Kornimate/medical-research-clean huggingface dataset:
safety, pharmacokinetic, and pharmacodynamic study of nktt120 in adult patients with stable sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of nktt120 in adult patients with stable sickle cell disease.


Eligibility criteria:
inclusion criteria: * age 18 to 50 years * subject has a confirmed diagnosis of hbss or hbsβ0thal * subject has stable scd defined as not having acute voc, acs, or other major scd associated event during the month prior to enrollment exclusion criteria: * subject had an scd-related voc or acs that required hospitalization or treatment in acute care outpatient setting in the month prior to enrollment * subject requires a program of prescheduled regularly administered packed red blood cell (prbc) transfusions or subject received a prbc transfusion in the month prior to enrollment * subject has evidence of latent or active tuberculosis * subject has a major concurrent illness or medical condition * subject is pregnant or nursing

Keywords: sickle cell disease
physical activity as an aid for smoking cessation

Conditions: Tobacco Dependence; Cardiovascular Diseases; Physical Activity

Summary: including a tailored moderate-intensity physical activity intervention in a standard smoking cessation treatment program (pharmaceutical treatment and counseling) increases the chances of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight gain.

the main objective is to determine whether a tailored physical activity intervention involving moderate-intensity exercise is an added value to a standard smoking cessation intervention in term of likelihood of smoking abstinence. the secondary objectives are 1) to determine whether this tailored physical activity intervention prevents weight gain, reduces withdrawal symptoms, stress and improve mood and self-confidence in quitting; 2) to assess the effect of this tailored physical activity intervention on body composition and leptin concentration. we assess this intervention in a randomized controlled trial of 600 sedentary adults regular smokers recruited from the community allocated into one of the two groups (intervention group vs. control group) during a 10-week period and 3 follow-up visits (6 and 12 months follow-up). all subjects (intervention and control groups) participate in a smoking cessation program composed of a pharmacological treatment (including nicotine replacement therapy) and counseling. the intervention group attend the 10-week physical activity program blending moderate-intensity exercise (swiss nationwide implemented program entitled "allez hop!") and lifestyle physical activity and the control group a 10-week health education program to ensure equal contact condition.

Eligibility criteria:
inclusion criteria: 1. current daily smoker \>10 or more cigarettes per day 2. having smoked (on average \> 10 cigarettes/day) regularly for at least 3 years 3. age between 18 and 65 years 4. sedentary lifestyle defined as less than 20 minutes a day of moderate-intensity physical assessed by the swiss baseline questionnaire. exclusion criteria: 1. current pharmacological agent use to quit smoking 2. medical problems that would alter training responses: arthritis, heart disease, and orthopedic problems 3. presence of an unstable medical condition 4. current or recent major cardiovascular event, such as recent myocardial infarction (\>12 months) or stroke, angina pectoris, major arrhythmia 5. current psychiatric illness 6. alcohol (\> 4 drinks/day for men and \> 3 drink/d. for women), or/and other substance abuse 7. current or planned pregnancy 8. systematic skin disease

Keywords: smoking cessation nicotine physical activity
a study of lurasidone compared with placebo for the treatment of bipolar i depression

Conditions: Bipolar I Depression

Summary: the study evaluates the efficacy and safety of lurasidone compared with placebo in treating bipolar i depression.

the primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with bipolar i depression by assessing the change from baseline in the madrs total score at week 6.

Eligibility criteria:
inclusion criteria: 1. patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks. 2. outpatients who are aged 18 through 65 years at time of informed consent. 3. patients with bipolar i disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by dsm-5 criteria).
efficacy study of prophylaxis with fosfomycin versus ciprofloxacin prior prostate biopsy

Conditions: Urinary Tract Infections

Summary: the purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy.

