Kornimate/medical-research-clean huggingface dataset:
sorting and expression profiling of airway cells from humans (the search study)

Conditions: Asthma

Summary: this will be a single site, mechanistic study of asthmatic subjects and healthy, non-asthmatic controls involving a baseline characterization visit and a research bronchoscopy visit. we will identify differences in airway epithelial epigenetic enhancer signatures in asthma, by analyzing freshly isolated airway epithelial cells from healthy controls and from well-characterized subjects with asthma.

the airway epithelium is critical for normal lung function and changes in the epithelium are central to the development of asthma. precise regulation of gene transcription is essential for airway epithelial cell differentiation and transcription changes lead to many abnormalities seen in asthma. despite the dominant role of enhancers in regulating transcription, little is known about how these dna regulatory elements control airway epithelial cell transcription or about how enhancer activity differs in asthma compared to health. closing this knowledge gap will have a major impact on our understanding of normal epithelial development and asthma. in addition, enhancer-based approaches for reprogramming the airway epithelium promise to be powerful tools for dissecting mechanism that will set the stage for developing a new class of precisely targeted treatments for asthma. our overall goals are to identify enhancers that are important in regulation of key airway epithelial cell genes, to determine how enhancer activity changes in asthma, and to develop approaches for targeting the activity of these enhancers.

Eligibility criteria:
inclusion criteria (healthy participants): 1. male and female subjects between the ages of 18 and 70 years 2. ability to provide written informed consent and ability to comply with the requirements of the study 3. no hyperreactivity to methacholine (pc20 fev1 methacholine \>16 mg/ml) 4. no history of allergic rhinitis/seasonal allergies inclusion criteria (asthmatic participants): 1. male and female subjects between the ages of 18 and 70 years 2. ability to provide written informed consent and ability to comply with the requirements of the study 3. history of asthma 4. no use of oral or inhaled corticosteroids for the treatment of asthma during the past 6 weeks 5. hyperreactivity to methacholine (pc20 fev1 methacholine \< 8 mg/ml) exclusion criteria: the same exclusion criteria will apply to both sub-studies. 1. current smokers, defined by (a) \>5 cigarettes smoked in past 12 months, and (b) ≤ 8 weeks since last time smoking; or former smokers who have a total smoking history ≥10 pack-years 2. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 3. subjects with a history of lung disease other than asthma 4. subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study 5. prior esophageal hernia surgery. 6. current participation in an investigational drug trial

Keywords: asthma
thermotherapy against persistent bacterial lung infections

Conditions: Lung Diseases, Obstructive; Bronchiectasis; Asthma; Copd; Chronic Obstructive Pulmonary Disease; Chronic Lung Infections

Summary: the aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

normally, bacterial lung infections are acute such as community-acquired pneumonia and typically resolve after antibiotic therapy without leaving much lasting damage on the lungs. however, a great amount of persons with disrupted clearance of mucus and/or lung immune system get persistent lung infections, which can be life-long, usually do not resolve even with antibiotics, and can greatly increase morbidity and mortality. ithese persistent lung infections are thus characterized by stable periods with exacerbations inbetween, akin to chronic lung diseases such as asthma, chronic obstructive pulmonary disease (copd) and bronchiectasis. in addition, it has not been thoroughly investigated whether antibiotic regimens have an effect on disease control, as biofilm formation prevents antibiotics from killing the bacteria. this is a randomized, controlled, multi-center, superiority trial evaluating the effect of a thermotherapy intervention, consisting of min. 7 minutes stay in min. 85℃ environment at least 4 times a week for 6 months, in persons with persistent bacterial lung infection, defined as min. 2 positive cultures during the last 24 months for one of the following bacteria: pseudomonas aeruginosa, achromobacter xylosoxidans, stenotrophomonas maltophilia, klebsiella oxytoca, klebsiella pneumoniae, haemophilus influenzae or staphylococcus aureus, incl. 1 positive culture after attempted eradication therapy. the aim of the study is to investigate whether thermotherapy may offer a valid proposal for treatment of chronic lung infections.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * competent and capable * fev1\>1,0 l * have had a positive culture from sputum or bal min. 2 times in the last 24 months for bacteria of the species: pseudomonas aeruginosa, stenotrophomonas maltophilia, staphylococcus aureus, haemophilus influenzae, achromobacter xylosoxidans, klebsiella oxytoca or klebsiella pneumoniae. in addition, min. 1 positive culture after treatment with antibiotics * willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months exclusion criteria: * allergy to lidocaine and/or midazolam * contraindications to bronchoscopy * previous severe laryngospasm (intubation requiring) * pregnancy/breastfeeding * severe linguistic problems or inability to give informed consent * severe mental illness that is not controlled with medication. nb: patients with controlled mental illness can be included and will be asked on an equal footing as others
decrease in sense of smell and associated cognitive decline in parkinson's disease

