Kornimate/medical-research-clean huggingface dataset:
sub-sensitivity to long-acting bronchodilators (laba)

Conditions: Asthma

Summary: the purpose of this study is to look at whether advair® and symbicort® have different effects on airway constriction by means of methacholine challenge testing.


Eligibility criteria:
inclusion criteria: * 20 subjects males or females 18-65 years of age with physician diagnosed asthma diagnosis of asthma \> 12 months currently on 2 puffs saba bid. baseline percent fev1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at screening visit positive mtc (≤ 8mg/ml) at the end of 2 week run-in currently symptomatic with act score less than 19 at the end of run in on ics ≥ 200 and ≤ 400 ug/day non-smoker or ex-smoker with \ 1 year ago exclusion criteria: * asthma exacerbation, significant airflow obstruction, or respiratory infection between visits 0 and 2. patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event). pre-existing lung disease other than asthma, including active infections clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study noncompliance or inability to participate in all assessments. current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. a current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for \>/= 30 days within the 24 months prior to visit 1. any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for \< 30 days in the 24 months prior to visit 1, must agree to abstain from all smoking from the time of consent through completion. history of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator. participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer. women with a positive urine pregnancy test.
telemonitoring in pulmonary rehabilitation: validity of a remote pulse oxymetry system

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Telemedicine

Summary: the purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease. the feasibility is assessed using the patient's satisfaction and it ease of use. the reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.


Eligibility criteria:
inclusion criteria: * age \> 18 years ; * chronicle obstructive pulmonary disease stage ii/iii/iv (fev1 \< 80%) ; * referred for pulmonary rehabilitation. exclusion criteria: * pregnant woman or likely to be ; * patient under guardianship ; * neuropathic disorder ; * contraindication to cardiopulmonary exercise testing or pulmonary rehabilitation ; * progressive cancer.
probiotics in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (gi) tracts. the polymicrobial community composition of respiratory and gi tracts is influenced by both genetic and environmental factors. children with cf may harbor an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane conductance regulator (cftr) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). the investigators have previously demonstrated that intestinal inflammation is highly frequent in cf children, being a major feature of intestinal involvement. in addition, specific probiotics significantly improved airway and gi inflammation in a preliminary trial. the investigators aim to characterize intestinal and respiratory microflora in cf patients and to investigate the effects of daily lactobacillus gg (lgg) supplementation on both gi and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. the investigators aim is to eventually improve the quality of life of cf patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.


Eligibility criteria:
inclusion criteria: 1. a confirmed diagnosis of cf documented by sweat chloride test over 60 mmol/l and confirmed by genotype analysis with the presence of f508del/f508del or f508del/other 2. boys and girls between 2 and 16 years of age 3. clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks 4. pancreatic insufficiency 5. basal forced expiratory volume 1 second above 50% of predicted value exclusion criteria: 1. colonization of respiratory tract with burkholderia cepacia spp. 2. steroid therapy within one month before enrolment 3. pregnancy and fertile women taking oral contraceptives 4. parenteral or oral antibiotics therapy within 2 weeks before enrolment 5. regular assumption of probiotics 6. regular assumption of azythromycin

Keywords: pulmonary exacerbation inflammation intestinal microbiota
urinary continence index for prediction of urinary incontinence in older women

Conditions: Urinary Incontinence

Summary: this study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. this would create significant opportunities for focused prevention and early intervention strategies.


Eligibility criteria:
inclusion criteria: * women exclusion criteria: * men

Keywords: continence index
an economic and relationship-strengthening intervention for hiv-affected couples who drink alcohol in malawi

Conditions: HIV/AIDS; Alcohol Abuse

Summary: a couples-based alcohol-reduction and economic and relationship-strengthening intervention for hiv-affected couples in malawi.

this project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to art. the study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to art. specifically, the project aims: (1) to adapt and integrate two proven interventions, suubi and uthando lwethu, using the adapt-itt method, into a combined intervention for hiv-affected couples with a heavy alcohol user (to be called mlambe); (2) to develop and pilot test the study procedures to evaluate mlambe; and (3) to assess the feasibility and acceptability of mlambe through a pilot study. in the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. in the pilot phase, 80 hiv-affected couples with a heavy alcohol user will be enrolled and randomized to either mlambe or the comparison arm (regular hiv care plus brief advice on alcohol use). the study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.

Eligibility criteria:
inclusion criteria: * in a married or cohabitating union * have at least one partner with a positive audit-c screen in prior 3 months who is also currently on art for at least 6 months who has disclosed their hiv status to their partner exclusion criteria: * severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
telehealth behavioral migraine management

Conditions: Migraine

Summary: this project aims to develop the protocol and obtain feasibility and acceptability information for telehealth behavioral migraine management in a single-arm pre-post pilot study. the investigator and study team aim to recruit 20 people with migraine from the montefiore headache center in the bronx ny. participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.