transrectal ultrasound guided (trus) prostate biopsy is the procedure of choice for the diagnosis of prostate cancer. this technique is usually safe and well tolerated with a low incidence of serious complications. however, one of these complications, the bacterial infection can be complicated and cause urinary sepsis. the investigators have developed different regimens of antibiotic prophylaxis. most of them include administering oral fluoroquinolones. in this area, approximately 40% of the strains of e. coli are resistant to ciprofloxacin (fluoroquinolone). therefore, research is warranted alternative prophylactic approaches. fosfomycin is an antibiotic ancient underused in recent decades that in recent years has been proposed as an alternative treatment for infections caused by multidrug-resistant microorganisms.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patients with prostate-specific antigen (psa) values \>4 ng/ml or presenting either abnormality in rectal examination * patients who accept to participate in the study signing the consent informed form exclusion criteria: * allergy to anyone of the study drug * intolerance to anyone of the study drug * urinary infection with positive uroculture * clinical finds suggesting infections * antimicrobial treatment during the las 4 weeks * patients with vesicle catheter * patients in dialysis * patients in hemodialysis

Keywords: transrectal ultrasound-guided prostate biopsy bacteriuria antibiotic prophylaxis prostate-specific antigen
radiation cystitis treated with pentosan polysulfate sodium trial

Conditions: Radiation Cystitis

Summary: the purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.

rct-pps is a phase ii/iii study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (pps) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region. approximately 72 patients were planned to be randomized in rct-pps trial in a 1:1 ratio to treatment with either pps or placebo. patients will receive oral treatment with 16 weeks (pps 100mg three times a day for 8 weeks and then with pps 100mg twice daily for another 8 weeks).

Eligibility criteria:
inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol. 2. patients must be ≥20 years of age 3. patients must have received definitive radiation therapy for cancer in pelvic area. 4. time from the end of radiation therapy to radiation cystitis must be longer than 6 months. 5. radiation cystitis with lower urinary tract symptoms or hematuria. exclusion criteria: 1. abnormal liver function with indication of ast, alt, or total bilirubin ≥ 1.5 times higher than normal 2. abnormal renal function with serum creatinine ≥ 1.5 times higher than normal 3. abnormal coagulation profile with pt/inr higher than normal 4. thrombocytopenia with platelet counts \< 100,000/μl 5. pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test 6. patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or wbc counts \>12,000/μl) 7. patients with known urinary tract infection within 6 months of randomization. 8. any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation) 9. any previous hyperbaric oxygen therapy within 6 months of randomization 10. any previous treatment with pentosan polysulfate sodium within 6 months of randomization 11. has history of thrombocytopenia, hemophilia or bladder cancer 12. has known history of human immunodeficiency virus (hiv) or organ transplantation 13. has known history of drug allergy to pentosan polysulfate sodium 14. has hematuria caused by clinically active urolithiasis or urothelial carcinoma
clinical study: analysis of glycemic control and satisfaction with a connected smart cap in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus (T1DM); Diabetes Management

Summary: this clinical study evaluates the impact of the cap insulclock device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (t1dm). despite advances in pharmacology and technology, a significant proportion of individuals with t1dm fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. cap insulclock is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time bluetooth transmission. its use may enhance adherence and optimize metabolic control. this study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. the primary objective is to assess differences in time above range (tar \>180 mg/dl) over the last 14 days of continuous glucose monitoring (cgm). secondary objectives include evaluating hba1c levels, time in range (tir), frequency of hypoglycemic episodes, and patient satisfaction. data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with t1dm


Eligibility criteria:
inclusion criteria: * men and women aged 18 years or older. * diagnosis of type 1 diabetes mellitus (t1dm). * users of flash continuous glucose monitoring (fgm) sensors with \>70% of recorded data, including intake and insulin dose logs. * adequate therapeutic adherence, with no missed appointments in the past year. * time above range (tar \>180 mg/dl) \>25%. * ability to provide informed consent to participate in the study. * access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the insulcloud app. exclusion criteria: * current pregnancy. * severe acute illness. * exclusion criteria for the use of real-time continuous glucose monitoring (rt-cgm) systems as per the framework agreement of the community of madrid for rt-cgm use (sermas). * inability to provide informed consent or to meet the study requirements for any reason.

