Kornimate/medical-research-clean huggingface dataset:
the luveris in vitro fertilization trial

Conditions: Infertility; Hypothalamic Amenorrhea; Hyperprolactinemia

Summary: the purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period). we are recruiting women who are trying to get pregnant through in vitro fertilization (ivf) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels. the ovaries can be stimulated with follicle stimulating hormone (fsh) alone and with fsh and luteinizing hormone (lh). fsh causes eggs to be made while lh causes estrogen (hormone) production. the women in this study have low hormone levels and need both fsh and lh. luveris® (lh hormone) is a new drug approved for egg production and is used in ivf. there is no set amount of lh nor a set protocol for lh use. therefore, we are testing this new regimen. one group of women will receive a fixed dose of lh throughout their cycle while the other will decrease the dose of fsh while at the same time increasing the lh dose which is what happens in the natural menstrual cycle.


Eligibility criteria:
inclusion criteria: 1. 30 women under 38 years old at time of signing informed consent form. 2. evidence of hypothalamic amenorrhea (irregular menses and fsh and lh \<5 miu/ml), uncorrected hyperprolactinemia (prolactin levels 10% above the upper limit of normal) or iatrogenic hypothalamic hypogonadism secondary to gnrha suppression. 3. in good general health off of current medications which may confound response to study medications except gnrha (lupron depot). 4. desire to seek pregnancy actively during the study period. 5. a normal uterine cavity must have been confirmed by either hysteroscopy or hydrosonogram within two years of entering the study. 6. a semen analysis on the male partner deemed adequate for ivf by the attending physician within the past year or donor sperm available for insemination. 7. only one treatment cycle per patient will be studied. exclusion criteria: 1. uncorrected thyroid disease. 2. heart disease (new york heart association class ii or higher). 3. a history of, or suspected cervical, endometrial, or breast cancer. a normal pap smear result within the last 24 months will be required. 4. enrolled into other studies that require medications, limit sex, or otherwise prevent compliance with the protocol at the same time. 5. to take other medications known to affect reproduction.
increasing patient knowledge of the signs of opioid overdose and naloxone in a suburban treatment program

Conditions: Opioid Dependence; Opioid Use Disorder

Summary: the purpose of this study is to determine the effect that an educational intervention has on patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a suburban outpatient treatment program.

the outpatient addiction services program at linden oaks will begin implementing an educational program on the signs of opioid overdose and naloxone for all patients who have a diagnosis of opiate dependence in the investigators suburban treatment program. subjects will be recruited from that population and administered a new, empirically validated scale (i.e. the opiate overdose knowledge scale; ooks) both pre- and post-intervention to measure the effect that the educational program has on patient knowledge. patients will also be surveyed (i.e. history survey) about their experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone) prior to treatment; and, this history survey will then be re-administered by phone, 1-3 months after discharge. the aim is to measure whether education influences patient behavior. finally, all subjects will be administered an empirically-validated measure to assess subject shame and guilt (i.e. guilt and shame proneness scale; gasp), and response patterns in their behavior, to evaluate whether shame and guilt predict behavior at follow-up. the investigators will compare to data (i.e. ooks, gasp, and history survey) from a historical control group prior to the implementation of the educational program - and, also at 1-3 month follow-up.

Eligibility criteria:
inclusion criteria: * adult subjects who have been diagnosed with a dsm opioid use disorder by loh staff. exclusion criteria: * subjects who are deemed to have moderate to severe cognitive impairment - as assessed by standard psychiatric evaluation from linden oaks clinical staff - will be excluded from the study.

Keywords: opioid dependence addiction naloxone naloxone education opiate overdose knowledge scale ooks
a technology-based intervention for the reduction of overweight and obesity among college students

Conditions: Overweight and Obesity

Summary: the purpose of this study is to determine the feasibility and acceptability and efficacy of a two month technology-based weight loss program for overweight and obese college students.

a randomized controlled trial design will be employed to investigate the effectiveness, feasibility, and acceptability of a technology-based weight loss pilot intervention for the reduction of overweight and obesity in college students. participants will be randomly assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention control group. both conditions include 8 weekly lessons over 8 weeks. undergraduate students (n=100) age 18-22 years who are overweight or obese (bmi ≥ 25 kg/m2) will be recruited from the university of tennessee knoxville. measurements will be taken at baseline and 8 weeks. since the study is a technology-based intervention, research staff will collect height and weight measures for bmi through a novel approach, utilizing skype video conferencing.

