Kornimate/medical-research-clean huggingface dataset:
the safety and effectiveness of methylprednisolone in the treatment of pneumocystis carinii pneumonia (pcp) in children with aids

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to determine the effect of methylprednisolone on respiratory failure in hiv-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

hiv-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo. treatment is administered for 10 days. primary antipneumocystis therapy with tmp/smx or systemic pentamidine is selected by the individual investigator and given for 21 days. patients are stratified at the time of randomization by the presence or absence of respiratory failure.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * recombinant erythropoietin and any fda-approved cytokine for management of anemia. * antiretroviral agents. patients must have: * documented hiv infection. * pcp. * no more than 36 hours of prior primary therapy for confirmed or presumed pcp. prior medication: allowed: * up to 35 hours of primary therapy for confirmed or presumed pcp. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * demonstrated intolerance to steroids. * requirement for steroids at greater than physiological doses for other medical conditions.

Keywords: pneumonia, pneumocystis carinii acquired immunodeficiency syndrome methylprednisolone
pilot of letrozole for uterine myomas

Conditions: Leiomyoma; Uterine Fibroids

Summary: plum evaluates the drug letrozole as a treatment for uterine fibroids. this study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (group a) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (group b).


Eligibility criteria:
inclusion criteria: 1. ≥21 years old 2. premenopausal (at least one menses in last 3 months) 3. symptomatic fibroids (fibroids visualized on ultrasound or mri and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia) 4. fibroids that are ≤4 in total number or fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each 5. fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid \>2cm) 6. up to date in pap smear screening and surveillance 7. endometrial biopsy (required if age\>45 years with irregular bleeding) does not indicate premalignant or malignant cells 8. agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy 9. has primary care provider or gynecologist 10. agrees not to start new medications/treatments for fibroids during the study 11. able to give informed consent exclusion criteria: 1. fibroids treated by surgery, radiologic procedure, or gnrh agonist or antagonist in the last 3 months 2. any submucosal fibroid ≥2cm that is \>50% in uterine cavity (figo type 0 or type 1 fibroids) amenable to hysteroscopic resection 3. use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months) 4. pregnant, lactating, or planning to become pregnant in the next 6 months 5. hematocrit \<27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo) 6. history of osteopenia or osteoporosis 7. history of hyperlipidemia 8. current liver or kidney disease 9. unable or unwilling to attend 4 study visits 10. pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system 11. does not have primary care provider or gynecologist
the culture of advanced/recurrent/metastatic colorectal cancer organoids and drug screening

Conditions: Colorectal Cancer

Summary: the study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.

the study was designed as a prospective, observational clinical trial in a single center. we establish organoids derived from patients with advanced/recurrent/metastatic colorectal cancer. organoids will be validated with a combination of next generation sequencing (ngs) analysis and histopathology. drug screening assay will be performed on organoids with the chemotherapy and targeted agents, and the sensitivity and speciality will be compared with the clinical practice.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily participated in the study and signed informed consent; 2. ecog score 0\~2; 3. expected survival over 6 months; 4. the serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial; 5. cbc: hb≥70g/l、wbc≥3.5×109/ l 、anc≥1.5×109/l、plt≥80×109/l； 6. serum alt≤2×ul, ast≤2×uln; serum creatinine≤1.5×uln； 7. colorectal cancer was unresectable and confirmed as adenocarcinoma by histopathology. patients have no significant symptoms in the primary lesion (no bleeding, perforation and obstruction in the primary focus). besides, the carcinoma is potentially resectable but the patient refuses surgery; 8. patients can comply with the research scheme according to the judgment of the researcher. exclusion criteria: 1. activity or uncontrol severe infection; 2. liver cirrhosis, decompensated liver disease; 3. history of immune deficiency, including hiv positive or suffering from a congenital immunodeficiency disease; 4. chronic renal insufficiency or renal failure; 5. other malignancies which diagnosed within 5 years or needed to be treated; 6. myocardial infarction, severe arrhythmia and nyha (new york heart association)≥2 for congestive heart failure 7. concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.

Keywords: drug screening advanced / recurrent / metastatic colorectal cancer orgnoids
prophylactic ondansetron in post-op cardiac surgery patients to prevent post-operative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: to evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. in patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg iv given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.

post-operative nausea and vomiting (ponv) is a significant source of morbidity for patients undergoing general anesthesia, and in particular, patients undergoing cardiac anesthesia. despite its common occurrence, literature on ponv prophylaxis in the cardiac surgical population is limited relative to other surgical populations. a rational approach to preventing ponv would be to administer prophylaxis prior to extubation once post-operative sedation has ceased. this timing of administration would be more standardized across patients, as duration of surgery and time of extubation after surgery can vary considerably, rendering plasma levels of ponv prophylaxis agents highly variable across patients. at st. paul's hospital, ponv prophylaxis has not been a routine part of cardiac anesthesia care. furthermore, there are no standardized guidelines, and practice varies between care providers. following surgery, patients recover from anesthesia and are extubated in the cardiac surgery icu (csicu). they are usually sedated on a propofol infusion for one to four hours after surgery until they are ready for extubation. when ponv occurs, the first line drug for treatment is ondansetron 4 mg. the investigators therefore propose the use of a single, prophylactic dose of ondansetron (4 mg iv), given at the time of propofol cessation. a randomized, double blinded placebo controlled model will be utilized

