Kornimate/medical-research-clean huggingface dataset:
effects of e-cigs vs pouches on cigarette smoking and addiction

Conditions: Smoking; Smoking Behaviors; Nicotine Dependence

Summary: the study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. participants will complete a final follow-up at week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. the investigators expect to observe which products and constituents lead to greater smoking reduction.

the study includes 5 visit and assessments over 6 weeks. the intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. the study is proposed to run for 5 years.

Eligibility criteria:
inclusion criteria: * 21+ years old * english literate * currently smoking cigarettes, biochemically confirmed * not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (nrt, bupropion, varenicline) in the next month. exclusion criteria: * currently using any smoking cessation services and/or pharmacotherapies * currently pregnant or breastfeeding * significant current medical or psychiatric condition * known hypersensitivity to propylene glycol.
phase 2a evaluation of safety, tolerability, and pharmacokinetics of pln-74809 in patients with primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis

Summary: a phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and pk of pln-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

three-part study: part 1 - 12-week treatment period evaluating 40 mg of pln-74809 or matching placebo \[complete\] part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of pln-74809 or matching placebo part 3 - minimum 24-week, up to 48-week treatment period evaluating 320 mg of pln-74809 or matching placebo

Eligibility criteria:
inclusion criteria: * established clinical diagnosis of large duct psc based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (mrcp), endoscopic retrograde cholangiopancreatography (ercp), and/or percutaneous transhepatic cholangiopancreatography (ptc) in the context of cholestatic liver chemistry * suspected liver fibrosis, as defined by liver stiffness measurement (lsm), assessed by ultrasound-based transient elastography (te, fibroscan®) or enhanced liver fibrosis (elf) score or historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) or magnetic resonance elastography (mre) * serum alp concentration within normal limits or \> 1 times the upper limit of normal (uln) * participants receiving treatment for ibd are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study * serum ast and alt concentration ≤ 5 times the upper limit of normal * if receiving treatment with udca, therapy is at a dose of \< 25 mg/kg/day, has been stable for at least 3 months before screening. exclusion criteria: * other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically * known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis * small duct psc with no evidence of large duct involvement (evidence of psc on historical liver histology, with normal bile ducts on cholangiography) * presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, elf score, mre, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy. * serum alp concentration \> 10 times the upper limit of normal.
the effect of post-surgical chlorhexidine mouth washing on the sub-gingival periodontal microbiome a pilot study

Conditions: Periodontitis; Subgingival Plaque

Summary: prospective applicants who conform with inclusion and exclusion criteria will be accepted into the study and sign a consent form. visit 1: after initial screening a case report form (crf) will be filled, including information regarding general health, medication, demographic, oral and dental information. participants will be clinically examined and the following data will be collected prior to surgery: microbial collection, plaque score (ps) , probing pocket depth (ppd), bleeding on probing (bop) at selected non-surgical and surgical teeth. surgery will be performed followed by discharge with a bottle of chlorhexidine mouthwash and written instructions on its usage. visit 2: ten days after surgery sutures will be removed and collected for microbial examination. microbial collection will be performed at non-surgical and surgical sites. adverse events will be recorded and participants will be discharged from the study.

microbial identification: periodontal samples will be collected by the genefix™ saliva dna microbiome collection device (isohelix). dna extraction - the magmax microbiome ultra nucleic acid isolation kits (termo fisher). dna yields and purity - measuring absorbance at 260 nm, a260/a280 and a260/a230 ratios with the nano-drop 2000 spectrophotometer (nanodrop products, wilmigton,usa). microbiome sequencing - target v4 region of 16s rrna gene will be sequenced on the ion torrent s5 instrument (thermofisher) and analysis will be performed with the ergo 2.0 platform ( igenbio). the investigators will perform comparisons of alpha and beta diversity before and after intervention, as well as differential abundance of the taxa.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * scheduled for periodontal/dental surgery without pre- and/or post-surgical antibiotic therapy exclusion criteria: * pre-existing conditions that may affect the microbiome, including diagnoses of diabetes, malignancy, alcoholism, previous head and neck radiation therapy * pregnancy and breast-feeding * chronic medications that are known to affect periodontal tissues such as ca channel blockers and phenytoin * antibiotic therapy within the previous 6 weeks * mouthwash therapy within the previous 2 weeks * known allergy to cm or any of its constituents * smoking \>10 cigarettes/day

Keywords: chlorhexidine subgingival plaque
the relief™ ureteral stent randomized controlled trial

Conditions: Kidney Stone

Summary: assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the relief® ureteral stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double j stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).


