Kornimate/medical-research-clean huggingface dataset:
to compare the efficacy of weekly azathioprine pulse versus betamethasone oral mini-pulse in the treatment of moderate to severe alopecia areata

Conditions: Alopecia Areata; Alopecia Areata(AA)

Summary: alopecia areata (aa) is an autoimmune condition characterized by non-scarring hair loss, ranging from minor patches to complete baldness. given the variable effectiveness of existing treatments, this study aimed to compare the efficacy of weekly azathioprine pulse (wap) therapy against betamethasone oral mini-pulse (bomp) therapy in managing moderate to severe aa.

alopecia areata (aa) is an autoimmune disorder characterized by non-scarring, solitary, or multiple circular or oval patches of hair loss on scalp or other hear bearing areas. these patches often feature "exclamation mark hairs" near their leading edges. it effects all demographics irrespective of age, sex, and ethnicity. clinically, alopecia areata can be categorized in various forms depending on extent of involvement, such as patchy hair loss on the scalp, alopecia totalis (complete scalp hair loss), or alopecia universalis (complete scalp and body hair loss), or less commonly, as band-like hair loss on specific regions of the scalp. given the uncertain pathogenesis and course of the disease, the effectiveness of treatment modalities remains unpredictable. effective treatment must address both the clinical efficacy and safety. previous studies have reported variable safety profiles, remission, and relapse rates for weekly azathioprine pulse therapy versus betamethasone oral mini-pulse therapy, particularly when compared to placebo. however, direct comparisons, especially within our local demographic, are notably lacking. therefore, this study aimed to bridge the existing gap in literature by offering a comparative evaluation of these therapies in the management of moderate to severe alopecia areata.

Eligibility criteria:
inclusion criteria: * aged 16-60 years * scalp area involvement of ≥ 15% by alopecia areata exclusion criteria: * used topical and intralesional treatment within last 1 month, * received systemic therapy or phototherapy within last three months, * anemia, leukocytosis, leukopenia, thrombocytopenia, deranged renal and liver function test * pregnant an lactating females * patients with contraindications to corticosteroids or azathioprine

Keywords: alopeica areata azathioprine oral betamethasone pulse therapy
impact of preoperative treatment of anemia and iron deficiency in cardiac surgery on outcome.

Conditions: Anemia; Iron Deficiency

Summary: we are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. the study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. the list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice . * trial with medical product

anemic or iron deficiency patients are randomized into treatment and placebo groups. treatment (see below) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). the treatment will not be disclosed to the patient or the health care workers treating the patients during and after the operation. patients without anemia or iron deficiency will also be observed and the same postoperative measurements performed. they will serve as a natural comparison group. treatment: erythropoietin alpha (eprex, janssen-cilag ag, baar) 40'000 u sc. ferric carboxymaltose (ferinject, vifor (international) ag, st. gallen) 1000 mg in 100 ml sodiumchloride (nacl) over 30 min. vitamin b12 (vitarubin®-superconc., streuli pharma ag, uznach) 1 mg sc. folic acid (acidum folicum, streuli pharma ag, uznach) 5 mg po. the current transfusion and coagulation guidelines of the university hospital of zurich are followed in both groups identically. postoperatively on the regular ward a hb transfusion trigger of 80 g/l is applied

Eligibility criteria:
inclusion criteria: * patients undergoing valve- and/or coronary bypass surgery * signed patient informed consent * only patients will be enrolled who won't have an emergency surgery on the same day exclusion criteria: * participation in another clinical trial within the last 4 weeks prior to enrollment * addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial * patients who do not sign the consent form or may not fully understand from inadequate knowledge of german. * patients who have not reached the age of legal majority * pregnant or lactating women * jehovah's witnesses * patients with endocarditis * existing allergy or intolerance to ferric carboxymaltose or mannitol

Keywords: anemia iron deficiency cardiac surgery perioperative care
cognitive behavioral therapy in treating anxiety in patients with stage iv non-small cell lung cancer and their caregivers

