Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of test product versus cysteamine 5% in treatment of facial epidermal melasma

Conditions: Melasma

Summary: this interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. the objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus cysteamine 5% in the acute management of melasma over 4 months. statistics: sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the test product versus cysteamine 5% on the modified melasma area and severity index (mmasi) change from baseline at month 4. to allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at month 4, 140 subjects in total (70 per group) are enrolled. statistical analysis: continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. for categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).

Eligibility criteria:
inclusion criteria: * facial epidermal melasma (exclude mixed and dermal melasma) * subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face exclusion criteria: * subjects with any other signs of significant irritation or skin disease * subjects using oral contraceptive pills or hormonal implants as birth control measures during the study * subjects who had a skin lightening procedure in the past 8 weeks

Keywords: facial epidermal melasma masi cysteamine 5%
multimodal spectroscopy to detect urothelial cancer in urine

Conditions: Urothelial Carcinoma; Urinary Bladder Cancer; Urinary Tract Cancer

Summary: to facilitate the follow-up of urothelial tumors and also make them more tolerable and less invasive for patients, there is a minimally invasive and easy to perform examination which is urinary cytology on 3 samples. this test is extremely specific, over 90% chance of cancer if it is positive and is performed by expert cytopathologists, but it is burdened by a very low sensitivity, which is especially acute in the case of low grade tumors. this makes it an extremely useful test in case of positivity, but of little use if negative or doubtful, not being able to consider it reliable. to overcome this problem, our study aims to bring an approach based on a physical principle, that is spectroscopy, which is fast non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in samples of urine. in our experience, multimodal optical fiber spectroscopy has proved extremely valid in discriminating healthy urothelial tissue from tumor ex vivo, as well as providing important information on the degree of urothelial neoplasia, with accuracy rates higher than 80%, for which developed the idea of a technique based on multimodal spectroscopy. if our method proves valid, it could improve the follow up and management of patients with urothelial cancer, being able to support normal cytology and provide further support to the cytopathologist, as well as simplify the diagnosis.


Eligibility criteria:
cases inclusion criteria patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the group of cases: * bladder cancer * urethral tumor * renal pelvis tumor * ureteral tumor the exclusion criteria will be: * age under 18 * pregnancy * lack of informed consent * persons with indwelling catheter * presence of prostate cancer * presence and / or history of renal cancer, except tumors of the renal pelvis checks inclusion criteria patients over the age of 18 who are known for urological interventions for the following pathologies will be considered for enrollment in the control group: * kidney, ureteral or bladder stones * bph the exclusion criteria will be: * age under 18 * pregnancy * lack of informed consent * indwelling catheter wearers * presence of prostate cancer * presence of kidney cancer, including kidney pelvic tumors * presence and / or history of ureteral cancer * presence and / or history of bladder cancer * presence and / or history of urethral cancer

Keywords: urinary tract cancer urine spectroscopy laser urine cytology
standard vs high dose of unfractionated heparin in the incidence of radial artery occlusion (definition) trial.

Conditions: Radial Artery Occlusion

Summary: double blind single center clinical trial to compare the incidence of radial artery occlusion (rao) using standard doses of unfractionated heparin (ufh) vs. high doses of ufh.

radial artery occlusion (rao) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure. currently worldwide, the transradial (tra) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access). although tra access is safer, it is not free of complications, being one of the most important the rao. there are universal efforts to reduce rao improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal tra, with evidence suggesting that higher doses of ufh can also decrease rao to a greater extent. the decrease in the incidence of rao have been proposed to be up to 2.8 times with high doses of ufh (single-center, retrospective study that compared regular not standard doses of ufh versus higher doses of ufh) although no proper prospective clinical trial have been undertaken to prove this. the standard dose that has shown a lower rate of rao is 5000 iu, which will be compared with 100 iu / kg of ufh, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with doppler ultrasound (dus) and its correlation with plethysmography to document rao, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by dus (and plethysmography). in order to address safety concerns of higher ufh doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age, both genders. * successful transradial acess for an elective diagnostic coronary angiography. exclusion criteria: * weight \<50 kg * puncture of the ipsilateral radial artery in the last month. * still ongoing effect of pre-procedural recently used oral anticoagulants. * use of enoxaparin in the past in the last 12 hours prior to the procedure. * use of unfractionated heparin in the last 6 hours prior the procedure * alterations in coagulation or platelets prone to bleeding or thrombotic complications. * anatomical alterations at the radial access site or radial artery. * arteriovenous fistula in the ipsilateral arm. * history of major bleeding associated with the use of ufh.

Keywords: radial artery occlusion percutaneous coronary intervention transradial access unfractionated heparin coronary angiography
a multi-center group to study acute liver failure in children

Conditions: Acute Liver Failure; Hepatic Encephalopathy

Summary: the palf study group began with 20 sites and now continues with 12 sites (11 in the united states and 1 in canada) in the new funding period. the primary objective of the pediatric acute liver failure (palf) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with alf, including information derived from biospecimens.

the palf study group will collect clinical, epidemiological and outcome data on children with alf. this information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. we believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. in addition, we hope to identify unrecognized mechanisms of liver injury resulting in alf in children. eligible study participants will be invited to participate in neurocognitive testing. since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.

