Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the efficacy of treatment vs discontinuation in a first episode of non-affective psychosis

Conditions: Psychosis Nos/Other

Summary: the purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by panss) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. the candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.

randomized, open label, multicenter, phase iii clinical trial. number of subjects: 104. age range: 18 - 55 years of both sex. timepoints for evaluation: every two weeks, during the first six months after initiation of treatment discontinuation/continuation. every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.

Eligibility criteria:
inclusion criteria: * adult age from 18 to 55 years old * non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv). * antipsychotic treatment for 12 months since clinical stabilization. clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). in case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family. * no changes in the antipsychotic doses in the last 4 months. * no suicide attempts in the last 12 months. * patient who shows remission criteria. * signed informed consent form. exclusion criteria: * patient who is not fluent in spanish language * patient who takes mood stabilizers (lithium, antiepileptic drugs...) * dependency on alcohol or other substances of abuse (cannabis, cocaine...) * history of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders. * intelligence testing (iq) less than 70. * suicide attempt from stabilization. * pregnancy or planning to become pregnant during the study.

Keywords: non affective psychosis first episode discontinuation scheme
complications and the influence of covid-19 on myocardial function and exercise capacity

Conditions: Covid19; Heart Failure

Summary: the subject of the study is the impact of covid-19 on the indicators of myocardial efficiency and exercise capacity. as a result of the observed dependencies, it will be possible to start an appropriate diagnostic procedure early, select personalized treatment and develop a model of cardiological care for people with a history of sars-cov-2 infection and improve the quality and extend their life.

about 100 adult patients hospitalized in the department of cardiology and congenital heart diseases of adults who had recovered from covid-19 will be included in the study. selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, co-morbidities, results of selected laboratory tests, lung imaging (x-ray or computed tomography) selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, body mass analysis. one year after inclusion in the study, a control hospitalization will be performed. the same factors will be analyzed.

Eligibility criteria:
inclusion criteria: * age equal to or older than 18 years * infection with the sars-cov-2 in past medical history * current hospitalization exclusion criteria: * severe hypertension; * unstable angina; * acute pulmonary embolism; * decompensated heart failure; * recent myocardial infarction; * unstable heart rhythm disturbances; * acute myocarditis or pericarditis; * active endocarditis; * advanced atrioventricular block; * diagnosis of cardiomyopathy (hypertrophic, dilated, restrictive, peripartum, arrhythmogenic) * lysosomal storage disorders * severe hyper- and hypothyroidism * pregnancy and lactation * chronic kidney disease (iv, v stadium according to nkf) and dialysis treatment * documented neoplastic process * the patient's inability to cooperate and/or provide informed consent to participate in a research * alcohol and drug abuse * active autoimmune disease * treatment using immunosuppressants, cytostatic drugs, glucocorticosteroids, or antiretroviral drugs * a history of bone marrow transplant or other organ transplant, treatment with blood products within the last 6 months * active systemic infection * hbv, hcv or hiv carrier or positive for hbs antigen or antibodies to hcv * surgery or serious injury within the last month * patients who did not express their informed consent to participate in the study
a clinical investigation of the benefit: bte hearing aids versus ite hearing aids

Conditions: Hearing Loss

Summary: the current study will evaluate a new in-the-ear (ite) hearing aid hardware. the goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. the study plans to compare the behind-the-ear (bte) hardware style with the ite devices regarding the benefit received from different microphone locations.

hearing aids constantly undergo incremental improvements from already marketed devices. the new devices are expected to perform as well or better than the previous ite devices. the aim of the testing is to grant quality control prior to product launch according to bernafon development requirements. the current study will evaluate a new ite hearing aid hardware. the firmware driving the hearing aid has already been sold on the market using the bte hardware for almost one year and will now be launched using the ite custom hardware. the goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. the study plans to compare the two hardware styles regarding the benefit received from different microphone locations. as human subjects are involved the validation falls under the definition of a clinical investigation. the validation will address the performance of the new chip using the ite hardware, and ensure that there is no reduction in speech understanding between using the bte and ite hardware styles. evaluating the overall performance of the mermaid 9 ite devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. all features available in mermaid 9 have been validated and are currently used on the market in mermaid 9 bte devices.

