Kornimate/medical-research-clean huggingface dataset:
observational study on costs and caregiver burden in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, adl capabilities and presence of behavioral disturbances in alzheimer's disease


Eligibility criteria:
inclusion criteria: * clinical diagnosis of possible or probable alzheimer's disease, with or without vascular elements * the primary caregiver can be identified * the patient and his/her primary caregiver are both willing and able to participate in the study exclusion criteria: * patient or caregiver affected by alcohol or narcotics to the extent that it interferes with the completion of the study * patient or caregiver does not understand english * patient and/ or caregiver is the physician or physician's staff * patient and/ or caregiver is a family member of the physician or physician's staff
a study of docetaxel polymeric micelles for injection in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is an open, multi-cohort phase ii clinical trial, the overall design is divided into two parts: dose confirmation stage and expansion stage. dose confirmation stage is to evaluate the safety and tolerability of three dosing regimenes of docetaxel polymer micelle for injection in patients with advanced esophageal cancer, and to determine the best dosing regimenes for entering the expansion stage. the expansion stage iwas used to evaluate the efficacy and further safety of the best dosing regimen identified in the dose confirmation stage in patients with advanced solid tumors. all subjects in the dose confirmation stage and expansion stage will continue treatment according to the injection docetaxel micelle regimen they received at enrollment until the disease progresses or the investigator determines that continuing treatment with the study drug will not benefit, or any intolerable toxicity occurs, or they voluntarily withdraw, or for other reasons, whichever occurs first.


Eligibility criteria:
inclusion criteria: * male or female aged 18\~75 years old * patients with histopathologically or cytologically confirmed advanced or metastatic solid tumors who have failed or are not eligible for standard therapy in the past * have an eastern cooperative oncology group (ecog) performance status 0 or 1 * there are measurable tumors(recist 1.1) exclusion criteria: * previous palliative chemotherapy with docetaxel failed * central nervous system metastasis or meningeal metastasis with clinical symptoms * has a history of serious cardiovascular disease * a history of immunodeficiency, including a positive test for human immunodeficiency virus (hiv) * active hepatitis b (hbsag positive, hbv dna\>; uln) or hepatitis c (hcv antibody positive and hcv rna\>uln) * has a history of allergies to yew medications * pregnant or lactating women * the investigator considered that there were other reasons for the subjects' ineligibility for this clinical study
efficacy and safety of nasal filters on seasonal allergic rhinitis (hay fever)

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.


Eligibility criteria:
inclusion criteria: * history of seasonal allergic rhinitis (sar) for a minimum of 2 years before study entry. documented by a positive skin test within 12 months of study enrollment. * written informed consent * reliable anticonception for fertile women * must be able to complete the study * forced expiratory volume at one second (fev1) higher than 70 % of predicted value * positive grass immunoglobulin-e (ige) blood sample equal to or higher than 3,50 ku/l exclusion criteria: * positive pregnancy test for fertile women * asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator * inadequate washout periods in regards to environmental exposure unit (eeu) appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), loratadine (10 days)) * rhinitis medicamentosa * use of long acting anti-histamines * documented evidence of acute or chronic sinusitis as determined by individual investigator * fev1 lower than 70 % of predicted value * subjects with perennial allergic rhinitis (par) to e.g. house dust mites, cats, dogs moulds unless symptom free * allergic rhinitis requiring medication caused by allergens other than grass unless symptom free * subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septum perforations, nasal polyps, chronic nasal obstruction or other nasal diseases * receipt of immunotherapy with grass pollen within the previous 10 years * women who are breastfeeding

Keywords: rhinitis allergic seasonal double blind doubleblind randomized randomised placebo crossover clinical nasal filter controlled trial hayfever hay fever efficacy safety prevention adult grass pollen symptom total nasal symptom score acoustic rhinometry
effect of beta-blocker therapy on qtc response in exercise and recovery in normal subjects

Conditions: Long QT Syndrome; Cardiac Repolarization

Summary: background. in congenital long qt syndrome type 1 (lqt1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy. in addition, lqt1 associated with a normal resting qt interval can be unmasked by the abnormal qt response to exercise testing (failure of the qt interval to shorten normally). preliminary data from our laboratory show that the exercise qt intervals of patients with lqt1 are partially normalized by beta-blocker therapy. it is still currently not known if beta-blockers modify the qt/heart rate relationship (a primary effect on repolarization) or if the "normalizing" effect is due to the inability of subjects on beta-blockers to attain sufficiently high workloads (due to reduced heart rate) for prolongation to occur. moreover, the physiologic response of the exercise qt interval to beta-blockers in healthy control subjects is not known. objective. the objective of this study is to define the impact of beta-blocker therapy on the qt response to exercise and recovery in normal subjects. methods. approximately 36 healthy adult subjects age-matched to previously studied lqt1 subjects will undergo 1) screening history, 2) two weeks of beta-blocker therapy ending in an exercise test, and 3) two weeks of placebo therapy ending in an exercise test. beta blocker and placebo will be given in random order in a double-blind fashion. the qt response to exercise and recovery will be compared between drug-free and beta-blocker-treated states. these data will be compared to those previously collected for lqt1 subjects. implications. these results will provide new information about the effect of beta-blocker therapy on repolarization parameters in normal subjects, and will provide a context in which to interpret the previous findings that beta-blocker administration modifies the qt response to exercise in lqt1 subjects.


