Kornimate/medical-research-clean huggingface dataset:
study of cb307 in patients with advanced and/or metastatic psma-positive tumours.

Conditions: Advanced and/or Metastatic Solid Tumours

Summary: fih, phase 1, open-label, multi centre study of cb307, a trispecific humabody® t-cell enhancer, in patients with advanced and/or metastatic psma+ solid tumours to assess safety and tolerability to determine mtd and preliminary rp2d.in addition this study will assess the safety and efficacy of cb307 when given in combination with pembrolizumab (keytruda®) in patients with metastatic psma+ castration-resistant cancer

fih, phase 1, open-label, multi centre, non randomised study of cb307, a trispecific humabody® t-cell enhancer, in patients with advanced and/or metastatic psma+ solid tumours (part 1 \& 2a) and patients with metastatic psma+ castration-resistant cancer (part 2b) . the study will consist of a dose escalation phase (part 1) and a cohort expansion phase (part 2) which will consist of 2 arms . part 2 will evaluate safety and preliminary efficacy of cb307 (both as monotherapy and in combination with pembrolizumab) at the mtd or preliminary rp2d as determined in part 1. approximately 70 patients will participate in total. patients will receive either cb307 alone or cb307 with pembrolizumab iv (part 2b), until loss of clinical benefit, unacceptable toxicity, withdrawal of consent or end of study. the dose escalation may be adapted by the src based on clinical experience and safety review.

Eligibility criteria:
inclusion criteria: 1. capable of understanding the written informed consent 2. aged at least 18 years 3. not amenable to standard of care 4. ecog ps \<=2 5. has documented histologically confirmed diagnosis of psma+ advanced or metastatic solid tumours 6. has radiologically measurable disease per recist v1.1 or elevated serum psa for castration resistant prostate cancer patients with only bone metastasis 7. adequate organ function exclusion criteria: 1. subjects with autoimmune disease or regular immunosuppressants 2. has discontinued from anti-ctla 4, anti-pd1 or anti-pd(l)1 antibody because of intolerable toxicity 3. has brain metastasis including leptomeningeal metastasis or primary brain tumour 4. has current or history of cns disease 5. has known active infection 6. part 2b only - has prior treatment with anti pd(l)1 or anti ctla4

Keywords: prostate specific membrane antigen (psma) solid tumours castration-resistant prostate cancer (crpc) first in human (fih) phase 1 study cd137 4-1bb crescendo biologics cb307 humabody® hsa pembrolizumab keytruda®
efficacy of clinical application of transcranial low intensity focused ultrasonic stimulation for patients with major deperessive disorder - exploratory clinical trial

Conditions: Major Depressive Disorder(MDD)

Summary: the non-invasive type ultrasonography system is applied to patients with major depressive disorder to evaluate their effectiveness and safety. brain computer tomography(ct) and magnetic resonance image(mri) are taken to induce images before transcranial low intensity focused ultrasonic stimulation. through random extraction, the group is divided into treatment group and placebo group. the treatment is started by targeting left dorsolateral prefrontal cortex(dlpfc) region according to assigned groups. as for women, considering mood change during menstrual cycle, the treatment is taken place 1 week after the menstruation has initiated. the treatment group and the placebo group will be treated three times a week for two weeks. to evaluate clinical symptoms, quick inventory of depressive symptomatology-self report, scale for suicidal ideation, state-trait anxiety scale, frontal lobe management function test, memory test, and continuous performance test are performed before, during, and after treatment. for the assessment of side effects, systematic asseseement for treatment emergent events-general inquiry(saftee) are conducted for treatment presentation events every week during the treatment implementation period and every two weeks after the treatment is completed.


Eligibility criteria:
inclusion criteria: 1)19 to 60 years of age 2)having major depressive disorder without psychotic feature according to the dsm-5 diagnosis criteria scid-5-cv: (icd-10 code : f32.0, f32.1, f32.2, f33.0, f33.1, f33.2) 3)montgomery-asberg depression rating scale (madrs) score ≥12 4)no history of suicidal attempt with suicidal ideation tendency score assessed by the scale for suicide ideation (ssi) ≤ 9 5)no antidepressants regimen for 4 weeks prior to enrollment. 6)n the case of active antidepressants regimen, patients with madrs score ≥12 and who will not change their medication doses during the study period exclusion criteria: * incompatibility with brain ct and mri * disorders that may cause depression (e.g., thyroid dysfunction, uncontrolled diabetes) or who taking medications that can influence on mood (e.g., thyroid hormones, steroids.) * history of epileptic seizures * history of major psychiatric disorder including schizophrenia and bipolar disorder * mental retardation * severe physical illness including cancer and tuberculosis * significant skin problems including contact dermatitis * pregnant women or women planning to become pregnant * (after ct scan) skull thickness ≥ 8, or significant calcification * (after mri scan) structural abnormalities such as brain tumors, hemorrhage, traumatic brain disease, or structural changes due to degenerative brain disorders
interest of self-compression technique on tolerance of mammography

