Kornimate/medical-research-clean huggingface dataset:
riociguat clinical effects studied in patients with insufficient treatment response to phosphodiesterase-5 inhibitor

Conditions: Hypertension, Pulmonary

Summary: bay63-2521 riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. in patients with pulmonary arterial hypertension riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. here dose of riociguat will be adjusted over 8 weeks then a maintenance phase of 16 weeks follows. patients with pulmonary arterial hypertension treated with stable doses of phosphodiesterase type-5 inhibitors (eg sildenafil, tadalafil) not appropriately responding to therapy will be included. based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if pde5i treatment is transitioned to riociguat. where riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (extended drug supply phase - edsp) under study conditions. patients may also transition at the end of the maintenance period or any time during the edsp to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. study termination is also possible at any time.


Eligibility criteria:
inclusion criteria: * male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated pah due to congenital heart disease (group i / dana point classification of ph) demonstrating insufficient response to treatment with pde-5i for at least 3 months * patients with and without endothelin receptor antagonist (era) therapy * world health organization functional class (who fc) iii at screening * 6-minute walking distance (6mwd) of 165-440 m * cardiac index \<3.0 l/min/m\*2. exclusion criteria: * all types of ph except subtypes of dana point group i specified in the inclusion criteria * evidence of clinically significant restrictive or obstructive parenchymal lung diseases * diffusing capacity of the lung for carbon monoxide (dlco) \<30% predicted * history or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization * patients unable to perform a valid 6mwd test * pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study.
valeo ol interbody fusion devices for posterior lumbar interbody fusion snap trial

Conditions: Disc Degeneration of Pfirrmann Grade III or Greater; Degenerative Spondylolisthesis; Isthmic Spondylolisthesis of Grade I or II

Summary: this study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional peek plastic implant. the procedure uses a single oblique cage in each group. the study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. the fusion status will also be judged with plane x-rays and one ct scan.


Eligibility criteria:
inclusion criteria: * male and female patients age 18-75 years * chronic low back pain unresponsive to at least six months of conservative care * mri and standing x-ray evidence of pfirrmann grade iii or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of grade i or ii exclusion criteria: * osteoporosis * patients with prior failed fusion at the same level * degenerative scoliosis * degenerative spondylolisthesis greater than grade ii * pregnancy * psychiatric or mental disease * alcoholism (drinking more than 5 units per day) * active infection or prior infection at the surgical site * active cancer * insufficient language skills to complete questionnaires * participation in another study * more than two symptomatic levels that need fusion

Keywords: spondylolisthesis disc degeneration lumbar interbody fusion randomized controlled trial ceramic interbody spacer
sensimed triggerfish® in sitting and supine position

Conditions: Healthy Subjects

Summary: the purpose of the study is to evaluate changes in intraocular pressure (iop) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.

20 subjects will be enrolled in the investigation. eligible subjects will receive one session of 22-hour continuous iop monitoring with sensimed triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. sensimed triggerfish® will be installed randomly on right or left eyes and the iop recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. subjects will then go home. the next morning, subjects will return to the hospital and during sensimed triggerfish® monitoring on one eye, iop measurements will be taken in the fellow eye in sitting position using goldmann, tonopen and pneuma-tonometers. then subjects will lie down on a flat bed. after 15 ± 5 minutes and again after 45 ± 5 minutes iop will be measured in supine position, using goldmann, tonopen, pneuma-tonometer and perkins tonometers. then subjects will sit up again. after 30 ± 5 minutes iop will be measured with the goldmann tonometer.

Eligibility criteria:
inclusion criteria: * subject is able to provide informed consent * healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism * no more than 4 diopters spherical equivalent * no more than 2 diopters cylinder equivalent * gat iop of less than or equal to 21 mmhg at inclusion and open iridocorneal angles, no history of any iop \> 21 mmhg * gat iop difference between eyes within 1 mmhg during initial exam * gat iop differences between initial sitting and supine positions, between left and right eyes, within 2 mmhg during initial exam * ≥ 18 years * for women with childbearing potential, adequate contraception exclusion criteria: * subjects with contraindications for wearing contact lenses * severe dry eye syndrome * keratoconus or other corneal abnormality * conjunctival or intraocular inflammation * history of eye surgery * full frame metal glasses during sensimed triggerfish® recording * known hypersensitivity to silicone, plaster or ocular anesthesia * pregnancy and lactation * simultaneous participation in other clinical studies

Keywords: glaucoma triggerfish body position
respiratory health study of children in kiryat tivon

Conditions: Bronchial Asthma; Signs and Symptoms, Respiratory; Allergy

Summary: kiryat tivon is located close to a major industrial zone. the aim of the study is to evaluate the health status of children living in k. tivon. the health status will be evaluated using health questionnaires and spirometry.

kiryat tivon is located close to a major industrial zone. the aim of the study is to evaluate the health status of children living in k. tivon. the health status will be evaluated while using health questionnaires and spirometry. objective: to evaluate the respiratory health of k. tivon children with comparatives, with respect to local air pollution levels. material and methods: all the school children from k. tivon (1800 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form. first step: a health questionnaire (based on hebrew version of isaac questionnaire) will be filled in by the parents. second step: spirometry checking of the children. in parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the haifa district municipality association for the environment (hdmae). the station provides half-hourly measurement of mean concentrations of gaseous (nox, so2, o3) and particular (pm 10) pollutants over the entire investigation window. additional meteorological data are also collected. risk maps: using a gis platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region. the prevalence of pulmonary disease will be evaluated according to the risk maps.

