Kornimate/medical-research-clean huggingface dataset:
exploratory study of sat-001 in treatment of pediatric patient with myopia

Conditions: Children Myopia

Summary: the purpose of this study is to explore the safety and effectiveness of sat-001, a medical device for the treatment of myopia in pediatric patient with myopia

myopic pediatric prevalence rate come to increase rapidly globally. this is a clinical trial to explore the safety and effectiveness of sat-001(as a software as medical device) developed for the treatment of myopia through suppressing the progress myopia

Eligibility criteria:
inclusion criteria: 1. pediatric patient age 5 to 12 years old at the screening visit 2. diagnosed with myopia as following refractive error via cycloplegic refraction(cr) 1. spherical equivalent (se) -0.75 d or more and less than -6.00 d in each eye 2. astigmatism of 1.50 d or less in each eye 3. anisometropia of less than 1.00 d 3. the age of birth over 38 weeks 4. over 2500g of birth weight 5. best corrected distance visual acuity of 0.2 logmar or better in each eye at the screening visit 6. intraocular pressure 21 mmhg or less in each eye at the screening visit exclusion criteria: 1. administration of anti-muscarine drugs within 1 month before screening visit 2. current or previous use of multi-focal lenses 3. planning to use or having used orthokeratology lenses (ortho-k lenses), rigid gas permeable (rgp) lenses, and other contact lenses to reduce the progression of myopia 4. history of atropine use for treatment of myopia within 1 month before screening visit 5. abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit 6. history of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision) 7. history of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery) 8. obsessive-compulsive disorder or attention deficit hyperactivity disorder(adhd) 9. down's syndrome or cerebral palsy 10. participation in another clinical trial within 6 months before screening visit 11. history of growth hormone treatment within 1 month before screening visit 12. medically clear to have abnormal range of intellectual development 13. significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease 14. currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit 15. history of injections with histamine release and cholinergic effect within 30 days before screening visit 16. incongruent to participate in this study at the discretion of the investigator
ct-validation of ultrasound based planning for high dose rate (hdr) prostate brachytherapy using vitesse

Conditions: Prostate Cancer; Interstitial Radiation; High Dose Rate Brachytherapy; Ultrasound-based Planning Compared to CT-based Planning

Summary: high dose rate (hdr) temporary prostate brachytherapy offers a precise form of dose escalation for prostate cancer. needles are placed, the position is confirmed and treatment is delivered. previously high dose rate prostate brachytherapy was performed under transrectal ultrasound (trus) guidance but planned with computed tomography (ct) imaging which introduced a source of error through needle displacement while transporting and repositioning patient. recently varian has introduced a one-step procedure where both implant and planning are based on ultrasound imaging and performed without patient repositioning. this planning system is approved by health canada and is commercially available. this study will use high dose rate brachytherapy to treat 20 men. treatment will be planned with transrectal ultrasound and validated using computed tomography imaging.

twenty men with intermediate risk prostate cancer, suitable for the combination of external beam radiotherapy and high dose rate brachytherapy will be entered in this study. high dose rate brachytherapy will be performed using transrectal ultrasound guidance and then planned using both cone-beam computed tomography and transrectal ultrasound. planning by computed tomography is to check the reliability and reproducibility of ultrasound imaging to correctly identify the needle positions. correct needle localization is essential because this is the basis for determining source dwell positions, dose calculation and dose optimization.

Eligibility criteria:
inclusion criteria: 1. patients must have histologically proven adenocarcinoma of the prostate. 2. patients must have intermediate risk prostate cancer. (clinical stage ≤ t2c, gleason score = 7 and initial prostate specific antigen (ipsa) ≤ 20, or gleason score ≤ 6 and ipsa \> 10 and ≤ 20. 3. patients must be fit for general or spinal anaesthetic. 4. patients must have an estimated life expectancy of at least 10 years. 5. patients must have an eastern cooperative oncology group (ecog) performance status of 0 - 2. 6. patients must have no contraindications to interstitial prostate brachytherapy. 7. patients on coumadin therapy must be able to stop therapy safely for at least 7 days. exclusion criteria: * men not able to fully understand the trial and the informed consent document * men suffering from claustrophobia and unable to have a computed tomography scan * men not wishing to have a cone-beam computed tomography scan following the insertion of the high dose rate brachytherapy needles to verify the accuracy of the treatment plan * men who cannot safely discontinue blood thinners for a few days.

