Kornimate/medical-research-clean huggingface dataset:
vaginal progesterone for prevention of preterm birth after an episode of preterm labor

Conditions: Preterm Birth

Summary: the investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. the investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine emg to assess the uterine muscle activity. the investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (toco), though emg is expected to provide much more information.


Eligibility criteria:
inclusion criteria: * patients with singleton pregnancies at gestational ages 25+0 to 33+6 weeks after an episode of preterm labor, with cervical length ≤25mm: * patients presenting with signs and symptoms of preterm labor will be admitted and given the standard treatment for preterm labor, i.e. tocolysis for 48 hours, and antenatal steroids. * those who will remain undelivered for 48 hours and will be found to have a cervical length of 25mm or less will be offered entrance into the study. * preterm labor will be defined as at least 4 contractions in 30 minutes with cervical change assessed by digital cervical examination. exclusion criteria: * patients with preterm premature rupture of membranes (pprom) will be excluded from the study, due to the possibility of ascending infection, as will those with suspected chorioamnionitis. * we will not include multiple pregnancies. * patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.

Keywords: preterm birth preterm labor progesterone uterine electromyography cervical length
transnasal cooling for migraine

Conditions: Migraine; Episodic Migraine; Migraine With Aura; Migraine Without Aura

Summary: this is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the coolstat transnasal thermal regulating device for acute treatment of migraine. the hypothesis is that evaporative cooling induced by the coolstat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.


Eligibility criteria:
inclusion criteria: 1. meets the international classification of headache disorders (ichd-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction). 2. patient is between 18 and 80 years of age. 3. patient experiences 2 to 8 migraine attacks per month. 4. patient is in good reported general health, with no fever (\<38.3c/101f). 5. patient has had diagnosis of migraine with or without aura over at least 1 year. 6. migraine onset before 50 years of age. 7. migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment. 8. able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack. 9. migraine pain severity of grade 2 or grade 3 on day of treatment. 10. provision of signed and dated informed consent form. 11. stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: 1. has difficulty distinguishing his or her migraine attacks from tension-type headaches 2. patient has uncontrolled hypertension. 3. patient has a fever (≥38.3c / 101f). 4. patient has used opioid medication or barbiturates in the past month. 5. patient has medication overuse headache (moh), new daily persistent headache (ndph) or chronic tension type headache (ctth). 6. patient has 15 or more headache days per month. 7. patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (otc) medications, prescription medications, or medical device). 8. patient has received botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks. 9. intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable. 10. recurrent epistaxis or chronic rhinosinusitis. 11. recent facial trauma, sinus or intranasal surgery within the last 4 months. 12. known or suspected pregnancy. 13. unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
bupropion & cardio birth defect (slone)

Conditions: Depressive Disorder

Summary: bupropion is a unique drug that is used both to treat depression and as an aid in smoking cessation. in 2008, the final report from the bupropion pregnancy registry described 24 congenital malformations among the 675 women exposed to bupropion in the first trimester of pregnancy. of these, 9 had congenital heart disease of varying severity, including a number of infants with ventricular septal defects (vsds); of note, 2 of these 9 had coarctation of the aorta. more recently, alwan et al, in an analysis of data from the centers for disease control and prevention's case-control national birth defects prevention study, reported an increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that includes coarctation of the aorta and hypoplastic left heart syndrome. data from the slone epidemiology center birth defects study will be used to test these observations. the outcomes of primary interest will include those hypothesized to be associated with bupropion in recent studies: left outflow tract defects considered as a group. coarctation of the aorta and hypoplastic left heart syndrome will also be examined separately. all infants with congenital heart defects are further classified into subgroups that are embryologically meaningful, including left outflow tract defects. in secondary analyses, other heart defect classes for which there are adequate numbers of cases will be evaluated.


Eligibility criteria:
inclusion criteria: * subjects with congenital heart defects who are born within the catchment areas of the 4 study centers * a sample of nonmalformed infants born at participating hospitals * subjects who were interviewed in 1992 or later * women who complete the study interview within 6 months of the infant's birth exclusion criteria: * infants with chromosomal anomalies

Keywords: first trimester left outflow tract obstruction bupropion cardiovascular malformation antidepressants pregnancy cardiovascular defect congenital malformation
ninlaro capsules drug use-results survey (all-case surveillance) "relapsed/refractory multiple myeloma"

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety of ninlaro in participants with relapsed/refractory multiple myeloma in daily clinical practice.

the drug being tested in this study is called ixazomib (ninlaro). ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. this study will look at the safety of ninlaro in participants with relapsed/refractory multiple myeloma in daily clinical practice. the study will enroll approximately 480 patients. • ixazomib 4 mg this multi-center trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: * all patients who have been confirmed as administration of the drug. exclusion criteria: * none
efficacy of [18f]psma-1007 pet/ct in patients with biochemial recurrent prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Recurrent

Summary: this study evaluates the diagnostic performance and safety of \[18f\]psma-1007 pet/ct imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


