Kornimate/medical-research-clean huggingface dataset:
the effect of education given to patients with heart failure on self-care, drug compliance and quality of life.

Conditions: Heart Failure

Summary: this study was planned as a randomized, controlled, experimental study to evaluate the effects of transtheoretic model-based education on self-care, drug compliance and quality of life in patients with heart failure. the number of samples required for the study was determined by the power analysis made in the gpower 3.1 package program. assuming that there may be losses in follow-up and considering that non-parametric tests can be performed, the research group will consist of a total of 72 people, 36 in each group, with an increase of 20%. patients with heart failure who do not have communication barriers to affect cognitive functions, can use tele-health applications (smartphone and application), volunteers aged 18 and over and agree to participate in the study will be included in the intervention and control groups. the data of the study, "socio-demographic characteristic data form", "question form regarding the disease", "european heart failure self-care behaviors scale-12", "beliefs about medication adherence scale," in which socio-demographic characteristics and information about the disease were questioned. (iuhio)'' and ''minnesota life with heart failure questionnaire''.

the patients in the intervention group will be trained through tele-health practices for at least 25-30 minutes on a transtheoretical basis, every 2 weeks in the 1st month and once a month in the following months. tele-health applications include phone monitoring, sms notification and application applications. educational topics based on model-based self-care behaviors; it will include regular exercise, nutrition-weight monitoring, fluid intake-edema control, smoking cessation, regular drug use, regular rest, vaccination. educational principles will be shared with patients by sms from time to time during the education process. treatment compliance levels and self-care behaviors of both groups of patients will be re-measured from the first week to the 6th month after the training, and any difference will be analyzed using statistical methods.

Eligibility criteria:
inclusion criteria: * have no communication barriers to affect cognitive functions, * ejection-fraction over 20 * diagnosed with heart failure for at least 6 months * able to use tele-health applications (smartphone and application) exclusion criteria: * patients with communication difficulties * patients who cannot use tele-health applications

Keywords: heart failure transtheoretic model treatment compliance self-care tele-health patient education
retrospective claims analysis of hysterectomy after sterilization

Conditions: Contraception

Summary: the research questions are: 1. what is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation? 2. what is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation? 3. what is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?


Eligibility criteria:
inclusion criteria: * women aged 18 through 49 years at the index date * at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during january 1, 2010 -december 31, 2012 * had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure * had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period) exclusion criteria: * women who underwent a postpartum tubal ligation procedure during the entire study period * women who had claims of a sterilization procedure during the baseline period * women who had a claim for pregnancy or delivery within 6 weeks prior to the index date * women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date * women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
validity of sentinel lymphnode biopsy after neoadjuvant chemotherapy cancer patients with radiologically positive axillary lymph nodes

Conditions: Breast Cancer

Summary: sentinel lymph node biopsy (slnb) after neoadjuvant chemotherapy (nac) is currently debatable. it is possible that the tumor response to chemotherapy may alter the lymphatic drainage thus causing lower sln identification rate and higher false negative rate. further, the response of nac can be different in each lymph nodes. it is doubtful whether slnb can accurately predict axillary lymph node (aln) status after nac. the aim of this study to determine the identification rate, the false-negative rate, and the accuracy of slnb after nac for node positive breast cancer.


Eligibility criteria:
inclusion criteria: * advanced breast cancer patients with node-positive proved in preoperative imaging study * ecog status 0-1 exclusion criteria: * no previous cancer history * no previous chemotherapy history

Keywords: sentinel lymph node biopsy neoadjuvant chemotherapy breast cancer locally advanced breast cancer positive axillary lymph node negative conversion
haploidentical transplantation in severe aplastic anemia

Conditions: Severe Aplastic Anemia

Summary: this is a prospective case-control study on saa patients treated with hsct, order to further discuss and assess the safety, feasibility and effectiveness of hfd-hsct which performed with reduced-intensity fludarabine-based conditioning regimen.our findings would indicate that saa patients who lack msd benefited most if hfd-hsct was performed with reduced-intensity fludarabine-based conditioning regimen, and our improved outcomes with hfd-hsct may lead to a salvaged therapy and an expanded direct role for saa in the future.


