Kornimate/medical-research-clean huggingface dataset:
investigating the efficacy of caloric vestibular stimulation in the treatment of substance use disorders

Conditions: Substance Use Disorders

Summary: the purpose of this study is to determine efficacy and effect of cvs (caloric vestibular stimulation)

this study is designed as a nonrandomized, single-blind, sham-controlled trail in which willing participants will receive a 5 day course of twice daily caloric vestibular stimulation (cvs) or sham treatment. cvs involves twice daily sessions of cvs each lasting 15 minutes. the week before the intervention baseline characterization of mood and substance craving will be conducted using standard mood and substance use questionnaires. prior to treatment beginning participants will undergo structural and functional mr imaging. participants will also undergo a standard battery of questionnaires, including cognitive testing, mood and affect surveys, and surveys specific to sud. during each of the 5 treatment days the participants will be asked to fill out questionnaires related to mood and craving symptoms. participants will be blinded to sham stimulation or the standard cvs protocol. at the end of the 5 day course participants will be scanned again in mri and asked to fill out the same battery of questions. consistent with the existing standard of care participants will also receive two urine drug screens (uds)

Eligibility criteria:
inclusion criteria: * subjects will have a diagnosed sud (including but not limited to opiate, alcohol, cocaine, nicotine, or amphetamine use disorders). * subjects will be between the age of 17 and 50 years old * subjects will have been abstinent on a stable treatment regimen for at least 4 weeks * subjects will be able to sit still for mri imaging * subjects will be able to read and complete survey questionnaires * subjects will reliably be abstinent from their drug of choice through the 5 day intervention as determined by the discretion of a clinician exclusion criteria: * subjects will be excluded for comorbid neuropathology (eg history of stroke or tbi) * subjects will be excluded if they are at high risk for relapse as determined by a clinician * subjects will be excluded if they are unable to tolerate the cvs devise * subjects will be excluded if they have malformations of or existing trauma to the external auditory canal

Keywords: opiate use disorder neuromodulation caloric vestibular stimulation adjunct therapy
a formative evaluation for improving breast cancer hormone receptor testing in tanzania

Conditions: Breast Cancer

Summary: the purpose of this study is to learn more about the challenges with breast cancer diagnosis in tanzania and the support available to improve this process.


Eligibility criteria:
participant inclusion criteria: * breast cancer survivor, patient advocate or key healthcare personnel * key healthcare personnel are defined as hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons, with: * \>12 months of employment at the affiliated institution * administrative or clinical involvement in the delivery of breast cancer care services. * age 18 years and above * permanent residents or citizens of tanzania * participant and/or lar willing and able to consent * fluent in swahili and/or english by self-report participant exclusion criteria: * key stakeholder not residing at their particular institutions during data collection will be excluded. eligibility criteria for chart reviews inclusion criteria for chart review: * age 18 years and above * permanent residents or citizens of tanzania * received breast cancer diagnosis exclusion criteria for chart review: none

Keywords: breast cancer hormone receptor testing breast cancer testing genexpert strat4 memorial sloan kettering cancer center 21-480
incmga00012 in combination with chemoradiation in participants with stage iii non-small cell lung cancer (pod1um-301)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to assess the efficacy and safety of incmga00012 in combination with chemoradiation therapy (crt) in participants with unresectable, stage iii non-small cell lung cancer (nsclc). the study will randomize approximately 360 participants in a 2:1 ratio into the incmga00012 in combination with crt followed by consolidation therapy with incmga00012 treatment group and placebo in combination with crt followed by consolidation therapy with placebo treatment group.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc that is locally advanced and unresectable. * adequate tumor sample from fresh biopsy or archival tissue block must be available. * evaluable disease per recist v1.1. * eastern cooperative oncology group performance status 0 to 1. * willingness to avoid pregnancy or fathering children. exclusion criteria: * receipt of cancer treatment for this malignancy, including but not limited to radiation therapy, investigational agents, chemotherapy, and immunotherapy for disease under consideration. * recent major surgery within 4 weeks before entry into the study. * any medical contraindication to platinum-based doublet chemotherapy. * active autoimmune disease requiring systemic immunosuppression in excess of physiologic consolidation doses of corticosteroids (\> 10 mg/day of prednisone or equivalent). * known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). * mixed small cell and nsclc histology. * evidence of interstitial lung disease or active noninfectious pneumonitis. * participants who are hiv-positive. * history of organ transplant, including allogeneic stem cell transplantation.

