Kornimate/medical-research-clean huggingface dataset:
iop and ocular biometrics changes after phacoemulsification in glaucoma patients and controls

Conditions: Glaucoma; Cataract

Summary: effect of phacoemulsification on intraocular pressure has been studied with variable results.furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. in our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

all patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. anterior chamber depth \& lens thickness will be measured by optical biometry (lenstar 900) as well as measurement of the angle \& lens vault using the ultrasound biomicrosopy (ubm) before and 1 month after cataract surgery. iop will be measured pre- \& postoperatively on day 7 and 30. possible risk (s): risks of surgery(hemorrhage, endophthalmitis), risks for investigations: minimal risk of infection to minimize the risk of infection: adherence to pre-\& intraoperative infection-control measures, postoperative ubm is to be done at 1 month.

Eligibility criteria:
inclusion criteria: * age 40-70 years. * glaucomtous and nonglaucomatous participants with visually significant cataracts. * best-corrected visual acuity (bcva) equal to or worse than 6/12. * patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks). exclusion criteria: * major intraoperative or postoperative complications from cataract surgery * peripheral anterior synechiae (pas) detected by indentation gonioscopy. * uveitis, severe retinal diseases, or congenital anomalies. * history of ocular trauma or any intraocular surgery. ocular trauma or any intraocular surgery

Keywords: ocular bio-metrics anterior chamber depth ubm
pulse oximetry_performance during severe signal interference - pcba-1 (printed circuit board assembly)

Conditions: Healthy

Summary: determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.


Eligibility criteria:
inclusion criteria: 1. male or female subjects between the ages of 18 to 50 years (inclusive). 2. must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ecg, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease 3. all female volunteers must have a negative urine pregnancy test prior to participation. exclusion criteria: 1. a room-air baseline % modulation \< 1.5% on all four fingers on the test hand 2. pregnancy or lactating women 3. history of syncopal episodes 4. hypertension (defined as a systolic pressure of \>145 mmhg or a diastolic pressure \>90 mm hg on three consecutive readings) 5. premature ventricular contractions (pvc's) that are symptomatic or occur at a rate of more than 5/minute 6. history of seizures (except childhood febrile seizures) or epilepsy 7. routine use of tranquilizers and/or excessive anxiety 8. history of frequent headaches or migraines 9. history of stroke 10. previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors 11. history of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\> 1 hour) 12. history of significant respiratory disease, such as severe asthma, emphysema, etc. 13. sickle cell disease or trait. 14. the use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study. 15. a clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ecg. clinical significance will be assessed by the principal investigator or designee. 16. prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., novocain) 17. prior or known allergies to heparin 18. history of transient ischemic attacks or carotid artery disease 19. history of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy 20. history of chronic renal impairment 21. history of recent arterial cannulation (less than 1 month prior to study) 22. history of complications from previous arterial cannulation 23. current use of blood thinners

Keywords: subjects
effects on physical fitness, immunity, and quality of life of yoga training in breast cancer survivors.

Conditions: Breast Cancer

Summary: this study wants to prove that yoga training can improve physical fitness, immunity, and quality of life of in breast cancer survivors. in summary, our findings show potential benefits of yoga for people with cancer in improvements of psychological health. because of the small number of studies having been conducted and the methodological limitations, the results should be regarded as preliminary and treated with caution. our preliminary findings also provide practitioners with important information that yoga may be a possible adjunctive therapy for cancer patients to help manage psychological distress and to improve quality of life.


Eligibility criteria:
inclusion criteria: * breast cancer with stage1 or stage2, sedentary life style, no orthopaedic disease and medical disease exclusion criteria * recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response
functional mri of relaxation response training in adults with attention-deficit/hyperactivity disorder

Conditions: ADHD

Summary: this research study is being done to examine how meditation and the relaxation response (rr) may change brain activity in attention-deficit/hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: 1. male or female adults (ages 18 - 49). 2. patients with the diagnosis of attention deficit hyperactivity disorder (adhd), by the diagnostic and statistics manual of mental disorders (dsm-iv), as manifested in clinical evaluation and confirmed by structured interview. exclusion criteria: 1. any current, non-adhd axis i psychiatric conditions 2. baseline beck depression inventory (bdi) \> 19. 3. any clinically significant chronic medical condition. 4. mental retardation 5. organic brain disorders 6. seizures or tics. 7. pregnant or nursing females. 8. clinically unstable psychiatric conditions (suicidal behaviors, psychosis). 9. current or recent (within the past 2 years) substance abuse or dependence. 10. patients currently or recently (within past 1 month) on psychotropic medication. 11. subjects with current or prior adequate psychopharmacologic treatment for adhd. 12. regular practice of an relaxation response-inducing technique within the past year 13. history of claustrophobia or any of the standard contraindications to magnetic resonance imaging (mri) scanning(metal objects within body).
pilot study of ejaculatory dyssynergia by electronic microsensors of sphincters

Conditions: Spinal Cord Diseases; Disorder of Ejaculation

Summary: the objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. for this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.


