Kornimate/medical-research-clean huggingface dataset:
disorders of sex development (dsd) 46.xy in three siblings

Conditions: Genotype

Summary: this is a case series of three siblings with dsd 46,xy with relevant discussion

this is a case series of three sisters with dsd 46 x,y. three sisters, aged nineteen, seventeen, and fifteen years old came with an identical complaint of late menarche. physical examinations, lab results and karyotypes were performed.

Eligibility criteria:
inclusion criteria: * 3 female siblings with identical complaints of no menarche exclusion criteria: * patients outside this family.

Keywords: disorders of sex development type 2 5-alpha reductase deficiency
lyrica (pregabalin) korean post marketing surveillance study

Conditions: Epilepsy; Neuropathic Pain; Fibromyalgia; Post-market Surveillance

Summary: this study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in korea.

continuous patients with target disorders in collaborating institutions

Eligibility criteria:
inclusion criteria: * any patient treated with pregabalin for an approved indication by korean food and drug administration exclusion criteria: * non-consenting * hypersensitivity to the active substance or to any of the excipients * galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.

Keywords: epilepsy neuropathic pain fibromyalgia post-market surveillance prospective observational
balance of angiotensin ii receptors in vessel function after preeclampsia

Conditions: Preeclampsia

Summary: otherwise healthy women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life. the reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during preeclampsia and persists postpartum, despite the remission of clinical symptoms. the purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women. the purpose of this study is to examine differences in the microvascular balance of angiotensin ii receptors women who have had preeclampsia. this will help the investigators better understand the mechanisms of dysregulated angiotensin ii receptors in formerly preeclamptic women, and how activation or inhibition of these receptors may restore microvascular function. in this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.


Eligibility criteria:
inclusion criteria: * women who had preeclampsia and women who did not have preeclampsia * 12 weeks to 5 years postpartum * 18-45 years old exclusion criteria: * history of hypertension or metabolic disease before pregnancy * history of gestational diabetes or gestational hypertension * skin diseases * current tobacco use * current antihypertensive medication * statin or other cholesterol-lowering medication * currently pregnant or planning to become pregnant * body mass index less than \ 30 kg/m2 * allergy to materials used during the experiment.(e.g. latex), * known allergy to study drugs

Keywords: postpartum vascular
a feasibility study of the nativis voyager® system in patients with recurrent glioblastoma multiforme (gbm)

Conditions: Glioblastoma Multiforme

Summary: this feasibility study will assess the effects of the nativis voyager therapy in patients with first or second recurrence of gbm who have either failed standard of care or are intolerant to therapy. the study will enroll and treat up to 32 subjects with voyager plus lomustine with or without bevacizumab. safety and clinical utility will be evaluated.


Eligibility criteria:
inclusion criteria: * subject has histologically confirmed diagnosis of gbm. * subject has failed or intolerant to radiotherapy. * subjects has failed or intolerant to temozolomide therapy. * subject has progressive disease with at least one measureable lesion on mri. * subject is at least 18 years of age. * subject has a kps ≥ 60. * subject has adequate organ and marrow function. exclusion criteria: * subject has received bevacizumab (avastin). * subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine. * subject is currently being treated with other investigational agents. * subject has received other investigational therapy within the last 28 days. * subject has received surgery within the last four weeks. * subject is within 12 weeks of completion of radiation. * subject has an active implantable or other electromagnetic device. * subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with mri. * subject is known to be hiv positive. * subject is pregnant, nursing or intends to become pregnant during the course of the study.
integrated collaborative care teams for youth with mental health and/or addiction challenges (youthcan impact)

Conditions: Mental Disorders; Addiction

Summary: among youth, the prevalence of mental health and addiction (mha) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. to address mha system gaps, this study will test the benefits of an integrated collaborative care team (icct) model for at-risk youth with mha challenges. in partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to mha services. this model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in toronto. a rapid, systematic, approach to mha services geared to need in a youth-friendly environment is expected to result in better mha outcomes for youth. moreover, the icct approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.