Conditions: Breast Cancer

Summary: mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast. it is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain. breast compression by the manipulator aims to reduce the thickness of the breast during mammography; this act is an important factor of pain or discomfort felt by the patient. but, it is also an image quality factor. this study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years and ≤ 75 years of age * ecog performance \<2 * mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion * ability to provide written informed consent * patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study. exclusion criteria: * eastern cooperative oncology group performance status ≥ 2 * treatment for benign lesion with surgery for less than 3 years * treatment for cancer with surgery and / or radiotherapy for less than 3 years * biopsy for less than 1 year * breast prosthesis * mastectomy * assessment motivated by a clinical breast abnormality

Keywords: mammography pain quality of life screening image quality radiology
acupuncture for shortness of breath in cancer patients

Conditions: Lung Neoplasms; Breast Neoplasms

Summary: the purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.


Eligibility criteria:
inclusion criteria: * diagnosis of local or metastatic breast or lung cancer * shortness of breath with onset after cancer diagnosis * life expectancy of at least 4 weeks exclusion criteria: * prior acupuncture * other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity * no chest wall deformity * neuromuscular disorders * pulmonary vascular disease * anemia * uncontrolled pain or infection * heart valve dysfunction

Keywords: lung cancer breast cancer shortness of breath dyspnea metastasis breathlessness acupuncture
extension study of idelalisib in participants with chronic lymphocytic leukemia (cll) who participated in gs-us-312-0116 (nct01539512)

Conditions: Chronic Lymphocytic Leukemia

Summary: the primary objective of this extension study (gs-us-312-0117) that is a companion study to study gs-us-312-0116 (nct01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. randomization was done in study gs-us-312-0116, and carried forward to study gs-us-312-117.


Eligibility criteria:
key inclusion criteria: * individuals in the primary phase 3 study (study gs-us-312-0116) who are compliant * tolerating primary study therapy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: cll cal-101 cal 101 gs-1101 gs 1101 pi3k leukemia gs-us-312-0116 idelalisib
expanded access program for gbm subjects

Conditions: Glioblastoma

Summary: this small-size patient population expanded access program is to provide access to investigational product rz-001 for up to around 4 patients with human telomerase reverse transcriptase(htert)-positive glioblastoma (gbm) who are not eligible to participate in the rz-001-201 clinical study or in any other study involving the use of rz-001

this expanded access protocol provides expanded access to rz-001 to patients with glioblastoma. after provision of written informed consent, subjects will be evaluated for eligibility during the screening period, a period of 28 days prior to the rz-001 administration on day 1. subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from rz-001 administration) survival follow-up.

Eligibility criteria:
inclusion criteria: 1. males and females legally considered to be adults in the country in which they are participating in the study. 2. histologically-confirmed grade 4 astrocytoma, gbm, per the 2021 who classification of central nervous system (cns) tumors. 3. recurrent gbm with radiographic evidence of the pd (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on mri, as defined by the mrano (modified response assessment in neuro-oncology) criteria. only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed. exclusion criteria: 1. diagnosis of other malignant tumors within 5 years prior to rz-001 administration. 2. have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from screening. 3. have received radiotherapy within 12 weeks from screening. 4. have extracranial metastases of the tumor cells. 5. the subject is eligible for participation in any ongoing clinical study with rz-001, or has already received rz-001 in the past. 6. the subject is being transferred from an ongoing clinical study for which they are still eligible.
10-year follow-up after aortic valve replacement surgery

Conditions: Aortic Stenosis; Anxiety; Depressive Symptoms; Quality of Life

Summary: there is a lack of data on patients self-reported outcomes (proms) on health-related quality of life (hrqol)and symptoms on anxiety and depression 10 years after surgical after aortic valve replacement (savr), and patient reported experiences with the health services (prems). in this 10-years follow-up study on patients alive from the study named "the impact of 24/ 7-phone support on readmission after aortic valve replacement, a randomized clinical trial (avrre)" nct02522663 we will repeat the survey on symtoms on anxiety and depresion using hospital anxiety and depression scale (hads), health-related quality of life (eq-5d) and questions about experiences with the health services.

