Kornimate/medical-research-clean huggingface dataset:
enjoy your bump : online cognitive behavioural therapy in pregnancy

Conditions: Perinatal Mental Health; Antenatal Depression; Antenatal Anxiety

Summary: a feasibility study evaluating how acceptable women experiencing low mood or anxiety during their pregnancy find an online cognitive behavioural therapy course called 'enjoy your bump'. this project will also begin to explore the effectiveness of this programme as a low intensity self-help intervention for mild to moderate depressive symptoms during pregnancy.

'enjoy your bump (eyb)' is an online life skills course based on cognitive behavioural therapy (cbt) principles which has been designed to specifically support women in the antenatal period. a survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. the aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. this will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. it is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the national health service (nhs). it is hypothesised that the 'enjoy your bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * mild-moderate chronic perinatal mental health identified by a score of 2 or higher on phq-2 and/or gad-2. * 16+0 to 32+6 weeks at recruitment exclusion criteria: * severe perinatal mental health problem such as schizophrenia, bipolar disorder, substance abuse/dependence, active risk of self-harm. * already receiving psychological therapy. * insufficient english language to engage with intervention or complete questionnaires. * unable to give informed consent. * illiterate * no internet access * taking part in another current research project focused on mental health.

Keywords: online cognitive behavioural therapy pregnancy self-help
the efficacy of vitamin k2 n human osteoporosis, blood-vessel calcification and sclerosis

Conditions: Healthy

Summary: this study used the generally recognized as safe (gras) grade of bacillus subtilis natto to produce vitamin k2, menaquinone-7(mk-7), via fermentation, for functional evaluation. there are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.


Eligibility criteria:
inclusion criteria: 1. men and non-pregnant women who are at least 20 years and under 75 years of age; and 2. female subjects cannot be pregnant or breast feeding. 3. patients who are, in the opinion of the investigator, able to comply with the requirements of the study; and 4. patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication. exclusion criteria: 1. women who are pregnant, as determined by a urine pregnancy test, or breast-feeding. 2. presence or history of congestive heart failure (nyha class iii/iv) within the prior 12 weeks. 3. recent myocardial infarction (within the prior 12 weeks). 4. unstable angina pectoris. 5. known or suspected renal insufficiency defined as creatinine\>1.5mg/dl. 6. known or suspected hepatic insufficiency defined as abnormal liver function tests (got/gpt) \>3x upper normal limit (i.e., 120 u/l). 7. known hypomotility syndrome: (such as hypothyroidism or scleroderma). 8. recent major trauma within the prior 12 weeks. 9. recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks). 10. recent hospitalization (within 12 weeks) 11. uncontrolled hypertension (defined as a systolic blood pressure\>180mmhg or a diastolic blood pressure \>105mmhg). 12. uncontrolled hyperlipidemia (defined as total cholesterol\>240mg/dl or triglyceride \>200mg/dl). 13. uncontrolled diabetes (defined as hba1c\>7%). 14. cigarette smoker (\>=1/day). 15. acute infection requiring current antibiotic therapy. 16. current use of anticoagulant medication (e.g., warfarin). 17. recent or abrupt change (within 1 month) in usual diet. 18. use of an investigational drug (within 30 days prior to enrollment). 19. known allergies to the component of study medication 20. patients have acute disease, and in the opinion of investigators, are not suitable to participate in this study.

Keywords: vitamin k2 vitamin d3 bioavailability of calcium volunteers men non-pregnant women twenty years of age
monitoring of attention according to fatigue in the healthy subject

Conditions: FATIGUE; Sleep Deprivation

Summary: to develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

objective and primary endpoint: demonstrate that the naox measurement tool detects sleep deprivation in medical residents performing medical shifts. the primary endpoint is the detection of a significant decrease in coefficient alpha attenuation (caa) between the pre- and post-sleep deprivation measurements. the data analysis will be blinded to the measurement. secondary endpoints and objectives : demonstrate a link between the alpha attenuation coefficient (aac) measured by the naox measurement tool and the vigilance tests. endpoint: significant increase in pvt (psychomotor vigilance task) time associated with a significant decrease in alpha attenuation coefficient (aac). demonstrate a link between the alpha attenuation coefficient (aac) measured by the naox measurement tool and the state of fatigue experienced. endpoint: significant increase in karolinska sleepiness scale (kss) score associated with a significant decrease in alpha attenuation coefficient (aac). experimental scheme: 3 cycles of 2 recordings with the naox measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident. population targeted: medical residents performing night shifts of at least 12 hours.

