Kornimate/medical-research-clean huggingface dataset:
testosterone undecanoate and quality of life of men and spouses

Conditions: Hypogonadism

Summary: this study will be conducted as a prospective, single-center (multiple clinics), single-arm open phase iv study. the study will follow hypogonadal patients, and aimed to confirm the hypothesis that testosterone undecanoate improves the patient satisfaction and quality of life, with parallel improvement in their spouses's quality of life and satisfaction. each patient/spouse will serve as his own control.

the study protocol will follow hypogonadal patients, who initiate treatment with testosterone undecanoate, given in accordance with the standard protocol. hypogonadal men eligible for treatment with testosterone undecanoate, who have not been treated with testosterone undecanoate within the last 6 months prior to enrollment, can be enrolled in the study. patients who were treated with another testosterone formulation (eg. testosterone gel, testosterone enanthate injections) will require a 4 week wash-out period. patients must be enrolled after the decision for treatment with testosterone undecanoate has been made. patients will be followed for an observation period of 28 weeks. observations will be recorded at 3 consecutive visits, and will assess patient and spouse satisfaction and quality of life with validated questionnaires. the study design is an intra-individual comparison. each patient/spouse serves as his own control. a laboratory test for total testosterone level will be required in the last visit. the need for concomitant phosphodiesterase-5 inhibitors use will also be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * hypogonadal patient age 40 to 80 who has newly been prescribed testosterone undecanoate. * the patient must be in a stable (\>3 months) heterosexual relationship to be eligible for the study * diagnosis of hypogonadism at the discretion of the physician, based on patient's symptoms and a laboratory evidence of t levels below 12 (symptomatic patients with borderline levels of 8.4 to 12 are also eligible for testosterone replacement therapy) * wash-out of 6 months for testosterone undecanoate, 4 weeks for other testosterone formulations, before study entry. * patient \& spouse must be capable and willing to fill-in questionnaires to be enrolled in the study * informed consent is required exclusion criteria: * the standard contraindications and warnings of treatment with testosterone replacement therapy, and specifically testosterone undecanoate, must be followed. contra-indications as copied from the product prescribing information are: androgen-dependent carcinoma of the prostate or of the male mammary gland; past or present liver tumors; hypersensitivity to the active substance or to any of the excipients * men with desired paternity will be excluded

Keywords: quality of life testosterone undecanoate partner questionnaire
austrian covid-19 registry

Conditions: Infectious Disease; COVID-19

Summary: the agmt_covid-19 registry is designed as multicenter observational cohort of patients, that are tested positive for sars-cov-2. data will be collected from all sites in austria willing to participate. due to the non-interventional nature of the agmt_covid-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the ecrf.

coronavirus disease 2019 (covid-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the disease was first identified at the end of 2019 in wuhan, the capital of hubei province in central china, and has since spread globally. there are currently no authorised vaccines or treatments in the eu (european union) to prevent or treat novel coronavirus disease (covid-19) specifically or any other coronaviruses. the agmt_covid-19 registry is designed as multicenter observational cohort of patients, that are tested positive for sars-cov-2. data will be collected from all sites in austria willing to participate. due to the non-interventional nature of the agmt_covid-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the ecrf. treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Eligibility criteria:
inclusion criteria: * age \>=18 years * positive test for sars-cov-2 exclusion criteria: * due to the non-interventional design of the registry there are no specific exclusion criteria.
response to chimeric antigen receptor (car)-t cells therapy in patients with hematologic malignancies depending on tumor characteristics

Conditions: Hematologic Diseases

Summary: immunotherapy with chimeric antigen receptor (car) t cells, t cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. this approach is promising for patients with hematologic malignancies refractory to chemotherapy. despite impressive results, too many patients are relapsing. the reasons for the relapse, after the injection of car t cells, need to be explored. in this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with car t cells, especially the characteristics of the tumor and its microenvironment. the objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to car-t cells therapy in patients with hematologic malignancies


Eligibility criteria:
inclusion criteria: * patient with hematological malignancy (lymphoma, all, mm) * patient integrated into a car-t cells program treatment * patient aged 15 years or over * patient having signed a written consent; as well as his legal representative if \<18 years old exclusion criteria: * patient with other hematological malignancies than lymphoma, lal or mm * patient's weight \<58 kg * patient treated with another treatment than car-t cells * patient under tutorship or curatorship * patient not covered by a health system
safety profile of idelalisib in patients with refractory follicular lymphoma

Conditions: Follicular Non-Hodgkin's Lymphoma Refractory

Summary: the primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (fl).


Eligibility criteria:
inclusion criteria: * individuals who were or are being treated for refractory follicular lymphoma (fl) according to the product information for idelalisib and treatment guidelines in routine clinical practice. exclusion criteria: * individuals included in clinical trials on idelalisib within the timeframe of this study.
viome nutritional programs to improve clinical outcomes for gastrointestinal conditions

Conditions: Gastrointestinal Health

Summary: us residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. this study is direct to participant and will not utilize clinical sites.

participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, viome's condition-based supplements (vcs) arm or the viome precision nutrition program (vpnp) arm. placebo, viome-designed condition-based supplements and viome's precision nutrition program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. the trial will last approximately 4 months for each participant.

