Kornimate/medical-research-clean huggingface dataset:
pulmonary rehabilitation in interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: interstitial lung disease (ild) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (ipf), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. people with ild frequently experience breathlessness on exertion, which limits their ability to undertake daily activities. people with ild report very poor quality of life due to low levels of physical functioning and vitality, and high levels of breathlessness and fatigue. there are few treatments for ild and those that are available have limited impact on quality of life. the aim of this study is to assess the effects of pulmonary rehabilitation, which consists of specialised exercise training for people with lung disease, on exercise capacity and quality of life in people with ild. we hypothesis that exercise training will result in reduced dyspnoea, improved exercise tolerance and enhanced quality of life.

interstitial lung disease (ild) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (ipf), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. people with ild frequently experience breathlessness on exertion, which limits their ability to undertake daily activities and reduces health-related quality of life.available treatments for ild have proved largely ineffective, offering no improvement in survival and demonstrating only limited impact on quality of life. aims of the research 1. evaluate the effects of pulmonary rehabilitation on exercise capacity and quality of life in patients with ild 2. determine the physiological response to pulmonary rehabilitation in patients with ild 3. determine the relationship between the aetiology and severity of ild and the effects of pulmonary rehabilitation. comparisons: 8 weeks exercise training compared to control group (maximal exercise capacity, functional exercise capacity, dyspnoea, quality of life).

Eligibility criteria:
inclusion criteria: * ambulant * stable medical therapy * dyspnoea on exertion following maximal treatment exclusion criteria: * a history of syncope on exertion * too unwell to attend the hospital for exercise training * any other comorbidities which would prevent exercise training * previous pulmonary rehabilitation in the last 12 months

Keywords: exercise pulmonary rehabilitation idiopathic pulmonary fibrosis connective tissue disorders
dose-ranging study of oral pha-022121 for prophylaxis against angioedema attacks in patients with hereditary angioedema type i or type ii

Conditions: Hereditary Angioedema; Hereditary Angioedema Type I; Hereditary Angioedema Type II; Hereditary Angioedema Types I and II; Hereditary Angioedema Attack; Hereditary Angioedema With C1 Esterase Inhibitor Deficiency; Hereditary Angioedema - Type 1; Hereditary Angioedema - Type 2; C1 Esterase Inhibitor Deficiency; C1 Inhibitor Deficiency

Summary: this study evaluates the safety and efficacy of pha-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (hae). the study consists of 2 parts, with patients completing participation in part 1 prior to initiation of treatment in part 2. part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of pha-022121 or matching placebo. patients will continue to the single open-label arm in part 2 of the study after completion of part 1. the screening period is up to 8 weeks and the treatment periods are 12 weeks (part 1) and 30 months (part 2) in duration.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * diagnosis of hae type i or ii * documented history of at least 3 hae attacks within the last 3 consecutive months prior to screening, or a minimum of 2 hae attacks during the screening period * reliable access and experience to use standard of care acute attack medications exclusion criteria: * pregnancy or breast-feeding * clinically significant abnormal electrocardiogram * any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study * use of c1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal hae therapy within a defined period prior to enrolment * abnormal hepatic function * abnormal renal function * history of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse * participation in any other investigational drug study within defined period

Keywords: hae hae type i hae type ii oral treatment bradykinin b2 receptor antagonist phvs416 pha121 prophylaxis deucrictibant
evaluation of pulpotomy using two different agents in mature anterior teeth with pulpitis

Conditions: Pulpitis

Summary: the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different biomimetic materials (neoputty® and biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.

in this randomized controlled trial, a total number of 75 mature vital permanent anterior teeth with recent trauma or deep caries in children aged between 9 and 14 years will be included. patients will be randomly allocated into three study groups: group a (premixed bioceramic neoputty®) test group, group b (biodentine™) test group and group c (root canal treatment) control group. cases will be evaluated clinically and radiographically to obtain baseline data. local anesthesia will be administered and then rubber dam isolation will be performed. pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with premixed bioceramic or biodentine™ according to the corresponding group then final composite restoration will be applied. root canal treatment will be performed to the control group followed by composite restoration. blinded clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Eligibility criteria:
inclusion criteria: * children and adolescents of both sexes aged between 9 and 14 years old. * vital mature permanent anterior teeth with deep caries lesions that approach the pulp with signs of pulpitis and respond positive to cold pulp testing. * vital mature permanent anterior teeth with pulpal exposure that occurred during caries excavation. * patients presented immediately after suffering recent trauma (at the same day) to mature anterior teeth that had resulted in a crown fracture with pulp exposure. exclusion criteria: * teeth with signs of infection such as swelling, sinus tract or pathological mobility or excessive mobility. * teeth with excessive bleeding from amputated radicular stumps * teeth showing radiographic evidence of pathologic root resorption, periapical pathology and calcifications in the canals. * lack of patient/parent compliance and cooperation. * children who are physically or mentally disabled or having any medical condition that will complicate the treatment. * patients allergic to any medicaments used.
preventing suicide among sexual and gender diverse young adults in primary care in texas

