Kornimate/medical-research-clean huggingface dataset:
phase 3 study of dienogest for the treatment of endometriosis in chinese patients

Conditions: Endometriosis

Summary: this study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis. there will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg dng daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.


Eligibility criteria:
inclusion criteria: * women between 18 and 45 years of age, inclusive * women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the screening visit * a score of at least 30 on a 100 mm visual analog scale (vas) for endometriosis-associated pelvic pain at screening visit and baseline visit * good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination * willingness to use a barrier method of contraception is required exclusion criteria: * pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) * wish for pregnancy within intended treatment period * before menarche or after menopause * amenorrhea (more than three consecutive months in the six months before screening) * undiagnosed abnormal genital bleeding * previous/use of hormonal agents * any disease or condition that may worsen under hormonal treatment * signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy * need for primary surgical treatment of endometriosis * regular use of pain medication due to other underlying diseases * contra-indication for the supportive analgesic medication (ibuprofen)

Keywords: endometriosis efficacy safety dienogest
quick large balloon dilatation for removal of large bile duct stones (shodbadi)

Conditions: Pancreatitis, Acute; Bleeding; Cholangitis

Summary: esge guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla. the investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. this scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.

this study is planned as a multicenter scandinavian prospective study including all the patients \>18 years with \>10mm diameter common bile duct stones visible in cholangiogram. before ercp all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. the endoscopists will decide whether the first step will be large est and stone extraction or small est and dilatation. if simple est does not success, the dilatation will remain as a rescue method. the diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. the duration of the dilatation measured, but it does not define the ending of dilatation. all adverse events will be recorded one month and a year after the procedure. classification of the patients: 1. est and stone extraction 2. eplbd when est and stone extraction did not succeed 3. short est and eplbd the investigators will collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure

Eligibility criteria:
inclusion criteria: * age \>18 years * common bile duct stone \>10mm diameter exclusion criteria: * altered anatomy after surgery (b ii, roux-en-y reconstruction) * common bile duct cysts * acute pancreatitis * distal common bile duct stricture or tumor * coagulation disorders * ongoing coagulation medication * pregnancy * inability to give an informed consent
botulinum toxin injection in patients undergoing hemorrhoidectomy-a prospective, randomized study

Conditions: The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control

Summary: this is a prospective, randomized study, which anticipatedly recruited 60 patients in the outpatient department who need hemorrhoidectomy from january 2019 to december 2019. after obtaining those patients' consent in the clinic, they were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (microsoft excel). one group received botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, eg), and the other group received injection during the operation(control group, cg). the two groups were compared for the influence of postoperative pain control and wound healing rate.


Eligibility criteria:
inclusion criteria: * patients with age over 20 but under 80, who need to undergo hemorrhoidectomy exclusion criteria: * patients under the age of 20 * patients with nonsteroidal anti-inflammatory drugs (nsaids) allergy or sensitivity * patients with botulinum toxin allergy or sensitivity * patients with dialysis or renal insufficiency * pregnant and breastfeeding women * vulnerable population

Keywords: hemorrhoidectomy botulinum toxin pain wound healing
preemptive analgesia in cruciate reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: the aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. one hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. both patients and surgeon were blinded to the allocation. all of the patients will be operated by one orthopaedic surgeon under regional anesthesia. each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.


Eligibility criteria:
inclusion criteria: * patients with anterior cruciate ligament injury age 15-50 yr exclusion criteria: * previous knee surgery

Keywords: preemptive analgesia cruciate ligament
ar vs vr in burns dressing changes

Conditions: Burns Multiple

Summary: for children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. this process is not only distressing for the children but also for their parents and the healthcare professionals involved. current methods to reduce this trauma include the use of play therapists, but such resources are often limited. there is good evidence that augmented reality (ar) and virtual reality (vr) can help by providing a distracting and immersive environment that eases pain and fear. however, no studies have yet compared these two modern technologies to see which is more effective


Eligibility criteria:
inclusion criteria: * • participants presenting with guardians with parental responsibility, who are willing and able to consent to recruitment. * aged 4-17 years * presenting with burns requiring a dressing change, on their first attendance to the burns clinic. * participating child is able to complete the faces pain scale exclusion criteria: * • children aged 4 or below * those with severe cognitive impairment, visual disorders, facial burns or other conditions preventing the safe use of vr/ar technology. * previous 'cybersickness' symptoms (nausea, dizziness).
cognitive markers of response to treatment in resistant depression

Conditions: Depression

Summary: patients with depression are frequently treatment resistant. clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. many factors are involved in treatment resistance. as no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment. the aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (stage 2 of thase and rush classification). to explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.