Eligibility criteria:
inclusion criteria: * patients evaluated by ejaculatory test during their usual care * men with spinal cord injury between 18 and 65 years old * patients who have given their informed consent * patients with social insurance affiliation exclusion criteria: * minors * patients with justice protection * patients over 65 years old

Keywords: spinal cord injury genito sexuals disorders ejaculatory test
efficacy and safety of clesrovimab (mk-1654) in infants (mk-1654-004)

Conditions: Respiratory Syncytial Virus Infection

Summary: the primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. it is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (rsv)-associated medically attended lower respiratory infection (malri) from days 1 through 150 postdose compared to placebo.


Eligibility criteria:
key inclusion criteria: * is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age) * for the phase 2b cohort only: has a chronological age \>2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (rsv) season at the time of obtaining documented informed consent. * for the phase 3 cohort only: has a chronological age from birth up to 1 year and is entering their first rsv season at the time of obtaining documented informed consent. * for participants in south korea only: weighs ≥2 kg key exclusion criteria: * is recommended to receive palivizumab per local guidelines or professional society recommendations. * has known hypersensitivity to any component of clesrovimab * has a bleeding disorder contraindicating im administration * has had a recent illness with rectal temperature ≥100.5°f (≥38.1°c) or axillary temperature ≥100.0°f (≥37.8°c) within 72 hours predose * has received any vaccine or monoclonal antibody for the prevention of rsv * is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study
using telemedicine to optimize teamwork and infection control of critical and highly-infectious patients in an emergency department

Conditions: Critical Illness; Infections, Respiratory; Emergency Service, Hospital; Telemedicine

Summary: since 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. with the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. the biological disasters, such as the severe acute respiratory syndrome (sars) in 2003, the middle east respiratory syndrome (mers) outbreak in south korean in 2015, and the coronavirus disease 2019 (covid-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. regarding the ongoing global epidemics and possible community outbreaks of the covid-19, the management of biological disasters for an overcrowded emergency department should be planned. in the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected covid-19. this application reduced the exposure time of the first responders and reserve adequate interview quality. however, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. these factors might led to poorer quality of critical care. the investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. this model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. this study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.


Eligibility criteria:
for patients: 1.patients triaged as highly-infectious patients, needed to be treated in isolation rooms in the emergency department. for healthcare providers: 1. those providers who participates in the critical care for the patients included in the study accordingly

Keywords: telemedicine isolation critical care emergency medicine covid-19
hypoglycemia and cardiac arrhythmias in type 1 diabetes

Conditions: Diabetes type1; Hypoglycemia; Arrhythmias, Cardiac

Summary: the investigators hypothesise that following episodes of hypoglycemia, rebound hyperglycemia may result in a prolonged period of increased qtc and, thereby, increased susceptibility to serious cardiac arrhythmias in patients with type - 1 diabetes.

in this study, changes in cardiac rhythm, haemodynamic regulation, and hormonal response will be evaluated during insulin-induced hypoglycemia followed by hyperglycemia and euglycemia, respectively, on two separate experimental days. twenty-four patients with type-1 diabetes are included. patients are randomised 1:1 to start with either the combined hypo- and hyperglycemic or the hypo- and euglycemic clamp. after an overnight 10 hour fast, participants are admitted for a 255 minute clamp. an individualised insulin infusion will be initiated targeting a plasma glucose level of 5.0-8.0 mmol/l. when the targeted plasma glucose level is achieved, the hyperinsulinemic euglycemic clamp will be initiated at time 0. the insulin infusion will be fixed at an infusion rate 80 mu/m2/min and a 20% glucose infusion will be initiated in order to regulate plasma glucose levels. after 45 min of monitoring at euglycemic plasma glucose level, plasma glucose will be decreased over a period of 30 minutes, targeting 2.5 mmol/l for a period of 60 min in a hyperinsulinemic hypoglycemic clamp. from 135 min to 195 min, plasma glucose levels will be increased to either hyperglycemic level or euglycemic level and will be kept constant for 105 minutes. echocardiography is performed at baseline, at hypoglycemic level and at hyper-or normoglycemic level. blood samples are taken every 15 minutes throughout the entire clamp, however bedside plasma glucose is analysed every fifth minute. a holter-ecg is obtained throughout the entire clamp.

Eligibility criteria:
inclusion criteria: * informed and written consent * type 1 diabetes diagnosed according to the criteria of the world health organization (who) * age 18-70 years * insulin treatment for ≥3 years exclusion criteria: * arrhythmia diagnosed prior to the screening visit * implantable cardioverter defibrillator (icd) or pacemaker at the time of inclusion * severe heart failure (left ventricular ejection fraction \<25%) * structural heart disease (wolf-parkinson-white syndrome, congenital heart disease, severe valve disease) * thyroid dysfunction (except for well-regulated eltroxin substituted myxoedema) * anemia (male: hemoglobin \<8.0; female: hemoglobin \<7.0 mmol/l)
effect of g17dt in patients with stage ii/iii colorectal cancer