Conditions: Suicidal Ideation

Summary: the aim of this pilot study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. this pilot study will compare two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit 40 youth from 4-6 primary care clinics in the dallas and austin, texas metropolitan areas. each clinic will be randomly assigned to deliver one of the two study interventions.

this is a cluster randomized study focused on youth suicide prevention which will recruit 40 youth from four primary care clinics serving sexual and gender diverse young adults in the dallas and austin, tx metropolitan areas. each clinic will recruit 10 youth. two clinics will be randomly assigned to deliver each of the two study interventions. the interventions are adapted versions of two existing, brief suicide prevention interventions: 1) suicidal teens accessing treatment after an ed visit (stat-ed) is a brief intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management; and 2) youth-nominated support team for suicidal adolescents (yst-ii) is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation. the revised interventions will be called stat-pc and yst-iii. for yst iii, participants will identify 1-2 supportive adults from their lives who agree to provide ongoing contact and support. the interventions will last two months. primary and secondary outcome assessments will be done at baseline and/or at 2 months. to be eligible, participants must report risk factors for suicide based on screening questions that will be implemented in our primary clinic sites.

Eligibility criteria:
inclusion criteria: * be aged 18-24 at the time of enrollment; and * not have received mental health services in the past 90 days, excluding medication; * english-speaking, and * screen positive for suicidal ideation. exclusion criteria: * are actively suicidal * have a developmental disability that would preclude them from participating in the study intervention or * who are impaired due to psychosis, mania, or substance use that would prevent them from providing consent. * participants will also be excluded at yst-iii sites if they are unable to identify a minimum of one support person to participate in the intervention with them. those who are excluded will be provided with referrals for treatment services.

Keywords: suicidal ideation depression suicide sexual and gender minority youth
drug interaction - oral contraceptive

Conditions: HIV Infections

Summary: the purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the hiv treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. the safety of this treatment regimen will also be studied.


Eligibility criteria:
inclusion criteria: * women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study. * documented acceptable pap smear within 1 year of the start of the study * bmi of 18-32 kg/m² exclusion criteria: * males * subjects with abnormal menstrual cycle within 2 months prior to the start of the study * history of conditions in which oral contraceptives are contraindicated * history of migraine with focal aura * history of uncontrolled hypertension * positive screening test for hiv-1,-2, hiv viral rna, hepatitis b surface antigen, or hepatitis c antibody * history of diagnosed mental illness or suicidal ideation

Keywords: hiv
fall risk reduction in multiple sclerosis (firms)

Conditions: Multiple Sclerosis

Summary: this study looks to see the effects of a home based exercise program on falls in people with ms.

the purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with ms; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

Eligibility criteria:
inclusion criteria: * the inclusion criteria involve having an established definite diagnosis of ms * ability to walk 25 feet with or without aid * relapse free in the last 30 days * being ≥ 50 years of age * having fallen at least once in the past year * physician approval to engage in light physical activity * willingness and ability to attend the training sessions and testing sessions. exclusion criteria: * we will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise. * during the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire. * those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.
a study to evaluate chronic hepatitis c infection

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to evaluate the safety and efficacy of abt-450, ritonavir and abt-267 (abt-450/r/abt-267; abt-267 also known as ombitasvir) and abt-333 (also known as dasabuvir) co-administered with ribavirin (rbv) in hepatitis c virus genotype 1 infected treatment-naïve adults.


Eligibility criteria:
inclusion criteria: * females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control * chronic hepatitis c, genotype 1-infection and hcv rna level greater than 10,000 iu/ml at screening * subject has never received antiviral treatment for hepatitis c infection * no evidence of liver cirrhosis exclusion criteria: * positive screen for drugs or alcohol * significant sensitivity to any drug * use of contraindicated medications within 2 weeks of dosing * certain predefined abnormal laboratory tests * positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody

Keywords: hepatitis c virus hepatitis c genotype 1 hepatitis c treatment-naïve interferon-free chronic hepatitis c viekira pak ombitasvir paritaprevir dasabuvir
a follow up safety study of patients who participated in previous studies of the drug org 24448 (study p05719)(completed)

Conditions: Psychosis

Summary: this is a safety study evaluating the subjects who participated in previous organon trials of the drug org 24448. patients will undergo a screening visit, 1 or 2 evaluation visits, and a possible follow-up period. during the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.

all subjects who participated in previous org 24448 trials and who do not meet any of the exclusion criteria are eligible.