this study is a pragmatic randomized control trial (rct) with random allocation occurring within each hospital site to either treatment as usual (tau) (4 out-patient hospital sites) or treatment at one of 3 community-based integrated collaborative care teams (iccts). a total of 500 youth aged 14-18 with mental health and/or addictions (mha) concerns, referred for out-patient services at one of four local hospitals, will be randomized to receive icct care versus tau. for each youth, a primary caregiver will also be recruited into the study, if available. with wide inclusion criteria and a design meant to emulate a "real world" setting, this study will rigorously evaluate a service delivery model composed of multiple interventions for youth presenting with a broad range of mha problems. the icct is expected to result in better mha outcomes, show better performance indicators, and be more cost-effective than tau.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. aged 14 - 17 years 11 months 3. new referrals to one of the four participating hospitals for out-patient mha services 4. among the population regularly accepted for out-patient services at that hospital exclusion criteria: 1. referral for specialty forensic or firesetting treatment 2. moderate to severe intellectual disability or autism without mha problems 3. primary diagnosis of an eating disorder 4. active psychosis or imminent risk of self-harm requiring immediate intervention 5. inability to read and write english or to consent to the study

Keywords: mental health randomized pragmatic integrated collaborative care addiction youth
imaging modalities in diagnosing necrotizing enterocolitis in preterm infants.

Conditions: Necrotising Enterocolitis

Summary: background necrotizing enterocolitis (nec) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (vlbw). in the most premature population mortality rates can rise as high as 60%. typical findings on abdominal radiography (ar) include pnuematosis intestinalis (pi), portal vein gas (pvg) and pneumoperitoneum, but are sometimes not present even in severe cases. abdominal ultrasound (aus) can depict pi, pvg and pnuemoperitoneum (in some cases a head of ar), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. these additional findings are helpful in expediting diagnosis and management of nec. methods and analysis the hypothesis being tested is that preforming an aur in patients with clinical symptoms of nec but inconclusive/normal ar will enhance detection rates, and expedite treatment in infants born at \<32 weeks. discussion the use of aus together with ar as an add-on test may increase the accuracy of diagnosing nec, and precipitate treatment. swift implementation of antibiotics and bowel rest is extremely important. to our best knowledge, our study will be the first to focus only on vlbw, who are most prone to nec. it will also be the first multi-centre study evaluating the use of aus as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.


Eligibility criteria:
inclusion criteria: * abdominal distension * visible bowels loops * feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of \>50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis) * temperature instability (defined as ≥ 2 consecutive measurements) * frank bloody stools * cardiovascular instability (hypotension; defined as map \ 160/' or bradycardia \< 80/') * recurrent apnea * increase of abdominal girth \> 2cm (allowing inter-observer variability of 1 cm) within 12 h * abdominal wall erythemia and/or at least 2 of the below laboratory findings5: * thrombocytopenia \< 50 x103/ul * leukopenia \<6 x106/ul * crp \> 10 mg/l * pct \> 1 ng/ml * coagulopathy exclusion criteria: * • \ 32 weeks (estimated by ultrasound) * congenital abnormalities * no parental consent

Keywords: nec abdominal ultrasound abdominal radiograph preterm
wats3d for the detection of esophageal dysplasia

Conditions: Barrett Esophagus; Esophageal Dysplasia; Esophagus Adenocarcinoma

Summary: patients will be recruited from participating institutions prior to planned routine care egd with wats3d brush samples and forceps biopsies. eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. if interested, participants will be consented and proceed with routine care egd. the study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. follow-up information collected will include wats3d cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. wats3d samples will be sent to cdx diagnostics for analysis.


Eligibility criteria:
inclusion criteria: * patients age: ≥ 18 years * patients should have a history of barrett's esophagus (with or without dysplasia of either indefinite, low grade or high-grade) * willingness to undergo both wats and forceps biopsies while undergoing conventional egd with sedation * ability to provide written, informed consent (approved by irb) and understand the responsibilities of trial participation * only patients who undergo both forceps biopsies and wats of the esophagus will be included in this study exclusion criteria: * coagulopathy with an international normalized ratio above 2.0; * thrombocytopenia with platelet counts below 50,000 * history of prior esophageal ablation therapies, esophageal or gastric surgery * unresolved drug or alcohol dependency * pregnancy or planned pregnancy during the study period * patients found to have a be length less than 1 cm or greater than 10 cm * patients with any visible lesions greater than 10 mm
total occlusion study in coronary arteries - 5

Conditions: Chronic Coronary Total Occlusions

Summary: a prospective, multi-center, double blind, 2 stage, placebo-controlled, phase ii study, evaluating acute intra-coronary injected collagenase prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (ctos).