Eligibility criteria:
inclusion criteria: * male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy * suspicion of recurrence or persistence * after radiotherapy or cryotherapy: 3 consecutive psa rises and/or psa rise by 2.0 ng/ml or more above nadir (astro-phoenix) * after prostatectomy, psa \> 0.2 ng/ml on 2 or more determinations (recurrence), or failure of psa to fall to undetectable levels post-prostatectomy (persistence) (american urological association) * for patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment. * life expectancy of 6 months or more as judged by the investigator * willing and able to undergo all study procedures * informed consent in writing exclusion criteria: * age: less than18 years * contraindications to any of the ingredients of \[18f\]psma-1007 * close affiliation with the investigational site * at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial * having been previously enrolled in this clinical trial * mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial * being clinically unstable or requiring emergency treatment * patients who are unwilling to consider a biopsy if clinically recommended * patients who are unable to undergo a pet/ct scan * patients for whom systemic therapy is the most likely course regardless of pet findings.
oesophageal pacing to check left atrial posterior wall isolation

Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation Ablation

Summary: patients undergoing hybrid af ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. this is done via a standard electrophysiogical study in accordance with routine clinical practice. investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study

oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. if the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid af ablation would be unnecessary. this would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.

Eligibility criteria:
inclusion criteria: • subjects capable of giving informed consent, * male or female * aged between 18 and 80 years * undergoing ablation under general anaesthetic with planned isolation of the left atrial posterior wall or who have previously undergone either catheter or surgical ablation for af with la posterior wall isolation exclusion criteria: * unable or willing to give fully informed written consent * turned down for general anaesthetic * pregnancy * terminal illness * any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.

Keywords: oesophageal pacing hybrid ablation persistent atrial fibrillation
a new surgical instrument in treatment of conlylar fracture: condylar reductor

Conditions: Mandibular Fracture

Summary: in condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

in this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from january 2014 to june 2016. patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. the primary outcome variable was reduction time and reduction rate. the continuity correction x2 and test student t test were used.

Eligibility criteria:
inclusion criteria: * patients aged 18-60 with mandibular condylar fractures were treated in oral and maxillofacial surgery department, west china hospital of stomatology, china from january 2014 to january 2016. exclusion criteria: * patients refused to participate in the clinical trial; * condylar fracture dislocation was not obvious, conservative treatment can be used; * mandibular condylar comminuted fracture; * mandibular condyle need to be reconstructed.
treatment of basal cell carcinomas with methyl aminolevulinate and daylight

Conditions: Photodynamic Therapy; Basal Cell Carcinomas

Summary: photodynamic therapy (pdt) is an effective treatment of basal cell carcinomas (bcc) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. the objective of this study is to evaluate the effect of daylight-mediated pdt of bcc.


Eligibility criteria:
inclusion criteria: * superficial bcc exclusion criteria: * immunosuppression
comparison of nn5401 versus biphasic insulin aspart 30 on a twice daily regimen in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to nn5401 (siac, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks) * hba1c below 10.0% * body mass index (bmi) \< 30.0 kg/m\^2 exclusion criteria: * known hypoglycaemia unawareness or recurrent major hypoglycaemia * current treatment with total insulin dose of more than 100 u or iu/day * current treatment or expected to start treatment with systemic corticosteroid * treatment with oral anti-diabetic drugs (oads: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: tzd\]) within the last 12 weeks prior to screening
new biomarkers of neurological outcome after a sudden cardiac death

Conditions: Cardiac Sudden Death; Hypoxia Brain; Cell Membrane Microparticles; Biomarkers

Summary: the aim of the project is to establish the value of circulating microparticles as a new biomarker for neurological prognosis of patients recovered from sudden cardiac death who remain comatose.

this is a pilot study. analytical, observational, longitudinal, retrospective and prospective, non-randomized. patients recovered from sudden cardiac death of ischemic cause and remain comatose will be included in the protocol if they fit the pre-specified inclusion criteria. biological samples will be collected (at admission, at 24 and 72 hours) and stored in the biobank of hospital de la santa creu i sant pau for further analysis. in addition demographic, clinical and analytical variables will be collected. at the end of the recruitment period, we will analyse the concentrations of circulating microparticles according to iccc-iibsantpau methodology in the samples obtained. the primary outcome variable will be the neurological status at coronary care unit discharge and at 6 months. the objective of the study will evaluate the relationship between the neurological status and the blood concentrations of circulating microparticles.

Eligibility criteria:
inclusion criteria: * over 18 years old. * patients recovered from a sudden cardiac death (in-hospital and out-of-hospital) with return of spontaneous circulation (rosc) (defined as systolic blood pressure \> 60 mmhg or palpable pulse for \> 5 minutes) who remain unconsciousness (defined as a score on the glasgow coma scale \ 5-10 minutes after rosc. * treated with hypothermia as recommended by the european guidelines for resuscitation ( 2010).. exclusion criteria: * non-cardiac sudden death. * active oncologic pathology . * traumatic or spontaneous intra-cranial haemorrhage. * inability to obtain required blood samples or refusal of the informed consent necessary for it.

Keywords: cardiac sudden death hypoxia brain biomarkers cell-derived microparticles
can 3d ultrasound be used as an alternative to mri to assess myometrial invasion in endometrial cancer?

