Kornimate/medical-research-clean huggingface dataset:
aim 3 particle swarm optimization pigd

Conditions: Parkinson's Disease and Parkinsonism

Summary: in parkinson's disease (pd) patients undergoing standard-of-care deep brain stimulation (dbs) therapy, to compare the effect on parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from globus pallidus (gp) to pedunculopontine nucleus (ppn), and the axonal pathway from ppn to gp.

in parkinson's disease (pd) patients undergoing standard-of-care deep brain stimulation (dbs) therapy, to compare the effect on parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from globus pallidus (gp) to pedunculopontine nucleus (ppn), and the axonal pathway from ppn to gp. in this respect, the present protocol is similar to protocol study00008644. in fact, that protocol, and this one, cover different aims of the same nih-funded project. protocol study00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. this is essential, for several reasons. first, clinically relevant outcome measures, such as adl (activities of dailly life) and qol (quality of life) scales require observation for longer than a few hours in the laboratory. second, dbs effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. third, we intend, if our hypothesis is confirmed (that activation of the ppn-to-gp pathway is most effective for the postural-instability / gait-disorder (pigd) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.

Eligibility criteria:
* diagnosis of parkinson's disease * bilateral dbs in stn or gp * at least 3 months after lead implantation * montreal cognitive assessment (moca): moca=23+ or: if moca score is 23 or less, ubacc will be performed to ensure capacity to consent. if ubacc results are unclear, the maccat-cr will be performed. failed or unclear maccat-cr results will exclude the study candidate. * between 18-85 years of age * has undergone pre-operative 7t mri (as part of protocol #1210m22183 or standard-of-care) and post-operative ct imaging (standard of care). 8.2 exclusion criteria: * inability to walk in the off-med, off-stimulation condition (even with safety harness) * gait impaired significantly by a condition other than pd * breaks or shorts in active contacts * ipg battery nearing end of life (in patients with primary-cell ipgs) * females who are nursing or pregnant
clinical evaluation of an investigational soft contact lens

Conditions: Myopia

Summary: the purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.


Eligibility criteria:
inclusion criteria: * germany: be of legal age. * usa: be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent. * sign informed consent. * wear soft contact lenses for at least 3 months prior to the study. * wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks prior to enrollment. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in any clinical trial. * regularly wear contact lenses on an extended/overnight basis. * germany: pregnant or lactating. * other protocol-defined inclusion/exclusion criteria may apply.
effect of the epischool-m app on teachers' epilepsy knowledge, attitudes, and self-management

Conditions: Epilepsy; Intellectual Disabilities; Teacher Training; Mobile Applications; Knowledge; Attitude; Self Management

Summary: the aim of this study was to determine the effects of the training given to the teachers of children with intellectual disabilities with the "epilepsy management at school mobile health application" and the "digital epilepsy education guide" on teachers' epilepsy knowledge, attitudes, and self management levels. this study was planned in a pretest, posttest design, follow-up, randomized controlled study. the sample of the study will consist of 90 teachers. intervention-1 (epilepsy management at school mobile health application, n=30), intervention-2 (digital epilepsy education guide, n=30) and control group (group without any intervention, n=30) will be included in the study. the data collection tools to be used in the research will be applied to all three groups at the same time intervals (t0: just before the application phase of the research, t1: 15 days after the application, t2: one month after the application). the data will be collected using the personal information form, the knowledge and attitudes toward epilepsy among school teachers scale, and the epilepsy self-management scale for teachers. statistical package for the social sciences (spss) 25.0 package program will be used in the analysis of the data.


Eligibility criteria:
inclusion criteria: * working at special education schools affiliated with the ministry of national education in antalya province, * teachers of children with moderate to severe intellectual disabilities, * having a smartphone with internet access and either an android or ios operating system. exclusion criteria: * teachers of children with hearing and visual impairments, without intellectual disabilities * teachers of children with mild intellectual disabilities

Keywords: epilepsy children with intellectual disabilities mobile health application epilepsy knowledge epilepsy attitude epilepsy self management
clinical evaluation of narrow band imaging colonoscope

Conditions: Colonic Neoplasms

Summary: the purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

this is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. a new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. as such, we hypothesized that the use of nbi would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. we aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Eligibility criteria:
inclusion criteria: * referred for elective outpatient colonoscopy exclusion criteria: * known inflammatory bowel disease * personal or family history of polyposis syndrome * referral for resection of a known lesion

Keywords: colonic neoplasms colonoscopy narrow band imaging diagnostic techniques
acute kidney injury in major abdominal surgery: retrospective study of 501 patients

Conditions: Acute Kidney Injury

Summary: retrospective study that aims to examine the presence of acute kidney injury (aki) during major abdominal surgery, non- cardiac surgery. using clinical and biochemical data in order to establish aki frequency and risk factors.

ethical approval was submitted and approved by the regional ethical committee, etisk prövningsnämnd uppsala, # 2017/418. patients were selected from the time span of april 2016 to september 2017. the investigators identified 499 patients that had undergone any of the selected procedures. the procedures were, pancreatic resection, hipec surgery in colorectal setting, gynecological debulking in metastasized ovarian cancer, and liver resection. the risk of acute kidney injury (aki) by the kdigo definition during the postoperative period will be estimated in the group as a whole, and for each type of surgery separately. in addition the data will be stratified by sex to investigate systematic gender disparities or physiological differences. length of stay, thirty day and sixty day mortality will secondary endpoints.