"the impact of 24/ 7-phone support on readmission after aortic valve replacement, a randomized clinical trial (avrre) was a prospective, randomized controlled study (rsc) including 286 patients after avr from 2015 til 2017, nct02522663. the results reported in international publications showed reduced symptoms on anxiety the first month after avr. reduction of anxiety revealed to be an important aim for the intervention. we found that symptoms of anxiety in the early rehabilitation phase after discharge following surgical aortic valve replacement phase was significantly reduced. there is a lack of data on patients self-reported outcome on symptoms on anxiety and depression 10 years after surgical after aortic valve replacement (savr), and patient reported experiences with health services. in this 10-years follow-up study on patients alive from the study named "the impact of 24/ 7-phone support on readmission after aortic valve replacement, a randomized clinical trial (avrre)" nct02522663 we will conduct a survey on symtoms of anxiety and depresion using hospital anxiety and depression scale (hads), quality of life (eq-5d) and questions about experiences with health services. the results of the planned 10-years follow-up may give guidance in how to allocate health resources and planning for and follow-up of patients after heart surgery.

Eligibility criteria:
inclusion criteria: treatment with avr (biological or mechanical) single, avr (b or m)+aortocoronary bypass, avr (b or m)+supra coronary tube graft can understand, speak and write native language (norwegian), and be able to fill in the questionnaires - exclusion criteria: patients not alive after the avrre study

Keywords: aortic valve replacement longitudinal study patient reported outcome symptoms of anxiety health-related quality of life
the association between core temperature and health

Conditions: Body Temperature Changes; Body Composition; Aging

Summary: the goal of this clinical trial is to learn if cold water drinking could promote body composition and further extend healthy lifespan in chinese older adults. the main questions it aims to answer are: 1. does cold water drinking lower the body fat percentage? 2. will cold water drinking positively extend lifespan in a long-term researchers will compare cold water intervention group to a control group (drinking 37℃ water instead) to see if cold water drinking works to promote health and slow down ageing process. participants will: 1. drink 4℃ or 37℃ water 4 times (9a.m., 12p.m., 15p.m., 18p.m.) every day for 6 months. 2. visit the institute and health checkup department for tests and checkup at baseline, the end of the 3rd month, and the end of 6th month.

according to pilot study, we found 4℃ water could significantly reduce core body temperature. thus, we aim to explore whether 4℃ water drinking could promote body composition and further help to extend lifespan. participants will be randomly divided into intervention (drinking 4℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) and control group (drinking 37℃ water at 9a.m., 12p.m., 15p.m., 18p.m.) for 6-month intervention. tests will be conducted in shenzhen institute of advanced technology, while checkup will be tested at health checkup department of shenzhen university general hospital. body composition will be tested by magnetic resonance imaging (mri), dual-energy x-ray absorptiometry (dexa), and tanita (bioelectrical method). in addition, we will test participants' waist and hip circumferences using 3d scanning. besides, we will test core body temperature and brown adipose tissue. apart from above main outcomes, we will also test their physical activity, food intake, metabolic rate, glucose, il-6, tnf-alpha, hdl, ldl, insulin level. meanwhile, ageing biomarkers, namely phenotypic age, eye fundus image, facial changes, bone density, gut microbiota, glycanage, will also be measured. the whole intervention period will last for 6 months. all the tests and checkup will be tested at baseline, the end of the third month and the endpoint of the study.

Eligibility criteria:
inclusion criteria: * aged between 50 and 65 years old (including 50 and 65) * no surgery in the past 6 months * healthy (no metabolic diseases, cardiovascular diseases, lung diseases (copd, asthma, et al.), endocrine diseases and gastrointestinal diseases) * based in shenzhen during the whole study period * no significant change on body weight in the past 3 months exclusion criteria: * those who need to take medication for a long term (including diet pills) * on a diet * disabled * females who are trying to get pregnant, pregnant, or breastfeeding * presence of a metal implant in the body (e.g. pacemaker) * those with claustrophobia * those with blood phobia, pathological hypotension or hypertension * those who are in other intervention studies

Keywords: body temperature body composition aging
prognosis of patients with relapsed/refractory hodgkin lymphoma treated with igev induction therapy before hdct with ahsct

Conditions: Hodgkin's Lymphoma

Summary: this is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory hl that received igev scheme as induction therapy to hdct and ahsct for reassess the most common prognostic factors and try to identify a prognostic score with clinical and therapeutic relevance by using 6 clinical tools: 1. b symptoms(yes/no) 2. relapse in previously irradiated areas(yes/no) 3. ann arbor stage (iii/iv vs i/ii) 4. disease status at accrual (refractory vs relapsed) 5. early relapse within 12 months of complete response (cr) versus late relapse after complete response (cr) lasting \> l2 months", 6. extranodal involvement (yes/no).