Eligibility criteria:
inclusion criteria: * has capacity to consent * stated willingness to comply with all study procedures and availability for the duration of the study * persons, 18 years of age or older * male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen x-ray kub (kidney ureter bladder) or ct (computed tomography) exclusion criteria: * distal ureteral obstruction where suture portion of stent may be placed * urinary reflux (assessed by pre-stent cystogram) * pregnancy or lactation * patients requiring bilateral surgical stone management procedure * infected stones * patients where 24cm or 26cm stent lengths are not suitable * ureteral structure in distal third of ureter * intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients

Keywords: ureteral stent
comparison between non-invasive heat-flux and invasive core temperature monitoring

Conditions: Body Temperature Changes

Summary: the body core temperature drops during general anesthesia. to maintain homeostasis, patients require warming measures. different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. a new monitoring device, tcore(tm), enables a non-invasive but accurate core temperature assessment. this study is performed to quantify accuracy and bias of the tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.


Eligibility criteria:
inclusion criteria: * patients with invasive femoral artery temperature monitoring exclusion criteria: * pregnancy

Keywords: body core temperature
gamification and energetic behavior changes

Conditions: Obesity

Summary: obesity \[body mass index (bmi kg/m2 ≥ 95th percentile)\] affects 1 in 5 adolescents in the united states, with 13 million suffering from severe obesity (bmi ≥ 120% \> 95th percentile or ≥ 35 mg/kg2). adolescents are able to lose weight with behavioral changes in diet and physical activity, but change in these behaviors requires self-monitoring and support, and weight loss is not always successful. parent involvement and parent weight-loss can help their children to lose weight and successfully change their behavior. guidance from pediatricians can also help to facilitate weight loss among obese adolescents. that said, treatment of obesity through behavior change within the time constraints of a pediatric practice visit is limited by treatment adherence and clinic visit attendance. therefore, finding cost-effective, timely, methods to keep adolescents with severe obesity engaged in therapy outside of standard practice is a critical need. the effects of monetary incentives through games (gamification), and a comprehensive remote digital monitoring system on sleep, physical activity, and dietary intake, has been successful in adults, but has not been tested in adolescents with obesity.


Eligibility criteria:
inclusion criteria: * child subjects age 10 - 16 * obese as defined by body mass index (bmi) * computer access and data plan with text messaging * ssb intake of 2 or more servings per day (1 serving=12oz) exclusion criteria: * active substance abuse. * syndromic or secondary obesity. * any developmental disorder. * eating disorder (with the exception of binge eating disorder). * psychosis. * untreated depression. * use of medications (prescription or otherwise) known to effect body weight. * weight loss of more than 5% body weight in the past 3 months. * history of bariatric surgery.
a phase ii trial of gemcitabine, capecitabine, and bevacizumab in metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.

* to determine the objective response rate and estimate the time to progression of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic clear cell renal cell cancer; * to determine survival of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic cell renal cell cancer; * to determine the toxicity of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic renal cell cancer; * to collect baseline serum and plasma samples for exploration of possible prognostic and predictive markers

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic clear cell renal cell cancer * measurable disease * age 18 or older * ecog performance status of 0 - 1 * blood pressure less than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart * normal organ function * women of child-bearing potential and men must agree to use adequate contraception * ability to understand and the willingness to sign a written informed consent document and to follow all required study procedures exclusion criteria: * patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * patients may not have had prior treatment with pyrimidine analogs or vegf binding agents * patients may not be receiving any other investigational or therapeutic agents * patients may not be receiving therapeutic anticoagulation with warfarin, its congeners, heparin, low molecular weight heparinoids, specific thrombin inhibitors, or other similar agents patients receiving low dose coumadin (1 mg daily) for central line patency are eligible * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment start, or anticipation of need for major surgical procedure during the course of the study fine needle aspirations or core biopsies within 7 days prior to treatment start are acceptable * serious, nonhealing wound, ulcer, or bone fracture * evidence of bleeding diathesis or coagulopathy * patients with known brain metastases * uncontrolled intercurrent illness * pregnant women * hiv-positive patients receiving combination anti-retroviral therapy are excluded from the study

Keywords: metastatic renal cell kidney neoplasm
effects of marijuana on symptoms of ocd

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this pilot research study is to test whether certain components of the marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with ocd. specifically, patients enrolled in the study will smoke marijuana containing different concentrations of 2 different cannabinoids, thc and cbd. both of these agents act on the brain's "endocannabinoid system," which has been hypothesized to play a role in ocd. neither compound is currently fda-approved for treating ocd.

prior research suggests that certain areas of the brain are receptive to chemicals like those found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be involved in anxiety disorders and ocd. more recent data shows that synthetic drugs that target these systems may be helpful in conditions related to ocd like anxiety disorders and tourette's syndrome. thus, these substances could also possibly be useful to treat ocd symptoms. however, to date there has been little research regarding the role of cannabinoids in ocd. the purpose of this study is to examine the effects of different cannabinoids on ocd symptoms in humans. to accomplish this in a laboratory setting, patients with ocd who are also occasional cannabis users will receive different combinations of two of the most well-studied cannabinoids, delta-9-tetrahydrocannabinol (thc, the main psychoactive component in cannabis) and cannabidiol (cbd, another component of the cannabis plant). we will then measure acute effects on ocd symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood pressure and heart rate).