Keywords: prostate cancer interstitial radiation, brachytherapy
a clinical study of online active play program with adolescents

Conditions: Anxiety; Depression

Summary: to assess the efficacy of an online, active play program (revival active program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old. program was conducted during covid-19 lockdown from march 2020 to june 2020 to support children and families in isolation.


Eligibility criteria:
inclusion criteria: * children at the online program for whole duration * indicating a symptom level of, at minimum, above mean on anxiety and/or depression on self-report measures * parental consent before stating the program exclusion criteria: * children at normal levels of mental health screening * children who did not complete the intervention period

Keywords: adolescents online active revival program
a phase i study of [225ac]-azd2284 in patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: the main purpose of the study is to assess the safety and tolerability of azd2284, azd2287, and azd2275.

this is a first-in-human, phase i, non-randomized, open-label clinical trial designed to evaluate azd2284, azd2287, and azd2275. this trial will consist of 2 parts: part a (imaging): * part a (cold antibody exploration): aims to determine the optimal dosing regimen, with or without unconjugated antibody (azd2275) pre-administration to improve the biodistribution of azd2287. * part a expansion: aims to explore the prevalence of psma and steap2 expression by imaging. part b (therapeutic): * part b (actinium-225 dose escalation): aims to assess the safety, tolerability, and efficacy of escalating doses of azd2284 informed by the optimal dosing regimen identified in part a. * part b expansion cohorts 1 and 2: aims to explore efficacy of azd2284.

Eligibility criteria:
main inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1. * histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer. * must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (\< 50 ng/dl or \< 1.7 nmol/l). * at least one metastatic lesion present on baseline computed tomography (ct), magnetic resonance imaging (mri), or bone scan obtained ≤ 28 days prior to the first dose of investigational medicinal product (imp). participants may have non-measurable lesions including bone only metastases. * adequate organ function main exclusion criteria: * treatment with any radiopharmaceutical within 6 weeks of the first dose of investigational medicinal product (imp). * radiation therapy (rt) within 28 days prior to the first dose and all rt-related events have not recovered to grade ≤ 1. * administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of imp or 5 half-lives, whichever is shorter. * all prior treatment-related adverse events must have resolved to grade ≤ 1. * concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements. * known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation. * clinically relevant proteinuria

Keywords: dose escalation study metastatic prostate cancer radiopharmaceutical radiotheranostics castration-resistant prostate cancer radiotherapy six transmembrane epithelial antigen of the prostate 2 (steap2) actinium radioconjugate radioligand
visualization of the stn and gpi for dbs

Conditions: Deep Brain Stimulation; Parkinson Disease

Summary: the purpose of the study is to determine if using sis system for dbs planning results in less distance between the planned target location and the actual implanted lead location than dbs planning without sis system.

this is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care dbs surgery to standard of care plus visualization with the sis system. the purpose of the study is to determine if using sis system for dbs planning results in less distance between the planned target location and the actual implanted lead location than dbs planning without sis system. parkinson's disease subjects indicated for dbs will undergo standard dbs surgery with preoperative planning for targeting of stn or gpi as indicated. subjects will be followed through six months after initial dbs programming to collect clinical outcomes.

Eligibility criteria:
inclusion criteria: * subject is diagnosed with idiopathic parkinson's disease and is indicated for de novo dbs surgery with bilateral dbs leads implanted in the stn or gpi. * subject is 18 years or older. * subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures. exclusion criteria: * subject is not a dbs surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate dbs surgery. * subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps. * subject's life expectancy is less than one year. * subject is hoehn and yahr stage 4-5 in the medication off condition. * subject is pregnant or interested in becoming pregnant during the duration of the study. * subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.

Keywords: subthalamic nucleus globus pallidus dbs
study to evaluate the effects of gabitril™ in patients with social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the main purpose of this study is to determine how safe and effective gabitril is for outpatients with social anxiety disorder (sad).

this study is being conducted at two sites in the united states. approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at emory. this study consists of two parts. the first part consists of 12 weeks of open-label treatment with gabitril. if the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. this part is a 24-week double-blind treatment period with either gabitril or placebo (inactive medication). there will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. altogether study participation is expected to last approximately 37 weeks.

