Kornimate/medical-research-clean huggingface dataset:
atg plus ptcy vs atg for cgvhd prophylaxis

Conditions: Acute Leukemia; Myelodysplasia; Chronic Graft-versus-host-disease

Summary: a randomized pilot trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.

patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.

Eligibility criteria:
inclusion criteria: 1. the participant is aged ≥ 16 and deemed medically fit per investigator for protocol 2. the participant has either acute myeloid leukemia in 1st or 2nd complete remission (cr), or has myelodysplastic syndrome 3. the participant will receive a blood progenitor cell graft ("hpc, apheresis") 4. the participant has a related or unrelated donor, who is fully mhc matched with the recipient at hla-a, b, c and drb1. 5. the participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning. 6. the participant has good performance status (karnofsky ≥60%) 7. the participant is able to understand and sign the informed consent form 8. ability and willingness to comply with study procedures and schedule, in the investigator's opinion. 9. the participant is receiving their first transplant exclusion criteria: 1. the participant is hiv antibody positive 2. the participant has a hypersensitivity to rabbit proteins or thymoglobulin® pharmaceutical excipients, glycine or mannitol. 3. the participant has active or chronic infection (i.e. infection requiring oral or iv therapy) 4. the participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment 5. the participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3 6. the participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3 7. the participant has urinary outflow obstruction 8. the participant is in poor condition (determined per institutional guidelines) 9. the participant has acute leukemia in relapse 10. the participant has myelodysplastic syndrome with \> 10% marrow blasts 11. the participant is having their second transplant 12. the participant is taking t-cell antibody prophylaxis (anti-cd52) 13. the participant is receiving a cord blood graft or t-cell depleted grafts 14. the participant has mixed phenotype acute leukemia 15. the participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. cancer treated with curative intent ≥ 5 years previously will be allowed. cancer treated with curative intent \< 5 years previously must be reviewed and approved by the sponsors. 16. the participant is in complete remission with incomplete recovery (cri)

Keywords: post transplant cyclophosphamide anti-thymocyte globulin
the effects of local vaginal estrogen in postmenopausal women with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse; Vaginal Atrophy

Summary: the purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). it also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Eligibility criteria:
inclusion criteria: * women aged 45 years or older * postmenopausal (\>55 if natural menopause) * clinical atrophic vaginitis (at least mild atrophy) * pelvic organ prolapse(at least stage 2 or greater) * posthysterectomy * surgery date between 2-12 weeks after recruitment exclusion criteria: * uterus present * well-estrogenized appearing vagina * known or suspected history of breast carcinoma * hormone-dependent tumor * genital bleeding of unknown cause * acute thrombophlebitis or thromboembolic disorder associated with estrogen use * vaginal infection requiring treatment * allergy to estrogen or its constituents * any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance. * use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment * initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Keywords: pelvic organ prolapse vaginal atrophy atrophic vaginitis postmenopausal posthysterectomy vaginal health vaginal cytology vaginal maturity index vaginal histology quality of life questionnaires
a study to evaluate the effectiveness and safety of ionis-fb-lrx, an antisense inhibitor of complement factor b, in adult participants with primary iga nephropathy

Conditions: Primary IgA Nephropathy

Summary: the purpose of this study is to evaluate the effectiveness and safety of ionis-fb-lrx, an antisense inhibitor of complement factor b messenger ribonucleic acid (cfb mrna), and to evaluate the effect of ionis-fb-lrx on plasma factor b (fb) levels and serum ah50, ch50 activity in participants with primary immunoglobulin a (iga) nephropathy.

this is a phase 2, single arm open-label clinical study in up to 25 participants that will consist of a screening period, a 24-week treatment period, an optional treatment extension period of up to an additional 48 weeks, and a 12- week post-treatment follow-up evaluation period.

Eligibility criteria:
inclusion criteria * females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or use a highly effective method of birth control * biopsy-proven primary immunoglobulin a (iga) nephropathy * hematuria * proteinuria exclusion criteria * clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of screening) * diagnosis of primary or secondary immunodeficiencies of b-lymphocyte function, splenectomy, or history of recurrent meningococcal disease * active infection 30 days prior to study * estimated glomerular filtration rate (egfr) ≤ 40 milliliters per minute per 1.73 square meters (ml/min/1.73m\^2) using the chronic kidney disease epidemiology collaboration (ckd-epi) * presence of another renal disease including, but not limited to, diabetes and/or diabetic nephropathy, thin basement membrane disease, alport's disease, iga nephritis (henoch-schonlein purpura), lupus nephritis, minimal change disease, post-infectious glomerulonephritis or any other cause of proteinuria or secondary iga nephropathy (including, but not limited to celiac disease, crohn's disease, human immunodeficiency virus (hiv), liver cirrhosis) * history of renal transplant or another organ transplant * treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer * administration of immunosuppressive/immunomodulatory medication 12 months prior to study drug administration, except for short-term treatments. * other protocol-specified inclusion/exclusion criteria may apply
cera™ asd occluder post-market clinical follow-up study

