Kornimate/medical-research-clean huggingface dataset:
therapeutic equivalence trial of two hormonal-iuds in patients with heavy menstrual bleeding

Conditions: Heavy Menstrual Bleeding

Summary: the primary objective of this study was to compare the efficacy of test product (levosert) vs. reference product (mirena® bayer-schering) based on the mean variation of menstrual blood loss volume in women with menorrhagia. the secondary objectives includes physical and gynaecological examinations, vital signs, clinical laboratory tests including hemoglobin and ferritin measurements, body weight and spontaneously reported adverse events were analysed and compared between levosert and mirena® treatment arms. plasma levels of levonorgestrel (lng) were also evaluated after various periods of time. the residual amounts of lng in the devices were finally measured after withdrawal at completion of the study. plasma levels of lng and residual amounts of lng were compared between the two treatment groups. contraceptive effect of levosert was estimated by pearl index.


Eligibility criteria:
inclusion criteria: * non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18 years of age. * patients with a clinical diagnosis of functional menorrhagia during the last 6 months. * patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them. exclusion criteria: * history of endometrial ablation or dilatation and/or curettage within the 3 months prior to screening * copper - coiled-intrauterine device or lng releasing ius use within 2 months prior to screening * abnormal liver function or jaundice * renal insufficiency * other hormonal treatment (sexual steroids), * organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous myomas of any size, or myometrial myomas \> than 3 cm, adenomyosis, atypical hyperplasia, carcinoma) * abnormal uterine morphology * presence of ovarian cyst \> 3 cm * lower genital tract infection * current or recurrent pid (present or recurrent pelvis infection (including history of postpartum endometritis, infected miscarriage) during the past 3 months * uncontrolled hypertension * congenital or acquired valvular disease (including corrections with prosthetic valves) * known or suspected pregnancy * known or suspected hormone-dependent tumor * bmi \> 30 * abnormal pap smear test or other evidence of cervical/endometrial mancy * unexplained amenorrhea * known hypersensitivity to device material and/or levonorgestrel
hyperbaric oxygen therapy and angiogenesis in diabetic patients with foot ulcers

Conditions: Diabetic Foot Ulcers; Hyperbaric Therapy; Angiogenesis

Summary: diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the united states. the cost of foot ulcers in diabetic patients averages almost $28,000 for the two years after diagnosis of the ulcer. hyperbaric oxygen (hbo) serves as primary or adjunctive therapy for a diverse range of medical conditions. hbo also has been used as an adjunct to antibiotics, debridement, and revascularization in the therapy of chronic, nonhealing wounds associated with diabetes or non-diabetic vascular insufficiency. the aim of the study is to assess whether hyperoxia induced angiogenesis in diabetic patients with foot ulcers.


Eligibility criteria:
inclusion criteria: * age 18 years or older, with type ii diabetes suffering from foot ulcers admitted to the institute of hyperbaric medicine and wound care clinic at assaf harofeh medical center (israel) exclusion criteria: * patients having chest pathology incompatible with pressure changes, inner ear disease, or suffering from claustrophobia, will be excluded from the study. patients with significant macrovascular disease, defined as obstruction of more than 50% in the femoral or the popliteal arteries, will also be excluded from the study.
improving the clinical encounter to enhance delivery of an individualized prematurity prevention plan

Conditions: Preterm Birth

Summary: the purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an individualized prematurity prevention plan (ip3) for preterm birth prevention. non-hispanic black (nhb) women are at higher risk for preterm birth compared to other racial and ethnic groups. building on qualitative data from nhb women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an ip3 in nhb women.

the study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant nhb women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. consenting participants will be randomized to the intervention or an active control. the intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the ip3, 2) structured encouragement via text messages and 3) employment law education sheet. the powerpoints will also be available for review on our you-tube channel for intervention patients. the active control arm includes: 1) a narrated powerpoint describing the duke prematurity prevention program and 2) text messages with general pregnancy information (i.e. it is safe to take tylenol in pregnancy). at study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index. the team will collect feedback on the intervention based on an intake questionnaire and an exit interview. information will also be collected on adherence to the ip3 based on review of the participant's medical record. the primary aim of the study is to evaluation feasibility and acceptability. these endpoints will be measured via enrollment and participant feedback during the exit interview.

Eligibility criteria:
inclusion criteria: * self described race as non-hispanic black * history of prior singleton preterm delivery (before 37 weeks gestation) * current singleton gestation exclusion criteria: * women with anomalous fetuses * age below 18\] * non-english speaking
aldosterone in diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to determine whether spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.


Eligibility criteria:
inclusion criteria: * diabetic subjects with maximum ten years after diagnostic * diabetic nephropathy with albuminuria * normal renal function * diastolic disfunction * taking a ieca or ara drug family previously exclusion criteria: * diabetics subjects with macroangiopathy * acute coronary syndrome in the three months before * hyperkalemia \> 5.5 meq/l * pregnancy

Keywords: aldosterone albuminuria diastolic disfunction hyperkalemia
postpartum management of hypertension in pregnancy with hydrochlorothiazide

Conditions: Pre-Eclampsia; Gestational Hypertension; Superimposed Pre-Eclampsia; Hypertension, Pregnancy-Induced; Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia

Summary: postpartum prophylactic hctz administration for prevention and relapse of preeclampsia or gestational hypertension.

to evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.