Keywords: non-small cell lung cancer unresectable stage iii pd-1 pd-l1
modulation of cerebral blood flow using quercetin, a nutritional supplement

Conditions: Stroke; Problem of Aging

Summary: the purpose of this study is to find out if quercetin can increase blood levels of hypoxia-inducible transcription factor 1 (hif-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Eligibility criteria:
inclusion criteria: * healthy volunteers between the ages of 18-75 years old exclusion criteria: * subjects taking vasoactive medications * hypertension or vascular disease * asthma * smokers * pregnant women * cancer * diabetes mellitus * history of seizures * history of stroke or head trauma * subjects taking digoxin, cyclosporine,felodipine, estradiol, or quinolone antibiotics * poor transcranial doppler insonation windows

Keywords: quercetin brain blood flow aging memory
psychological assessment and treatment of chronic benign headache

Conditions: Headache; Migraine; Tension Headache; Stress Headache; Vascular Headache

Summary: subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback or relaxation training after fulfilling screening, intake interviews, \& psychological testing requirements. they will chart headache pain, anger level, \& medication usage throughout baseline, treatment, and 3 month follow-up periods. migraine sufferers will receive a combination of progressive muscle relaxation training and thermal biofeedback (learning to warm hands). subjects are randomly assigned to receive treatment either in the office with the therapist or from another room (where communication will be over a computer). the research is designed to compare the effectiveness of treatment based on location. tension headache sufferers will receive training in how to reduce their muscle tension levels. they will be randomly assigned to have equipment monitor muscle tension levels either in the forehead or shoulder regions. the research is designed to compare the effectiveness of feedback to the forehead versus the shoulder muscles.


Eligibility criteria:
subjects must be at least 18 years old and have chronic headaches of any of the following types: migraine, coexisting migraine/tension, or tension. participants must be intellectually intact and have no significant physical, neurological, or psychological problems. they must have seen a physician for their headaches within the past year. they must successfully complete screening/interview/testing process prior to admission to treatment. all vascular headache subjects must meet the criteria for chronic migraine or coexisting migraine and tension type headache as set forth by the headache classification committee of the international headache society. all tension headache subjects must meet the criteria for either episodic or chronic tension headache set forth by the headache classification committee, as well as the ad hoc committee's criteria for tension headache.

Keywords: relaxation techniques behavior therapy feedback psychophysiology
comparative study of bay86-5300 with an extended flexible regimen for endometriosis

Conditions: Endometriosis

Summary: this is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase. the primary objective of this study is to confirm the superiority of bay86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in japanese endometriosis patients within 24 weeks. the secondary objective is to investigate the long-term safety of bay86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of bay86-5300 when administered with an extended flexible regimen compared to dienogest.


Eligibility criteria:
inclusion criteria: * patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of cul-de-sac or uterine immobility * patient with pelvic pain judged by the highest visual analogue scale (vas) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase) * patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase) * patients who do not wish to become pregnant during the course of the study exclusion criteria: * patients who have organic diseases of which surgical treatment is prioritized by investigator * patients in whom any hormonal therapies, including combined oral contraceptives (cocs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain) * patients for whom yaz combination tablet is contraindicated (according to japanese labeling) * patients for whom dienogest is contraindicated (according to japanese labeling of dinagest tab 1mg)

Keywords: yaz flexible regimen drospirenone ethinylestradiol betadex endometriosis dienogest japanese patients
a longitudinal, observational biomarker study in pancreatic cancer patients receiving chemotherapy

Conditions: Pancreatic Cancer

Summary: 1. based on the literature, the pancreatic cancer treatment predictor biomarker, which is used in the domestic clinical field, is actually applied to the pancreatic cancer patient cohort of the national cancer center. 2. to systematically prospectively identify prospective treatment response biomarkers for pancreatic cancer cohort in the national cancer center

1. immunohistochemistry and gene test for hent1, dck, smad4, ces2, brca 1/2,palb2, mmrd, msi, tumor ag and etc. on cancer sample 2. collect data of biomarker for pancreatic cancer 3. compare with big data and cohort study in national cancer center 4. the number of subjects is changed by statistical consideration. 218-\>238

Eligibility criteria:
inclusion criteria: * pathologically confirmed pancreatic cancer patients exclusion criteria: * subjects who do not agree with the study

Keywords: pancreatic cancer biomarker chemotherapy pharmacogenomic clinical trials
an open-label, single and multiple oral dose pharmacokinetic study of vigabatrin in infants with infantile spasms

Conditions: Infantile Spasms

Summary: the primary objective of the study is to evaluate vigabatrin pharmacokinetics (pk) in neonates receiving vigabatrin for infantile spasms (is); and to determine the safety of vigabatrin.