Eligibility criteria:
inclusion criteria: * patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance. exclusion criteria: * patients with major depressive episode during more of 12 months * alzheimer dementia or related disease (cim 10) * score hamilton depression rating scale (hdrs) \< 18
brain function and psychological changes related to cell therapy for autoimmune hemolytic anemia

Conditions: CAR T-cell Therapy; Autoimmune Hemolytic Anemia; Brain Function; Psychological Well-Being

Summary: cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. although it offers potential benefits for autoimmune hemolytic anemia (aiha), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior. brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. this study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on aiha patients to develop safer and more effective treatment strategies that enhance their quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of aiha * subjects will receive cell therapy such as car t-cell therapy * male or female, aged 18-65 years * willing and able to comply with the requirements for this study and written informed consent exclusion criteria: * history of psychiatric illness * history of severe brain disease * subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
anal cancer radiotherapy study

Conditions: Anal Cancer

Summary: this is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. treatment effect in terms of survival and local recurrence will be analyzed. the utility of pet-ct and mri for radiotherapy and for prediction of treatment effect will be investigated. molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. a structured intervention program for management of late effects will be evaluated. symptom relief of palliative radiotherapy will be investigated. the main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.


Eligibility criteria:
inclusion criteria: * histologically verified anal squamous cell carcinoma * radiotherapy or chemoradiotherapy planned * ecog performance status 0-2 * \>= 18 years of age * signed informed consent and expected cooperation of the patients for treatment and follow up exclusion criteria: - cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
impact of advance care planning on care for patients with advanced heart failure

Conditions: Heart Failure

Summary: aims: advance care planning (acp) is considered to be one of the most promising interventions to enable patients with life limiting illnesses to receive treatment at the end of life (eol) according to their own preferences and to promote eol conversations between patients and their health care providers. through a 2-arm randomized controlled trial (rct) of patients with class iii and iv heart failure (new york heart association functional classification), we propose to assess: 1. whether patients in the acp arm have a greater likelihood of receiving eol care consistent with their preferences as stated in the latter of the last acp document or the last patient interview, compared to patients in the control arm. 2. heath care costs during study duration between patients in acp and control arms. 3. patient's understanding of own illness and their participation in decision making between the acp and control arms. 4. patient's quality of life, anxiety and depression between acp and control arms. methodology: a total of 254 patients with advance heart failure will be randomized to receive intervention (acp arm; n=127) or usual care (control arm; n=127). the rct will be conducted at the national heart centre and singapore general hospital. patients in both arms will be followed for one year or till death, whichever is earlier, and interviewed every 4 months during this duration. clinical significance: if benefits of acp are shown to add value through this trial, then this study will help to promote acceptance of acp among patients and health care providers across singapore and elsewhere.


Eligibility criteria:
inclusion criteria: patient participant: * patients must be 21 years old or older and must be diagnosed with advanced heart failure (new york heart association class iii and iv). patients must be aware of their diagnosis * caregiver/decision-maker participant: subject must be 21 years old or older participant must be either * appointed substitute decision maker or * most likely to be substitute decision maker for patient (if patient were to lose decision-making capacity) exclusion criteria: * patient participant: patients must not have any psychiatric or cognitive disorders * caregiver/decision-maker participant: cannot be a maid or foreign domestic worker

Keywords: advanced care planning end of life care
dose-escalation study to assess the safety, tolerability, and pharmacokinetics of donepezil from single dose of gb-5001 im depot and aricept® oral tablets in healthy male volunteers

Conditions: Alzheimer Disease

Summary: this study is to evaluate the safety and tolerability of single dose of gb-5001 (donepezil) im depot in healthy male volunteers. and, it is to predict the multiple-dose pharmacokinetics based on the single-dose pharmacokinetics of gb-5001 im depot and the oral aricept® (donepezil hydrochloride) tablet by pk modeling.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking male volunteers, 18-55 years of age, inclusive at the time of informed consent. * body mass index (bmi) that is within 18.5 - 30.0 kg/m2, inclusive, and weight at least 55 kg and above. * healthy, according to the medical history, ecg, vital signs, laboratory results and physical examination as determined by the pi/sub-investigator. * systolic blood pressure between 95-140 mmhg, inclusive, and diastolic blood pressure between 55-90 mmhg, inclusive, and heart rate between 60-100 bpm, inclusive, unless deemed otherwise by the pi/sub-investigator. * clinical laboratory values within the clinical site's most recent acceptable laboratory test range, and/or values are deemed by the pi/sub-investigator as "not clinically significant". exclusion criteria: * known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the pi/sub-investigator. * known history or presence of seizure or convulsion, unless determined as not clinically significant by the pi/sub-investigator. * known history or presence of peptic ulcer or gastrointestinal bleeding within 3 months prior to study drug administration, unless determined as not clinically significant by the pi/sub-investigator. * known risk of developing ulcers (for example, if you are taking non-steroidal anti-inflammatory drugs \[nsaids\] or high doses of acetylsalicylic acid \[asa\] \[aspirin®\]), unless determined as not clinically significant by the pi/sub-investigator. * clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug experienced within 7 days prior to study drug administration, as determined by the pi/sub-investigator. * presence of any clinically significant illness within 30 days prior to dosing, as determined by the pi/sub-investigator * presence of any clinically significant illness within 30 days prior to dosing, as determined by the pi/sub-investigator.
comparison of topical anesthesia and analgosedation in micropulse transscleral glaucoma treatment

