Kornimate/medical-research-clean huggingface dataset:
prostac: prospective multi-centre study of prognostic factors in mcrpc patients treated with docetaxel or cabazitaxel.

Conditions: Advanced Prostate Cancer; Cabazitaxel; Docetaxel

Summary: prostac is a prospective multicentre observational study in metastatic castration-resistant prostate cancer (mcrpc), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel

this study is a prospective biomarker study of patients with mcrpc undergoing treatment with docetaxel or cabazitaxel as standard of care treatment. the participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility criteria:
inclusion criteria: 1. male age ≥ 18 years 2. histologically confirmed adenocarcinome of the prostate 3. ecog performance status ≤ 2 4. castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/ml (\< 2.0 nm). 5. men diagnosed with at least one metastatic lesion on ct or bone scan. 6. documented biochemical and/or radiographic progression to previous treatment according to pcwg2 criteria. 7. patients who are candidates for standard of care treatment with docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously. 8. availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. 9. acceptable hematological, hepatic and renal functions. exclusion criteria: 1. previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas. 2. any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data

Keywords: metastatic castration resistant prostate cancer taxanes biomarkers
evaluation of the cryopreserved amniotic membranes in the care of resistant vascular ulcers

Conditions: Resistant Vascular Ulcers

Summary: to evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers. to evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life. to evaluate rate of amputations and recurrence at one year after complete cicatrisation

treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. a cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week. main criterias: tolerance will be evaluated on clinical criterias. efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months). secondary criterias: reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption. evaluation of infections, amputations, complete healing, improvement of quality of life by sf36 questionnaire and recurrence at one year for patients with complete healing.

Eligibility criteria:
inclusion criteria: * obtained informed consent * leg or foot arterial or mixed ulcer older than at least 3 months exclusion criteria: * no obtained informed consent * possibility for surgical treatment (revascularisation) * age less than 18 * pregnancy * indication for major amputation (below /above the knee) * venous ulcer * ulcer with infection and / or necrosis * mycotic ulcer
jsp191 (briquilimab) in subjects with lr-mds

Conditions: Lower-risk Myelodysplastic Syndrome

Summary: a phase 1 study in subjects with lr-mds to assess the safety and tolerability of jsp191 as a second-line therapy.

an open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (mtd) or optimal biologic dose (obd), and recommended phase 2 dose (rp2d) of jsp191 (briquilimab) monotherapy for lr-mds subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * mds with ipss-r very low, low, or intermediate risk features * symptomatic cytopenias * women of childbearing potential (wocbp) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of jsp191 * women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry * male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of jsp191 * must be willing and able to provide informed consent exclusion criteria: * anemia secondary to iron deficiency, vitamin b12 deficiency, or folate deficiency * prior allogeneic or autologous stem cell transplant * known history of human immunodeficiency virus (hiv) (no laboratory testing is required), or active infection with hepatitis b or hepatitis c * pregnant women or women who are nursing and do not wish to discontinue breastfeeding * any other medical condition that, in the opinion of the investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study * subjects who, in the opinion of the investigator, may not be able to comply with the requirements of the study

Keywords: lr-mds cytopenia
icancope with sickle cell pain

Conditions: Sickle Cell Disease

Summary: the project will test a tailored web and smartphone-based application (icancope with scd) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. the program will include goal setting, peer-based social support, and pain self-management training. the investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.

cognitive-behavioral therapies (cbt) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. however, most people with scd do not receive cbt-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. first, the investigators plan to apply a user-centered design approach to develop and refine the icancope with scd program. second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. the investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. these results will enable a future full-scale randomized controlled trial.

Eligibility criteria:
inclusion criteria: * aged between 12-18 years * diagnosed with any type of scd * able to speak and read english * score at least 4 (indicating some days with pain interference over the past month) on the sickle cell pain burden interview * willing and able to complete online measures exclusion criteria: * significant cognitive limitations that would impair their ability to use and understand the icancope with scd program, as per their healthcare provider or parent * have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
comparison between 7 and 14 day primaquine combined with dihydroartemisinin-piperaquine or 3 day chloroquine radical cure of p. vivax (bpd)

