Kornimate/medical-research-clean huggingface dataset:
24-hour control of intraocular pressure (iop) in ocular hypertension

Conditions: Ocular Hypertension

Summary: this study was designed to compare the 24-hour efficacy on intra ocular pressure (iop) of drugs acting either on aqueous humor production ("inflow drugs") or on aqueous humor outflow ("outflow drugs") in human eyes affected by ocular hypertension and virgin to treatment. the enrolled patients will be exposed, in a cross-over design, to n = 2 aqueous suppressants and n= 3 uveoscleral outflow enhancers, and 24 hr iop will be measured. it is hypothesised that outflow drugs may offer a better and more stable control of iop through the 24 hours.

(a) study design: prospective, open label, investigator-masked clinical trial, with cross-over design, both eyes treated, od chosen for analysis; (b) study population: patients, showing ocular hypertension, who were never exposed to hypotensive treatment (see inclusion and exclusion criteria for details). (c) study drugs: timolol and dorzolamide will be chosen as inflow drugs. the three prostaglandin analogues (pga) latanoprost, travoprost and bimatoprost will be chosen as outflow drugs. (d) study flow-chart: upon enrollment, patients will be initiated to the following schedule: 60 days timolol 0.5% bid, 60 days washout, 60 days timolol 0.5%-dorzolamide 2% fixed combination bid, 60 days washout, 60 days pga1, 60 days washout, 60 days pga2, 60 days washout, 60 days pga3. patients were assigned to the pgas according to a sequence (l-t-b) randomly generated. data will be collected at baseline and at the and of each study phase (i.e. active treatment and washout)(e) main efficacy outcome: change in the mean iop (with respect to baseline) at the end of each study phase and change of iop (with respect to baseline) at the different time points of the 24-hour phasing. iop will be measured at 8 a.m., 11 a.m., 3 p.m., 6 p.m. and 9 p.m. by means of goldmann applanation tonometry at the slit lamp. at midnight, 2 a.m. and 6 a.m. the tonopen in supine position will be used. (f) statistics: the analysis of co-variance (ancova) for paired samples with bonferroni correction will be adopted. a minimum sample size of 51 patients is needed for a minimal expected difference in mean iop between inflow and outflow drugs = 2.5 mmhg, with an estimated pooled variance = 4 , a power = 90% and an alpha probability = 5%.

Eligibility criteria:
inclusion criteria: * iop \> 22 mmhg and \< 30 mmhg on at least three readings on separate days , * open angle on gonioscopy, * cct \> 550 m, * optic disk classified as "within normal limits" by moorfields regression analysis, hrtii, * normal visual field (standard achromatic perimetry, humphrey field analyzer, 24/2 sita standard), * age \> 40 and \< 70 years, * refraction between - 5 and + 2 dyopters, * best corrected visual acuity better than 0.2 logmar, exclusion criteria: * pex * pds * ocular comorbidiities other than refractive problems and/or mild dry eye * history of diabetes * treatment with systemic beta blockers and steroids * previous treatment with ocular hypotensive drugs

Keywords: glaucoma 24-hour iop outflow drugs inflow drugs
sa4ag safety, tolerability, and immunogenicity study in japanese adults

Conditions: Staphylococcal Infections

Summary: the purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of staphylococcus aureus 4 antigen vaccine in japanese adults aged 20 to \<86 years.


