Kornimate/medical-research-clean huggingface dataset:
aqueous humor concentration of insite vision (isv) 303 (bromfenac in durasite) to bromday once daily (qd) prior to cataract surgery

Conditions: Cataract

Summary: the purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of isv-303 or bromday™ qd prior to routine cataract surgery.


Eligibility criteria:
inclusion criteria: * male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation * if a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. post menopausal is defined as having no menses for at least 12 consecutive months. * signature of the subject on the informed consent form * willing and able to follow all instructions and attend all study visits * able to self-administer study drug (or have a caregiver available to instill all doses of study drug) exclusion criteria: * use of any drug containing bromfenac within 2 weeks prior to surgery * contact lens wear during the dosing period * known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (imp) or any of the procedural medications * any serious complications with or macroscopic damage to the corneal epithelium * currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test * currently suffer from alcohol and/or drug abuse * prior participation in this study protocol * prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device * a condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

Keywords: bromfenac concentrations isv-303 bromday
complicated grief in icu in the aftermath of covid-19

Conditions: Complicated Grief; Intensive Care; Covid19

Summary: an increased proportion of deaths occur in the intensive care unit (icu). some amenable factors such as end-of-life practices may contribute to complicated grief. because of the covid-19 pandemic, visitor restrictions in health care facilities have been implemented. families were also unable to implement usual funerals. the investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. the aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the icu during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * adult relative (\>18 years) * adult relative from patients who died in icu after sars-cov-2 infection exclusion criteria: * adult relative (\<18 years)

Keywords: complicated grief intensive care covid19
oral health promotion strategy for persons with intellectual/developmental disabilities

Conditions: Oral Health

Summary: a phase ii cluster randomized controlled trial of the (ohprom) strategy/intervention will be conducted in partnership with several organizations that provide residential services for persons with intellectual developmental disabilities (idd) in north central kentucky and southern indiana. the investigators have identified a purposive sample of group homes, caregivers, and persons with idd and have the support of these organizations.

the proposed intervention is comprised of four components : (a) planned action including a behavioral contract activity 1) with caregivers and action planning for oral health (activity 2), (b) caregiver capacity building with didactic training (activity 3), observational learning and caregiver practice (activity 4); (c) environmental adaptations with location of oral health activities and reminder posters - physical environment (activity 5) and administrative oral health support- (social environment (activity 6); and (d) reinforcement with caregiver coaching (activity 7).

Eligibility criteria:
inclusion criteria: * persons with idd: to be eligible to participate in this study, an individual must meet all of the following criteria: * be a resident in a group or family home associated with one of the six partner organizations participating in this study * provide signed and dated informed consent form, to be signed by self or a legally authorized representative (lar), if one has been appointed * be willing and able to comply with all study procedures and expect to be available for the duration of the study * be aged 18 to 75 * have at least six teeth * have diagnosis of mild, moderate, severe, or profound intellectual and/or developmental disability caregiver staff: to be eligible to participate in this study, caregiver staff must meet all of the following criteria: * work as a direct care staff member in a group/family home * provide signed and dated informed consent form * be willing to comply with all study procedures and be available for the duration of the study * be aged 18 to 75 exclusion criteria: * persons with idd: will be excluded (screen failure) if they are unable to cooperate or refuse the oral examination. * caregivers: there are no exclusions.
use of pharmacogenetics in the treatment of children with autistic spectrum disorders

Conditions: Autism; Neuroleptic Treatment

Summary: children with autism are often treated with psychiatric drugs. these medications have been shown to improve their language and social function, and are important in improving their quality of life. in many cases it is difficult to determine the best drug dose, and a favorable response occurs in only 30%-70% of individuals, with many children suffering significant adverse drug reactions. pharmacogenetics is the study of the role of different genes on drug behavior. the cytochrome p450 is the most important enzyme, involved in the metabolism of a vast number of drugs, including psychiatric medications. the multiple variations in this gene can result in the different response observed in different patients, even when treated with similar doses of the drug. hypothesis(es): mapping the different types of cytochrome p450 gene, in children with autistic disorders will improve the rate of success of medical treatment, and prevent adverse drug reactions. potential impact: if successful, our study can help thousands of children and their families by developing a system of "tailored medicine" that is based on the specific activity of the various enzymes present in that particular patient. better medical treatment will facilitate better daily interactions with the children and enhance their quality of life. furthermore, recognizing children that are resistant to medication will prevent unnecessary use of drugs. it should be noted this is the first study focusing on children receiving psychiatric medications using pharmacogenetics. found to be effective, this method can also be applied to other groups of medications and to other patients.


