Kornimate/medical-research-clean huggingface dataset:
skb264 in combination with pembrolizumab in subjects with selected solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to evaluate the efficacy and safety of combination of skb264 and pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.


Eligibility criteria:
inclusion criteria: 1. subjects with eastern cooperative oncology group (ecog) performance status score of 0 or 1 . 2. subjects with expected survival ≥ 3 months. 3. cohort a: subjects with recurrent or metastatic cervical cancer 4. cohort b: subjects with locally advanced or metastatic urothelial carcinoma 5. cohort c: subjects with recurrent ovarian cancer 6. cohort d: subjects with metastatic prostate cancer 7. subjects have at least one measurable lesion per response evaluation criteria in solid tumors (recist) 1.1 criteria. 8. subjects able to provide tumor blocks or slides for biomarker test. 9. subjects have relatively good organ function and bone marrow function. 10. subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk. 11. contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 12. subject is capable of giving signed informed consent. 13. cohort e: subjects with advanced endometrial cancer. exclusion criteria: 1. subjects with active or untreated central nervous system (cns) metastases and/or carcinomatous meningitis are not eligible. 2. subjects who suffer from cardiovascular diseases of clinical significance. 3. subjects with serious and/or uncontrolled concomitant diseases. 4. subjects diagnosed active hepatitis b or hepatitis c. 5. subjects have known human immunodeficiency virus (hiv) infection that is not well controlled. 6. subjects with known active tuberculosis. 7. known allergy or hypersensitivity to pembrolizumab or skb264, or the excipients of pembrolizumab or skb264. 8. subjects with history of allogeneic tissue/solid organ transplant. 9. subjects previously treated with trop2 targeted therapy. 10. subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period. 11. subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study. 12. the investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
post-authorization observational study to evaluate cognition and fatigue in relapsing-remitting multiple sclerosis (rrms) patients treated with rebif®

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the study is planned to evaluate the cognitive functions in subjects with rrms treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

besides the motor and sensory dysfunctions, the progression of cognitive decline is a frequent manifestation of rrms. fatigue is another important symptom of ms, and can negatively affect subject's quality of life (qol) and socio-economic functioning, including the ability to work, independent of the direct effects of disability. this is a phase iv observational, non-interventional, prospective, multicentric study to evaluate cognition in rrms subjects treated with rebif and its relationship to the fatigue and neurological dysfunction status. the study plans to enroll 300 subjects, across 14 centres in czech republic, who will be prescribed with rebif according to its summary of product characteristics (smpc). assessment of cognitive and fatigue status will be done at baseline and follow-up visits at months 3, 6, 12, 24. subjects will be selected using the convenience method following the non-probability sampling. objectives primary objective: * to assess changes of cognition \[measured by paced auditory serial addition test (pasat)\] in rrms subjects treated with rebif secondary objectives: * to assess changes of fatigue \[measured by fatigue descriptive scale (fds)\] in rrms subjects treated with rebif * to assess a correlation between cognition, fatigue and neurological status in rrms subjects treated with rebif * to assess a relationship between rebif dosage \[22 mcg vs 44 mcg thrice a week (tiw)\] and cognition (pasat) * to assess a relationship between rebif dosage (22 mcg vs 44 mcg tiw) and fatigue (fds) * to assess adherence to rebif treatment * to explore the use of antidepressive and antifatigue medicaments

Eligibility criteria:
inclusion criteria: * subjects diagnosed with rrms * subjects eligible for treatment with rebif as per smpc, the czech local guidelines and the actual health insurance policy. * subjects 18-65 years of age * subjects with edss score \< 4 * subjects who are willing and able to give informed consent exclusion criteria: * treatment with rebif for more than 24 months prior the informed consent form has been obtained. * subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients * female subject who is pregnant or breast feeding and/or planning to become pregnant * subjects with current severe depression and/or suicidal ideation * any contraindication for rebif therapy as per smpc * subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance * prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.

Keywords: multiple sclerosis, relapsing-remitting rebif interferon beta-1a
self-myofascial release with foam roller in patients with hemophilic knee arthropathy

Conditions: Haemophilia

Summary: introduction: hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity. design. a randomized clinical trial. directed: to evaluate the safety and effectiveness of a myofascial self-release protocol with foam roller applied in patients with hemophilic knee arthropathy. patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. the patients will be recruited in 5 centers, from different regions of spain. intervention: each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. the treatment program includes 11 exercises to be administered bilaterally. a mobile application will be developed where each patient can observe the exercises to be performed. measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); hemophilia joint health score (joint condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); mobile device (activity log); finger floor test (muscle flexibility). at the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment. expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. likewise, an improvement in ankle pain, function and joint movement is expected.


