Kornimate/medical-research-clean huggingface dataset:
dermatological evaluation of topic compatibility - dermacyd breeze

Conditions: Healthy

Summary: the purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product dermacyd pocket br.


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv * integral skin test in the region exclusion criteria: * use of antiinflammatory and/or immunosuppression drugs * personnel history of atopy * history of sensitivity or irritation for topic products * active cutaneous disease * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hygiene
the effetcs of non-surgical periodontal treatment on salivary biomarkers of patients with osteoporosis and periodontitis

Conditions: Osteoporosis; Periodontitis

Summary: inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. the hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of il-1β, il-17, alp and 8-ohdg. therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of il-1β, il-17, 8-ohdg and alp in patients with periodontitis and osteoporosis.


Eligibility criteria:
inclusion criteria: * the participants were postmenopausal patients defined as absence of menstruation for at least 12 months. * patients with periodontitis; * patients who had no systemic diseases and were periodontally healthy (no attachment loss), * patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly) exclusion criteria: * if they had received any periodontal treatment in the preceding three months, * if they were pregnant or in the period of lactation, * if they had systemic diseases that may interfere with normal healing mechanism, * if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months. * smokers

Keywords: non-surgical periodontal treatment bisphosphonates interleukin-1β interleukin-17 8-hydroxydeoxyguanosine alkaline phosphatase
the effect of prior learning on treatment of morpheme errors

Conditions: Developmental Language Disorder

Summary: this is a small-scale treatment study designed to determine which teaching methods result in the best learning. treatment focuses on helping children with a developmental language disorder learn parts of grammar. preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. children will receive one-on-one behavioral treatment over a six week period. half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. the other half will start with a grammatical form they rarely use. the study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. the children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.


Eligibility criteria:
inclusion criteria: * native english speaking * passed a pure-tone hearing screening * 4-6 years of age * spelt-p2 (language) test score of \< 87 * k-abc-ii nonverbal scale (cognition) test score of \>75 * sufficient morpheme errors to serve as treatment and control targets * articulations skills sufficient to judge use of language targets * able to attend treatment daily exclusion criteria: * parent report of other handicapping conditions * clinical signs of other disorders * enrolled in outside treatment

Keywords: treatment
safety study of a contact lens with ketotifen in healthy, normal volunteers

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers


Eligibility criteria:
inclusion criteria: * healthy normal, soft contact lens wearing volunteers * normal ocular health * contact lens correction from +6.00 to -12.00d in each eye and astigmatism of -1.00d or less in each eye exclusion criteria: * active ocular infection * history of ocular surgery * use of topical ophthalmic preparations (including rewetting drops) * pregnancy or lactation
raltegravir and atazanavir replacing current suppressive treatment because of side effects in current treatment

Conditions: HIV Infections

Summary: subjects with hiv who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of raltegravir and atazanavir and be monitored for viral and immunological response and quality of life.

subjects with intolerance to current regimen will receive raltegravir 400 mg twice daily and atazanavir 400 mg daily will be monitored for viralogical and immunological outcomes, changes in lipids, renal and hepatic safety and quality of life.

Eligibility criteria:
inclusion criteria * history of no pi resistance or antiretroviral failure while receiving a pi. * on a current antiviral regimen with plasma hiv viral load (vl) \< 400 copies/ml for 4 months or longer. * intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia. * continuously using the same regimen for 3 months prior to screening. * women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see section 1.10). -women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential. * willing to adhere to the prohibitions and restrictions specified in this protocol. exclusion criteria: * use of any drug contraindicated in the current us package insert for atazanavir or in the investigators brochure for raltegravir, including ppi inhibitors. * use of any investigational drug up to 4 weeks prior to screening. * prior or current therapy with raltegravir. * allergy to raltegravir or atazanavir * history of medication non-compliance significant to the study regimen as deemed significant by the investigator. * known achlorhydria that would inhibit the absorption of atazanavir * concurrent active chronic hepatitis b requiring therapy with 3tc, ftc or tenofovir (entecavir permitted). * ast or alt \>5 times uln * calculated crcl \< 30 ml/min. * female subject who is pregnant or breastfeeding. * general medical condition that may interfere with the assessments and completion of the trial.

Keywords: drug substitution raltegravir atazanavir treatment experienced
castro-b - study on crp apheresis in stroke patients in berlin

Conditions: Stroke, Ischemic

Summary: this study explores the use of crp level reduction in patients after suffering from acute ischemic stroke. using selective crp-apheresis, the investigators aim to reduce the secondary inflammatory tissue damage in the course of infarction maturation using infarction growth in mri as the primary outcome as a surrogate.

c-reactive protein (crp) is an acute-phase protein binding to phosphocholine, thereby marking damaged tissue. this in turn activates the complement system and the cellular immune system engaging the unspecific immune system in an inflammatory tissue-degrading reaction. such a pattern is observed in ischemic stroke, and elevated crp levels can be measured in stroke survivors' sera. several observational studies reproduced higher crp levels with negative outcome in stroke. in another vascular model disease, myocardial infarction, selective crp apheresis reduced infarct size in humans. the investigators therefore designed this pilot study to explore the effects of selective crp reduction in ischemic stroke patients.