Conditions: Anxiety Disorder; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: this pilot clinical trial studies cognitive behavioral therapy in treating anxiety in patients with stage iv non-small cell lung cancer and their caregivers. cognitive behavioral therapy may reduce anxiety and improve the well-being and quality of life of patients who have stage iv non-small cell lung cancer and their caregivers.

primary objectives: i. to identify, through both quantitative and qualitative methods, clinical correlates of anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer and their primary caregivers. ii. to apply these findings to develop a brief dyadic intervention based on cognitive behavioral therapy (cbt) to reduce anxiety in late-stage lung cancer patients and their primary caregivers. iii. to evaluate the feasibility and acceptability of the pilot intervention through number of completed visits and assessment pre- and post- intervention. outline: participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors. after completion of study treatment, participants are followed up at 1 week.

Eligibility criteria:
inclusion criteria: * diagnosis of stage iv non-small cell lung cancer * at least 6 weeks post-diagnosis * current symptoms of anxiety (e.g., hamilton rating scale for anxiety \[ham-a\] \>=14) * ability to understand and the willingness to sign a written informed consent document * caregiver: identified by patient as primary caregiver * caregiver: at least 14 hours/week spent caring for patient * caregiver: current symptoms of anxiety (e.g., ham-a \>= 14) * caregiver: ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients and caregivers: * active, unstable, untreated serious mental illness * other cognitive inability to complete informed consent process or study procedures
the use of the bakri postpartum balloon in the management of postpartum hemorrhage refractory to conservative measures

Conditions: Postpartum Hemorrhage

Summary: the broad objective of the study is to determine if the bakri postpartum balloon is effective in preventing morbidity and mortality from postpartum hemorrhage (pph) as part of a standardized management algorithm. specific objectives * to estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to pph in 4 academic centers after introduction of a standardized protocol for management of pph, but prior to the inclusion of the bakri postpartum balloon as part of the protocol. * to estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to pph in 4 academic centers after introduction of a standardized protocol for management of pph, after the inclusion of the bakri postpartum balloon as part of the protocol. * to compare morbidity * to generate preliminary data for (a) a larger confirmatory study of the use of the bakri postpartum balloon in centers with surgical and blood transfusion services, and (b) design of a pilot study of the use of the bakri device of temporary control of pph in settings outside of surgical centers (such as by trained midwives or emergency transport personnel).

phase i: development and training of staff in standardized algorithm for management of pph using available local resources (not including bakri balloon). phase ii: data collection after introduction of the standardized algorithm. phase iii: revision of protocol to include the bakri postpartum device phase iv: data collection after introduction of the bakri device bakri postpartum balloon 510k premarket notification/cook obgyn #k062438

Eligibility criteria:
inclusion criteria: * any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage, defined as * clinically estimated blood loss of greater than 500 ml for a vaginal delivery, or * clinically estimated blood loss of greater than 1000 ml for a cesarean delivery, or * hemodynamic changes that, in the opinion of the care team, require interventions beyond routine postpartum or postdelivery care (such as intravenous fluids or the use of more than one uterotonic agent). exclusion criteria: * minors (less than 18 years of age) * arterial bleeding requiring surgical exploration or angiographic embolization * cases requiring immediate lifesaving hysterectomy * ongoing intrauterine pregnancy * cervical cancer * purulent infections of the vagina, cervix or uterus * untreated uterine anomaly * disseminated intravascular coagulation * a surgical site which would prohibit the device from effectively controlling bleeding * patients who are referred for obstructed labor * patients with signs, symptoms or other evidence of ruptured uterus

Keywords: postpartum hemorrhage bakri postpartum balloon
awareness, care & treatment in obesity management

Conditions: Obesity

Summary: action france is a cross-sectional, observational, descriptive, and exploratory survey-based study without collection of laboratory data. the study is not related to any specific treatment options or pharmaceutical product. collection of data will be performed via quantitative online survey by a third-party vendor. the goal of this study is to provide insights to drive awareness around the needs of people living with obesity (plwo) and health care professionals (hcps) involved in obesity treatment and management.


