Kornimate/medical-research-clean huggingface dataset:
retrospective study of the safety and efficacy of plla for skin flaccidity in labia majora and/or pubis region

Conditions: Skin Laxity

Summary: phase iv, retrospective, single-center, clinical trial, chart review to evaluate the safety and efficacy of poly-l-l-lactic acid \[plla-sca, sculptra®\] in women who underwent at least one treatment for skin flaccidity of the labia majora and/or pubis region for safety evaluation and three treatment sessions for efficacy evaluation.

this is a phase iv, retrospective, single-center, clinical trial of medical record data collection to evaluate the safety and effectiveness in subjects who have undergone at least one application of poly-l-l-lactic acid (sculptra®) for skin flaccidity treatment in the labia majora and/or pubis region. all medical charts of subjects treated for this condition at the clinic treated from jan1st 2022 and on will be screened for inclusion. the reason for not including a subject will be documented. during the study, the medical records of subjects who presented skin flaccidity of the labia majora and/or pubis region will be evaluated to anamnesis and physical examination and information will be obtained on demographic data, clinical history, previous treatment(s) in the study region, number of treatment sessions with sculptra®, as well as data on product dilution, technique used, doses injected, and adverse events related to sculptra® and/or the injection procedure. clinical evaluations will also be performed through the information and photographic records obtained through the evaluation of the medical records of these subjects.

Eligibility criteria:
inclusion criteria: 1. subjects able to read, or follow reading, understand, and sign the informed consent form and the authorization form for imaging usage approved by the rec/conep system; 2. subjects aged 18 years or older; 3. having received at least 1 (one) session of sculptra® for labia majora and/or mons pubis skin flaccidity. 4. available clinical information and treatment data in the medical records. 5. having medical records that present suitable photographic records prior and after the sculptra® injections that allow a skin condition assessment of labia majora and/or mons pubis. exclusion criteria: 1. having any clinical condition or laboratory disorder, recorded at the medical record, which may compromise trial participation according to the investigator assessment. 2. having any procedure performed on the labia majora and/or mons pubis skin within12 months prior to the first administration of plla (sculptra®). 3. participation in another clinical trial in the 30 days previous the study start.
open-label poc trial of ganaxolone in children with pcdh19 female pediatric epilepsy and other rare genetic epilepsies

Conditions: Epilepsy

Summary: to evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with pcdh19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.

the purpose of this proof-of-concept study is to evaluate ganaxolone as adjunctive therapy for uncontrolled seizures in female children with pcdh19 mutations and other rare genetic epilepsies. after establishing baseline seizure frequency, qualifying subjects will enter the study and be treated with open-label ganaxolone for up to six months.

Eligibility criteria:
key inclusion criteria: 1. have parent or legal guardian available and willing to give written informed consent. 2. male and female outpatients between 2 and 18 years of age years of age at time of consent. 3. have any of the following epilepsy syndromes: pcdh19; cdkl5; dravet syndrome; lennox gastaut syndrome (lgs); continuous spikes and waves during sleep (csws) 4. have uncontrolled cluster seizures and/or non-clustered seizures. 5. subjects should be on a stable regimen of anti-epileptic medication, and generally in good health. 6. parent or guardian is able and willing to maintain an accurate and complete daily written seizure calendar. 7. able and willing to take study medication with food, two or three times daily. key exclusion criteria 1. have had previous exposure to ganaxolone. 2. known sensitivity or allergy to any component in the study drug, progesterone, or other related steroid compounds. 3. exposure to any investigational drug or device \< 90 days prior to screening, or plans to participate in another drug or device trial at any time during the study. 4. concurrent use of vigabatrin, tiagabine, or ezogabine is not permitted. 5. have any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to: clinically significant cardiac, renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism or excretion of drugs. 6. have active suicidal plan/intent, or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years. 7. have alanine transferase (alt; sgpt) or aspartate transferase (ast; sgot) levels \> 3 times upper limits of normal (uln), or total bilirubin \>1.5 time uln at the screening and baseline visits.

