Kornimate/medical-research-clean huggingface dataset:
smoking-cessation and stimulant treatment (s-cast)

Conditions: Cocaine Dependence; Methamphetamine Dependence; Nicotine Dependence

Summary: the primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (tau+sct), relative to substance-abuse treatment as usual (tau), on drug-abuse outcomes. specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cocaine/methamphetamine dependence * smoked cigarettes for at least 3 months * currently smoking \> 6 cigarettes/day * have an interest in quitting smoking * enrolled in outpatient treatment at a participating site exclusion criteria: * clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a life-time diagnosis of anorexia nervosa or bulimia * seeking/receiving treatment for opiate-agonist replacement therapy * medical conditions that could compromise participant safety * taking medications with known/potential interactions with bupropion * hypersensitivity to bupropion, nicotine, or menthol * pregnant or breastfeeding * abnormal ecg * recent smoking cessation treatment * use of tobacco products other than cigarettes in the past week * likely to enter residential/inpatient treatment within 10 weeks * have all stimulant-positive urine drug screens during screening/baseline

Keywords: stimulant treatment smoking cessation
a research study of the effect of etavopivat on other drugs in healthy participants

Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia

Summary: the study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. the purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. during the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. these marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. during a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. the study will last for about 34 to 64 days.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening. * body weight greater than (\>) 50.0 kg at screening. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * known or suspected hypersensitivity to study interventions or related products. * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening. * participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (ugt) enzymes, cyp3a4, cyp2c9, mate1, oatp1b1/1b3, bcrp, oct2, or p-gp, including st. john's wort for 28 days prior to dosing and throughout the study. * use of any medication with unknown or unspecified content within 90 days before screening. * use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for: * adequate contraceptive methods. * hormone replacement therapy (hrt) (for menopausal females). * over-the-counter topical medications known to not reach systemic circulation. * occasional use of acetaminophen up to 2 grams (g) (4 x 0.5 g) daily. * not able or not willing to adhere to study procedures, including: * eating the food provided in the study. * refraining from ingesting food or drinks that are not allowed during the study. * swallowing tablets. * abstaining from concomitant medication not allowed during the study.
promoting oral health among smokers randomized trial

Conditions: Oral Disease; Smoking

Summary: the current study will test the effectiveness of a multi-modal behavioral intervention (the oral health 4 life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines. the investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will: 1. be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up \[primary outcome\] and at 2 month follow-up \[secondary outcome\]. 2. be more likely to see a dental care professional in the past 6 months at 6 month follow-up \[primary outcome\]. 3. exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program. follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. in addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the oral health 4 life program will be examined.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 or older * eligible for multi-call services through a participating tobacco quitline managed by alere wellbeing * can read and speak in english * current daily smoker and smokes at least 5 cigarettes a day * interested in quitting smoking in next 30 days * have some or all natural teeth * have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months * has a cell phone capable of receiving text messages and provides cell phone number * has internet access for personal use * willing to talk about ways to improve their oral health * provides verbal consent to participate exclusion criteria: * self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment) * have lived at the current address less than 6 months or plans to move in the next 6 months * are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated * has a household member already enrolled in the study, based on self-report and/or mailing address on file

Keywords: smoking cessation oral health care tobacco quitlines
long term administration study of opc-12759 ophthalmic suspension

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate safety and efficacy of opc-12759 ophthalmic suspension during 52 weeks in dry eye patients


Eligibility criteria:
inclusion criteria: 1. out patient; 2. ocular discomfort severity is moderate to severe; 3. corneal-conjunctival damage is moderate to severe; 4. unanesthetized schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less; 5. best corrected visual acuity of 0.2 or better in both eyes. exclusion criteria: 1. presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca; 2. ocular hypertention patient or glaucoma patient with ophthalmic solution; 3. anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study; 4. anticipated use of contact lens during the study; 5. patient with punctal plug; 6. any history of ocular surgery within 12 months; 7. female patients who are pregnant, possibly pregnant or breast feeding; 8. known hypersensitivity to any component of the study drug or procedual medications; 9. receipt of any investigational product within 4 months.
a study on the prevalence of clinically useful mutations in solid tumor characterized by next generation sequencing methods on liquid biopsy analysis (popcorn)

Conditions: Solid Tumor; Advanced Solid Tumor; Locally Advanced Solid Tumor; Colon Rectal Cancer; Gastric Cancer; Pancreatic Cancer; Bile Duct Cancer; Hepatocarcinoma; Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulva Cancer; Melanoma