Eligibility criteria:
inclusion criteria: * age\> 3 years * diagnosed with autism * treated with neuroleptics exclusion criteria: * patients with known allergy to second generation neuroleptics. * patients with moderate to severe renal insufficiency * patients with liver disease * patients with active cardiac disease * patients with hypertension not responsive to anti-hypertensive therapy * patients with substance abuse * suicidal patients
real-world effectiveness of a triple combination bdp/ff/gb in a single pressurised metered dose inhaler in copd patients (triphy)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of the study is to evaluate real-world effectiveness of a triple combination beclometasone diproprionate/formoterol fumarate/glycopyrronium bromide (bdp/ff/gb) in a single pressurised metered dose inhaler (trimbow® pmdi) in subjects with chronic obstructive pulmonary disease (copd).

this real-world study is a multi-centre, single-cohort, ambi-directional observational cohort study with both retrospective and prospective data collection, with the primary objective to assess the 12-week effectiveness of bdp/ff/gb for copd subjects in china. the index date is the initiation date of bdp/ff/gb, and subjects may have initiated treatment with bdp/ff/gb up to 12 weeks before enrolment. baseline period is the 12 weeks prior to index date. the end of study (eos) for each subject will be the earliest of the following: approximately 12 weeks after bdp/ff/gb initiation (the week 12 visit), bdp/ff/gb discontinuation plus 2 weeks, or at early withdrawal (such as consent withdrawal, death, or lost to follow-up).

Eligibility criteria:
inclusion criteria: 1. subjects who are willing and able to give their written consent to participate in the study 2. aged ≥40 years at bdp/ff/gb initiation 3. had documented diagnosis of copd prior to bdp/ff/gb initiation 4. baseline cat total score ≥10 (at the time of bdp/ff/gb initiation or within the 12 weeks prior to treatment initiation, if no cat total score is available on bdp/ff/gb initiation date) 5. subjects who have initiated treatment with bdp/ff/gb within 12 weeks prior to informed consent form (icf) signature, or on date of icf signature exclusion criteria: 1. subjects who had been admitted to hospital for a copd exacerbation within the last 4 weeks prior to bdp/ff/gb initiation 2. subjects who are not likely to come back 12-weeks after bdp/ff/gb initiation, per investigator judgement 3. participation in any clinical trial in the 4 weeks prior to bdp/ff/gb initiation 4. subjects had used any other single inhaler triple therapy before or at bdp/ff/gb initiation

Keywords: lung functions copd
concurrent and adjuvant nimotuzumab combined with induction chemotherapy plus chemoradiation in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage

Summary: nimotuzumab is an igg1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (egfr). nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (scchn), glioma and nasopharyngeal cancer in different countries. this is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 70. 2. pathological type: non-keratinizing carcinoma (world health organization criteria). 3. diagnosed with lanpc (stage iii-iv, except for patients with t3n0)) according to the 8th edition clinical staging system of the american joint committee on cancer \[ajcc\]/union for international cancer control \[uicc\]. 4. ecog performance score: 0 to 1. 5. primary lesions can measurable. 6. adequate marrow function: neutrocyte count≥1.5×10e9/l, hemoglobin ≥90g/l and platelet count ≥100×10e9/l. 7. alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤2.5×upper limit of normal (uln), and creatinine clearance rate ≥ 50 ml/min (cockcroft-gault formula). 8. patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. exclusion criteria: 1. primary lesions or lymph node have been operated (except of operation for biopsy). 2. previous received other anti egfr monoclonal antibody treatment;previous chemotherapy or immunization therapy. 3. other malignant tumor. 4. participation in other interventional clinical trials within 1 month. 5. history of serious lung or heart disease. 6. pregnant or breast-feeding women and women who refused to take contraceptive method. 7. drug abuse or alcohol addiction. 8. history of serious allergic or allergy. 9. refused or can't signed informed consent form. 10. other patients who are considered ineligible for the study by the investigator.