Eligibility criteria:
inclusion criteria: * eligibility will include utk undergraduate students who are overweight or obese (bmi ≥ 25 kg/m2) and between 18-22 years of age, with access to the internet, a personal computer (laptop, tablet, or desktop computer), and a smartphone. exclusion criteria: * any individual who does not meet all the inclusion criteria will be excluded from participation in the study. * students who have a medical condition that precludes adherence to dietary recommendations * who are currently prescribed medications that may impact weight, or who are currently participating in or planning to participate in another weight loss programs in the next six months * who have been diagnosed with a major psychiatric illness (e.g., bipolar disorder, schizophrenia, or depression) within the last 12 months * who are pregnant or plan to become pregnant in the next six months * who have given birth within the last six months * who have been diagnosed with any type of eating disorder within the past 12 months will be ineligible.

Keywords: overweight obesity technology college students
the efficacy of pulmonary rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with copd

Conditions: Pulmonary Disease

Summary: pulmonary rehabilitation exercise is beneficial for individuals with chronic obstructive pulmonary disease (copd). however, merely 30% patients know how to do the exercise correctly. therefore, it is worthy to investigate the applications in clinical practice. in addition, there are no relative research in taiwan to see effects of an 8-week pulmonary rehabilitation exercise in home care for the non-invasive ventilator-dependent elderly with copd.

according to estimation of the world health organization (who), chronic obstructive pulmonary disease (copd) would become the third major cause of death. moreover, the lung recovery exercise is proven beneficial for mild, moderate, or severe copd by the guideline of gold. however, research in taiwan focused on follow-up medical status for mild or moderate copd in clinics, or weaning of severe copd in intensive care unit (icu). there was no relative research investigating non-invasive ventilator-dependent elderly with copd on home care. therefore, this study would explore effects of pulmonary rehabilitation exercise for this group. the pulmonary rehabilitation exercise program in this study is divided into two stages in the experimental group. the first four weeks, 10 minutes for each training (upper extremity without loading, exercise of lower extremity, and respiratory muscles), and totally 30 minutes is required. consequent four weeks, 15 minutes for upper extremity without loading, 15 minutes for exercise of lower extremity, and 10 minutes for training of respiratory muscles, and totally 40 minutes is scheduled.

Eligibility criteria:
inclusion criteria: 1. age \> 65 y/o, and is diagnosed with copd; 2. is non-invasive ventilator-dependent in home care; 3. is stable evaluated by a doctor; 4. is conscious clear and can perform the exercise (upper, lower extremity, and respiratory muscle training); 5. do not accept exercise training as (4)-mentioned currently exclusion criteria: 1. conscious is not clear enough to perform the exercise training; 2. cannot leave his/her bed independently; 3. cannot wean a ventilator and need to use for 24 hours; 4. severe heart disease (eg. acute myocardial infarction, severe arrhythmia); 5. oxygen saturation (spo2) lower than 90% during oxygen therapy 6. fever or acute infections 7. reject to sign consent form 8. age \< 20 y/o

Keywords: rehabilitation
evaluation of efficacy and safety of dapagliflozin as monotherapy in subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone

Conditions: Type 2 Diabetes

Summary: this study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.