Eligibility criteria:
inclusion criteria: subjects must: * be verified by the investigator to have participated in a previous organon sponsored org 24448 trial. * sign an affirmative informed consent before evaluations are conducted; exclusion criteria: subjects must not have: * a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). if possible, evaluation of such subjects is deferred until resolution of such conditions.
the ecovita study - validation of lus score in sars-cov-2 disease, i.e covid-19

Conditions: Respiratory Distress Syndrome

Summary: lung ultrasound (lus) has been revealing an extremely useful tool to identify and monitor complications from sars-cov-2 disease. recently, a research group has proposed a score, named lus score, able to optimize the use of this diagnostic technique. lus score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (b lines), the characteristics of the pleural line and the presence or not of consolidation areas. the comparison between lus and chest tomography (ct), the current gold standard for the diagnosis of interstitial pneumonia by covid-19, has confirmed from the preliminary data, the reliability of such technique. hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.


Eligibility criteria:
inclusion criteria: * men and women; * confirmed covid19 diagnosis after nasal-oropharyngeal swab; * any symptom at hospitalization * any therapy * any pre-existing comorbidity exclusion criteria: * pregnant women * healthy subjects with other respiratory diseases different from covid-19

Keywords: lung ultrasound
transoral incisionless fundoplication (tif) registry study for treatment of gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia

Summary: the study objective is to evaluate the safety and efficacy of tif among a broad range of gerd patients treated in routine clinical practice at multiple centers across the united states.

primary effectiveness endpoint: typical and atypical gerd symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline. secondary effectiveness endpoints: gerd symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of ppis; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Eligibility criteria:
inclusion criteria: * age 18-75 years * gerd for \> 1 year * history of daily ppis use for \> 6 months * moderate to severe typical or atypical gerd symptoms off ppis * complete (responders) or partial (nonresponders) symptom control on ppis * deteriorated gastroesophageal junction (hill grade ii or iii) * proven gastroesophageal reflux by either endoscopy, ambulatory ph or barium swallow testing * willingness to undergo ph/impedance testing, if required * willingness to cooperate with the postoperative diet for 6 weeks * availability for follow up visits at 6 months and 12 months * willingly and cognitively signed informed consent exclusion criteria: * bmi \> 35 * incompletely reducible hiatal hernia with residual of \> 5 mm * esophagitis grade d * barrett's esophagus \> 2 cm * esophageal ulcer * fixed esophageal stricture or narrowing * portal hypertension and/or varices * active gastro-duodenal ulcer disease * gastric outlet obstruction or stenosis * gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment * coagulation disorder * history of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for tif procedure per physician judgment, cervical spine fusion, zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis * pregnancy or plans of pregnancy in the next 12 months * enrollment in another device or drug study that may confound the results

Keywords: gerd esophagitis fundoplication anti-reflux surgery ppi dependent
evaluation of influence of two treatment protocols on mandibular movements and condyle-fossa relation

Conditions: Temporomandibular Disorders

Summary: the edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. the reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. however, there are not randomized controlled clinical trials (rcts) testing the combined use of these two treatments in reestablishing these functional aspects. the, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. for this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. the volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: control (c)volunteers will receive new complete denture without any previous intervention in their old complete denture; relining denture (rd)volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; interocclusal appliance (ia) volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of gothic gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by willis compass and photographic record. these evaluations will be performed at three periods, t0 baseline; t1 after application of randomized treatment, reline denture and interocclusal appliance); t3 after final rehabilitation. the control group will be evaluated only at periods t0 and t3.


Eligibility criteria:
inclusion criteria: 1. healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years; 2. have availability to attend fo / ufpel days predetermined; 3. agree with the term informed consent, approved by the research ethics committee of fo / ufpel. exclusion criteria: 1. patients younger than 40 years; 2. patients who are not users of denture upper and lower; 3. patients denture wearers during periods of less than five years.
effect of valsartan on proteinuria in patients with hypertension and diabetes mellitus

Conditions: PROTEINURIA; Hypertension; Type 2 Diabetes

Summary: this is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.


Eligibility criteria:
inclusion criteria: - mild to moderate hypertension, mild renal dysfunction, type 2 diabetes, exclusion criteria: pregnant or breast feeding, type 1 diabetes other protocol criteria apply

Keywords: proteinuria hypertension valsartan type 2 diabetes