Keywords: nimotuzumab nasopharyngeal carcinoma induction chemotherapy chemoradiation adjuvant therapy
the use of human acellular dermal matrix to improve infraauricular depressed deformities and frey's syndrome

Conditions: Parotid Tumor

Summary: the aim of the study was to explore whether human acellular dermal matrix (adm) implantation could prevent infraauricular depressed deformities and frey's syndrome following total parotidectomy.

seventy patients who underwent total parotidectomy were selected for inclusion in the study. we analyzed 41 cases of total parotidectomy (control group) and 29 cases of simultaneous adm implantation following total parotidectomy (adm group) for infraauricular depressed deformities and the presence of gustatory flushing or sweating. the follow-up periods ranged from 6 months to 7 years. the results showed facial contours and bilateral symmetry improved after surgery in the adm group. in the control group, an infraauricular depressed deformity was evident in all 41 cases. frey's syndrome was recorded in one patient (3.4%) from the adm group and 14 patients (34.1%) from the control group. no cases of immune rejection, infection, hematoma, or salivary fistula were observed in either group.

Eligibility criteria:
inclusion criteria: * (1) a clinical and imaging diagnosis of either a malignant parotid tumor or deep parotid tumor * (2) no previous surgical treatment exclusion criteria: * recurrent parotid tumors or patients who had previously undergone unsuccessful surgery

Keywords: human acellular dermal matrix parotid tumor total parotidectomy
integrated parent training for treating depression in mothers of children with attention deficit hyperactivity disorder

Conditions: Depression; Attention Deficit Disorder With Hyperactivity

Summary: this study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with attention deficit hyperactivity disorder (adhd).

adhd is one of the most common childhood mental disorders. children with adhd have impaired functioning in multiple settings, including home and school, and in relationships with peers. parenting a child with adhd can be discouraging and stressful. research has shown that parent-child interactions are more negative among families with adhd children. additionally, families with children with adhd experience increased parental stress, maternal depression, and marital distress, as compared to families with healthy children. these interactions may exacerbate the child's adhd symptoms. behavioral parent training has been used to improve parent-child relationships. this study will determine the effectiveness of integrated parent training versus standard behavioral parent training in treating depression and stress in mothers of children with adhd. individuals interested in participating in this open-label study will first undergo an assessment of their eligibility for inclusion in the study. this session will last between 3 and 4 hours and will involve both the mother and the child. if eligible, mothers will be randomly assigned to receive either standard behavioral parent training or an integrated treatment, involving both behavioral parent training and cognitive-behavioral therapy targeted at coping with stressful parenting situations. the integrated treatment will also include a course on coping with depression. both groups will meet for 2 hours every wednesday evening for 14 weeks. childcare will be provided, as well as free treatment for childrens' adhd symptoms and mothers' depression. both the child's and the mother's psychological functioning will be assessed upon study completion and at the 3-month follow-up visit.

Eligibility criteria:
inclusion criteria: mothers: * scores at least 10 on the beck depression inventory (bdi)-ii scale on two occasions approximately 1 week apart * does not meet criteria for current substance abuse, psychosis, or bipolar disorder, which would likely warrant other immediate treatment children: * meets dsm-iv criteria for adhd according to parent and teacher reports on rating scales and parent diagnostic interviews * estimated iq of at least 70 * aged between 6 and 12 years * lives with mother exclusion criteria: * child has current pervasive development disorder * mothers and children participating in psychosocial treatment that cannot be suspended

