Kornimate/medical-research-clean huggingface dataset:
continuation study of b1371019(nct03416179) and b1371012(nct02367456) evaluating azacitidine with or without glasdegib in patients with previously untreated aml, mds or cmml

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Summary: an open-label study available to all eligible participants from study b1371019 and participants originating from study b1371012 continuing on study intervention with azacitidine with or without glasdegib.


Eligibility criteria:
inclusion criteria: * any participant who continues to demonstrate clinical benefit (as determined by the principal investigator) from study treatment with azacitidine with or without glasdegib in this study or from study b1371012. * capable of giving signed informed consent as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. exclusion criteria: * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * female participants who are pregnant or breastfeeding (if continuing to receive study intervention); * participant has been withdrawn from study b1371019 and study b1371012 for any reason (including int cohort participants required to end study treatment)
vldl-triglyceride under acute hyperinsulinaemia

Conditions: Obesity

Summary: the purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. we want to investigate the effect of postprandial hyperinsulinaemia on vldl-triglyceride metabolism


Eligibility criteria:
inclusion criteria: - written consent exclusion criteria: * known diseases * alcohol abuse * smoker * regular use of medicine

Keywords: vldl kinetics hyperinsulinaemia obesity
long-term prognosis of patients with sepsis after immunotherapy

Conditions: Long-term Effects of Thymosin Alpha 1 Treatment

Summary: current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy. based on the preliminary clinical study (nct02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.


Eligibility criteria:
inclusion criteria: * sepsis patients in the tests study patients who discharged from hospital after recovery exclusion criteria: * none

Keywords: long-term thymosin alpha 1 sepsis immunotherapy
rectal indomethacin to prevent post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: the purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ercp pancreatitis.


Eligibility criteria:
inclusion criteria: 1. scheduled for an ercp at dartmouth-hitchcock 2. age greater than 18 years old 3. ability to provide written informed consent exclusion criteria: 1. inability to provide written informed consent 2. ercp being performed for diagnosis and/or treatment of acute pancreatitis 3. current ongoing acute pancreatitis 4. previously documented allergy to non-steroidal anti-inflammatory drugs (nsaids) 5. contra-indication to nsaid therapy (creatinine level \>1.4 or active peptic ulcer disease), already taking nsaids (other than aspirin therapy for cardioprotection) 6. pregnant or nursing mothers

Keywords: post ercp acute pancreatitis post fine needle aspiration (fna) acute pancreatitis indomethacin rectal non steroidal anti-inflammatory drugs (nsaids)
the effect of transcranial direct stimulation on cognitive functions of healthy adults

Conditions: Cognitive Symptom; Healthy

Summary: background: transcranial direct current stimulation(tdcs) has been used to improve cognitive functions in healthy young adults. purpose: to investigate the effect of tdcs application on different cortex regions on cognitive function. methods: sixty individuals aged 18-30 were included in the study. the participants were randomly divided into the left dorsolateral prefrontal cortex (left dlpfc group)(n=20), the right posterior parietal cortex (right ppc group)(n=20), and the sham group (sham group)(n=20). tdcs was applied for 20 minutes on weekdays for 2 weeks. the participants were evaluated in terms of cognitive functions with neuropsychometric test battery before and after treatment.


Eligibility criteria:
inclusion criteria: * being 18-30 years old exclusion criteria: * alcohol and substance addiction * previous mental illness * having mental and cognitive problems * a history of head trauma * having cardiovascular disease.

Keywords: tdcs dorsolateral prefrontal cortex posterior parietal cortex cognitive function
open prospective study on reduction of bacteriuria following bladder irrigation with chlorhexidine

Conditions: Bacteriuria, Intermittent Catheterization

Summary: this a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent catheterisation (ic). patients will be treated with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days. the study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short term reduction of bacteriuria in patients performing intermittent catheterization (ic).


Eligibility criteria:
inclusion criteria 1. provision of informed consent 2. female or male spinal cord injured subject aged 18 years and over 3. bacteriuria of \>10\^5 cfu/ml of \>1 bacterial species verified during screening visit 4. regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month) 5. ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator exclusion criteria 1. signs or symptoms of symptomatic uti that requires treatment, as judged by the investigator. 2. ongoing antibiotic treatment 3. known anatomical pathology of the urinary tract that could compromise results, as judged by investigator 4. subject with severe catheterisation difficulties, as judged by investigator 5. known hypersensitivity to chlorhexidine 6. use of other instillation products 7. pregnancy 8. use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate) 9. involvement in the planning and conduct of the study (applies to both wellspect healthcare staff and staff at the study site) 10. previous enrolment or allocation of treatment in the present study. 11. simultaneous participation in another clinical study that may interfere with the present study. 12. severe non-compliance to protocol as judged by the investigator and/or wellspect healthcare
long-acting injectable antiretroviral treatment to improve hiv treatment among justice-involved persons being released to the community