Eligibility criteria:
inclusion criteria: * all school children exclusion criteria: * children that their parents did not signed the informed consent

Keywords: asthma allergy respiratory pollution children air pollution
memory support system feasibility study

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to determining the feasibility of providing the memory support system (mss) to individuals with mild cognitive impairment (mci) and their partners at a clinic in ontario, canada. this will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the mss; and b) a cost analysis related to implementation of the mss. the study will also measure efficacy outcomes of the mss regarding program adherence as well as to self-reported iadls, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with mci and their care partners

a survey will be created and sent out to participants with mci who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. the survey will consist of a likert scale and open questions related to patient interest in and preferred length of mss administration and preference for in-person versus virtual administration. during and after collection of the survey data, a sample of 20 individuals with mci (ages ≥50) and their care partners will undergo mss training. at enrollment in the mss training, participants with mci and their care partners will complete measures of cognitive and functional status. participants and partners will also complete measures of treatment adherence, iadls, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. participants will complete the mss training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. training will be offered in english or french. after the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the mss, teaching curriculum, and intervention logistics.

Eligibility criteria:
inclusion criteria: * diagnosis of single or multi-domain mci * clinical dementia rating global (cdr) score of ≤ 0.5 * montreal cognitive assessment score of ≥18 * available contact with a care partner ≥ 2 times weekly * absence or stable intake of nootropic(s) for ≥ 3 months exclusion criteria: * visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with mss training * concurrent participation in another related clinical trial

Keywords: cognition intervention french
effect of prophylactic medical compression therapy on the reduction of breast cancer-related lymphedema in patients with adjuvant docetaxel chemotherapy: a randomized controlled study

Conditions: Breast Cancer Lymphedema

Summary: in this study, the purpose of this study is to investigate whether prophylactic medical compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could reduce the incidence and severity of lymphedema in the upper limbs that received axillary lymph node resection (sentinel lymph node biopsy or axillary lymph node dissection).


Eligibility criteria:
inclusion criteria: 1. patients who underwent radical mastectomy and sentinel lymphctomy or axillary lymphectomy after diagnosis of unilateral breast cancer 2. patients who are scheduled for adjuvant chemotherapy including docetaxel after surgery 3. patients aged 19 to 70 4. patients who can understand the contents of this study and obtain consent exclusion criteria: 1. patients with a history of breast-related surgery prior to this breast cancer surgery 2. patients with metastases to other organs 3. patients who have undergone neoadjuvant chemotherapy or have previously received radiation therapy 4. patients with systemic diseases that may not be able to conduct clinical research 5. patients with skin diseases who cannot receive medical compression treatment
a chinese randomized crossover study of erlotinib versus docetaxel/cisplatin in previously untreated stage iiib/iv lung adenocarcinoma with egfr mutations

Conditions: Neoplasms, Lung; Carcinoma, Non-Small Cell Lung; Drug Therapy; Genes, EGFR

Summary: objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage iiib/iv lung adenocarcinoma with egfr mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .


Eligibility criteria:
inclusion criteria: * male and female patients aged over 18 years * histologically proven lung adenocarcinoma * clinical stage iiib/iv * ecog performance status 0-2 * had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma * at least one measurable lesion (according to recist) * provision of written informed consent * life expectancy of at least 12 weeks exclusion criteria: * history of malignant disease. * evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) * expected life expectancy less than 2 months * as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) ≥ 2.5 x uln if no demonstrable liver metastases (or \>5 x in presence of liver metastases) * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * pregnancy or breast-feeding women (women of child¬bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Keywords: mutation analysis first-line second-line targeted therapy
a non-interventional pilot study assessing whether lysyl oxidase-like 2 (loxl2) is present in subjects with scleroderma

Conditions: Limited Scleroderma; Diffuse Scleroderma

Summary: to treat patients with scleroderma by blocking the expression of loxl2. the investigators first need to confirm (through observation) that loxl2 is overexpressed in disease.

scleroderma is a chronic skin-hardening disease. there are two types of scleroderma. the first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. the second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. this study will determine if the disease is associated with an elevated expression of loxl2 levels in tissue samples from patients.