Eligibility criteria:
inclusion criteria: * patient with a history of classical hl relapsed/refractory which received igev regimen as induction therapy before high dose chemotherapy with ahsct * age \>18 years * patients with relapsed/refractory disease after standard treatments (chemotherapy +/- radiotherapy) before igev induction regimen. (relapsed = disease relapse after cr. refractory = non cr with last chemotherapy line, or progression during last treatment, or disease progression within three months from previous treatment completion). * availability of clinical data, laboratory values and ct scan results of patients enrolled, performed from diagnosis to the last follow-up * patient scheduled to receive three or four igev cycles as pretransplantation induction regimen. * first igev course started before december 31st 2007 * assessment of tumor response by cheson 1999 criteria 11 exclusion criteria: * none

Keywords: hodgkin's lymphoma ifosfamide, gemcitabine and vinorelbine (igev) high dose chemotherapy (hdct) autologous hematopoietic stem cells transplantation (ahsct)
evaluation of tethered capsule endomicroscopy as a screening tool for barrett's esophagus in the primary care setting

Conditions: Barrett Esophagus; Barrett's Esophagus Without Dysplasia; Barretts Esophagus With Dysplasia

Summary: the investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for barrett's esophagus (be) in the primary care practice environment. the investigators are also determining the prevalence of barrett's esophagus in a primary care practice cohort at mgh.

the investigators have developed a tethered capsule oct device intended as an inexpensive screening tool for be. the capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (gej) via peristalsis. cross-sectional microscopic oct images of the entire esophagus are collected during transit. the total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. the investigators have tested the feasibility and the tolerability of this new oct screening technology in 250 procedures in healthy volunteers and patients with various esophageal diseases including be. the procedure has been safe and well tolerated. high quality microscopic images of the esophagus have been obtained in 90% of the enrolled subjects.

Eligibility criteria:
inclusion criteria: * subjects registered as patients at the assembly row primary care practice. * 18 years or older * able to give informed consent * subject must have no food for 1 hour before the procedure exclusion criteria: * subjects older than 75 years. * subjects with current symptoms of dysphagia * subjects with gastro-intestinal strictures with a diameter less than 8mm, prior gi surgery (esophageal and/or stomach surgeries), or history of intestinal crohn's disease * pregnancy * patients scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.

Keywords: oct optical coherence tomography endomicroscopy capsule endomicroscopy tethered capsule endomicroscopy tce
analysis of the eye in patients with primary open-angle glaucoma and a visual field defect in one eye

Conditions: Glaucoma

Summary: the study aims to further understand glaucoma pathogenesis and progression by utilizing enhanced depth imaging optical coherence tomography to visualize and measure lamina cribrosa in vivo and segmentation technology to accurately delineate and measure boundaries of the retinal layers. investigators will elaborate further on key concepts of lamina cribrosa thickness and trans-synaptic degeneration.

two important areas of the eye that need investigation in order to further understanding of glaucoma. first is the retina (part of the eye that converts images from the eye's optical system into electrical impulses sent along the optic nerve to the brain). newer technology, spectral domain optical coherence tomography (sd-oct), allows us to look at different layers of the retina and carefully measure thickness of each layer. second area is lamina cribrosa (a portion of the white part of the eye which has nerve fibers passing through it connecting the eye to the brain). if lamina cribrosa is thin, it is possible it may bend easily and disrupt nerve fibers. sd-oct allows measurement of lamina cribrosa thickness. findings will help monitor changes that occur in the eye as a result of glaucoma. individuals with primary open-angle glaucoma and unilateral visual field defects were chosen as the main patient population (in addition to normal controls). by approximating each participants baseline anatomy using the fellow, "internal control" eye, investigators will be able to better determine if any changes occur in the macula or the lamina cribrosa as a result of glaucoma.

Eligibility criteria:
inclusion criteria: * best-corrected visual acuity of 20/40 or better * no media opacities * spherical equivalent refractive errors in a range of -6 to +6 diopters * cylinder correction within 3.0 diopters. exclusion criteria: * age \< 18 years old * visual acuity \< 20/40 * nuclear sclerosis \> +2 * corneal diseases * contact lens use * history of posterior segment intraocular surgery * systemic or ocular diseases that can cause visual field loss.

Keywords: glaucoma optical coherence tomography primary open angle glaucoma visual field