Eligibility criteria:
inclusion criteria: * primary diagnosis of sad * cgi (s) ≥ 4 at screen * lsas ≥ 50 at baseline * covi anxiety scale score greater than the raskin depression scale total score at screen exclusion criteria: * non-responsive to adequate trials of two or more treatment medications, if previously treated for sad. * ham-d ≥15 or a score of \>2 on item 1 at baseline * serious or unstable medical condition * alcohol or substance use disorder within 6 months prior to study

Keywords: social anxiety disorder mental health
proprioception on balance and gait in hemiparetics

Conditions: Hemiparesis; Proprioceptive Disorders; Gait, Hemiplegic

Summary: the loss of sensorial feedback causes gait impairment in hemiparesis. the studies show that proprioceptive impairment of knee is related to falling in these patients. the aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility criteria:
inclusion criteria: * between the ages of 20-65 and discharged from the hospital, * diagnosed with hemiparesis at least 4 weeks ago, * first time and unilateral hemiparesis, * modified rankin score ≤ 3, * hodkinson mental test ≥ 6, * individuals who agree to receive treatment will be included in the study. exclusion criteria: * having vision and hearing problems, * having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis, * medically unstable, * diseases that will affect the lower extremity sense, * individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.
ceftriaxone versus chloramphenicol for treatment of severe pneumonia in children

Conditions: Pneumonia

Summary: acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub saharan africa. the world health organisation (who) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. however, up to 20% of children fail treatment due to the emergence of resistance by bacteria. several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. however the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. the purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five. we hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).

a recent report from the world health organization showed pneumonia was the leading cause of death in children less than 5 years. who recommends intravenous chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. ceftriaxone 75mg/kg daily is the second line drug. the efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. however the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. a study comparing penicillin g plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in turkey found that both drugs were equally effective in normalization of the outcome parameters. a recent cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia. the objective of this study it to compare the efficacy of ceftriaxone versus chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to mulago hospital. this will be a double- blinded randomized controlled trial. three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. the primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.

Eligibility criteria:
inclusion criteria: * children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing * consent from parent/carer exclusion criteria: * children with severe asthmatic attack * allergy to any of the study drugs * diagnosis of pneumocystis jirovecipneumonia on therapeutic treatment

Keywords: ceftriaxone chloramphenicol severe pneumonia children
identifying and addressing barriers to retention in the cervical cancer treatment cascade among women with hiv in south africa: part 2

Conditions: Cervical Cancer; Hiv

Summary: the investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with hiv (wwh). in aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among wwh who have had a recent high-risk abnormal pap smear in the past six months, via qualitative interviews with wwh who have either attended at least one follow-up visit (n\<10) or have not yet attended a follow-up visit (n\<10). in aim 1b, the investigators will explore provider awareness of the hiv-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n\<8). for aim 2, the study team will leverage the aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among wwh who are at heightened risk for cervical cancer. the study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. in aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (rct) (n\<60). the study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. in aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n\<10).


Eligibility criteria:
inclusion criteria: * having a cervix * aged 18+ * living with hiv * recent high-risk abnormal pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets). exclusion criteria: * younger than 18 years old * hiv-negative * no cervix/history of hysterectomy * recent normal or low-risk abnormal pap results * unable to provide informed consent or assent in english or isizulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
post-authorization study evaluating safety of tigecycline

Conditions: Intra-Abdominal Infections; Skin Disease, Infectious; Soft Tissues Infections

Summary: this is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (ciai) and complicated skin and soft tissue infections (cssti) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.

since around 50 patients were included in spanish centers involved in the phase iii tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. with this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.

Eligibility criteria:
inclusion criteria: * informed consent signed by patients prior to this study entry. * 18 years of age or older at the screening visit. * patients with ciai or cssti. * patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections. * in the opinion of the investigator, the patient will be able to comply with the requirements of the protocol. exclusion criteria: * known hypersensibility to tigecycline. * females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. * use any investigational drug within four weeks of the screening visit. * uncooperative patients or a history of poor compliance.

Keywords: tigecycline complicated intra-abdominal infections (ciai) complicated skin and soft tissue infections (cssti).