Eligibility criteria:
inclusion criteria: * over 18 years of age * documented diagnosis of scleroderma * willing and able to provide written informed consent exclusion criteria: * use of experimental therapies within 28 days prior to screening. * aspirin use \> 81 mg daily within 1 week prior to screening. * any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study

Keywords: limited scleroderma diffuse scleroderma sclerosis progressive limited
photocil (topical) for the treatment of psoriasis vulgaris

Conditions: Psoriasis

Summary: photocil is a topical drug (cream) that selectively delivers narrow band - ultraviolet b (nb-uvb) therapy when exposed to sunlight. photocil is intended to help protect users from non-therapeutic ultraviolet b (uvb) radiation while selectively passing wavelengths of light in the nb-uvb range with peak transmission of 308nm. the aim of the study is to assess the safety and efficacy of photocil in the treatment of psoriasis

nb-uvb phototherapy is a common treatment for patients with psoriasis, and has been reported to be safe and effective in numerous clinical trials. clinical trials have reported achievement of psoriasis area severity index (pasi)-75 in 50-70% of patients after 4-6 weeks of nb-uvb treatment. many drawbacks limit patients compliance, access, and acceptance of traditional nb-uvb phototherapy. the strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback. in order to address the drawbacks of phototherapy, we developed a novel topical cream - photocil - that selectively delivers nb-uvb therapy when exposed to sunlight. when used with natural sunlight, photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.

Eligibility criteria:
inclusion criteria: * diagnosed with psoriasis vulgaris confirmed by a dermatologist * psoriasis lesions affecting at a minimum 5% of the facial, legs, or arms surface area * ￼age: 18 to 65 * participants able to give informed consent exclusion criteria: * subject did not respond to prior phototherapy treatment * subject completed phototherapy for same lesion(s) in last 6 months * subject has previous history of skin cancer * subject has previous history of photosensitivity * subject has a history of herpes (hsv i or ii) outbreaks * subject has previous history of autoimmune disease may be excluded at investigator's discretion * subject is currently taking of immunosuppressive or photosensitizing drugs * subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. these patients may be excluded at investigator's discretion * subject is pregnant or lactating women
ologen (oculusgen)-glaucoma case control trial in india

Conditions: Glaucoma

Summary: the purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (oculusgen) biodegradable collagen matrix implant and trabeculectomy without antifibrotic agents.

1. study objective: to determine the safety and effectiveness of the ologen (oculusgen) biodegradable collagen matrix implant in filtration surgery. the primary endpoint is to prove the effectiveness via the reduction of iop, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. study design: the study is designed as an open-label, randomized, parallel, comparative study. patients who meet the inclusion/exclusion criteria and sign informed consent will be included. after enrollment, patients will be randomized into two groups: trabeculectomy with oculusgen implant or trabeculectomy without antifibrotics. 3. follow-up: there will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. a window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. further follow-up of subjects after the trial will be the responsibility of the investigator.

Eligibility criteria:
inclusion criteria: * age 30 years or over. * no previous intraocular operative surgery * uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy. * subject able and willing to cooperate with investigation plan. * subject able and willing to complete postoperative follow-up requirements. * subject willing to sign informed consent form. exclusion criteria: * known allergic reaction to porcine collagen. * subject is on warfarin and discontinuation is not recommended. * patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma. * participation in an investigational study during the 30 days proceeding trabeculectomy. * ocular infection within 14 days prior to trabeculectomy. * pregnant or breast-feeding women

Keywords: glaucoma collagen matrix ologen oculusgen trabeculectomy
digital exercise for middle-aged adults with type 1 diabetes and other absolute insulin deficiency diabetes

Conditions: Type 1 Diabetes; Latent Autoimmune Diabetes in Adults; Pancreatitis

Summary: the challenges of living with type 1 diabetes often stand in the way of getting enough exercise. continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. this research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.


Eligibility criteria:
inclusion criteria: * diagnosis with type 1 diabetes (t1d) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis) * low exercise levels * smartphone ownership * english literacy * under regular care by a healthcare provider * home broadband wireless internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads) exclusion criteria: * diabetic ketoacidosis not clearly related to pump site failure in past 6 months * \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months * a1c ≥10.0% * resting blood pressure \>160mmhg systolic or \>100 mmhg diastolic * myocardial infarction or angina in past 12 months * uncontrolled arrhythmia (e.g., afib with rvr, new onset afib, ventricular tachycardia, escape rhythms) * congestive heart failure (stage 3 or 4) * exercise-induced asthma (not controlled on inhalers) * chronic obstructive pulmonary disease (requiring home oxygen) * renal failure * pregnancy * cognitive impairment * severe retinopathy or neuropathy. * other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
weight loss in diabetic, older obese adults

Conditions: Metabolic Syndrome X

Summary: this study examines the effects of weight loss and aerobic exercise training on sugar metabolism and other risk factors for heart disease in obese older individuals.


Eligibility criteria:
inclusion criteria: * age \> 50 years, * body mass index (bmi) \> 27kg/m(2), * no prior history of diabetes or coronary disease, * sedentary

Keywords: aging exercise metabolic syndrome insulin resistance