Kornimate/medical-research-clean huggingface dataset:
inhaled amikacin solution bay41-6551 as adjunctive therapy in the treatment of gram-negative pneumonia

Conditions: Pneumonia, Bacterial

Summary: to demonstrate that as adjunctive therapy to intravenous (iv) antibiotics, bay 41-6551 400 mg (amikacin as free base) administered as an aerosol by the pulmonary drug delivery system (pdds) clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the pdds clinical every 12 hours, in intubated and mechanically-ventilated patients with gram-negative pneumonia. the secondary endpoint objectives are to evaluate the superiority of aerosolized bay 41-6551 versus aerosolized placebo in pneumonia-related mortality, the early clinical response at day 10, the days on ventilation, and the days in the intensive care unit (icu).


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females, 18 years of age or older * intubated and mechanically-ventilated * diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph * presence of gram-negative organism(s) by either gram stain or culture of respiratory secretions, or suspected gram-negative pathogen * impaired oxygenation * clinical pulmonary infection score (cpis) of at least 6 * presence of a multi-drug resistant (mdr) organism in a pre-therapy respiratory specimen or at least two risk factors for mdr organisms exclusion criteria: * history of hypersensitivity to amikacin or other aminoglycosides * has received antibiotic therapy for gram-negative pneumonia for greater than 48 hours at the time of randomization * known or suspected bacteremia secondary to staphylococcus aureus * a positive urine and/or serum beta-human chorionic gonadotropin pregnancy test * patients with a serum creatinine \> 2 mg/dl (177 µmol/l) \[exception: patients with a serum creatinine \> 2 mg/dl (177 µmol/l) and being treated with continuous renal replacement therapy (continuous veno-venous hemodialysis and cvvhemodiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\] * has been on mechanical ventilation for \> 28 days * is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment * the risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy * has an acute physiology and chronic health evaluation (apache) ii score \< 10 * patients receiving veno-venous extracorporeal circulation membrane oxygenation (v-v ecmo)

Keywords: gram-negative pneumonia intubation mechanical ventilation amikacin
a trial of a modified cystoscopy method to reduce pain perception

Conditions: Hematuria; Bladder Cancer; Bladder Disease

Summary: the goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. however, there is limited research into reduction of patient discomfort throughout this procedure. the proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. it is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study. exclusion criteria: * cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded. * patients currently taking medication for chronic pain (e.g. opioids, tricyclic antidepressants (tcas)) will be excluded from the study. * patients less than 18 years of age will be excluded. * patients who have received a cystoscopy previously will be excluded.
exosomes for hairloss treatment

Conditions: Hair Loss

Summary: many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. there are devastating physical and psychological consequences as a result. exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. this study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.


Eligibility criteria:
inclusion criteria: 1. subjects are able to read documents and can sign informed consent. 2. 18\~75 years old (including the threshold), gender is not limited. 3. the subject's "hair loss grade" meets the following criteria: 1) basp grade: basic type (m2 to m3, or c2 to c3, or u1 to u3) or special type (v1 to v3, or f1 to f3); 2) for female: ludwig grade i to ii. or for male: hamilton-norwood grade iii to iv; 3) hair density by phototrichogram: ≤ 190 hair/cm² ; 4. hair dryness ≥ 5%; 5. until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo. exclusion criteria: 1. people with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss. 2. those with a combination of diseases that have an impact on hair growth. 3. use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months). 4. have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening. 5. participated or are participating in a interventional clinical trial within 3 months. 6. persons with a history of hereditary alopecia areata. 7. women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months. 8. have undergone hair transplantation in the previous 24 months. 9. individuals testing positive for active infectious diseases or carriers of communicable pathogens. 10. those with keloid, keloid-prone or hyperplastic scarring. 11. those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.