Eligibility criteria:
inclusion criteria: (i) diagnosis of saa, very saa or saa and paroxysmal nocturnal hemoglobinuria (pnh) according to the international aplastic anemia study group; (ii) saa patients no response to previous ist; (iii) adequate performance status \[eastern cooperative oncology group (ecog) score 0-2\]. exclusion criteria: (i) congenital forms of aplastic anemia; (ii)patients with any severe pulmonary, cardiac, liver, or renal diseases or active infection.

Keywords: haploidentical hematopoietic stem cell transplantation severe aplastic anemia
patient reported outcomes reported via pc / tablet home versus touch screen at hospital among patients with arthritis

Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis

Summary: to investigate if electronic reporting of patient reported outcome measures from home is comparable to the traditional touch-screen solution to hospital among patients with rheumatoid arthritis and axial spondyloarthritis


Eligibility criteria:
inclusion criteria * rheumatoid arthirtis or axial spondyloarthritis * active treatment and monitoring of the knowledge center for rheumatology and spine diseases, rigshospitalet, denmark * patients must have reported patient reported outcome measures via danbios touch-screen solution ≥ 3 times exclusion criteria * impaired vision * non-danish speaking * no electronic device at home,, tablet or computer
pre-lemniscal radiation deep brain stimulation for et

Conditions: Essential Tremor

Summary: the hypothesis is that prelemniscal radiation (raprl) deep brain stimulation (dbs) is more effective for axial (head/neck/voice) tremor, and perhaps, appendicular tremor control in essential tremor patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis of essential tremor based on clinical criteria established by the essential tremor consortium 2. moderate or severe axial-dominant (head/neck/voice) tremor (tremor rating scale \[trs\] face, tongue, voice, head or trunk tremor score of 2 or above) 3. may have bilateral appendicular tremor 4. tremor refractory to at least two medications, including primidone and propranolol 5. age between 21 and 75 6. male or female 7. significant disability due to essential tremor despite medical treatment (trs score of 2 or above in any one of the items 16-23 \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\]) exclusion criteria: 1. tremor due to other etiologies 2. pregnancy 3. presence of any other neurodegenerative disease 4. presence of significant cognitive impairment 5. presence of any medical condition that precludes neurological surgery 6. patients with another implanted stimulator or metallic implant, e.g. cochlear implant, cardiac pacemaker, spinal cord stimulator, aneurysm clips 7. patients who have a known need for future mris using a full body radio-frequency (rf) coil or a head transmit coil that extends over the chest area or that do not comply with medtronic's "mri guidelines for medtronic deep brain simulation systems" 8. patients with a history of seizures 9. patients with psychiatric illness that are not well controlled 10. patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 125,000 per cubic millimeter, pt and ptt not within normal limits) 11. patients with brain tumors

Keywords: essential tremor deep brain stimulation
iscar for second line treatment of advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: to determine if iscar quercus improves immune function and quality of life among patients with stage iv non-small cell lung cancer.

randomized pilot study of supplemental iscar in combination with gemcitabine vs. gemcitabine alone as second line treatment for advanced non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * newly diagnosed iiib and iv nsclc who have failed one prior line of chemo * karnofsky score 60% or greater * patients who will be treated with gemcitabine

Keywords: advanced stage lung cancer
association of type 1 diabetes mellitus in offsprings with positive parental history of diabetes

Conditions: Type 1 Diabetes

Summary: primary objective: to measure the association between a parental history of diabetes and the odds of an offspring being type 1 diabetics. secondary objectives: * to document the profile of type 1 diabetes patients. * to document the glycemic parameters (fasting blood glucose \[fbg\] and glycosylated hemoglobin \[hba1c\]) of type 1 diabetes. * to capture the current therapeutic management.

the overall duration of this study is expected to be 12 months. the recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days. \*each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin a1c tests. both the tests will be conducted through centralized laboratories for all recruited patients. since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.