Eligibility criteria:
inclusion criteria * resident of the united states * females and males ages 25-75 (inclusive) * able to speak and read english * no unexplained weight loss, fevers, anemia, or blood in stool * willing and able to follow the trial instructions, as described in the recruitment letter * signed and dated informed consent prior to any trial-specific procedures. * diagnosis of ibs according to rome iv criteria and ibs-sss score of 125-450 (inclusive) exclusion criteria * unwilling to change current diet * prior use of viome products or services * antibiotic use in the previous 4 weeks * women who are pregnant (current or planned in the next 4 months), or breastfeeding * \< 90 days postpartum * active infection * unable or unwilling to use viome's app on an iphone or android smartphone * significant diet or lifestyle changes in the previous 1 month * ibd diagnosis * use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial * cancer therapy within the previous 1 year * major surgery in the last 6 months or planned in the next 4 months * prescribed any drug(s) that may interact with the supplement formulations * have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements * allergies to any study-specific supplement ingredients * currently on a specific diet: fodmap keto paleo - gastrointestinal disease including: esophagitis celiac disease gi malignancy or obstruction peptic ulcer duodenal or gastric ulcer disease * gi surgery except: appendectomy and benign polypectomy

Keywords: nausea vomiting diarrhea constipation bloating gastroesophageal viome nutrition supplements vpnp viome precision nutrition program reflux diet microbiome biome gastrointestinal
covid-19 vaccine boosters in patients with ckd

Conditions: Chronic Kidney Diseases; COVID-19

Summary: this study is a 12-month, four-arm parallel-group randomized control trial of pfizer-biontech versus moderna covid-19 (corona virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following covid-19 vaccination, in collaboration with 5 dialysis centers in ontario and british columbia, canada . patients will be randomized to moderna or pfizer-biontech covid-19 vaccine, they may have received either moderna or pfizer-biontech covid-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (moderna or pfizer-biontech ) prior to randomization, which will result in four study groups.

moderna : nucleocapsid modified messenger rna biontech: bio-pharma new technology

Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease (ckd)stage 3b-5 defined as an egfr( estimated glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible. stage 5 ckd will include patients receiving in-center hemodialysis, home dialysis (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the covid-19 vaccine will be eligible for a third dose to be given 2-12 months following the second dose. * age ≥18 at the time of study enrolment exclusion criteria: * patients not vaccinated against covid-19 vaccination. * patients who received heterologous first two doses of vaccine * patients with a severe allergic reaction to prior covid-19 vaccination or any of the ingredients. * new covid-19 infection

Keywords: vaccine ckd
gadopiclenol in contrast enhanced mri of the prostate

Conditions: Prostate Cancer

Summary: the fundamental aim of this study is to show that the novel contrast agent gadopiclenol (elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on prostate mri, as categorized by the pi-rads v2 classification categories.

gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (mvd), and therefore increase visibility of cancerous tissue. in this study, the objective is to demonstrate that gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to t2-w (t2 weighted image) and diffusion weighted imaging (dwi), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed mri-us fusion biopsies.

Eligibility criteria:
inclusion criteria: * scheduled to undergo a clinically indicated mri of the prostate with contrast. * scheduled to undergo, or likely to be scheduled to undergo, a prostate mri-us fusion biopsy with histology results available within 6 months of their mri. exclusion criteria: * prisoner * have already begun therapeutic treatment for prostate cancer including surgery (turp, prostatectomy), radiotherapy, hormone therapy or chemotherapy. * patients with end stage renal failure who are on dialysis. patients who have chronic kidney disease or acute kidney injury are contraindicated for mri per fda and acr (american college of radiologists) guidelines and would thus be excluded as well.

Keywords: mri prostate contrast agent
relationships and differences analysis in heart failure

Conditions: Heart Failure; Chronic Heart Failure; Chronic Heart Disease

Summary: this study characterizes heart failure patients who attended the university hospital würzburg. the primary aim is a better understanding of the relationships and differences between the subgroups hfref (ef \ 50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.

the varying clinical picture of heart failure (hf) represents a major challenge for patient care in germany. hf is one of the most common reasons for hospitalization in the western world. in the chronic course of heart failure, affected patients are committed to morbidity, lifelong therapy and high risk of cardiac decompensation, also associated with high mortality. heart failure patients, who visited the cardiology department of the university hospital wuerzburg, shall be analyzed with regard to all clinical data and outcome. this retrospective work should help to better understand the three groups hfref (ef \ 50%) and help identifying similarities and differences between the groups. hereby we hope for progress in diagnostic, prognostic and therapeutic aspects of heart failure.

