Kornimate/medical-research-clean huggingface dataset:
habitual abortion study: oral dydrogesterone treatment during pregnancy in women with recurrent miscarriage

Conditions: Recurrent Miscarriage

Summary: the purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (duphaston).


Eligibility criteria:
inclusion criteria * women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner exclusion criteria * any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus \[sle\], infections with chlamydia or mycoplasma) * any gynecological neoplasias or anatomical abnormalities that oppose pregnancy * concurrent infertility treatment/superovulation protocol

Keywords: pregnancy immunology unexplained recurrent miscarriage
pharmacodynamics, safety/tolerability and efficacy of topical omiganan in patients with uvin

Conditions: Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Summary: to assess the pharmacodynamics, safety/tolerability and efficacy of topical omiganan (cls001) in patients with usual type vulvar intraepithelial neoplasia (uvin).


Eligibility criteria:
inclusion criteria: 1. women ≥ 18 years 2. biopsy proven uvin, biopsies to have been taken within the last three months 3. written informed consent to participate in the trial 4. at least one lesion that can be accurately measured (using recist criteria) * in at least one dimension with longest diameter ≥ 20mm * or in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm) * this is to ensure that 4x4mm biopsies can be performed on this lesion. exclusion criteria: 1. has any concomitant disease or significant medical conditions that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial. 2. clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ecg. in the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 3. indication of a current active infectious disease of the vulva, other than hpv 4. pregnant, breast feeding or trying to conceive 5. active treatment for uvin (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month 6. patients receiving immunosuppressive therapy 7. hiv positive or transplant patients 8. any condition that in the opinion of the investigator could interfere with the conduct of the study
suprachoroidal injection of triamcinolone acetonide with ivt aflibercept in subjects with macular edema following rvo

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with rvo.

a randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal cls-ta in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

Eligibility criteria:
inclusion criteria: * has a clinical diagnosis of rvo in the study eye * has a cst of ≥ 300 µm in the study eye * has an etdrs bcva score of ≥ 20 letters read and ≤ 70 letters read in the study eye; * is naïve to local pharmacologic treatment for rvo in the study eye; exclusion criteria: * any active ocular disease or infection in the study eye other than rvo * history of glaucoma, intraocular pressure \> 21 mmhg or ocular hypertension requiring more than one medication * any uncontrolled systemic disease that, in the opinion of the investigator, would preclude participation in the study * any evidence of neovascularization in the study eye

Keywords: rvo me central subfield thickness oct optical coherence tomography cystoid macular edema subretinal fluid eylea aflibercept anti-vegf suprachoroidal triamcinolone acetonide
pdiffir: geriatric periprosthetic distal femur: fixation versus replacement

Conditions: Distal Femur Fracture; Periprosthetic Fracture Around Prosthetic Joint Implant Knee; Knee Fracture

Summary: periprosthetic distal femur fractures are a significant source of morbidity and mortality for elderly patients. one treatment option involved a surgical fixation with plates or nails, screws and cables/wires along the side of your fractured bone. the second method consists in replacing your knee joint with an artificial knee prosthesis (artificial knee joint). the primary objective is to determine if acute distal femur replacement improves knee pain and functional outcomes compared to surgical fixation. secondary outcomes are mortality, reoperation, complications, post-operative pain and quality of life. a health economic analysis will be conducted to assess the cost-effectiveness of both treatments. a total of 148 patients (74/group) will be enrolled in the study.


Eligibility criteria:
inclusion criteria: * • 65 years and older * isolated periprosthetic fracture of the distal femur around a stable primary total knee arthroplasty (lewis and rorabeck type 1-2) * fracture is acute (within 1 week from time of injury) * patient was ambulatory (with or without walking aids) in the community and at home prior to the injury * independent or moderately frail with score of 3 to 6 on the validated clinical frailty scale * patient is able to read and understand the consent form document, or an interpreter is available to the patient at the time of consent and follow-up * patient or substitute decision maker is able to provide written informed consent to participate in the study exclusion criteria: * • active infection around the fracture (soft tissue or bone) * open fracture * bilateral femur fractures * major neuro-vascular injury requiring intervention, compartment syndrome and major neurologic injuries * pathological fracture excluding osteoporosis * ipsilateral total knee arthroplasty using revision components (varus/valgus constraint, stemmed femoral components) * periprosthetic distal femur fracture around a loose or failing primary total knee arthroplasty (lewis and rorabeck type iii) * ipsilateral primary partial knee or patellofemoral arthroplasty * previous orif of the distal femur or proximal tibia or patella * current or previous extensor mechanism (patellar tendon, quadriceps tendon, or patella fracture) disruption or repair * poly-trauma status (injury severity score\>15) or any associated major injuries of the lower extremities that may hinder post-operative ambulation * medical contraindication to surgery

