Kornimate/medical-research-clean huggingface dataset:
leo 29102 single and multiple dose study by dermal application

Conditions: Atopic Dermatitis

Summary: the principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when leo 29102 is administered cutaneously as single and multiple doses to healthy male subjects. the study is divided into one single dose part followed by a multiple dose part.


Eligibility criteria:
inclusion criteria: * male adults between the age of 18 and 55 years (both inclusive) and with a bmi between 19 and 30 kg/m2 (both inclusive). * subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ecg), blood pressuer and heart rate, and clinical laboratory evaluation. exclusion criteria: * subjects who show signs of eczema or other skin lesions. * subjects who have any clinical signs of allergic diseases (excluding non active hay fever).
exercise in critically ill patients with sepsis

Conditions: Sepsis Syndromes

Summary: this study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.

this study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care. the primary hypothesis is that an early targeted rehabilitation icu patients with sepsis syndromes over 7 days will prevent loss of lean muscle mass by within 7 days of recruitment to the study. decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.

Eligibility criteria:
inclusion criteria: * systemic inflammatory response syndrome with a proven or suspected infectious etiology. * 18 years and over * relatives willing to give consent * admitted to intensive care and likely to remain ventilated for \> 48 hours exclusion criteria: * patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours * head injuries * burn injury * multiple lower limb fractures

Keywords: sepsis severe sepsis septic shock septicaemia bacteremia
genomic sequencing in patients with hcm undergoing septal myectomy

Conditions: Hypertrophic Cardiomyopathy; Genetic Disease; Gene Product Sequence Variation

Summary: investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations. for this study, investigators have targeted hypertrophic cardiomyopathy.

the hypothesis is that sporadic or simplex occurrences of what are typically autosomal dominantly inherited diseases can instead be caused my mosaic mutations, specifically, mutations in the heart itself. this hypothesis mandates that investigators sequence both affected and unaffected tissues, which in this case, investigators will construe to be peripheral blood dna and discarded myocardium from cardiac procedures. eligible individuals will first undergo informed consent to be part of the study prior to their scheduled myomectomy. the study participants will also have phlebotomy for research samples. the nih intramural sequencing center (nisc) will perform paired exome or genome sequencing and we will first screen for germline mutations in known cardiomyopathy genes that meet acmg standards of likely pathogenic or pathogenic. then, if this is negative, investigators will screen for sequence variants that are present in cardiac tissue but absent in the blood dna. investigators will also screen blood dna for secondary findings in genes recommended for annotation and results return by the acmg and sequence variants deemed clinically relevant in this gene set will be validated in a clia-certified laboratory and the results returned to that participant.

Eligibility criteria:
inclusion criteria: * patient is 18 years and older has a clinical diagnosis of hypertrophic cardiomyopathy. * patient scheduled for clinically-indicated myomectomy. * patient has a negative family history of hypertrophic cardiomyopathy * patient is willing to receive results of secondary variant screen exclusion criteria: * pregnant * inability to give informed consent
safety and effectiveness of the yaari extractor for management of shoulder dystocia

Conditions: Shoulder Dystocia

Summary: prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the yaari extractor used by board certified or board eligible u.s. ob/gyn physicians in the management of shoulder dystocia.


Eligibility criteria:
inclusion criteria: 1. subject 18 years of age or older at time of consent. 2. subject planning on vaginal birth. 3. singleton pregnancy in vertex presentation. 4. full-term pregnancy having completed 37 weeks or more gestational weeks. 5. able and willing to provide written informed consent prior to enrollment. 6. in the opinion of the investigator, the subject has sufficient mental capacity to understand the informed consent form (icf). 7. subject with fetus experiencing shoulder dystocia as defined by acog practice bulletin 178 "shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery." exclusion criteria: 1. patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (mcroberts/suprapubic pressure), prior to use of the yaari extractor. 2. cesarean section is planned for the patient. 3. obstetric contraindications to vaginal birth. 4. subject carrying fetus with known significant chromosomal or structural anomalies. 5. clinically estimated fetal weight ≥5kg in non-diabetic subjects. 6. clinically estimated fetal weight ≥4.5kg in subjects with diabetes. 7. subject has any general health condition or systemic disease that may represent, in the opinion of the investigator, a potential increased risk associated with device use or pregnancy. 8. bleeding disorders, such as thrombocytopenia, von willebrand's disease, bleeding disorder currently using anticoagulation medication, etc. 9. any maternal disease or disorder that precludes the subject from pushing effectively. 10. if the maternal cervix is not fully dilated. 11. if the fetal head is not completely out of the birth canal. 12. in the presence of a non-reducible nuchal cord.
a study of immunopet imaging using 89zr-dfo-regn5054 in adult participants with solid cancers treated with cemiplimab