Eligibility criteria:
inclusion criteria: * healthy volunteers. * male, female. * medical residents. * aged between 24 and 34 years. * doing emergency, intensive care or "inside" shifts. * working in a health institution. * no history of epilepsy. * no background treatment that could have an impact on the eeg (electroencephalogram) data (type: benzodiazepines, anti-epileptics). * no significant change in background treatment during the study, if any. * affiliation to the social security system. * informed volunteer who has signed a consent form. exclusion criteria: -

Keywords: measurement tool eeg data sleep deprivation attention electroencephalogram
healthy homes study

Conditions: Home Air Radon Testing; Lung Cancer

Summary: this study is about home air radon testing and has two phases. the goal of the first phase is to learn about renters' and homeowners' views and plans related to radon testing. the main question this phase aims to answer is: 1. does taking part in a focus group with information about radon testing change people's plans to test for radon? participants in the first study phase will: * take a survey about their views on and plans for radon testing. * take part in a focus group discussion about radon testing, during which they will receive information about radon testing. * right after the focus group, take a survey about their plans for radon testing. the second phase is a pilot interventional study. the goal is to test interventions about radon testing with renters and homeowners who smoke and do not smoke. the main questions this phase aims to answer are: 1. does the recruitment strategy result in enough participants enrolling within 3 months? 2. will at least 80% of participants complete data collection activities? 3. will more participants who view an online intervention developed by the researchers request free radon test kits, set them up in their homes, and complete radon testing, compared to participants who view a standard public health infographic? and will even more participants who receive reminder messages, in addition to the online intervention, request free radon test kits, set them up in their homes, and complete radon testing? participants in this second phase will: * take a survey about their views on and plans for radon testing. * view an intervention about radon testing. * right after viewing the intervention, take a survey about their views on and plans for radon testing. * 2 months later, take a survey about what, if any, steps they've taken to test their homes for radon. * provide the researchers permission to collect data from their state radon program on: a) whether they requested a free radon test kit and b) whether testing was completed. some participants will receive reminder messages for 2 months after viewing the intervention. researchers will compare an online intervention they developed about radon testing to: a) a standard public health infographic and b) their online intervention combined with reminder messages about radon testing. they will compare the interventions by proportion of participants who: a) request a free radon test kit from their state radon programs, b) set-up the radon test kit in their homes, and c) complete radon testing.

this study is a pilot research study.

Eligibility criteria:
inclusion criteria: * be at least 18 years old * have a valid mailing address in new hampshire or vermont, * have not tested their current homes for radon, * rent or own their home, and * live at their home year-round exclusion criteria: * n/a

Keywords: radon testing behavior change smoking air quality
laser spot treatment of perioral rhytids

Conditions: Facial Aging

Summary: perioral rhytides present a difficult problem in facial rejuvenation. they cannot be addressed with rhytidectomy (face lift) and direct excision can leave visible unfavorable scars. currently, fine static wrinkles are most effectively treated with facial resurfacing, usually with laser treatment. often the peri-oral area is treated with additional spot treatments with an ablative laser to cause a more robust healing response and better aesthtic result. to date, no studies have specifically shown efficacy of additional spot treatment over full facial laser alone. this study is designed as a split-face study, to compare the aesthetic results of full field laser resurfacing on one half of the face with that of spot treatment of perioral rhytides on the other half. to clarify further to the irb board, this is not an experimental treatment. spot treatment is used by many surgeons/laser proceduralists for addressing specific areas of the face. this is an fda indicated use of the laser for facial resurfacing. due to the many genetic and enviromental factors that can effect the results the best design for the study to is have each patient serve as their own control with a split-face study.

cohort study, with split face treatment methods: patients will be evaluated in the office for possible inclusion. those who agree to partipate will receive preoperative photos. on the day of the procedure patients will have a topical anesthestic applied for 30 minutes, then patients will recieve a 20um laser resurfacing of the entire face to remove dead skin and debris. after that, patients will have reapplication of a topical anesthetic for an additional 10 minutes. they will then undergo a 50 um peel to one side of the face and a patient tailored spot treatment of perioral wrinkles to the other side of the face. the depth of this may vary from 100 to 400um. patients will return to clinic at 1 week, 2 weeks, and 3 weeks post-procedure and fill out a short survey and have medical photography done. patients will return at 3 and 6 month follow-up for additional photography and surveys. these visits will typically take 10 to 20 minutes. preoperative and post-operative photos will be analyzed by 2 independent plastic surgeons for post-operative changes and improvements.