Eligibility criteria:
inclusion criteria: * age 18 - 85 years * informed consent signed by patient * patients with acute ischemic stroke in the arteria cerebri media (mca) territory within 36 hours of event * acute mri with evidence of infarction * nihss ≥ 4 * crp \> 5 mg/l exclusion criteria: * withdrawal of consent * systolic blood pressure \<100 mmhg before the apheresis * blood pressure relevant extra- and intracranial stenoses (nascet 70) * apheresis contraindication * participation in other interventional studies

Keywords: ischemic stroke crp apheresis
post-covid-19 monitoring in routine health insurance data

Conditions: Virus Diseases; Epidemiology

Summary: the sars-cov-2 infection was in 2020 responsible for new disease related chronic conditions which have been referred to as post-covid. to date it is still unknown how common this condition is and which symptoms are related to it. the aim of the study is to monitor the onset of these conditions in a large observational study consisting of german health insurance data.

sars-cov-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. the sars-cov-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as post-covid. to understand the prevalence and variety of post-covid a large observational study of health insurance data from germany was set up. the exposed patients were identified by a diagnosis indicating a confirmed laboratory test for covid. the basic question concerns the burden of the post-covid condition. the study investigate which symptoms are more common in humans after the exposure to the virus compared to a matched unexposed cohort. further will this be investigated in the subgroup of children and adolescents and those who have been hospitalized due to the virus infection.

Eligibility criteria:
inclusion criteria: * at least one outpatient or inpatient diagnosis of covid-19 with laboratory detection of the virus (icd-10: u07.1!) * continuously insured with the respective health insurance between 2019-01-01/birth and 2020-12-31/death exclusion criteria: -

Keywords: post-covid cohort study children
effect of genetic polymorphisms on response to preoperative nsaids in endodontic postoperative pain management

Conditions: Postoperative Pain

Summary: this study aims to evaluate the influence of genetic polymorphisms on the effectiveness of preoperative non-steroidal anti-inflammatory drugs (nsaids) in managing postoperative pain following endodontic treatment. participants will receive standard preoperative nsaids before undergoing root canal therapy, and their pain responses will be assessed. genetic analysis will be performed to investigate possible associations between drug response and individual gene variations. the study seeks to improve personalized approaches in endodontic pain management.


Eligibility criteria:
inclusion criteria: 1. patients aged between 18 and 65 years 2. vital mandibular molar teeth diagnosed with symptomatic apical periodontitis 3. asa physical status classification i or ii 4. preoperative vas pain score greater than 50 5. no known genetic disorders (e.g., down syndrome, congenital insensitivity to pain) exclusion criteria: 1. patients classified as asa iii or higher 2. pregnant women or those suspected of being pregnant 3. presence of root canal curvature greater than 25° (schilder classification) 4. patients with generalized periodontitis 5. presence of periodontal pockets deeper than 3 mm in the affected tooth 6. history of systemic disease or known allergies 7. patients with diagnosed psychiatric or psychological disorders 8. presence of swelling, sinus tract, or preoperative tenderness on palpation 9. patients with bruxism 10. presence of resorption in the affected tooth 11. use of analgesic or anti-inflammatory drugs within 12 hours prior to the procedure 12. teeth with root fractures, ankylosis, or pathological mobility

Keywords: endodontics genetic polymorphism nsaids preoperative analgesia pain sensitivity
reduced infant response to a routine care procedure after glucose 25% analgesia in comparison to materna rtf stage 1

Conditions: Infant, Newborn, Diseases

Summary: glucose has analgesic and calming effects in newborns. to date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. the investigators objective is to determine the effect of glucose 25% analgesia in comparison to materna rtf stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

during hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby. pain experienced during the neonatal period is known to have long term effects on the baby. the red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. the examination causes discomfort to the infant glucose has analgesic and calming effects in newborns. to date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. the investigators objective is to determine the effect of glucose 25% analgesia in comparison to materna rtf stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

Eligibility criteria:
inclusion criteria: * full term above 37 weeks gestation. * normal birth-weight, healthy infants * males and females * whose parents have signed the informed consent form exclusion criteria: * premature born below 37 weeks * chromosomal abnormalities or congenital malformation. * suffering neurological imbalance * inability of oral feeding

Keywords: glucose analgesic newborns
effects of home-based exercise rehabilitation on healthcare utilization in heartmate 3 patients

Conditions: Heart Failure; Left Ventricular Dysfunction

Summary: to demonstrate that home-based exercise rehabilitation (her) compared to usual care (uc) results in a significant reduction in healthcare utilization in heartmate 3 (hm3) left ventricular assist device (lvad) patients.(defined as rehospitalization, vad clinic visits, and er visits during the 1st year after index discharge following lvad implantation).

her subjects: get garmin activity watch (has its own smartphone app to be activated)\*, datos app get resistance bands and light weights exercise prescription: initially by physical therapist prior to discharge home \& updated every month. uc subjects: get garmin activity watch (has its own smartphone app to be activated), datos app exercise prescription: try to get to 30 min of exercise 5 days a week

