Kornimate/medical-research-clean huggingface dataset:
electroconvulsive therapy for treatment refractory schizophrenia - a randomized, double-blinded, sham-controlled study

Conditions: Treatment-refractory Schizophrenia

Summary: the purpose of the study is to determine whether addition of electroconvulsive therapy to antipsychotic treatment improves the mental health of patients with treatment-resistant schizophrenia.

the purpose of the study is not achieved.

Eligibility criteria:
inclusion criteria: * an icd-10 schizophrenia diagnosis f20.0-20.3 or f20.9 * panss total score \>= 70 * cgi-s \>= 4 (clinical global impression) * panss score \>= 4 on minimum 2 og the following items: delusions, conceptual disorganization,hallucinatory behavior, excitement, grandiosity, suspiciousness, hostility, disorientation. * previous/current treated with clozapine or refused clozapine treatment * lack of response to at least three different antipsychotics * new antipsychotic medication prescribed more than 8 weeks before inclusion * fixed dosage of antipsychotics 1 month before inclusion * no chance of additional neurotropic 4 weeks before inclusion * signed informed consent and power of attorney exclusion criteria: * significant substance abuse * somatic disease that increases the risk of complications of ect/anesthesia * epilepsy * for women: pregnancy or breast-feeding * homelessness * use of benzodiazepines (apart from tbl. oxazepam 10 mg., max 30 mg. daily) * use of antiepileptic * previous no effect on psychotic symptoms after ect treatment (minimum 15 ect- treatments) * concrete suicidal plans

Keywords: electroconvulsive therapy treatment-refractory schizophrenia
a study of ak0529 in adults patients hospitalized with rsv infection

Conditions: Respiratory Syncytial Virus Infections

Summary: this is a randomized, double-blind, placebo-controlled, multicenter, phase ii study to be conducted in adults hospitalized with rsv infection in china. the main objectives of this study are to investigate the safety, pharmacokinetics and efficacy of ak0529 in adult rsv patients.


Eligibility criteria:
main inclusion criteria: 1. . male or female patients of any ethnicity with an age of 18-85 years. 2. . diagnosis of rsv infection by any virological means within 36 hours preceding initial dosing. 3. . at least one of the following high-risk diseases or states for rsv infection 1. asthma or chronic lung disease (such as copd or cystic fibrosis), 2. immunocompromised, 3. heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms, 4. chronic kidney disease, 5. age ≥65 years old. 4. . with at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate. 5. . onset of rsv infection symptoms should be ≤ 7 days. main exclusion criteria: 1. . 3 days for drugs with potential antiviral effects on rsv such as ordinary interferon, 8 days for long-acting interferon, and 35 days for ribavirin for 5 half-lives before expected administration. 2. . prohibited medicine are being used or planned to be used during the study treatment periods. 3. . severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.). 4. . received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year. 5. . patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy. 6. . patients with autoimmune diseases who are in the induction treatment. 7. . hiv infection, cd4 count\< 350 cells/mm3 with opportunistic infection and need treatment. 8. . other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period. 9. . history of drug abuse within 12 months prior to screening. 10. . allergy to the investigational drug or its component. 11. . female patients with positive pregnancy test or breastfeeding.

Keywords: adult patient with rsv infection high-risk disease ak0529
stereotactical photodynamic therapy with 5-aminolevulinic acid (gliolan®) in recurrent glioblastoma

Conditions: Glioblastoma Multiforme, Adult

Summary: in this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent glioblastoma.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age 18 - 75 years 3. karnofsky performance score (kps) of ≥60 % 4. radiologically suspected diagnosis (according to rano criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular and diencephalon. tumors in the brain stem are excluded. first mri with signs of first recurrence (radiologic rano criteria for disease progression) within 8 weeks prior to informed consent. not necessarily identical to primary tumor location 5. single or single progressive contrast-enhancing lesion on mri, largest diameter not more than 2.5 cm 6. for female and male patients of reproductive potential: willingness to apply highly effective contraception (pearl index \<1) during the entire study exclusion criteria: 1. multifocal disease \> 2 locations 2. patients with significant non-enhancing tumor portions 3. previous treatment of recurrence 4. other malignant disease except basalioma 5. hypersensitivity against porphyrins or gliolan® or fluorethylenpropylen (fep ) 6. porphyria 7. hiv infection, active hepatitis b or c infection 8. bone marrow reserve: * white blood cell (wbc) count \<2000/μl, * platelets \<100000/μl, 9. liver function: * total bilirubin \> 1.5 times above upper limit of normal range (uln) * alanine transaminase (alt) and aspartate transaminase (ast) \> 3 times uln 10. renal function: - creatinine \> 1.5 times uln 11. blood clotting: - quick/inr or ptt out of acceptable limits 12. conditions precluding mri (e.g. pacemaker) 13. past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (nyha iii/iv), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) 14. any active infection (at the discretion of the investigator) 15. any psychological, cognitive, familial, sociological or geographical condition that, in the investigator's opinion, compromises the patient's ability to understand the patient information, to give informed consent or to comply with the trial protocol 16. previous antiangiogenic treatment 17. participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial. 18. pregnancy or breastfeeding
biological and clinical measurements following systemic leakage when a citrate or heparin lock is used

Conditions: Acute Renal Insufficiency

Summary: in the verrourea study, there were two cases of an abnormal increase in tca. in theory no leakage of the lock into the bloodstream should have been seen. lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. the aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. the findings will complete safety data already collected in the verrou rea study.