Eligibility criteria:
inclusion criteria: * the patient's parent or legally authorized representative is able to read and understand the patient information sheet and informed consent form. * the patient's legally authorized representative has signed the informed consent form. * the patient has is, diagnosed according to the international league against epilepsy (ilae) criteria. * the patient is a full term (38 weeks gestation) male or female, aged \>=1 month to \<6 months at the time of enrollment. * the patient's length and body weight for gestational age is \>=5th and \<=95th percentile, according to centers for disease control and prevention (cdc) growth charts. exclusion criteria: * the patient is currently being treated or has been previously treated with vigabatrin. * the patient is a member of the site personnel's immediate family. * the patient takes or has taken disallowed recent or concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. * the patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the investigational medicinal product (imp) or the excipients (povodone/iodine) of the imp. * the patient has any other disorder for which the treatment takes priority over treatment of is or is likely to interfere with study treatment or impair treatment compliance. * the patient has been treated with any imp within 30 days or 5 half lives (whichever is longer) prior to the screening visit. * the patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. * the patient has been diagnosed or is judged by the investigator to have anemia. * the patient has been diagnosed or is judged by the investigator to have renal insufficiency. * the patient's parent or legally authorized representative is, in the investigator's opinion, unlikely or unwilling to comply with the protocol or the patient is unsuitable for any reason.

Keywords: is pharmacokinetics area under the curve maximum plasma concentration time to maximum concentration
assessment of use of rapid diagnostic testing in the context of home management with acts

Conditions: Malaria; Pneumonia

Summary: this study is to assess the value of incorporating a malaria rdt based strategy in hmm. the primary activity of the study wil be a two armed cluster randomised trial in two study sites in uganda, one in ghana and one in burkina faso. one of the uganda sites is highly endemic and the other meso-endemic for malaria. in one arm the children will be treated presumptively for malaria with act (control arm) and the other arm the children will receive act only when they have a positive rdt result (implementation arm). the children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. the primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on day 3. in addition, an acceptability assessment of rdts in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the rdt strategy will also be completed. for a sub-sample, microscopy slides will also be taken on day 0 to demonstrate comparable levels of endemicity in control and intervention groups. these activities will be carried out over a two year period.

this is an open, cluster randomised multicentre two arm trial in the three countries of burkina faso, ghana and uganda. clusters are villages (catchment populations) of individual community health workers (chws). within the study areas, clusters that are more than 5 km from a designate health facility where chws referred cases for special care will be excluded. a cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the chws maintained the correct treatments based on the tests in the intervention arm and the presumptive treatment in the control arm.

Eligibility criteria:
inclusion criteria: * children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor exclusion criteria: * children classified as having severe illness according to imci guidelines. children suffering from chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate

Keywords: malaria act rapid diagnosis community health worker artemesinin based combination therapy anti malarial treatment antibiotics
unraveling perioperative myocardial injury

Conditions: Myocardial Injury; Myocardial Injury After Non-Cardiac Surgery

Summary: the aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.

as above

Eligibility criteria:
inclusion criteria: * age \> 18 year of age * undergoing non-cardiac surgery in the erasmus mc, with (high-sensitive) troponin t \> 50 ng/l measured in any of the first three days after surgery. exclusion criteria: * re-operations within the study period. * daycare surgery
susceptibility to chronic post-traumatic extremity pain

Conditions: Chronic Pain

Summary: the association between the comt haplotypes and the presence or absence of cpsp or crps will be assessed stratifying the patients based on the individual categories of trauma or elective surgery.

this will be a prospective association study in which we will recruit patients who have experienced single extremity trauma, or who have scheduled elective surgery on a single extremity. hrqol will be determined at recruitment. we will identify their haplotypes and genotypes for 4 linked snps in the coding region of comt as described by diatchenko \[2\]. patients will receive follow-up at 3 and 6 months following trauma or surgery. individuals who report either neuropathic pain or a reduced hrqol score will be more closely examined, in order to identify cpsp or crps. statistical analyses will be performed to determine whether haplotypes are associated with the development of either condition, and to determine the strength of this association.

