Kornimate/medical-research-clean huggingface dataset:
feasibility of a life coping program: a study protocol

Conditions: Health Literacy; Health Related Quality of Life; Physical Activity; Pediatric ALL

Summary: the goal of this observational study is to evaluate the feasibility of the intervention life coping program in children and adolescents 8-16 years of age. the main question it aims to answer is: is the life coping program in its current form feasible among children and adolescents with a variety of primary conditions? the health care providers of participants already undergoing the life coping program will answer survey questions after key procedures of the intervention, and the research team will be given access to measures provided by the participants.

feasibility and acceptability of the intervention life coping program will be evaluated in an uncontrolled open-label trial using quantitative measures. sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. feasibility will be assessed by tracking attendance and participation in different parts of the intervention. acceptability of the intervention will be assessed using patient reported experience measures (prem). health related quality of life (hrqol) and level of physical activity will be measured using the kidscreen 27 and actigraph gt3x+ monitor, respectively, at baseline and post-intervention. the study is based on the british medical research council's (mrc) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. the findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the mrc framework for developing and evaluating complex interventions.

Eligibility criteria:
inclusion criteria: * have received treatment at haukeland university hospital * one or more of the following primary conditions: congenital heart defects, congenital oral clefts, premature birth before 32 weeks of gestation, completion of cancer treatment, chronic pain conditions, or significant burn injuries * must be able to answer questionnaires in norwegian exclusion criteria: * medical condition that may hinder og alter participation * treatment plan that may hinder or alter participation
biological markers of treatment response to repetitive transcranial magnetic stimulation for depression

Conditions: Oxidative Stress

Summary: the main objective of this study is to determine whether biological stress markers (oxidized phosphatidylcholines and oxylipins) in the blood can be used to predict the efficacy of rtms in the treatment of major depressive disorder (mdd). it is our goal to identify biomarkers that may be used to determine which patients will benefit from rtms treatment. a second objective of this study is to measure any changes in stress markers that occur across the course of rtms therapy.

250 patients who have been prescribed repetitive transcranial magnetic stimulation (rtms) therapy for the treatment of major depressive disorder will be recruited for this study. prior to undergoing rtms, patients will give a small blood sample. an additional blood sample will be given upon completion of rtms treatment. 60 healthy control individuals will also be recruited to provide a one-time blood sample for comparison. control individuals will not receive rtms treatment. blood samples will be analysed for levels of oxidized phosphatidylcholines and oxylipins. the investigators wish to determine whether there is a difference in the pre-treatment levels of stress markers between individuals who ultimately respond to rtms and those who do not. additionally, the investigators wish to determine whether there is a change in stress markers as a result of rtms treatment.

Eligibility criteria:
patient inclusion criteria: * patients with a major depressive episode * not actively receiving psychotherapy patient exclusion criteria: * history of a psychotic episode * history of neurological illness * head injury * active alcohol or substance abuse * history of a seizure disorder * pregnant control subject exclusion criteria: * history of depression or psychiatric illness * history of a psychotic episode * history of neurological illness * head injury * active alcohol or substance abuse * history of a seizure disorder * pregnant

Keywords: oxidized phosphatidylcholines oxylipins
laser resurfacing versus dermabrasion for scar revision

Conditions: Cicatrix; Dermabrasion; Coagulation, Laser

Summary: dermabrasion has been the historical standard used for resurfacing scars on the skin. recently, fractionated laser therapy has been fda approved for scar resurfacing. this study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.


Eligibility criteria:
inclusion criteria: * post-surgical or post traumatic scar on face or scalp. * age 18 or older * able to read and comprehend english * willing to follow treatment schedule and post treatment care requirements * signed the informed consent form * fitzpatrick skin type i-iii exclusion criteria: * known photosensitivity * taken any medications known to induce photosensitivity in previous three months * taken accutane within past 12 months * pregnant or nursing * currently on topical or oral antibiotics * immunocompromised status * skin type iv or greater

Keywords: cicatrix dermabrasion coagulation, laser
hypofractionated stereotactic radiosurgery in treating patients with large brain metastasis

Conditions: Metastatic Malignant Neoplasm to Brain; Unspecified Adult Solid Tumor, Protocol Specific

Summary: this phase i trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. giving fractionated stereotactic radiosurgery may kill more tumor cells.

primary objective: to demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (hr) delivered in 5 fractions, 2-3 fractions per week. outline: this is a dose-escalation study. patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks. after completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Eligibility criteria:
inclusion criteria: * pathologic proven diagnosis of solid tumor malignancy * one brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.) * recursive partitioning analysis (rpa) class i-ii/ karnofsky performance status (kps) ≥ 70% exclusion criteria: * prior stereotactic radiosurgery (srs) to adjacent lesion such that planning target volume would have received more than 12 gy * rpa class iii (kps \< 70%) * brain metastasis or resection cavity volume \ 6 cm * radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies * concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation) * evidence of leptomeningeal disease by magnetic resonance imaging (mri) and/or cerebrospinal fluid (csf) cytology * current pregnancy * more than 8 weeks between resection and radiosurgical procedure * metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm) * inability to undergo mri evaluation for treatment planning and follow-up

Keywords: brain metastasis
calpeg for newly diagnosed acute lymphoblastic leukemia (all)

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.


