Kornimate/medical-research-clean huggingface dataset:
dailies® aquacomfort plus® multifocal (mf) - comparative assessment of visual performance

Conditions: Presbyopia

Summary: the purpose of this study is to evaluate the visual performance of dacp mf and proclear 1d mf daily disposable contact lenses in an established presbyopic population.


Eligibility criteria:
inclusion criteria: * must sign an informed consent; * adapted soft contact lens wearer; * vision correctable to 20/30 \[(0.2 logmar (logarithm of the minimum angle of resolution)\] or better in each eye at distance; * willing to wear lenses every day or for at least 5 days per week, 6 hours per day; * other protocol-specified inclusion criteria may apply. exclusion criteria: * currently wearing multifocal contact lenses; * currently wearing monovision; * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * use of systemic or ocular medications which could contraindicate contact lens wear; * eye injury or surgery within 12 weeks prior to enrollment; * prior refractive surgery; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * other protocol-specified exclusion criteria may apply.

Keywords: visual performance
intervention on development and growth at children in poverty

Conditions: Child Malnutrition

Summary: children in extreme poverty lack adequate care and face increased health risks. the earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. there is, however, growing evidence that early interventions can prevent the negative consequences. such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. recently, baseline assessment of developmental and nutritional status of sos children and children in extreme poverty in jimma region of south-west ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. the impact of play-oriented stimulation activities integrated into the existing sos basic program, on developmental outcomes, has never been investigated in this context. the main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic sos program on the developmental outcomes of children living with foster families. this was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. it was hypothesized that this package would significantly improve the developmental skills of these children.


Eligibility criteria:
inclusion criteria: * children who were selected by the sos children's village as lacking parental care and receive basic services; * children living in jimma town; * children from 3 months to 59 months of age. exclusion criteria: * children with observable physical disabilities which hinders mobility; * children with severe mental retardation; * children with discernable hearing and visual impairments.
phosphate binder switch study of khk7791 in hyperphosphatemia patients on hemodialysis

Conditions: Hyperphosphatemia

Summary: to investigate the safety of repeated administration of khk7791 for 52 weeks while switching from a phosphate-binding agent to khk7791 in hemodialysis patients with hyperphosphatemia.


Eligibility criteria:
inclusion criteria: 1. has voluntarily provided written informed consent to participate in the study. 2. aged ≥ 20 years (expressed in completed years) at the time of providing informed consent. 3. stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination. 4. dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination. 5. the prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination. 6. serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dl at screening examination. 7. if on any vitamin d, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. 8. kt/v urea ≥ 1.2 at the most recent test in routine medical practice before screening examination. exclusion criteria: 1. peritoneal dialysis was performed within 12 weeks before screening examination. 2. ipth \> 600 pg/ml (should be based on the most recent value from patient's medical records before pre-enrollment) 3. history of inflammatory bowel disease (ibd) or diarrhea predominant irritable bowel syndrome 4. history of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination. 5. subjects who used anti rankl preparations within 6 weeks before screening examination. 6. subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination. 7. severe heart disease, hepatic impairment, or concurrent cirrhosis. 8. developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination. 9. uncontrollable hypertension or diabetes 10. subjects experienced more than 3 times diarrhea or loose stool in a day at least six bsfs score more than two days in a week. 11. scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period. 12. any diagnosis of or treatment of malignancy within 5 years before screening examination.

Keywords: tenapanor hyperphosphatemia hemodialysis
qudratus lumborum block versus unilateral intrathecal block for inguinal hernia repair

Conditions: Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block

Summary: compare between quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.

comparison between unilateral intrathecal block anesthesia (unilateral sa) and quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events. previous case report studies stated that we can use quadratus lumborum block as the sole anesthetic technique for open hernia repair.

Eligibility criteria:
inclusion criteria: - physical status asa: i-ii bmi \>18kg/m2\<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair exclusion criteria: * uncooperative patient * allergy to local anesthetic drugs * patients on chronic alcohol, opioid, tranquilizer or sedative use * pregnant females. * psychological, mental disorders, or depression. * patients receiving anticoagulants therapy or suspected coagulopathy. * patients with infection or previous surgery at sit of anesthetic procedures. * patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease
pharmacokinetic (pk) and safety study of iptacopan (lnp023) in participants with mild, moderate, and severe hepatic impairment compared to matched control healthy participants with normal hepatic function.

Conditions: Hepatic Impairment

Summary: this was an open-label, single dose parallel group study to evaluate the pk of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.

the study comprised of a screening period up to 28 days, one baseline evaluation on day -1, a single dose administration of 200 mg of iptacopan followed by pk sampling to 240 hr, and an end-of-study (eos) visit (day 11). all participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.