Eligibility criteria:
inclusion criteria: * all classifications of hearing loss (sensorineural, conductive, mixed) * if the hearing loss is conductive or mixed it must be approved for amplification by a physician * all shapes of hearing loss (flat, sloping, reverse slope, notch) * severity ranging from mild to severe * german speaking * current hearing aid users * both genders * ages 18 and older * ability and willingness to sign the consent form exclusion criteria: * contraindications for amplification * active ear disease * inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant * a reduced mobility making them unable to attend weekly study appointments * uncooperative so that it is not possible to record a valid pure tone audiogram * a strongly reduced dexterity * central hearing disorders * bernafon employees * family members of bernafon employees
video-observed therapy for active tuberculosis: a feasibility study

Conditions: Tuberculosis Active

Summary: tuberculosis (tb) is still present in switzerland, and concerns mainly foreign-born subjects. monitoring compliance to treatment by directly observed therapy (dot) is strongly encouraged by the world health organization (who). it is however time-consuming, costly and stigmatising. this study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone, a concept known as vdot (video-observed therapy). the study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance, compliance, and technical issues related to vdot.

the study aims to include all patients who are treated de novo for active tuberculosis is our area. the aim of this study, was to show that vdot was feasible in a low-incidence high income area, that it had a high acceptance rate among patients and health-care professionals, with a low rate of technical difficulties or pitfalls. all patients with a diagnosis of tuberculosis irrespective of site(s) of infection, were invited to participate in this study. the division of pulmonology of geneva university hospital diagnoses and follows virtually all cases of tuberculosis in the canton of geneva. annual number of cases in geneva between 2020 and 2023 was on average 43/year (range: 36-53). incidence was 7-10.3/105 inhabitants compared to a national incidence of 3.99-4.72 /105 inhabitants during the same period. specialized tb nurses were trained to use the vdot platform and provided the training with the help of translators whenever required. the application (app) was installed with the patient, and a test video was sent to the platform. the app uses simple understandable pictograms and is thus not per se language-dependent . vdot was started as soon as possible after initiation of tb treatment, either during a hospital stay or during the first outpatient follow-up visit at our centre. whenever necessary, a portable cell phone was provided for the patient, for the duration of the treatment. the sureadhere platform was used for vdot (https://dimagi.com/sureadhere/). once the videos have been recorded, they are sent automatically as soon as the patients' cell phone has access to internet. for each patient, the number of videos to be sent each week was specified (5 as default option).

Eligibility criteria:
inclusion criteria: * age above 16 years of age; providing informed consent (translators were used whenever necessary to ensure understanding of study and vdot procedure); having a diagnosis of untreated active tuberculosis, irrespective of site of infection, confirmed by culture and/or polymerase chain reaction test (pcr) and follow-up ensured by geneva university hospital. exclusion criteria: * refusal to participate, not fulfilling inclusion criteria

Keywords: compliance directly observed therapy video-observed therapy
retrospective observational safety effectiveness with kuvan in hpa

Conditions: Tetrahydrobiopterin Deficiency

Summary: a retrospective study to collect the effectiveness and safety data of the past treatment with kuvan in chinese patients with hpa caused by bh4 deficiency. the data was collected from relevant past medical history and past clinical and safety assessments.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent (unless exemption of obtaining consent is obtained as per local regulation). assent (if required defined by local regulation and requirement) should also be obtained from the subject and the legal authorized representative. * diagnosed with bh4 deficiency per local practice. * kuvan® was taken at least 1 dose to treat hpa caused by bh4 deficiency during the period of observation. * baseline phe concentration ≥ 450 µmol/l exclusion criteria: * subject diagnosed to have phenylketonuria (pku) * has any condition that, in the view of the investigator, the medical record of the subject in the duration of observation is not reliable, or not accessible.
postop pain management in pituitary tumour patients

Conditions: Pituitary; Pain, Postoperative

Summary: to assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. the medication (bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. some patients will be randomized to a third, sham group that do not receive any additional injection. the aim is to improve patient outcomes and reduce the need for pain medication after surgery.