Eligibility criteria:
inclusion criteria: * patient aged \> 18 years * requiring dialysis for acute kidney failure * in whom a first non-tunnelled catheter has been inserted * in the jugular or femoral position * once informed consent has been obtained from the patient, a family member or a person of trust exclusion criteria: * patients with active and poorly-controlled bleeding * known allergy to citrate * liver failure (factor v \<30%) * thrombopenia \< 30 000/mm3 in the absence of planned corrective measures at the time of randomization * known or suspected heparin-induced thrombopenia * positive blood cultures without treatment or with inappropriate treatment at the time of randomization * catheter inserted in the subclavian position * person without national health insurance cover * pregnant women * adults under guardianship

Keywords: patients
winrop algorithm validation for retinopathy screening in a cohort of premature infants

Conditions: Retinopathy of Prematurity

Summary: when a child was born too early, it is more likely to develop an alteration of its visual function than in the case of term birth. significant visual disturbances are found in 3% of children born prematurely, but visual impairment can be very severe, up to the loss of vision in case of retinopathy of prematurity (rop) in the most immature infants. the introduction of screening surveillance systems, such as winrop software, might reduce the need for stressful eye examination in low risk neonates. this retrospective study aimed at validating the winrop algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had systematic eye examination for rop screening over 4 year period.


Eligibility criteria:
inclusion criteria: * all infants born below 32 weeks gestation within the study period * at least one eye examination recorded by retcam exclusion criteria: * any ophthalmic abnormality * any genetic abnormality

Keywords: very premature infants screening retinopathy
the effect of menopause on sexual life and depression: a case-control study.

Conditions: Menopause; Depression; Sexual Dysfunction

Summary: work completed but not yet published

work completed but not yet published

Eligibility criteria:
inclusion criteria: * case group: women between the ages of 45-65, who are in the postmenopausal period, who are literate, who do not have communication difficulties / mental disabilities, and who volunteer to participate in the study were included. control group: women between the ages of 45-55, who were not menopausal, who were literate, who had no communication difficulties / mental disabilities and who volunteered to participate in the study were included. exclusion criteria: * for case group: women with premature menopause (before the age of 40), chronic systemic disease (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study. for control group: women under the age of 45, over the age of 55 with chronic systemic diseases (diabetes, heart disease, hypertension, thyroid, rheumatic disease, psychiatric disease history) and using psychiatric drugs were not included in the study.
veclose five year follow-up extension study

Conditions: Great Saphenous Vein (GSV) With Venous Reflux Disease

Summary: the veclose five year follow-up extension study will seek to gain additional follow-up data from the patients enrolled in the veclose study (nct01807585).

the veclose five year follow-up extension study will continue to assess the safety and efficacy of the venaseal closure system for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the veclose study.

Eligibility criteria:
inclusion criteria: 1. enrolled in the veclose study. 2. able and willing to complete the required 5 year study visit including duplex ultrasound exam. 3. able and willing to provide written informed consent prior to study specific data collection. exclusion criteria: 1. withdrew consent from the veclose study.

Keywords: gsv
developing a psychosexual educational partners program: pepp a feasibility study

Conditions: Breast Cancer; Gynecologic Cancer

Summary: this is a single arm study to evaluate the feasibility, adherence, and usefulness of a psychosexual education partner program (pepp) to improve partner communication and sexual function. this study is intended to get initial input from a small group of up to 10 women and their partners about the appropriateness, usefulness, and critical nature of the content as well as the feasibility and appeal of the method of delivery.

the overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast or gynecologic cancer. the investigators are developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vaginal symptoms, desire/energy, and relationship-partner concerns. this proposal addresses the evaluation of this last component, relationship-partner concerns. the planned intervention to address these concerns is a psychosexual education partner program (pepp) delivered by workbook and three follow up phone calls (to coincide with the end of each module) to women and their partners who have experienced a negative change in their relationship since their cancer diagnosis. ten women with breast or gynecological cancer and their stable partners (ten dyads) will evaluate the content and delivery method of the intervention through self-report questionnaires and a qualitative interview.