Conditions: HIV

Summary: the federal research award entitles "long-acting injectable antiretroviral treatment to improve hiv treatment among justice-involved persons being released to the community" aims to conduct interviews with justice and treatment experienced pwh (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition pwh with viral suppression on oral art to lai art in prison with continuation during community re-entry; develop an initial lai art community re-entry protocol based on aim 1 findings and conduct an open label pilot study. post-release follow up will occur for three months among 20-30 incarcerated pwh eligible for lai art who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of lai art in prison, transition of lai art to community providers, and to pilot study retention methods and assessments, including post-release hiv viral loads and urine drug testing, during the follow-up period.

r34-funded mixed methods study that will develop and pilot test an lai art protocol designed specifically for pwh who are experiencing community re-entry

Eligibility criteria:
inclusion criteria: * 1) ≥18 years of age; 2) english speaking; 3) hiv positive (confirmed by medical record review); 4) receiving oral art; 5) documentation of hiv viral suppression (\< 50 copies/ml) on oral art within 12 weeks of recruitment; 5) eligible to transition from oral art to injectable cab/rpv based upon medical record review and pre-treatment evaluation; 6) willing to transition art to injectable cab/rpv; 7) anticipated release from mdpscs facility within 12 weeks; 8) anticipated release to baltimore city; 9) willing to receive post-release cab/rpv injections at community-based sites; and 10) able to provide informed consent for study participation. exclusion criteria: * persons who are currently prescribed injectable cab/rpv within mdpscs will not be eligible for study enrollment, however, we do not anticipate use of injectable cab/rpv will be common in this population during the conduct of this study given slow roll out in the community to date and no experience within carceral facilities. potential participants unable to provide informed consent, including people with severe mental illness (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed) requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia), will be excluded.

Keywords: hiv infection substance use disorders community re-entry hiv treatment long-acting injectable incarceration
study of nuv-422 in combination with fulvestrant in patients with hr+her2- abc

Conditions: Advanced Breast Cancer; Metastatic Breast Cancer; Breast Cancer; Breast Carcinoma; Cancer of the Breast; Cancer of Breast; Malignant Tumor of Breast; Breast Tumor

Summary: nuv-422-03 is a randomized, non-comparative phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of nuv-422 in combination with fulvestrant relative to nuv-422 monotherapy and fulvestrant monotherapy. the study population is comprised of adults with hr+her2- abc. patients will self-administer nuv-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (im) on days 1 and 15 of cycle 1 and day 1 of every cycle thereafter. patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.


Eligibility criteria:
inclusion criteria: 1. men and women with diagnosis of locally advanced inoperable or metastatic hr+her2- breast cancer 2. evidence of disease progression on immediate prior therapy as determined by the investigator per standard criteria 3. patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant * prior standard of care treatments must include treatment with hormonal therapy in combination with an approved cdk4/6 inhibitor 4. patients must have endocrine-resistant disease 5. have no known active or symptomatic central nervous system (cns) disease 6. eastern cooperative oncology group performance status (ecog ps) ≤ 1 7. life expectancy of \> 6 months 8. eligible to receive fulvestrant 9. adequate bone marrow and organ function exclusion criteria: 1. have received chemotherapy, hormonal therapy (with the exception of ongoing lhrh analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of nuv-422 and fulvestrant 2. received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of \< 5 half-lives) for myelosuppressive agent prior to first dose of nuv-422 and fulvestrant 3. moderate liver impairment which would require a reduced dose of fulvestrant 4. requires medications that are known to be strong inducers and/or inhibitors of cyp3a4/5 enzymes * for phase 1b only: requires medications that are known to be moderate inducers and/or inhibitors of cyp3a4/5 enzymes 5. known allergy or hypersensitivity to fulvestrant 6. for phase 2 only: prior therapy with fulvestrant and/or investigational er targeted agent 7. females who are pregnant or breast feeding

Keywords: phase 1 phase 2 metastatic breast cancer advanced breast cancer hormone receptor positive hr+ human epidermal growth factor receptor 2 negative her2- hr+ her2- estrogen receptor positive er+ nuv-422 fulvestrant cdk cdk inhibition cdk2/4/6
the role of estrogen in the neurobiology of eating disorders

Conditions: Eating Disorders; Hypoestrogenemia

Summary: this is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. study procedures comprise behavioral, neuroimaging, and endocrine assessments.


Eligibility criteria:
inclusion criteria: * female * 14-35 years * bone age ≥13.5 years (applicable only for participants \<16 years) * clinically significant eating disorder characterized by restriction and/or excessive exercise and high drive for thinness * hypoestrogenemia: oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at \>15 years if premenarchal or low estradiol levels evaluated by the study physician * low or normal weight defined by a body mass index that is \<85th percentile for 14-18 year olds and a body mass index \<25 kg/m2 for adults exclusion criteria: * suicidal ideation where outpatient treatment is determined unsafe by study clinician * other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual periods are more likely a consequence of restrictive eating * medications that contain estrogen ± progesterone within the past 3 months * levonorgestrel-releasing intrauterine device if subject is unable to provide two to three weekly blood samples for estradiol of if estradiol levels are determined to be too high by study doctor * neurological or psychiatric disorders that may impact neural circuitry of interest * lifetime history of seizure disorder or electroconvulsive therapy * pregnancy/breastfeeding * gastrointestinal tract surgery * contraindications to estrogen use * any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk

Keywords: adolescent amenorrhea anorexia nervosa cognitive flexibility dietary restriction eating disorders estrogen excessive exercise females hypoestrogenemia reward
the impact of real time ventilation feedback on ventilation rate and tidal volume during cardiac arrest.