Conditions: Atrial Septal Defect

Summary: the objective of this post-market study is to: * collect real-word clinical data and confirm the long-time safety and performance of the lifetech cera™ asd occluder * identify previously unknown side-effects

atrial septal defect (asd) is a type of congenital heart defects (chd) that have the potential to be closed without open-heart surgery. the treatment of choice for asd closure has long been surgical closure. an alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for asd. with percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. the lifetech cera™ asd occluder is a percutaneous, transcatheter closure device for the non-surgical closure of asd. in order to collect real-word clinical data and confirm the long-time safety and performance of the lifetech cera™ asd occluder, this post-market clinical follow-up study is planned under the regulation (eu) 2017/745. the study intends to enroll 139 subjects. the anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of secundum atrial septal defect (asd). * patients was implanted with the study device from 01 jan 2020 to 31 dec 2023 as per ifu instructions. * patients or legally authorized representative are willing to the collection and processing of his/her data or sign the informed consent. exclusion criteria: * patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery. * patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement. * patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months. * patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi). * patients whose size (i.e., too small to tolerate tee probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization. * patients where the margins of the defect are less than 5mm from the coronary sinus, av valves or right upper lobe pulmonary vein. * patients did not conduct any follow up visit after hospital discharge.

Keywords: atrial septal defect
impact of endometriosis on pregnancy and delivery - a retrospective cohort study

Conditions: Endometriosis; Pregnancy Complications; Delivery Complication; Complication; Miscarriage

Summary: purpose: to study the impact of endometriosis on subsequent pregnancy and delivery. methods: retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the university hospital muenster, germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using clavien-dindo-classification, role of deep infiltrating endometriosis using enzian classification; data analysis using t-test with p \< 0.050% being considered significant.


Eligibility criteria:
inclusion criteria: * cases: operation because of endometriosis at the endometriosis center, university hospital muenster, child wish, wants to participate, correct age group * controls: operation because of sterility, exclusion of endometriosis during this operation, child wish, wants to participate, correct age group exclusion criteria: * cases / controls: declines participation, incorrect age group, no child wish

Keywords: endometriosis pregnancy delivery miscarriage cesarian section
the effect of physical fatigue on lower limb functional performance tests in a healthy population

Conditions: Physical Fatigue; Return to Sport; Injury Prevention; Functional Performance

Summary: the main objective of this project is: 1. to assess the influence of physical fatigue on a return-to-play test battery in a healthy population. in a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population). the researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. twenty healthy subjects will visit the lab 3 times. on the first visit (familiarisation trial), the investigators will collect the participants' characteristics. the participants will also be familiarized to the procedures and materials of the experiment during this first visit. the second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (m-vas) and motivation scale. in the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. next, the subjects will carry out a functional test battery (hop test, vertical jump test, y-balance test, and a balance reaction-time test). session rate of perceived exertion (srpe) is measured to indicate how fatigued the participants feel due to the test battery; also, m-vas is collected once more, as well blood lactate, glucose and blood pressure. these measures are followed by either a physical fatigue inducing task (modified 30 seconds wingate protocol) or time-matched control task (sitting on the bike without pedalling). afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in m-vas (2x), perform the same test battery, and fill in the srpe scale one more time. heart frequency will be measured continuously during the trials.


Eligibility criteria:
inclusion criteria: * healthy (no neurological/cardiorespiratory/psychological/musculoskeletal disorders) * male and female * no medication * non-smoker * between 18 and 35 years old exclusion criteria: * back and/or lower extremity injuries during the past 6 months * bone/joint abnormalities * dizziness, history of loss of consciousness, any inner ear disorders * nervous system disorders or dysfunctions * uncorrected eye disorders/dysfunctions * illness * use of medication or any kind of drugs * use of alcohol, caffeine and heavy efforts 24 hours before each trial * not eating the same meal the night before and the morning of each experimental trial
effectiveness of digital cognitive behavioral therapy for the treatment of depression: a real-world study

Conditions: Depression; Bipolar Affective Disorder; Schizophenia Disorder; Psychiatric &amp;or Mood Disorder

Summary: the project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. the digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. the therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including ai-guided course work and homework. this study aims to evaluate the therapeutic effects of cbt-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.


Eligibility criteria:
inclusion criteria: 1. aged 14-60 years (including 14 and 60), no gender restriction; 2. hamd \>= 17; 3. written informed consent obtained from the patient; written informed consent obtained from the guardian for minors. exclusion criteria: * persons with severe suicidal tendencies (item 10 of the madrs scale ≥ 5).