Eligibility criteria:
inclusion criteria: any of the selected procedures. exclusion criteria: patient has expressed his or her will to nor participate in any study.
educational program associated with a conventional spa therapy of knee osteoarthritis patients

Conditions: Knee Osteoarthritis

Summary: the main objective of this work is to measure the efficiency of 18 days spa therapy in orientation rheumatology associated with an educational intervention in patients with knee osteoarthritis on a priority objective, personalized and determined by the patient, chosen in the list of 5 objectives determined during the educational assessment.

this program begin with a shared educational balance assessment allowing to set up the individual program adapted to the objectives personalized by the patients. the objectives to achieve are to allow the patients to acquire knowledge and skills (attitudes, behavior) concerning their pathology and the existing treatment. a multidisciplinary team trained in the therapeutic education of the patient assure the educational interventions. the proposed educational activities (7 educational workshops) concern major axes of the care of the knee osteoarthritis: knowledge of the pathology, the adapted physical exercise, the dietetics, the management of the pain, the articular hygiene and the technical helps.

Eligibility criteria:
inclusion criteria: * patients, male or female, aged 50 to 75 years * patients with knee osteoarthritis clinical criteria of the american college of rheumatology (acr) * patient affiliated to a social security scheme (beneficiary entitled) * patient registered spa * pain intensity equal or more than "3" at the visual analogical scale * patient has given its consent in writing to exclusion criteria: * contraindication to the spa therapy * trouble behavior or understanding making it impossible to assess

Keywords: physical activity education dietary self-management
phase ⅲ trial for combination treatment of peg-tα1 and adefovir for hbeag-positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this trial is to assess the efficacy and safety of polyethylene glycol thymosin alpha1 (peg-tα1), a new long immunomodulator (category 1.1 of chemical drugs) being developed from hansoh pharmaceutical of china, in combination with adefovir in hbeag-positive patients with chronic hepatitis b.

a total of 463 hbeag-positive patients were recruited from 33 hospitals in china, and randomized to two groups. the combination group received peg-tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. the control group received placebo and adefovir. the primary endpoint was the loss of hbeag at 48 weeks. the secondary endpoints included 1) loss of hepatitis b virus (hbv) dna, 2) hbeag seroconversion and 3) alanine aminotransferase (alt) normalization etc. at week 4, 12, 24, 36 and 48. the number of cd4＋and cd8＋t cells was also determined during 48 weeks.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial. * alt level \> 2 × upper limit normal (uln). * serum bilirubin \< 2 × uln. * positive hbeag and negative hbeab. * hbv-dna between 1.00e＋05 iu/ml and 9.99e＋09 iu/ml. * informed consent form (icf) signed. exclusion criteria: * hepatitis a,c,d,e or hiv infection. * autoimmune hepatitis. * hepatic cirrhosis. * serum creatinine \>1.5 × uln or ccr \ uln＋3 seconds, cholinesterase\<4000u/l. * hepatitic carcinoma or alpha fetal protein (afp) \>100ng/ml . * patients with other severe diseases combined, which could affect the therapy. * patients accepted other clinical trial within 6 months before the first administrated. * thymosin allergy. * pregnant or breast feeding.

Keywords: polyethylene glycol thymosin alpha1 adefovir hepatitis b e antigens positive
program to overcome pelvic pain study

Conditions: Pelvic Pain; Chronic Pelvic Pain; Recurrent Pelvic Pain

Summary: to refine and evaluate the feasibility of procedures for a future full-scale efficacy trial of a group-based therapeutic yoga intervention versus physical conditioning (stretching and strengthening) intervention for women with chronic pelvic pain.


Eligibility criteria:
inclusion criteria: * women aged 18 years or older who report chronic or recurrent pelvic pain for at least 6 months * report an average daily pain intensity score of at least 4 (on a 0 to 10 scale) on a screening 7-day pain log * report prior clinical evaluation of pain by a healthcare professional including at least a superficial pelvic exam * willing to refrain from initiating new clinical treatments that may affect their pain during the study period exclusion criteria: * report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (note that women with at least some pain between menses or intercourse are still eligible) * participation in organized yoga classes or muscle strengthening programs (e.g., pilates) in the past month, or prior yoga therapy specifically directed a pelvic pain * currently pregnant (by self-report or screening test), pregnant within the past 6 months, or planning pregnancy * diagnosed with an alternate, reversible cause of pain that is unlikely to respond to yoga and requires another treatment modality (e.g., current pelvic infection or a gynecologic dermatosis) * initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic pain severity in the past 1 month (e.g., pain medications, antidepressants, anticonvulsants)-note that women on stable doses will be eligible * surgery to the genital or pelvic structures within 3 months, or prior cancer or irradiation to these structures * use of formal psychological therapies specifically for pelvic pain (e.g., systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of screening * use of formal behavioral therapies for pelvic or genital pain (e.g., pelvic floor rehabilitation or biofeedback performed by a certified healthcare practitioner) within 1 month of screening * unable to walk up a flight of stairs or at least 2 blocks on level ground (i.e., functional capacity \< 4 mets), or unable to get up from a supine to a standing position without assistance * participation in another interventional study that might interfere with or confound study procedures * known conflict with multiple available intervention class dates * inability to sign an informed consent or fill out questionnaires or complete study interviews in english, or lacking technical requirements to complete intervention classes or study visits by video
effect of progesterone administration on severely head injured patients