Eligibility criteria:
inclusion criteria: people living with obesity 1. informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, aged above or equal to 18 years at the time of signing informed consent lives in france 3. current bmi based on self-reported height and weight of at least 30 kg/m\^2 health care professionals 1. informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol) 2. male or female, aged greater than or equal to 18 years at the time of signing informed consent. 3. physician with a license to practice 4. specialty is not surgeon (including bariatric or plastic surgeon) 5. practices in france 6. in clinical practice greater than or equal to 2 years 7. spends at least 70 percent time in direct patient care 8. has seen at least 100 patients in past month 9. has seen at least 10 patients in past month needing weight management defined as: a patient with a bmi greater than or equal to 30 kg/m\^2 with or without comorbidities. employers 1. informed consent before any study related activities (study-related activities are any procedure related to recording/collection of data according to protocol) 2. age 18 years old or older 3. works in france 4. company offers health insurance benefits 5. responsible for making or influencing decisions about employee benefits plan or health and wellness programs 6. works in a company that has at least 20 employees 7. not affiliated with pharma, mr or advertising firms exclusion criteria: people living with obesity 1. previous participation in this study. participation is defined as having given online consent in this study 2. currently pregnant 3. participates in intense fitness or body building programs 4. has had significant, unintentional weight loss (due to major injury, illness, etc) in the past 6 months 5. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation health care providers 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. unwillingness, inability, or language barriers precluding adequate understanding or cooperation. employers 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
how bleeding affects delirium in older patients with hip fractures: the improve-hip study

Conditions: Bleeding; Hip Fracture; Delirium - Postoperative

Summary: the goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. the main question the trial aims to answer is: • do patients aged 75 and older with hip fractures benefit from quicker treatment of anaemia (low blood count) to reduce the risk of delirium? researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium. participants will: * undergo blood tests and have their vital signs checked, as well as be screened for delirium three times a day for the first 48 hours after surgery. * receive blood transfusions promptly if their haemoglobin levels drop below a specified threshold. * have a follow-up visit at 30 days to assess their memory and overall quality of life. * have another follow-up at 90 days to check for hospital readmissions and survival


Eligibility criteria:
inclusion criteria: * hip fracture exclusion criteria: * pathological hip fracture * periprosthtic fracture * unable to speak or understand danish * does not wish to recieve blood transfusion * if the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)

Keywords: hip fracture delirium blood transfusion
evaluation of risk factors leading to conversion from laparoscopic cholecystectomy to open surgery

Conditions: Cholelithiasis; Cholecystitis, Acute; Cholecystitis, Chronic; Gallbladder Diseases

Summary: this retrospective controlled study aims to evaluate risk factors that affect open conversion in laparoscopic cholecystectomy. patient characteristics, medical history, biochemical and radiological studies of the patient will searched from the hospital database and factors affecting open conversion will be analysed.

cholecystectomy is a commonly performed procedure in general surgical practice, and with advancements in technology, it is widely conducted using the laparoscopic method. despite the decreasing trend in open surgical procedures with increasing experience and technological developments, the literature reports conversion to open surgery in laparoscopic cholecystectomy ranging from 2% to 15%. although some studies exist regarding patient groups at risk of conversion to open surgery, the current literature is insufficient to draw a clear conclusion on this matter. this study aims to evaluate risk factors for conversion to open surgery by examining cases of laparoscopically initiated cholecystectomy. the study will be conducted retrospectively by reviewing archive records. patients operated for cholecystectomy will be included. patients that open surgical method used from start will be excluded from study. age, comorbidities (asa score), laboratory findings (leukocyte count and crp), imaging findings (abdominal ultrasound, ct, or mri), history of previous abdominal surgery, history of ercp, and history of pancreatitis will be evaluated. laparoscopic cholecystectomy cases will be compared with open-conversion cholecystectomies to assess factors influencing the conversion.