Eligibility criteria:
inclusion criteria: * patients with a medical diagnosis of hemophilia a or b. * patients with a severe phenotype of hemophilia (\<1% fviii/fix). * patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the hemophilia joint health score. * being over 18 years old. * no scheduled orthopedic surgeries during the study phase exclusion criteria: * patients with hemarthrosis in the month before the beginning of the study. * patients unable to walk. * severe functional alterations of the upper limb that prevented the exercises. * failure to sign the informed consent document
lipo-dox and cyclophosphamide /5-fluorouracil in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: to determine the overall objective response rate of pegylated liposomal doxorubicin （lipo-dox）combined with cyclophosphamide/5-fu as second-line treatment in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically proved breast cancer with metastatic disease exclusion criteria: * life expectancy less than 3 months.

Keywords: phase ii metastatic breast cancer
cytomegalovirus (cmv) transmission and immune tracking (transmit) study

Conditions: Cytomegalovirus Infections

Summary: the goal of stage i of the cmv transmit study is to determine the prevalence of cmv shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. participants will complete a health survey and provide one saliva sample for cmv pcr testing. in addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. these activities will inform the design of stage ii.


Eligibility criteria:
inclusion criteria children 1. all children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. children living in the same household can each be enrolled. 2. parent(s) has provided written informed consent for the child to be screened for cmv by saliva pcr collected at the center or at home center staff 1. individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time. 2. staff member has provided written informed consent to be screened for cmv by saliva pcr collected at the center or at home exclusion criteria children 1. \>/= 37 months of age 2. state department of children and families (dcf) custody center staff 1. do not regularly (average \< 5 days per year) work inside the center 2. work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Keywords: cytomegalovirus cmv congenital cytomegalovirus ccmv
dose painting of head and neck cancer

Conditions: Head and Neck Cancer

Summary: dose-painting may increase the chance of cure at minimised radiation-induced toxicity in volumetric-arc radiotherapy (vmat) for head and neck cancer. this trial (radpaint) investigates the safety of fdg-pet guided radiotherapy using vmat dose-painting by contours for patients with head and neck cancer of poor prognosis.

in this study, radiotherapy is planned using 18f-fdg pet/ct (18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose positron emission tomography) making one experimental "dose-painting by contours" sib (simultaneous integrated boost) plan with a maximum point dose of 83 gy. the participants will be given 73 gy and 78 gy minimum doses to two gtvs (gross tumor volumes inside the conventional gtv (68 gy). gtv_73gy and gtv_78gy are determined from the suv (standardized uptake values) from the 18f-fdg pet/ct according to the formula proposed by the ghent group (van der straeten et al, r\&o -06). it is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 68 gy). in addition to the routine follow-up, the participants will be examined with 18f-fdg pet/ct (3 months after treatment and toxicity scoring at 6 weeks, 6 months, 1 year, 1.5 years and 3 years after radiotherapy (in addition to the routine follow-up).

Eligibility criteria:
inclusion criteria: histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; oral cavity, hypopharynx cancer, larynx cancer and hpv ((human papillomavirus) negative oropharyngeal cancer. patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer) planned treatment at the oslo university hospital age \> 18 years who (world health organization) performance status 0-2 exclusion criteria: tnm (primary tumor, regional nodes, metastasis) stage ct1 cn0-n1 cm0 glottic cancer ct1-t2 cn0 cm0 hpv positive oropharyngeal carcinoma cancer in the soft palate diabetes mellitus

Keywords: dose painting 18f-fdg positron emission tomography radiotherapy
psychological impact of covid-19 outbreak on caregivers

Conditions: Critical Illness; Covid19; Stress Disorders, Post-Traumatic

Summary: based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. in public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of covid-19. in this purpose, the number of available beds in intensive care units (icu) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. that means: 1. for the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in icus. 2. for the less severe patients, personals of non-busy units have been transferred in busier ones. all these measures lead to major daily-life change sets that could be stressful. in the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of post-traumatic stress disorder (ptsd) syndrome in about 30% overall population. importantly, high depressive symptoms have been reported in 9% of hospital staff. numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms. in hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. however, two studies reported a high prevalence of burn-out syndrome (bos) in icu physician and ptsd syndrome and depression in icu nurses. as the consequences of all the measures decided and applied during covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of ptsd syndrome in a large population of caregivers implied or not in intensive care units. the secondary objective were 1) to assess the prevalence of severe depression and anxiety and bos 2) to isolate potential factors associated with ptsd, severe depression, anxiety or bos.


