Kornimate/medical-research-clean huggingface dataset:
etonogestrel implant as emergency contraception

Conditions: Contraception

Summary: the investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (lh) surge. the investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an lh surge, in persons with prior documented regular cycles and confirmed ovulation. the researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an lh surge. based on data from the food and drug administration label for nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an lh surge. this study is novel as there have been no published studies evaluating an etonogestrel implant for this indication. the contribution of this proposed research to the literature is significant because current recommendations from the center for disease control (cdc) regarding timing of etonogestrel implant placement are stringent and not patient-centered. any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. if results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.


Eligibility criteria:
inclusion criteria: * bmi less than or equal to 28kg/m2 * intact uterus with at least one ovary * regular menstrual cycles that occur every 21-35 days * if patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment * if patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment * desires insertion of an etonogestrel contraceptive implant for contraception * not currently pregnant or trying to become pregnant * willing to abstain from medications and supplements known to induce/inhibit cyp3a4 during the study exclusion criteria: * have a known hypersensitivity or contraindications to etonogestrel. * medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report) * known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel. * uncontrolled thyroid disorder. * use of long-acting injectable hormonal contraceptive within the past 9 months * current use of hormonal oral, patch, intravaginal, or intrauterine contraception
validity of strain elastography for the evaluation of chronic allograft nephropathy

Conditions: Chronic Allograft Nephropathy

Summary: chronic allograft nephropathy is one of dreaded complication of kidney transplant. it is one of the major determinants of long term graft survival. there are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . this includes infection and bleeding. the non invasive renal sono-elastography (strain and shear wave imaging) technique has shown very good yield of detecting and scoring fibrosis. in this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biops

chronic allograft nephropathy is one of dreaded complication of kidney transplant. it is one of the major determinants of long term graft survival. there are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . this includes infection and bleeding. the non invasive renal sono-elastography (strain and shear wave imaging) technique has shown very good yield of detecting and scoring fibrosis. in this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biopsy

Eligibility criteria:
inclusion criteria: renal transplant patients of more than 2 years duration, chronic allograft nephropathy proved by renal biopsy done within 1 month from the date of the strain elastography, body mass index less than 30 kg/m2, skin allograft distance of less than 3.5 cm, parenchyma thickness of more than 1 cm and no fluid accumulation around the allograft. exclusion criteria: body mass index more than 30 kg/m2, skin allograft distance more than 3.5 cm, parenchymal thickness less than 1 cm, presence of any fluid collection around the allograft, gfr less than 15 ml/min, graft stones or backpressure and less than 14 years old or more than 55 years old.

Keywords: nephropathy, chronic tubulointerstitial kidney transplantation ultrasonography elasticity imaging techniques
omt to improve feeding after hypothermia

Conditions: Neonatal Encephalopathy; Feeding; Difficult, Newborn

Summary: the goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment. the treated infants will be compared to matched historical controls.

infants affected by neonatal encephalopathy (ne) have been shown to have better survival rates and improved long term neurodevelopment following treatment with therapeutic hypothermia. however, a barrier to hospital discharge for these infants is a successful transition from gavage to either breast or bottle feeding. often, the factor delaying hospital discharge is slow transition to full oral feeds. osteopathic manipulative treatment (omt) helps to effectively stabilize and regulate the autonomic nervous system as well as the cranial nerves important in the sucking and latching reflexes, which may in turn help to ease the transition to full oral feeding. we hypothesize that infants who receive omt will accelerate the transition to full oral feeds, thus decreasing their overall length of hospitalization compared to historical matched controls.

Eligibility criteria:
inclusion criteria: * neonate \> 37 weeks gestational age at birth * neonate been diagnosed with neonatal encephalopathy or hypoxic ischemic encephalopathy and treated with therapeutic hypothermia * neonate with mild to moderate encephalopathy * eeg without seizure activity * brain mri without basal ganglia injury exclusion criteria: * neonate \< 37 weeks gestational age at birth * neonate with severe encephalopathy (as defined by sarnat) * eeg demonstrated seizure activity or evidence of status epilepticus during therapeutic hypothermia treatment * brain mri demonstrating moderate or severe basal ganglia injury * neonate affected by neonatal abstinence syndrome (nas) * neonate affected by intrauterine growth restriction (iugr) * neonate born with major congenital anomalies (i.e., cleft palate) * prenatal history of maternal insulin dependent gestational or type 1 diabetes * moribund status (i.e., infants unlikely to benefit from or are not responsive to aggressive life support)

Keywords: hypothermia treatment omt in infants
pregabalin, celecoxib, total knee arthroplasty and intrathecal morphine

Conditions: Postoperative Pain Management; Total Knee Arthroplasty

Summary: to evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.