Eligibility criteria:
inclusion criteria: * provision of informed consent before participating in the study * diagnosed with type 2 diabetes (high blood sugar); hba1c ≥ 7.2% and ≤10.0% * subjects should be drug naïve * women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test exclusion criteria: * subjects received insulin therapy within one year of enrollment * subjects who have severe uncontrolled hypertension * subjects who have history of unstable or rapidly progressing renal disease * subjects who have severe liver disease * subjects who receiving treatment for human immunodeficiency virus (hiv)

Keywords: phase iii type 2 diabetes mellitus inadequate glycaemic control
lifetech konar mfo post-market clinical follow-up study

Conditions: Ventricular Septal Defect

Summary: the purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the lifetech konar-mf™ vsd occluder for patients with ventricular septal defect (vsd).

this is a non-randomized prospective post-marketing clinical follow-up study (pmcfs) in order to evaluate the feasibility and safety of the lifetech konar-mf™ vsd occluder device used for patients with ventricular septal defect. the implantation should be performed in accordance with the instructions for use (ifu).

Eligibility criteria:
inclusion criteria: 1. patients have a clinically relevant ventricular septum defect (vsd) by echocardiography and/or x-ray examination according to current clinical standards and center-specific protocols. 2. the patient should be older than 6 months of age and a bodyweight heavier than 8kg. 3. defect diameter (by 2d echocardiography): the size of the vsd is larger than or equal to 2mm and less than 10mm. 4. upper margin of vsd to aortic valve distance \>2 mm for models 6-4, 8-6, 10-8, 12-10, 14-12 and \>2.5mm for models 5-3, 7-5, 9-7, in case of pmvsd. 5. only left to right shunt of the ventricular shunt. exclusion criteria: 1. any contraindication mentioned in the corresponding ifu\*. * note: in ifu, contraindications for the konar-mftm vsd occluder are as follows: 1. patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery. 2. presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained. 3. active endocarditis or other infections-producing bacteria. 4. the implant of konar-mftm vsd occluder would cause an obvious interference with the aortic valve or the atrioventricular valve. 5. patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease. 6. patients with contraindications to anti-platelet therapy or agents. 2. the patient does present with an aortic valve prolapsing into the vsd. 3. currently participating in other investigational drugs- or device studies. 4. the patient who is pregnant, planning to become pregnant, or breastfeeding. 5. patients don't give informed written consent for the procedure. 6. patient with other cardiac anomalies by surgery therapy.

Keywords: vsd
the helpp score: a pretreatment score to predict survival in pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: the goal of this observational study is to validate a pretreatment prognostic score (heidelberg prognostic pancreatic cancer score - helpp) in patients with pancreatic ductal adenocarcinoma. the main questions it aims to answer are: * is the helpp score able to predict median overall survival in a prospective multi-institutional cohort of patients with pretherapeutic localized non-metastatic pancreatic cancer? * is the helpp score able to predict median recurrence-free survival and patterns of recurrence after resection of pancreatic cancer?

accurate pretreatment staging and subsequent prediction of prognosis in pancreatic ductal adenocarcinoma (pdac) is challenging due to subclinical micrometastasis as well as variations in tumor biology. moreover, patients with non-metastasized localized pdac are increasingly treated with neoadjuvant chemotherapy prior to resection. the investigators recently developed a preoperative prognostic score to predict postoperative outcomes based on routine laboratory biomarkers and the american society of anesthesiologists (asa) score, the helpp score (heidelberg prognostic pancreatic cancer score). based on a large retrospective analysis of 1197 patients and an external validation cohort the helpp score was able stratify patients based on expected survival only utilizing routinely available preoperative data. however, prospective validation is currently lacking. this multi-site prospective observational study aims to prospectively validate the helpp score in the clinical scenarios described above. additionally, it aims to investigate its utility regarding median recurrence-free survival and patterns of recurrence. the study includes all consecutive patients with pdac undergoing exploration (without or without neoadjuvant treatment) with the aim of resection within a timeframe of 12 months (all-comers concept, snapshot study). the parameters on which the score is based on are routinely available to hospitals worldwide. simplicity of the grading system facilitates implementation in daily clinical practice. this score could potentially help tailor treatments, aid in patient stratification in clinical trials, and provide new insights into tumor biology.

