Kornimate/medical-research-clean huggingface dataset:
an extension study to a clinical study that will continue to evaluate the effectiveness and safety of sep-363856 in people with schizophrenia that switch to sep-363856 from their from their current antipsychotic medication

Conditions: Schizophrenia

Summary: an extension study to a clinical study that will continue to evaluate the effectiveness and safety of sep-363856 in people with schizophrenia that switch to sep-363856 from their from their current antipsychotic medication. this study will accept both male and female participants that have completed study sep361-308. this study will be held in approximately 24 study sites in north america. participation in the study will be approximately up to 25 weeks.

this is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of sep-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed study sep361-308 treatment period, during which they were switched from a previous antipsychotic treatment to sep-363856.

Eligibility criteria:
inclusion criteria: (list is not all inclusive) * subject has given written informed consent and privacy authorization prior to participation in the study. * subject has completed the treatment period of study sep361-308. * subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during study sep361-308. * female subject must have a negative rapid urine pregnancy test at the end of treatment (eot) visit of study sep361-308. exclusion criteria: (list is not all inclusive) * subject is suicidal based on the columbia - suicide severity rating scale (c-ssrs) assessment at the end of treatment (eot) visit of study sep361-308. * subject has a clinically significant abnormality including physical examination, vital signs, or ecg finding at the end of treatment (eot) visit of study sep361-308. * subject has a positive rapid urine drug screen at the eot visit of study sep361-308. * female subject is pregnant or lactating.

Keywords: schizophrenia
to evaluate the efficacy and safety of capecitabine prior to surgery in women with breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (iv) 5-fluorouracil (5-fu), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. the participants will receive 4 cycles of neoadjuvant capecitabine + epirubicin + cyclophosphamide (cex) or 5-fu + epirubicin + cyclophosphamide (fec 100) chemotherapy during first treatment period (period 1, days 1-85). after 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (period 2, days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m\^2) by iv infusion on day 1 of each 21-day cycle. upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. during this period participants will be evaluated once a year on the anniversary date of randomization.


Eligibility criteria:
inclusion criteria: * females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as t2-3, n0-1, m0 according to the tumor-nodes-metastasis (tnm) classification * clinically or radiologically measurable lesion (in 2 dimensions) * eastern cooperative oncology group (ecog) performance status less than equal to (\<=) 1 exclusion criteria: * females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance * previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer * previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix * serious concomitant infection * pregnant or lactating females
contribution of learning and practice of different complementary therapies in pulmonary transplant patients

Conditions: Lung Transplant

Summary: the aim of the study is to evaluate, 3 months after lung transplantation, integration and appropriation by the patient of complementary techniques (" toolbox " included relaxation, autohypnosis, relaxation therapy, tens (if pain) and holistic gymnastics to improve the comfort and the quality of life in very high-technology care pathway

patients approaching a lung transplant will face specific infectious, immunological, ventilatory and hemodynamic problems but also to painful, stressful and anxiety-provoking situations. learning different complementary therapies in the pre-transplant period allows patients to have personal tools to improve their comfort before and after the transplant. these tools can be used by patients who have acute or chronic pain symptoms, to support painful examination or care, and for situations of stress and anxiety. the project aims to present different therapies complementary to patients. before and after transplant, patients benefits of learning and realization sessions of these techniques. they appropriate the techniques and choose the ones that suit best. the overall benefit will be judged comparing period before transplant to period after transplant on different criteria.

Eligibility criteria:
inclusion criteria: * candidates for a lung transplantation benefiting from a pre-transplant evaluation exclusion criteria: * transplant patient in emergency * delay between pre-transplant evaluation and transplantation over 12 months

Keywords: pain quality of life
a survival study for women with advanced lung cancer who have not previously received chemotherapy.

Conditions: NSCLC

Summary: this is a randomized, open-label, multinational, phase iii study in women with histologically- or cytologically-confirmed advanced nsclc who are chemotherapy naïve and have ps 2. study drug will be administered on day 1 of each 21 day cycle

see summary

Eligibility criteria:
inclusion criteria: 1. female. 2. histologically- or cytologically-confirmed diagnosis of nsclc. 3. ecog performance score of 2. 4. patients who meet one of the following criteria: * stage iiib who are not candidates for combined modality therapy (primary radiation therapy or surgery), or * stage iv. 5. age greater than or equal to 18 years. 6. adequate bone marrow function 7. adequate renal function 8. adequate hepatic function 9. patients with known brain metastases must have received standard antitumor treatment for their cns metastases as defined by the site's institutional standards. 10. patients who have had major surgery must be fully recovered from the surgery. 11. ability to comply with the visit schedule and assessments required by the protocol. 12. for patients of reproductive potential, commitment to use adequate contraception. 13. signed approved informed consent, with understanding of study procedures. 14. agreement to begin study therapy within 8 calendar days after randomization. exclusion criteria: 1. any intolerance to poly-l-glutamic acid, poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of ct-2103). 2. evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. any prior systemic chemotherapy for the treatment of lung cancer. this includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. grade 2 or greater neuropathy. 6. evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (if unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9). 7. clinically significant active infection for which active therapy is underway. 8. investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable. 10. pregnant women or nursing mothers. 11. any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Keywords: non-small cell lung cancer nsclc ps 2 female chemotherapy
impact of oab symptoms on quality of life in croatia

Conditions: Overactive Bladder

Summary: overactive bladder (oab) has a negative impact on the daily activities of affected individuals. oab affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. it has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs. the primary objective of the present study was to evaluate, in a croatian population reporting symptoms of oab, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).