Eligibility criteria:
inclusion criteria: * pathologically confirmed philadelphia negative b- or t-cell acute lymphoblastic leukemia, with \>10% peripheral blood or bone marrow lymphoblasts at diagnosis. * treatment and full recovery from arm 1a of the hyper-cvad regimen. * be willing and able to provide written informed consent/assent for the trial. * able to adhere to the study visit schedule and other protocol requirements. * eastern cooperative oncology group (ecog) performance status 0-1. * cardiac ejection fraction ≥ 50% by echocardiography or muga, as measured prior to arm 1a of hyper-cvad. * serum bilirubin and creatinine \< 1.5x upper limit of normal (uln). ast and alt must be \<3x uln. * females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening. a fcbp is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months. * a fcbp must agree to use of two methods of highly effective non-hormonal contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 monthsafter the last dose of study treatment. * male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. men must agree to not donate sperm during and after the study for 3 months exclusion criteria: * induction therapy with any regimen other than hyper-cvad 1a. * diagnosis of l3 type burkitt's lymphoma * clinical evidence of active central nervous system (cns) leukemia. * any major surgery or radiation therapy within four weeks. * diagnosis of down syndrome. * any active infection requiring systemic therapy, including hiv, hepatitis b, and/or hepatitis c. * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severeheart failure (new york heart association class iii-iv). * recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment. * severe comorbid conditions for which life expectancy would be \<6 months. * patients with active (uncontrolled, metastatic) second malignancies are excluded. * is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.

Keywords: a.l.l.
a phase 1 study assessing local cutaneous effects of sb204

Conditions: Acne Vulgaris

Summary: in this study, color (erythema) and ph will be measured on 3 consecutive days after application of 2 doses of sb204 to the cheeks of healthy volunteers.

this study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in ph following 5 applications (twice daily for two days and once daily on the third day) of sb204 2% and sb204 4% twice daily to the face for 3 days.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * women who are pregnant or nursing * subject with known sensitivity to a component of the test materials

Keywords: acne
a study of shr-1826 for injection in combination with other antitumor therapies in subjects with nsclc

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this is an open label, multi-center, multiple dose phase ib/ii study to evaluate the safety, tolerability and efficacy of shr-1826 for injection in subjects with nsclc.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. eastern cooperative oncology group (ecog) score: 0-1. 4. with a life expectancy ≥ 3 months. 5. pathologically diagnosed nsclc. 6. be able to provide fresh or archived tumour tissue. 7. at least one measurable lesion according to recist v1.1. 8. adequate organ function. 9. contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. exclusion criteria: 1. meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. previous or co-existing malignancies. 3. spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. uncontrollable tumor-related pain. 5. have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; minor traumatic surgery within 7 days prior to the first dosing. 6. received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment. 7. unresolved ctcae 5.0\>grade 2 toxicities from previous anticancer therapy. 8. with poorly controlled or severe cardiovascular disease. 9. active hepatitis b and hepatitis c. 10. patients with a history of immunodeficiency. 11. severe infection 30 days before the first dose.
can dexmedetomidine with hyalase augment quality and duration of analgesia when added to lumbar epidural steroid in failed back surgery. randomized double blind study

Conditions: Pain, Neuropathic

Summary: use of dexmedtemodine to augment analgesia in cases of failed back surgery


Eligibility criteria:
inclusion criteria: * age group. 25-75ys old * both sex. * persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence * patients suffering from persistent (\> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (mri) were included for screening and enrollment. exclusion criteria: * diabetic patients. * refusal to participate * mri with disc sequestration, concurrent sacro-ilitis, facet arthropathy . * coagulopathic patients

Keywords: neuropathy
experiences and needs of patients with a high-grade glioma and their caregivers

Conditions: Brain Neoplasms, Primary Malignant

Summary: the purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. semi-structured interviews with patients and caregivers will be conducted and analysed using grounded-theory approach.


Eligibility criteria:
inclusion criteria: * adults * patients with a primary high-grade glioma who are treated with chemo or were treated with chemo * caregivers of patients with a primary high-grade glioma who are treated with chemo or were treated with chemo * able to be interviewed * dutch exclusion criteria: * patients with cerebral metastases * patients and caregivers who withdraw their informed consent * emotionally and cognitive not being able to be interviewed
safety and efficacy study in patients with retinitis pigmentosa due to mutations in pde6b gene

Conditions: Retinitis Pigmentosa

Summary: the study is a phase i/ii, monocentric, open-label, dose-ranging safety and efficacy gene therapy intervention by subretinal administration of aav2/5-hpde6b. at least twelve patients 18 years of age or older, within four consecutive cohorts of patients, will be recruited. then at least four patients 13 years of age or older, within a fifth cohort, will be recruited.

retinitis pigmentosa (rp) is a disease where part of the eye (the retina) is degenerating over time. patients initially present with night blindness, and later in life experience loss of central vision which leads to blindness. rp is a highly variable disorder with some patients developing symptomatic visual loss in childhood whereas others remain asymptomatic until mid-adulthood. there are no treatments available. this study focuses on the form of rp caused by mutations (modifications) in the genetic information necessary to make the protein called rod cgmp phosphodiesterase 6 β subunit (or pde6β). clinical diagnosis is made by function tests of the eye and confirmed using a specific method called molecular testing to verify that the pde6b gene is not correct. this study uses a gene therapy vector inspired from an adeno-associated virus (aav) called aav2/5-hpde6b. this vector intends to supply to the target cells the pde6b therapeutic gene that is not functioning properly in the cell. the aav parts of the gene therapy vector work as a vehicle to deliver the normal human pde6b gene into the cells of the retina.