Eligibility criteria:
inclusion criteria: * aged between 18 and 95 years old. * operated for gallbladder disease (cholecystectomy) * surgery must started with laparoscopic approach exclusion criteria: * open surgery from the start * cholecystectomy as a part of bigger surgical intervention (such as pancreaticoduodenectomy)

Keywords: laparoscopic cholecystectomy conversion cholelithiasis acute cholecystitis
megadyne ace incision/dissection study

Conditions: Abdominoplasty; Bilateral Breast Reduction; Bilateral Breast Lift; Bilateral Brachioplasty; Bilateral Lateral Thigh and Buttocks Lift

Summary: the megadyne ace™ incision/ dissection study is a post market, prospective assessment of the e-z clean ace electrosurgical electrodes using the ace blade in the ace mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.


Eligibility criteria:
inclusion criteria: * subject is \>18 years of age or \< 60 years old * subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof * subject is able to discontinue anticoagulant therapy (including aspirin) * subject is willing and able to comply with study follow-up procedures * subject is willing to provide written informed consent for their participation in the study exclusion criteria: * subject has a history of smoking in the last 6 months prior to surgery. * subject has a history of type i or type ii diabetes. * subject has an active infection of any kind at the time of enrollment * subject has a known coagulopathy
a study to evaluate the safety, pharmacokinetics and pharmacodynamics of mk-8325 in hepatitis c-infected males (mk-8325-002)

Conditions: Hepatitis C, Chronic

Summary: this study is being done to assess the safety, pharmacokinetics (pk) and pharmacodynamics (pd) of mk-8325 in male hepatitis c virus (hcv)-infected participants. there will be 3 parts to this study. part i will enroll only genotype 1 (gt1) hcv patients, part ii will enroll only genotype 3 (gt3) hcv-infected participants, and part iii will enroll only gt1a hcv-infected participants. all parts may run concurrently, or may be staggered as needed by the clinical sites.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to ≤37 kg/m\^2 * diagnosis of chronic hcv infection * must be infected with hcv gt1a, gt1b, or gt3 exclusion criteria: * co-infection with gt1 and gt3 hcv * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of neoplastic disease * positive hepatitis b surface antigen * history of human immunodeficiency virus (hiv) infection or positive hiv serology * major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior * history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months * evidence or history of chronic hepatitis not caused by hcv including but not limited to non-hcv viral hepatitis, non-alcoholic steatohepatitis (nash), drug-induced hepatitis, autoimmune hepatitis * previous treatments(s) with nonstructural 5a (ns5a) protein inhibitors * treatment with protease inhibitor(s) \<30 days prior to study enrollment * previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of mk-8325 in the study * clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (metavir score ≥3) from prior liver biopsy
a study of the efficacy and safety of medi-546 in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy and safety of medi-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (sle) with an inadequate response to standard of care treatment for sle.

this is a phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (iv) treatment regimens in adult participants with chronic, moderately-to-severely active sle with an inadequate response to soc sle. the investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.

Eligibility criteria:
inclusion criteria: * fulfills at least 4 of the 11 american college of rheumatology (acr) criteria for systemic lupus erythematosus (sle) including a positive antinuclear antibody (ana) greater than or equal to 1:80 or elevated anti-double-stranded dna or anti-smith antibody at screening * pediatric or adult sle with chronic disease activity for greater than or equal to 24 weeks * weight greater than or equal to 40 kg * currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives * active moderate to severe sle disease based on sle disease activity score (sledai) and british isles lupus assessment group index (bilag) and physicians global assessment * no evidence of cervical malignancy on pap smear within 2 years of randomization * female participants must be willing to avoid pregnancy * negative tuberculosis (tb) test or newly positive tb test due to latent tb for which treatment must be initiated at or before randomization. exclusion criteria: * active severe sle-driven renal disease or unstable renal disease prior to screening * active severe or unstable neuropsychiatric sle * clinically significant active infection including ongoing and chronic infections * history of human immunodeficiency virus (hiv) * confirmed positive tests for hepatitis b or positive test for hepatitis c * history of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes * live or attenuated vaccine within 4 weeks prior to screening * participants with significant hematologic abnormalities.

Keywords: medi-546 anifrolumab systemic lupus erythematosus