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor

Summary: this study is researching an experimental drug called 89zr-dfo-regn5054 and cemiplimab. the study is focused on patients with a type of cancer that can be potentially imaged using 89zr-dfo-regn5054 and show special tumor features that may be important to the way the immune system fights cancer. the aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89zr-dfo regn5054. the study is looking at several other research questions, including: * what side effects may happen from taking the study drugs * how much study drug is in the blood at different times * whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: * advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (pd-1) immunotherapy * measurable disease according to response evaluation criteria in solid tumours (recist) 1.1 criteria * eastern cooperative oncology group (ecog) performance status of ≤1 * adequate organ and bone marrow function as defined in the protocol * willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for part b) key exclusion criteria: * currently receiving another cancer treatment or inadequate time since last therapy, as defined in the protocol * has not yet recovered from acute toxicities from prior therapy; exceptions defined in the protocol * prior treatment with a blocker of the pd-1/programmed death ligand 1 (pd-l1) pathway * currently receiving or has received chimeric antigen receptor (car-t) cell therapy * symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression * known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis note: other protocol defined inclusion/exclusion criteria apply.

Keywords: positron emission tomography (pet) scan immuno-pet
treatment of patients with major depressive disorder with mk0869 (0869-059)

Conditions: Major Depressive Disorder

Summary: a clinical study to determine the efficacy and safety of mk0869 in the treatment of depression

the duration of treatment is 8 weeks.

Eligibility criteria:
major depressive disorder
effect of fixed and removable space maintainer on some salivary parameters: an in-vivo study

Conditions: Premature Loss of Primary Teeth

Summary: the aim of this study is to evaluate and compare the effect of lower lingual holding arch space maintainer versus removable partial denture space maintainer on some salivary parameters (salivary flow rate, ph, viscosity and buffering capacity).

this study is a randomized clinical trial, it will be conducted on forty children, aged from (7-10) years, who are in need for space maintainer. * children will be randomly and equally divided into two groups according to type of space maintainer used; group (1): twenty children with lower lingual holding arch, group (2): twenty children with removable partial denture. * un-stimulated and stimulated saliva will be collected at specific duration of time from children before the delivery of the appliance and after 1, 3 and 6 months of wearing the space maintainer to measure salivary flow rate, ph, viscosity and buffering capacity.

Eligibility criteria:
inclusion criteria: apparently healthy with no systemic disease. age between 7-10 years old. both boys and girls will be included. children with the following dental criteria: clinical criteria: * children should have a good oral hygiene. * children in mixed dentition stage. * fully erupted permanent lower first molar. * children with multiple loss of deciduous molar teeth. * seek for space maintainer appliance. radiographic criteria : * presence of at least 1mm bone overlaying successor. * tooth germ with less than one third of the root formed. exclusion criteria: * allergy to any used material

Keywords: teeth loss missing teeth
evaluation of splenic irradiation in chronic lymphatic leukemia

Conditions: Leukemia, Chronic Lymphatic

Summary: retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (cll).

the study will include patients with cll treated with splenic irradiation in maastro clinic, maastricht, the netherlands, maxima medisch centrum veldhoven/catharina hospital, eindhoven, the netherlands and modena hospital, modena, italy. data will be collected from patient records in an uniform database. data will include demographic data, cll stadium (rai and binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death