Eligibility criteria:
inclusion criteria: * physician diagnosis of migraine * current self-reported symptoms meeting the international classification for headache disorders -- 3 criteria for migraine * self-reported between 4 and 20 headache days/month * aged 18-65 * can read english * capacity to consent exclusion criteria: * psychiatric illness that would interfere with study participation * meeting criteria for probable medication overuse headache
evaluation efficacy of melatonin gel as adjunctive therapy in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: this study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (srp) in the treatment of chronic periodontitis.

forty chronic periodontitis selected patients ,divided into two groups. group i: included 20 chronic periodontitis patients, treated by conventional periodontal therapy srp combined with intra- pocket application of melatonin gel once weekly for 1 month begin application at the second week after initial therapy. group ii: included 20 chronic periodontitis patients, treated by srp combined with the injection of placebo, weekly for one month. the periodontal parameters were recorded at baseline, 1week, 1and 3 months.gingival crevicular fluid (gcf) samples were collected and a quantitative measurement of receptor activator nuclear k ligand (rankl) was carried out by using enzyme-linked immunosorbent assay (elisa) at baseline, 1week, 1 and 3 months.

Eligibility criteria:
inclusion criteria: clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene exclusion criteria: diabetic mellitus immunsuppressive medication

Keywords: chronic periodontitis melatonin rankl (receptor activator nuclear k ligand) elisa (enzyme-linked immunosorbent assay) gingival crevicular fluid
physical activity and participation

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to investigate if the investigators can improve physical activity and social participation level among veterans with diabetes.

physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. the investigators developed a lifestyle intervention based on individual's home activity patterns. the goal of the study is to test the efficacy of this intervention among veterans with diabetes in a randomized-controlled trial. in addition to physical activity, the investigators will also assess if the intervention will improve social participation among veterans.

Eligibility criteria:
inclusion criteria: * veterans * aged 60 years or older * has type 2 diabetes mellitus * able to operate accelerometer * competent to consent to the study * no dementia diagnosis * ambulatory with or without assistive device * english-speaking * community living (i.e., not a nursing home resident) * not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week) exclusion criteria: * medically unstable * hospitalized within the last 6 months * 2 or more days of complete bed rest in the last month * hemiplegia or limb amputation * self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study * work involved in shift schedule * current enrollment of a physical activity program * replacement of hip or knee within the last 6 months. * parkinson's disease * frequent falls

Keywords: diabetes physical activity participation
a observational study to evaluate the efficacy and safety of pacitol inj.

Conditions: Chronic Kidney Disease 5D; Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the efficacy and safety of pacitol inj.(paricalcitol) for secondary hyperparathyroidism with stage 5d chronic kidney disease (ckd 5d) receiving hemodialysis


Eligibility criteria:
inclusion criteria: * among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (ckd 5d), those who are scheduled to administer pacitol inj. according to the product information. * those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study. * those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. exclusion criteria: * those with a history of hypersensitivity reactions to this drug or its components * those with evidence of vitamin d toxicity * those with hypercalcemia at enrollment * pregnant or lactating women * those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy. * those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(visit 1). * those who are judged by the principle investigator or sub-investigator to be ineligible to participate in the study.
acute concussion management in emergency medicine with 7t mri: a feasibility study

Conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Summary: the goal of this observational study is to learn about the brain imaging changes associated with concussion using a very detailed (7t) mri scanner. to do this, the investigators will study 7t mri brain imaging in patients aged 18-40 who present to the emergency department within 96 hours of a head injury. patients will be eligible if they have had a normal ct brain as part of their usual care. the investigators will compare brain imaging from patients who have completely recovered from an episode of concussion to patients who still have significant symptoms at approximately 28 days after a head injury. the study attempts to answer the following questions: 1. do patients with ongoing symptoms after concussion show greater 7t mri brain imaging evidence of changes to the blood vessels at approximately 28 days after their injury in comparison to patients who have recovered fully? 2. do patients with ongoing symptoms after concussion show greater 7t mri brain imaging evidence of changes in brain signaling pathways at approximately 28 days after their injury, in comparison to patients who have recovered fully?

evaluation of symptoms will be conducted at presentation in the emergency department and at 25 +/- 3 days after head injury. this will be assessed using 2 validated questionnaires: the neurological assessment questionnaire (naq) and the post concussion symptom scale (pcss). lifetime incidence of concussion will be assessed at 7t mri using the a modified version of the brain injury screening questionnaire (bisq). information will also be collected regarding painkiller use, anticoagulation, return to work, and any related further unscheduled care admissions or ct head imaging.

Eligibility criteria:
inclusion criteria: 1. isolated head trauma 2. initial review within 96h of injury 3. no acute findings on ct head 4. aged 18-40 years exclusion criteria: 1. patient unable to give informed consent 2. patient unable to speak and understand english 3. patients where alternative diagnosis cannot be excluded 4. polytrauma 5. contra-indication to mri 6. bmi \>40 or unable to comfortably lie on mri scanner 7. pregnant 8. major confounding neurological disease e.g multiple sclerosis, stroke, parkinson's disease. 9. patient participation in other research studies concurrently

Keywords: concussion 7t mri head injury mildtbi mri brain
treatment of atrophic acne scars with platelet-rich plasma and skin needling

Conditions: Atrophic Acne Scars

Summary: investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. a split-face design is going to used in this randomized controlled trial. in the control side of the face, micro-needling to the skin will occur using a specific tool (dermapen).

atrophic acne scar is a common problem with a challenging treatment. platelet-rich plasma (prp) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition. skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. the combination of skin needling and prp could enhance the efficacy of both modalities.