Eligibility criteria:
inclusion criteria: * consenting adult patients who had an oab diagnosis by their healthcare practitioner and were about to start mirabegron treatment as part of routine clinical practice were eligible for enrollment. exclusion criteria: * mixed incontinence where stress incontinence was the predominant symptom (as determined by the investigator) * severe uncontrolled hypertension (i.e. systolic blood pressure ≥180 mm hg and/or diastolic blood pressure ≥110 mm hg) * anxiety and/or depression * pregnancy * women who reported having either a current or previous (within one month) urinary tract infection
adductor canal block with continuous infusion versus intermittent boluses and morphine consumption

Conditions: Postoperative Pain

Summary: the investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. the aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. the investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.


Eligibility criteria:
inclusion criteria: * patients scheduled for total knee arthroplasty in spinal anesthesia * patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions * american society of anesthesiologists 1-3 * ability to perform a timed up and go test preoperatively exclusion criteria: * patients who cannot cooperate * patients who cannot understand or speak danish. * patients with allergy to the medicines used in the study * patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks * patients suffering from alcohol and/or drug abuse - based on the investigator's assessment * rheumatoid arthritis * bmi \> 40 * neuromuscular pathology in the lower limbs * pregnancy
intravenous cg7870 in combination with docetaxel in patients with metastatic hormone-refractory prostate cancer

Conditions: Prostate Cancer

Summary: v-0039 is a phase 1/2 dose escalation trial of cg7870 in combination with docetaxel in metastatic hormone-refractory patients who have not received chemotherapy. all patients will receive docetaxel. in the dose escalation phase of the study, patients will receive treatment intravenously with cg7870 at one of up to four dose levels. in the phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in phase 1.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy) * detectable metastases by bone scan, and/or ct scan, and/or mri, and/or cxr * ecog performance status 0-1 exclusion criteria: * transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer * history of deep vein thrombosis or pulmonary embolus * patients taking anticoagulants (such as coumadin or heparin). the use of aspirin while on study is acceptable. * history of a bleeding disorder or recent clinically significant bleeding * seropositive for hiv * history of hepatitis b, hepatitis c, or chronic liver disease * prior gene therapy or immunotherapy * prior chemotherapy for prostate cancer * radiation therapy within 4 weeks of the first treatment. * history of myocardial infarction within 6 months of the first treatment * history of cerebrovascular accident * history of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage i or ii cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years * evidence of active prostatitis * known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80

Keywords: chemotherapy prostate cancer cancer metastatic hormone refractory chemotherapy naive dose escalation
trial of prognostic factors and surgical methods for the treatment of idiopathic macular holes

Conditions: Idiopathic Macular Hole

Summary: the project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (icg) assisted inner limiting membrane ( ilm) peeling or vitrectomy plus trypan blue (tb) assisted ilm peeling. at baseline patients are characterized using early treatment diabetic retinopathy study (etdrs) visual charts, tests of aniseikonia, optical coherence tomography 3 (oct3), visual field and fundus photography. per- and postoperative complications are registered. data analyses will help clarify the effect of ilm peeling on hole closure and visual acuity. comparing results after icg- and tb assisted ilm peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ilm. changes in intraretinal morphology before and after dye-assisted ilm peeling will be studied using oct3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.


Eligibility criteria:
inclusion criteria: * idiopathic macular hele stage 2 or 3. * duration of symptoms ≤ 12 months. * visual acuity ≥ 34 etdrs letters. * intraocular pressure ≤ 23 mmhg. * informed consent. exclusion criteria: * previous macular hole in project eye * macular pucker worse than a cellophane macular reflex. * previous surgery or disease in the eye affecting retinal function. * systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a. * amblyopia i project eye.
wellness coaching for caregivers of thoracic transplant candidates

Conditions: Stress, Psychological; Caregiver Burden

Summary: researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

this is a randomized trial of health coaching compared to usual care. caregivers for patients on the adult heart or adult lung transplant waiting list at the mayo clinic will undergo informed consent. consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. questionnaires and demographic information will be collected at baseline and after 12 weeks.

