Kornimate/medical-research-clean huggingface dataset:
evaluating the clinical cost-effectiveness of two primary mental health service frameworks in yogyakarta, indonesia

Conditions: Mental Disorders

Summary: this study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. this study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.

two primary mental health service frameworks in yogyakarta are compared: the specialist framework and the enhanced usual care framework. both frameworks have not been evaluated in the indonesian context, despite their potential to be the framework of choice for other provincial and district governments to adopt. extension to existing services has been planned, which provides us with the opportunity to implement in a random manner the enhanced usual care framework in new areas. this study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients. this study receives ground-level support from the centre for public mental health, universitas gadjah mada, which manages the specialist primary mental health framework in yogyakarta province, regional and national-level support from the ministry of health of indonesia, and will be hopefully funded by the lpdp, ministry of finance of indonesia.

Eligibility criteria:
inclusion criteria: * participants are adults who meet the screening criteria for depression and anxiety on the self-report general health questionnaire (ghq-12) exclusion criteria: * potential participants who are currently receiving treatment for any mental health disorders will not be invited to participate in the study.
gefitinib and capecitabine in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: this phase i trial is studying the side effects and best dose of gefitinib and capecitabine in treating patients with advanced solid tumors. biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining gefitinib and capecitabine may kill more tumor cells

objectives: i. determine the maximum tolerated dose of gefitinib and capecitabine in patients with advanced solid tumors. ii. determine the dose-limiting toxic effects of this regimen in these patients. iii. determine the pharmacologic profile of this regimen in these patients. outline: this is a dose-escalation study of gefitinib and capecitabine. patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on days 8-21. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 11-41 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists * no uncontrolled brain metastases, including symptomatic lesions or lesions requiring treatment (e.g., glucocorticoids and/or anticonvulsants) * performance status - ecog 0-2 * at least 12 weeks * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9 g/dl * bilirubin no greater than 1.5 mg/dl * ast and alt no greater than 2.5 times upper limit of normal (5 times uln if liver metastases present) * creatinine no greater than 1.5 mg/dl * creatinine clearance at least 60 ml/min * no active infections * no other serious concurrent systemic disorders that would preclude study participation * no other malignancy * no prior hypersensitivity to sulfonamide-based drugs, nonsteroidal anti-inflammatory drugs, or fluorouracil * no documented dihydropyrimidine dehydrogenase deficiency * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no concurrent immunotherapy * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * no concurrent hormonal therapy * at least 28 days since prior radiotherapy * no concurrent radiotherapy * at least 4 weeks since prior investigational agents * no other concurrent experimental medications * no concurrent drugs known to induce cytochrome p450 3a4 (e.g., rifampin, phenytoin, carbamazepine, or barbiturates)
safety study of duotrav aps in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * willing and able to sign an informed consent document. * open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator. * stable treatment of an iop-lowering medication. * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant, breastfeeding, or not using adequate birth control. * best-corrected visual acuity (bcva) worse than 55 etdrs letters. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension pseudoexfoliation pigment dispersion
a study of mk-2225 in healthy participants (mk-2225-003)

Conditions: Systemic Sclerosis

Summary: the purpose of the study is to learn about the safety of mk-2225, including how well people tolerate it. researchers also want to learn what happens to different doses of mk-2225 in a person's body over time.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * is in good health before randomization * body mass index (bmi) ≤32 kg/m\^2, inclusive exclusion criteria: the key exclusion criteria include but are not limited to the following: * history of clinically significant endocrine, gastrointestinal (gi), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * history of hypersensitivity to the mk-2225 drug substance, its inactive ingredients or the placebo (normal saline)
late onset postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of this trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting.

the authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.

Eligibility criteria:
inclusion criteria: * children undergoing elective strabismus surgery under general anesthesia exclusion criteria: * children experienced retching or vomiting * children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery

Keywords: postoperative nausea and vomiting pediatric strabismus late onset postoperative nausea and vomiting
evaluation of nt-probnp in chronic inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; NT-pro-BNP

Summary: nt-probnp is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology. its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the opera study where in a population of 12 patients showed an increase in nt-probnp correlated with the biological and endoscopic activity of the disease. this larger study is therefore a pilot study that could see ntprobnp as a new biomarker of inflammation in mici.