Eligibility criteria:
inclusion criteria: patient who are electively presenting to the plastic surgery department for evaluation and treatment of facial aging and elect/seek to have laser treatment will be asked to voluntarily participate in the study. fitzpatrick type 1-4 skin exclusion criteria: 1 patients undergoing additional invasive cosmetic procedure at the same time including rhytidectomy, fat injection 2 history of photosensitvity 3 use of photosenstive medications 4 history of keloid or hypertrophic scarring 5 use of isotretinoin in the previous year 6 previous resurfacing procedure (laser or chemical peel) within the previous 6 months

Keywords: laser resurfacing rhytids perioral
safety evaluation study for patients with aggressive nk-cell leukemia

Conditions: Aggressive NK Cell Leukemia

Summary: this is phase i/ii dose-escalation study to evaluate the tolerability, safety, efficacy and pharmacokinetics of ppmx-t003 in aggressive nk-cell leukemia.


Eligibility criteria:
inclusion criteria: * patients diagnosed with ankl (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the world health organization (who) 4th edition (2017) criteria. exclusion criteria: * patients eligible to receive chemotherapy as treatment for ankl

Keywords: neoplasms
feasibility of a program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women

Conditions: Arterial Hypertension; Medication Nonadherence

Summary: this study evaluate the feasibility of a 6-month personalized support program for hypertensive and non-observant women, led by nurses by telephone follow-up.

the program includes 2 themes: 1. "realizing my blood pressure self-measurement" according to the recommendations 2. "optimizing my compliance": understand the antihypertensive treatment, identify the brakes and the levers when taking medication, organize the treatment taking visits : 1. inclusion visit : * collection of consent by the nurse * verification of inclusion and non-inclusion criteria : measurement of compliance with a scale for each antihypertensive treatment and bp measurement * data collection and goal setting * urine collection for dosing anti-hypertension drugs * delivery of the schedule of telephone visits that were determined with the patient 2. implementation of personalized support with the following steps : * data collection : evaluate knowledge and its potential as a patient, identify his needs * determination of objectives : define the objectives of the program in each theme with the patient according to the collection of data implementation of personalized support * 7 telephone interviews of 20 to 30 minutes use of specific teaching tools and materials by thematic assessment of achievements, validation of objectives evaluation of the accompaniment: - assessment at the final visit 3. final visit at 6-month : same as the inclusion visit with assessment of the support and questionnaire to assess the patient satisfaction level.

Eligibility criteria:
inclusion criteria: * woman ≥ 18 to 79 years old, * hypertensive and treated with antihypertensive drug(s) * unsatisfactory compliance for at least one of her antihypertensive treatment with a score below 80% at the medication adherence scale * uncontrolled blood pressure (bp) : systolic bp equals to ou greater than140 and / or diastolic bp equals to ou greater than 90 mmhg at inclusion visit * inform consent signed * affiliation to a french social security scheme or beneficiary of such a scheme exclusion criteria: * patient with a history of cardio or cerebrovascular disease in the last 6 months (stroke or transient ischemic attack, myocardial infarction, heart failure) * patient with kidney failure requiring dialysis * patient with cognitive pathology: dementia, ... etc. * patient with type i diabetes * unreachable patient by phone or foreseeable inability or unwillingness to comply with study follow-up * patient who does not understand and does not speak french

Keywords: nurse-led management home blood pressure nurse-led telephone follow-up
predict recurrence of barrett's esophagus after complete eradication of intestinal metaplasia

Conditions: Barrett Esophagus

Summary: researchers are trying to see if the nvision® imaging system (vle) can accurately determine the risk of recurrent barrett's esophagus in patients with barrett's esophagus which have been clear of disease.

patients with barrett's esophagus (be) undergoing endoscopic therapy through our barrett's esophagus unit will be approached for study enrollment. patients with no endoscopic evidence of be will be considered for the study. surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. patients who have achieved complete eradication of intestinal metaplasia (crim) will be enrolled in the study and will undergo the nvision® imaging system (vle). patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. at each follow-up visit, endoscopic data will be collected to determine if patients remain in crim or show evidence of recurrent disease. patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2). .