a single-dose spinal anesthesia combining with morphine for total knee arthroplasty (tka) is a simple, economical anesthetic technique commonly used in our hospital. still some patients could not get effective postoperative pain control. pregabalin, an anticonvulsant, has been shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy, and reduce postoperative morphine requirement after total hip arthroplasty, and celecoxib, a selective cyclo-oxygenase (cox) - 2 inhibitor, with perioperative prescription is successfully reduces pain score and opioid consumption after tka under spinal anesthesia alone. however, no clinical study has yet investigated whether preoperative single-dose of pregabalin, celecoxib or in combination compared to placebo can improve analgesic efficacy of intrathecal morphine after tka. the primary objective of this study was to evaluate whether these medications could reduce pain scores at rest / when movement and morphine requirement after tka under spinal anesthesia with intrathecal morphine. secondary outcome assessed include adverse effects, anxiety score and patients' satisfaction score.

Eligibility criteria:
inclusion criteria: * patients between 50-75 years of age * patients with an american society of anesthesiologists physical status of i to iii * patients scheduled for primary tka with a diagnosis of osteoarthritis under spinal anesthesia exclusion criteria:. * patients had a known allergy to any of the medications being used * a history of drug or alcohol abuse * a history of taking chronic pain medications (ie, show-release preparations of opioids, given that morphine consumption was the primary outcome) * a history of taking pregabalin or gabapentin / non-steroidal anti-inflammatory drugs / cox-2 inhibitors * a psychiatric disorder * a history of impaired renal function (cr \> 1.5 mg/dl), peptic ulcer, asthma, thrombotic cerebrocardiovascular diseases, uncontrolled hypertension * a history of contraindication for spinal anesthesia * a history of bleeding tendency * pregnancy * unable or unwilling to use patient - controlled analgesic (pca)

Keywords: pregabalin celecoxib intrathecal morphine total knee arthroplasty
app-technology to increase physical activity among patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Exercise

Summary: the aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. the hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of hba1c than usual care.


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 2 diabetes * 18 years of age or older * ability to communicate in swedish * have and be able to use a smartphone exclusion criteria: * not being able to walk
evaluation of the optimum brushing force on dental plaque removal and the abrasive effect of brushing force on enamel surface.

Conditions: the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic

Summary: objective 1. to determine the optimum brushing force for dental plaque removal. 2. to investigate the effect of brushing force on enamel characteristic. hypothesis h0 : structural tooth loss is not significantly different between before and after brushing with excessive force on enamel surface. h1 : structural tooth loss is significantly different between before and after brushing with excessive force on enamel surface. study design: experimental study


Eligibility criteria:
inclusion criteria: * extracted bovine incisors exclusion criteria: * no
evaluation of meniscal extrusion by dynamic ultrasonography in patients with ostearthritis

Conditions: Knee Osteoarthritis; Meniscus Disorder

Summary: this is a diagnostic, open-label, single-center interventional study. the aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by mri study in patients with knee oa. as a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.

patients with a diagnosis of knee oa will be included in a study involving evaluation of the correlation between meniscal extrusion assessed by dynamic ultrasonography and bone edema assessed on mri. a total of 202 patients will be included, who, after providing their signed informed consent to participate in the study, will undergo dynamic ultrasonography. after giving signed consent to participate in the study, the patient will undergo the following examinations:: * ultrasound evaluation for assessment of possible meniscal extrusion; * at the same time as the ultrasound examination, subjective questionnaires will be administered to patients.recent radiological examinations of the patients or from the patient's medical record will be collected during or before the diagnostic investigation.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years; 2. signs and symptoms of degenerative pathology of knee cartilage; 3. patients with radiographic (x-ray or mri) signs of oa (k-l grade 0-4); 3. 4. cooperative patients with pain that does not prevent orthostatism 5. ability and consent of patients to actively participate in clinical follow-up; 6. recently performed mri (maximum 1 month). exclusion criteria: 1. patients unable to express consent; 2. patients undergoing intra-articular infiltration of other substance in the previous 6 months; 3. patients undergoing knee surgery in the previous 12 months; 4. patients with malignant neoplasms; 5. patients with rheumatic diseases; 6. patients with a history of total/subtotal meniscectomy; 7. patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7. 8. patients abusing alcoholic beverages, drugs or medications; 9. body mass index \> 40; 10. pregnant or lactating women; 11. patients with axis deviation \> 5°.

Keywords: dynamic ultrasonography nuclear magnetic resonance imaging meniscal extrusion osteoarthritis
evaluation of sodium bicarbonate to reduce the incidence of contrast induced chronic kidney injury in patients with kidney disease

Conditions: Contrast Induced Kidney Injury.

Summary: patients with stage 3b, 4,or 5 chronic kidney disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. if so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. they will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.