Eligibility criteria:
inclusion criteria: * caregivers (doctors senior and junior, nurses, aid nurses) involved in the staff (permanent or transient, full or partial time) of icu patients during covid-19 outbreak * approved to participate exclusion criteria: * participation refusal * no internet connection for responding to the questionnaire with redcap file
safety and tolerability of a timolol releasing intraocular implant in subjects with primary open-angle glaucoma

Conditions: Primary Open-angle Glaucoma

Summary: the purpose of this study is to test a new method to deliver an approved medicine called timolol in the eye of participants with glaucoma and pseudophakia (currently present or to be performed during the concomitant implantation surgery in subjects with age-related cataract eligible to intra-capsular iol placement). the main questions it aims to answer are how safe the investigational drug is and how the body tolerates it. the study will also check: * how safely the implant is placed in and removed from the eye and how the body responds to the procedure, * how safe different doses of timolol are and how the body handles taking it, * the amount of timolol released in the bloodstream, * if there is any positive effect on the pressure inside the eye.

timolol will be delivered through an investigational drug called 'timod implant'. this implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system. three dose ranges of timod implant will be tested (low, intermediate, and high) in 3 groups of 6 participants. the timolol will be released slowly through the implant for up to 1 year (main phase). approximately 1 year after the timod implant is placed into the eye and in absence of contraindications, the participants will be invited to continue the study in an extension phase. if the participants agree to enter the extension phase and the study investigator confirms it is safe for them, the timod implant will remain in the study eye for one additional year.

Eligibility criteria:
inclusion criteria: * capable of giving signed informed consent. * in good general and mental health without ongoing clinically significant abnormalities in medical history. * clinically proven diagnosis of primary open-angle glaucoma (poag) in the previous 12 months. * subjects with iop not adequately controlled with the standard medication. * pseudophakia. exclusion criteria: * concomitant treatment with timolol (systemic), corticosteroids, cytochrome p450 2d6 inhibitors, or α2-agonists. * subjects with a history of hypersensitivity or contraindications to β-blockers. * significant risks caused by washout of ocular hypotensive medications. * history of any glaucoma not specified as poag. * history of elevated iop due to corticosteroid use. * history of ocular trauma.

Keywords: glaucoma poag
premature rupture of membranes at 34 to 37 weeks' gestation

Conditions: Premature Rupture of Membrane

Summary: prelabour rupture of membrane is deﬁned as rupture of membranes prior to the onset of labour. approximately 8% of pregnant women at term experience prom, but the decision as to how term prom should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. although for the majority of women labour will start spontaneously within 24 hours following term prom, up to 4%of women will not experience spontaneous onset of labour within seven days.


Eligibility criteria:
inclusion criteria: * preterm premature rupture of membranes. * singleton gestation. * pregnant between 34 weeks 0 days to 36 weeks 6 days. exclusion criteria: * non cephalic presentation. * fetal distress. * labour on admission. * medical or obstetric complications such as(suspected chorioamnionitis ,hypertensive disorders, diabetes mellitus , active genital herpes , placenta previa , infection, meconium stained amniotic fluid ,severe fetal anomalies).
effects of psycho-education of patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose for this study is to determine whether psycho-education in groups is more effective than individual psycho-education for patients with bipolar disorder.

the main aim of the study is to compare the effects of psycho-education in groups with short individual psycho-education. it is a randomized controlled trial including bipolar 1 and 2 patients in a stable euthymic phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 42 or 43 patients will receive three individual sessions of education. symptoms, admittances to hospital and function will be followed for two years.

Eligibility criteria:
inclusion criteria: * bipolar disorder 1 or 2 euthymic exclusion criteria: * active depression or mania/hypomania

Keywords: bipolar disorder psycho-education
microcurrent stimulation therapy for intermediate to advanced nonexudative age-related macular degeneration

Conditions: Age-Related Macular Degeneration; Age-related Macular Degeneration (ARMD); Intermediate AMD; Geographic Atrophy Secondary to Age-related Macular Degeneration

Summary: the goal of this clinical trial is to characterize the safety and effectiveness of the i-lumen amd transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative amd. participants will: * undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * participants will return monthly through month 14 (3 months post-last treatment) for evaluation and monitoring.


Eligibility criteria:
key inclusion criteria: * presence of at least one large druse \>125 microns in diameter due to amd. * bcva letter score of 35 to 70 letters (inclusive) (snellen equivalent 6/12 to 6/60 \[20/40 to 20/200\]) key exclusion criteria: * any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker. * implanted metallic device within 20 cm of the treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck). * uncontrolled diabetes, defined as glycated haemoglobin (hba1c) \>10% (13.3 mmol/l). * current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day). * known severe allergy to fluorescein dye. * medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., restasis, xiidra, or cequa). * history of seizure disorders, chronic migraines and/or cluster headaches. * history and/or evidence of diabetic retinopathy in either eye as assessed by cf, fundus fluorescein angiography (fa), and oct, to be confirmed by the central reading centre. * other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., stargardt's disease, best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.). * history and/or evidence of exudative amd in the study eye as assessed by cf, fa (or oct-a ), and oct, to be confirmed by central reading centre. * ga involving the foveal centre, as assessed by the central reading centre using af and oct. * history of intravitreal injections for ga (e.g., syfovre or izervay). * treatment with photobiomodulation (pbm) therapy or short pulse laser within 12 months prior to screening. * glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy. * history of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from screening. * history of yttrium aluminium garnet (yag) laser posterior capsulotomy \<1 month from screening. * visually significant cataracts and/or visually significant posterior capsular opacification. * history of amblyopia.

Keywords: amd intermediate amd dry amd geographic atrophy