Kornimate/medical-research-clean huggingface dataset:
using agn-190584 in subjects utilizing single -use daily, contact lenses

Conditions: Presbyopia

Summary: agn-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. there has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. there are many other applications agn-190584 could be used for and further studies will show the effectiveness for each.

the study is a single center open label, single arm study with no control and no randomization. investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. investigators will measure change in letters read at near and intermediate vision from baseline. subjects will be required to apply agn-190584 drops once daily ou. subjects will be applying the drops on their own every day including the day of visits. during treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. these visits will be conducted between 2 and 4 hours after instillation of agn-190584, with 3 hours being the target time.

Eligibility criteria:
inclusion criteria: * subjects from age 40-55 * prescription range: -4.00 - +1.00 * correctable to 20/25 or better for distance * adapted single use contact lens patients * subjects able to understand the consent agreement and willing to participate exclusion criteria: * non-contact lens wearer * previous use of agn-190584 * out of age range * out of prescription range * any corneal abnormality * any eye pathology * iritis * know allergy to pilocarpine

Keywords: presbyopia
efficacy of hyperbaric oxygen therapy in the treatment of osteoradionecrosis

Conditions: Osteoradionecrosis

Summary: the purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.

late radiation damage to the lower jaw (osteoradionecrosis (orn)) is often seen in patients treated with radiotherapy for a tumor in the head and neck region. part of the lower jaw becomes non-vital and has to be treated. orn proofs to be a condition difficult to treat and the treatment for this condition varies. in many countries hyperbaric oxygen therapy (hbot) is added to the surgical treatment of orn. unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of orn is beneficial or not. this study has the aim to investigate the efficacy and cost-effectiveness of hbot in the treatment of orn

Eligibility criteria:
inclusion criteria: * informed consent * age ≥ 18 jr * who performance status 0-2 * last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 gy. the affected part of the jaw must be in the target volume area of the radiotherapy field. * local recurrence must be ruled out * necrosis of the jaw with at least one of the following symptoms for over 3 month present: * bone exposition which measures at least 1 cm * evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis orn. * non-healing extraction socket exclusion criteria: * former hbo treatment * contra indication for hbo treatment (pneumothorax) * bisphosphonate treatment in the medical history * reirradiation in the medical history * osteosynthesis material in the affected area * distant metastasis * primary or recurrent tumor in the affected area * malignancies elsewhere

Keywords: osteoradionecrosis mandible radiotherapy hyperbaric oxygen therapy
efficacy/safety study as h. pylori eradication of triple therapy for 7 days treatment

Conditions: Peptic Ulcer

Summary: the purpose of this study is to evaluate of efficacy and safety as h.pylori eradiation effect between ilaprazole and pantoprazole triple therapy for 7 days treatment in gastric and/or duodenal ulcer patients with h.pylori positive infection.

this study is to evaluate of efficacy and safety as h.pylori eradiation effect between ilaprazole and pantoprazole triple therapy for 7 days treatment in gastric and/or duodenal ulcer patients with h.pylori positive infection.

Eligibility criteria:
inclusion criteria: * 18 year old ≤ male or female \< 75 year old * patients who had endoscopically confirmed gastric and/or duodenal ulcer and h.pylori infection confirmed by urea breath test * patients who understand the study conditions * patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud exclusion criteria: * patients with known allergy or hypersensitivity reaction to the investigational products * patients who use the investigational products * patients who undergone h.pylori eradication * patients with abnormal laboratory results, as specified below: total bilirubin, creatinine \> 1.5 x upper limit of normal aspartate transminase, alanine transminase, alkaline phosphatase, blood urea nitrogen \> 2 x upper limit of normal * patients who used proton pump inhibitor agents or antibiotics within the last 2 weeks before the start of the investigational products * pregnant women and lactating women * women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(menopausal women who did not have a menstrual period for at least 12 months were considered infertile) * patients with uncontrolled diabetes mellitus * patients with uncontrolled hypertension * patients with alcoholics * patients with a history of malignancy within 5 years prior to the study entry (day 1) (except for basal cell carcinoma of the skin) * patients who had undergone a esophageal or gastric surgery * patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption * patients who had participated in other investigational study within 30 days before the study entry (day 1) * patients who, in the investigator's opinion, are not suitable for the study for any other reason
efficacy of nasal naphazoline hydrocloride + pheniramine maleate + panthenol compared with naphazoline hydrocloride in the symptomatic control of nasal congestion and nasopharyngeal