Conditions: Parkinson's Disease

Summary: the overarching goal of this prospective cohort study is to test the hypotheses that greater severity of hyposmia is associated with increased risk of cognitive decline in pd and that worsening hyposmia parallels progressive cholinergic limbic denervation. to achieve the goals of this project, patients with pd without dementia or at-risk of dementia or with dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. ache \[11c\]pmp or vacht (vesicular acetylcholine transporter) \[f18\]-feobv pet will be performed both at study entry and at 2-years (± 6 months) follow-up. brain mri scans will also be performed at study entry and at 2-years (± 6 months) follow-up. brain beta-amyloid pet will be performed at study entry or at 2 years (± 6 months). annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and pet outcome measures.

smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson disease * hoehn \& yahr stage 2 and higher, and/or duration of motor disease 5 years or longer * 50 and older exclusion criteria: * other disorders which may resemble pd * subjects with definite dementia * subjects with unstable or severe medical disorders * subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs * subjects in whom mri imaging is contraindicated * subjects who have received ionizing radiation that would, together with the current project exposures, exceed exposure limits permissible to research volunteers * pregnant

Keywords: parkinson disease smell cognitive
female cancer patients' preference for sexual health interventions

Conditions: Breast Cancer; Gynecologic Cancer

Summary: the purpose of this study is to survey female cancer patients' awareness of and preference for methods to improve sexual health. this information will help to improve our understanding of the needs and preferences for sexual health strategies and interventions of our female patients. the findings of this survey will also be used to develop feasible sexual health resources for our patients and enhance the success of grant proposals to support future sexual health interventions at mskcc.


Eligibility criteria:
inclusion criteria: * participants must be able to communicate in english to complete the tests. * study group of breast and/or gynecological cancer survivors. * history of primary diagnosis of breast and/or gynecological cancer * at least 21 years of age. * in the judgement of the consenting professional able to provide informed consent * in the judgement of the consenting professional, able to communicate well enough in english through verbal and written communication to complete the study assessments. exclusion criteria: * in the judgement of the consenting professional, the individual is able to provide informed consent. * patients with a psychiatric disorder precluding response to the surveys.

Keywords: survey sexual health issues 10-034
home exercise with wearable sensors

Conditions: Stroke; Hemiparesis

Summary: repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. however, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. with the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. in response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. however, the technologies often have not passed their initial stages of development. in contrast, a company named 4d motion is actively working alongside the restorative neurology clinic at burke medical research institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. this device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. the device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. the 4d motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.


Eligibility criteria:
inclusion criteria: * able to follow 1-2 step commands * neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit * fugl meyer upper extremity score of at least 20/66 exclusion criteria: * has a metal implant anywhere on or inside the body * fixed contracture or deformity of affected upper extremity * individuals with bilateral stroke (i.e. if both arms are affected) * unable to tolerate repetitious movement as determined by likert scale rating greater than 5 out of 10

Keywords: outpatient wearable sensors home exercise
clinical trial for evaluating the efficacy and safety of electrocoagulation vs topic sinecatechins vs topic cidofovir within the treatment to high-grade anal intraepithelial neoplasia in hiv homosexual males

Conditions: High-grade Anal Intraepithelial Neoplasia

Summary: this study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (hgain). the target patients are human immunodeficiency virus (hiv)-infected homosexual males. all these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

this trial addresses one of the emerging problems in patients with hiv infection, such as the high incidence of anal dysplasia and anal cancer. the study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost). topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. this makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation. on the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.

Eligibility criteria:
inclusion criteria: * men who have sex with men, older or same than 18 years old. * hiv-1 positive men. * high grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study. * informed consent is signed voluntarily. exclusion criteria: * patient with any disease or condition which rules him out to participate in the research, by investigator opinion. * treated patients for hgain in the previous 6 months. * patients with relapsed hgain two or more times in the last three months. * people with learning difficulties
vascular dysfunction in offspring of assisted reproduction technologies

Conditions: Infertility

Summary: the prevalence of infertility has been estimated at 9% worldwide. the steadily increasing use of assisted reproductive technologies (art) has allowed millions of infertile couples to have children. these children make up for 1 to 4% of the population in developed countries. art involves the manipulation of early embryos at a time when they may be particularly vulnerable to external disturbances. in line with this concept, studies in mice suggest that art alters the activity of enzymes involved in the regulation of metabolic and cardiovascular homeostasis. alternatively, infertility itself or the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring. the safety of art for long-term health is, therefore, of utmost importance. among the potential long-term consequences of art, cardiovascular disease may represent an important candidate, but there is no information. investigators show that, children born after in vitro fertilization (ivf) present systemic and pulmonary vascular dysfunction at high-altitude when compared to age- and sex-matched control subjects. a 5 years follow-up study shows that premature vascular aegieng persist and evolve to arterial hypertension. arterial hypertension may induce cardiac dysfunction. therefore, the major goal of this proposal is to assess cardiac function in apparently healthy participants born after art.