Conditions: Severe Head Trauma

Summary: to investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome


Eligibility criteria:
inclusion criteria:patients with severe traumatic head injury gcs ≤8 both sexes. \>16yrs, - exclusion criteria: * -tumor that may flare with progesterone. * patients with spinal injuries with neurological deficits. * severe chest trauma that causes shock and hypoxia. * life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest * pegnancy
quantification of tenofovir alafenamide adherence (quanti-taf)

Conditions: HIV/AIDS; Adherence, Medication

Summary: this study is being done to evaluate the relationship between adherence to antiretroviral therapy (art) and hiv drug concentrations in persons living with hiv (plwh) that are taking tenofovir alafenamide (taf). adherence will be measured with an ingestible biosensor (digital pill). antiretroviral drug concentrations will be measured in different types of blood cells.

plwh taking or initiating/re-initiating taf will be recruited for a 16-week study. upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. study participants already taking taf will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. participants initiating/re-initiating taf will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

Eligibility criteria:
inclusion criteria: 1. females or males with hiv, able to give informed consent and comply with study procedures. 2. currently on (\> 6 months), or planning to initiate/re-initiate taf. exclusion criteria: 1. for females of childbearing age, active pregnancy or any intent to become pregnant 2. hepatitis c (hcv) infection for which treatment is anticipated within the next 16 weeks after enrollment. treated hcv with sustained virologic response is allowable if last dose of hcv antivirals was \>12 months prior to enrollment 3. advanced renal (egfr \<30 ml/min/1.73m\*\*2) or liver (child-pugh b or c) disease 4. history of extensive bowel surgery, gastric bypass, or gastroparesis 5. concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the pk of taf (e.g. rifamycins, carbamazepine, phenytoin, st. john's wort, tipranavir)

Keywords: adherence dried blood spots tenofovir-diphosphate antiretroviral therapy tenofovir alafenamide
a prospective non-interventional study in participants receiving nivolumab in adjuvant setting for resected melanoma in real-world conditions in france

Conditions: Melanoma

Summary: this is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage iii/iv resected melanoma, and subsequent treatments administered in case of relapse.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation,please visit www.bmsstudyconnect.com. inclusion criteria: * participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease * decision to treat with adjuvant nivolumab therapy has already been taken * participants who provide oral informed consent to participate in the study exclusion criteria: * any participant with a current diagnosis of persisting advanced melanoma * participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for os/rfs can be enrolled. in case of a blinded study, the treatment arm needs to be known). * pregnant women * person under guardianship other protocol defined inclusion/exclusion criteria apply
stimulate the face to improve tactile acuity on the hand

Conditions: Stroke; RSS; Face

Summary: the study is a comparative study, to show that the administration of rss stimulation on the face compared to the administration of strategy sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.


Eligibility criteria:
inclusion criteria: * age: 30-80 years old * patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke * stroke event dates at least 3 months before the date of inclusion to the study * mild-to-moderate sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand) * capacity to provide written consent * affiliation to a social security scheme non-inclusion criteria: * sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy * severe speech disorder, global aphasia and/or cognitive impairment * multiple stroke events * bilateral stroke event * hemineglect * history of neurological or psychiatric illness * allergy to glue/tape * male participants refusing to shave their moustaches or beards during the study * other experimental procedure is forbidden during the weeks where the study is performed * pregnant, parturient and lactating women * persons deprived of their liberty * adult persons subject to a legal protection measure: guardianship, curatorship * congenital or acquired malformation/injury of the test finger exclusion criteria: * impossibility to maintain hand position necessary for the tests due to severe spasticity * severe impairment of the sensibility of the face preventing the administration of the rss * severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mn)
evaluation of prognostic monitoring for triple negative breast cancer patients

Conditions: Triple Negative Breast Cancer

Summary: the relationship between immune inflammation-related protein complexes in blood of triple negative breast cancer patients and recurrence or metastasis of breast cancer will be studied.

200 patients with triple negative breast cancer will be followed up. peripheral venous blood was collected every 3 to 6 months. change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. the relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria:
inclusion criteria: * female * postoperative pathology confirmed invasive breast cancer after surgery for breast lump * breast cancer-related chemotherapy and radiotherapy completed * triple negative breast cancer patients * age ≤ 60 years old exclusion criteria: * male * aged above 60 * breast carcinoma in situ * women in pregnancy or breastfeeding * suffering from other malignant tumors * non-compliant patient