Conditions: Flu; Cold; Allergic Disorder of Respiratory System

Summary: the common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. at the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment. the study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

study design * randomized,double blind, prospective, multicentric, parallel group, intent to treat trial * experiment duration: 3 days * 2 visits (days 0 and 2) * evaluation of symptoms reduction * adverse events evaluation

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the study procedures, agree to participate and give written consent. 2. patients aged over 18 years of both sexes; 3. patients with clinical signs of flu and colds or other upper respiratory allergies; 4. patients with early signs and symptoms with time of evolution not more than 72 hours. exclusion criteria: 1. patients treated with antibiotics 2. current treatment with immunosuppressants (eg.cyclosporine or methotrexate); 3. use of intranasal cromalin the week before inclusion; 4. use of decongestants or anti-histaminic (intranasal or systemic); 5. presence of any disease or anatomical abnormality that may difficult the data analysis ; 6. uncontrolled hypertension; 7. presence of respiratory symptoms for more than 14 days; 8. history of abuse of drugs and alcohol; 9. presence of other concomitant pulmonary diseases; 10. hypersensitivity to any compound of investigational product

Keywords: nasal and nasopharyngeal congestion
kinesiotaping method for rib fractures

Conditions: Rib Fractures; Pain, Chest

Summary: kinesiotaping is used as a physiotherapy method to reduce muscle pain. in this technique, kinesiotaping tapes are attached to the relevant parts of the body. patients experience serious pain in rib fractures. kinesiotaping technique can potentially reduce pain by contributing to external stabilization of the ribs. in this study, patients with isolated rib fractures will be divided into two groups. the first group will be treated with kinesiotaping technique and routine painkillers. the second group will receive routine painkiller treatment. pain scores between both groups will be compared.


Eligibility criteria:
inclusion criteria: * isolated thoracic injury within the last 24 hours * patients aged 18-100 years exclusion criteria: * hemothorax and pneumothorax requiring intervention * injury severity index\>16 * asthma and copd * tape allergy * loss of consciousness (gcs \<15) * incapacitated patients * fracture of rib number 1-3
covid-19 and lactating mothers

Conditions: Coronavirus Infection

Summary: the purpose of this study is to determine if there may be covid-19 virus in various samples collected from mothers and infants.


Eligibility criteria:
inclusion criteria: * currently lactating mother: * english-speaking * greater than or equal to 18 years of age * assigned female at birth (afab) * having a positive covid-19 test within 14 days * child: * infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included exclusion criteria: * non-english speaking
predictability of thromboelastography parameters in severe post partum hemorrhage

Conditions: Post Partum Hemorrhage

Summary: the aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.


Eligibility criteria:
inclusion criteria: * women presenting with a post partum hemorrhage * needing sulprostone infusion * during third trimester of pregnancy exclusion criteria: * known coagulation disorders

Keywords: thromboelastography
measurement of cerebral flow using transfontanellar doppler in infants under cardiopulmonary bypass

Conditions: Cardiopulmonary Arrest

Summary: transfontanellar doppler can measure the velocity at both the carotid artery and the anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients. this study can provide reference value of appropriate cerebral blood flow velocity during pediatric cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass 2. written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee exclusion criteria: 1. synostosis 2. skull abnormality or fracture 3. epidural hematoma, scalp hematoma
placebo and active controlled study of rivoglitazone in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. the study tests rivoglitazone and uses a placebo and active treatment group for comparison.