Keywords: i-cbt a real-world study
comparison of the effect site concentration of remifentanil for preventing cough during emergence between male and female patients with thyroidectomy

Conditions: Patients Undergoing Thyroidectomy

Summary: the clinical studies demonstrate more powerful analgesic effect among female to both μ- and κ-opioid agonist (fillingim et al. 2004). the antitussive effect of opioid is mediated predominantly by μ-, κ-opioid receptors (kamei j. 1996). therefore, the investigators hypothesized that there are sex differences in the antitussive responses to opioid. it has been reported that target-controlled infusion (tci) of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. some studies, reporting the ec50 and ec95 of remifentanil in effect-site tci for preventing cough during emergence in different sex and surgeries (b. lee et al. 2009, e.m.choi et al. 2012), showed differences in ec50 and ec95. the purpose of this study was to find out ec50 and ec95 of remifentanil in effect-site tci for preventing cough during emergence in each sex and to evaluate whether there were sex differences in ec50 and ec95 of remifentanil in effect-site tci or not.


Eligibility criteria:
inclusion criteria: * aged 20-46 * asa classification i\~ii * patients undergoing thyroidectomy exclusion criteria: * patient who has signs of a difficult airway * patient who has smoking history * patient who has upper respiratory infection or sore throat in the previous two weeks * patient who has hypertension, dm * female patients who were pregnant, breast-feeding or menopausal
progesterone in threatened abortion

Conditions: Threatened Abortion in First Trimester

Summary: the main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. the secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.


Eligibility criteria:
inclusion criteria: * pregnant women attending the emergency room of the study sites with the following characteristics: * able and willing to sign the subject informed consent form and adhere to the study visit schedule; * age: 18-37 years; * bmi: 18-28 kg/m2; * symptoms of threatened abortion (vaginal bleeding , with or without pelvic pain); * ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat); * gestation week ≥6 weeks (5 w +1d) and \<12 weeks (11 w + 1d) according to ultrasound dating (crl); * closed uterine cervix; * at the first case of threatened abortion in the current pregnancy. exclusion criteria: * pregnancy obtained via art treatment; * subchorionic haematoma with \>50% placental detachment; * history of recurrent miscarriage; * severe uterine malformations; * known hypersensitivity to study medication; * neoplasias (known or suspected breast or genital tract cancer); * severe impairment of hepatic or renal function; * use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility); * active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events; * porphyria; * a history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy; * antiphospholipid syndrome; * diabetes mellitus; * known thyroid diseases or autoimmune conditions.
epiduo pediatric acne study

Conditions: Acne

Summary: the purpose of this study is to evaluate the safety and efficacy of epiduo® (adapalene and benzoyl peroxide) gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acne vulgaris with facial involvement * score of 3 (moderate) on the investigator's global assessment (iga) scale * a minimum of 20 but not more than 100 total lesions (noninflammatory and/or inflammatory) on the face (including the nose) at baseline exclusion criteria: * acne nodule or acne cyst * acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment * underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments * use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
comparison of outreach methods to encourage enrollment in diabetes prevention and weight management programs

Conditions: PreDiabetes; Obesity

Summary: individuals with prediabetes are at increased risk for developing diabetes. higher hemoglobin a1c's (6.1-6.4%) are associated with a high risk of developing diabetes. it is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. however, engagement of kaiser permanente colorado members in these activities is low. the purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.


Eligibility criteria:
inclusion criteria: * kaiser permanente member * age 18-75 * prediabetes * bmi \>= 25 * a1c 6.1-6.4% * no dietitian visit within the past 3 years exclusion criteria: - pregnancy
anti-histamines promote electroacupuncture analgesia: basic and clinical research

Conditions: Pain

Summary: acupuncture has been used in traditional chinese medicine for around 3,000 years and is increasingly practiced worldwide. the effects of acupuncture in chronic pain have been investigated in many clinical trials. histamine h1 receptor antagonists are commonly used for treating allergy. recently, investigators found that histamine h1 receptor antagonists at relatively low doses facilitate ea analgesia in the acetic acid-induced abdominal writhing test. investigators aim to further explore whether histamine h1 receptor antagonists also facilitate ea analgesia in humans.the aims of the proposed studies are to: conduct a clinical trial to demonstrate that h1 receptor antagonists at relatively low doses facilitate ea analgesia in healthy volunteers. this study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) sham acupuncture (shallow needling without electrical stimulation) at st36 and gb34; (2) ea at st36 and gb34; (3) ea at st36 and gb34 plus low-dose chlorpheniramine (2 mg); (4) ea at st36 and gb34 plus regular-dose chlorpheniramine (4 mg). the primary endpoint will be the pain threshold. it is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.


Eligibility criteria:
inclusion criteria: 1. . age: 20 to 30 years of age. 2. . agrees to undergo a comprehensive medical history and physical examination. 3. . no history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment. exclusion criteria: 1. . an ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy). 2. . a compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the ea procedure and assessments of the study. 3. . an implant such as a pacemaker, defibrillator, or electronic medical equipment. 4. . pregnancy, or planning for pregnancy.

Keywords: electroacupuncture (ea) antihistamine pain