Eligibility criteria:
inclusion criteria: 1. japanese male and female adults aged 20 to \<86 years, 2. determined as healthy by the investigator (subjects with preexisting chronic medical conditions determined to be stable may be included), 3. must be available for the 12 month duration of the study, 4. subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children). exclusion criteria: 1. any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components, 2. unstable or serious chronic medical condition that would increase the subject's risk of participation, 3. immune system suppression or treatment with medications that suppress the immune system, 4. receipt of blood products or immunoglobulins within the past 12 months, 5. any infection proven or suspected to be caused by s.aureus within the past 6 months, 6. a staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study, 7. living in a nursing home, long-term care facility or other institution or requiring any types of nursing care, 8. a pregnant or a breast feeding woman.
evaluation of the extended depth of focus after bilateral implantation of hydrophobic iols

Conditions: Cataract Senile

Summary: this will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (luxsmart, bausch \& lomb). the device under investigation is ce-mark approved and commercially available. the device under investigation and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. in addition, no invasive or other burdening examinations will occur for the patient. investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past. the device under investigation luxsmart (bausch \& lomb) is a hydrophobic, acrylic copolymer containing uv absorber intraocular lens (iol). the iols will be implanted as part of the routine cataract surgery on patients suffering from cataract development. in total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the luxsmart. the maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. however there will be a minimum of 1 week between the implantations in the first 10 patients.


Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity; * calculated iol power is within the range of the study iols; * male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes; * regular corneal astigmatism ≤1.5d (measured by an automatic keratometry) in one or both eyes; * clear intraocular media other than cataract; * dilated pupil size large enough to visualize iol axis markings postoperatively * availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits. * subjects able to read, understand and provide written informed consent form on the ethics committee approved informed consent form and provide authorization as appropriate for local privacy regulations. exclusion criteria: * age of patient \<50 years; * regular corneal astigmatism \>1.5d (measured by an automatic keratometry) in both eyes; * irregular astigmatism; * subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; * subjects with amd suspicious eyes as determined by oct examination; * subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema; * previous intraocular or corneal surgery; * traumatic cataract; * history or presence of macular edema; * instability of keratometry or biometry measurements; * advanced or decompensated glaucoma; * significant dry eye;
addressing intimate partner violence, mental health, and hiv in antenatal care

Conditions: Partner Abuse; Depression; Adherence, Medication

Summary: this quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in johannesburg, south africa. using the bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. while this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of ipv exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).

prevention of mother-to-child transmission (pmtct) programs are effective if women take medication regularly, yet many perinatal women in sub-saharan africa have sup-optimal adherence. intimate partner violence (ipv) worsens women's ability to adhere to antiretroviral therapy (art), and leads to higher rates of depression. in a quasi-experimental feasibility study in south africa, 2 inner-city johannesburg clinics will be assigned to intervention or enhanced standard of care conditions. intervention consists of training health workers to deliver one-on-one sessions in pregnancy (4 sessions) and postpartum (2 sessions) using problem-solving therapy and safety planning. following n=80 women in a prospective cohort will allow for preliminarily assessment of intervention effects on: perinatal depression, ipv exposure, and art adherence at 6 months postpartum. additional qualitative research with 10 providers and 15 beneficiaries will help us qualitatively assess acceptability of intervention content, measures, and study conditions. this pilot trial can establish acceptability of intervention and control conditions and provide preliminary point estimates to inform future trial design.

Eligibility criteria:
inclusion criteria: * 18 years or older (the age of research consent in south africa) * currently pregnant and less than 30 weeks gestation (from antenatal green card) * speak a study language (english, isizulu, sesotho) * living with hiv (self-reported and confirmed on green card) * report past-year ipv (score of ≥1 on who multicountry study instrument) * are willing to provide informed consent exclusion criteria: * fail to meet all of the inclusion criteria * at risk of immediate danger (current suicidality, homicidality, or risk to child safety) * planning to terminate the pregnancy

Keywords: intimate partner violence perinatal depression art adherence hiv antenatal care prevention of mother-to-child transmission
implementing hpv dna self-collection to increase rates of cervical cancer screening in transgender men

Conditions: Transgenderism; Cervical Cancer; Human Papilloma Virus

Summary: transgender men are individuals born genetically female that have a gender identity that is incongruent with their biological sex. for those who have begun or completed transition, they may present as males but still have a uterus and cervix. thus far, no distinction has been made between routine cervical cancer screening guidelines in non-transgender women and those for transgender men, despite wide variations in sexual practices, including lifelong vaginal abstinence. the purpose of this study is to offer transgender men seen at clinic visits self-collected hpv testing to evaluate for improved cervical cancer screening rates, as well as a survey to further investigate sexual practices, rates of appropriate screening prior to being offered self-collection, and barriers to obtaining appropriate care.


