Kornimate/medical-research-clean huggingface dataset:
a study of mosliciguat in ph-ild

Conditions: Pulmonary Hypertension; Interstitial Lung Disease; Lung Diseases; Vascular Diseases; Cardiovascular Diseases; Fibrosis

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (ph-ild).

this study is a randomized, double-blind, placebo-controlled study with an extension. the study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks). participants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period. all participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants will receive mosliciguat.

Eligibility criteria:
inclusion criteria: * participants willing and able to provide informed consent * participants with diagnosis of interstitial lung disease (ild). diagnosis will be confirmed by a high-resolution computerized tomography (hr-ct) scan showing diffuse parenchymal disease. eligible diagnosed diseases include: 1. idiopathic interstitial pneumonia (iip) 2. chronic hypersensitivity pneumonitis 3. ild associated with connective tissue disease (ctd) with a forced vital capacity (fvc) \< 70% of predicted * confirmed pulmonary hypertension (ph) by right heart catheterization (rhc). * ability to perform 6mwd ≥100 meters. exclusion criteria: * diagnosis of ph group 1 (eg. pulmonary arterial hypertension), group 2 (related to left-heart dysfunction), group 4 (eg, chronic thromboembolic pulmonary hypertension), or group 5 (eg, unclassified). * exacerbation of underlying lung disease within 28 days prior to randomization. * initiation of pulmonary rehabilitation within 28 days prior to randomization. * receiving \>10 l/min of oxygen supplementation by any mode of delivery at rest at baseline. * history or intolerance to or lack of efficacy with mosliciguat or sgc stimulators or activators. * receipt of investigational, or experimental therapy within 42 days or 5 half-lives prior to randomization. note: other inclusion and exclusion criteria may apply.

Keywords: ph ild 6 minute walk test mosliciguat
bosentan for severe mitral valve dysfunction

Conditions: SECONDARY PULMONARY HYPERTENSION; MITRAL STENOSIS; CHILDHOOD RHEUMATOID FEVER; CONGESTIVE HEART FAILURE

Summary: vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary arterial hypertension, but has also been documented in secondary pulmonary hypertension due to congestive heart failure, including cardiac valve disease. the investigators aim to examine the clinical and physiologic effects of bosentan therapy in patients with secondary pulmonary hypertension due to severe, inoperable cardiac valve disease, using a single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients with severe mitral stenosis due to childhood rheumatoid fever. primary end-point will be exercise capacity at six months determined by six-minute walking distance and cardiopulmonary exercise testing. secondary end-points will be symptomatic relief, echocardiographic left ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse events at six months.


Eligibility criteria:
inclusion criteria: * outpatient * \> 60 yrs old * \< 85 yrs old * stable disease * congestive heart failure nyha iiib/v * inoperable mitral stenosis due to childhood rheumatoid fever * mean pulmonary artery pressure \> 40 cm h2o exclusion criteria: * prior treatment with endothelin receptor antagonist(s) * hospitalization (exacerbation) * cardiac valve surgery

Keywords: endothelin receptor antagonist bosentan secondary pulmonary hypertension rheumatoid fever congestive heart failure secondary pulmonary hypertension due to mitral stenosis
evaluation of safety and efficacy of new infant formula in infantile colic

Conditions: Infantile Colic

Summary: the study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic. primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.


Eligibility criteria:
inclusion criteria: * healthy term infants * subjects appropriate for gestational age between 35 and 41 weeks * subjects between 15-60 days old * subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week) * diagnosis of infantile colic according to modified wessel criteria (crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week) * subjects exclusively bottle-fed at study entrance * day care of the child only by mother/father * provide written informed consent in accordance with legal requirement exclusion criteria: * neonatal problems (respiratory distress, asphyxia, hypoglycaemia, sepsis, nec) * clinical evidence of chronic illness or gastrointestinal disorders (ger, gastroenteritis) * assumption of any kind of medication (except vitamin d, vitamin k and fluoride prophylaxis) during the week before the beginning of the study and during the study period * subjects receiving formula for special medical purposes * exclusively breast-fed infants * feeding of supplemental pro- and/or prebiotics two weeks prior to inclusion * allergic diseases (manifest atopic dermatitis, cow's milk allergy) * participation in any other clinical intervention

Keywords: infant nutrition, infantile colic
a randomised controlled trial of lumbar drainage to treat communicating hydrocephalus after severe intraventricular hemorrhage

Conditions: Intracerebral Hemorrhage; Obstructive Hydrocephalus

Summary: the purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.

all patients requiring external ventricular drain (evd) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-pa via the ventricular catheter. lumbar drainage (ld) is inserted at a timepoint, when communication between the internal and the external csf-spaces is recognizable on ct ("opening" of third and fourth ventricle and aqueduct).