Conditions: Colorectal Cancer

Summary: this phase 2 study was an open label, single-center 18-week study to compare basal and meal stimulated plasma gastrin levels before and after treatment with 3 intramuscular injections of 250 µg g17dt, with and without the concomitant administration of omeprazole.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 70 years, inclusive * written informed consent was provided * histologically confirmed stage ii/iii colorectal cancer after radical surgery * a minimum of 3 months elapsed since completion of the chemotherapy for subjects who had received adjuvant chemotherapy * subject had recovered from any toxic effects of chemotherapy exclusion criteria: * had a known local recurrence of colorectal cancer or presence of metastatic colorectal cancer lesions * was using an inadequate method of contraception (determined at the discretion of the investigator), only for women of childbearing potential who were sexually active * was unable to comply with the protocol * was unable to abstain from h2 receptor antagonists, ppis or anticholinergics medications for 2 weeks * required h. pylori eradication therapy during the study * had prior vaccination with g17dt or any other product with a similar mechanism of action * had a history of gastric or vagus nerve surgery * had any clinically significant laboratory abnormalities and medical conditions which were unexplained, or, in the opinion of the investigator, did not allow for safe entry of the subject into the study * had contraindications to intramuscular injections (e.g., bleeding disorders or treatment with anticoagulants \[except for aspirin\]) * had serious and unstable cardiovascular or respiratory disease, other malignancy or any other condition that would have jeopardized subject safety or confounded the results * had a known hypersensitivity to diphtheria toxoid, g17dt, any of its components or any similar compound * had any other condition that might have influenced the plasma gastrin level (e.g., achlorhydria, zollinger-ellison syndrome) * had used of an investigational drug within the previous month * had taken treatments that alter the immune response such as radiotherapy, corticosteroids, and antineoplastic drugs (inhaled corticosteroids were permitted.) * had conditions that impaired the immune response (e.g., acquired immune deficiency syndrome) * had a history of drug or alcohol abuse within the past year * was unable to accept a standard breakfast for dietary reasons
a study to assess the ability of stereotactic radiotherapy to restore the efficacy of immunotherapy in patients with metastatic cancer.

Conditions: Metastatic Cancer

Summary: this study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression. in this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 gy, lasting 20 minutes and spaced 72 hours apart (day 1, day 4, day 7). the radiotherapy device itself is not the subject of this study and will be used in accordance with its ce mark and indications. the objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. in particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older, 2. patient with a metastatic solid tumor, 3. patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable, 4. measurable disease according to recist 1.1 and irecist criteria, 5. patient undergoing anti-pd1 immunotherapy as part of standard of care treatment, 6. disease progression with immunotherapy (progression assessed by irecist criteria) but having received at least 6 months of immunotherapy, 7. performance status (ps) of 0 or 1, 8. patient eligible for stereotactic radiotherapy, 9. patient affiliated to or benefiting from a social security scheme, 10. patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures, 11. patient willing and able to undergo all examinations and procedures in accordance with the clinical investigation plan. exclusion criteria: 1. patient having received previous radiotherapy since the start of immunotherapy, 2. patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage), 3. patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment, 4. patient with hematological cancer, 5. symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment, 6. concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion, 7. pregnant or breast-feeding women, 8. patient under legal protection.

Keywords: stereotactic radiotherapy immunotherapy
technology enabled mental health intervention for individuals in the criminal justice system

Conditions: Depression; Anxiety; Mood

Summary: in the united states, over 60% of the 2.2 million people who are incarcerated struggle with mental health problems. currently, correctional facilities are limited in their ability to provide care. as technology-enabled interventions for mood disorders have demonstrated efficacy outside of correctional facilities, the investigators propose to build and test a technology-enabled mood disorder treatment intervention for individuals who are incarcerated.

in the united states, over 2.2 million people are incarcerated. while these numbers are alarming, even more distressing is the rapid growth in the number of mentally ill individuals caught in this system. within any given year, approximately 73% of females and 55% of males in jail will experience a mental health problem. this results in the criminal justice system serving as a de facto mental health treatment facility for hundreds of thousands of individuals, despite constrained funding and a paucity of qualified providers and interventions. more than one in five jails have no access to mental health services. there is strong evidence that technology-enabled interventions for the treatment of mood disorders are efficacious and cost effective. technology-enabled mental health care has many strengths, including the ability to deliver treatment reliably, increase privacy for those seeking services, and provide a scalable evidence-based intervention at a lower cost than traditional face-to-face services. edovo has previously developed secure tablet hardware, protected networks and a learning management system that deliver static content in the areas of academic, job skill, and life skill programming to those incarcerated. the aim of this project is to develop and demonstrate the feasibility of a dynamic intervention for the treatment of inmates with mood disorders utilizing the edovo system. a user centered design approach will be used to modify existing evidence-based, technology-enabled mood interventions to be appropriate for the incarcerated population. software will be modified to run the intervention on the existing edovo system. the resulting intervention will be tested in a sample of inmates for an initial clinical signal. the development of such a technology would help correctional facilities more effectively meet their treatment requirements and rehabilitation goals.

Eligibility criteria:
inclusion criteria * incarcerated middlesex county jail or woodford county jails; * has access to the edovo tablet; * is at least 18 years of age; * is able to speak and read english exclusion criteria * none

Keywords: jail prison technology depression cbt