Eligibility criteria:
eligibility criteria below apply only to the patient. (the patient's partner must be 18 years of age or older.) patient inclusion criteria: 1. age ≥18 female with a history of any stage breast and/or gynecological cancer. 2. completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration. 3. may use concurrent adjuvant endocrine therapy or her2-targeted therapy while on study. 4. responds yes to the question "has there been change in communication and/or intimacy with your partner since your cancer diagnosis?" 5. ability to read and write english. 6. a stable partner, defined as anyone with whom the woman has had an intimate relationship with for at least 3 months prior to her cancer diagnosis. 7. both partner and woman must agree to participate in the study and sign informed consent to the study. patient exclusion criteria: 1. antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change. 2. past history of sexual abuse. 3. psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (defined per medical history and/or patient self-report.) 4. currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
improving care for unhealthy alcohol use in primary care

Conditions: Alcohol Drinking; Alcohol Use Disorder

Summary: in order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one va primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . it is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

alcohol use is a significant risk factor of disability and death for u.s. adults and one out of every six veterans seen in primary care report unhealthy alcohol use. based on substantial evidence from randomized controlled trials and the u.s. preventive services task force, va/dod clinical guidelines stipulate that all veterans screening positive for unhealthy alcohol use should receive evidence-based alcohol care in primary care, including brief counseling interventions (bi) and additional treatment (e.g., pharmacotherapy) for those with alcohol use disorders (aud). the va was a pioneer in implementing alcohol screening and bi in primary care, yet substantial implementation gaps remain. in order to improve the quality and fidelity of alcohol-related care, the current research proposes to use an evidence-based implementation strategy, practice facilitation, at one va to pilot test whether practice facilitation has the potential to improve quality of primary care-based alcohol-related care. the project will first conduct qualitative interviews assessing veteran and clinical stakeholders to understand barriers and facilitators to high-quality alcohol care. results from qualitative interviews will be used to refine and hone the practice facilitation intervention. clinical stakeholders will then be recruited to participate in focus groups in order to evaluate the acceptability and feasibility of the proposed practice facilitation intervention prior to testing it. last, a pilot test of the practice facilitation intervention will be conducted within one va primary care clinic to understand whether practice facilitation improves the quality of primary care-based alcohol-related care.

Eligibility criteria:
inclusion criteria: veteran patients: * veteran presenting for care at va primary care site during pilot testing of the practice facilitation intervention, and * age 18 years and older. primary care providers: * primary care staff who screen for unhealthy alcohol use and providers who practice at the primary care clinic at least 1 day per week. exclusion criteria: * none.

Keywords: unhealthy alcohol use alcohol misuse alcohol use disorder alcohol abuse alcohol dependence binge drinking alcohol drinking
rct comparing ion levels and clinical outcomes of a-class bfh to metal on polyethylene total hip replacement

Conditions: Hip Joint; Osteoarthritis; Arthroplasty

Summary: the main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

the primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to conserve® a-class total hip with bfh® technology. secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Eligibility criteria:
inclusion criteria: * individuals undergoing unilateral total hip replacement. * patients 50 to 70 years of age. exclusion criteria: * patients who have previously undergone any type of joint replacement. * patients with evidence of active infection. * patients with a documented allergy to cobalt chromium molybdenum.

Keywords: individuals undergoing unilateral total hip replacement.
attitude change of hearing health professionals on bone-anchored hearing devices over time in a developing country

Conditions: Hearing Loss; Bone Anchored Hearing Aids

Summary: this study aims to examine shifts in attitudes about bone-anchored hearing instruments (bahis) among hearing health professionals over a period of time.

a survey was designed to assess the knowledge and attitude of participants concerning bahis. the survey was administered in both 2019 and 2023 at various conferences, with the questionnaires placed on chairs in different rooms. responses were collected from otorhinolaryngologists and audiologists for analysis.

Eligibility criteria:
inclusion criteria: working as a licensed health professional as a medical doctor or an audiologist - exclusion criteria: none -
ileus after lumbar spine surgery

Conditions: Lumbar Spine Surgery Postoperative Ileus

Summary: postoperative ileus (poi) after lumbar spine surgery is not uncommon. however, the incidence, severity and risk factors of ileus after spine surgery remain uncertain because there is not yet a prospective investigation using a subjective grading evaluation tool.

this study aims to prospectively investigate the incidence of poi after spine surgery by using the i-feed scoring system. the severity of poi after spine surgery thus could be stratified and then an investigation of possible risk factors could be identified.

Eligibility criteria:
adult patients who undergoing elective lumbar spine surgery

Keywords: post-operative ileus,lumbar spine surgery
study of mra for systemic juvenile idiopathic arthritis (sjia)

Conditions: Systemic Juvenile Idiopathic Arthritis

Summary: this is a double-blind, phase iii study to evaluate the efficacy, safety and pk of mra in patients with sjia.


Eligibility criteria:
inclusion criteria * patients diagnosed as having systemic jia based on the international league of associations for rheumatology criteria (1997) * patients between 2 and 19 years of age * patients who are under 16 years of age at onset * patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions exclusion criteria * patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product * patients who have received the following treatments within 4 weeks before treatment with the investigational product 1. surgical treatment (e.g., operation) 2. plasma exchange therapy"