Eligibility criteria:
inclusion criteria: * supratentorial intracerebral hemorrhage \<60ml * intraventricular hemorrhage with casting of the third and fourth ventricles * obstructive hydrocephalus with need of external ventricular drainage * gcs \<9 on admission or within 48h of symptom onset * admission within 48h of symptom onset * preceding modified rankin scale ≤3 * age 18-85 years exclusion criteria: * ich related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis * infratentorial hemorrhage * pregnancy * admission 48h after symptom onset * preceding modified rankin scale \>3

Keywords: intracerebral hemorrhage intraventricular hemorrhage hydrocephalus intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
tea tree oil in the treatment of chronic blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to determine: * the prevalence of demodex sp. in chronic blepharitis. * the efficacy of the treatment of topical tree tea oil in chronic blepharitis for demodex sp.

patients with clinical diagnosis of chronic blepharitis were included in this study. a check list of symptoms and an ophthalmologic examination including best corrected visual acuity and biomicroscopy were performed. under a slit lamp visualization, three lashes with cylindrical dandruff of each eyelid were epilated by fine forceps. the lashes were immersed in fluorescein dye and examined under a light microscope at a 20-times magnification. the mites were detected based on its morphological characteristics and movement. the patients with chronic blepharitis who had demodex were randomly divided in two groups. the treatment group was prescribed lid hygiene with tea tree oil shampoo 0.25% and ointment 5% daily and tea tree oil oily solution 50% once a week - produced by ophthalmos, são paulo. the control group used the same posology of placebo similar products. after six weeks, all subjects underwent the initial clinical and laboratory examination. the symptoms and the quantity of mites (mites/eye) were compared before and after the treatment in both groups.

Eligibility criteria:
inclusion criteria: * chronic blepharitis with out treatment previously exclusion criteria: * patients under 18 y.o. * pregnant woman * others ocular surface disease (severe dry eye, lagoftalmo, entropium, ectropium)

Keywords: tea tree oil chronic blepharitis
effectiveness of different hypopressive exercises in pelvic floor dysfunction

Conditions: Pelvic Floor Disorders

Summary: the purpose of the study is to compare the efficacy of different modalities of hypopressive exercises and biofeedback with ultrasound in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.

female 18-65 years old inclusion criteria: women diagnosed with pelvic floor dysfunction by their doctor. with minimum strength of the pelvic floor muscles of 3 according to modified oxford score exclusion criteria: women who are pregnant or women who have had a vaginal or caesarean birth in the past six months. women whose pfd is severe and the first indication is surgical (pop-q grade iii-iv prolapses). women with only urinary incontinence or fecal urgency. women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine. women who have received pelvic floor physiotherapy treatment in the last 12 months. women who are unable to voluntarily contract the pelvic floor muscles, quantified by the modified oxford score by a score less than or equal to 2. women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria. women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.

Eligibility criteria:
inclusion criteria: * women diagnosed with pelvic floor dysfunction by their doctor. * with minimum strength of the pelvic floor muscles of 3 according to modified oxford score exclusion criteria: * women who are pregnant or women who have had a vaginal or caesarean birth in the past six months. * women whose pfd is severe and the first indication is surgical (pop-q grade iii-iv prolapses). * women with only urinary incontinence or fecal urgency. * women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine. * women who have received pelvic floor physiotherapy treatment in the last 12 months. * women who are unable to voluntarily contract the pelvic floor muscles, quantified by the modified oxford score by a score less than or equal to 2. * women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria. * women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.

Keywords: hypopressive exercises pelvic floor muscle trianing ultrasound
luminopia one amblyopia vision improvement study

Conditions: Amblyopia

Summary: the objective of the study is to demonstrate the safety and efficacy of luminopia one in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

the proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye best corrected visual acuity from baseline with luminopia one ("therapeutic") to refractive correction ("control"). one-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. participants will be randomized 1:1 to the "therapeutic group ", to use luminopia one, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * age 4 to 7 years at the time of consent. * amblyopia associated with anisometropia and/or mild strabismus. * current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logmar lines. * amblyopic eye best-corrected visual acuity (bcva) 20/40 to 20/200 inclusive. * fellow eye bcva 20/32 or better. * interocular difference ≥ 3 logmar lines. * heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by spct. exclusion criteria: * atropine treatment in the past 2 weeks. * prior amblyopia treatment (other than refractive correction) for \> 12 months in total. * high myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay. * history of low adherence with amblyopia treatment or light-induced seizures.
plastic stents compared with metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer

Conditions: Esophageal Cancer; Gastrointestinal Complications

Summary: rationale: placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer. purpose: this randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.