Eligibility criteria:
inclusion criteria: * age \>21 for survey and age\> 25 for hpv testing * transgender male or gender non-conforming identity * female sex at birth * consent to participate in the study exclusion criteria: * impaired decision making capacity * absence of cervix * non-english speaking
image guided vats vs. vats resection

Conditions: Lung Cancer

Summary: to evaluate workflow and outcomes of ivats and standard vats for small pulmonary nodules. the outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

this is a prospective phase ii clinical study to evaluate ivats and standard vats for small pulmonary nodules. we have successfully completed and published a phase i/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with vats. this phase ii clinical study will further expand upon the safety and feasibility of this procedure. additionally, this data will be used to design a phase iii comparison study between ivats and standard vats.

Eligibility criteria:
inclusion criteria: * subject must be 18 years and older * subject must be deemed a candidate for the ivats surgery, by their treating thoracic surgeon * subject must have nodules/ggo or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm * subject's lesions that are located in the outer half portion of the lung/lobe. * subjects must be evaluated at bwh and/or dfci thoracic surgery outpatient clinics exclusion criteria: * if participant is a pregnant woman or breast feeding they will not be eligible. * if treating thoracic surgeon deems the participant not eligible for the study.

Keywords: image guided lung nodule lung cancer lung mass
an open-label continuation trial to assess the continued efficacy and safety of ascending doses of lacosamide in subjects with chronic refractory neuropathic pain

Conditions: Chronic Refractory Neuropathic Pain

Summary: this trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. it is conducted at one site in the united kingdom and the patient enrollment is completed. the patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of lacosamide. after a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. different pain qualities are assessed by a patient's diary.


Eligibility criteria:
inclusion criteria: * subject is informed and given ample time and opportunity to think about her/his participation in this extension trial and has given her/his written informed consent * subject met all inclusion criteria defined in the sp611 trial with spm927 at the time of enrollment into trial sp611 * subject has successfully completed trial sp611 and, in the investigator's opinion, would benefit from long-term administration of spm927 * subject is willing and able to comply with all trial requirements, including the ability to complete trial questionnaires exclusion criteria: * subject previously participated in this trial * subject has participated in another trial of an investigational drug within the last 3 months (excluding trial sp611) or is currently participating in another trial of an investigational drug * subject has had prior therapy with a nonsteroidal anti-inflammatory drug (nsaid) or anti-epileptic drug (aed) within 28 days prior to the eligibility visit * subject has evidence or history of significant cardiovascular disease within 12 months prior to the eligibility visit * subject has laboratory values, which are outside the normal range and judged by the investigator to be clinically significant * subject has abnormal renal or hepatic function * subject has a history of malignancies with the exception of subjects with a documented disease-free interval of 5 years or more * subject has a history of chronic alcohol or drug abuse within the last 12 months * subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this continuation trial * subject with a known history of severe anaphylactic reaction and/or serious or life threatening blood dyscrasias
is non-cardiac chest pain caused by sustained longitudinal smooth muscle contraction?

Conditions: Chest Pain Atypical Syndrome

Summary: non-cardiac chest pain (nccp) is a common disorder whose pathophysiology is poorly understood. some evidence suggests it may be related to sustained esophageal contractions (secs) of longitudinal smooth muscle. the investigators have previously shown that acid is a trigger for secs and results in shortening of the esophagus. in this study, the investigators plan to prospectively evaluate esophageal shortening responses to acid in a group of patients with nccp compared to controls. the investigators will use high resolution esophageal manometry coupled with acid infusion to evaluate shortening. the investigators hypothesize that at least a subset of patients with nccp will have an exaggerated esophageal shortening response to acid which correlates with symptom production. if our hypothesis proves true, this may lead to a future therapeutic target in the treatment of these patients.