Eligibility criteria:
inclusion criteria: * type 2 diabetes in male or female patients * between 18 and 75 years of age * with a hba1c greater than or equal to 7.5% and less than 10.5% at randomization exclusion criteria: * type 1 diabetics or type 2 diabetics currently on insulin therapy * patients unwilling or unable to discontinue their anti-diabetic medication(s) * history of ketoacidosis * history of therapy with rosiglitazone, troglitazone, pioglitazone

Keywords: placebo and active control dose response study of rivoglitazone in type 2 diabetics
collaborative adolescent research on emotions and suicide

Conditions: Suicidal and Self-injurious Behaviour

Summary: suicide is the third leading cause of death among adolescents in the us yet there is a paucity of research on effective treatments for this population. the primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (dbt) for suicidal adolescents. dbt has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (bpd). while dbt is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of bpd such as poor emotion regulation and impulse control, no randomized trial of dbt with suicidal adolescents has ever been conducted. and, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether dbt for suicidal adolescents is efficacious or not. given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. the second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (seattle and los angeles) will be randomized to dbt or individual and supportive group therapy (igst). both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.


Eligibility criteria:
inclusion criteria: 1. current suicide ideation; 2. more than one intentional self-injury or suicide attempt; 3. has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder; 4. 13-17 years of age; 5. at least one family member or responsible adult available to participate in assessments and treatment. exclusion criteria: * has significant developmental delays * has significant current mania, psychosis or life threatening anorexia * has a court order for treatment
evaluation of retinal and vascular features in macular degeneration after intravitreal injections of bevacizumab

Conditions: Exudative Age-related Macular Degeneration

Summary: this study evaluates the retinal and vascular features in patients with macular degeneration under the effects of bevacizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment for exudative age-related macular degeneration acting on vascular hyperpermeability. the optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of retinal and vascular features. the study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of bevacizumab in exudative amd.

Eligibility criteria:
inclusion criteria: * age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with bevacizumab for exudative age-related macular degeneration. exclusion criteria: * age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before bevacizumab for exudative age-related macular degeneration.

Keywords: optical coherence tomography angiography optical coherence tomography angiography angiography bevacizumab vascular endothelial growth factor antagonists intravitreal injection
valproic acid in the induction of ebv lytic cycle antigen expression in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the proposed study will test the safety and efficacy of sodium valproate in the induction of epstein-barr virus (ebv) lytic cycle antigen expression in tumor tissue of patients undergoing primary therapy for nasopharyngeal carcinoma. up to 20 patients will be given valproic acid for 2 weeks. the primary surrogate endpoint for efficacy will be expression of ebv lytic antigens by immunohistochemistry in tumor tissue. biopsies of primary tumor will be taken after 2 weeks with achievement of a therapeutic concentration of valproate. expression of immunodominant ebv latency antigens in tumor tissue, ebv viral load by real time pcr, and valproate levels will be measured. adverse events associated with valproate in npc patients will be described.


Eligibility criteria:
inclusion criteria: all subjects must fulfill the following criteria to be eligible for study admission: * subjects are of age 18 years and above * biopsy proven nasopharyngeal carcinoma - who type 3 * must have tumor which is accessible to biopsy * for patients with disease localized to the pns, the lesion must be visualized by endoscopy * subjects with metastatic disease with disease accessible to biopsy in the pns if they are deemed by their treating physicians not to require treatment for at least two weeks. * an ecog performance status of 0-2 * for sexually active women of child-bearing potential, negative pregnancy test within 14 days of enrolling on trial * must be able to give informed consent exclusion criteria: * for patients with localized npc, pns lesions that cannot be visualized by endoscopy * patients with disease inaccessible to biopsy * history of anaphylaxis after exposure to valproic acid * hepatic dysfunction as defined by total bilirubin 1.0x upper limit of normal. ast (sgot) and alt (sgpt) 3x upper limit of normal * hemoglobin 8g/dl, absolute neutrophil count 1500 cells/mm, and platelet count 100,000 /mm * creatinine 3x upper limit of normal * pt/ptt blood test result not within normal range * patients who require treatment with an anticonvulsant besides valproic acid during the course of valproate prescribed by the protocol * ecog performance status 3-4 * patients who are pregnant or breast feeding (sexually active women of childbearing potential must use contraception during course of therapy and within 4 weeks of completion of trial) * participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
functional connectivity changes during early recovery as a marker for relapse