Eligibility criteria:
inclusion criteria: * adult subjects (age 18 years) * mici group: patients monitored for probable hc or mc * control group: patients referred for consultation in gastroenterology with a clinical and endoscopic picture eading to the diagnosis of tf i * person who agreed to participate in the study * patient covered by social insurance exclusion criteria: * causes of increased concentrations of natriuretic peptides: acute heart failure, acute or chronic pulmonary disease with right ventricular repercussion, valvulopathies, primary or secondary hvg, atrial fibrillation cardiac arrhythmia, chronic systolic dysfunction, hyperthyroidism, addison's disease, hyperaldosteronism primary, diabetes, cirrhosis with ascites, cancers, chronic renal insufficiency. * inflammatory and autoimmune diseases (excluding mc and rch), chronic inflammatory syndrome * ongoing treatment that may affect the concentration of natriuretic peptides: ace inhibitor, angiotensin ii receptor antagonists, diuretics * patient deprived of liberty or protected major (under guardianship or curatorship)
exploring semi-quantitative pregnancy tests and their impact on reproductive health service provision

Conditions: Infertility

Summary: this study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dbest one step hcg panel test kit) recently approved by the food and drug administration (fda) for both professional (physician office) and over-the-counter (consumer) use. the study seeks to: 1. assess the correlation of this pregnancy test results with serum values (as distinct from urine) hcg. 2. assess whether or not time of day of urine collection has any impact on the outcome of the dbest test. 3. assess user comprehension of the pregnancy test, especially assessment of the result.

this study will examine the feasibility, practicality, utility and usability of a semi-quantitative urine pregnancy test (dbest one step hcg panel test kit) recently approved by the food and drug administration (fda) for both professional (physician office) and over-the-counter (consumer) use. the study seeks to: 1. assess the correlation of this pregnancy test results with serum values (as distinct from urine) hcg. 2. assess whether or not time of day of urine collection has any impact on the outcome of the dbest test. 3. assess user comprehension of the pregnancy test, especially assessment of the result.

Eligibility criteria:
inclusion criteria: * women 18 years or older, presenting for early abortion, pre-natal care, or fertility services. * if pregnant, gestational age \< 84 days by lmp, ultrasound or clinical assessment. * agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up. * able to consent to study participation. exclusion criteria: * women less than 18 years of age. * women who are not pregnant, except if presenting for ivf services.
automated quantification of radiologic pulmonary alteration during acute respiratory failure: application to the covid-19 pandemic

Conditions: SARS-CoV-2 Infections; Respiratory Failure With Hypoxia

Summary: automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during covid-19 infection or perioperative medicine, for example. this study aims at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation : 1. sars-cov-2 infections 2. postoperative hypoxemic acute respiratory failure.


Eligibility criteria:
inclusion criteria: * subject admitted to a care unit of the university hospitals of strasbourg or the university hospital of nancy and presenting a suspicion of sars-cov-2 infection or postoperative hypoxemic respiratory failure * able to understand the objectives and risks of the research and to give dated and signed informed consent. subjects may also be included in emergency or immediate life-threatening situations. * subject with insurance covering exclusion criteria: * pregnant woman (pregnancy confirmed by a urine or blood test) * subject usually on home oxygen therapy * subject under court protection * subject under guardianship or curatorship
a prospective, noninterventional follow-up study of children aged 23 to 25 months, born to mothers who received hydroxyprogesterone caproate injection, 250 mg/ml, or vehicle for prevention of preterm birth

Conditions: Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial

Summary: in the continuing efforts to understand the benefits and risks of in utero exposure to 17p this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17p efficacy trial sponsored by hologic (protocol number 17p-es-003).

this will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17p efficacy trial. when subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month asq version 3. subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month bayley scales of infant and toddler development (3rd edition, bayley-iii) and a neurological examination.

Eligibility criteria:
inclusion criteria: * 1. maternal enrollment which resulted in a live birth in the 17p efficacy trial: a multi-center, randomized, double-blind study of hydroxyprogesterone caproate injection, 250 mg/ml, versus vehicle for the prevention of preterm birth in women with a previous singleton spontaneous preterm delivery. 2. during their involvement in the above protocol, mothers must have received at least one dose of study drug (safety population). 3. children between 22 and 25 months of age adjusted for gestational age. exclusion criteria: * 1. there is no parent/legal guardian available to sign an informed consent. 2. born to women who are unblinded to study group assignment.