Keywords: pcdh19 ganaxolone neurosteroid cdkl5 lgs csws
fluid responsiveness and venous congestion evolution during volume expansion

Conditions: Hemodynamic; Fluid Responsiveness; Venous Congestion; Fluid Challenge

Summary: fluid responsiveness is a critical determinant guiding fluid therapy in critically ill patients. however, excessive fluid administration can result in fluid overload, leading to venous congestion and worse clinical outcomes. venous congestion, a marker of impaired fluid clearance, is increasingly recognized as a significant contributor to poor prognosis. previous studies have demonstrated the coexistence of fluid responsiveness and venous congestion in critically ill patients. notably, these studies were limited by the absence of fluid challenge-the gold standard for assessing fluid responsiveness-leaving the dynamic relationship between fluid responsiveness and venous congestion incompletely understood. this study aims to investigate the interplay and temporal evolution of fluid responsiveness and venous congestion following a standardized fluid challenge in critically ill patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalized in the intensive care unit (icu) * hemodynamic monitoring in place, with a pulse wave contour analysis- derived estimation of cardiac output (either calibrated or uncalibrated) * decision made by clinicians to perform volume expansion through intravenous infusion of crystalloid fluid exclusion criteria: * pregnancy * refusal to participate by relatives of the patient or the patient himself
effect of exercise on gdf-15 levels in prediabetic patients

Conditions: PreDiabetes

Summary: the aim of this study is to evaluate whether there is a change in gdf-15 levels in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program with guide-based exercise programs.

gdf-15, which has anorexigenic effects, increases with exercise. in prediabetic patients, gdf-15 is higher than healthy controls. the effect of exercise on gdf-15 levels in prediabetic patients is unknown. the aim of this study is to evaluate whether there is a change in gdf-15 levels after the application of guideline-based exercise programs in individuals with prediabetes at the 2nd hour after the first exercise and after a 12-week exercise program.

Eligibility criteria:
inclusion criteria: * body mass index 30-34.9 kg / m2 * sedentary life-style (physical activity below 300 kcal / day will be assessed by minnesota leisure physical activity questionnaire) * those who have sufficient motivation to participate in the exercise program (will be evaluated by face-to-face interview by the researchers) * having the same weight for 6 months before participating in the study (± 2.5 kg) * those diagnosed with prediabetes by oral glucose tolerance test and / or hba1c measurement will be included. exclusion criteria: * serious medical condition (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) * having cardiovascular disease * having diabetes * using metformin * taking hormone replacement therapy * less than 1 year life expectancy * hiv positivity * substance use * functional dependence * cognitive weakness * those with other diseases that will affect the study result (respiratory diseases, muscle diseases, etc.) * those who use drugs or supplements that will affect the results of the study

Keywords: gdf-15 physical exercise prediabetes
safety and efficacy of corneal cross-linking in subjects with keratoconus

Conditions: Progressive Keratoconus

Summary: clinical trial to evaluate the safety and efficacy of corneal cross-linking in subjects with keratoconus.

this is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. the study will evaluate safety and efficacy in subjects who have keratoconus.

Eligibility criteria:
inclusion criteria: * provide written informed consent * ability to hold gaze sufficiently stable for study testing * willingness and ability to follow all instructions and comply with schedule for follow-up visits * have a diagnosis of keratoconus exclusion criteria: * known allergy or sensitivity to the test articles or components * any disease causing abnormal topography other than keratoconus * prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications

Keywords: eye rubbing collagen cross-linking keratoconus progressive keratoconus
incobotulinumtoxina (xeomin) for upper limb spasticity

Conditions: Upper Limb Spasticity

Summary: this study will investigate the efficacy and safety of incobotulinumtoxina (xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxina (xeomin).

incobotulinumtoxina (xeomin) is a botulinum toxin type a preparation free of complexing proteins. injected into a muscle, incobotulinumtoxina causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. incobotulinumtoxina is widely used for various severe neurological conditions. there is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxina is diluted before injection.