Summary: the implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctdna. among these, the next generation sequencing (ngs) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. it is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. in this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. the aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to meet all of the following criteria: * patients, 18 years of age or older * competent and able to comprehend, sign and date an ethics committee (ec) approved informed consent form (icf) before performance of any study-specific procedures or tests * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * histologically proven diagnosis solid tumor * diagnosis of advanced or locally advanced disease * patients candidated to receive standard therapy in the following line: * first, second or third-line therapy for colon-rectal cancer in iv stage * first or second-line therapy for gastric cancer in iv stage * primary intent or first-line therapy for pancreatic cancer * first-line therapy for bile duct cancer * first or second-line therapy for hepatocarcinoma * first, second, third, fourth or fifth-line therapy for breast cancer in iv stage * chemotherapy for ovarian cancer in advanced stage (figo iii-iv) and at the time of first relapse * first or second-line therapy for endometrial cancer in advanced stage (figo iii-iv) * first or second-line therapy for advanced or locally advanced cervical cancer * therapy for locally advanced or first line therapy for metastatic vulva cancer * first, second or third-line therapy for melanoma (third-line therapy only in braf-mutated melanoma) exclusion criteria: * diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. * patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints
body weight gain, parkinson, subthalamic stimulation

Conditions: Parkinson's Disease

Summary: chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. however, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. the aim of this study to determine the energy expenditure in usual conditions of life.

patients will be studied before (between 3 and 1 months) and after (1 month) stn-dbs surgery. each time the same measurements will be taken. the principal ones will be : * clinical examination * autoevaluation dietary questionnaire * biological tests * study in calorimetry chamber (only in clermont-ferrand centre) * heart rate recorded during 7 days in usual conditions of life * energy expenditure recorded during 14 days in usual conditions of life with normalized water (18o 10 %) and deuterium oxide (99.94 %d) * acute ldopa challenge (in both conditions of dopa and stim) * apathy evaluation * body weight, and body compositions measurements

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years old * diagnosis of parkinson' disease established for 5 years at least * ldopa effect \> 50 % * hoehn and yarh score \> 2.5 in on phase exclusion criteria: * metabolism disorder * biological analysis abnormal

Keywords: energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, parkinson's disease patients with parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
a pilot implementation study of gla:d back

Conditions: Low Back Pain

Summary: gla:d back is a program developed in denmark to help people with persistent low back pain. this pilot study will assist in contextualizing danish content into an english version of the program.

gla:d back is a program developed in denmark to help people with persistent low back pain. unfortunately, all materials developed for the program are in danish. in this pilot, the investigators will translate the danish materials into english, then use them to conduct an english training session for community clinicians in edmonton, alberta, canada. interested clinicians will then implement the program in their communities and provide feedback to contextualize the program for use in english. specifically, surveys, interviews and focus groups will be used to help fine-tune the printed content of the course (e.g. manuals), it's training materials (e.g. lectures) and processes related to redcap data collection (e.g. surveys).

Eligibility criteria:
inclusion criteria: * patients must have persistent low back pain of at least 1 month's duration. exclusion criteria: * participating currently in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial. * patients with nerve root involvement, suspected serious pathology, unstable trauma to the spine, aspects of pregnancy or other conditions that would prevent participation or disallow trial completion within the prescribed time period. * persons with conditions that require a specialist consult are suspected of needing a specialist consult, or have conditions that would be aggravated or worsened if treated by the interventions in this study.

Keywords: low back pain
propolis versus calcium hydroxide on post-operative pain in patients with necrotic pulp

Conditions: Post-Operative Pain, Chronic; Necrotic Pulp

Summary: propolis is a resinous product of honeybees. propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. the clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.

propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. the aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. methods: forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. treatment was done in two visits and intracanal medicament was applied for one week in between. participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.

Eligibility criteria:
inclusion criteria: * • asymptomatic patients with age range 20 - 40 years * necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space. * medically - free of any systemic disease * teeth with complete root formation exclusion criteria: * • pregnant or lactating females * teeth with vital pulps, internal or external resorption or anatomic abnormalities * teeth with cracks, curvatures, root caries and calcified canals * double or triple-rooted teeth * patients with facial swelling, acute pulpal or periapical lesion * teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile or recessed * previously endodontically-treated teeth

Keywords: calcium hydroxide propolis post-operative pain necrotic pulp
assessment of safety and effectiveness of novosorb® btm in severe burns

Conditions: Burns

Summary: this is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using novosorb® biodegradable temporizing matrix (btm).

this is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using novosorb® biodegradable temporizing matrix (btm). a comparison will be made between burn wounds treated with btm and the institution's standard of care (soc).