Conditions: Vivax Malaria

Summary: in southeast asia, plasmodium vivax (pv) infection reaches 50-80% and bears a greater burden of disease than plasmodium falciparum (pf). as control over pf improves, pv will assume increasingly larger percentages of malaria prevalence. the chronicity of pv, due to the latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability and compounds the economic burden of those with symptomatic disease. the only widely available treatment for hypnozoites is primaquine, which, because of challenges with tolerability, safety in g6pd deficient persons, and compliance, is not commonly prescribed for the treatment of pv. currently, chloroquine is used for the treatment of the blood stages of pv, however, there are concerns about increasing parasite resistance. alternative treatments, such as artesunate, should be considered in the future of the treatment of blood stage pv. the use of primaquine in the treatment of hypnozoites (radical cure) should be emphasized so that transmission of pv can be controlled. this study aims to determine the optimal primaquine regimen for radical cure of plasmodium vivax. chloroquine is currently the standard of treatment for plasmodium vivax. chloroquine may have synergistic effects when used with primaquine and due to its long half-life may delay the first relapse of vivax malaria. in contrast, artesunate does not have documented interactions with primaquine and has a very short half-life, thus, presumably will have no impact on first relapse. combining primaquine with these two anti-malarials may lead to an alternative regimen for pv infection and changing the primaquine dosing regimen may lead to a more practical and efficacious therapy.


Eligibility criteria:
inclusion criteria: * ≥ 6 months old * microscopic diagnosis of plasmodium vivax malaria mono-infection * participant or parent/guardian is willing and able to give informed consent for participation in the study * able (in the investigators opinion) and willing to comply with all study requirements. exclusion criteria: * severe malaria * history of allergy or adverse reaction to artesunate, piperaquine, chloroquine, or primaquine * blood transfusion in the past 3 months * g6pd deficiency by rapid test * hematocrit ≤ 25% * pregnancy at the time of screening * breastfeeding an infant \< 6 months old * presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Keywords: vivax chloroquine primaquine dihydroartemisinin-piperaquine
evaluation of performance and safety of ambu® ascope™ 4 cysto and aview™ urologia for flexible cystoscopy

Conditions: Cystoscope; Lower Urinary Tract Symptoms; Bladder Disease

Summary: in this study, the new ascope 4 cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. this study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. for an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. the flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. it will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. if an intervention is performed the ascope 4 cysto will be used with an endoscopic accessory.

clinical phase: pre-ce study design: a prospective, multicenter, single- arm open-label clinical study on the performance and safety of ambu® ascope™ 4 cysto and aview™ urologia, a single-use, flexible cystoscope for flexible cystoscopy population: adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes. planned sample size: a total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "performance level acceptable" to be 11%. this width is considered to be useful in the interpretations of the results from this part of the trial. study duration: screening, procedure and follow-up will take 14 days maximum. a follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure. planned trial period: 3 months investigational device: ambu® ascope™ 4 cysto and aview™ urologia. a pre-ce, single use cystoscope.

Eligibility criteria:
inclusion criteria: * adults (males and females), ≥18 years of age or older, presenting for cystoscopy * ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes * willing to participate in a clinical trial exclusion criteria: * history of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes * history of prior bladder/urethral reconstructive surgery * presence of symptomatic urinary tract infection (uti) * known unpassable urethral stricture * unable to read and/or understand the study requirements * unable or unwilling to provide consent to participation in the study * pregnant or lactating women
effect of aromatase inhibitors on ultrasonographic measurements and static and dynamic balance scores in breast cancer

Conditions: Breast Cancer; Aromatase Inhibitors; Balanced

Summary: to evaluate the effects of aromatase inhibitors on lower extremity ultrasonographic measurements, static and dynamic balance scores in breast cancer patients using aromatase inhibitors

breast cancer is the most common cancer in women. 2/3 of breast cancer patients are estrogen and progesterone receptor positive. tamoxifen or aromatase inhibitors are preferred in most of these patients depending on menopausal status. the increase in the life expectancy of breast cancer patients with medical treatments pushes us to find the cause of the drug side effects encountered during this extended life span and work on preventing/correcting them. it has been proven that aromatase inhibitors cause arthralgia in 40-50% of patients and a loss in bone mineral density, leading to a tendency towards osteoporosis. in this patient group, changes in the tendon and tendon sheath were also observed in ultrasonographic and magnetic resonance imaging and were stated to be the cause of the current symptoms. in the literature, breast cancer patients have been evaluated in detail in terms of balance, and it has been shown that static and dynamic body balance is worse in this group compared to the control group. among the breast cancer population, the presence of arthralgia in the patient group using aromatase inhibitors causes an increased risk of falls. in addition, it is thought that lower extremity tendon changes may be a factor in balance and proprioception disorders. based on this information, quantitative evaluation of static and dynamic balance in patients is important since there is an increase in the frequency of falls and a tendency to osteoporosis in patients using aromatase inhibitors in breast cancer. no similar study has been found in the literature.