Eligibility criteria:
inclusion criteria: * elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including: * coronary artery bypass grafting (cabg) * valve surgery (ie. repair and/or replacement) * cabg and valve surgery exclusion criteria: * undergoing 'off-pump' cabg (not involving the cardiopulmonary bypass machine) * with a contraindication to the study drug - including but not limited to congenital long qt syndrome, allergy to ondansetron, or a history of migraines * unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available * receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ecmo) * intubated for more than 12 hours post-operatively * with a known history of ponv * sedated with dexmedatomine instead of propofol

Keywords: postoperative nausea and vomiting ponv csicu post-cardiac surgery cardiac intensive care unit
safety and efficacy study of azasite® in subjects with blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to evaluate the safety and efficacy of azasite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe chronic blepharitis * if female of childbearing potential, are non-pregnant and non-lactating exclusion criteria: * had ocular surface surgery (lasik, refractive, etc.) within the past year * unwilling to discontinue use of contact lenses during the study * have glaucoma * unable or unwilling to withhold the use of lid scrubs during the study * have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance * currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
efficacy and safety of fs vh s/d 4 s-apr for flap adherence in rhytidectomy

Conditions: Face-lift; Facial Rhytidectomy

Summary: the purpose of the study is to compare the safety and efficacy of fs vh s/d 4 s-apr versus standard of care in adhering tissue and improving wound healing in subjects undergoing facelift.


Eligibility criteria:
inclusion criteria: * male or female subject is 18 to 75 years of age at the time of screening * subject is planned for facial rhytidectomy * subject has read, understood and signed the written informed consent * subject is healthy, as determined by the investigator using standard pre-operative assessments to include laboratory tests and electrocardiograms * subject is of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study * subject is willing and able to comply with the requirements of the protocol exclusion criteria: * subject is indicated for an abbreviated or modified face-lift procedure such as deep plane procedures, minimal undermining procedures, thread lifts, and minimal access cranial suspension * subject is indicated for concurrent facial surgeries during the operation (eg forehead plasty,blepharoplasty, rhinoplasty, buccal fat removal, any filler injections including fat injections, lip augmentation, skin resurfacing procedures etc.) * subject is indicated for additional procedures to the body during the same operation (eg liposuction, mastoplasty etc.) * subject has undergone a prior rhytidectomy surgery * subject is an active smoker, as assessed by the investigator * subject has a known (documented) bleeding or coagulation disorder * subject is being treated with anti-coagulants or with aspirin (that was not discontinued 7 days prior to surgery) * subject has a vascular disorder, cardiovascular disease, and/or uncontrolled hypertension * subject has diabetes mellitus with glycosylated hemoglobin (hba1c) \> 7 * subject is receiving active treatment for a malignancy * subject has a connective tissue disorder * subject has an active or chronic skin disorder * subject has history of bell's palsy * subject has a documented history of pathologically or pharmacologically induced immune deficiency * subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery * subject has a known sensitivity to components of fs vh s/d 4 s-apr * subject has a known psychiatric disorder (eg, obsessive compulsive disorder, anxiety, eating disorders, etc.) * subject has documented healing complications following previous surgeries (eg, hypertrophic scarring) * subject is pregnant or lactating at the time of enrollment * subject has participated in another clinical study involving an investigational product/device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product/device during the course of this study
midlevel versus physician-provided medical abortion in the second trimester

Conditions: Induced Abortion; Second Trimester Abortion; Medical Abortion; Health Personnel

Summary: the purpose of the study is to determine the safety and effectiveness of second trimester medical abortion when provided by nurse midwives compared with physicians. the study sample will be obtained from michu clinic, affiliated with st paul's hospital, in addis ababa.

about 10% of all abortions globally take place at or after 13 weeks gestation. women seeking second-trimester abortion services are often the most vulnerable and socially disadvantaged population.studies show the rate of second-trimester abortion procedures remains stable over time, even in high-access locations, confirming the ongoing need for accessibility to services in rural locations with limited access to care. in ethiopia, second-trimester abortion services are widely available in addis ababa, making up a high proportion of the total number of abortions occurring each year in the country; however, access to accurate and reliable data is limited. the world health organization recommends that abortion can be provided at the lowest level of the healthcare system (who abortion guidelines). training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct second trimester aspiration abortions is proposed as a way to increase women's access to safe abortion procedures and has been highlighted by the who as an area in which rigorous research is needed (who task-sharing guidelines). the investigators seek to conduct a comparative study of patients undergoing second trimester medical abortion provided by either physicians or nurse midwives.