to further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (spg) block (spgb) for pain management in the context of an enhanced recovery after surgery (eras) protocol for minimally invasive (mis) endoscopic transsphenoidal pituitary surgery. the spg is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of spgb following sinus surgery and showed positive results for endoscopic sinus surgery. however, there is limited research on the use of spgb in the context of pituitary surgery. in this randomized placebo-controlled trial, the investigators aim to assess the benefit of spgb with bupivacaine in addition to multimodal general anesthesia on pain management, after mis pituitary surgery. the results of the trial will provide valuable insights into the potential benefits of spgb and its optimal use for pituitary surgery.

Eligibility criteria:
inclusion criteria: * adult patients (18 yrs or older) * undergoing endonasal pituitary adenoma resection exclusion criteria: * patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs * contraindications to the performance of spgb such as known allergy to used medications * chronic alcohol abuse * uncontrolled systemic arterial hypertension * severe kidney or liver diseases * cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)

Keywords: nerve block bupivacaine sphenopalatine ganglion
supplementation of n-3 pufa in the modulation of lean mass in patients with lung cancer receiving a high-protein diet

Conditions: Lung Cancer

Summary: this study is conducted to test the hypothesis that patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine kinase inhibitors receiving a high protein diet and supplemented with fish oil will improve muscle mass, therapeutic response and modulate the intestinal microbiota within a 4 month period.

lung cancer (pc) is the most prevalent tumor. the loss of muscle mass, myosteatosis and changes in body composition have been associated with inflammation in cancer and pufa n-3 have been shown to be an important modulator of the inflammatory response and epigenetic mechanisms. additionally, the intestinal microbiome has received prominence with the use of immunotherapy, as it is demonstrating that resistance to this therapy can be attributed to the abnormal composition of the intestinal microbiome. aims: the purpose of this study is to assess the effects of fish oil supplementation in the modulation of lean mass and intestinal microbiome in patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine kinase inhibitors receiving a high-protein diet. methods: fifty patients will be randomly allocated either to treatment with fish oil or to placebo for 4 months. the following assessments will be made: lean mass, myosteatosis, sarcopenia, adipose compartment, inflammation, micro rna, food consumption, membrane phospholipid composition, composition of the intestinal microbiota, toxicity, response to antineoplastic treatment and survival.

Eligibility criteria:
inclusion criteria: * diagnosis of non-small cell lung cancer, both sexes, ecog performance status (0-2) eligible for treatment with immunotherapy, chemotherapy and tyrosine kinase inhibitors. exclusion criteria: * supplementation of pufa n-3 in the last 6 months; weight loss\> 10% in 6 months, chronic liver disease, previous chronic kidney disease, anorexia, decompensated diabetes mellitus and dementia.

Keywords: fish oils body composition microbiota epigenetics lung cancer
"a comparative clinical evaluation of the efficacy of topical adapalene, benzoyl peroxide gel, oral lactobacillus rhamnosus, d-chiro-inositol, inulin capsule, and their fixed combination in mild to moderate acne vulgaris patients."

Conditions: Acne Vulgaris

Summary: the study aims to conduct a comparative clinical evaluation of the effectiveness of a fixed topical combination of adapalene with benzoyl peroxide in the form of a gel, a fixed combination of lactobacillus rhamnosus, d-chiro-inositol and inulin in the form of capsules and their combination in patients with acne vulgaris of mild and moderate severity and laboratory lipid analysis profile of sebum, lipid metabolism, and igf-1 (insulin-like growth factor).


Eligibility criteria:
inclusion criteria: * patients with mild to moderate level of acne vulgaris exclusion criteria: * pregnancy
use of a novel computerized decision aid for prenatal aneuploidy screening

Conditions: Aneuploidy; Pregnancy Complications

Summary: the investigators aim to assess whether use of a novel, tablet-based computerized decision aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit in improving patient knowledge and decreasing decisional conflict.