Conditions: Endometrial Cancer; Endometrial Neoplasms; Endometrial Hyperplasia

Summary: aim: assess the diagnostic accuracy of 3d ultrasound, compared to mri and final histology with respect to myometrial invasion of endometrial cancer. this study will assess whether 3d ultrasound is accurate at predicting myometrial invasion aqnd lymph node metastasis of endometrial cancer. all patients will receive routine standard of care (mri). the results of the 3d ultrasound will be compared to the mri report and final histology.

aim: assess the diagnostic accuracy of 3d ultrasound, compared to mri and final histology with respect to myometrial invasion of endometrial cancer. background: when a diagnosis of endometrial cancer is confirmed on biopsy, women get staged to assess the level of spread. current gold standard is an mri. a proportion of women, are unable to undergo or complete an mri scan due to their morbid obesity or claustrophobia. to this end, many have assessed the role of ultrasound in staging endometrial cancer as a cheaper and easier alternative to an mri. in the last 20 years there has been a rise in the use of 3d ultrasound as it has become commercially available. there is, however a paucity of data on the role of 3d ultrasound in the assessment of myometrial invasion and lymph node metastasis. this research project will assess whether 3d ultrasound is a safe, effective alternative to mri to assess the depth of spread of womb cancer. the study: all women with suspected endometrial cancer will receive a pelvic (internal) ultrasound as per routine care. in addition to the normal 2d ultrasound, women will receive a 3d ultasound and images will be saved. this adds an additional 1-2 minutes scan time. in those women with confirmed cancer on histology an mri is performed to assess stage of cancer (current routine standard of care). this will include t1, t2, dwi and contrast enhanced sequences. patients referred to hammersmith hospital from other trusts will also be able to undergo a 3d ultrasound if this was not already performed. definitive management of endometrial cancer includes a hysterectomy and the surgical specimen will be examined for depth of myometrial invasion and lymph node involved (if removed). in the meantime, the saved 3d ultrasound images will be analysed and rendered to predict the stage of the endometrial cancer and lymph node involvement. the results of 3d ultrasound, and mri will be compared against the stage found on the gold standard test (on histological examination).

Eligibility criteria:
inclusion criteria: all women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer. exclusion criteria: anyone lacking capacity. \<18years old. pregnant.

Keywords: endometrial cancer staging 3 dimensional ultrasound myometrial invasion
clinical effect of reflexology and homeopathy added to conventional asthma management

Conditions: Asthma

Summary: there is a lack of scientific evidence that homeopathy and reflexology is effective treatment of asthma. systematic reviews have found that many clinical trials testing homeopathy and reflexology have major flaws, such as small number of participants, lack of control groups or inadequate allocation concealment. the aim of the present study was to assess the effect of reflexology and individualised homeopathy as an adjuvant treatment in asthma. in order to address this issue, the investigators conducted an investigator-blinded, randomized, controlled parallel group study.


Eligibility criteria:
inclusion criteria: * forced expiratory volume in 1 second (fev1) ≥60% predicted * a history of bronchial asthma for minimum 6 months prior to baseline * an objective measure of abnormal variation in bronchial calibre(the objective measure were defined as at least one of the following) 1. a positive bronchodilator reversibility test, defined as increase in fev1≥10% after 400 µg inhaled salbutamol; 2. a positive methacholine test, defined as a pd20 of \<1000 μg; 3. a positive test for exercise induced asthma defined as a fall in fev1\>15% after a standardised 6 min exercise test; and 4. a positive peak expiratory flow (pef) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening pef of \>20% during a 2-week period. exclusion criteria: * hospitalization for asthma within 3 months, * asthma exacerbation during the last month, * changes in asthma medication within 30 days of screening * a smoking history \> 10 pack-years and smoking within the last year.

Keywords: complementary and alternative medicine reflexology homeopathy asthma randomized controlled trial
adapting the penny chatbot for perinatal oud patients: copilot

Conditions: Perinatal Opioid Use Disorder; Opioid Use Disorder

Summary: to address both loneliness and engagement in perinatal and oud care among perinatal women, the investigators plan to adapt an existing texting support chatbot, penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with oud. the newly adapted chatbot, penny copilot, will allow for two way short message service (sms) messaging to respond appropriately and accurately to user generated input. the investigative team, in collaboration with the penn mixed methods research lab (mmrl) and penn's way 2 health team, will use intervention mapping guided by the consolidated framework for implementation science. the investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted penny copilot in a sample of 20 perinatal women with oud to evaluate acceptability, feasibility, and patient satisfaction. the goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and oud care and decrease perceived loneliness.


Eligibility criteria:
inclusion criteria: * biological females who are currently pregnant or within 6 weeks postpartum. * able to read, write, and speak english at a 6th grade level. * diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder. * receiving prenatal care and oud care at a penn affiliated hospital. exclusion criteria: -current untreated psychosis, mania, or active suicidality as assessed by the mini international neuropsychiatric interview (mini).

Keywords: maternal health maternal substance use perinatal oud chatbot mhealth interventions loneliness