Eligibility criteria:
inclusion criteria: * healthy normal adults, age- and gender-matched to previously studied lqt1 subjects exclusion criteria: * cardiac disease * diabetes * hypertension * severe allergic reaction * asthma requiring treatment * use of medications other than oral contraceptives, acetaminophen, nonsteroidal anti-inflammatory drugs, or synthroid or other thyroid medications * pregnancy (subjects will be asked if they are pregnant) * inability to sign informed consent

Keywords: qt interval beta-blocker exercise electrocardiogram repolarizaton
lifting and tightening of the face in subjects with skin of darker color

Conditions: Facial Skin Laxity

Summary: this prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the ulthera® system to deliver focused ultrasound energy below the skin surface.

the primary objective of this clinical trial is to demonstrate the effectiveness of the ulthera® system for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Eligibility criteria:
inclusion criteria: * male or female, aged 30 to 65 years. * subject in good health. * subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity. * fitzpatrick skin phototypes of 3 through 6. * provide written informed consent and hipaa authorization exclusion criteria: * pregnant or lactating. * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat on the cheek. * excessive skin laxity on the lower face and neck. * significant scarring in areas to be treated. * significant open facial wounds or lesions. * severe or cystic acne on the face. * presence of a metal stent or implant in the facial area to be treated.
opicapone treatment initiation open-label study

Conditions: Parkinson Disease

Summary: this is an observational study to describe the treatment patterns and clinical outcomes observed with use of ongentys as adjunctive treatment to levodopa/carbidopa in parkinson's disease patients experiencing "off" episodes with motor fluctuations


Eligibility criteria:
inclusion criteria: * must be able to complete electronic patient-reported outcome instruments * parkinson's disease patients experiencing "off" episodes * patient receiving concomitant levodopa/carbidopa, and as deemed appropriate by the physician, newly initiating ongentys as adjunctive treatment exclusion criteria: * patient is not cognitively able to complete the study requirements * patient is not able to complete the study duration of 6 months * history of moderate or severe hepatic impairment * patient has end-stage renal disease * concomitant use of non-selective monoamine oxidase (mao) inhibitor or catechol-o-methyltransferase (comt) inhibitors (patients entering study may switch from other comt inhibitors to ongentys) * history of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms * currently enrolled in an interventional clinical trial * currently or previously received ongentys

Keywords: parkinson's disease (pd) levodopa carbidopa motor fluctuations non-motor fluctuations adjunctive treatment comt inhibitor
effect of weight loss on reproductive function in overweight men

Conditions: Overweight; Obesity

Summary: obesity has been found to be a risk factor for female infertility. studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. to date, no studies have investigated the effect of weight reduction on male fertility. the purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.


Eligibility criteria:
inclusion criteria: * age \> 18 * bmi \> 27 kg/m2 exclusion criteria: -

Keywords: overweight, obesity, male, fertility
high-intensity, brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of high-intensity, brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.

objectives: i. determine the complete response rate to high-intensity, brief-duration chemotherapy with cyclophosphamide, methotrexate, vincristine, doxorubicin, and dexamethasone followed by ifosfamide, methotrexate, vincristine, cytarabine, etoposide, and dexamethasone in patients with relapsed or refractory acute lymphocytic leukemia (all). ii. determine the toxic effects of these regimens in these patients. outline: all patients receive up to six alternating courses (every 3-4 weeks) of two chemotherapy regimens: cyclophosphamide, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, and doxorubicin over 5 days; and ifosfamide/mesna, oral dexamethasone, methotrexate with leucovorin rescue, vincristine, cytarabine, and etoposide over 5 days. g-csf is given following each course until recovery of the neutrophil count. all patients receive triple intrathecal chemotherapy on day 1. patients with cns disease receive intrathecal therapy twice weekly until the csf is clear, then weekly for 4 weeks, and monthly for 1 year; those who have not received prior cns irradiation also receive whole-brain radiotherapy. patients are followed monthly for 6 months, every 3 months for 18 months, every 6 months for 2 years, then annually. projected accrual: a total of 37 evaluable patients will be accrued if at least 4 of the first 17 patients respond.