Eligibility criteria:
main inclusion criteria: * female or male patients ≥ 18 years * stable upper limb spasticity of diverse etiology * focal spasticity with equal or more than 2 points on the ashworth scale in the wrist flexors * disability assessment scale (das) ≥ 2 points for primary therapeutic target at both screening and baseline visits main exclusion criteria: * fixed contracture * bilateral upper limb paresis/paralysis * previous treatment with bont of any serotype and for any body region within the 4 months prior to screening * previous or planned treatment with phenol- or alcohol-injection in the target limb * other muscle hypertonia (e.g. rigidity) * diagnosis of myasthenia gravis, lambert-eaton-syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study * severe atrophy of the target limb muscles
radiation exposure reduction protocol for minimally invasive lumbar decompression (mild) techniques

Conditions: Lumbar Spinal Stenosis; Radiation Exposure

Summary: to evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (mild) procedure. additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure.


Eligibility criteria:
inclusion criteria: * age \> 65 years old * patient has meets eligibility criteria for (mild) * patient has signed study-specific informed consent form * patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements * patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care. exclusion criteria: * patient does not meet criteria for mild * patient is unable to receive radiation exposure. * current local or systemic infection that raises the risk of surgery * patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation. * currently pregnant * known or suspected drug or alcohol abuse * diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation * patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation * implanted intrathecal pain pump or spinal cord stimulator system in place * patient who has received other means pain management with minimally invasive implantable devices (spacer, sacroiliac joint (sij) fusion, etc). * patient with physical inability to ambulate independently, otherwise. * patient underlying neurologic pathology preventing safe independent ambulation.

Keywords: fluoroscopy radiation exposure reduction minimally invasive lumbar decompression
a phase 3 study to evaluate the long-term safety of thermoprofen™ in patients with mild to moderate pain associated with osteoarthritis of the knee.

Conditions: Osteoarthritis

Summary: thermoprofen is a transdermal ketoprofen patch that is integrated with a long-lasting chadd (controlled heat-assisted drug delivery) unit for the treatment of chronic pain associated with osteoarthritis. this study will evaluate the safety of long-term administration of thermoprofen™ for the pain associated with osteoarthritis of the knee in adults. the study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of thermoprofen.

the objective of the study is to evaluate the safety of long-term administration of thermoprofen for the pain associated with osteoarthritis of the knee in adults.

Eligibility criteria:
inclusion criteria: * patient completed a previous efficacy study of thermoprofen. exclusion criteria: * patient has a known allergy to nonsteroidal anti-inflammatory drugs (nsaids) (including aspirin). * patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in thermoprofen (such as that found in adhesive bandages, e.g. band-aid®). * patient has asthma that has been induced or made worse by the use of aspirin or any other nsaid. * patient has a relevant history of serious gastrointestinal disease. * patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations. * patient has neurological or psychiatric disease sufficient to compromise data collection or integrity. * patient is taking warfarin, heparin, or low molecular weight heparin. * patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.

Keywords: osteoarthritis pain
laser based focal ablation of low grade prostate cancer

Conditions: Low Grade Prostate Cancer

Summary: the purpose of this study is to evaluate the safety of mri-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.


Eligibility criteria:
inclusion criteria: * male, 45 years of age or older * diagnosis of prostate adenocarcinoma * clinical stage t1c or t2a * gleason score of 7 or less * a minimum of 12 biopsy cores sampled during diagnostic biopsy * three or fewer biopsy cores with prostate cancer * no single biopsy core with greater than 50% of tumor involvement * a radiographically visible prostate lesion on mri with concordance to biopsy sextant * a documented karnofsky performance status of at least 70 * estimated survival of 20 years or greater, as determined by treating physician * ability to give informed consent exclusion criteria: * previous surgery, radiation, or androgen deprivation therapy for prostate cancer * presence of any condition (e.g., metal implant, shrapnel) not compatible with mri * history of previous pelvic radiation * severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater. (see appendix a) * history of other primary non-skin malignancy within previous three years

Keywords: prostate cancer ablation laser-induced focal therapy
the value of concurrent chemoradiotherapy for stage ii nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (imrt) for stage ii nasopharyngeal carcinoma.