Conditions: Cardiac Arrest

Summary: during out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.

during cardiac arrest, patients are intubated, ventilation is performed using a manual resuscitator. hereafeter, a flowsensor is connected. during the first cycle, patients are ventilated without any feedback (whilst the sensor is recording the delivered ventilation). during the second cycle, realtime delivered flow is shown on the screen, informing the user on the delivered ventilation volume and ventilation rate. data is saved automatically after use.

Eligibility criteria:
inclusion criteria: - exclusion criteria: traumatic cardiac arrest inability to intubate patient
myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.

Conditions: System; Lupus Erythematosus

Summary: introduction. systemic lupus erythematosus is an autoimmune disease. the musculoskeletal system is affected in 90% of patients. the most common manifestations are myalgias, arthralgias and arthritis. objective. to analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus. methods. randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. the intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. the intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques. expected results. improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue.


Eligibility criteria:
inclusion criteria: * subjects over 18 years of age * with a medical diagnosis of systemic lupus erythematosus * who sign the informed consent form. exclusion criteria: * patients with fever or acute phlebitis. * patients with recent lower limb fractures * amputees and people with neurological or cognitive impairments that prevent them from correctly understanding the questionnaires and performing the guided techniques.

Keywords: systemic lupus erythematosus physiotherapy joint pain range of motion functionality balance fatigue
administration of methylprednisolone for prevention of ovarian hyper stimulation syndrome

Conditions: Ovarian Hyperstimulation Syndrome

Summary: this study is a prospective randomized clinical controlled trial to assess the efficacy of the methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (ivf) cycles.

ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. the objective of this study is to determine the effect of methylprednisolone to prevent ovarian hyper stimulation syndrome in ivf cycles. the study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. the pco subjects will be recognized based on the rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), lh/fsh\>2 and ovarian morphological evidences in doppler ultrasound. the existence of more than 20 follicles in both ovaries and e2 concentration \>4000 pg/ml will be considered as the ohss risk factors. in this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method: treatment group (case) will be administered 16 mg methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). furthermore, these patients will receive a bolus iv dose methylprednisolone, 1g on the day of egg collection and embryo transfer. patients in the control group will not receive any treatment with glucocorticoids. if each group confronts with every kind of high risk signs or symptoms, they will undergo coasting or gonadotropin withdrawal or other treatment strategies. the presence of ohss is defined in accordance with the golan 5 grade system and women who at least are at grade 2 of this classification (mild) considered as ohss cases and will experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and enlargement of ovaries(5-12cm). in moderate forms, ultrasound evidences of ascites will be observed and severe ohss accompany with clinical signs of ascites, hydrothorax, breathing disorders, hemoconcentration, coagulopathy and renal perfusion decrease.

Eligibility criteria:
inclusion criteria: * poly cystic ovarian syndrome patients * indication for ivf/icsi and long protocol ovarian stimulation * basal fsh≥10 * normal bmi (20-25) * physical health exclusion criteria: * allergy to gnrh analogues, fsh and corticosteroids * presence of heart failure, recent myocardial infarction * hypertension * diabetes mellitus * epilepsy * glaucoma * hypothyroidism * hepatic failure * osteoporosis * peptic ulceration * renal impairment * using drugs that have interaction with corticosteroids such

Keywords: ovarian hyper stimulation syndrome methylprednisolone ivf
a study to assess efficacy and safety of empasiprubart versus ivig in adults with cidp

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Summary: the main purpose of this study is to compare empasiprubart and ivig for treating people with cidp. this study consists of a part a where participants will either receive empasiprubart and a placebo resembling ivig, or ivig and a placebo resembling empasiprubart for 24 weeks (6 months). following part a, participants will enter part b in which all participants will receive empasiprubart for 96 weeks (24 months).


Eligibility criteria:
inclusion criteria: * meets criteria for cidp based on ean/pns task force cidp guidelines, second revision (2021) * has either typical cidp or 1 of the following cidp variants: motor cidp, multifocal cidp (also known as lewis-sumner syndrome), focal cidp, or distal cidp * has responded to ivig in the past 5 years * receiving treatment with ivig within a standard optimal maintenance dosing regimen, with a minimum weekly ivig dose of at least 0.125 g/kg * has residual disability and active disease exclusion criteria: * besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of cidp or puts the participant at undue risk, including polyneuropathy of other causes * meets the criteria for possible or sensory cidp based on ean/pns task force cidp guidelines, second revision (2021) * use of other long-acting immunomodulatory treatment