Kornimate/medical-research-clean huggingface dataset:
telemedicine vs. face-to-face cancer genetic counseling

Conditions: Hereditary Breast and Ovarian Cancer Syndrome; Lynch Syndrome

Summary: cancer genetic counseling (cgc) has been found to have "substantial" benefits for individuals with breast cancer and their family members; it has been deemed by multiple organizations as "standard of care" for women with breast cancer and their relatives. unfortunately, there is a disparity in access to cgc, especially among women who live in rural and underserved areas. in north carolina, only two cancer genetic counselors practice in rural clinics - each only for a few days per month. therefore, in an effort to make cgc more widely available in a timely manner, we propose to test provision of counseling through telemedicine (tm), in which a patient and health care provider communicate with each other using videoconferencing. in 4 rural oncology clinics, we will implement low-cost tm and compare satisfaction and cost-effectiveness between groups of women designated to have their cgc session by tm or ftf. we'll use a validated measure to assess satisfaction by a phone survey one week after the cgc appointment; cost-effectiveness will be measured at project's end by calculating length of wait time for appointment and costs of equipment, labor, and mileage. study hypothesis: tm is as satisfactory as ftf counseling and is a more cost-effective way to provide this beneficial service.


Eligibility criteria:
inclusion criteria: * individuals referred for cancer genetic counseling (e.g., by medical oncologist, primary care physician or self) in one of 4 oncology clinics: gibson cancer center in lumberton, nc; scotland cancer treatment center in laurinburg, nc; johnston cancer center in smithfield, nc; and maria parham cancer center in henderson, nc. * willing to be randomized to receive counseling via telemedicine or face-to-face. exclusion criteria: * referred for cancer genetic counseling from any clinic other than the 4 listed above. * unwilling to be randomized to receive counseling via telemedicine or face-to-face.

Keywords: hereditary breast and ovarian cancer syndrome genetic counseling breast cancer ovarian cancer telemedicine cancer genetic counseling
study of induction docetaxel, cisplatin and 5-fluorouracil

Conditions: Squamous Cell Carcinoma; Oral Cancer

Summary: this is a phase ii study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

this is a phase ii study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the emory winship cancer institute in atlanta, georgia.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven squamous cell carcinoma of the oral cavity. * primary tumor sites eligible: oral cavity. although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection. * stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or ct scan (liver function test abnormalities); bone scan in case of local symptoms. * at least one uni- or bi-dimensionally measurable lesion. * age ≥ 18 years. * world health organization (who) performance status of 2 or less. * no active alcohol addiction. * final eligibility for a clinical trial is determined by the health professionals conducting the trial. exclusion criteria: * pregnant or breast feeding * previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. * any prior treatment with radiotherapy or chemotherapy is an exclusion criterion. * patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry. * concurrent treatment with any other anti-cancer therapy. * participation in an investigational trial within 30 days of study entry. * patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80. * no previous chemotherapy or radiotherapy for any reason and no previous surgery for scchn \[squamous cell carcinoma of the head and neck\] (other than biopsy) are allowed at the time of study entry. * final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Keywords: squamous cell carcinoma of the oral cavity
measuring time windows in patients with schizophrenia and healthy controls

Conditions: Schizophrenia

Summary: abnormalities in the ability to distinguish events in time may have a great impact on everyday life. the main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. the investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. they explore also the neurobiological bases of the impairment by means of electroencephalogram (eeg) recordings. event-related potentials (n50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. the distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia (dsm-iv criteria) * healthy controls matched with patients on age, sex and education level * age between 18 and 50 * informed consent signed * no severe somatic illness * no invalidating sensory disease * no drug abuse, as defined by dsm-iv criteria * no general anesthesia in the past 3 months * no intake of drug affecting the cns, except for patients

Keywords: schizophrenia time perception cortical synchronization electroencephalography
sphenopalatine ganglion block for post-dural puncture headache

Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block

Summary: the investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. the investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists assigned class i-iii * age \>/= 18 years * experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated \>3/10 pain score exclusion criteria: * allergy to study medications \<18 years of age pain score on presentation \</=3/10 for headache
cervical spine manipulation affects on balance and proprioception

Conditions: Neck Pain; Headache

Summary: cervical spine manipulation (csm) is utilized by many health care practitioners in the management of patients with neck pain and headache. how csm works is not understood however, most researchers agree that there is likely a combination of mechanical, neurophysiological and placebo effects. this study will test for possible neurophysiological effects by examining for changes in a person's ability to reposition their head and neck in space, and maintain their balance following csm.

consenting participants will have their proprioception tested through a joint repositioning error test for their cervical spine, and also have their balance tested through a neurocom balancemaster. following these pre-intervention measures, they will receive in a random order, either a cervical spine manipulation (csm) or a sham manipulation, and then have tests repeated to analyze for changes and differences between interventions.

Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18 and 60 exclusion criteria: * current neck pain/symptoms; neck pain symptoms within the last 6 months; confirmation or possibility of pregnancy; dizziness; vertigo, or nausea; history of cervical spine surgery; rheumatoid arthritis; osteoporosis; osteopenia; ankylosing spondylitis; cancer; or vertebral artery insufficiency.

Keywords: manipulation balance proprioception
bioequivalence study of metformin hydrochloride extended release 750 mg tablets versus glucophage xr® 750 mg tablet in healthy volunteers under fed conditions.

Conditions: Type 2 Diabetes

Summary: objective: to study bioequivalence of metformin hydrochloride extended release 750 mg tablets (test formulation, torrent pharmaceuticals ltd., india) versus glucophage xr® 750 mg tablet (reference formulation, bristol-myers squibb company, usa) in healthy volunteers under fed conditions. study design: an open-label, randomized, 2-period, 2-treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: * volunteers must meet all of the following criteria in order to be included in the study: 1. sex: male. 2. age: 18 - 45 years. 3. volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. 4. healthy and willing to participate in the study. 5. volunteer willing to adhere to the protocol requirements and to provide written informed consent. 6. non-smokers or smoker who smokes less than 10 cigarettes a day. exclusion criteria: * the volunteers will be excluded from the study based on the following criteria: 1. clinically relevant abnormalities in the results of the laboratory screening evaluation. 2. clinically significant abnormal ecg or chest x-ray. 3. systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. 4. pulse rate less than 50/minute or more than 100/minute. 5. oral temperature less than 95°f or more than 98.6°f. 6. respiratory rate less than 12/minute or more than 20/minute 7. addiction to alcohol or history of any drug abuse within the past 2 years. 8. recent history of kidney or liver dysfunction. 9. history of allergy to the test drug or any drug chemically similar to the drug under investigation. 10. administration/ intake of prescription or otc medication for two weeks before the study. 11. patients suffering from any chronic illness such as arthritis, asthma etc. 12. hiv, hcv, hbsag positive volunteers. 13. opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, cocaine positive volunteers based on urine test. 14. volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. 15. administration of any investigational products in the period 0 to 3 months before entry to the study. 16. intake of barbiturates or any enzyme-inducing drug in last three months. 17. history of significant blood loss due to any reason, including blood donation in the past 12 weeks. the total blood loss in last 3 months including for this study will not exceed 350ml. 18. existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. 19. inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
a multi-center,prospective, os to evaluate the effectiveness of 'nac' nebulizer therapy in copd (newest)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to evaluate the effect of mucomyst nebulizer therapy on improvement in symptoms and quality of life in copd patients with difficulty of expectoration.

in this non-interventional observational study, treatment for individual subjects is determined by the investigator according to the status of individual subjects in routine clinical practice. in this circumstance, doses for each drug product will not be specified in the protocol but will be determined as appropriate by the investigator with the product label and the subject's medical condition taken into consideration. primary objective to evaluate the effect of mucomyst on improvement in difficulty of expectoration symptoms in copd patients with difficulty of expectoration. secondary objective to evaluate the effect of mucomyst on improvement in quality of life and safety in copd patients with difficulty of expectoration.

Eligibility criteria:
inclusion criteria: 1. man and woman at the age of ≥40 years old 2. diagnosed with copd within the past 1 year based on pulmonary function test (post bronchodilator fev1/fvc\<0.7) 3. copd assessment test (cat) phlegm score ≥2 4. smoking history ≥10 pack-years\* (\*pack-year: number of packs of cigarettes smoked per day x number of years the individual has smoked) 5. patient who is to be treated with mucomyst nebulizer therapy to alleviate difficulty of expectoration symptoms 6. voluntary written informed consent to study participation and to use of personal information for this study exclusion criteria 1. history of hypersensitivity reactions to any of the components of nac or contraindicated to nac therapy according to the product label 2. treated with mucomyst within the past 4 weeks 3. newly treated with 'drugs for the alleviation of expectoration symptoms (antitussives/expectorants)' or dose changed for ongoing therapy within the past 4 weeks 4. pregnant and lactating woman 5. participating in another trial with investigational product treatment at the time of enrollment to the present study 6. ineligible for study participation in the opinion of the investigator
pharmacogenetics associated with iv ketamine

Conditions: Treatment Resistant Depression

Summary: the canadian rapid treatment center of excellence (crtce) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from treatment resistant depression. patients who have received iv ketamine at the clinic are eligible to participate in this study where genetic biomarkers are correlated with response to iv ketamine.