clinical stage ii nasopharyngeal carcinoma consisted of t2n0m0, t1n1m0, t2n1m0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the n1 groups suffered more distant metastasis than n0 group, and some literature showed that combined chemotherapy with radiotherapy in stage ii patients can improve the treatment results. intensity-modulated radiotherapy (imrt)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that imrt can improve the quality of life in nasopharyngeal through salivary gland preservation. compared imrt alone with imrt plus cisplatin concurrent chemotherapy in the treatment of stageii nasopharyngeal carcinoma, we hope to confirm whether stage ii (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * pathological confirmed squamous cell carcinoma, who ii-iii type, * clinical stage ii (uicc 7th edition, 2009) * karnovsky performance score \> 70 * first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer. * anticipated life span more than 6 month * hemoglobin \> 120g/l, wbc \> 4.0x10\*9/l, plt \> 100x10\*9/l * liver and renal function under the 1.25 normal upper limit * with written consent information exclusion criteria: * have other cancer history * have chemotherapy history * have radiotherapy history * have head and neck surgery history(exclusion lymph node biopsy) * evidence showed distant metastasis or other cancer * other severe medical comorbidity

Keywords: nasopharyngeal carcinoma stage ii intensity-modulated radiotherapy concurrent chemoradiotherapy cisplatin
multi-modality mri study on effect to collateral circulation and blood perfusion of acute cerebral infarction by human urinary kallidinogenase

Conditions: Cerebral Infarction

Summary: human urinary kallidinogenase can promote the establishment of collateral circulation in the ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then increase the perfusion.

patients with acute ischemic stroke will be given human urinary kallidinogenase .then we will estimate the cerebral collateral circulation in ischemic regions and final infarct volume, comparing with traditional therapy such as shuxuening injection, which will provide new evidence for the treatment of ischemic stroke. perfusion weighted imaging(pwi) could be a method to reflect the infarction center and low perfusion of tissue.

Eligibility criteria:
inclusion criteria: * age:greater than or equal to 18 years old and less than or equal to 70 years old; * time of onset is less than 7 days; * acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery diagnosed by ct or mri; * the national institute of health stroke scale(nihss) score is 4 to 20; * excluding intracranial hemorrhage using ct or mri. exclusion criteria: * the nihss score is less than or equal to 3; * patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and laceration of brain and other diseases; * intracranial hemorrhage displaying by ct or mri; cardiac insufficiency; * cardiac insufficiency; * chronic liver disease(a/g inversion),elevated alanine aminotransferase(alt)(more than 1.5 times the normal value); * increased serum creatinine(more than 1.5 times the normal value); * poorly controlled diabetes; * recently suffered from hemorrhagic disease or bleeding tendency; * recent use of angiotensin-converting enzyme inhibitor (acei) drugs; * allergic constitution and had a variety of drug allergy history; * women in period of pregnancy or lactation.
comparison of colloid (20% albumin) versus crystalloid (plasmalyte) for fluid resuscitation in cirrhotics with sepsis induced hypotension.

Conditions: Cirrhosis With Sepsis

Summary: consecutive cirrhotics who present to emergency department of institute of liver \& biliary sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. at admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. the aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of hg at 6th hour. the randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. after the intervention changes in map (mean arterial pressure), lactate level, urine output, incidence of complications, duration of ventilator, icu (intensive care unit) stay and mortality after one week will be studied.


Eligibility criteria:
inclusion criteria: * patients of cirrhosis with suspected or documented sepsis with map \< 65 mm hg exclusion criteria: * age \ 75 yrs * already received colloid or 2 litres of fluid within the first 12 hours of presentation * already on vasopressors and/or inotropes * patients with spontaneous bacterial peritonitis and serum albumin less then 1.5g/dl * patient with structural heart disease * on maintenance hemodialysis * other causes of hypotension * pregnant or lactating women * patients in need for emergent surgical interventions * known chronic obstructive lung disease and congestive heart failure * a previous adverse reaction to human albumin solution