possible mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency, water-holding capacity or gel formation).


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* living in the community (not a nursing home or assisted living facility)
* self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period
* toilets independently
* ability to read and write in English.
* Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI criteria were also eligible.

Exclusion Criteria:

* difficulty swallowing,
* a gastrointestinal (GI) tract altered by surgery,
* a malabsorption disorder,
* inflammatory bowel disease,
* gastrointestinal cancer or active cancer treatment,
* allergy to the fibers,
* regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications.
* a score ≤24 on the Mini Mental State Examination
* having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period
Patient-related Effects of Primary Nursing

After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW. PP plan, coordinate and evaluate the nursing carried out. In the further course, an examination between the project ICU and another ICU without PP with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out.

The primary goal of this pilot study is to test the feasibility of a large-scale RCT with patient-related outcomes.

After a one-year phase of development, primary nursing (process-responsible nursing; PP) has been practically implemented on a pilot ICU since January 2022 at the Heart and Diabetes Center NRW.

Previously, the system of room care (standard care) was carried out. PP plan, coordinate and evaluate the nursing carried out. In addition, they take on the care responsibility for a maximum of two patients and also carry out the care at the same time. In the further course, an examination between the project ICU and another ICU with a focus on thoracic and cardiovascular surgery (surgical ICU) is to be carried out.

The primary goal of this pilot study is to test the feasibility of a large-scale RCT. For this purpose, the duration of delirium after the introduction of a PP on the project ICU should be compared with the previous care organization as standard care in a surgical ICU. Secondary goals e.g. include: the incidence of delirium, anxiety, as well as the satisfaction of the relatives and the effects of PP on nurses are shown.

Eligibility Criteria:
Inclusion Criteria:

* All patients are included who are at least 65 years old,
* understand German language,
* whose health insurance company has concluded a quality contract with the Heart and Diabetes Center NRW (HDZ NRW),
* Elective thoracic and cardiovascular surgery,
* Intensive care for at least three days on ICU.

Relatives:

* at least 18 years old,
* patients have to receive PP.

Focus group interview with nurses of the intervention-ICU:

* Nurses have to be at least 18 years old,
* Nurses belong the the intervention-ICU.

Exclusion Criteria:

Patients who

* are \< 65 years old,
* whose health insurance company has not concluded a quality contract with the HDZ NRW,
* cannot be admitted due to allocation by randomization and a lack of free bed on the destination ICU,
* have not given their informed consent,
* cannot participate in the CAM-ICU screening due to neurological diseases,
* in whom the screening using CAM-ICU could not be carried out over the entire intensive care stay and/or
* belong to the target group but stay less than three days after their elective operation in the ICU.

Relatives:

* not at least 18 years old and/or
* the patients do not receive PP.

Focus group interview with nurses of the intervention-ICU:

* Nurses who are not at least 18 years old and
* Nurses do not belong to the intervention-ICU.
A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)

The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. First or second progression of Glioblastoma;
2. Measurable disease by RANO criteria at progression;
3. Patients ≥18 years of age;
4. Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;
5. Surgery completed at least 28 days before randomization;
6. An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
7. Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
8. Adequate renal, liver, and bone marrow function according to the following criteria:

   * Absolute neutrophil count ≥1500 cells/ml,
   * Platelets ≥ 100,000 cells/ml,
   * Total bilirubin within upper limit of normal (ULN),
   * Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
   * Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),
   * PT, PTT (in seconds) not to be prolonged beyond \>20% of the upper limits of normal.

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab, aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.);
2. Prior stereotactic radiotherapy;
3. Pregnant or breastfeeding patients;
4. Concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids;
5. Active infection;
6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
7. Expected to have surgery during study period;
8. Patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months);
9. Patients with known proliferative and/or vascular retinopathy;
10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune);
11. Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening;
12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the last 6 months;
13. Patients that have undergone major surgery within the last 4 weeks before enrollment;
14. Patients who have received treatment with any other investigational agent within 4 weeks before enrollment.
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for bilateral LASIK surgery
* Patient is in good general health
* Eye glasses prescription of -1 to -8

Exclusion Criteria:

* Significant Dry Eye
* Presence of eye disease
* Uncontrolled systemic disease
Phenotypic and Genetic Factors in Autism Spectrum Disorders

The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

Participation in this research study involves two research visits, at least one of which is at Children's Hospital Boston. The first visit lasts about 4-6 hours. On this visit, the child will work with a research assistant on a few different cognitive assessments while one or both parents answer interview questionnaires about the child's development, along with other family history information. The second visit at the hospital lasts about 2 and a half hours and involves medical history and family history questionnaires, as well as height, weight, and head circumference measurements and a blood draw from each family member. In addition, digital photographs will be taken of each family member and a 3-D picture of the child's face will be taken. Shortly after the visits, participants will receive a research report of our observations. These results include cognitive, behavioral, developmental, and social findings. The total time commitment for the study is 6 to 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray)
* Age ≥ 18 months

Exclusion Criteria:

* Presence of a metabolic disorder
* Acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy
Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* HCC, proven by histology or according to EASL criteria
* Intermediate stage HCC (stage B according to BCLC)
* At least one measurable lesion in magnetic resonance imaging (MRI)
* Tumor load ≤ 50%
* preserved liver function (Child Pugh A and B)

Exclusion Criteria:

* Patients feasible for curative treatment (e.g. resection or local ablation)
* Previous TACE or SIRT
* Chemotherapy during the last 4 weeks
* Child Pugh stage C
* BCLC stage D
* ECOG Performance Status \>0
* Tumor involvement \>50% of the liver
* Extrahepatic tumor
* Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml
* Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
* Esophageal bleeding during the last 3 months
* Hepatic encephalopathy
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Infiltration or occlusion of the portal vein
* Hepatofugal blood flow in the portal vein
* Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
* Contraindications against angiography
* Gravidity
Treatment for Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified Modification of Diet in Renal Disease (MDRD) equation 9, 10 : eGFR = 186 x \[serum creatinine\]-1.154 x \[Age\]-0.203 x \[0.742 if subject is female\] x \[1.212 if subject is black\] - Clinically stable, in the judgment of the investigator - Mean Hb greater than or equal to 11.0 g/dL to less than or equal to 13.0 g/dL (mean of 2 values drawn at least 3 days apart during the screening period) - Transferrin saturation (Tsat) greater than or equal to 15.0% - Serum vitamin B12 and folate levels above the lower limit of the normal range - Receiving stable Q2W subcutaneous (SC) doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period Exclusion Criteria: - Prior recipient or scheduled to receive a kidney transplant - Diastolic blood pressure (BP) greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening - Acute myocardial ischemia - Hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - Parathyroid hormone level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study