Eligibility criteria:
inclusion criteria: * ≥18 years old * fit to undergo elective pancreatic resection or palliative therapy * localized non-metastatic pancreatic ductal adenocarcinoma * informed consent provided exclusion criteria: * patients with a diagnosis other than pancreatic ductal adenocarcinoma on histopathology * missing informed consent * missing mandatory pretreatment laboratory values * missing mandatory pretreatment clinicopathologic data * patients receiving surgery for peripancreatic cancer * incomplete follow-up records * follow-up \< 24 months * pregnancy

Keywords: pancreatic ductal adenocarcinoma pancreatic resection preoperative prognostic score localized non-metastatic pancreatic ductal adenocarcinoma recurrence
therapeutic drug monitoring of ixekizumab in psoriasis patients

Conditions: Psoriasis Vulgaris

Summary: biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. but they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.

patients will be included after siging informed consent. after inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injections (80 mg) every 4 weeks). during each study visit, blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards ixekizumab. in addition, the psoriasis severity and area index (pasi) and the investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: 1. participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: 1. participants who have currently a predominant nonplaque form of psoriasis 2. participants who are pregnant, nursing or planning a pregnancy 3. participants who are unable or unwilling to undergo multiple venapunctures 4. participants who are treated according to a different dosing schedule than standard dosing of ixekizumab

Keywords: psoriasis therapeutic drug monitoring ixekizumab
early phase pre-clinical and initial clinical research on epicatechin (part 2)

Conditions: Pre-diabetes

Summary: this will be a double-blind, randomized, placebo-controlled, single dose study of (+)- epicatechin with one 30mg dose/day for a total of 7 days

this project is a double-blinded, placebo-controlled, randomized, phase i study that will include (+)-epicatechin dosing over seven days. * subjects will meet the american diabetes association (ada) criteria for pre-diabetes, including impaired fasting glucose (ifg) \[refer to inclusion/exclusion criteria\]. * the project includes: 7 day evaluation of a single daily dose of synthetic (+)-epicatechin in pre-diabetic individuals as compared to placebo. * the project has 4 outpatient clinic study visits: screening (visit 1), randomization (visit 2), end of study drug (visit 3), follow up end of study (visit 4). * this project has 2 telephone visits primary hypothesis: as these studies are designed to evaluate safety and tolerability, there is no primary hypothesis to test. primary outcome measures. vital signs and safety labs: bp, hr, creatinine, alkaline phosphatase, and liver transaminases these studies will provide initial data about if (+)-epicatechin can influence glycemic control in individuals with prediabetes.

Eligibility criteria:
inclusion criteria: * pre-diabetic based on medical history and screening results * male or female * must be 21 to 75 years of age (inclusive) * able to give informed consent to the procedures * if female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. women on estrogen therapy will be included. * if female of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study * medication use stable for 4 weeks prior to screening * body mass index (bmi) \> 27 kg/m2 * definition of pre-diabetes: impaired fasting glucose (ifg, fasting glucose = 100-125 mg/dl) and/or elevated hba1c (5.7-6.4%), each in the absence of other risk factors for diabetes exclusion criteria: * type 2 diabetes * pregnancy * younger than 21 or older than 75 years of age * clinically significant abnormalities in liver or kidney function (\>3x upper limit of normal (uln)), determined in the last 6 months by a certified clinical laboratory * recent myocardial infarct or stroke (within 6 months of screening) * blood pressure (bp) \>160 mmhg systolic and \>100 mmhg diastolic * medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs * other diseases, besides type 2 diabetes, influencing carbohydrate metabolism

Keywords: epicatechin pre-diabetes
effect of high protein, high-calorie oral nutritional supplementation in malnourished elderly in nursing homes.

Conditions: Other Malnutrition

Summary: the hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.

a prospective, multi centric, observational study. the study is conducted in elderly living in nursing homes in spain.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 65 years, * living in nursing homes, * malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 kcal / ml) and high-protein (protein 20%). exclusion criteria: * tube feeding (nasogastric or gastrostomy) * terminally ill or palliative treatment and residents with life expectancy of less than 6 months * special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).

Keywords: malnutrition disability oral nutritional supplementation