Keywords: hair loss exosomes
effect of grape seed extract on blood pressure

Conditions: Elevated Blood Pressure

Summary: the purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.

background: high blood pressure is a major risk factor for morbidity and mortality from stroke, heart disease, and end-stage renal disease. several studies have shown that dietary polyphenols derived from fruits and vegetables (including those from grape products) can lower blood pressure in both normotensive and hypertensive subjects. study objectives: primary objective: to study, in subjects with elevated blood pressure levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic and diastolic blood pressure (sbp and dbp, respectively). secondary objective: to explore mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood pressure lowering effect is shown. study population: each treatment group will consist of 35 men and postmenopausal women (35-75 years of age) with daytime sbp between 120 and 159 mmhg. the total number of subjects will be 70. study design: this study will have a randomized, double-blind, placebo-controlled parallel design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. the 2 treatments will consist of placebo capsules and capsules with grape seed extract. study outcomes: daytime ambulatory blood pressure (abp) will be measured every 20 minutes for 2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. furthermore, before and after the intervention period, 24-hour urine will be collected and 2 blood samples will be taken in order to investigate mechanistic pathways and platelet function.

Eligibility criteria:
inclusion criteria: * male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study * bmi ≥ 18.5 and ≤ 30.0 kg/m2 * apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range * informed consent signed * willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study exclusion criteria: * mean of 6-hour ambulatory sbp \ 159 mmhg and/or dbp \> 99 mmhg * 10-year risk mortality risk on cvd \> 10% according to nhg standard m84. for subjects \> 65 years of age and sbp ≥ 140 mmhg the study physician will assess eligibility * irregular pulse or pulse \ 100 bpm * intense exercise \>10 h/w * reported weight loss/gain \> 10% of body weight in the 6 month preceding pre-study examination * the habit of smoking during the past year

Keywords: blood pressure grape seed
the triggerhappy trial

Conditions: Trigger Finger; Trigger Thumb; Minimally Invasive Surgery

Summary: this is a prospective randomized multicenterstudy focusing on proms after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

this study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. the patient assess: 1. pain 2. motion and 3. triggering by vas scale every day for four weeks.

Eligibility criteria:
inclusion criteria:• 1. triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion 2. localized tenderness volar to the mcp joint of the affected finger 3. the patient seeks treatment exclusion criteria: 1. previous treatment for triggerfinger in the finger to be treated 2. impaired function of finger due to previous trauma/infection or other condition 3. suspicion of other cause than triggeriinger/tendovaginitis 4. patient not able to follow instructions
evaluation of celsior® in liver transplant preservation.

Conditions: Liver Transplantation

Summary: the aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. its efficacy will be compared to the efficacy of other currently used preservation solutions.

the quality of organ preservation is a major determinant of initial graft function and survival. graft viability is based on hypothermia, the organ being stored in a cold preservation solution. celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. the aim of the study is to evaluate the efficacy and safety of celsior® in liver transplant preservation. celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the european transplantation register between 1997 and 2001).

Eligibility criteria:
inclusion criteria: * adult * primary liver transplantation * whole organ transplantation * agreement for a 1 year follow-up * informed written consent exclusion criteria: * liver disease secondary to clotting abnormalities * uncontrolled bacterial or viral disease at the time of transplantation * combined transplantations

Keywords: cold storage liver transplantation preservation solution
a study using electronic health information to learn about rivaroxaban compared to warfarin in participants with non-valvular atrial fibrillation (nvaf) and diabetes

Conditions: Atrial Fibrillation

Summary: in people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. this results in high blood sugar levels. people with diabetes are more likely to have non-valvular atrial fibrillation (nvaf) compared to people who do not have diabetes. having both nvaf and diabetes can increase the chances of developing other serious health conditions, like blood clots and strokes. people with nvaf may receive treatments to help lower the risk of blood clots. this can then help to lower the risk of having a stroke. two of these treatments are rivaroxaban and warfarin. in this study, the researchers will look at how well rivaroxaban works and how safe it is compared to warfarin in routine clinical practice. the study will include men and women who are at least age 18 and who have nvaf and type 2 diabetes. the researchers in this study will use the participants' health information from an electronic database.