Eligibility criteria:
inclusion criteria: * male or females patients \> 18 years of age who has a clinically driven, planned pci of the target cto, in a major epicardial coronary artery, without planned revascularization of other coronary stenosis/stenoses in major epicardial segments. * target cto must be greater than or equal to 3 calendar months prior to screening * target cto must meet protocol defined criteria for entry * patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy) exclusion criteria: * documented chest radiation exposure \> 4.0 gray within 8 weeks of day 0 * target vessel is not an occluded stent, saphenous vein graft * patient had acs \< 4 weeks from screening, attributable to any coronary vessel * patient has non-healed dissection plane extending to a point adjacent to the coronary lumen distal to the target cto * patient has a known or suspected target vessel perforation within 30 days of day 0 * angiographic exclusion criteria as defined in the protocol

Keywords: cto pci angioplasty
hepcifer study: hepcidin overexpression after hepatectomy : does iron supplementation make sense ?

Conditions: Anemia; Postoperative Blood Loss

Summary: hepcifer trial is designed to assess the value of iv iron administration immediately after liver surgery and consequences of inflammation on iron balance. fifty patients will be randomized in two treatment groups. patients will be assigned to receive either iv iron or placebo immediately after liver resection surgery. biological inflammation parameters, hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1, 3, 7, 15 and 30 after surgery.

the iron homeostasis is now well known. indeed, the discovery of hepcidin, a protein synthesized by the liver, has provided a better understanding of iron metabolism and the resulting anemia disruption of this homeostasis. although morbidity decreased hepatic surgery remains a major surgery as by surgical difficulty by support intra- and postoperatively. a preliminary study, the investigators found that patients had preoperative anemia (oncological context) increased postoperatively, increasing the morbidity. few clinical studies on hepcidin and anemia were carried out, because of the difficulty of metering (mass spectrometry) as well as its cost. in this clinical trial, the investigators plan to assess the value of iv iron administration versus iv placebo treatment immediately after liver surgery and consequences of inflammation on iron balance. in addition, an evaluation of the well being of patients will be performed postoperatively to measure the functional and psychological impact of anemia. this is a monocentric, randomized, double blinded and placebo controlled trial. iron iv injection will be administered postoperatively. hematology assessments, biological iron deficiency, inflammation and coagulation will be realized pre and postoperatively. hepcidin is assayed by an elisa method.

Eligibility criteria:
inclusion criteria: * scheduled liver surgery, * liver resection \> 2 segments. exclusion criteria: * age below 18yrs, * pregnancy, * emergent surgery, * sepsis, * immunosuppressive therapy, * renal insufficiency (gfr\<30ml/min/m2), * hypersensitivity to iron, * iron overload.

Keywords: hepcidin
safety and efficacy of inhaled pre-prandial human insulin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and oceania. the aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * treated with oad(s) for more than or equal to 2 months * body mass index (bmi) less than or equal to 40.0 kg/m2 * hba1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in oad monotherapy * hba1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on oad combination therapy exclusion criteria: * recurrent major hypoglycaemia * current smoking or smoking within the last 6 months * impaired hepatic or renal function * cardiac problems * uncontrolled hypertension * proliferative retinopathy or maculopathy
the effect of g-csf on mrd after induction therapy in newly diagnosed aml

Conditions: Granulocyte Colony-stimulating Factor; Minimal Residual Disease; Acute Myeloid Leukemia

Summary: granulocyte-colony stimulating factor (g-csf) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. minimal residual disease (mrd), an index for early treatment response, plays an important role in prognostic prediction. numbers of data have shown mrd at day 14 after induction therapy significantly predicts prognosis. however, the retrospetive data from the investigators showed that patients with g-csf treatment after induction had higher mrd at day 14 but not significantly different at day 28, suggesting that g-csf might work on the differenciation of hemapoetic stem cells and increase mrd levels at day 14. in this multicenter prospective randomized controlled study, the effect of g-csf on mrd after induction therapy in newly diagnosed acute myeloid leukemia (aml) is evaluated.