Eligibility criteria:
inclusion criteria: 1. provide written informed consent directly or via legal representative prior to any clinical study procedures being performed 2. willing to comply with all study procedures and expects to be available for the duration of the study 3. male and females ≥ 18 years of age and ≤ 75 years of age 4. patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (tbsa). types of burns include the following: * scalding including from hot water, cooking oil, grease * flame * flash * contact 5. subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft. 6. the minimum total area across all lesions to have novosorb® btm applied is 3% tbsa 7. females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study. exclusion criteria: 1. has a known hypersensitivity to polyurethane 2. only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash 3. multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin 4. presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy 5. presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound 6. for females - has known or suspected pregnancy, planned pregnancy, or during lactation 7. has exposure to any other investigational agent within the last 6 months 8. has exposure to any other treatment/device that will interfere with novosorb® btm integration 9. anticipated inability to perform wound care and follow-up procedures 10. anticipates of a level of non-compliance 11. the use of off-label treatments for full-thickness / deep-dermal burns is not permitted 12. clinical signs of wound infection at areas to be potentially treated using novosorb® btm that in the opinion of the investigator may compromise safety and study objectives 13. the use of novosorb® btm on the face and in the perineum area is not permitted
thai version of functional rating index

Conditions: Questionnaire

Summary: the purposes of this study were to conduct cross-cultural adaptation of the functional rating index (fri), to test psychometric properties of the translated questionnaire and to examine head-to-head comparisons with other questionnaires.

this study comprised 2 major stages: 1) cross-cultural adaptation and 2) psychometric properties testing. cross-cultural adaptation stage: the fri was cross-culturally adapted to thai following the well-accepted guideline for the process of cross-cultural adaptation of self-report measure. psychometric properties testing stage: the patients with back or neck pain completed the questionnaires at the first visit, the second visit and at 2-week (or at discharge or when reporting 80% improvement from the first visit).

Eligibility criteria:
inclusion criteria the participants were eligible if they were: 1. aged 18 years or older 2. seeking physical therapy treatment for a complaint of back and/or neck pain 3. able to understand, read, speak and write thai exclusion criteria: the participants who were not willing to take part in the study, unable to understand, read, speak and write thai were excluded from this study.

Keywords: questionnaire functional rating index cross-cultural adaptation psychometric properties testing
watd and cancer-related fatigue: a study for patients undergoing anti-cancer treatment

Conditions: Pancreatic Cancer; Breast Cancer

Summary: the purpose of this study is to evaluate the feasibility of using a commercial watd (wearable activity tracker device) to collect hrv (heart rate variability) data from pancreatic and breast cancer patients.

this feasibility study is designed to evaluate the collection of longitudinal hrv (heart rate variability) data and assess acceptability of the device among adult cancer patients in the research setting. over the course of the four-week study, participants will be asked to provide experiential diaries detailing adherence to and acceptability of the watd (wearable activity tracker device) and conduct pro (patient reported outcome) measures at week two and week four (end of study). during the final research visit at week four, subjects will return the watd and will complete the acceptability survey. each week of the four-week study, the watd data and experiential diaries will be downloaded for analysis.

Eligibility criteria:
inclusion criteria: * written informed consent and hipaa authorization for release of personal health information * patients pancreatic or invasive breast cancer per enrolling investigator who is planning on or has started anti-cancer treatment. note: patients with cancer who are not planning to receive anti-cancer treatment are not eligible for study participation * patients with any severity of self-reported fatigue per enrolling investigator * age ≥ 18 years at the time of consent * ability to read and understand the english language * as determined by the enrolling investigator, the ability of the participant to understand and comply with study procedures (i.e., completing questionnaires and device return) for the entire length of the study exclusion criteria: * any documented, clinically significant cardiac-related abnormality per enrolling investigator that could compromise the outcome of the study. note: the heart rate data collected using the watd will not be used for patient care. * other factors or conditions, per investigator discretion, for which participation in the study would not be in the patient's best interest or could interfere with study assessment results or preclude study completion * no internet, wi-fi access or email account * no access to a smartphone or mobile device

Keywords: fatigue