Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tak-385 in the treatment of endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to determine the efficacy and safety of tak-385, once daily (qd), for 12 weeks in women with endometriosis.

this phase ii, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of tak-385 following oral administration for 12 weeks in women with endometriosis.

Eligibility criteria:
inclusion criteria: 1. premenopausal women 2. the participants must have dysmenorrhea and pelvic pain associated with endometriosis. 3. the participant has experienced a regular menstrual cycle. 4. the participant has been diagnosed with endometriosis by method a), b), or c). * laparotomy * laparoscopy * chocolate cyst of the ovary confirmed by mri exclusion criteria: 1. participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger 2. participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis 3. participants with a previous or current history of thyroid dysfunction 4. participants with current or previous history of pelvic inflammatory disease 5. participants with positive pap smear test result conducted 6. participants with a history of panhysterectomy or bilateral oophorectomy 7. participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding 8. participants with a previous or current history of a malignant tumor 9. participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (serm), activated vitamin d, other vitamin d, calcitonin, ipriflavone, steroid hormone, vitamin k, teriparatide,or denosumab 10. participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (gnrh) analogue, dienogest, danazol, or aromatase inhibitor 11. participants who have been treated with bisphosphonate preparation 12. participants with a previous or current history of hypersensitivity or allergy to leuplin, synthetic lh-rh, lh-rh derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs 13. participants with non-diagnosable abnormal genital bleeding 14. participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases 15. participants with clinically significant cardiovascular disease or uncontrollable hypertension 16. participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ecg) findings 17. participants with active liver disease or jaundice, or with alanine aminotransferase (alt), aspartate aminotransferase (ast), or total bilirubin \> 1.5 times the upper limit of normal (uln) in the clinical laboratory tests

Keywords: drug therapy
the effect of electrical stimulation on impairment of the painful post-stroke shoulder

Conditions: Stroke

Summary: examination of the effects of short-term use of tens and t-nmes on passive pain-free rom of the painful post-stroke shoulder. treatments are compared with no stimulation.

single cohort, cross-over study. subjects undergo passive pain-free rom of the painful post-stroke shoulder under 3 stimulation conditions. the stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of tens, 10 seconds of t-nmes, and 10 seconds of no stimulation. each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. this protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.

Eligibility criteria:
inclusion criteria: * at least 3 months post-stroke * worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale, * adequate cognitive ability to be able to rate their pain in the past week exclusion criteria: * history of tachyarrhythmia with decreased blood pressure * uncontrolled seizures (defined as more than one per month) * an implanted electrical device * uncompensated hemi-neglect

Keywords: electrical stimulation therapy tens t-nmes stroke
web-app based lifestyle physical activity promotion program (wpapp) for middle aged latinas

Conditions: Middle Aged; Women; Depressive Symptoms; Physical Activity; Hispanic or Latino

Summary: the purpose of the proposed project is to conduct a pilot randomized controlled trial (rct) of the web-app based lifestyle physical activity promotion program (wpapp) for middle-aged latinas. the wpapp is a web application (app) to promote lifestyle physical activity that was developed and tested with korean american middle aged women. it shows promise for effectiveness with latinas. the specific aims are: 1. to test the feasibility and satisfaction of the wpapp modified for latinas. 2. to examine preliminary effectiveness of the wpapp-latina on increasing physical activity and decreasing depressive symptoms.


Eligibility criteria:
inclusion criteria: women aged 40-60 who self-identify as latina or hispanic women, are able to read and write in english or spanish, live in the united states, and can use the app and complete online data collection using a smart phone, tablet, or computer. - exclusion criteria: pregnancy within 3 months of starting the study, having or being of high risk for cardiovascular or musculoskeletal illnesses or injuries -

Keywords: web-based app
thalidomide plus chemotherapy versus chemotherapy alone for advanced breast cancer

Conditions: Metastatic Breast Cancer

Summary: sixty advanced breast cancer patients are planed to enrolled in this clinical trial. forty patients are enrolled into thalidomide plus chemotherapy group. twenty patients are enrolled into chemotherapy alone group. there is no restriction on chemotherapy regimen and lines.

the study compares the combination of thalidomide and chemotherapy with chemotherapy alone for the treatment of stage iv breast cancer. efficacy and safety of the chemotherapy-thalidomide combination will be evaluated. assessing the isolated effects of thalidomide in a setting where pre and post treatment serum specimens can be obtained will provide essential information about the mechanisms by which vascular endothelial growth factor(vegf) inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of thalidomide on breast tumor.