Eligibility criteria:
inclusion criteria: * willing and able to give consent for participation * intrauterine pregnancy with confirmed gestational age \>13 weeks and \<20 weeks * presenting for induced abortion at michu clinic * speaker of amharic or oromo exclusion criteria: * women unable to give consent for participation * gestational age \ 20 weeks * adolescents aged less than 16 years * women with an allergy to or contraindications to mifepristone or misoprostol * women with a history of more than one previous hysterotomy * women seeking treatment for incomplete abortion, intrauterine fetal demise, or postabortion care * women with chronic hypertension or adrenal failure * women on chronic steroid treatment

Keywords: midlevel provider
fnb in meniscal tear under sa

Conditions: Meniscus Tear; Femoral Nerve Block

Summary: the investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia

this study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and mri or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. the 100 patients will be assigned to group i (with femoral nerve block) or group ii (without femoral nerve block) under double-blinded randomization. the randomization will be performed by an independent nurse using a computerized random sequence generator. the operators who participated in the procedure will be blinded to the participant's information. both group will undergo spinal anesthesia for arthroscopic meniscal surgery. after anesthesia, sono-guided femoral nerve block will be performed. the injection for group1 is 20 ml ropivacaine and for groupii is 20 ml 0.9% saline. a visual analog scale (vas) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. vas scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility criteria:
inclsuion criteria: * individuals who are scheduled to undergo meniscal surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate. exclusion criteria: * who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear. * who have previously undergone surgical treatment within the knee joint. * who have declined to participate in the research. * where medical, surgical, or anesthetic complications occurred during surgery. * other cases deemed necessary by the researchers.

Keywords: meniscus tear femoral nerve block
risk factors for recurrence of thrombosis or thrombotic extension, in the event of acute non-cirrhotic portal vein thrombosis secondary to a local cause.

Conditions: Portal Vein Thrombosis; Local Cause

Summary: in case of acute portal vein thrombosis (pvt) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). to date the impact of prothrombotic factors associated with local conditions responsible for acute pvt has not been well studied except for acute or chronic pancreatitis. no significant association has been pointed out in this pathology. the aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic pvt, and to evaluate the rate of secondary long term anticoagulant therapy.


Eligibility criteria:
inclusion criteria: * acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months. * patients already included in european cohort envie-valdig exclusion criteria: * liver cirrhosis * liver, biliary or pancreatic neoplasia * thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence * cavernoma or budd-chiari syndrom

Keywords: liver vascular disease portal vein thrombosis
prosthetic pelvic organ prolapse repair

Conditions: Cystocele

Summary: the cystocele is the most frequent clinical shape of the genital prolapse. it is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders. it's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

this is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.

Eligibility criteria:
inclusion criteria: * cystocele superior or equal to stage ii of the international classification pop-q, isolated or associated with other elements of prolapse. * patient must have provided written informed consent form prior to enrolment * patient must be insured exclusion criteria: * previous of surgery for prolapse * unfavourable conditions to one or other of the 2 evaluated procedure * pelvic malignancy in the course of evolution * contraindication to the use of mesh * women not reading french * patients haven't have a social insurance * pregnancy or desire for future pregnancy * to be under guardianship or deprived of liberty * simultaneous participation in another biomedical research

Keywords: bladder prolapse (cystocele) pelvic organ prolapse repair coelioscopic prosthetic surgery vaginal approach randomized study laparoscopic sacropexy vaginal mesh surgery stage ii clavien dindo
impacts of clean cookstoves and empowerment training on women's health in refugee settings

Conditions: Gender-based Violence; Adherence; Mental Health Wellness 1; Empowerment; Food Insecurity; Relationship, Family

Summary: the main objective of this study is to understand the links and outcomes of adoption of a cleaner cookstove/fuel and exposure to a personal empowerment training on women's health outcomes in a congolese refugee camp in rwanda, with a focus on gender-based violence (gbv).

this randomized controlled trial examines the impacts of a phased-in integrated technology -behavior change intervention on women's health with a focus on gender-based violence. in a population of approximately 1500 congolese households in kigeme refugee camp in rwanda, two interventions are randomly deployed in the camp. the first intervention is the inyenyeri cookstove/pellet fuel system, a tier 4 clean cookstove system; the second intervention is a behavior change intervention (referred to as i-act, individual-agency-centered training) designed to foster personal agency and empowerment, given to women and, if applicable, their male partner. analyses will be done with interviews on 1500 women (ages 18-45) from these households that may have received one, both or none of the interventions, either as the full sample or the sub-sample of partnered-only women.

Eligibility criteria:
inclusion criteria: * study participants are between the ages of 18 years - 45 years of age * reported as currently living in a refugee camp with no intention to relocate * has lived in any refugee camp for at least 1 year and can be interviewed in private * has the ability to give informed consent exclusion criteria: * inability to provide informed consent * individuals having evidence of significant illness and/or are not able to engage fully in the surveys * women younger than 18 or over 45 years of age * those who have not lived continuously in a refugee camp setting for the past 12 months * if two or more women live in a household, only one of these will be included in the study. the one responsible for fuel purchase/collection will be selected. if more than one woman is responsible for fuel collection, we will randomly choose one woman to participate in the study.

Keywords: gender-based violence intimate-partner violence empowerment food insecurity humanitarian settings depression fuel use clean cookstoves