Eligibility criteria:
inclusion criteria: * postmenopausal woman * between 40-70 ages * stage 1-3 breast cancer * chemotherapy treatment due to breast cancer (last dosage at least 6 months ago) * using an aromatase inhibitors for at least 1 year for group 1 * never using an aromatase inhibitors at all for group 2 * volunteers must sign and agree to participate in the study. exclusion criteria: * stage 4 breast cancer * having active chemotherapy * older age patient (over 70 years old) * using of steroid * presence of diabetes mellitus that lasts longer than 3 years or insulin usage * neuropathic complaints * lack of vitamin b12 and thyroid dysfunction * dn4 (dolour neuropathic 4 question) score of 4 and above * history of stroke * presence of polyneuropathy diagnosis * medication due to polyneuropathy diagnosis (gabapentin, pregabalin, duloxetine) * loss of motor function in the lower extremity * use of assistive devices for walking * presence of vestibular disorder * presence of cognitive impairment

Keywords: aromatase inhibitors breast cancer
safety and efficacy of different formulations of bimatoprost ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of bimatoprost 0.03% formulation b ophthalmic solution with lumigan® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * patient has ocular hypertension or glaucoma in both eyes * requires iop-lowering therapy in each eye exclusion criteria: * active or recurrent eye disease that would interfere with interpretation of study data in either eye * history of any eye surgery or laser in either eye within 6 months * required chronic use of other eye medications during the study * anticipated wearing of contact lenses during the study. * intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
telepharmacy on patients with arterial hypertension

Conditions: Hypertension

Summary: the goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. the main questions it aims to answer are: 1. how effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care? 2. how effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care? participants will undergo four visits. two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). these will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy. researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.

specific objectives * characterize the clinical and socio-demographic profile of the studied population. * compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups. * evaluate patient adherence to medication treatment in the teleconsultation group and in person * evaluate patient satisfaction in the teleconsultation group and in-person consultation. * compare satisfaction between the telepharmacy and in-person (control) groups.

Eligibility criteria:
inclusion criteria: * elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription. * patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included; * patients must have a cell phone and know how to use it; * patient not have previously received pharmaceutical care. exclusion criteria: * elderly people who are unable to use their cell phones due to cognitive impairments (mini mental state examination (mmse). * elderly person considered unable of using a telephone (instrumental activities of daily living) * elderly with controlled blood pressure according to home monitoring.

Keywords: pharmaceutical care telepharmacy elderly patients
intravenous clarithromycin in septic syndrome

Conditions: Sepsis; Ventilator Associated Pneumonia

Summary: the aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.

the rationale of the trial is based on the favorable results of experimental studies of sepsis by multidrug-resistant pseudomonas aeruginosa and by susceptible escherichia coli in rabbits where clarithromycin was administered intravenously. data from these latter studies suggest that administration of clarithromycin extended survival and attenuated systemic inflammatory response. their major endpoint was successful immunotherapy achieved when clarithromycin was administered on presentation of symptoms of sepsis-induced pulmonary edema; on the contrary, former clinical trials for immunotherapies of sepsis were based on animal studies where the under evolution immunomodulator was administered before bacterial challenge. the efficacy of administration of clarithromycin upon presentation of septic syndrome in animal studies, renders its application promising in the clinical field.

Eligibility criteria:
inclusion criteria: 1. written informed consent provided by first or second degree relatives; 2. intubation and mechanical ventilation at least 48 hours prior to enrolment; c) age of patients equal to or more than 18 years; d) diagnosis of ventilator associated pneumonia; and e) signs of sepsis exclusion criteria: 1. neutropenia, defined as less than 500 neutrophils/mm3; 2. hiv infection; 3. oral intake of corticosteroids at a dose equal to or higher than 1mg/kg equivalent prednisone for a period greater than one month; 4. administration of drotrecogin alpha the last five days prior to enrolment; and e) atrioventricular block of second or third degree.

Keywords: clarithromycin sepsis immunomodulation
metformin plus insulin on non-obese autoimmune diabetes

Conditions: Type 1 Diabetes Mellitus; Autoimmune Diabetes

Summary: the objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes according to ada criterias \<5 years. * age≥ 18 years and less than 70 years. * non-obese: defined as bmi less than 28 kg/m2 * positive for at least one of the anti-islet autoantibodies: gada, ia2a, znt8a * fasting or postprandial plasma c-peptide more than 100 pmol/l * written informed consent from the patient or family representative. exclusion criteria: * history of any malignancy or other severe diseases * female patients who are pregnant or breastfeeding before or during the three-year follow-up * poor compliance or refusal to participate.