objectives: primary * assess differences from baseline in health-related quality of life of patients with malignant dysphagia due to cancer of the esophagus or gastroesophageal junction palliated with self-expanding plastic stents (seps) compared to those who receive self-expanding metal stents (sems). secondary * perform a cost-effective analysis of each type of stent by independent evaluation of the rates of seps-related and sems-related morbidity that necessitates repeat endoscopic interventions and/or additional healthcare costs in these patients. * analyze effective palliation (degree and duration of improvement of dysphagia) in these patients. * determine the individual rates of complication associated with each type of esophageal stent in these patients. outline: this is a randomized, controlled study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo placement of a self-expanding metal stent on day 1. * arm ii: patients undergo placement of a self-expanding plastic stent on day 1. health-related quality of life is assessed at baseline, 30 days, and 3 months. projected accrual: a total of 90 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed primary cancer of the esophagus or gastroesophageal junction * squamous cell or other type * diagnosis of malignant dysphagia * disease deemed surgically inoperable, but may be any of the following: * locally contained * locally advanced * metastatic * unresponsive to previous chemoradiotherapy * recurrent despite previous surgical resection * must be either an inpatient or outpatient at johns hopkins hospital * no known tracheal compression by tumor burden patient characteristics: * karnofsky performance status 50-100% * life expectancy ≥ 6 months * platelet count \> 50,000/mm³ * inr \< 1.5 prior concurrent therapy: * see disease characteristics * prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed * no concurrent surgery, chemotherapy, biologic therapy, or radiotherapy

Keywords: recurrent esophageal cancer stage iii esophageal cancer stage iv esophageal cancer squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus gastrointestinal complications
a safety study in patients with advanced prostate cancer treated with firmagon

Conditions: Prostate Cancer

Summary: this study is a large observational study, set-up to observe how long-term treatment with firmagon (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. subjects will be treated according to their routine clinical care and not dictated by the study. as the study is observational in nature, the study will collect data relating to the events specified above. subjects that agree to this study will be followed-up for 5 years. subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.


Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer and indicated for androgen deprivation therapy (adt) * decision made to prescribe adt prior to enrolment * willing and able to provide written informed consent exclusion criteria: * participation in an interventional clinical study in which any treatment or follow-up is mandated * treatment with a gnrh receptor antagonist other than firmagon * had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. treatment should be terminated at least 6 months prior to baseline.
international ataxia rating scale in younger patients

Conditions: Ataxia Telangiectasia

Summary: the project will collect information on the mapping of clinical ratings on a number of scales that are used in the assessment of patients with ataxias.


Eligibility criteria:
inclusion criteria 1. patients aged 6-18 years with diagnosed with ataxia, preferably at will be included. the diagnosis of at will be made based on the criteria: typical clinical picture plus one of the following: 1. a proven mutation in the atm gene 2. deficient atm protein proven by western blotting 3. elevated α-fetoprotein, cerebellar atrophy on mri and immune deficiency/ chromosomal breakage/ t- cell lymphoreticular malignancy. 2. children aged 6-18 years with suspected at (fulfilling partially the above criteria will be included) 3. children aged 6-18 years with at like disease, with or without proven mutation in the mre11 gene will be included 4. children aged 6-18 years of age with ataxia of other known or unknown etiologies might be included, but their total number should not exceed 20% of the cohort in each site
a safety, tolerability, pharmacokinetics and pharmacodynamics study of pf-06700841, with bioavailability/food effect investigation

Conditions: Plaque Psoriasis

Summary: the main purpose of the study is to determine if pf-06700841 is safe and well tolerated when administered to humans. a secondary purpose is to assess what the body does to pf-06700841 and to assess what pf-06700841 does to the body when given as single and multiple doses. the pharmacokinetic properties of different forms of pf-06700841 may be studied (tablet and solution/suspension forms).


Eligibility criteria:
inclusion criteria: key inclusion criteria for healthy subject cohorts: * healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) key inclusion criteria for psoriasis subject cohorts: * male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive * have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose exclusion criteria: key exclusion criteria for healthy subject cohorts: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product key exclusion criteria for psoriasis subject cohorts: * currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis). * have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium * males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
endoscopic remission, histologic remission and barrier healing for predicting disease behaviour in ibd

Conditions: Inflammatory Bowel Diseases

Summary: within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent ibd patients.

mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (ibd) that is associated with favorable long-term disease outcome. in addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (cle) correlates to clinical disease behavior and outcome. within this study, the investigators will prospectively include ibd patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. participants will then be closely followed up in the ibd outpatient department of the university hospital erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. at each visit, clinical disease activity using the mayo clinical score (mcs) and the crohn's disease activity index (cdai), respectively, routine laboratory parameters and current and past medications will be recorded. further, at each visit, major clinical events (mce), defined as (i) disease flare; (ii) ibd-related hospitalization, (iii) ibd-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. the primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of mce in ibd patients in clinical remission

Eligibility criteria:
inclusion criteria: * patients with an established ibd diagnosis for at least 12 months duration * ibd patients in clinical remission exclusion criteria: * patients with poor bowel preparation * patients with total colectomy, * patients with concomitant beta blocker therapy, * patients with known allergy to fluorescein * patients with a planned change in ibd-related pharmacotherapy