Eligibility criteria:
key inclusion criteria: * clinical and molecular diagnosis of retinitis pigmentosa caused by defect in pde6b gene without other syndromic manifestations * aged above 13 years * ability to give informed consent key exclusion criteria: * previous ocular surgery or thermal laser within 6 months before the surgery * lens opacities or obscured ocular media upon recruitment such reliable evaluation or grading of the posterior segment cannot be performed * known serious allergies to the fluorescein dye used in angiography, to the mydriatic, steroidal and non-steroidal eye drops * participation in another clinical trial with an investigational agent * enrolled or being enrolled in another gene therapy clinical trial * active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents * chronic medical conditions, cancer * abnormal laboratory values * on immunosuppressive therapy

Keywords: adeno-associated virus aav retinitis pigmentosa pde6b gene therapy gene transfer retinal dystrophy eye diseases vision disorders eye diseases, hereditary retinal diseases retinal degeneration
ankylosing spondylitis and spondyloarthritis evaluation tool study

Conditions: Ankylosing Spondylitis; Spondylarthritis

Summary: this study aims to test whether a new instrument (questionnaire) is useful for identifying patients with ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent exclusion criteria: * inability to provide informed consent

Keywords: ankylosing spondylitis spondylarthritis inflammatory back pain seronegative
single and multiple dose safety, tolerability, pk and food effect study of hec73077 in healthy subjects

Conditions: Diabetic Nephropathy

Summary: the safety, tolerability pharmacokinetic and food effect study of hec73077 in healthy subjects


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions. 2. be able to complete the study according to the trail protocol. 3. subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures. 4. subjects and must be 18 to 45 years of age inclusive. 5. body weight ≥ 45 kg(for female) or ≥ 50 kg(for male) and body mass index（bmi）between 18 and 28 kg / m\^2, inclusive, at screening. 6. there was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening. 7. subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, chest x-ray and 12-lead electrocardiogram (ecg). exclusion criteria: 1. use of \>5 cigarettes per day during the past 3 months. 2. known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies). 3. history of alcoholism or drink regularly within 3 months prior to the study (defined as alcohol consumption of \> 14 units/week). 4. positive results from urine drug screen test. 5. donation or loss of blood over 450 ml within 3 months prior to screening. 6. subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening. 7. use of any prescription or non-prescription medications within 14 days prior to initial dosing 8. consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 9. subjects who participated in another clinical trial within 3 months prior to initial dosing. 10. female subjects were lactating or had positive serum pregnancy results during the screening or testing period. 11. subjects deemed unsuitable by the investigator for any other reason.
surufatinib combined with serplulimab plus chemotherapy in the treatment of extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: to evaluates the effectiveness and safety of surufatinib combined with serplulimab plus chemotherapy for the first-line treatment of es-sclc, and maintenance therapy are surufatinib combined with serplulimab


Eligibility criteria:
inclusion criteria: 1. patients must have the ability to understand and voluntarily sign informed consent; 2. age: 18-75 years old; 3. expected survival period ≥ 3 months; 4. histologically or cytologically diagnosed with es-sclc (combined small cell lung carcinoma excepted); 5. no prior systemic therapy for es-sclc; 6. according to the recist 1.1 standard, the patient has at least one target lesion with a measurable diameter; 7. ecog ps: 0-1; 8. major organs are functioning well; 9. the urine or serum pregnancy test results of premenopausal women were negative. exclusion criteria: 1. patients with symptomatic brain metastases; 2. people with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmhg, diastolic blood pressure≥90 mmhg); 3. urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0g; 4. cardiovascular disease history: congestive heart failure\> new york heart association (nyha) standard ii, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment; 5. active severe clinical infections (\>nci-ctcae 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and tb examination in line with local clinical practice), hepatitis b (known hbv surface antigen \[hbsag\] positive), hepatitis c or human immunodeficiency virus (hiv 1/2 antibody positive);patients who have previously had hbv infection or have been cured (defined as the presence of hepatitis b core igg antibodies and the absence of hbsag) are eligible. hepatitis c virus (hcv) antibody-positive patients are only eligible if the hcv rna polymerase chain reaction is negative. 6. patients with bleeding tendency or coagulation disorders; 7. in the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment); 8. patients who are pregnant or breastfeeding; 9. allergy to any of the drugs in the study; 10. imaging (ct or mri) shows that the tumor invades or is poorly demarcated from large vessels; 11. researchers think it is inappropriate to participate in this trial.