Eligibility criteria:
inclusion criteria: * patients with chronic lymphatic leukaemia. exclusion criteria: * none
continuous intraocular pressure (iop) monitoring in pigmentary dispersion syndrome and pigmentary glaucoma patients

Conditions: Pigmentary Dispersion Syndrome; Pigmentary Glaucoma Patients

Summary: this study monitors the intraocular pressure (iop) over 4 to 6 hours using the sensimed triggerfish® device and goldmann applanation tonometry (gat) in pigment dispersion syndrome and pigmentary glaucoma patients. the aim of the study is to detect sensimed triggerfish® output signal peak after induced fluctuation by physical exercise or pupil dilation.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both eyes * iop of ≥ 15 mmhg * 18-60 years. * patients able to jog continuously for at least 25 minutes * phakic eyes * patients who accept signing an informed consent approved by the ethics committee. exclusion criteria: * pigmentary glaucoma already treated with peripheral laser iridotomy (pli), argon laser peripheral iridoplasty (alpi), argon laser trabeculoplasty (alt) and selective laser trabeculoplasty (slt) in any eye * patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in any eye * anti-hypertensive treatment in the 4 weeks preceding the study and throughout the study. following signature of informed consent, anti-hypertensive treatment will be washed out for 4 weeks prior to study procedures in enrolled patients * patients with pseudoexfoliative (pex) syndrome or pex glaucoma in any eye * patients not able to understand the nature of the research * patients under tutorship * corneal abnormality * subjects with contraindications for wearing contact lenses * full frame metal glasses during sensimed triggerfish® monitoring * history of other ocular surgery except uncomplicated strabismus surgery no later than 3 months prior to study procedures * ocular inflammation or infection * history of cardiac or pulmonary disorder * pregnancy and lactation * simultaneous participation in other clinical research
baseline physiology studies in carriers of gene variant x conferring major risk of cvd-prone metabolic disorders

Conditions: Hyperlipidemia; Diabetes Mellitus; Metabolic Syndrome; Arterial Hypertension; Obesity

Summary: the purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant x in order to determine the effect of the genetic variant on various metabolic parameters.


Eligibility criteria:
inclusion criteria: * male * 18-70 years of age * member of biobank vejle * bmi\<30 exclusion criteria: * diabetes mellitus * severe illness
study evaluating two different sirolimus-based immunosuppressive regimens in elderly kidney transplant recipients

Conditions: Kidney Failure; Graft Rejection; Aged

Summary: the purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * end stage renal disease * kidney transplantation * both donor and recipient older than 60 years exclusion criteria: * prior or concurrent transplant of any organ other than the kidney * current clinically significant infections

Keywords: kidney transplant elderly
effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus outline: among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively. sample size: experimental group (n=50), control group (n=50) inclusion criteria: patients with type 1 diabetes with a1c\>8.0% exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics method: we divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. we perform telemedicine and education with smartphone application to the experimental group every 2 weeks. we evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking a1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research. variables: a1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking primary endpoint: improvement in hba1c of experimental group secondary endpoint: no improvement in hba1c of control group


Eligibility criteria:
inclusion criteria: a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose a1c more than 8.0% within 6 months f. patients who can use smartphone all day 2) exclusion criteria 1. chronic disease (except thyroid disorders with euthyroidism), psychological disease 2. patients aged under 12 whose parents have psychological disease 3. patients who cannot use smartphone app properly 4. athletics 5. patients who use continuous glucose monitoring exclusion criteria: -

Keywords: diabetes mellitus, telemedicine, smartphone, type 1, child, adolescent, young adult
sensitivity and specificity of the clinical classifications generated by the cureety digital telemonitoring tool