Eligibility criteria:
inclusion criteria: * diagnosis: heart failure * minimum of two echocardiographic examinations in a minimum time frame of six months * patients must have reached the age of 18

Keywords: hfmref hfref hfpef heart failure
nutrition childhood cancer survivors

Conditions: Childhood Cancer; Nutrition Disorders

Summary: nutrition ccs is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. the study was conducted in the clinic for childhood cancer survivors. the clinic is attended by patients older than 18 years and was built in 2016 at the st. anne's hospital in brno.

nutrition ccs is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. objectives of the study 1. to determine the prevalence (incidence) of nutritional disorders, especially obesity and metabolic syndrome, in cured paediatric cancer patients in adulthood; 2. to investigate the role of adipokines in the development of cardiometabolic complications in this group of patients; 3. to determine whether targeted dietary and lifestyle interventions can lead to improvements in nutritional status and subjectively perceived quality of life of treated paediatric cancer patients in adulthood and objectively assessed cardiometabolic risk

Eligibility criteria:
inclusion criteria: * patients after treatment from childhood and adolescent cancers. * the subject is male or female, aged 18 - 64 years exclusion criteria: * patients with acute cancer therapy * pregnant women

Keywords: children cancer survivors adiposity late effects nutriton adipokines
impact of transcranial direct current stimulation of the motor cortex on language functions in residual aphasia

Conditions: Residual Aphasia

Summary: the present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

patients will participate in two tdcs sessions (atdcs; sham) in a cross-over within subjects design. tdcs or placebo will be administered during simulatneous fmri to assess neural signatures of the stimulation. order of stimulation will be counterbalanced between subjects

Eligibility criteria:
inclusion criteria: * right handedness * german native speaker * cerebrovascular stroke in left hemisphere (\>6 months) * mild aphasia (according to aachen aphasia test battery classification, huber et al., 1983) * residual anomia in naming test (\>75 correct responses) exclusion criteria: * other current or previous neurological or psychiatric diseases * alcohol or drug abuse * mri contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
sound therapy for tinnitus relief in cochlear implant users

Conditions: Tinnitus, Hearing Loss, Cochlear Implant Users

Summary: the aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. the sound therapy is a combination of tinnitus counselling and sound enrichment with the cochlear active relief from tinnitus (cart) firmware.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * self-reported tinnitus during standard cochlear implant (ci) activation for at least one month * at least three months use of unilateral or bilateral nucleus ci(s) driven by a cp900 sound processor. for bilateral use the most recently activated ci is used for at least three months * native speaker and fluency in the language used in the assessments (i.e. dutch) exclusion criteria: * additional handicaps that would prevent participation in evaluations * history of psychiatric disorders or depression (on investigator's opinion) * unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study * pulsatile or diagnosed objective / middle ear tinnitus

Keywords: sound therapy tinnitus relief
staining potential and caries arresting effect of silver diamine fluoride⁄potassium iodide and silver diamine fluoride

Conditions: Dental Caries in Children

Summary: the main objective of this study is to evaluate staining potential and caries arresting effect of silver diamine fluoride⁄potassium iodide and silver diamine fluoride in carious anterior primary teeth

despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. in this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. among these simple treatments is silver diamine fluoride (sdf) treatment. the major drawback to sdf treatment has been its black staining, which has limited its use. to counter the staining, researchers have tested sdf treatment immediately followed with application of saturated solution of potassium iodide (ki).

Eligibility criteria:
inclusion criteria: * children with carious primary anterior teeth. * children with no spontaneous pain exclusion criteria: * tooth mobility * signs of pulpal or periapical infection * severe medical conditions that would not allow management in the clinic * sensitivity to silver or other heavy-metal ions * presence of any gingival or perioral ulceration or stomatitis
a treatment protocol for patients with gastrointestinal stromal tumor (gist) who may derive benefit from treatment with su011248

Conditions: Gastrointestinal Neoplasm

Summary: the purpose of this study is to permit access to su011248 for treatment use by patients with gist given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as a6181004; and b) patients have gist which standard treatments have not been able to control with acceptable toxicity and c) patients have the potential to derive clinical benefit from treatment with su011248.

given that an expanded access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per nih, basic results for such studies are not required to be reported. protocol a6181036 has been identified as an expanded access trial, and has been registered to clinicaltrials.gov, however basic results will not be posted.

Eligibility criteria:
inclusion criteria: * histologically proven gastrointestinal stomal tumor (gist) that is not amenable to standard therapy * undergone screening and found to be ineligible for participation in ongoing su011248 clinical studies * patient judged to have potential to derive clinical benefit from su011248 treatment by the treating physician * failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment * male or female, 18 years or older * resolution of all acute toxicities of prior therapies * adequate organ function exclusion criteria: * symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication * symptomatic central nervous system metastases * serious acute or chronic illness * current treatment on another clinical trial * pregnant or breastfeeding.
continuous non-invasive hemodynamic monitoring in early-onset severe preeclampsia: a comparison of echocardiography, bioreactance, and finger cuff measurements

Conditions: Pre-Eclampsia

Summary: the purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (nicom; cheetah medical) and pulse wave analysis as assessed by finger cuff arterial pressure (clearsite, edwards life sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.


Eligibility criteria:
inclusion criteria: * bp \>160 or dbp \>110 * gestational age between 20-34 weeks * singleton pregnancy exclusion criteria: * prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy * multi-fetal pregnancy