Eligibility criteria:
inclusion criteria: participants eligible for inclusion in this study met the following key criteria: * written informed consent was obtained before performing any assessment. * male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive). * participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (bmi) within the range of 18 to 35 kg/m2 for healthy participants. for hepatic impairment participants without overt ascites, the bmi was to be within the range of 18 to 40 kg/m2. for hepatic impairment participants with overt ascites, the bmi was to be within the range of 18 to 45 kg/m2. * ability to communicate well with the investigator, to understand and comply with the requirements of the study. * participant was willing to remain in the clinical research unit as required by the protocol exclusion criteria: participants meeting any of the following criteria were excluded from this study: * use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer. * history of hypersensitivity to the investigational compound/compound class or its excipients being used in this study. * pregnant or nursing (lactating) women. pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test. * known history of, or current clinically significant arrhythmias, history of prolonged qt correction formula (qtcf) interval or qtcf \> 450 msec (males) or qtcf \> 460 msec (females) at screening in healthy participants and history of prolonged qtcf interval or qtcf \> 470 msec (males) or qtcf \> 480 msec (females) at screening in participants with hepatic impairment.

Keywords: lnp023 iptacopan hepatic impairment single-dose
68ga-aazta-ni-093 pet/ct: first-in-human study

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: 68ga-aazta-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(ni)-moiety and a psma-targeting. in this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68ga-aazta-ni-093 pet/ct in patients with prostate cancer.

prostate cancer (pca) is one of the most common malignancies worldwide in men. prostate specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. various low molecular weight radiopharmaceuticals targeting psma such as psma-11, psma-617 for 68ga- or 177lu- labeling have been developed. 68ga-aazta-ni-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(ni)-moiety and a psma-targeting. this pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68ga-aazta-ni-093 pet/ct in prostate cancer patients.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated prostate cancer patients; * signed written consent. exclusion criteria: * known allergy against psma; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Keywords: psma prostate cancer
study intended to evaluate the safety and effectiveness of a johnson & johnson vision care inc, (jjvci) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Conditions: Myopia

Summary: study in the us intended to evaluate the safety and effectiveness of a johnson \& johnson vision care inc, (jjvci) contact lens for use on an extended-wear basis for up to 7 days (6 nights).


Eligibility criteria:
inclusion criteria: * the subject must be at least 18 years of age. * the subject must read and sign the statement of informed consent and be provided with a copy of the form. * minimum of 7 days of successful lens wear * contact lens prescription requiring between -1.00 to -6.00 d spherical power * less than 1.00 d of astigmatism in either eye exclusion criteria: -
safety and efficacy evaluation of pregabalin (lyrica) with patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of pregabalin (lyrica).


Eligibility criteria:
inclusion criteria: * diagnosis generalized anxiety disorder * ham-a score \>=18 and ham-d (item 1) score \>=2 at screening and baseline * needs pharmacological treatment exclusion criteria: * current or past diagnosis of any other dsm iv axis i disorders * a history of failed treatment with a benzodiazepine * any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
a phase iv study of travoprost + brinzolamide to treat glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * written informed consent * diagnosis of bilateral primary open angle glaucoma or ocular hypertension * intra ocular pressure above 19 millimeters mercury at screening visit at 8:00 am * stable visual field in last 6 months * 6 weeks wash out from previous topical medications exclusion criteria: * age
vestibular rehabilitation and severe traumatic brain injury

Conditions: Severe Traumatic Brain Injury; Gait Disorders, Neurologic

Summary: severe brain injury (stbi) is one of the most common causes of long-term disability and is considered the most frequent cause of mortality and serious disability in young adults in industrialized countries. it is defined as an alteration of brain function with loss of consciousness in the acute phase for at least 24 hours (glasgow coma scale (gcs) \<8) and it can induce a wide range of deficit, including cognitive-behavioural, motors, psychics, language, vision, coordination and balance impairments. chronic vestibular symptoms such as dizziness and balance deficits (both static and dynamic postural instability) are present in patients with brain injury. these aspects can cause functions limitation and psychological distress, negatively impacting negatively on subjects' quality of life and social reintegration and are considered unfavourable prognostic factors of the recovery process. the literature supports the use of vestibular rehabilitation techniques in patients with mild and moderate brain injury, however, to date, no studies investigated the effect of vestibular rehabilitation in stbi patients. the main aim of this randomized controlled trail is to verify the effect of a personalized vestibular training on balance and gait disorders in stbi patients.