Conditions: Glaucoma

Summary: topical anesthesia will be compared to analgosedation for pain control in micropulse transscleral laser treatment for glaucoma (mp-tlt).

for a patient, the perspective of a surgical treatment can mean both, hope, and anxiety. in particular the fear of pain during and after surgery can cause tremendous anxiety. in addition, possible side effects of general anesthesia and sedation should be considered, in particular, in patients with multiple comorbidities. the investigators want to help patients to cope with their anxiety and, in addition, minimize risks of surgical procedures including side effects of anesthesia. with this project, the investigators aim to investigate whether topical anesthesia - often used in ophthalmologic surgical procedures - can sufficiently control pain during and after a glaucoma laser procedure compared to intravenous analgosedation. as primary objective, the effectiveness in pain control of analgosedation and topical anesthesia in mp-tlt will be compared. as secondary objective, the effect of the anesthetic protocol used on postoperative visual related quality of life will be investigated.

Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma (poag) * age ≥18 years of age * visual acuity ≥0.6 decimal-snellen * iop ≥21 mmhg * \</=3 anti-glaucoma drug (agd) classes exclusion criteria: * diagnosis of cystoid macula edema (cme) observed by optical coherence tomography (oct) * status post cme * diagnosis of epiretinal fibroplasia * status post other operations than uncomplicated cataract interventions * status post cataract operation less than 3 months ago

Keywords: glaucoma micropulse transscleral treatment for glaucoma pain
prophylactic tranexamic acid use after vaginal delivery

Conditions: Postpartum Hemorrhage; Vaginal Delivery; Prophylactic Tranexamic Acid Use

Summary: in this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.

it was carried out as a double-blind prospective randomized controlled phase 4 drug study with 480 singleton pregnant women in bursa yüksek i̇htisas training and research hospital between september 1, 2021 and february 28, 2022. the patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. group 1: were given intravenous tranexamic acid and group 2: were given placebo. the blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.

Eligibility criteria:
inclusion criteria: * singleton pregnant women * woman between the ages of 18-45 years * woman who gave birth at 34 weeks and above exclusion criteria: * pregnancies with less than 1 hour period between hospitalization and delivery * women with placenta previa, invasion anomaly or diagnosis of abruptio placentae * women with previous uterine surgery or cesarean section * women with a history of thromboembolism * women with serious illness

Keywords: tranexamic acid vaginal delivery postpartum hemorrhage active management of vaginal delivery
high flow nasal cannula use in infants with bronchiolitis

Conditions: Bronchiolitis

Summary: infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. in earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. this study is a randomized controlled trial in two pediatric university hospitals in finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. in earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. this study is a randomized controlled trial in five pediatric university hospitals in finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis. the investigators will recruit 160 infants who require oxygen therapy (oxygen saturation \<92%) during hospitalization due to a viral bronchiolitis. the participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.the infants are closely observed by study physicians for clinical parameters. the primary end point is treatment failure (need for change of respiratory support method). secondary endpoints are respiratory rate (rr) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.

Eligibility criteria:
inclusion criteria: * admission to pediatric ward due to a presumed viral bronchiolitis * need of oxygen therapy (oxygen saturation \< 92%) exclusion criteria: * pertussis * needs intubation or cpap on admission * severe congenital heart defect * down's syndrome

Keywords: infant high flow nasal cannulae oxygen therapy bronchiolitis
the university of freiburg medical center extracorporeal organ support device registry

Conditions: Medical Condition Requiring Extracorporeal Organ Support

Summary: a prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., vv ecmo, va ecmo, ecpr, impella, iabp, and others) on the wards of the department of interdisciplinary medical intensive care at the freiburg university medical center.


Eligibility criteria:
inclusion criteria: * treatment with any kind of extracorporeal organ support exclusion criteria: * none

Keywords: acute respiratory distress syndrome acute respiratory failure severe respiratory failure cardiogenic shock cardiac arrest extracorporeal cardiopulmonary resuscitation