Eligibility criteria:
inclusion criteria: * age 21-55 * physically healthy * diagnosed with ocd * current marijuana user * women of childbearing potential must be using an effective form of birth control * not currently taking psychotropic medications * ability to provide informed consent exclusion criteria: * history of any significant medical condition that may increase the risk of participation * females who are pregnant or nursing * if female, not pregnant * current or lifetime history of psychiatric disorders other than ocd that may increase the risk of participation * current substance use disorder * severe depression or positive urine toxicology (other than thc) at screening, or any adverse reaction to a cannabinoid * patients who are seeking treatment for substance abuse * patients who are planning to begin a course of cognitive-behavioral therapy within 8 weeks of beginning the study

Keywords: ocd marijuana thc cannabis cbd cannabinoid
alternative method: chewing gum in labor

Conditions: Labor Pain

Summary: this study is a clinical trial. it aimed to examine the effects of chewing gum on pain, anxiety, fatigue, and thirst in pregnant women (47 experiments; 47 controls) in the first stage of labor. criteria for inclusion in the study: pregnant women who gave birth vaginally; voluntarily accept to participate in the research. exclusion criteria from the study: pregnant women who have auditory or mental health problems; whose baby dies during labor, who with cervical dilatation of 5 cm or more, who receiving epidural anesthesia, do not like chewing gum, have difficulty chewing, such as weak/loose-fitting dentures. the pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours until their dilatation reached 5 cm. pregnant women in the experimental group chewed gum and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until their dilation reached 5 cm. the main questions it aims to answer are: * chewing gum during labor is not effective in reducing pain, anxiety, fatigue, and thirst levels. * chewing gum during labor; it is effective in reducing the level of pain. * chewing gum during labor; it is effective in reducing anxiety. * chewing gum during labor; it is effective in reducing thirst. * chewing gum during labor; it is effective in reducing fatigue. routine medical treatment of pregnant women continued all groups. only pregnant women who in the experimental group chewed gum also.

objective: in this study, it was aimed to examine the effects of chewing gum on pain, anxiety, fatigue and thirst in pregnant women in the first stage of normal labor. methods: the study was conducted in a randomized controlled experimental manner. the universe consisted of all pregnant women who applied to the delivery room of a public institution between april and november 2022. power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. the study was started after the approval of the ethics committee and the institution. as a data collection tool in the research;"personal information form","gum chewing follow-up form" and "pregnant follow-up form" were used.

Eligibility criteria:
inclusion criteria: * vaginal delivery, * who volunteered to participate in the research exclusion criteria: * have auditory or mental health problems, * the baby dies during labour, * cervical dilatation of 5 cm or more, * receiving epidural anaesthesia, * people who don't like chewing gum, * chewing difficulties due to weak/loose prostheses

Keywords: labor gum pain anxiety fatigue thirst
rural south and southeast asia household health survey

Conditions: Noncommunicable Disease; Infections; Risk Factors; Health Status

Summary: a cross-sectional household survey with two-stage cluster-randomized sampling. this cross-sectional household survey design to recruit a random sample of households that is representative for each of the study sites. from the selected households, all consenting, household members will be included in the study. this study is funded by the uk wellcome trust. the grant reference number is 215604/z/19/z

371 households will be randomly selected from each site in bangladesh, cambodia, myanmar, and thailand. assuming each household has an average of 4.5 members and all members will be sampled, 1500 participants will be recruited per site. this sample size allows for the overall prevalence estimation of key survey indicators with 95% confidence and 5% degree of precision. the survey components include questionnaire interview, physical examination, blood sample collection, and point of care (poc) tests. the questionnaire interview will collect information on household characteristics, members' disability, presence or history of disease, risk factors, self-perceived quality of life, and health seeking behaviour. for women, questions about reproductive health and antenatal care, and for young children, vaccination coverage and achievement of child development goals, will also be assessed. for physical examinations, tympanic temperature, weight and height will be measured in all household members, mid-upper arm circumference in young children, and blood pressure in adults. blood sample will be collected from all participants aged 6 months and above. venous blood samples will be collected from participants aged 5 years and older, and dried blood spot will be collected from children under 5 years. samples will be shipped to a central laboratory and analysed. haemoglobin poc will be administered to all participants. all data will be collected directly on an electronic case report form using tablets, and uploaded to an electronic database.

Eligibility criteria:
inclusion criteria: * all members of the selected households at the time of the survey; and able to provide informed consent. exclusion criteria: * adults or children whose parent/guardian/ caretaker are unable or unwilling to provide informed consent.

Keywords: cross-sectional household survey
longitudinal follow-up of patients treated with hypofractionated stereotactic photon radiotherapy due to uveal melanoma

Conditions: Uveal Melanoma

Summary: the purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine. exclusion criteria: * unwillingness to participate in the study * severe media opacity