Eligibility criteria:
inclusion criteria: * 18 years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at mayo clinic in rochester and jacksonville, fl exclusion criteria: * individuals younger than 18 years * non-english speaking, non-verbal, or extremely hard of hearing

Keywords: caregiver heart transplant lung transplant stress
adaptation and pilot testing of a behavioral parent training program for parents of deaf and hard of hearing children

Conditions: Hearing Loss; Behavior Disorders; Parenting

Summary: despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (dhh) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. this pilot project will systematically adapt an evidence-based behavioral parent training (bpt) intervention to increase its acceptability and relevance for parents of young dhh children. two parents of dhh children will be trained in the adapted bpt for dhh children. they will each deliver the intervention to five families with dhh preschool-aged children.


Eligibility criteria:
parent/caregivers and children: inclusion criteria: * parent/caregiver is age 18 years or older * parent/caregiver is the custodial guardian of a deaf or hard of hearing (dhh) child * dhh child is 2-5 years old * dhh child has used hearing aid(s) and/or cochlear implant(s) for \> 6 months * parent/caregiver is able to read english and either speak/understand english or use american sign language exclusion criteria: * active child protective services case * dhh child of interest has been diagnosed with a severe developmental delay, severe autism, debilitating neurological condition, etc. * parent/caregiver has already accessed behavioral health services for the dhh child parent coaches/interventionists: inclusion criteria: * age 18 years or older * parent of a dhh child * able to speak, understand, and read english exclusion criteria: - none
vitamin d replacement in nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver

Summary: vitamin d deficiency is very common in patients with fatty liver disease as evidenced by our observations in the metabolic liver clinic and that reported by others. we also observed that patients with more severe fatty liver disease had lower vitamin d concentrations. others have shown that replacing vitamin d in patients with cirrhosis is effective and even patients with vitamin d replete status have lowering of vitamin d over time if not supplemented. one of the measures of liver injury in nafld is the plasma concentration of alt and we will use this to follow patients as is currently done as standard of care. all patients in the metabolic liver clinic are being routinely screened for vitamin d deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. we hypothesize that patients with nafld with low vitamin d levels will respond appropriately to vitamin d supplementation for 6 months.


Eligibility criteria:
inclusion criteria: * adults of age 18 or greater * diagnosis of fatty liver disease with a low vitamin d level (\< 30 ng/dl) in the past 6 months * able to give consent exclusion criteria: * those currently receiving vitamin d supplementation
construction of a database for tma

Conditions: Thrombotic Microangiopathies

Summary: information about patients was collected by reviewing the hitech case system and telephone and outpatient follow-up, and the case database was constructed by epidata software. the sample size is expected to be 200 cases, the participating hospital is the first affiliated hospital of soochow university, and the study time frame is from dec 1, 2022, to nov 31, 2027. the observation indexes of the study include the basic information of patients' age and gender and the clinical-related data of thrombotic microangiopathy.


Eligibility criteria:
inclusion criteria: * the patient has elevated lactate dehydrogenase to more than twice the baseline value, platelets less than 20 or decreased by more than 50% within 24 hours, and more than 2% of schistocytes visible on a peripheral blood smear. alternatively, pathological sections show extensive micro thrombosis. exclusion criteria: * the investigator considers the subject unable or unwilling to cooperate with the study procedures.
phase 3 study to evaluate iop lowering therapy in open angle glaucoma and ocular hypertension c-02-41

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility criteria:
adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (snellen equivalent) or logmar visual acuity not worse than 0.6. clinically relevant ophthalmic or systemic conditions may be excluded.

Keywords: open-angle glaucoma ocular hypertension poag
renal sympathetic denervation and potential effects on glucose metabolism and cardiovascular risk-factors

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: the re-shape cv-risk study is a clinical study where renal adrenergic denervation (rdn) is done in high risk patients with treatment-resistant hypertension. rdn is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. rdn leads to sympathetic denervation of the kidneys, which in the "symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmhg). in a pilot study, where 40 % of the patients had diabetes, rdn seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia. the investigators aim to introduce rdn as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of rdn on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. the investigators hypothesis is that rdn will have positive effect on glucose metabolism, qol and sub-clinical organ damage.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * resistant hypertension, as defined in the 2007 esh-esc guidelines and confirmed by ambulatory or home blood pressure measurements. (here office bp \> 140/90 mmhg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance). * no known secondary reason for hypertension * negative pregnancy test (preferably blood hcg) for female patients of childbearing potential * estimated gfr (glomerular filtration rate) \> 45 ml/min/1.73m². * willing and able to comply with follow-up requirements * signed informed consent exclusion criteria: * type 1 and type 2 diabetes * pregnancy * allergy to the contrast medium used during rdn and iohexol clearance. * age \> 68 years * hemodynamically significant heart valve disease * pacemaker or icd * medication that may interfere with the procedure (anticoagulation, platelet inhibitors, steroids), if they cannot be temporarily reduced or stopped. * cancer * patients with transplanted kidneys * reno vascular conditions like diameter \< 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting

Keywords: renal denervation resistant hypertension cardiovascular disease diabetes quality of life