Kornimate/medical-research-clean huggingface dataset:
improvement of women's health after allogeneic stem cell transplantation

Conditions: GVHD, Chronic

Summary: the aim of this prospective research project is to better understand vulvovaginal cgvhd to improve care of allografted women. the expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cgvhd, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. the knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.

the invetigators plan to recruit 100 women who will be evaluated 9 times over a period of 2 years (before allograft, at + 3 months, +6 months, +9 months, +12 months, +15 months, +18 months, +21 months, and +24 months +/- 14 days). if a new diagnosis of cgvhd is made between 2 visits, an additional gynecological examination will be performed. visits by the hôpital maisonneuve-rosemont hospital transplant team will include a physical examination to assess for the presence of cgvhd using the nih criteria. the fact-bmt quality of life questionnaire will also be completed before the allograft, at 3 months and 6 months after transplant. if cgvhd is diagnosed, the participants will also have to complete two questionnaires specific to cgvhd (lee scale for cgvhd, patient self-assessment of cgvhd) at diagnosis and then at + 6, +12, +18 and +24 months from day 0 of allograft. assessments by chum gynecologists will take place before the allograft, then at +3, +6, +12, +18 and +24 months from day 0 of the allograft and will include: a vulvar/vaginal examination, a sample for hpv testing and sexual health questionnaires to be completed (personal assessment of intimacy within relationships - pair, female sexual function index - fsfi , female sexual distress scale-revised - fsds-r).

Eligibility criteria:
inclusion criteria: * all women aged 18 and over who will receive a first allogeneic hsct (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the ciusss-emtl. recruitment will begin when the project receives ethical approval. recruitment period will be of 2 to 3 years. exclusion criteria: 1. those who receive a second hsct allograft. 2. those who receive an autologous transplant. 3. inability to give informed consent. 4. unable to communicate in french or english. 5. any other reason which, according to the investigators, makes it preferable for a patient not to participate.
effect of treatment modality on psychosocial functioning of survivors of unilateral retinoblastoma

Conditions: Survivors of Unilateral Retinoblastoma

Summary: the purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). by quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. the investigators want to see if either treatment option would affect quality of life differently. the investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.


Eligibility criteria:
inclusion criteria: * ability to speak and understand english or spanish * diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution * treatment of retinoblastoma between 2006 or later * patients must between the age of 8-17 years old * at least 1 year since completion of all cancer-directed therapy * treatment with enucleation of the affected eye or intra-arterial chemotherapy parent of patient: * ability to speak and understand english or spanish * ability to confirm that he or she is the parent of a child treated for unilateral retinoblastoma who meets the eligibility criteria listed above * ability to provide informed consent exclusion criteria: * patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible

Keywords: quality of life physical health emotional health 18-397
group versus individual care in diabetes clinic

Conditions: Diabetes Mellitus; Group Meetings

Summary: in this prospective, randomized, non blinded, one center (university hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. primary end-point included change in hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non hdl cholesterol, diabetes related and quality of life questionnaires and hospitalizations.

in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 or type 2 diabetes * fluency in hebrew * attendance at least for the second time at the diabetes clinic * follow up of at least one year by a general practitioner * willingness to participate in the study and to give informed consent. exclusion criteria: * uncontrolled psychiatric diseases * active cancer * pregnancy
modafinil for atypical depression

Conditions: Atypical Depression

Summary: the purposes of the study are to: 1) evaluate the short-term efficacy and safety of modafinil in atypical depression; and 2) to evaluate the efficacy of modafinil in preventing relapse of atypical depression. the hypothesis is that modafinil is safe and effective in the treatment of atypical depression.

this study on the safety and efficacy of modafinil on atypical depression has an initial 12-week open label treatment period with modafinil that is followed by a 12-week double-blind, randomized parallel treatment period with either modafinil or matching placebo. patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to either continuing treatment at their current dose or switched to matching placebo for 12 weeks.