Conditions: Neoplasms

Summary: cureety is a digital telemonitoring platform specifically designed to monitor cancer patients through self-reporting of adverse events, accompany patients and their medical teams and complement existing healthcare practices. the platform aims to detect signs and symptoms of health deterioration and disease progression, allowing the medical team to intervene earlier than usual compared to conventional care. the patients are asked to respond to an electronic patient-reported outcome (epro) questionnaire. the digital tool is configured for each patient that generates specific questions that allow grading of adverse events relevant to their specific treatment and disease profile. at the core of the platform is the medical device "cureety techcare", an algorithm that outputs a "clinical classification" based on the adverse events reported by the patients. there are four levels that correspond to the patients' health states, either "critical" ("red"), "to be monitored" ("orange"), "compromised" ("yellow"), or "correct" ("green"). in the case of a red or orange classification, the patients are asked to contact their medical team. in addition, the medical team can monitor the patient classifications from a distance including receiving notifications when patients are classified red and orange. the present study was designed to retrospectively evaluate the performance of the "cureety techcare" medical device in real-life using data collected in the cureety database.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older. * patients that have completed at least one questionnaire in cureety * patients that have not exercised their right to oppose to the use of their data for clinical research. exclusion criteria: * n/a
treatment of port wine stains in children with pulsed dye laser and timolol gel

Conditions: Melanoma

Summary: pulsed dye laser (pdl)is the gold standard treatment of port wine stains (pws). however, many sessions are required and failure or relapses are not uncommon. it has been demonstrated that a neoangiogenesis occurs after pdl, explaining at least partially those failure. the objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with pdl for treating pws. methods. prospective multicenter study comparing pdl alone to pdl + timolol. sessions of pdl will be performed once a month for 3 months. one group will be treated with pdl alone and the other will also applied timolol 1% gel twice a day during treatment. the evaluation will be done one month after the third session.


Eligibility criteria:
inclusion criteria: * children from 6 months to 18 year-old. * pws of the face * no prior treatement with pdl * membership or beneficiary of a national insurance scheme. * consent signed by the parents and by the patient if he is old enough to understand exclusion criteria: * child with whom the angioma plan was already handled by laser or pulsed lamp * histories of asthma or obstructive bronchitis * severe allergic rhinitis and hyper bronchial ability to react * bradycardie sinusale, block auriculo-ventriculaires of the second or third degree * unchecked cardiac insufficiency * cardiogenic shock * untreated phéochromocytome * sentimentality in the timolol or in one of these excipients, and\\or in the other bétabloquants * taken by floctafénine or by sultopride * taken of bétabloquants by oral route, of inhibitors calcic or of amiodarone * severe peripheral circulatory disorders(confusions of raynaud) * arterial low blood pressure * pregnancy and feeding * absence of effective contraception at the girls old enough to procreate * contraindication in the use of cream with lidocaïne and with prilocaïne
program evaluation of people with arthritis can exercise

Conditions: Arthritis; Osteoarthritis; Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the health and arthritis-specific benefits of participation in the arthritis foundation people with arthritis can exercise program and to collect information to improve community-based dissemination of this program.

only about 24% of people with arthritis report sufficient physical activity to provide general health benefits. research has demonstrated that many people with arthritis can safely exercise to improve fitness and health. the people with arthritis can exercise (pace) program, developed by the arthritis foundation, is a land-based recreational physical activity and exercise program. pace has been offered as a community-based program for over 10 years and small studies have reported benefits for people with arthritis. however, there has been no randomized controlled community trials that evaluate the effectiveness of pace in the community. the goals of the evaluation of pace project are to: (1) appropriately evaluate the af pace exercise program, and (2) provide information to support effective content, recruitment and programming. specific objectives for meeting these goals include: 1. identify the theoretical foundations and constructs for evaluating the program and select and use appropriate outcome measures; 2. plan and conduct a randomized controlled trial of 8 and 16 week pace programs; 3. perform a qualitative evaluation using focus groups of pace instructors and participants; 4. disseminate findings and make recommendations.

Eligibility criteria:
inclusion criteria: * adults age 18 and older * self-reported arthritis or chronic joint symptoms * community-dwelling exclusion criteria: * serious medical conditions which would contraindicate exercise * no severe physical or mental condition

Keywords: arthritis exercise physical activity physical function pain