Eligibility criteria:
inclusion criteria: * atrophic acne scars on both sides of the face exclusion criteria: * patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer * systemic retinoids intake in the previous 6 months, * diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy * patients on anticoagulant therapy or aspirin or have a coagulation issue, * patients with hemoglobin less than 10g\\dl or platelet less than 105 micron\\l * any previous procedures for acne scar within the last 6 months
cipami-study: clopidogrel administered prehospital to improve primary pci in patients with acute myocardial infarction

Conditions: Myocardial Infarction

Summary: acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can be achieved by either thrombolytic therapy or primary pci. primary pci is facilitated if the flow in the target vessel is restored prior to the intervention. in addition the results of recent trials hint that clinical outcome is improved by a patent infarct-vessel before primary pci. the cipami-study analyses the effect of an early administration of clopidogrel on the flow-rates in subjects who suffered an acute myocardial infarction. for this purpose they are divided into two groups, both receiving standard baseline treatment. the subjects of one group additionally receive 600mg of clopidogrel, as early as possible, while the subjects in the second group receive standard therapy. in the second group clopidogrel is not allowed before initial angiography. in both groups the flow-rates before and after pci are analysed and compared in order to evaluate the efficacy, feasibility, and safety of the administration of a high loading dose clopidogrel in the very early phase of stemi in the prehospital setting.


Eligibility criteria:
inclusion criteria: * acute stemi \<= 6 hrs. * planned percutaneous coronary intervention * age \>= 18 years * ability to understand the natures, scope, and possible consequences of the study / legal capacity * informed consent exclusion criteria: * thrombolytic therapy within 24 hours before randomization * effective oral or intravenous anticoagulation (inr\>2, or ptt\>2xcontrol) * known hemorrhagic diathesis * stroke or tia within 3 months * evidence of an active gastrointestinal or urogenital bleeding * major surgery (including cabg) within 6 weeks * contraindication to clopidogrel * severe renal or hepatic insufficiency * contraindication to coronary angiography * planned administration of a gp iib/iiia-inhibitor before angiography * pregnant or nursing (lactating) women * women with childbearing potential * patients currently (within the last 10 days) treated with clopidogrel or ticlopidine * participation in another clinical or device trial within the previous 30 days

Keywords: myocardial infarction clopidogrel primary pci timi-flow stemi within 6 hrs.
a study to evaluate efficacy and safety of lifitegrast in subjects with dry eye (opus-3)

Conditions: Dry Eye Disease

Summary: evaluate the efficacy and safety of lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.


Eligibility criteria:
inclusion criteria: * patient-reported history of dry eye disease in both eyes. * use of over the counter artificial tears within the past 30 days. * a negative urine pregnancy test for females and willingness to use adequate birth control throughout the study. * able and willing to comply with all study procedures. exclusion criteria: * presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;. * unwilling to stop wearing contact lenses during the study. * lasik or other ocular surgical procedures within 12 months prior to or during the study. * use of prohibited medications * significant medical conditions that could affect the study parameters.
als phase ii study of nx210c

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study will investigate the efficacy, safety, tolerability and pharmacokinetics (pk) of multiple intravenous infusions of nx210c, at two dose levels, in patients with amyotrophic lateral sclerosis (als).

amyotrophic lateral sclerosis (als) is a fatal neurodegenerative disease that predominantly affects motor neurons of both the brain and the spinal cord. this leads to muscular atrophy and paralysis, with the majority of patients succumbing to respiratory failure 3-4 years from symptom onset. to date, therapeutic options for als are limited and there is no curative treatment. management of als is otherwise supportive and palliative. there is strong evidence for blood-brain and blood-spinal cord barrier dysfunction in the early stages of als. preclinical in vitro and in vivo data have shown that nx210c exhibits important properties that may be suitable for the treatment of neurological disorders in humans i.e., blood-brain barrier (bbb) integrity restoration, neurotransmission enhancement and neuroprotection. based on the safety data collected in a first-in-human single ascending dose study and a multiple ascending dose (mad) study in healthy elderly subjects, nx210c has been demonstrated to be well tolerated and without safety concerns.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years, inclusive at screening. * patients diagnosed as having possible, probable, probable laboratory-supported, or definite als according to el escorial revised criteria. * king's clinical staging stage ≤3, disease duration of ≤ 36 calendar months exclusion criteria: * patients with any cognitive or psychological disorder, intellectual disability or other significant impairment that would result in an inability to understand and sign the informed consent. * history of any clinically significant or unstable medical, neurological, psychiatric condition, disorder or disease (other than als) or social circumstances that, based on the investigator's judgment, would interfere with the conduct of the study or pose a risk to the patient if they were to participate.

Keywords: als