Eligibility criteria:
inclusion criteria: * age between 15 and 65 years; * glasgow coma scale (gcs) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury) * level of cognitive functioning (lcf) ≥7; * ability to understand verbal commands and the informed consent. * presence of static and dynamic balance impairments. * functional ambulation classification (fac) ≥ 3 exclusion criteria: * glasgow coma scale (gcs) score \>8 * level of cognitive functioning (lcf) \<7 * inability to understand verbal commands * absence of static and dynamic balance impairments. * functional ambulation classification (fac) \< 3
primary health management for chronic obstructive pulmonary disease

Conditions: Pulmonary Disease; Chronic Obstructive Pulmonary Disease

Summary: the core objective of the "pilot project for the primary health management of chronic obstructive pulmonary disease (copd)" is to explore a primary health management model and service standards that are suitable for copd patients and aligned with grassroots realities. it also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. the primary outcomes are to evaluate the efficacy and cost-effectiveness of copd essential public health services (ephs) intervention in communities in china. participants are already receiving intervention b, "usual primary health care," as part of their regular medical care under the current health policy. researchers will compare intervention a, which is"the ephs for copd", with intervention b to determine if intervention a performs better in copd management.


Eligibility criteria:
inclusion criteria: 1. age ≥ 35 years. 2. diagnosis of chronic obstructive pulmonary disease (copd) according to the 2024 gold guidelines. 3. post-bronchodilator fev1(forced expiratory volume in one second) predicted ≥ 30%. exclusion criteria: 1. inability to provide informed consent. 2. contraindications for pulmonary function tests, including: * recent myocardial infarction, stroke, or shock within the past 3 months. * severe heart failure, severe arrhythmias, or unstable angina within the past 4 weeks. * recent major hemoptysis within the past 4 weeks. * major thoracic, abdominal, or ophthalmic surgery within the past 3 months. * psychiatric disorders requiring antipsychotic medication or with a history of seizures requiring medication. * cognitive impairment, including dementia or severe comprehension deficits. * uncontrolled hypertension (systolic blood pressure \> 200 mmhg, diastolic blood pressure \> 100 mmhg). * resting heart rate \> 120 beats per minute. * presence of aortic aneurysm. * severe hyperthyroidism. * pregnancy or lactation. * respiratory tract infections (e.g., tuberculosis, influenza, pneumonia) within the past month. * presence of pneumothorax, large pulmonary bullae not scheduled for surgery, or tympanic membrane perforation. 3. currently participating in, or planning to participate in, any other copd health management or clinical intervention projects during the study period.

Keywords: primary health management health economic evaluation efficacy community-based
physical function during arsi treatment

Conditions: Advanced Prostate Carcinoma

Summary: this single arm observational pilot study aims to determine the longitudinal effects of androgen receptor signaling inhibitors (arsi) in men with advanced prostate cancer. the primary outcome for this trial is physical function, which will be evaluated at baseline, 12 and 24 weeks. secondary outcomes including body composition, muscle function, balance, arterial stiffness and patient reported outcomes.

the purpose of this pilot trial is to obtain objective measurements of physical function in men with metastatic prostate cancer (mpc) initiating arsi treatment at baseline, 12, and 24 weeks later. grip strength, muscular power, body composition, balance, arterial stiffness, along with qol, fatigue, anxiety, and depression will also be measured. finally, the potential associations in primary and secondary outcomes by the type of arsi, stage of mpc, and physical activity levels will be explored. with more men requiring arsi treatment for metastatic castrate resistant prostate cancer (mcrpc), as well as being an efficacious option earlier in metastatic castrate sensitive prostate cancer (mcspc), accurate estimates of declines from arsi initiation are required to determine the true effects. utilizing novel assessments in mpc like muscular power tests will provide insight into potentially more relevant assessments and outcomes to intervene on. the data from this pilot study will also determine effect sizes to adequately power future studies.

Eligibility criteria:
inclusion criteria: * written informed consent obtained to participate in the study and hipaa authorization for release of personal health information. * subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * age ≥ 18 years at the time of consent. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinician * initiation of an arsi (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mpc with concurrent androgen deprivation therapy (adt). * availability to begin baseline testing within 8 weeks of arsi treatment initiation. * physician clearance to perform physical assessments. * ability to speak and read english. exclusion criteria: * prior arsi treatment * current chemotherapy * history of bone fractures or musculoskeletal injuries * neurological conditions that affect balance and/or muscle strength * intention to leave the region prior to completion of study * dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent

Keywords: androgen deprivation therapy arsi physical function