Eligibility criteria:
inclusion criteria: * offspring of art * healthy * born at term exclusion criteria: * cardio-pulmonary malformations * neuro-muscular malformations

Keywords: vascular function in offspring of art
evaluation of the effects of bicarbonate-calcium water in premenopausal and postmenopausal women as a prevention of osteoporosis

Conditions: Osteoporosis Risk

Summary: the goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. participants are women in pre- or post- menopausal state. the intervention group must drink bicarbonate-calcium water while the control group low mineral water


Eligibility criteria:
inclusion criteria: * premenopausal women aged ≥40 years * menopausal women, period of early menopause 1-10 years exclusion criteria: * inclusion in other study protocols * estrogen-replacement hormone therapy * osteoporosis therapy * corticosteroid therapy * insulin therapy. * calcium supplementation * kidney diseases of medium-severe level * liver diseases of medium-severe level * severe osteoporosis

Keywords: bicarbonate-calcium water
gamified occupational therapy for adolescents with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Gamification; Occupational Therapy

Summary: this research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with duchenne muscular dystrophy compared to the classical occupational therapy program. the findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with duchenne muscular dystrophy.


Eligibility criteria:
inclusion criteria: * being diagnosed with duchenne muscular dystrophy * to be literate in turkish * to have scored 27 points or more on the modified mini mental test * having a computer, tablet and internet connection * volunteering to participate in the study by their parents and reading and signing the informed consent form exclusion criteria: * having a neurological disease other than duchenne muscular dystrophy and/or another diagnosed neurological disease accompanying duchenne muscular dystrophy * having a cooperation problem that prevents completing the assessments for any reason * difficulty understanding and speaking the turkish language
evaluation of prognostic factors for tubo-ovarian cancer in france

Conditions: Ovarian Cancer

Summary: evaluation of the following prognostic factors in france, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,upfront surgery.


Eligibility criteria:
inclusion criteria: * - diagnosic of ovarian or tubal cancer c56 et c570 * +/- * carcinose péritonéale c786 * tumueur maligne secondaire de la plèvre c782, * tumueur maligne secondaire des ganglions c770 à c779, * tumueur maligne secondaire du foie c787, * tumueur maligne secondaire du péritoine c786 exclusion criteria: * autres causes de : * carcinose péritonéale c786 * tumueur maligne secondaire de la plèvre c782, * tumueur maligne secondaire des ganglions c770 à c779, * tumueur maligne secondaire du foie c787, * tumueur maligne secondaire du péritoine c786

Keywords: ovarian or tubal cancer upfront surgery surgical thresholds
spread of muscle hyperalgesia and pain in a low dose ngf-induced pain model

Conditions: Hyperalgesia; Healthy Subjects

Summary: the purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose ngf model. it is hypothesized that low dosages i.m injections of ngf are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in ngf studies. furthermore, it is also speculated if several injections of low dose ngf into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of ngf injected into the tibialis anterior muscle will be compared to a high dose i.m injection of ngf injected into the contralateral side in healthy pain-free subjects.

Eligibility criteria:
inclusion criteria: * healthy and pain free volunteers exclusion criteria: * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, mental illnesses, or psychiatric diseases. * past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue) * participation in other pain trials throughout the study period * lack of ability to cooperate * taking any analgesic 24 hours before the injections * performing any strenuous leg exercise through out the study period causing sore muscles

Keywords: muscle soreness ngf-induced pain pain model long-lasting sensitization
a study to evaluate safety and efficacy of ibi306, a pcsk9 monoclonal antibody in chinese subjects with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: a study to evaluate safety and efficacy of ibi306 in subjects with homozygous familial hypercholesterolemia.

this is a phase 2b/3 study to assess the efficacy and safety of ibi306 in subjects with homozygous familial hypercholesterolemia. part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of ibi306 in subjects with homozygous familial hypercholesterolemia. part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of ibi306 in subjects with homozygous familial hypercholesterolemia.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 to ≤ 80 years of age 2. diagnosis of homozygous familial hypercholesterolemia 3. ldl cholesterol ≥ 130 mg/dl (3.4mmol/l) 4. triglyceride ≤ 400 mg/dl (4.5 mmol/l) 5. bodyweight of ≥ 40 kg at screening exclusion criteria: 1. history of liver transplant 2. uncontrolled hypertension 3. moderate to severe renal dysfunction 4. active liver disease or hepatic dysfunction 5. known sensitivity to any of the products to be administered during dosing
drug-coated balloon in de novo chronic total occlusions

Conditions: Coronary Artery Disease; Total Occlusion of Coronary Artery

Summary: the cto-denovo study is a multicenter registry of consecutive patients with de novo coronary chronic total occlusions (cto) undergoing successful cto recanalization with the use of drug-coated balloon (dcb)-only strategy. the primary endpoint is target lesion failure at 6 months. the secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.


Eligibility criteria:
inclusion criteria: * de novo coronary cto undergoing successful recanalization with the use of dcb-only strategy at the occlusion site exclusion criteria: * de novo coronary cto undergoing successful recanalization with the use of des at the occlusion site * in-stent cto

Keywords: chronic total occlusion percutaneous coronary intervention drug-coated balloon