Eligibility criteria:
inclusion criteria: 1. must have received iv ketamine previously to treat treatment-resistant depression 2. between the ages of 18-65 years old. 3. clinical diagnosis of mdd 4. individuals may have had comorbid psychiatric conditions (e.g., anxiety), but the comorbid psychiatric condition cannot be the primary clinical concern. 5. ability to provide informed consent exclusion criteria: 1. individuals who meet dsm 5 criteria for a substance use and/or alcohol use disorder in the past 3 months. 2. individuals who are currently experiencing psychotic symptoms as part of an mde (mood congruent/mood incongruent). 3. individuals who are unable to consent to the procedure. 4. individuals who are unable to adhere to the protocol in its totality
application of forward-looking infrared for the identification and evaluation of fractures in the acute trauma setting

Conditions: Acute Fracture

Summary: the overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.

human subjects will be enrolled into the study from nyu langone health and bellevue hospital center. when orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. the collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. if any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. no obtunded or unresponsive patients will be enrolled into the study. the goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 to 95 * have fracture injury exclusion criteria: * subjects suffering from a hypothermia- or hyperthermia - related illness or other environmental exposure-type illness * those with a concomitant fracture * subjects with no specific medical history or surgical history * subjects who cannot provide informed consent
quality of life and pain with infiltration or suprascapular nerve block in glenohumeral arthirtis

Conditions: Shoulder Arthritis

Summary: efficacy in pain and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in glenohumeral arthritis

to describe the efficacy in pain management and health related quality of life of suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with glenohumeral arthritis

Eligibility criteria:
inclusion criteria: * imss affiliated * glenohumeral arthritis diagnosed exclusion criteria: * previusly treatment for the same disease * no follow up * dead
the female microbiome in patients undergoing bladder instillation therapy

Conditions: Interstitial Cystitis; Bladder Pain Syndrome; Microbial Colonization

Summary: the underlying pathophysiology for bps/ic is currently an active area of research. there is speculation that there may be alteration in the bladder and vaginal microbiome that contributes to the symptomatology of bps/ic, however existing literature is limited and contradictory. nickel et al (2015) studied the bladder microbiota in women with ic/bps during a flare versus nonflare. the study collected initial stream and midstream urine specimens and detected overall, there was no significant differences in the species composition. however, a greater prevalence of fungi (candida and saccharomyces) was seen in the flare group (15.7%) versus the non-flare group (3.9%) midstream urine specimens. pearce et al (2015) sought to characterize the urinary microbiome via catheterized specimens from women with urgency urinary incontinence, a condition that can present similarly as ic/bps. the study found that more than half of the patients were sequence positive, most commonly for lactobacillus (45%) or gardnerella (17%), with 25% made up of various other bacteria. in contrast, abernethy et al (2017) showed via catheterized urine specimens from patients with ic/bps that the urinary microbiome is less diverse and less likely to contain lactobacillus species. there have been two recent studies investigating the female urinary microbiome in patients with ic/bps. nickel et al (2019) found no differences in species composition between urine from patients with ic/bps versus controls. meriwether et al (2019) reported similar findings, and additionally found no differences when comparing the vaginal bacterial microbiome in patients with ic/bps versus controls. however, in evaluating the bladder microbiome, both studies utilized uncatheterized urine specimens. wolfe et al (2012) showed microbiome differences between clean-catch and catheterized urine specimens, therefore vaginal contamination in both studies cannot be ruled out.

this study uses samples collected under an interventional study and consented for use in future research - this study is use of those samples under the future research provision, and this study was deemed to meet exempt category 4.

Eligibility criteria:
inclusion criteria: * patients who previously or will be undergoing bladder instillation therapy for treatment of ic/bps and whom had or will have urine/vaginal specimens collected at the beginning and between 4-6th instillations. exclusion criteria: * patients not meeting inclusion criteria
photobiomodulation therapy on inflammatory mediators on low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is ranked as one of the most prevalent health conditions. it is likely that some inflammatory mediators could be associated with pain and disability in these patients. photobiomodulation therapy (pbmt) is a non-pharmacological therapy often used in patients with lbp that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. the present research project aims to evaluate the effects of pbmt on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.

this is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled trial, with voluntary patients with non-specific chronic low back pain. eighteen patients will be randomly allocated to two treatment groups: placebo or pbmt and one single session of treatment will be provided. the data will be collected by a blinded assessor and the outcomes of interest it will be levels of inflammatory markers and pain intensity and it will be collected at baseline and 15 minutes after the single session of treatment. the statistical analysis will follow the intention-to-treat principles. the findings will be tested for their normality using the shapiro-wilk test. parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. parametric data will be analyzed by two-way repeated measures analysis of variance (anova; time versus experimental group) with post-hoc bonferroni correction. non-parametric data will be analyzed using the friedman test and, secondarily, the wilcoxon signed-rank test.

Eligibility criteria:
inclusion criteria: * patients with chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month); * with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale; * aged between 18 and 65 years; exclusion criteria: * evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit); * serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases); * serious cardiovascular and metabolic diseases; * previous back surgery; * pregnancy. * severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);

Keywords: low back pain photobiomodulation therapy pbmt low-level laser therapy lllt