Keywords: periprosthetic distal femur fracture knee replacement surgical fixation geriatric patients
community engagement and conditional incentives to accelerate polio

Conditions: Polio; Immunization; Infection; Incentives

Summary: immunization is one of the most cost-effective and successful public health strategy in reducing the health, economic and societal burden of many infectious diseases. pakistan and afghanistan remain the only countries where polio is endemic, and pakistan reports the most cases in the world. although the rate is lower than in previous years, the situation remains alarming. this study objective is to decrease polio vaccine refusals and zero-dose vaccines by motivating behaviour change

study design:the study will adopt a pretest/post-test quasi-experimental approach with two intervention ucs and two control ucs. for each target, intervention shruc, a separate, matched control shruc of comparable size and location will be identified for eventual pre-post comparison. children under-five will be eligible for inclusion. intervention: the intervention package will include community mobilization and incentivization. clusters will be formed on a population of 2000-2500 in each intervention uc, thus approximately ten clusters in each. project will form or liaise with community groups or committees (male and female) in each cluster, which are already operational in many parts of the target ucs. however, to focus on reducing polio vaccine refusals, our program will adopt a unique incentivization approach, preceded by trust-building community mobilization. clusters will be determined based on the existing micro plans of the ppep. microplans are a population-based set of components, at uc-level, used by the program for delivering polio vaccination efficiently. baseline and end-line surveys will be conducted in the target and control ucs. study site: the study will be conduucted in district karachi, sindh and other in district bannu, kp. intervention ucs: haji mureed goth karchi and mira-khel kp control ucs : nazivmabad uc 49 karachi and khwajamad- bannu) the research team will engage with multiple village/mohalla committees in the intervention ucs to address and eliminate misconceptions about polio. one-to-one meetings and group sessions which will be led by the committee members, to provide messages on childhood immunization with project-specific iec material, will be held in each targeted cluster. these platforms would be helpful to identify and counsel their underlying fears and socio-psychological factors about the vaccines, such as painful neonatal experiences, mishandling, doubts, fear of vaccine-related side effects, distrust, etc. the community-based incentives will be conditional based on the decrease in vaccine refusal rates within stipulated time. communities successful in achieving these targets will be rewarded incentives to improve their infrastructure, including sanitation and hygiene, and water resources.

Eligibility criteria:
inclusion criteria: • household with at least one child 0-59 months of age exclusion criteria: • thise not willing to participate in study

Keywords: community engagment theory of change
comparative assessment of esophagitis in cases with and without esophageal motility disorders: a prospective study

Conditions: Esophageal Diseases

Summary: achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (les), thought to be due to damage to the myenteric plexus with an unknown cause.1 per-oral endoscopic myotomy (poem) is an established endoscopic treatment modality for achalasia. leading gastrointestinal (gi) societies endorse poem as one of the primary treatment option for achalasia.this study aims to characterize and compare the morphological characteristics of reflux related erosions after the poem procedures versus those in cases without esophageal motility disorders. data collection 1. demographic characteristics: age, gender, type of achalasia 2. manometry findings (pre and post poem): integrated relaxation pressure, lower esophageal sphincter pressure 3. comorbidities 4. medications 5. eckardt score: before procedure and 3-months after procedure 6. poem procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay 7. evaluation at 3-months symptom: standardized questionnaire (gerdq) endoscopy: grade of esophagitis erosions vs ulcers dimension of erosions anatomical location (according to clock)

poem will be performed using a standardized technique.8 the patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after poem. consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. ppis will be discontinued for at least 4 weeks prior to objective evaluation of gerd. each patient returning after 3 months for follow up will undergo several follow up examinations, including gerd questionnaire scoring, esophagogastroduodenoscopy, 24 hour ph impedance test. presence of endoscopically visible esophagitis . endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of gerd who have endoscopically visible esophagitis.