Conditions: Substance Use Disorder

Summary: the study purpose is to examine whether there are structural or functional differences in the brains of individuals who use cocaine or amphetamines as opposed to control participants who have never used cocaine or amphetamines. more specifically, it will allow the investigator to see how the brain changes once people get sober and how those changes relate to successful recovery. this study will allow the investigator to examine the interaction between cocaine/amphetamines and impulsivity (meaning to act on impulse rather than thought). results from this study will inform new biologically-based interventions to compliment existing treatment programs, in the hope of leading the field in a new direction.


Eligibility criteria:
inclusion criteria: * at least 18 but no more than 45 years old at the time of consent. * able to provide written consent and comply with study procedures. exclusion criteria: * any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness for more than 30 minutes, seizures, hiv). * any contraindications to mri scanning (i.e. metal implants, pacemakers, etc.). * intellectual developmental disorder as defined in the dsm-v. participant may have a diagnosis of an axis i disorder (i.e. anxiety disorders, mood disorders, eating disorders, psychotic disorders), but it must be considered stable. * actively suicidal. * positive screen for alcohol and/or drugs. participants who screen positive for drugs and/or alcohol may return at a later date to screen for the study again. * evidence for wernicke-korsakoff syndrome. * healthy controls may never have had any form of substance use disorder other than caffeine or nicotine. nicotine use will be recorded but will not be an exclusion criterion.

Keywords: fmri brain networks biomarker relapse stimulants
improving resilience and longevity for workers through exercise

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: the purpose of this study is to examine the impact of an oa-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip oa as well as those with no joint pain. the investigators hypothesize that exercise designed for oa, delivered at work, will improve all of these outcomes.

the canadian workforce is aging. the most prevalent age group is 50-54 years and most of these canadians will aim to continue working over the next 10 years. however, the impact of arthritis on aging canadians compromises their ability to continue working. by 2031, over 2 million canadians aged 45 to 64 years will have arthritis. the investigators aim to boost the ability of adults with the most common arthritis, osteoarthritis (oa), as well as adults without oa, to engage in the workforce for as long as they desire. identifying strategies to promote productivity among workers with knee and hip oa will be of great public health significance in the coming decades. however, the investigators face two challenges. first, obesity among sedentary workers is a risk for worsening knee and hip oa. second, large occupational loads on the knee and hip worsen oa. exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. thus, there is a call for studies examining exercise for workers with knee and hip oa.

Eligibility criteria:
inclusion criteria: * full-time or part-time administrative employees exclusion criteria: * any other forms of arthritis * osteoporosis-related fracture * history of patellofemoral symptoms * active non-arthritic hip or knee disease * hip or knee surgery * use of cane or walking aid * unstable heart condition * neurological conditions * hip, knee or ankle injuries in past 3 months * physician-advised restriction to physical activity * any injuries that would prohibit participation in exercise * ipsilateral ankle conditions * currently receiving cancer treatment * currently pregnant

Keywords: resilience exercise in the workplace
bacterial vaginosis; a randomized trial to reduce recurrence

Conditions: Bacterial Vaginosis

Summary: randomized controlled trial (rct) to evaluate the effectiveness of applying purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with bv for preventing bv recurrence after treatment.


Eligibility criteria:
inclusion criteria: * vaginal symptoms * nugent score \> 6 for vaginal fluid gram stain * woman and her male partner both interested in study participation * woman able to return for follow-up visits * woman able to provide detailed contact information for tracing exclusion criteria: * either male or female partner not recruited within 24 hours of the other

Keywords: bacterial vaginosis recurrence male factor