Eligibility criteria:
inclusion criteria: * candidate for angiography * stage 3b, 4 or 5 chronic kidney disease (i.e. egfr \<=44) * either sex over 18 years of age exclusion criteria: * pregnant or breast feeding * on any kidney replacement list * gastric tube in place or gastric drainage * uncorrected hypoglycemia

Keywords: chronic kidney disease
a study of ejaculatory dysfunction in men with low testosterone levels

Conditions: Ejaculatory Dysfunction; Hypogonadism

Summary: the purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.


Eligibility criteria:
inclusion criteria: * total testosterone level \<10.4 nanomoles per liter (nmol/l) \[300 nanograms per deciliter (ng/dl)\] at screening * presents with 1 or more of the following symptom(s) of ejaculatory dysfunction: delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment * prostate-specific antigen (psa) \<4 nanograms per milliliter (ng/ml) at screening exclusion criteria: * sexual partner who is or becomes pregnant at any time during the study * premature ejaculation as determined by investigator assessment * currently receiving testosterone replacement therapy or have a history of insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms * currently receiving treatment with cancer chemotherapy or antiandrogens * history of use of estrogenizing agents * current use of warfarin * history of selective serotonin reuptake inhibitor (ssri) and/or serotonin-norepinephrine reuptake inhibitor (snri) treatment in the 6 months prior to screening * history of frequent opioid use within 30 days prior to screening, with exception of treatment for chronic pain as determined by investigator. * body mass index (bmi) \>35 kilograms per square meter (kg/m\^2) at screening * significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic function * hematocrit ≥50% at screening * exhibit systolic blood pressure \>170 millimeters of mercury (mm hg) or \ 100 mm hg or \<50 mm hg at screening (if stress is suspected, retest under basal conditions at screening), or have history of malignant hypertension * history of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (for example, angioplasty or stent placement) * known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious nodules on digital rectal exam at screening * known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)

Keywords: ejaculatory dysfunction orgasmic dysfunction sexual dysfunction climax dysfunction erectile dysfunction impotence hypogonadism low testosterone low t
observational study on safety and efficacy of novoseven® in subjects with congenital fvii deficiency

Conditions: Congenital Bleeding Disorder; Congenital FVII Deficiency

Summary: this study is conducted in japan. the aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor vii (novoseven®) in subjects with congenital fvii deficiency.


Eligibility criteria:
inclusion criteria: * congenital fvii deficiency * never been treated with novoseven® before * patients already in treatment with novoseven® exclusion criteria: * history of hypersensitivity to any of the components in novoseven®
stepping stones and creating futures plus pilot

Conditions: Intimate Partner Violence; Poverty

Summary: the goal of this randomised controlled clinical trial is to test the stepping stones and creating futures plus (sscf+) intervention, in young (18-25 years) people living in urban informal settlements in durban and rural communities in kwazulu-natal, south africa. the main questions it aims to answer are: * is the intervention acceptable and feasible * what is the potential effect size on key outcomes of intimate partner violence participants will be randomised (1:1) to compare sscf+ and a control arm to see if there are differences between the two on intimate partner violence.

intimate partner violence is very common in south africa, particularly urban informal settlements. we have co-developed an intervention, called stepping stones and creating futures plus (sscf+), which will be evaluated in women and men aged 18-25 years living in kwazulu-natal, south africa. this is a pilot randomised controlled trial and as such there is focus on understanding whether the intervention is acceptable (to participants), feasible to deliver, and the potential effect sizes we may see in a full trial.

Eligibility criteria:
inclusion criteria: * normally resident in the community where recruiting * aged 18-30 years old * not in formal employment, or full-time education * able to communicate in the main languages of the study (english, isixhosa or isizulu) * able to provide informed consent exclusion criteria: * only in the community temporarily * unable to provide informed consent * under 18 years of age, or over 31 years old at point of recruitment * unable to communicate in main study languages
adapting food culture to the mediterranean pattern for international students in italy

Conditions: Physical Inactivity; Eating Disorders; Eating Habit; Diet, Healthy; Diet Habit

Summary: the goal of this clinical trial is to describe the adherence to the mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the university of pavia before and after a food education intervention. the main questions it aims to answer are: does the intervention of food education change the nutritional status of the international students of the university of pavia? does the intervention of food education change the level of physical activity of international students of the university of pavia? does the intervention of food education change the possible risk of eating disorders related to the possible change of diet from the country of origin of international students? researchers will compare the measurements done at the first meeting to the measurements made at the last meeting (6 months) to see if the food educational intervention helped the students. participants will: * have the body composition analysed by anthropometric measurements (weight, height, electric bio impedance) * receive personalized guidance and support from our team of experts for 6 months. visit the clinic 3 times (beginning, 3 months, and by the end of 6 months) for check-ups and tests, and participate in online meetings the other 3 months (second, fourth, and fifth). answer online questionnaires and perform a 3-day food diary (beginning, 3 months, and by the end of 6 months).


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * able to understand english or italian * nationality diverse than italian * absence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc. exclusion criteria: * ≤18 years old; * italian nationality; * presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.