granulocyte-colony stimulating factor (g-csf) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. minimal residual disease (mrd), an good index for early treatment response, plays an important role in prognostic prediction. numbers of data have shown mrd at day 14 after induction therapy significantly predicts prognosis. however, the retrospetive data from the investigators showed that patients with g-csf treatment after induction had higher mrd at day 14 but not significantly different at day 28,suggesting that g-csf might work on the differenciation of hemapoetic stem cells and increase mrd level at day 14. in this multicenter prospective study, the investigators randomizedly divide all participants with newly diagnosed acute myeloid leukemia (aml) into g-csf treatment group and g-scf-free group. in g-csf treatment group, all participants are treated with g-csf at the dose of 5ug/kg pre day until neutrophil higher than 0.5 g/l or 14 days from day three after induction therapy. mrd is monitored at day 14 and 28 with flow cytometry and quantity pcr if a fusion gene is available in both g-csf treatment and g-csf-free groups. comparision of the difference of mrd levels between the two groups is performed to evaluate the effect of g-csf on mrd.

Eligibility criteria:
inclusion criteria: newly diagnosed aml exclusively of apl; 14-65 years old; neutrophil \< 1.5 g/l at the day three after induction. exclusion criteria: any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure); patients with any conditions not suitable for the trial; nr at day 28 after induction.
efficacy of mi078 capsules in treating postpartum depression

Conditions: Postpartum Depression

Summary: this study is a multicenter, randomized, double-blind, placebo-controlled trial. it includes three groups. each group will enroll 24 participants. the trial aims todetermine： to evaluate the efficacy of mi078 capsules in treating postpartum depression and to explore the optimal dosing regimen for mi078 capsules. to assess the safety of mi078 capsules in postpartum depression patients.

this study employs a multicenter, randomized, double-blind, placebo-controlled parallel design. it plans to include three groups: one for the test drug at dose 1, one for the test drug at dose 2, and one for the placebo group, with 24 subjects in each group. the study consists of a screening period (d-14 to d-1), a treatment period (day 1 to day 4), and a follow-up period (day 5 to day 31). enrolled subjects will be randomly assigned in a 1:1:1 ratio and will take the study medication for a total of 3 days.

Eligibility criteria:
inclusion criteria: * female patients aged 18 to 45 years (inclusive) with a body mass index (bmi) ranging from 18.5 to 37.0 kg/m² (inclusive). * the patient meets the diagnostic criteria for major depressive disorder (mdd) as defined in the diagnostic and statistical manual of mental disorders(dsm-5), based on the investigator's clinical evaluation. the onset of illness must occur between 28 weeks of pregnancy and 4 weeks postpartum (inclusive). * the patient is within 9 months postpartum during the screening period. * the total score on the hamd17 is ≥26 during both the screening and baseline periods. * the patient understands and voluntarily agrees to participate in the study, consents to comply with all study requirements, and is able to provide written informed consent prior to the initiation of any study-specific procedures. * the patient is able to communicate effectively with the investigator, is willing and able to adhere to the lifestyle restrictions or requirements specified in the study protocol, and can cooperate fully in completing the trial. exclusion criteria: * current diagnosis of another mental disorder according to dsm-5 criteria, as assessed by the investigator * history of bipolar disorder, schizophrenia, and/or schizoaffective disorder * history of sleep apnea * presence of suicidal ideation/intent, or a score \>3 on item 3 (suicide) of the hamd17, or a response of "yes" to item 4 or 5 on the columbia-suicide severity rating scale (c-ssrs) within the past 6 months, or a history of suicidal behavior within the past year * meeting the diagnostic criteria for treatment-resistant depression * continuous use of therapeutic doses of antidepressants for more than 14 days during the current episode * failure to discontinue psychotropic medications for at least 5 half-lives prior to the use of the study drug. * need for concurrent use of other psychotropic medications, such as antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics (excluding benzodiazepines), during the trial dosing period.