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age on the date of randomization * patient implanted with a new heartmate 3 lvad at urmc * patients enrolling in the study at the time of index discharge home following new hm3 lvad implantation will be evaluated by a hf cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. patients enrolling in the study after their index discharge home following hm3 lvad implantation will be evaluated by a hf cardiologist or vad coordinator and will need to demonstrate ability to ambulate independently. * patient willing to participate in her. * patient owns a smartphone with internet connection. exclusion criteria: * major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated hf, uncontrolled arrhythmias, unstable angina). * patient with a life expectancy \<12 months. * patient unwilling to sign the consent for participation. * patient unwilling or unable to cooperate with the study protocol * patient who does not anticipate being a resident of the area for the scheduled duration of the research study * pregnancy
risk factors for barrett's esophagus in patients with be, gastroesophageal reflux, or gastrointestinal bleeding

Conditions: Precancerous Condition

Summary: rationale: a study that evaluates dna changes and other disease-related health information in patients with barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may help doctors learn more about the risk factors for barrett's esophagus. purpose: this clinical trial is looking at dna changes and other disease-related health information as risk factors for barrett's esophagus in patients with barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding.

objectives: * assess the role of several genetically determined factors that, in combination with caga status, cigarette smoking, alcohol, and diet to varying degrees, result in an increased risk for barrett's esophagus. outline: this is a controlled study. patients complete questionnaires about demographics, medical history, smoking and alcohol history, current medications, frequency and chronicity of gastroesophageal reflux symptoms, and diet history. blood and tissue are collected and analyzed by dna-based assays and enzyme-linked immunosorbent assay for caga status and polymorphisms in detoxifying enzyme systems, other xenobiotic metabolism pathways (e.g., cyp1a1, cyp2e1, cyp3a4, cyp3a5, nqo, nat-2), inflammatory gene pathways (e.g., igf, igfbf3), and in dna repair genes or p53 pathways (e.g., xrcc1, p53 gene). projected accrual: a total of 350 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * undergoing elective esophagogastroduodenoscopy for any of the following reasons: * surveillance of barrett's esophagus * evaluation of severe or refractory gastroesophageal reflux disease or chest pain thought to be due to reflux * gastrointestinal bleeding patient characteristics: * not pregnant prior concurrent therapy: * not specified

Keywords: barrett esophagus
rotator cuff pathway

Conditions: Shoulder Pain

Summary: rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids. the specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. this is a 'before and after' study. we plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. both groups will receive identical postoperative follow-up.

previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (goon et al. 2014). these surgeries were done as inpatient and patients had availability of intravenous opioids. assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, sd 2.1 (kahn) which is often categorized as "severe" pain. given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. with outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (rosenfeld et al. 2016, yadeau et al. 2016, kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. this study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.

Eligibility criteria:
inclusion criteria: * ambulatory rotator cuff patients with participating surgeons. includes the following concomitant procedures: * arthroscopic slap (superior labrum anterior and posterior) repair * arthroscopic stabilization * arthroscopic ac (acromioclavicular) resection * arthroscopic sad (sub-acromial decompression) * arthroscopic or mini open biceps tenodesis * age 18-80 exclusion criteria: * chronic pain history (defined as use of opioids \> 3 months or current gabapentinoids for pain) * open surgery (but sub pectoralis mini open biceps tenodesis is not excluded) * revision surgery * kidney disease (gfr \< 60 ml/min/1.73 m2 for 3 months or more) * liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy) * planned avoidance of regional anesthesia * any contraindication to or patient refusal of any component in the pathway * non-english speakers
sox versus xelox for patients with peritoneal metastasis of colorectal cancer

Conditions: Colorectal Neoplasm

Summary: the aim of this study is to compare the activity and safety of oxaliplatin and s-1 (sox) and oxaliplatin and capecitabine (xelox) in patients with peritoneal metastasis of colorectal cancer.

peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sct), or supportive care .oxaliplatin and oral fluoropyrimidines (capecitabine or s-1) are active agents for colorectal cancer. recent a phase ii trial of combination chemotherapy of oxaliplatin with s-1 (os) and several phase ii trial of combination chemotherapy of oxaliplatin with capecitabine (xelox) demonstrated good activity and mild toxicity in advanced colorectal cancer. oxaliplatin and s-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.

Eligibility criteria:
inclusion criteria: histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred peritoneal metastasis of colorectal cancer at least one uni-dimensional measurable lesion by recist criteria age 18 to 80 years old estimated life expectancy ≥3 months ecog performance status ≤2 adequate bone marrow function (wbcs ≥ 4,000/µl or absolute neutrophil count ≥ 1,500/µl, platelets ≥ 100,000/µl) adequate kidney function (creatinine \< 1.5 mg/dl) adequate liver function (bilirubin \< 2.0 mg/dl, transaminase levels \<2.5 times the upper normal limit) written informed consent exclusion criteria: other tumor type than adenocarcinoma previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin) presence of cns metastasis, psychosis, or seizure obvious bowel obstruction evidence of serious gastrointestinal bleeding past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri pregnant or lactating women, women of childbearing potential not employing adequate contraception other serious illness or medical conditions