Eligibility criteria:
inclusion criteria: * patient undergoing an upper endoscopy with prior biopsy confirmed barrett's esophagus. * ability to provide written, informed consent * no significant esophagitis (la grade \<b, c, and d) exclusion criteria: * patients for whom use of the nvisionvle device would be in conflict with the instruction for use. * prior esophageal or gastric surgical resection * significant esophageal stricture requiring dilatation * patients who require anti-coagulation for who biopsy would be contraindicated * patients who are known to be pregnant

Keywords: laser endomicroscopy intestinal metaplasia
a bioequivalence and food effect study of sep-190 in japanese healthy subjects (study sep 190-102)

Conditions: Insomnia

Summary: the purpose of this study is to investigate and evaluate the bioequivalence and food effect of sep 190-102 in japanese healthy subjects by assessing the pharmacokinetics parameters.


Eligibility criteria:
inclusion criteria; 1. participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will 2. japanese healthy male adult volunteers 3. participants who are between 20 and 54 years of age at the time of obtaining written consent 4. body mass index (bmi) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening exclusion criteria; 1. participants with a present illness or history of allergy to drug or food, or seasonal allergy 2. participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation 3. participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions 4. participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening 5. participants who are positive for hepatitis b surface antigen (hbs antigen), hepatitis c virus (hcv) antibody, or those who are human immunodeficiency virus (hiv)-positive, or those who are positive for syphilis screen 6. participants who underwent blood transfusion within 12 weeks prior to, those whose 400 ml or more of whole blood was collected within 12 weeks prior to, or those whose 200 ml or more of whole blood was collected within 4 week prior to study drug administration

Keywords: insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)
trial of artesunate combination therapy in pakistan

Conditions: Uncomplicated Falciparum Malaria

Summary: this study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in pakistan. a placebo controlled trial was carried out to assess two potential benefits of artesunate combination therapy (act): efficacy and potential for transmission reduction.

a randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria. arms: 1. cq 2. cq+primaquine 3. cq+ artesunate 4. sp 5. sp+primaquine 6. sp+artesunate patients were allocated to treatment groups using a pseudo-randomised table split by age and sex. primary outcomes: * clinical and parasitological cure/treatment failure by day 28. secondary outcomes: * time to resolution of fever * time to clearance of trophozoites * time to clearance of gametocytes * gametocyte carriage on or after day 7 after treatment all clinical assessments and slide readings were carried out by staff blind to treatment arm. slides were double read.

Eligibility criteria:
inclusion criteria: * presentation at basic health unit with suspected clinical malaria * mono-infection infection with p. falciparum confirmed by microscopy * over 2 years of age (no upper age restriction) * weight over 5 kg (no upper weight restriction) * if of child bearing age then non-pregnant and willing to remain so for the duration of the study * greater than 1 asexual parasite per 10 fields * understands and is willing to sign the consent form * a resident in the study site willing to collaborate for a full period of follow-up * no signs of severe malaria exclusion criteria: * other serious disease (e.g., cardiac, renal or hepatic) * in women of child bearing age, pregnancy * allergy to any of the study drugs or related compounds * reports to have used any malaria drugs in the last 21 days * other species of malaria seen * signs of severe malaria

Keywords: placebo controlled efficacy artemisinin-based combination therapy primaquine gametocytes
chronic pain management during a pandemic

Conditions: Chronic Pain

Summary: this is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. the aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. the null hypothesis is that there is no difference in the international statistical classification of diseases 10th edition (icd-10) codes established via telehealth and subsequent clinic visits. the patients will complete standard health questionnaires online and undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. a limited telehealth physical examination based on direct observation will be conducted. at the subsequent clinic visit, the accuracy of diagnosis and adherence to the plan of care will be evaluated. the primary and secondary endpoints will be gathered from the electronic charts and from the recruited participants by questionnaires completed online one week after the telemedicine consultation. the diagnosis and plan of care semi-structured match will be performed during the in-person follow-up visit.


Eligibility criteria:
inclusion criteria: all patients referred for consultation exclusion criteria: 1. not english-speakers 2. patients who do not have any compatible telecommunication devices 3. patients illiterate in basic telecommunication and have no one in their household to help 4. patients unable to complete online self-assessment forms and study questionnaires 5. patients unable to make a follow-up visit 6. individuals with unstable pain complaints

Keywords: chronic pain, telehealth