Keywords: diabetes tecnhology type 1 diabetes smart cap time above range
volatile organic compounds as markers of acute rejection in lung transplant

Conditions: Transplant; Complication, Rejection

Summary: the aim of research is to identify markers of acute rejection by voc analysis in exhaled breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies and patients with no acute rejection. exhaled breath will be collected for voc analysis woth electronic nose and mass spectrometry. voc profiles will be compared between the two groups of patients.

prospective single-center study. a single visit, no follow-up. the visit will take place before or within five days from date of transbronchial biopsies (btb). it will include a noninvasive collection of exhaled breath for voc analysis. voc analysis will be conducted using two types of devices: "electronic nose" and mass spectrometry. 200 bi-lung transplanted patients will be enrolled and divided into two groups. * group a, acute rejection: 100 patients. diagnosis of acute rejection retained on transbronchial biopsies or functional anomalies with the necessity of modifying the immunosuppressive regimen. * group b, control: 100 patients. patients without respiratory functional abnormality and normal transbronchial biopsy. voc, detected by electronic nose and identified by mass spectrometry, will be compared between patients with a confirmed diagnosis of acute rejection (group a) and patients without rejection (control group b) the duration of participation of each patient is 1 day. the duration of the inclusion period is estimated at 54 months from the first inclusion. the expected total duration of the research is 54 months

Eligibility criteria:
inclusion criteria: * bi-pulmonary transplant patient * acute rejection group: patients with transbronchial biopsies performed as part of their usual follow-up or for functional abnormality ; diagnosis of acute rejection retained on the following arguments: histological lesions of cellular rejection or histological lesions of humoral rejection or normal histology but diagnosis of "functional rejection" retained and immunosuppressive treatment indicated * control group: patients benefiting from systematically programmed transbronchial biopsies as part of post-transplant follow-up with normal histology and absence of functional respiratory abnormality exclusion criteria: * patient unable to realize a vital capacity measure * neoplasia currently treated * unresolved acute bronchial complication (stenosis or dehiscence) * immunosuppressive treatment of acute rejection already begun * patient who has already participated in the protocol and already included in one of the two study groups

Keywords: lung transplant acute resection volatile organic compounds
doll therapy in dementia

Conditions: Dementia

Summary: behavioral and psychologic symptoms in dementia (bpsd) are frequent and represent a burden for patients and caregivers, the use of a first line non-pharmacologic approach is highly recommended. describe is a randomized controlled trial on the effect of doll therapy (dt) on bpsd in different clinical settings. the investigators will enroll fifty-two nursing homes residents and 52 acute in-patients with dementia and bpsd. subjects will be randomized to dt or standard treatment (st), the investigators will measured agitation, delirium and caregiver burden with standard clinical scales at baseline and during treatment. nursing home residents will be evaluated after 45 and 90 days of treatment, in-patients will be evaluated at baseline and at hospital discharge. in acute in-patients, a follow-up of 4 weeks after hospital discharge will be carried out in order to evaluate the effect of dt withdrawal. primary outcomes will be the reduction of bpsd and the reduction of professional caregiver burden secondary outcome will be the reduction of delirium and of effect of family caregiver burden.


Eligibility criteria:
inclusion criteria: * age ≥65 years; * diagnosis of dementia moderate to severe clinical dementia rating scale (cdr) ≥2; * presence of agitation and/or aggressiveness; * manual and visual abilities sufficient in order to interact with the doll. exclusion criteria: * age \<65 years; * refuse to participate; * mild forms of dementia (cdr\<2); * contraindication for dt as experience of mournful or traumatic events related to parental experience; * life expectancy lower than 3 months; * negative interaction with the doll.

Keywords: behavioral and psychologic symptoms in dementia; hospital; doll therapy; non-pharmacological approach; nursing homes
burden and outcome of shoulder disorders in primary health care

Conditions: Shoulder Pain; Shoulder Mobility Impairment

Summary: consumption of medical care and outcome of shoulder pain and disability in primary care.

shoulder pain and impairment are common in primary health care. the prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. the objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care. a composite questionnaire consisting of demographic information and ases questionnaire was used to measure the shoulder function. the patients were sent a second questionnaire after one year.

