Kornimate/medical-research-clean huggingface dataset:
safety, pk, pd, and clinical activity of orally administered kt-621 in adult patients with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: this is a study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered kt-621 in adult male and female patients with moderate to severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * participants aged 18 to 55 years (inclusive) at the time of screening * participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures * participants must have had chronic atopic dermatitis (ad) for at least 1 year before screening. * moderate to very severe eczema as determined by eczema area and severity index (easi) score of at least 16 at the baseline visit. * a validated investigator global assessment (viga) score of at least 3 at the baseline visit, indicating moderate to severe ad. * at least 10% body surface area (bsa) of ad involvement at the baseline visit. * weekly average peak pruritus numeric rating scale (nrs) of at least 4 at the baseline visit. * documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for ad. * application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit. exclusion criteria: * participants who have a clinically relevant history of respiratory, gastrointestinal (gi), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, ophthalmological, or connective tissue diseases or disorders. * participants who have any surgical or medical procedure planned during participation in the study. * participants with a history of alcohol or substance abuse within the previous 2 years. * participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results. * participants whose results from clinical laboratory safety tests are outside the local reference range at screening. * participants who have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of kt-621 administration. * participants with a history of lack of response to any medication targeting interleukin (il)-4, il-13, and/or janus kinase (jak)- signal transducer and activator of transcription (stat) pathways (e.g. dupilumab, tralokinumab, upadacitinib, abrocitinib) at approved doses after at least 16 weeks of therapy. * pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. * female participants of childbearing potential with a positive or undetermined pregnancy result at the screening and baseline visits. * participants with a known sensitivity to any of the components of kt-621. * participants who are a member of the investigational team or his/her immediate family.

Keywords: kt621 stat6 stat6 degrader targeted protein degrader phase 1
new procedure to reduce mother-newborn separation

Conditions: Neonatal Disease

Summary: the goal of this single-centre interventional study without medication neither device (for procedure) is to limit the separation between mother and newborn by implementing a new procedure for the management of the newborn with respiratory distress in the delivery room. the main questions it aims to answer are: * is it possible to reduce neonatal intensive care unit admissions within 24 hours of life by applying this new procedure, thus limiting separation between mother and newborn? * does the implementation of this procedure, reducing mother-newborn separation, improves the rate of exclusive breastfeeding? newborns with respiratory distress at birth will be evaluated in the delivery room in a dedicated pre-heated incubator, providing additional oxygen if necessary. in case of improvement they will be reunited with the mother, in case of worsening a thoracic ultrasound will be performed to assess the severity and possible hospitalization in neonatal intensive care unit

this procedure provides that newborn infants, who at 15 minutes of life manifest tachypnea or respiratory distress (that responds to supplementary oxygen with fio2 \<30% and without the need for mechanical ventilation) they are placed in a preheated incubator with the required oxygen concentration (if necessary) and carefully monitored by medical and nursing clinicians. a clinical evaluation will be carried out every 15 minutes, with the detection of vital parameters, such as heart rate, oxygen saturation and respiratory rate. in case of clinical improvement and suspension of oxygen therapy, the newborn will be transferred to the neonatal observation ward to perform multiparameter monitoring of vital signs up to 6 hours of life and then be reunited with the mother. in case of clinical worsening, a bedside thoracic ultrasound will be carried out and depending on the result and the lung ultrasonography score, it will be evaluated whether to continue the observation in the delivery room or hospitalize the newborn in the neonatal care, neonatal sub-intensive care or neonatal intensive care units.

Eligibility criteria:
inclusion criteria: * infants born by elective cesarean section, with gestational age ≥34 weeks, weight at birth ≥2000 grams, manifesting mild respiratory distress with need for oxygen at fio2 ≤30% * signature by both parents of an informed consent exclusion criteria: * multiple pregnancy * need for invasive respiratory assistance * need for resuscitation at birth * criteria for perinatal asphyxiation * fetal pathology * failure by both parents to sign up for informed consent
comparative study of hydroxychloroquine and ivermectin in covid-19 prophylaxis

Conditions: Coronavirus Infections

Summary: we have to be aware of the challenge and concerns brought by 2019-ncov to our healthcare workers. front-line healthcare workers can become infected in the management of patients with covid-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of sars-cov-2. if prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of covid-19?

the study is a open-blind, randomised trial that will be conducted in asymptomatic professionals working in areas of high exposure and high risk of transmission of sars-cov-2. after obtaining fully informed consent, the investigator will recruit workers in areas of high exposure and high risk of transmission of sars-cov-2. participants will be divided into 2 groups: * hydroxychloroquine (hcq) = 400mg twice on day 1, 400mg/day on day 2, 3, 4, and 5 followed by 400mg once every 05 days, for the next 7 weeks associated with 20 milligrams twice on day of active zinc for 45 consecutive days; * ivermectin (ivm) = dosage guidelines based on participant body weight, once on day for 2 consecutive days, this dose schedule should be repeated every 14 days for 45 days associated with 20 milligrams twice on day of active zinc.