184 women will be randomized in a 1:1 fashion to use of a novel computerized ipad-based decision aid in addition to routine counseling or routine counseling only during a single study visit. this decision aid was developed at a 10th grade literacy level using input from maternal fetal medicine physicians and certified genetic counselors, and piloted by 20 english and spanish speaking women of varying education levels. following completion of genetic counseling, participants will complete several surveys assessing knowledge and decision conflict. data will be abstracted regarding demographics, screening and diagnostic testing uptake, and testing results.

Eligibility criteria:
inclusion criteria: * pregnancy at less than 22 weeks gestation * english or spanish speaking * undergoing genetic counseling at north carolina women's hospital for aneuploidy screening exclusion criteria: * known fetal anomalies * known multiple gestations * prior genetic counseling or aneuploidy screening in current pregnancy

Keywords: decision aid
effectiveness of a natural ingredient on appetite regulation

Conditions: Appetite Regulation; Overweight and Obesity

Summary: single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.

subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Eligibility criteria:
inclusion criteria: * age 18-65 years. * both genders. * bmi 25-34.9 kg / m2, both inclusive. * weight maintained during the last 3 months. * smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study. * absence of disease diagnosed at the start of the study. exclusion criteria: * thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory). * history of allergic hypersensitivity or poor tolerance to any component of the products under study. * subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study. * participation in another clinical trial in the three months prior to the study. * lack of will or inability to comply with clinical trial procedures. * pregnant woman. * subjects whose condition does not make them eligible for the study according to the researcher's criteria.
mechanical recanalization with flow restoration in acute ischemic stroke

Conditions: Acute Stroke

Summary: the objective of this study is to collect data on the use of the solitair fr device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of solitair is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.


Eligibility criteria:
inclusion criteria: * age 18-85 years * acute ischemic stroke with occlusion if ica, mca, va or ba (tici 0 or 1 flow) within the first 6 hours exclusion criteria: * rapidly improving neurological signs * nhiss\>30 or coma * female patients, who are pregnant or lactating * use of warfarin anticoagulation with inr \> 1.5 * platelet count \< 30,000 * glucose \< 50 mg/dl * life expectancy of less than 90 days * computed tomography (ct) or magnetic resonance imaging (mri) evidence of hemorrhage on presentation * ct showing hypodensity on presentation

Keywords: stroke mechanical recanalization self-expanding stent solitaire
low-level laser therapy in wrist fractures

Conditions: Colles' Fracture

Summary: approximately 15,000 persons in norway suffer from wrist fractures during a year, making it the most prevalent fracture in this country. treated conservatively, a cast is used for 4-6 weeks before removal. after discontinuation of the cast, physiotherapy is implemented to aid in improving range of motion and regaining function of the injured wrist. the pain after injury can affect the patient to a greater or lesser extent, and it is common to prescribe sick leave for shorter amounts of time after the injury. studies suggest that a physiotherapy intervention with low level laser therapy (lllt) may reduce pain and swelling after acute trauma, and potentially promote healing. the aim of this study is to evaluate the effect of lllt on pain and function at 2, 4, 8 and 26 weeks after injury.

patients with wrist fractures are recruited from bergen municipal emergency ward, where they are randomly divided into two groups with concealed allocation. the fracture is immobilized with a cast, with a small opening where low level laser therapy can be administered in skin contact. the patients will receive treatment 3 times a week, for 3 weeks. after discontinuation of the cast, the patients swelling, pain, grip strength and function of the wrist is measured. the patients will meet for follow-up controls until 26 weeks after injury.

Eligibility criteria:
inclusion criteria: * patients with distal radiusfraktur, with or without ulna fracture colles' fracture * the breach must be closed * under 10 degrees dorsal displacement of radius * under 5mm shortening of the radius * under 3 mm step in the joint * 18+ years exclusion criteria: * people who do not speak norwegian or english * if the patient is pregnant * patient with smith fracture * wounds over fracture area * if the patient have a peripheral nerve injury * if the patient had (previously) operated wrist * persons with verified osteoporosis at the time of injury, systemic inflammatory disease (rheumatism), mental illness, stroke, parkinson's disease, multiple sclerosis, cancer or congenital malformations in wrist * if the laser treatment can not be started within 3 days after fracture

Keywords: distal radius fracture, low level laser therapy