Eligibility criteria:
inclusion criteria: * adults 18-65 years of age * dsm-iv criteria for major depressive episode with atypical features as assessed by the atypical depression diagnostic scale * minimum score of 18 on the hamilton depression scale (29-item version) at baseline * baseline clinical global impressions severity score of 4 or more * written informed consent * negative serum pregnancy test for women of childbearing potential exclusion criteria: * any current primary dsm-iv axis i disorder other than depression * history of dsm-iv diagnosis of bipolar i disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition * history of substance abuse or dependence within the last 3 months * suicide risk or serious suicide attempt with the last year * clinically significant medical condition or laboratory or ekg abnormality * history of non-response to three prior adequate trials of antidepressants * women of childbearing potential who are unwilling to practice an acceptable method of contraception * history of hypersensitivity to modafinil * use of an investigational medication within the last 28 days * use of antidepressant medication with 28 days of screening

Keywords: atypical depression psychostimulants modafinil
study of safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of jtt-252

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety, tolerability, and pk of single oral doses of jtt-252 and the effect of food on the pk of jtt-252 in healthy subjects, and to evaluate the safety, tolerability, pk and pd of single oral doses of jtt-252 in type 2 diabetes mellitus subjects.


Eligibility criteria:
inclusion criteria: healthy subject cohorts: * healthy male or female subjects * age 18 to 50 years (inclusive) * body mass index (bmi) between 19.0 and 31.0 kg/m2 (inclusive) type 2 diabetic subject cohorts: * male or female type 2 diabetic subjects who are currently being treated with a stable dose of metformin * age 18 to 65 years (inclusive) * bmi between 25.0 and 40.0 kg/m2 (inclusive) * have a glycosylated hemoglobin (hba1c) of \>7.0% to ≤9.5% * have a fasting plasma glucose (fpg) \<240 mg/dl exclusion criteria: healthy subject cohorts: * known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic and dermatological or connective tissue disease * subjects with a systolic blood pressure \>140 mmhg and/or diastolic blood pressure \>90 mmhg type 2 diabetic subject cohorts: * subjects with a known medical history or presence of type 1 diabetes mellitus * subjects with known medical history of acute metabolic diabetic complications * subjects with uncontrolled hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>95 mmhg

Keywords: safety tolerability pharmacokinetics food-effect diabetes
ultrasound guided modified thoracolumbar interfascial plane block for spinal surgery

Conditions: Pain, Postoperative; Spine Disease

Summary: ultrasound guided thoracolumbar interfascial plane (tlip) block was first described in 2015 by hand et al. tlip block involves injection of local anesthetics between multifidus and longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of thoracolumbar nerves. in new approach differently, the investigators made the injection between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral. the aim of this study is to determine effectiveness of ultrasound guided thoracolumbar interfascial plane (tlip) block in patients undergoing spinal surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients undergoing spinal surgery exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases

Keywords: postoperative analgesia ultrasound guided thoracolumbar interfascial plane block
4kscore using serum stored uncentrifuged

Conditions: Prostate Cancer

Summary: the purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure


Eligibility criteria:
inclusion criteria: * men capable of donating five 5 ml tubes of whole blood * 40 to 80 years old * no prior diagnosis of prostate cancer; prior negative prostate biopsy included * total psa (tpsa) value measured within last year to be: at 1.5 ng/ml to 4 ng/ml, 4.1 ng/ml to 10 ng/ml and 10 ng/ml and above exclusion criteria: * in the previous 96 hours (4 days), underwent a digital rectal exam * any invasive urologic procedure in the 6 months prior to study participation * underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months * radical prostatectomy since tpsa measurement * received within the previous 6 months 5-alpha reductase inhibitor (5-ari) therapy such as avodart (dutasteride) or proscar (finasteride)
effect of heart rate on left ventricular performance

Conditions: Myocardial Function; Myocardial Strain

Summary: the current study is aimed at determining the normal response to increasing heart rates. for this purpose, atrial pacing will be used to increase heart rate.

participants will be patients with pacemakers and normal a-v node conduction with a possibility for right atrial pacing mode. detailed echo studies will be performed at baseline. echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. each stage will last 2-3 min or as long as it takes to record the echo study. heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia. hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other echo data), for each stage.