Eligibility criteria:
inclusion criteria: 1. age≥18y, 2. confirmed diagnosis of achalasia, 3. no contraindication to poem, 4. erosive esophagitis on endoscopy exclusion criteria: 1. non-esophageal esophageal motility disorders, 2. treatment other than poem, 3. current ppi use before assessment for gerd
the safety and efficacy of the buprenorphine transdermal delivery system in subjects with chronic low back pain.

Conditions: Back Pain

Summary: the objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. the double-blind treatment intervention duration is 60 days.

buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria:
inclusion criteria: * unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day. * taking \>/=3 opioid doses per day with or without acceptable pain control. exclusion criteria: * receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. * scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic back pain opioid transdermal
perinatal conditions influencing morbidity, mortality, and medical care in newborns

Conditions: Preterm Birth; Low Birth Weight; Intrauterine Growth Restriction (IUGR); Perinatal Asphyxia; Neonatal Sepsis; Respiratory Distress Syndrome (RDS); Neonatal Jaundice; Congenital Malformations; Neonatal Hypoglycemia; Gestational Diabetes Mellitus (GDM); Placental Abruption; Preterm Premature Rupture of Membranes (PPROM); Hypertension, Pregnancy-Induced; Pre-Eclampsia

Summary: this study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the isidro ayora hospital. the investigators will review data from 2008 to 2022 to identify key factors that may contribute to complications, help improve medical care, and reduce risks for newborns. by doing so, we aim to provide better support to families, healthcare providers, and ensure safer births.

this research investigates the impact of various perinatal conditions-such as maternal health, prenatal complications, delivery methods, and neonatal management-on morbidity and mortality rates in newborns treated at the isidro ayora obstetric-gynecologic hospital. using a retrospective cohort design, the study analyzes data from 2008 to 2022 to identify patterns and correlations between perinatal factors and neonatal outcomes, aiming to inform evidence-based clinical practices and enhance neonatal care protocols. key aspects include evaluating the influence of gestational age, birth weight, maternal comorbidities (e.g., hypertension, diabetes), and obstetric complications on the health of neonates. outcomes of interest include nicu admissions, length of hospital stay, and incidence of conditions such as respiratory distress syndrome, sepsis, and neonatal mortality. findings will contribute to improving resource allocation, optimizing care strategies, and potentially guiding policy decisions to reduce adverse neonatal outcomes.

Eligibility criteria:
inclusion criteria: * neonates born at the isidro ayora obstetric-gynecologic hospital between january 2008 and december 2022. * live-born neonates with complete medical records in the hospital's perinatal database. * neonates whose mothers received antenatal care and delivered at the hospital. availability of maternal and neonatal data, including gestational age, birth weight, and outcome information. exclusion criteria: * neonates with incomplete or missing medical records. * neonates born outside the hospital and referred postnatally. * stillbirths and pregnancies terminated due to maternal or fetal indications. * neonates discharged to other facilities immediately after birth without follow-up data in the hospital\&#39;s database.

Keywords: infant, premature infant, low birth weight fetal growth retardation asphyxia neonatorum sepsis, neonatal respiratory distress syndrome, newborn jaundice, neonatal congenital abnormalities hypoglycemia, neonatal hypertension, pregnancy-induced diabetes, gestational placental abruption premature rupture of fetal membranes
pain study using intermittent bupivacain injections after breast reconstruction with diep flap

Conditions: Breast Reconstruction

Summary: patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. the hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days


Eligibility criteria:
inclusion criteria: * all patients planned to undergo reconstructive breast surgery with a diep exclusion criteria: * regular use of analgesics * known allergic reaction to bupivacain * bleeding disorders * pregnancy

Keywords: bupivacain breast reconstruction diep pain postoperative catheter anesthesia
the atherogenic index of plasma（aip） in patients with atrial fibrillation

Conditions: Atrium; Fibrillation; Lipid Metabolism Disorders; Cardiovascular Diseases; Event, Cardiac