Eligibility criteria:
inclusion criteria : inclusion criteria for cases * age ≥ 2 years and ≤ 20 years. * type 1 diabetes mellitus (t1dm) at any stage of life assessed as: * insulin initiated within one year of diagnosis. * one or more islet autoantibodies (insulin auto-antibodies \[iaa\], glutamic acid decarboxylase (gad), or ia2) positive at the time of enrolment. the laboratory value for iaa ≥ 2.4 units/ml, ≥ 10 iu/ml for ia2 and ≥ 5 iu/ml for anti-gad to be labelled as positive. * consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age. inclusion criteria for controls * age ≥ 2 years and ≤ 20 years. every control will be matched for a specific patient within ± two years of age. * non diabetic. * all islet autoantibodies negative at the time of enrolment (iaa, gad, or ia2). the laboratory value for iaa ≤ 2.4 units/ml, ≤ 10 iu/ml for ia2, and ≤ 5 iu/ml for anti-gad to be labelled as negative. * consenting to participate in the study or care giver ready to sign data release consent if the patient is less than 18 years of age. exclusion criteria: exclusion criteria for cases: * age ≤ 2 years and \>20 years. * patients with any other pre-existing auto-immune disease. * gestational diabetes. * pregnant woman. exclusion criteria for controls: * age ≤ 2 years and \> 20 years. * patient with history of type 1 (t1) and type 2 diabetes mellitus (t2dm). * history of t1 and t2dm in siblings. * gestational diabetes. * pregnant woman. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
combination chemotherapy in treating patients with previously untreated stage iii or stage iv ovarian or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage iii or stage iv ovarian or primary peritoneal cancer.

objectives: i. determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma. ii. determine the response rate (in patients with measurable disease) and progression-free interval in these patients receiving this treatment. outline: this is a feasibility study. on day 1, patients receive paclitaxel as a 3 hour continuous iv infusion followed by carboplatin as a 30 minute infusion. gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8. in the absence of disease progression or unacceptable toxicity, courses repeat every 21 days for a maximum of 8 courses. patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter. projected accrual: a total of 15-45 patients will be accrued for this study within approximately 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed, previously untreated: stage iii or stage iv ovarian epithelial cancer stage iii or stage iv primary peritoneal cancer patient characteristics: age: 18 to 80 performance status: gog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 3 times uln alkaline phosphatase no greater than 3 times uln renal: creatinine no greater than 1.5 mg/dl other: effective contraception required of fertile patients no significant infections no other severe medical problems that would subject patient to undue risk from this protocol no other active malignancy within past 5 years except nonmelanomatous skin cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for this or any other malignancy endocrine therapy: not specified radiotherapy: no prior radiotherapy for this or any other malignancy surgery: no prior surgery other than cytoreductive surgery and recovered

Keywords: stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer primary peritoneal cavity cancer
effects of forskolin on intraocular pressure in glaucomatous patients under maximum tolerated medical therapy

Conditions: Primary Open Angle Glaucoma; Intraocular Pressure

Summary: elevated intraocular pressure is still the main risk factor for development and progression of glaucoma. several drugs exist on the market that may decrease iop in glaucomatous patients. however, some patients cannot reach the target pressure despite a multitherapy with a combination of drugs, and are therefore addressed to surgical treatments. forskolin is a natural compound that is a receptor-independent adenyl-cyclase activator, that increases intracellular camp. it has been shown to be able to decrease iop after topical application, by a mechanism that is not used by the other drugs. aim of the present study is to see whether a food supplement containing forskolin (kronek) has any effect on the iop of poag patients that cannot reach their target pressure, and are therefore on the waiting list for surgical intervention.