Eligibility criteria:
inclusion criteria: * all individuals suffering from shoulder pain or impairment exclusion criteria: * no

Keywords: shoulder pain range of motion disability evaluation function sick leave primary health care visual analog scale visual analog pain scale the american shoulder and elbow surgeons standardized shoulder assessment form
correlation of preoperative olfactory identification function with frailty and postoperative complications and mortality

Conditions: Frailty; Perioperative/Postoperative Complications; Olfactory Disorder

Summary: the aim of this research project is to evaluate whether olfactory identification impairment is a reliable predictor of preoperative frailty and of postoperative complications and mortality in a population of older patients scheduled for elective surgery. 1. the investigators will measure preoperative olfactory identification function and evaluate whether olfactory impairment predicts frailty, using the edmonton frail scale and handgrip strength. 2. the investigators will analyze whether preoperative olfactory impairment predicts postoperative complications and mortality.

olfactory impairment increases with age, affecting more than 50% of the population aged between 65 and 80 years old. recently, many studies have demonstrated a strong association between olfactory impairment and overall mortality risk. at the moment, the underlying physiopathology linking olfactory impairment to mortality remains unknown and only putative mechanisms are suggested. among them, accelerated physiological brain aging seems to be involved, making olfactory decline a possible marker of frailty. to date, only a few studies (mostly using subjective olfactory assessment) investigated the potential relationship between olfactory impairment and frailty. surgery, and more broadly the perioperative period, remains a major source of morbidity and mortality. meanwhile, the average age of the surgical population continues to rise, making preoperative risk assessment an essential step in order to detect the most vulnerable patients. yet, it is well-known that frailty is associated with worse perioperative outcome. the first objective of this research project is thus to evaluate olfactory identification function of preoperative older surgical patients in light of an assessment of their frailty status. frailty will be tested with the edmonton frail scale and handgrip strength, which are both validated tools. the second objective is to correlate postoperative morbidity and mortality with preoperative olfactory function. hopefully, this research project will address the misunderstood link between olfactory impairment and mortality, focusing on frailty assessment and using surgery as a heavy stressor for the older patient.

Eligibility criteria:
inclusion criteria: * scheduled for elective surgery (covering general, gynecologic, urologic, orthopedic, plastic, head and neck, spine neurosurgery) exclusion criteria: * day case surgery * history of neurological or psychiatric disorder * history of severe head trauma * history of olfactory trouble or chronic rhinosinusitis or sinus surgery * history of suspected or diagnosed covid-19
effects of visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women

Conditions: Female Sexual Function; Vulvovaginal Atrophy; Postmenopausal Atrophic Vaginitis

Summary: this clinical trial, a double blind randomized controlled trial, is conducted to determine the effects of daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women with vulvovaginal atrophy within 8-week of treatment. we compare the active ingredient in emulgel to the emulgel only. we also evaluate the improvement of the vulvovaginal atrophy symptoms in postmenopausal women, the safety and the tolerability of visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel. this study is conducted in the menopause clinic and the gynecology clinic, king chulalongkorn memorial hospital, bangkok, thailand.

topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel is a cosmetic product. visnadin is an active ingredient which has the vasodilator effect and improve blood flow to female vulvovaginal area. this will improve lubrication from increase bartholin's gland secretion. as the clitoral blood flow increase, the sexual response could be improved. the ethyl ximeninate, coleus barbatus and millet are plant extract which have moisturizer, anti-inflammation and antioxidant effects. our hypothesis is a daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel could improved sexual function and vulvovaginal atrophic symptoms in postmenopausal women with vulvovaginal atrophy.

Eligibility criteria:
inclusion criteria: * women age 45-65 years old * bmi 19-29 kg/m2 * menopause or removal of both ovaries more than 1 year * has moderate to severe vulvovaginal atrophic at least 1 symptom * has sign of vulvovaginal atrophy * vaginal ph ≥ 5 * has sexual intercourse at least 1 time/month exclusion criteria: * hormonal use within 3 months * use vaginal estrogen/ moisturizer within 3 months * use aromatase inhibitor/tamoxifen within 3 months * has vaginal bleeding within 6 months * acute or chronic urinary tract infection * history of radiation therapy at vulvovaginal and pelvic area * history of diabetes mellitus or cardiovascular disease * history of neurosis or psychosis * history of vulvovaginal cancer * history of smoking more than 20 cigarettes/day * history of alcoholic drink/ drug abuse * history of visnadin, ethyl ximeninate, coleus barbatus and millet allergy * has disease of vulva

Keywords: vulvovaginal atrophy genitourinary syndrome of menopause postmenopausal women female sexual function visnadin