Summary: the goal of this observational study is to learn about the atherogenic index of plasma(aip) in patients with atrial fibrillation(af). the main questions it aims to answer are: (1)to investigate the correlation between aip and the occurrence rate of af. (2) to investigate the correlation between aip and the occurrence rate of cardiovascular outcome events (mace events, heart failure, embolism events) in patients with af. patients's clinical data including medical history, laboratory tests, and imageological examination will be collected and further analysed.

baseline demographic data: age, gender, height, weight, systolic blood pressure, diastolic blood pressure, smoking habit, drinking habit, physical activity, fasting blood glucose, medication use (statins, acei/arb, anticoagulant related drugs), basic medical history (hypertension, diabetes mellitus, coronary heart disease).

Eligibility criteria:
inclusion criteria: 1. atrial fibrillation was detected by electrocardiogram or 24-hour holter or portable electrocardiogram monitor; 2. age ≥18 years old; 3. "low-intermediate" risk group of af cardioembolic stroke: male patients with cha2ds2-vasc score 0-1 or female patients with cha2ds2-vasc score 1-2 exclusion criteria: 1. patients with rheumatic heart disease, congenital heart disease, cardiomyopathy, hematological diseases, severe hepatic and renal insufficiency and connective tissue diseases; 2. echocardiography showed valvular heart disease; 3. patients with transient atrial fibrillation secondary to reversible causes: hyperthyroidism, acute pulmonary embolism, recent surgery, acute myocardial infarction, etc. 4. severe carotid artery stenosis and intracranial artery stenosis; 5. af patients with recent major surgery. 6. patients with serious lack of clinical data.
this is a single ascending dose tolerance study

Conditions: Cognition Disorders

Summary: this is a single rising dose tolerance (part a) followed by a functional magnetic resonance imaging (part b)

the part a of this study is a parallel design followed in a second part by a cross-over design

Eligibility criteria:
inclusion criteria * bmi 18.0 to 28.0 kg/m2, * systolic blood pressure 90-140 mmhg, * diastolic blood pressure 50-90 mmhg, * heart rate 50 100 beats/min (all inclusive), * clinically normal safety ecg and laboratory results exclusion criteria * relevant disease, * treated with slv354 before

Keywords: healthy volunteers slv354 phase i srdt
effect of intravitreal bevacizumab on non -age-related macular degeneration (amd) related choroidal neovascularization (cnv)

Conditions: Choroidal Neovascularization

Summary: to evaluate the effect of bevacizumab for treatment of non-amd choroidal neovascularization (cnv); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc


Eligibility criteria:
inclusion criteria: * cases with subfoveal or juxtafoveal cnv due to a non-amd related cause. exclusion criteria: * evidence of amd

Keywords: choroidal neovascularization (cnv) bevacizumab non amd high myopia angioid streaks ocular histoplasmosis idiopathic
effect of selenium on serum adiponectin, homocystein and malnutrition-inflammation complex syndrome in hemodialysis patients

Conditions: Oxidative Stress; Inflammation; Malnutrition

Summary: the aim of this study is to determine the effect of selenium supplementation as an antioxidant on serum adiponectin, hscrp , ferritin , transferrin, albumin and homocysteine level.

after screening all of 280 patients under regular hd in faghihi hospital hemodialysis center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and give their informed consent to participate in this trial.the ethics committee of shiraz university of medical sciences reviewed and approved the protocol of this study.these patients are randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and followed for 12 weeks.before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient. the blood was taken from the patient's arm used for hemodialysis cannulae just before the beginning of the hd session. the serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°c. serum levels of adiponectin,high sensitive c-reactive protein (hscrp), ferritin, transferrin, homocysteine, calcium, phosphate, albumin, blood urea nitrogen (bun), and creatinine as well as hemoglobin (hb) levels (g/dl) were measured in all patients at the baseline and at the end of treatment phase of study.

Eligibility criteria:
inclusion criteria: * patients who were dialysed three times a week for at least 3 months or more exclusion criteria: * patients who took multivitamins or immunosuppressive medications * patients consuming antioxidant supplements including vitamin e, vitamin c, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations * patients who had active infection * patients who were hospitalized in the previous month. * being pregnant

Keywords: inflammation oxidative stress selenium hemodialysis