Eligibility criteria:
inclusion criteria: * written informed consent/assent * birth through 17 years of age * biochemical evidence of acute liver injury * coagulopathy not corrected by vitamin k (or other intervention intended to correct coagulopathy) * the presence of encephalopathy (enc) is required if the inr is at least 1.5 and less than 2.0 * if inr is at least 2.0, the presence of enc is not required exclusion criteria: * known chronic underlying liver disease * multi-organ system failure following heart surgery or ecmo * solid organ or bone marrow transplantation * acute trauma * previously enrolled in the palf cohort study * other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study

Keywords: acute liver failure hepatic encephalopathy acetaminophen toxicity
pneumoperitoneum management with surgiquest airseal at low vs. higher pressure ( pressure )

Conditions: Shoulder Pain

Summary: this study is designed to evaluate physician preference related to the use of the surgiquest airseal® insufflation system (ais) at low verses high pressure for the management of pneumoperitoneum.

the objective of this study is to evaluate physician preferences related to use of the surgiquest airseal insufflation system (ais) used at low vs. higher pressures for maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures. the study is designed and powered to demonstrate superiority of the ais used at low insufflation pressure (9±mmhg ±1mmhg) vs higher pressure (15mmhg ±1mmhg) in relation to a single key effectiveness measure: incidence of shoulder pain. patients will be randomized 1:1 to either ais with an insufflation pressure target of 9±1mmhg) or to ais with an insufflation target pressure of 15±1mmhg. secondary outcome measures include severity of shoulder pain measured using a vas scale and medication use, procedure time, the number of procedure interruptions, length of hospital stay, aspects of anesthesia management including end tidal co2 and the frequency of adverse events. these outcomes will be evaluated in a controlled population undergoing laparoscopic/robotic surgery.

Eligibility criteria:
inclusion criteria: 1. 18 to 80 years of age; 2. capable and willing to give informed consent; 3. acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery; exclusion criteria: 1. advanced refusal of blood transfusion, if necessary; 2. active systemic or cutaneous infection or inflammation; 3. pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4. uncontrolled diabetes mellitus 5. known, significant history of bleeding diathesis, coagulopathy, von willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline inr ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6. severe co-existing morbidities having a life expectancy of less than 30 days; 7. currently involved in any other investigational clinical studies; 8. significant anemia with a hemoglobin level less than 10 g/dl or a hematocrit less than 30%; 9. renal insufficiency (serum creatinine of \> 2.5 mg/dl); 10. females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 11. extreme morbid obesity (bmi greater than 45 kg/m2) or underweight (bmi less than 20 kg/m2); 12. patients presenting with ascites -
amifostine in treating patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: rationale: amifostine may improve blood counts in patients with myelodysplastic syndrome. purpose: phase ii trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.

objectives: i. define the activity of amifostine in improving blood counts in patients with myelodysplastic syndrome. outline: this is an open label, nonrandomized, single center, dose escalation study. patients receive amifostine iv for two weeks, followed by 2 weeks of rest. each treatment cycle is 4 weeks. responses are evaluated after each cycle (for a minimum of 2 induction cycles). patients with a grade 0 toxicity in the first course receive a 25% increase in dose during the second course. patients with grade 1 or 2 toxicity receive no dose change. patients with grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. all patients demonstrating response are eligible for maintenance therapy. treatment is continued for up to 12 months or a total of 13 cycles. projected accrual: a total of 14-30 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven myelodysplastic syndrome less than 30% blasts in bone marrow patient characteristics: age: 18 and over performance status: zubrod 0-2 karnofsky 60-100% ecog 0-2 hematopoietic: not specified hepatic: bilirubin no greater than 2 mg/dl renal: creatinine no greater than 2 mg/dl cardiovascular: no new york heart association class iv disease no antihypertensive medication within 24 hours of amifostine administration other: not pregnant or nursing effective contraceptive method must be used during study no medical illness no psychosis eligible patients with an hla compatible donor are referred to bone marrow transplantation prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy within 4 weeks of study and recovered endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes amifostine ethyol ethiofos gammaphos
perioperative ischemic evaluation-3 trial: a pilot study

Conditions: Atherosclerotic Disease; Perioperative Bleeding

Summary: a placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (txa) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

the poise-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. utilizing a partial factorial design, the poise-3 pilot will determine the effect of rosuvastatin versus placebo and txa versus placebo in the perioperative setting.