Eligibility criteria:
inclusion criteria: * age: 30-70 years * sex: both * pathology: poag * characteristics: target pressure not achieved with current treatments exclusion criteria: * concomitant ocular pathologies * previous ocular surgery * known hypersensitivity to any of the components in the kronek tablets * concomitant participation in other trials

Keywords: poag iop forskolin food supplement
cholestasis in extreme low birth weight infants (elbw)

Conditions: Cholestasis

Summary: parenteral nutrition associated liver disease (pnald) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (pnac). extreme low birth weight infants (elbw, birth weight \< 1000 g) are at increased risk for development of pnac. important factors implicated in the aetiology of pnac are high caloric parenteral nutrition using amino acids or dextrose, but also intravenous lipids and infections in particular necrotizing enterocolitis (nec). due to a change of paradigm a more aggressive nutrition with early use of parenteral amino acids/lipids and early fortification of mothers milk or alternatively high caloric preterm formula is warranted. accordingly - in line with the existing expert opinion and evidence - the feeding policy at the neonatal care units of our hospital was adapted. evidence exists that pnac might be caused by the use of high concentrations of amino acids and lipids in parenteral nutrition. furthermore nec is associated with high osmotic feeds. therefore the incidence of pnac might be increased directly and indirectly after introducing the new feeding policy. the investigators therefore aim at retrospectively investigating the incidence of pnac before and after introduction of a feeding policy of "aggressive nutrition" for elbw infants.


Eligibility criteria:
inclusion criteria: * elbw infants below 1000 gram birth weight * born in house between january 2005 - december 2006 ("before") and july 2007- june 2009 ("after") exclusion criteria: * signs of cholestasis at birth * death or transfer before 28 days of life * diseases associated with cholestasis

Keywords: cholestasis liver damage parenteral nutrition aggressive nutrition preterm extreme low birth weight infant parenteral nutrition associated cholestasis
assessment of chemotherapy-induced peripheral neurotoxicity using a point-of-care nerve conduction study device

Conditions: Cancer

Summary: the purpose of this study is to evaluate the feasibility of the mediracer® ncs device in early detection of cipn in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen \[folfox, xelox, (r)-chop/choep/cvop, docetaxel, docetaxel-doxorubicin\] 3. age \>18y 4. ecog 0-2 5. patient compliant with the study procedures exclusion criteria: 1. patient not fit/suitable for aforementioned chemotherapy regimen at baseline 2. any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves 3. general vulnerability affecting the participation in the trial

Keywords: cipn, ncs
mindfulness in-home for diabetes and sleep health

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: the study investigates the effects of a mindfulness intervention on sleep and subsequent cardio-metabolic risk in an adult atlanta population aged 18 and older.

type 2 diabetes mellitus has been identified as a leading cause of death in the united states. this problem is alarmingly higher in southern state, including georgia. sleep, a modifiable health behavior, may be a target for reducing the burden of diabetes. this research study will enroll adults from the community to participate in a mindfulness-based stress reduction program (mbsr) via an app on his/her cellular phone. participants will also wear a wrist monitor to estimate activity and sleep as well as provide a blood sample before and after the mbsr. following the 6-week intervention program, participants will provide information via focus groups to obtain feedback on his/her experiences during the program. this pilot study will enroll (n=20) racially diverse men and women who are 18 years and older and reside in atlanta. participants will be recruited from the community via advertisements, community events and existing community partnerships. trained research assistants will screen potential participants. eligible participants will be contacted via phone and scheduled to attend a baseline visit to collect a blood sample and attend a sleep education session.

Eligibility criteria:
inclusion criteria: * resident in the atlanta, georgia area * proficient in english * have a smartphone * sleep quality score \>5 on the validated pittsburgh sleep quality index * prediabetes (defined as fasting glucose between 100-125 mg/dl or hba1c between 5.7-6.4%) exclusion criteria: * pregnant women * sleep quality score less than a score 5 on the validated pittsburgh sleep quality index * refusal to download mindfulness mobile application * diagnosis of hiv, aids, liver disease (diagnosed, i.e. chronic or alcoholic hepatitis, cirrhosis), renal/kidney disease * current cocaine, heroin, or methamphetamines use and/or has a history of treatment for alcohol or drug abuse * pre-diabetes: defined as a score greater than 3 on the american diabetes association 60-second type 2 diabetes risk test

Keywords: diabetes mindfulness public health sleep