Eligibility criteria:
disease characteristics: histologically confirmed acute lymphocytic leukemia that is relapsed after or refractory to induction therapy 1 or 2 prior inductions allowed, but refractory to only 1 regimen cns involvement allowed patient characteristics: age: 18 and over performance status: 0-3 hematopoietic: not specified hepatic: bilirubin no greater than 1.5 times normal (unless directly attributable to leukemia) renal: creatinine no greater than 1.5 times normal (unless directly attributable to leukemia) cardiovascular: no uncontrolled or severe cardiovascular disease including: myocardial infarction within 6 months congestive heart failure other: no uncontrolled duodenal ulcer no uncontrolled infection no second malignancy within 5 years except curatively treated: in situ cervical cancer basal cell skin cancer no other serious medical illness that would limit survival to under 2 years no psychiatric illness that would prevent informed consent or compliance no pregnant or nursing women adequate contraception required of fertile patients prior concurrent therapy: see disease characteristics

Keywords: recurrent adult acute lymphoblastic leukemia
pediatric and adult registry for patients with arthrogryposis

Conditions: Arthrogryposis Multiplex Congenita (AMC)

Summary: the aim of the study is epidemiological evaluation of a single-centre national cohort of patients with arthrogryposis multiplex congenita (amc)

arthrogryposis multiplex congenita (amc) is a group of rare diseases characterized by joint limitation at least two distinct articular levels at birth which represents about 100 to 200 births with amc in france per year. the reference center (cr) at grenoble alpes university hospital set up multidisciplinary consultations for pediatric and adult patients with amc such as (mpr, orthopedics, genetics for children and adults, and pulmonologist, rheumatologist for adults , also including individual or group therapeutic education sessions) . for develop the diagnostic and follow-up approach, the reference center initiated the drafting of a diagnostic and care protocol (pnds), on the one hand based on the data of the literature and on the other hand on expert opinions. the project is based on four elements : 1. this project is pediatric and adult registry. it should be possible to obtain more comprehensive prognostic data, particularly in relation to complications and possible comorbidities related to older ages. 2. the recruitment of the patient is done immediately in france who's followed at the reference center in grenoble alpes university hospital. 3-there are several ways for patient addressing. indeed these are also addressed by the professionals or patients contact the center directly 4-the patient's assessments are multidisciplinary from the outset, this should lead to get comprehensive functional and diagnostic data.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with arthrogryposis multiplex congenita prenatally or postnatally seen at least once at the reference center from january 2008 to july 2023. 2. pediatric and adult individuals. 3. addressed to the reference centre of the university hospital grenoble alpes. 4. living in france. exclusion criteria: 1. individuals who did not consent to use their data (or the data of their children). 2. individuals with less than two affected joint levels. 3. individuals under guardianship or deprived of liberty. 4. inability to collect comprehensive medical information (individuals recently arrived in france)
effect of bristle-less toothbrush (periclean) on gum recession

Conditions: Gingival Recession

Summary: this study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush. subjects are recruited from patients attending the western university of health sciences dental center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. the exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.

purpose: this randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles. materials and methods: the investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at western university of health sciences dental center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. the investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. in addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. for added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.

Eligibility criteria:
inclusion criteria: * receive regular periodontal treatment at the western university of health sciences dental center * have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths exclusion criteria: * unable to provide consent * had severe uncontrolled medical conditions resulting in an american society of anesthesiologist's physical status class greater than 3 * acute pain or infection * caries near the gingival margin * restorations covering the gingival recession defect * presence of miller class iii or iv defects * severe or aggressive periodontitis * missing more than one anterior tooth * severe malocclusion * presence of occlusal trauma requiring more than limited adjustment * tobacco use * ongoing or planned orthodontic therapy * oral piercings * history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits * preferred use of an electric tooth brush over a manual brush
replication of the the multi-media social skills project for adolescents with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with asperger's syndrome or high functioning autism. approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.

this study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. approximately 300 adolescents will participate in this study. the study will be conducted in ten cohorts of 12. each cohort will have 6 participants and 6 adolescent volunteers (peers). cohorts will be run in a time sequential manner with up to four cohorts running at a time. participants and their parents will complete pre-test measures including both paper and pencil, online, or phone measures and a video-recording to assess the participant's social interaction skills and fluency. these adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. upon completion of the intervention, participants and parents will complete paper and pencil, online, or phone measures and video post-test measures. participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.

Eligibility criteria:
inclusion criteria: * between 13 and 17 years of age * must be a pennsylvania resident * a primary diagnosis of asperger's syndrome or high-functioning autism, as confirmed by the checklist for autism spectrum disorders (casd; mayes, 2012) * english as primary language spoken * ability to fluently speak in full sentences * a verbal iq of 85 or above on the kaufman brief intelligence test, second edition(kbit-2; kaufman \& kaufman, 1990) exclusion criteria: * a significant language delay * difficulty with aggression directed at peers * a primary thought disorder * a secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment * low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals

Keywords: aspergers social skills adolescents high-functioning autism
hypoxia in flight simulation in obese patients

Conditions: Obesity, COPD, OHS

Summary: the purpose of this pilot study is to determine whether obese adults,obese (bmi\>30 kg/m2) with obesity hypoventilation or obese copd-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with copd (gold i-iv group a-d) with obesity (bmi\> 30kg/m2), obese healthy adults with bmi\> 30kg /m2, patients with obesity hypoventilation syndrome * informed consent provided exclusion criteria: * patients less than bmi \<30 kg/m2 with or without copd, ohs * age \< 18 years * pregnancy, lactation * any medical, psychological or other condition restricting the patient's ability to provide informed consent * participation in another clinical trial