Eligibility criteria:
inclusion criteria: * be ≥18 years of age at the time of anticoagulation initiation * have diagnoses of type 2 diabetes and non-valvular atrial fibrillation (nvaf) * have no record of prior oral anticoagulant (oac) use in the prior 12-months * newly initiated on rivaroxaban or warfarin (index date) * have ≥12-months of electronic health record (ehr) activity prior to the index date and received care documented in the ehr database from at least one provider in the 12-months prior exclusion criteria: * evidence of valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement * pregnancy * use of rivaroxaban doses other than 15 mg once daily or 20 mg once daily or the presence of other indication(s) for oac use * any prior oac utilization per written prescription or self-report at baseline
ql block in laparoscopic myomectomy

Conditions: Postoperative Pain; Fibroid Uterus

Summary: this study aims to determine the efficacy of a quadratus lumborum (ql) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. a ql block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. because of its demonstrated effects, the ql block is becoming a standard of anesthesia and surgical care. since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. the investigators will be comparing patients who receive the ql block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the ql block (in addition to standard care). the participants will be randomly assigned to one of the two groups and may or may not actually receive the block.


Eligibility criteria:
inclusion criteria: * presence of uterine fibroids requiring surgical excision with preservation of the uterus * stated willingness to comply with all study procedures and availability for the duration of the study * provision of signed and dated informed consent form exclusion criteria: * pre-existing diagnoses of anxiety or depression * pre-existing coagulopathies * pre-existing neuropathic or chronic pelvic pain * chronic opioid use * illiteracy due to inability to read and understand plain questionnaire * non-english speaking * bmi \>38

Keywords: ql block myomectomy
pharmacokinetics and pharmacodynamics study of pegfilgrastim in chemotherapy patients

Conditions: Neutropenia

Summary: the purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of pegfilgrastim in patients with chemotherapy-induced neutropenia.


Eligibility criteria:
inclusion criteria: * age: 18～70 years * confirmed malignant tumor patients by histopathological or cytological diagnosis, not previously treated with chemotherapy or radiotherapy,suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin * karnofsky score ≥ 70 * normal coagulation function, no evidences of hemorrhage,wbc ≥ 3,500 per cubic milliliter, anc ≥ 1,500 per cubic milliliter, plt ≥ 100,000 per cubic milliliter * normal liver, heart, kidney function * life expectancy \> 3 months * signed informed consent exclusion criteria: * not adequately controlled infections(e.g. anc ≥ 12,000 per cubic milliliter,temperature \> 38.2℃) * evidence of metastatic disease in bone marrow,or with other malignant tumors * subjects with symptomatic brain metastases * pregnant or breast-feeding or in menstrual period females * participated more than 3 clinical trials in nearly a year(as subjects) * currently participated in any other clinical trials,or used any prescription medication could impact on the metabolism of investigational drug, or participated in any other clinical trial within one month from the date of the screening visit * donation of whole blood or a unit of blood within three months prior to the start of study * known hypersensitivity to filgrastim or any of the products to be administered during dosing * evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit * other conditions which in the opinion of the investigator preclude enrollment into the study

Keywords: pegylation g-csf pharmacokinetics pharmacodynamics
pelvic floor dysfunction and its influence on body image and sexual function

Conditions: Body Image; Urinary Incontinence; Anal Incontinence; Anorectal Disorder; Constipation; Pelvic Organ Prolapse; Sexual Dysfunction; Pregnancy Related; Postpartum Disorder