Eligibility criteria:
inclusion criteria: * maternal age ≥ 18 years and \<50 years. * diagnosis of gestational hypertension\* or preeclampsia\^ at any time during pregnancy, labor or postpartum. * defined as isolated systolic bp of 140 mm hg or greater, a diastolic bp of 90 mm hg or greater, or both) or \^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dl or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.) exclusion criteria: * subject requiring antihypertensive therapy at time of screening. * planned discharge with oral anti-hypertensive medication. * contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides). * subject not able to follow up postpartum. * lactose intolerance. * pre-gestational diabetes.

Keywords: readmission triage visit for pregnancy related hypertension hydrochlorothiazide
the effect of acupuncture treatment on the perception of pain and coping with pain

Conditions: Pain

Summary: the purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.

the effect of acupuncture on pain intensity has been already investigated and confirmed. recent publication (pariente j., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain. the pain self regulation model (levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. according to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (levental at al., 2001). this study will try to assess the hypothesis that acupuncture treatment is involved in this process. the study is designed as pilot study, limited to 45 patients.

Eligibility criteria:
inclusion criteria: * patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study exclusion criteria: * children under 18 years of age

Keywords: pain acupuncture
artificial intelligence-assisted evaluation of pulmonary hypertension

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Summary: pulmonary hypertension represents a challenging and heterogeneous condition that is associated with high mortality and morbidity if left untreated. artificial intelligence is used to study and develop theories and methods that simulate and extend human intelligence, which is being applied in fields related to cardiovascular diseases. the study intends to combine multimodal clinical data of patients who undergo right heart catheterization at fuwai hospital with artificial intelligence techniques to create programs that can screen and diagnose pulmonary hypertension.

patients with pulmonary hypertension (ph) represent a challenging and heterogeneous cohort with high morbidity and mortality if left untreated. to make a definitive diagnosis of ph, one needs to conduct an invasive right heart catheterization (rhc) in order to assess the mean pulmonary artery pressure (mpap). as ph occurs sporadically in various medical conditions, including connective tissue disease, and congenital heart disease, and presenting symptoms are non-specific, there is a need to raise the suspicion of ph early in the community. for this reason, noninvasive tools that are widely available for upfront screening would be ideal to enable timely diagnosis of ph. transthoracic echocardiography has emerged as the mainstay for screening of ph, yet the sensitivity and specificity of this approach remain limited even in experienced hands. as high-throughput technologies advance and access to ph big data improve, it will be critical to prudently select artificial intelligence approaches for data analysis, visualization, and interpretation. by combining the multimodal clinical data (such as indicators from chest x-ray, electrocardiography, and echocardiography), this study aims to develop artificial intelligence-assisted programs to assist the screening and diagnosis of ph, and to evaluate its diagnostic accuracy for ph as compared with rhc, and to estimate whether this approach outperforms the conventional echocardiographic method.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * patients previously received chest x-ray, electrocardiography, echocardiography, other routine examinations, and rhc at the fuwai hospital, cams \& pumc, beijing, china exclusion criteria: * patients without rhc * the quality of routine examinations and rhc cannot meet the requirement for further analysis * severe loss of results of routine examinations (chest x-ray, electrocardiography, echocardiography, etc.)

Keywords: pulmonary hypertension pulmonary vascular disease right heart catheterization echocardiography electrocardiography chest x-ray artificial intelligence machine learning deep learning screening diagnosis
effect of nn5401 in japanese subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in japan. the aim of this clinical trial is to investigate the blood sugar lowering effect of nn5401 (insulin degludec/insulin aspart (idegasp)) in japanese subjects with type 1 diabetes. each subject will be randomised to one of the two possible treatment sequences (nn5401 followed by biphasic insulin aspart (biasp) 30 or biphasic insulin aspart 30 followed by nn5401).


Eligibility criteria:
inclusion criteria: * japanese subject * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index (bmi): 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * loss of more than 400 ml blood (inclusive) in total with in the last 12 weeks or more than 200 ml blood (inclusive) in total within the last 4 weeks prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
behavioral interventions for active duty service members and veterans with chronic pain

Conditions: Chronic Pain

Summary: the central aim of this proposed study is to test a multimodal, mindfulness-oriented intervention designed to disrupt the risk chain leading to prescription opioid dose escalation, opioid misuse and opioid addiction, which are mounting threats to active duty service members and veterans with chronic pain conditions, who may develop disordered opioid use as a consequence of long-term opioid pharmacotherapy.