Eligibility criteria:
inclusion criteria: 1. patients with aai or ddd pacemaker with intact av nodal conduction that can be set to work in aai mode. 2. stable rhythm (either sinus or paced). 3. good quality baseline echo. 4. able and willing to sign informed consent form. exclusion criteria: 1. prior heart failure or ischemic heart disease. 2. severe valvular lesions. 3. severe pulmonary hypertension. 4. known intolerance to rapid pacing. 5. multiple extrasystoles (more than 1 per echo or monitor screen). 6. age over 70.

Keywords: strain ejection fraction diastolic function
momsonline2 ; a pilot study testing recruitment and retention of women of color to an online support group for bereaved mothers

Conditions: Stillbirth; Grief; Infant Death

Summary: this is a 6-week pilot study to see how research participants feel about an internet support site after a stillbirth or infant death. losing a baby through stillbirth or early infant death is typically devastating for families. however, investigators do not know if internet on-line support for parents helps manage grief more easily. in addition to using the babycenter.com website, participants will be asked to complete online surveys at the beginning and the end of the study, as well partake in an interview. data from this pilot study will help develop a much larger randomized control study of on-line support outcomes after perinatal loss.


Eligibility criteria:
inclusion criteria: * michigan residence and infant delivery * non-caucasian race and/or hispanic ethnicity * read/speak english * gave birth to a stillborn baby or had an infant death in the first 28 days of life * did not give the baby up for adoption pre-loss * internet access exclusion criteria: * don't read/speak english

Keywords: internet support site babycenter.com.
protein timing, lean mass, strength and functional capacity gains in postmenopausal women

Conditions: Sarcopenia

Summary: this study evaluated the effect of protein intake immediately after resistance exercise on lean mass, strength, and functional capacity gains in postmenopausal women. participants were randomly assigned to protein-carbohydrate group (pc) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (cp) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. both groups performed the same resistance training protocol in the morning.

both groups performed the same training protocol, differing only the time of protein or carbohydrate supplementation. the dietary assessment was made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. one maximum repetition (1-rm), handgrip strength and 1-mile walk were performed.

Eligibility criteria:
inclusion criteria: * women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - lh and high fsh and estradiol decreased); * healthy; * who agree to participate and sign the consent term. exclusion criteria: * the one who does not provide the necessary information for the development of the study; * present orthopedic limitations; * patients with previously diagnosed and treatment of diseases such as type ii diabetes mellitus, hypertension and cardiovascular disease.
plasma rich in growth factors (prgf-endoret)in the treatment of androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: * androgenetic alopecia (aga) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals. * this clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (prgf-endoret) in the treatment of androgenetic alopecia.


Eligibility criteria:
inclusion criteria: * androgenetic alopecia according to the following scales: * men: hamilton/norwood scale: grades ii-vi * women: ludwig scale grades i-ii. * possibility of follow-up during the study exclusion criteria: * no androgenetic alopecia * telogen and anagen effluvium * active inflammation or infection in the intervention area * presence of active systemic infections. * background of cancerous or precancerous lesions. * background of connective or rheumatic diseases. * suffering from any serious blood disorders. * to have undergone treatments for alopecia in the previous 6 months. * previous hair implants * intake of drugs that affect hair loss. * be undergoing immunosuppressive therapy and/or anticoagulants. * known intolerance to mesotherapy. * taking contraceptives containing cyproterone acetate. * pregnancy * in general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.
microcirculation and inflammatory markers in patients with resistant, stages 1/2 hypertension and normal blood pressure

Conditions: High Blood Pressure

Summary: nailfold videocapillaroscopy (nvc), venous occlusion plethysmography (vop) and inflammatory biomarkers have been used to study endothelial function in patients with resistant hypertension, stages 1 and 2 hypertension and normotensive. this was a cross-sectional study.