Eligibility criteria:
inclusion criteria: * provide written informed consent prior to participation in the study * be at lease 18, but not more than 80 years of age * have the ability to read and understand the study procedures and the use of the pain scales and have the ability to communicate meaningfully with the study investigator and staff. * be free of other physical, mental, or medical conditions, which, in the opinion of the investigator, makes study participation inadvisable * is scheduled to undergo open or arthroscopic shoulder surgery * if the subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery. exclusion criteria: - has significant medical disease(s), laboratory abnormalities or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation

Keywords: complex regional pain syndrome chronic post-surgical pain genetic susceptibility comt
detection and management of acute kidney injury (aki) in low and low middle income countries: a pilot feasibility project

Conditions: Acute Kidney Injury

Summary: this feasibility study will be conducted at 4 international sites located in asia (dhahran, nepal); africa (blantyre, malawi and kilimanjaro, tanzania) and latin america (cochabamba, bolivia). each site comprises a cluster (including 3-4 health centers - 1 district hospital - 1 regional referral hospital) that service the population around the site area. patients presenting at a health care clinic or hospital emergency department with signs and symptoms associated with high and moderate risk of developing aki will undergo a point of care (poc) test to measure serum creatinine, saliva urea nitrogen dipstick (exclusively in malawi), and a urine dipstick test for color, protein, glucose, blood and specific gravity. patients who meet the study inclusion criteria will be approached for consent. patients enrolled in the study will be followed throughout the health care evaluation and tracked through their course by location i.e. health care center, hospital, and home. outcomes will be recorded through 6 months following the health care evaluation. the protocol will have an initial observation phase, during which relevant healthcare staff and the research team will be trained to identify patients at moderate or high risk of aki and use of the point of care (poc) test for serum creatinine, saliva urea nitrogen dipstick (exclusively in malawi), and urine dipstick test. during this phase patients will be tracked throughout the health care evaluation, however the teleconsultation will not be implemented and no specific guidance for managing the patient will be provided. during the subsequent intervention phase, the research team will interact with the local healthcare providers to and the teleconsultation physician, providing guidance on the management of the patient based on a standardized protocol. protocols for patient care will be pre-specified, with minor adjustments to meet local requirements.


Eligibility criteria:
inclusion criteria:presence of signs and symptoms determining aki risk * decreased urine volume * hypotension/ shock * coma * jaundice * confusion * dyspnea * symptoms of respiratory infection * petechia, ecchymosis, bleeding * hypertension (in pregnancy) exclusion criteria: * chronic kidney disease in patients receiving regular dialysis treatment * kidney transplant patients * unable to give informed consent
autotaxin: a potential biomarker for breast cancer.

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to test the efficiency of autotaxin (atx) as a biomarker for breast cancer patients. the main questions it aims to answer are; * is atx a reliable tumor marker for breast cancer patients in diagnosis * can atx differentiate cancer patients from non-cancer ones

80 breast cancer patients and 30 normal patients with no known cancer history were enrolled in this study. all patients were female. the mean ages of cancer patients were 58.2 and 52.7 consecutively for cancer and non-cancer patients. the mean serum atx levels of cancer and non-cancer patients were 1570.72 and 121.86 ng/ml consecutively (p=0.001). the cut-off value of atx serum level was 178.49ng/ml according to the roc analysis. the area under the roc curve was 0.901showing that atx is very efficient in distinguishing between two diagnostic groups (diseased/normal). atx also showed good correlations with known tumor markers (cea, ca15-3, ca125 levels). atx levels were still higher than the cut-off value even in cancer patients with normal or low classical tumor marker levels.

Eligibility criteria:
inclusion criteria: * preoperatively diagnosed breast cancer patients with no synchronous cancer and without known hepatic or other inflammatory disorders. exclusion criteria: * patients with benign breast diseases and no known cancer history.

Keywords: breast cancer autotaxin tumor marker