Eligibility criteria:
inclusion criteria: * aged 18 - 70 years; * professionals working in areas of high exposure and high risk of transmission of sars-cov-2; * understands and agrees to comply with planned study procedures; * signed informed consent for participation in the study. exclusion criteria: * pregnancy or breastfeeding; * major allergy to hidroxychloroquine, chloroquine or 4-aminoquinolines; * serum potassium lower than 3.4 meq/l; * serum magnesium lower than 1.7 mg/dl; * qtc interval \> 470 ms for man and \> 480 ms for woman; * weight \< 40 kg;

Keywords: coronavirus infections health personnel hydroxychloroquine pre-exposure prophylaxis antimalarials antirheumatic agents ivermectin
hiv prevention during chemsex

Conditions: Men Having Sex With Other Men

Summary: in 2016, the number of discoveries of hiv seropositivity is estimated at about 6000 in france. men who have sex with men (msm) account for 44% of these infections (68% in the occitanie region). for the past ten years, there have been new practices of sexual drug use among msm referred to as chemsex. these practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. in the "prevagay study" conducted in montpellier in 2015, about 30% of msm included said they had consumed at least one psychoactive product before or during sex during the last 12 months. in addition, this percentage was significantly higher among hiv-positive men (51% versus 24% of hiv-negative men) and 1% (n = 9) had practiced slam (sexual injection). the results of this study also showed that prep (prophylaxis pre-exposure to hiv) was known by 52% of msm included and 4% (n = 4) had already used it in the last 12 months. several observations are needed: many chemsex users do not use the prep despite the fact that its effectiveness has been proven in many studies. the social sciences have been studying the hiv epidemic since its emergence. in the era of hiv chronic disease, the sociologist gabriel girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. some contradictory logics explains this epidemiology of hiv which is maintained, particularly in montpellier despite the arrival of the prep. the main objective of our study is to explore the reflexive logic structuring the report to hiv prevention by msm practicing chemsex in montpellier, in the context of the appearance and dissemination of the prep.


Eligibility criteria:
inclusion criteria: * men who have sex with men (msm) * living in montpellier * using chemsex drugs at least one during sexual intercourse exclusion criteria: * under 18 years * seropositive hiv

Keywords: msm chemical sex hiv prevention hiv pre-exposure prophylaxis
effect of rosuvastatin on amnesia and orientation through galveston outcome amnesia test in moderate head injury

Conditions: Head Injury

Summary: the purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.

the head injury is a frequent problem of health, which produces high morbid-mortality. today is the main cause of death and disability between 18 and 40 years. in addition it originates expensive expenses in health care systems. head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. the management today is trying to avoid progression in secondary damage without good outcome. many drugs and measures has been ineffective. in the last years has been demonstrated in head injury microvascular damage like stroke. statins o inhibitors of hmg coa reductase are drugs used in dyslipidemia, frequently for reduction in ldl. experimental and clinical studies in stroke have shown improvement in outcome. the toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins. we have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.

Eligibility criteria:
inclusion criteria: * man or woman \>16 and \<50 years with hi less 24 hours in progression and glasgow between 9 y 12. * man or woman \>16 and \<50 years with hi and glasgow l3, with lesions in tc scan. * acceptance of family to participate (first grade). exclusion criteria: * history of hi with disability * history of neurological or psychiatric disease with disability. * administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone. * existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock). * administration of tham, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters * existence of intracranial lesion which needs surgery. * lesions not classifiable or in brainstem. * allergy to the drug. * hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease. * management previous in other hospital. * pregnancy

Keywords: moderate head injury rosuvastatin statin amnesia orientation
phase i/iia trial of gemcitabine plus trastuzumab and pertuzumab in previously treated metastatic her2+ breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (her2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus her2 targeted agent such as t-dm1, trastuzumab, or lapatinib.


Eligibility criteria:
inclusion criteria: * adult males or females (aged 18 or older) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (her2)+ (by immunohistochemistry (ihc) 3+ or fluorescence in situ hydridization (fish) ratio ≥ 2.0) breast cancer * have progressed on at least one prior line of chemotherapy plus her2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. t-dm1 would count as a line of therapy and patients previously treated with t-dm1 are eligible. * have not been treated with gemcitabine in the metastatic setting * measurable disease per response evaluation in solid tumors (recist) 1.1 criteria * eastern cooperative oncology group (ecog) performance status 2≤ * left ventricular ejection fraction (lvef) ≥ 50% at baseline as determined by either echocardiogram (echo) or multiple gated acquisition scan (muga) * adequate bone marrow function as indicated by the following: absolute neutrophil count (anc) \>1500/µl; platelets ≥100,000/µl; hemoglobin \>10 g/dl * adequate renal function, as indicated by creatinine ≤1.5x upper limit of normal (uln) * adequate liver function, as indicated by bilirubin ≤1.5x uln, aspartic transaminase (ast) or alanine transaminase (alt) \<2x uln unless related to metastatic breast cancer to the liver (in which case ast/alt \< 5x uln is allowed). * signed informed consent * adequate birth control in sexually active women of childbearing potential exclusion criteria: * active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study * uncontrolled central nervous system (cns) metastases. treated, non-progressing cns disease (documented by brain magnetic resonance imaging \[mri\]) off corticosteroids for at least 1 month potential participants are eligible. * women who are pregnant or lactating * prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin) * prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation) * other concomitant active malignancies * history of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias * ejection fraction \<50% or below the lower limit of the institutional normal range, whichever is lower * hypersensitivity to any of the study medications * untreated psychiatric conditions preventing informed consent