Keywords: 17p efficacy trial follow up
risk and protective factors for relapse to alcohol use in patients with liver disease undergoing liver transplantation

Conditions: Alcohol Related Liver Disease; Orthotopic Liver Transplantation

Summary: this is an observational, monocentric study, consisting of both a retrospective and a prospective component. the aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (arld) who have undergone orthotopic liver transplantation (olt).

for the retrospective part of the study, clinical data will be collected and analyzed from patients diagnosed with arld and with components of exotoxicity who underwent liver transplantation in the past five years. this data will be obtained from patient medical records, including results from laboratory tests and multidisciplinary outpatient consultations conducted as part of routine clinical practice. the prospective phase of the study will involve the consecutive enrollment of patients diagnosed with arld or with exotoxicity-related etiological components who are undergoing liver transplantation at the irccs aoubo. four patient assessment points are planned, which will take place during routine follow-up visits already scheduled as part of the patient's care pathway. during these visits, data will be collected on the patient's medical history, laboratory and/or histological results, as well as diagnostic and surgical information. additionally, through the administration of clinical questionnaires, data will be gathered on the patient's psychiatric-psychological status, history of exotoxicity, and psychosocial background.

Eligibility criteria:
inclusion criteria: * patients who have signed the informed consent * candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial) * for the retrospective part: patients who underwent olt for arld during the time frame 2017-2022 exclusion criteria: * major psychopathologies and active psychoses
survival rates and longterm outcomes after covid-19

Conditions: Covid19; Acute Respiratory Failure; Acute Respiratory Distress Syndrome; Post Intensive Care Unit Syndrome; Survivorship

Summary: the study 'survival rates and long-term outcomes for patients with covid-19 admitted to norwegian icus' is a national observational study, including patients admitted to a norwegian icu between march 2020 and march 2021. the study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after icu admission caused by covid-19 disease.

the study 'survival rates and long-term outcomes for patients with covid-19 admitted to norwegian icus' has two different aims. the first aim is to synthesis data from a national register (norwegian intensive care register-nir) on all covid-19 patients in norway admitted to an icu. these results are of great public interest for many reasons. first of all, it will give us information on the severity of this novel virus, but also how the health care system has coped in treating the severe cases that was admitted to an icu. the results will potentially be compared to other patient populations with viral pneumonia, but most interestingly to survival rates from other countries. in addition, the data will give us a description on how the distribution of severe cases of covid-19 have been within norway (e.g., gender, age, health regions etc.) the second aim of this study is to measure and describe health related challenges covid-19 patients may experience during their first year from icu admission. the health-related domains that will be investigated will capture both mental, physical and cognitive health. knowledge from other patient population admitted to an icu with acute respiratory failure, indicates that these are the main domains that negatively affect the activity of daily living. physical, mental and cognitive health challenges will be investigated for the norwegian covid -19 population admitted to icu, and will give important insight to the impact covid-19 can have on survivors of severe cases, as well as the need for rehabilitation.

Eligibility criteria:
inclusion criteria: * patients registered in norwegian intensive care register, that are ≥ 18 years with confirmed cases of covid-19. exclusion criteria: * exclusion criteria only for follow-up study: do not understand norwegian.

Keywords: icu treatment
a contralateral dispensing clinical trial of study test sapphire lens against enfilcon a silicone hydrogel lens

Conditions: Myopia

Summary: this was be a randomized, contralateral, double-masked, dispensing study comparing the study test lens against the control lens over one month of lens wear. the study results were not used for design validation of test lens.

subjects were randomized to wear the test lens in one eye and control lens in the other eye. both test and control lenses were used in a daily wear modality for one month. the study results were not used for design validation of test lens.

Eligibility criteria:
inclusion criteria: * subjects will only be eligible for the study if: 1. is at least 18 years of age for the usa and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is an adapted soft contact lens wearer; 5. requires spectacle lens powers between -0.50 to -6.50 diopters sphere; 6. has no more than 0.75 diopters of refractive astigmatism; 7. willing to wear contact lens in both eyes; 8. has manifest refraction visual acuities (va) equal to or better than logmar equivalent of 20/25 in each eye; 9. to be eligible for lens dispensing, the subject must have va of logmar equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable. exclusion criteria: * subjects will not be eligible to take part in the study if: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. is aphakic; 8. has undergone refractive error surgery; \* for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.