Eligibility criteria:
inclusion criteria: 1. undergoing noncardiac surgery 2. \>45 years of age 3. expected to require at least an overnight hospital admission after surgery; and 4. have a preoperative nt-pro-bnp measurement \>100 ng/ml; or 5. if a preoperative nt-pro-bnp measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria: * history of coronary artery disease * history of peripheral vascular disease * history of stroke * undergoing major vascular surgery * have any 3 of the following 9 risk criteria: * undergoing major surgery * history of congestive heart failure * history of a transient ischemic attack * diabetic and currently taking an oral hypoglycemic agent or insulin * age \>70 years * hypertension * serum creatinine \> 175 umol/l (\>2.0 mg/dl) * history of smoking within 2 years of surgery * undergoing emergent/urgent surgery exclusion criteria: 1. planned use of systemic tranexamic acid during surgery 2. hypersensitivity or known allergy to txa 3. creatinine clearance \<30 ml/min (mdrd) 4. history of seizure disorder 5. history of venous thromboembolism 6. acute arterial thrombosis 7. no preoperative measurement of hemoglobin 8. subarachnoid hemorrhage within the past 30 days 9. hematuria caused by diseases of the renal parenchyma 10. previously enrolled in poise-3 pilot trial 11. not consenting to participate in poise-3 pilot trial prior to surgery patients meeting any of the following criteria will be excluded from the rosuvastatin/placebo arm: 1. preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery 2. hypersensitivity or known allergy to rosuvastatin 3. pre-disposed factors for myopathy or rhabdomyolysis
association of transcutaneous pulse co-oximetry with inflammatory lung diseases

Conditions: Asthma; Allergic Rhinitis; Cystic Fibrosis; Pneumonia

Summary: this is a pilot cross-sectional study of measured transcutaneous co-oximetry in children with inflammatory and non-inflammatory conditions.

children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited. subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. transcutaneous carboxyhemoglobin will be recorded. this study is cross-sectional and will only require one visit coinciding with the clinical visit. analysis will determine the pairwise differences in spco between conditions tested.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group) * ability to complete study procedures exclusion criteria: * cardiopulmonary disease outside of the specific conditions for inclusion * prematurity * congenital heart disease * current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection * recent serious bacterial infection (except for pneumonia in the pneumonia group) * concurrent clinical chest x-ray with findings other those that expected for the group (i.e. normal chest x-ray in pneumonia group or suspected pneumonia on chest x-ray in asthma group). to be determined by attending radiologist's interpretation.

Keywords: asthma allergic rhinitis rhinitis pneumonia cystic fibrosis
prevention of congenital toxoplasmosis with pyrimethamine + sulfadiazine versus spiramycine during pregnancy

Conditions: Congenital Toxoplasmosis

Summary: background : when a mother contracts toxoplasmosis during pregnancy, the parasite may be transmitted from to her unborn child. this results in congenital toxoplasmosis, which may cause damage to the eyes and nervous system of the child. to date, no method has been proved effective to prevent this transmission. in france, spiramycin is usually prescribed to women who have toxoplasma seroconversion in pregnancy, however its efficacy has not been determined. the standard treatment for toxoplasmosis is the combination of the antiparasitic drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the prevention of mother-to-child transmission. purpose : randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more effective than spiramycin to prevent congenital toxoplasmosis.

the protocol is a comparison of 2 strategies to prevent mother-to-child transmission of t. gondii following maternal seroconversion. screening for toxoplasmosis is mandatory in france. patients with confirmed seroconversion will be eligible for the trial, after 14 weeks gestational age. participants will be randomly allocated to one of the treatment groups, and will receive open-label pyrimethamine + sulfadiazine or spiramycin. the protocol will not change the usual procedures for prenatal diagnosis, nor will it change the management of infected fetuses and neonates.

Eligibility criteria:
inclusion criteria: * \> 18 years old * toxoplasmosis infection acquired during the pregnancy documented by at least one negative serology in the first trimester and seroconversion with presence of specific igg antibodies * gestational age \> 14 weeks from last menstrual period * signature of informed consent exclusion criteria: * lack of a documented negative serology during the pregnancy * antiparasitic therapy with spiramycin, pyrimethamine or sulfa drugs for more than 10 days after seroconversion and before randomization, * known allergy to any of the study drugs, serious allergic conditions or g6pd deficiency, * known hepatic or renal insufficiency, * other ongoing severe conditions in mother or fetus * lack of public health insurance

Keywords: congenital toxoplasmosis, pregnancy, prenatal diagnosis, mother-to-child transmission, prevention, spiramycine, pyrimethamine-sulfadiazine
anesthesia and cancer study: renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. the participants will be allocated to either the group receiving the total intravenous anesthesia (tiva) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.

the effect of anesthesia on cancer recurrence and survival is controversial. according to some retrospective studies and preclinical studies, tiva is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. however, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for elective nephrectomy due to renal cell carcinoma exclusion criteria: * emergency surgery * pregnancy * allergies to anesthetics * palliative surgery * refusal to participate in the study * history of diagnosis or surgery for other cancer

Keywords: anesthesia propofol inhaled anesthetics renal cell carcinoma nephrectomy
animation-based storytelling education in relation to moral development in 8-12 year olds with dementia-affected caregivers

Conditions: Dementia

Summary: this retrospective, single-blind, parallel group study investigates the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.

with the measure of moral reasoning and empathy-related traits to investigate the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.

Eligibility criteria:
inclusion criteria: * full time students in public education. live with family members who have dementia. can keep attention for a 15-min animation exclusion criteria: * any major neurological illness

Keywords: young people caregivers