Summary: the first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. the second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and body image. this is a single center prospective cohort study. women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan. the presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: wexner questionnaire for anal incontinence, pac-sym for constipation, international consultation on incontinence questionnaire short form for urinary incontinence, the pelvic organ prolapse distress inventory for pelvic organ prolapse, pop/ui sexual questionnaire - iuga revised for sexual function. the body image perception will be assessed using the dutch-validated version of the self-administered body image disturbance questionnaire. the anatomy of the pelvic floor will be objectively assessed off line on 3d/4d transperineal ultrasound volumes and pop-q examination. the demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years * dutch-speaking * ongoing pregnancy before 14 weeks ga * intending to deliver in uz leuven * icf exclusion criteria: * age \< 18 years * not dutch-speaking * non evolutive pregnancy * pregnancy over 14 weeks ga * intention to deliver elsewhere
high-flow nasal oxygenation versus standard oxygenation in gastrointestinal endoscopy with sedation.

Conditions: Gastrointestinal Endoscopy; Sedation

Summary: this study is a randomized controlled trial comparing high-flow nasal oxygen therapy (hfno) versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask) during gastrointestinal (gi) endoscopy with sedation to reduce the incidence of hypoxia.

hypoxemia is the most common complication during a gastrointestinal endoscopy with sedation. oxygenation is usually applied during the procedure to prevent the occurrence of desaturation. conventional oxygen is typically administered by conventional nasal cannula, by nasopharyngeal catheter or by a facemask with mild flow of oxygen. the flow of standard oxygen is limited to 15l/min. high-flow nasal cannula oxygenation is a new method of humidified and heated oxygenation with a higher flow rates (up to 70l/min). the primary outcome will be the incidence of hypoxia defined by pulsed saturation with oxygen (spo2) ≤92%. the investigator's hypothesis is that high-flow nasal oxygen therapy will decrease the frequency of hypoxemia during gastrointestinal endoscopy under sedation.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * having gi endoscopy expected under sedation * at risk of hypoxia defined by (one of the item): an underlying cardiac disease ; an underlying respiratory disease ; age greater than or equal to 60 years ; asa ii, iii or asa iv ; with an body mass index greater or equal to 30 (kg/m²); with sleep apnea syndrome diagnosed or suspected with a stop-bang score ≥ 3 exclusion criteria: * age below 18 * emergency gi endoscopy * need of intubation for the procedure * patient with chronic oxygen treatment * patients with tracheostomy * pregnancy, breastfeeding * not affiliated to french social security

Keywords: high-flow nasal cannula oxygenation gastrointestinal endoscopy upper gasatrointestinal endoscopy colonoscopy sedation hypoxia
guatemala internal medicine physicians' knowledge of non-communicable disease clinical preventive services

Conditions: Non-communicable Diseases

Summary: a national cross-sectional survey was conducted to evaluate recommendations on clinical preventive services and additional information on non-communicable disease prevention. trained surveyors interviewed interns, residents and attendings of the internal medicine departments of all teaching hospitals in guatemala. analysis compared recommendation practices within and between hospitals.

a voluntary, anonymous, self-completed, cross-sectional survey was administered to all available internal medicine staff in guatemalan teaching hospitals. the questionnaire included: physician's demographics, work time dedicated to outpatients, knowledge of leading causes of death in guatemala, guidelines used for non-communicable disease prevention, simulated cases asking for recommendation(s) on different preventive services for asymptomatic adults (i.e. whether they recommended them or not, appropriate frequency and starting age, preferred screening method, and availability of the service(s) at their hospital). the survey also assessed barriers faced in providing adequate services, and opinions on who should implement changes in national health care and in medical education. the answers given by the internal medicine staff were compared with the united states preventive services task forces (uspstf) recommendations and guatemalan ministry of health guidelines. analysis compared recommendation practices within and between hospitals.

Eligibility criteria:
inclusion criteria: * all interns, internal medicine residents and attendings (including department director, unit directors and regular attendings) that are currently training or working in an internal medicine department in any of the ten teaching hospitals in guatemala. exclusion criteria: * staff that is on vacations, on sick leave or suspended by any reason.

Keywords: non-communicable diseases preventive services medical education guatemala