Eligibility criteria:
inclusion criteria: * men/women ≥18 years of age * ability to understand and speak the english language * current chronic pain diagnosis (including but not limited to icd-9 diagnoses 338.0, 338.2xx, 338. * current use of prescription opioids for \>3 consecutive months. exclusion criteria: * mindfulness training experience (participation in mbsr/mbrp) * opioid withdrawal evidenced by score ≥13 on the clinical opiate withdrawal scale * current cancer diagnosis * having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication
breathe 2 project 3: comprehensive chronic care

Conditions: Smoking Cessation; Smoking Abstinence

Summary: this study will evaluate comprehensive chronic care (ccc), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. this research will compare ccc with standard of care (sc) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. participation in the study will last 18 months.

this project is a 2-arm randomized controlled trial (rct) designed to evaluate whether comprehensive chronic care (ccc), relative to standard care (sc), increases smoking abstinence and treatment use in primary care patients who smoke. the aims are as follows: * primary aim * aim 1: to determine whether comprehensive chronic care (ccc), relative to standard care (sc), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment. * secondary aims * aim 2: to determine the effects of ccc relative to sc on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment. * aim 3: to compare ccc with sc on cessation treatment use over 18 months of treatment access. comprehensive chronic care (ccc) provides ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt. standard care (sc) involves one offer of cessation treatment per year (8 weeks of nicotine patch plus referral to the tobacco quit line).

Eligibility criteria:
inclusion criteria: * on smoking registry at a participating clinic or report current smoking at a clinic visit * smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine) * able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent) * able to speak and read english. exclusion criteria: * activated healthcare power of attorney or cognitive impairment that would preclude informed consent.

Keywords: chronic care tobacco treatment standard of care reduction treatment motivation phase treatment
traceit tissue marker to mark the primary resection bed margins of oropharyngeal cancers

Conditions: Oropharyngeal Cancer

Summary: the purpose of this research study is to look at how using an injectable marker called traceit can help with the radiation treatment planning process. traceit is a gel that dissolves in the body over time and can be injected and is visible on many types of images that can be used in the treatment planning process. if the exact edges of negative tumor margins can be marked before treatment planning, it is thought that the area receiving radiation can be more personalized, thus potentially reducing unnecessary radiation to areas that are cancer-free.


Eligibility criteria:
inclusion criteria: * pathologically confirmed (by routine h\&e staining) or highly suspicious for oropharyngeal squamous cell cancer. * planned treatment includes transoral surgery followed by adjuvant intensity modulated radiation therapy (imrt). * at least 18 years of age. * ability to understand and willingness to sign an irb approved written informed consent document. exclusion criteria: * distant metastatic disease at the time of definitive treatment, and thus study, initiation. * history of major head \& neck surgery or previous head \& neck irradiation. * history of or current oral disease that may interfere with interpretation of study outcomes. * currently enrolled in another radiation therapy trial that has not completed its primary endpoint or that clinically interferes with this study. * poor surgical candidate * prisoners
insulin resistance and severity of coronary artery disease

Conditions: Insulin Resistance

Summary: this is an observertional study aimed at study the association between insulin resistance estimated by homa and angiographic severity of coronary artery disease in non diabetic \& non obese patients.


Eligibility criteria:
inclusion criteria: * patients undergoing coronary angiography (ca) for acs or stable angina in the catheterization laboratory of internal medicine department and el noor specialized cardiac center at the study period. exclusion criteria: * age \< 18 years, * pregnancy or breastfeeding, * bmi \>30 kg/m2 and * presence of pre-diabetes or overt diabetes.
early diagnosis of ppd through self-portraits

Conditions: Postpartum Depression

Summary: the target of the research is development of a predictive tool for early identification of women which are at higher risk for development of postpartum depression. the evaluating tools include self portraits and questionnaire during the third trimester of pregnancy. the suggested research aims to evaluate if and how it would be possible to predict the potential for postpartum mood swing disorders in pregnant women while in the third trimester. the later to prevent the mother from enduring such a detrimental experience, which influences the child development, the family as well as the mother's intimate relationship. the aim is to identify indicators to predict such potential, using questionnaires and self-portraits during pregnancy, to allow early intervention and treatment. early diagnosis and quick treatment of pregnant women or post-partum mothers will allow them a higher level of functioning and may even prevent eventually infant neurological and developmental delays and hardships.

the target of the research is to evaluate a method based on self portraits and targeted questionnaire done in the third trimester and three months later in order to identify pregnant women in higher risk to develop ppd. the minimal number of objectives participating in the research would be 100 pregnant women during the third trimester of pregnancy. the draw a person (dap) test was described by machover in 1949. it is still considered a reliable and well recognized test for evaluation of mental stress and disorders (gilory, 2012). in the research approximately 100 pregnant women in the third trimester would be asked to draw a self portrait in two different time points (during the third trimester and three to six months postpartum). in addition to the self portraits the participants would be asked to fill a set of questionnaires to evaluate the degree of depression, self esteem, personal history of traumatic events, and demographic data. the self portraits would be evaluated by three judges. the reliability between judges would be tested using kappa test.

Eligibility criteria:
inclusion criteria: * third trimester pregnant women exclusion criteria: * pregnant women with established diagnosis of mental disorders * still birth or intra uterine disorders

Keywords: postpartum, depression, self portraits