Keywords: adhd cognitive behavioral therapy parent training
sp robotic versus vats anatomical pulmonary resection for patients with nsclc

Conditions: Robotics; Lung Cancer

Summary: single-port robotic-assisted thoracic surgery versus single-port video-assisted thoracic surgery major pulmonary resection for patients with non-small cell lung cancer (sports trial): a single-center, a single blinded, randomized controlled trial

investigators initially began single-port robotic thoracic surgery using the sp robotic system for simple procedures, such as thymectomy and mediastinal mass excision. as their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. however, the long-term outcomes of sp robotic anatomical pulmonary resection using the sp robotic system have not yet been studied. the aim of this study is to compare the short-term and long-term outcomes of sp robotic anatomical pulmonary resection using the sp robotic system with those of single-port video-assisted thoracoscopic surgery (sp-vats) anatomical pulmonary resection. this trial is a single-center, single-blinded, randomized controlled trial. participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (sp-vats) or single-port robotic thoracic surgery.

Eligibility criteria:
inclusion criteria: * candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (rats or vats) for patient with non-small cell lung cancer or suspected malignant lesion. * age ≥ 18 years * patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial * patients with the nationality of south korea * american society of anesthesiologists score 1-3. * clinical stage i, ii or iiia non-small cell lung cancer (nsclc) exclusion criteria: * patients who require surgery for accompanying other organ diseases * tumor invasion into the chest wall, diaphragm, another lobe or diaphragm * patients who are considered unsuitable based on the researcher's judgment * patients with cognitive impairments who are unable to understand the instructions and informed consent of this study * patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy) * patients who previously undergone a thoracic surgical procedure in the hemithorax to be operated on * pathological results other than nsclc (ex, benign nodules, metastatic lung cancer, sclc) * patients who received neoadjuvant therapy. * candidate for pneumonectomy, bilobectomy, lobectomy plus segmentectomy, non-anatomic resection (ex, wedge resection). * history of other cancers in the past 5 years.

Keywords: sing-port surgery, robotic-assisted thoracic surgery, lung cancer
prowess (prostate cancer wearables exercise and structured supports): a pilot supportive care intervention

Conditions: Prostate Cancer; Prostatic Neoplasms

Summary: the goal of this research study is to conduct an open pilot of a behavioral change intervention called prostate cancer wearables, exercise, and structured supports (prowess) for integrating health behavior change tools and to increase exercise, reduce side effects of androgen deprivation therapy (adt), and improve quality of life in black and hispanic/latino men with prostate cancer. the name of the intervention used in this research study is: prowess (behavioral change intervention)

this research study is to test a behavioral change intervention called prostate cancer wearables, exercise, and structured supports (prowess) for integrating health behavior change tools with wearable technology, to increase exercise, reduce side effects of androgen deprivation therapy (adt), and improve quality of life in black and hispanic/latino men with prostate cancer on androgen deprivation therapy (adt). study procedures include screening for eligibility, intervention sessions, questionnaires and surveys, and an exit interview with study staff. participation in this research study is expected to last for up to four months. the goal and primary outcome of this open pilot study is refinement of the intervention and study procedures to allow for us to conduct a larger feasibility study in the future. it is expected that about 10 people will take part in this research study. this research study is being supported by the mgh cancer center

Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer. * planning to be on androgen deprivation therapy (adt) for at least three months * black race and/or hispanic/latino ethnicity (confirmed by patient self-report) * verbal fluency in english or spanish. * receiving ongoing oncology care at mgh cancer center. * age ≥ 18 years. * self-report less than or equal to 150 minutes of moderate or vigorous structured exercise per week, as assessed by the exercise is medicine physical activity vital sign assessment * completion of baseline assessment exclusion criteria: * unwilling or unable to participate in the study. * significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study. * currently receiving chemotherapy. * prognosis less than 6 months, per the judgment of the primary oncologist. * medical contraindication to physical activity, as assessed by outpatient oncologist.

Keywords: prostate cancer prostatic neoplasms androgen deprivation therapy adt cbr cognitive behavioral therapy