Eligibility criteria:
1. inclusion criteria: * women \>/= 18 and \< 65 years of age . * histologically or cytologically confirmed breast cancer with evidence of metastatic disease. (note: the participant must be recovered from any clinically significant toxicity thereof last therapy.) * ecog performance status 0-2. * adequate bone marrow, kidney and liver function. * er/pr breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. 2. exclusion criteria: * prior treatment with thalidomide. * patients with her2 positive disease. * untreated and/or uncontrolled brain metastases. * prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, dcis or stage i grade 1 endometrial cancer allowed. * known hiv (human immunodeficiency virus) infection. * pregnant or breast-feeding women. * bilateral invasive breast cancer. * cardiac and thrombotic disease or risk for same as judged by investigator. * other serious illness or medical conditions such as (partial list- review with investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest.
oropharyngeal space in videolaryngoscopy

Conditions: Abrasion of Soft Palate; Intubation Complication

Summary: in this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of asa i-iii patients with a normal mouth opening. we compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic macintosh laryngoscope.

intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the macintosh laryngoscope. there are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. the space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.

Eligibility criteria:
inclusion criteria: * informed patient consent * asa i - iii * age \> 18 years * elective surgery, other than head and/or neck surgery * pre-operative mallampati i - iii * bmi \< 35 kg/m2 * fasted (≥6 hours) exclusion criteria: * no informed patient consent * asa ≥ iv * age \< 18 year * emergency surgery, surgery of head and/of neck * locoregional anaesthesia * pre-operative mallampati iv * bmi \> 35 kg/m2 * fasted \< 6 hours * pre-operative expected difficult airway (restrict neck movement, thyromental distance \< 65mm, retrognathia) * bad, fragile dentition * dental crowns and/or fixed partial denture

Keywords: videolaryngoscopy palatopharyngeal distance trauma
resminostat for maintenance treatment of patients with advanced stage mycosis fungoides (mf) or sézary syndrome (ss)

Conditions: Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Summary: the purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or sézary syndrome that have recently achieved disease control with previous systemic therapy.


Eligibility criteria:
main inclusion criteria: * patients with histologically confirmed mf (stage iib-ivb) or ss in an ongoing complete response (cr), partial response (pr) or stable disease (sd) after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy) \[the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation\] * eastern cooperative oncology group (ecog) status score 0-2 * adequate haematological, hepatic and renal function main exclusion criteria: * patients with progressive disease (pd) * baseline corrected qt (qtc) interval \> 500 milliseconds * concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (puva), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications

Keywords: cutaneous t-cell lymphoma (ctlc) maintenance resminostat 4sc hdac mycosis fungoides sézary syndrome
comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis

Conditions: Spinal Stenosis; Spinal Cord Compression

Summary: introduction: this observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. however, data on surgical outcomes are limited. open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. in recent years a growing tendency towards less invasive decompressive procedures has emerged. many spine surgeons today perform microdecompression for central lumbar spinal stenosis. prospectively registered treatment and outcome data are obtained from the norwegian registry for spine surgery (norspine).


Eligibility criteria:
inclusion criteria: * diagnosis of central lumbar spinal stenosis * operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between october 2006 and december 2011 * included in the norspine registry exclusion criteria: * history of lumbar fusion * previous surgery in the lumbar spine * discectomy as part of the decompression * associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.

Keywords: surgical procedures, operative lumbar vertebrae decompression, surgical microdecompression laminectomy registries
patient registry in patients undergoing contrast-enhanced harmonic endoscopic ultrasound imaging

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Summary: this study creates a patient registry of patients undergoing contrast-enhances-harmonic endoscopic ultrasound imaging. in order to improve what doctors see on the ultrasound exam, sometimes intravenous contrast can be used to better emphasize the blood flow in a particular organ or lesion. creating a local database that can be used as a patients registry may help doctors keep track of all patients that undergo contrast-enhanced endoscopic ultrasound procedures and also to monitor for possible procedure adverse events.

primary objective: i. to describe the findings and outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound (ce-eus) imaging. outline: this is an observational study. patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their medical records reviewed.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years to 99 years old who were undergo ce-eus are eligible for study inclusion * based on clinical judgement of the advanced endoscopist will include those who present with lesions where increased microvasculature and perfusion visualization with contrast-enhanced harmonic endoscopic ultrasound imaging would be of beneficial for lesion characterization * clinical medical stability to undergo sedation for endoscopy and provide informed consent exclusion criteria: * medical condition that preclude the patient from having an endoscopic procedure * patients who cannot provide adequate research authorization * patients with known allergies to ultrasound contrast agents * patient who did not receive contrast during endoscopic ultrasound (eus) exams
current practices of intensive care for the management of acute respiratory distress syndrome in europe.