Eligibility criteria:
inclusion criteria: * healthy volunteers: * free of esophageal symptoms * not on any acid suppressing medications * non cardiac chest pain patients: * angina like chest pain occuring at least once per month * coronary artery disease ruled out by stress test or angiogram exclusion criteria: * pre existing motility disorder of the esophagus * connective tissue disease * pregnancy * taking calcium channel blockers, nitrates, gabapentin, narcotics, tricyclic antidepressants, anti seizure medications

Keywords: non cardiac chest pain
the connection between gait variability parameters and balance performance in children with physical disability

Conditions: Brain Injury; Cerebral Palsy

Summary: the purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability

step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (eei) and rating of perceived exertion (omni scale).

Eligibility criteria:
inclusion criteria: 3 years of age and older ambulate, with or without an aid - exclusion criteria: -
interest of ascorbic acid in the management of pneumonia in elderly people hospitalized.

Conditions: Pneumonia With Hospitalized Elderly Patient

Summary: pneumonia is the second common infection and its risk increases for elderly. in this population, it is the first cause of mortality by infections, and source of many complications. geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. it is well known that vitamin c is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. a cochrane database published in 2013 analyzed the impact of vitamin c for preventing and treating pneumonia. two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin c, and for one of those studies it was noted a significant reduction of mortality. the main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin c for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.

this study is french non-comparative phase ii clinical trial, double-blind randomized, with placebo, single-center. one group would be treated the placebo group, and another would receive an adjuvant treatment by vitamin c : 500 mg twice a day by intra-venous way from the first day to the second included, and then 500 mg twice a day by oral way from the third day to the seventh. for each patient, the study's duration is 7 days, which is the mean stay of hospitalization. during those 7 days, we will make clinical exams and blood tests at d0, d2, d4 and d7. the vitamin c blood level will be measured at d0 and d7.

Eligibility criteria:
inclusion criteria: * people aged ≥ 75 years old * pneumonia's symptoms according to the spilf (société de pathologie infectieuse de langue française) : * cough * at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at the auscultation * at least one general sign suggesting an infection : fever, sweat, headache, sore joints, common cold * pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included exclusion criteria: * palliative care's patients * patients with deglutition's disorders * patients who can't be on a drip * antibiotherapy since more one day * other concomitant infection(s) * patients who can't make their own transfer 15 days ago * patients who have a nyha score at iv 15 days ago * patients with contraindication to a vitamin c treatment : hemochromatosis, oxalo-calcic lithiasis antecedent, g6pd deficit (glucose 6 phosphate dehydrogenase), and treatment by deferoxamine

Keywords: pneumonia elderly ascorbic acid vitamin c hospitalized patient
effect of talnetant versus risperidone versus placebo on psychotic symptoms in schizophrenic patients

Conditions: Schizophrenia

Summary: the purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.


Eligibility criteria:
inclusion criteria: * subjects must have schizophrenia which is not secondary to another medical condition or substance abuse. * require inpatient hospitalization. * women may enroll only if they are not of child-bearing potential or are on a protocol-approved birth control method. exclusion criteria: * subject is in their first episode of schizophrenia. * subject has other psychotic disorders or bipolar disorder. * subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition. * subject has a recent history of substance dependence, or tests positive for illicit drug. * subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke. * subject has any significant abnormalities in any of the screening tests (ecgs, labs, physical examinations, etc.). * subject poses a current serious suicidal or homicidal risk. * subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study. * subject has recently or is currently participating in another clinical study. * subject is stabilized on their current schizophrenia treatment. * subject needs to take any of the medicines not permitted in the study, or has recently had ect (electroconvulsive therapy) or tms (transcranial magnetic stimulation). * subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years. * subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.

Keywords: psychosis cognition