microcirculation determines peripheral resistance contributing to increased blood pressure. the nailfold videocapillaroscopy (nvc), venous occlusion plethysmography (vop) and biomarkers can be used to evaluate the microcirculation in arterial hypertension (ah). the objective of this study is to analyze the behavior of serum inflammatory markers and study the microcirculation by nailfold videocapillaroscopy (nvc) and venous occlusion plethysmography in patients with resistant hypertension (rh), with stages 1 and 2 hypertension (mmh ) and normotensive (cg). a cross-sectional study with 75 patients has been performed: 25 with resistant hypertension (rh), 25 with stages 1 and 2 hypertension (mmh) and 25 normotensive (cg). all underwent anamnesis, dosage serum markers and conducting nvc, vop. hypertensive patients without statin use and with controlled or uncontrolled blood pressure were also analyzed. for the statistical analysis were used: kruskal -wallis anova, dunn test and ancova for correction of confusion factors such as age and bmi.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of controlled high blood pressure stages 1 and 2 (blood pressure levels from 140/90 mmhg to 179/109 mmhg) . * resistant hypertension (uncontrolled hypertension, with values ≥140/90 mmhg, using three or more antihypertensive drugs of different classes, including a diuretic, or controlled hypertension with four or more drugs). * normal blood pressure. exclusion criteria: * diabetes mellitus, types 1 or 2. * heart failure. * myocardial infarction or stroke with less than three months of the event. * chronic kidney disease. * use of hormonal or non-hormonal anti-inflammatory drugs. * recent trauma (less than three months). * autoimmune diseases. * infectious processes in activity. * neoplasia. * aspirin use (anti-inflammatory dose). * obesity grade iii (body mass index\>40 kg/m2).

Keywords: nailfold videocapillaroscopy venous occlusion plethysmography endothelial function microcirculation inflammatory biomarkers
a study of belimumab in subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (sle) disease.


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by acr criteria. * active sle disease. * autoantibody-positive. * on stable sle treatment regimen. key exclusion criteria: * pregnant or nursing * have received treatment with any b cell targeted therapy. * have received treatment with a biological investigational agent in the past year. * have received iv cyclophosphamide within 180 days of day 0. * have severe lupus kidney disease. * have active central nervous system (cns) lupus. * have required management of acute or chronic infections within the past 60 days. * have current drug or alcohol abuse or dependence. * have a historically positive test or test positive at screening for hiv, hepatitis b, or hepatitis c.

Keywords: autoimmune diseases lupus sle systemic lupus erythematosus belimumab antibodies
back-to-back endoscopy versus single-pass endoscopy and chromoendoscopy in ibd surveillance

Conditions: Inflammatory Bowel Diseases; Colorectal Neoplasms

Summary: the current international guidelines for crc surveillance in ibd recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (hdwle) for optimal dysplasia detection, based on data from clinical trials. however, data on the superiority of ce over hdwle are not consistent in literature. the investigators hypothesize that the better performance of ce in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. currently, no studies have been published evaluating the dysplastic yield of back-to back hdwle compared to hdwle with a single pass or ce in patients with ibd. in the present study, the investigators aim to compare the yield of dysplasia/crc between 1) regular hdwle, 2) hdwle back-to-back, and 3) ce.

the investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (imperatore et al 2019). to show non-inferiority of back-to-back hdwle compared to ce, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required. to demonstrate a superiority of back-to-back hdwle compared to a regular hdwle, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. therefore, the investigators will include 226 patients in group back-to-back hdwle, 226 in group ce, and 113 patients in group regular hdwle. this amounts to a total of 560 patients. to account for any screen-failures the investigators will include at most 5% (of 560) additional patients until 80% power is reached.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis). * previous assessable surveillance endoscopy \> 1 year * age \> 18 years exclusion criteria: * active colitis \> 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist. * allergy or intolerance to methylene blue * insufficient bowel cleansing (bbps \<6) * refusing or incapable to agree with informed consent * pregnant women * \> 50 % of the colon surgically removed

Keywords: ibd inflammatory bowel diseases colorectal cancer surveillance dysplasia back-to-back chromoendoscopy white light