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Summary: this study seeks to gain a comprehensive understanding of current ards management practices across european icus, with a particular focus on the use of ltv and pp therapy, which have been shown to improve outcomes in ards patients. the primary objectives focus on evaluating how ltv and pp are implemented across different institutions, while secondary objectives encompass a broader assessment of other ards treatment strategies. these include mechanical ventilation approaches, including peep titration, the use of nmbas, and advanced extra-corporal therapies like ecmo and extracorporeal carbon dioxide removal (ecco2r). additionally, the study will explore diagnostic methods and decision-making processes that guide ards management in diverse clinical settings.

this is a cross-sectional survey designed to collect data on the current practices of ards management in icus across europe. the survey will be administered electronically, allowing for the efficient collection of responses from a broad and diverse group of healthcare professionals.

Eligibility criteria:
inclusion criteria: • healthcare professionals (physicians and nurses) who are currently employed in an icu that treats ards patients and are actively involved in their management. exclusion criteria: • there are no specific exclusion criteria for this study, as the aim is to gather as broad a range of perspectives and practices as possible from icus treating ards patients.

Keywords: ards prone position ecmo ecco2r vvecmo vv-ecmo mechanical ventilation tidal volume
postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy

Conditions: Pancreatic Fistula After Pancreaticoduodenectomy; C-Reactive Protein; Albumin

Summary: pancreaticoduodenectomy (pd) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. postoperative pancreatic fistula (popf) is the most common and clinically significant complication following pd. in this study, the investigators aim to predict pancreatic fistula using the c-reactive protein-albumin ratio (car). the total number of participants expected to be included in this research comprises patients who underwent pd between 2017 and 2023 and developed pancreatic fistula. the participants invitation is based on the detection of a pancreatic fistula. this study is conducted for research purposes and participation is voluntary. no interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. if the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form.

pancreaticoduodenectomy (pd) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following pd are 41.56% and 2.88%, respectively, which remain unsatisfactory. postoperative pancreatic fistula (popf) is the most common and clinically significant complication following pd. therefore, accurate and timely prediction of popf after pd is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. the c-reactive protein-albumin ratio (car) is an inflammatory marker calculated by dividing serum crp levels by albumin levels and has been associated with poor prognosis in sepsis patients. this study aimed to investigate the predictive significance of car for popf.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 80 years * diagnosed with pancreatic cancer * patients without recurrence exclusion criteria: * patients who underwent total pancreatectomy * data were not available * patients outside the specified age range

Keywords: albumin pancreatic fistula c- reactive protein
long-term follow-up study of rgx-314 and fellow eye substudy

Conditions: Neovascular Age-related Macular Degeneration; Wet Macular Degeneration

Summary: this is a prospective, observational study designed to evaluate the long-term safety and efficacy of rgx-314. eligible participants are those who were previously enrolled in a clinical study in which they received a single subretinal administration of rgx-314 in their study eye. enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. participants will be followed for up to 5 years post-rgx-314 administration (inclusive of the parent study). after enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-rgx-314 administration follow-up period. additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal rgx-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of rgx-314 in their study eye. participants who qualify for the substudy will receive subretinal administration of rgx-314 in their fellow eye and complete 13 study visits in a 54-week period. following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post rgx-314 administration in their fellow eye.


Eligibility criteria:
main observational study: inclusion criteria: 1. able and willing to provide written consent 2. previously enrolled in a clinical study of rgx-314 and received a single subretinal administration of rgx-314 exclusions criteria: 1. none fellow eye substudy: inclusion criteria 1. age ≤ 93 years 2. currently or previously enrolled in the main observational study 3. diagnosis of bilateral choroidal neovascularization secondary to age-related macular degeneration 4. active namd in the fellow eye 5. bcva between ≤ 80 and ≥ 20 letters in the fellow eye exclusion criteria: 1. cnv or macular edema in the fellow eye secondary to causes other than namd 2. subfoveal fibrosis or atrophy in the fellow eye 3. advanced glaucoma or history of secondary glaucoma in the fellow eye or any invasive procedure to treat glaucoma 4. myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months 5. history of intraocular surgery in the fellow eye within 12 weeks of screening 6. history of intravitreal therapy, such as intravitreal steroid injection or investigational product, other than an intravitreal therapy for namd, in the fellow eye within 6 months of screening

Keywords: gene therapy wet amd namd
pathogenic mechanisms of port wine stain and repository of port wine stain biopsy samples

Conditions: Port-Wine Stain

Summary: the purpose of this study is to investigate the pathogenic mechanisms of port wine stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from port wine stain.

the researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of port wine stain . unveiling the pathogenic mechanisms of pws is crucial to the design of new therapeutic strategies and can use the results to improve current pws therapeutic outcomes.

Eligibility criteria:
inclusion criteria: * male or female of all ages. * not pregnant. * has diagnosis of port wine stain on the arms, legs, chest, bac. * ability to understand and carry out subject instructions. * subject willing to have skin biopsies on port wine stain and normal skin areas. exclusion criteria: * pregnant women. * port wine stain on the face. * history of skin cancer. * current participation in an investigational drug evaluation * concurrent use of known photosensitizing drugs.