Keywords: breast - female metastatic her2+
bunionectomy study (0000-063)

Conditions: Acute Pain

Summary: we are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. it has been used to study the effect of non-steroidal anti-inflammatory (nsaids) medications (such as ibuprofen) and other pain relieving drugs. we are interested to know if this model is useful to study other drugs for the treatment of acute pain. the other drugs being tested in this study are pregabalin and naproxen sodium. these drugs are approved for use by the food and drug administration (fda). this study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.


Eligibility criteria:
inclusion criteria: * patient is a man or woman between 18 and 65 years of age * for women of child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit * patient is scheduled to have a bunionectomy * patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up * patient is capable of operating a patient controlled analgesia device exclusion criteria: * patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery * patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs * patient has an estimated creatinine clearance of \< or = 60 ml per min * patient has a history of drug abuse or dependence, or patient has a positive urine drug screen * patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)

Keywords: primary, unilateral, first metatarsal bunionectomy with osteotomy
sleep in women with bilateral salpingo-oophorectomy

Conditions: Bilateral Salpingo-oophorectomy

Summary: the purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.


Eligibility criteria:
inclusion criteria: * women who participate in the parent score studies (nct03821857) exclusion criteria: * night shift workers will be excluded

Keywords: salpingo-oophorectomy sleep cognitive decline
safety study of sodium divalproate in bipolar disorder in adolescents

Conditions: Bipolar Disorder

Summary: - main objective: to evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months. - secondary objective: to evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.


Eligibility criteria:
inclusion criteria: * adolescent boys or girls aged 13 to 18 inclusive * weighing more than 40 kg * capable of understanding the protocol * who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday * presenting the diagnostic characteristics of manic, mixed or hypomanic episodes of bipolar disorder established in accordance with the dsm iv, gathered in a semi-structured interview (mini international neuropsychiatric interview - m.i.n.i.) * with a score on the ymrs scale (young mania rating scale) \>= 14 for the manic or mixed episode or \>= 10 for the hypomanic episode * absence in blood of valproic acid at the inclusion visit * willing to use effective contraception in the case of girls of child-bearing potential. in this case the investigator should satisfy him/herself as to the psychological capacity of the patient to understand and undertake use of this contraception. * whose physiological test results are normal: hepatic function, blood count, lipid levels, fasting blood glucose level, blood urea, blood ammonia, blood protein, serum creatinine levels and plasma ions exclusion criteria: * general criteria: * pregnant girls, or those breast-feeding or those for whom a pregnancy test is positive (blood beta hcg test) * simultaneous participation in another study or in the 2 months preceding selection of the patient * psychiatric criteria: * established or known mental retardation * autistic disorders * established schizophrenia * schizoaffective disorders * somatic criteria: * medical or organic disease of the cns (epilepsy, tumour etc.) * any known renal, cardiac or haematological disease, or disease of the immune system * endocrine disorders and/or any biochemical abnormality known or existing at the moment of inclusion * exclusion criteria linked to the treatment * known hypersensitivity to valproate or to sodium divalproate or to one of the constituents of the drug * hepatic disease: acute hepatitis, chronic hepatitis, past personal or family history of severe hepatitis particularly caused by medicinal products, hepatic porphyria * treatment with lamotrigine, (lamictal) * treatment with mefloquine, (lariam) * any treatment based on valproate * treatment with methylphenidate (ritalin) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
end button tenodesis in failed developmental dysplasia of the hip surgery

Conditions: Orthopedic Disorder

Summary: adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. any alteration in these two conditions leads to a hip dysplasia \& dislocation


Eligibility criteria:
inclusion criteria: - patient with developmental dysplasia of the hip (ddh) with : * age: up to 9 years old. * recurrent ddh . * failed open reduction through medial approach in the management of ddh. * traumatic hip dislocation . exclusion criteria: * • paralytic hip dislocation . * post septic hip dislocation. * refusal to participate in this study.
identifying saliva markers of patients with stomach, colorectal (including pre-cancer polyp) and pancreatic cancers

Conditions: Gastric Cancer; Colorectal Cancer and Pre-cancer Polyps; Pancreatic Cancer

Summary: colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. diagnosis in the early stages improves survival rates. up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy. oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers. the aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility criteria:
inclusion criteria: * has not yet started treatment for the identified cancer exclusion criteria: * medically compromised patients * congenital syndromes * being treated with radiotherapy or chemotherapy.