Kornimate/medical-research-clean huggingface dataset:
algorithm guided treatment strategies for major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to compare treatment outcomes between measurement based algorithm guided treatment and treatment as usual strategies in a chinese population with major depressive disorder.

the agt arm includes a 2-step medication monotherapy and a combination treatment algorithm. the first step (level 1) includes two medication monotherapy options: escitalopram and mirtazapine. for those participants who don't remit with the initial intervention after up to 6 to 12-week treatment, the second step (level 2) with a variety of treatment options will be provided. in level 2 intervention, a switch strategy for those who don't remit with escitalopram will be switched to mirtazapine, or for those who don't remit with mirtazapine will be switched to escitalopram, combination strategy (i.e. escitalopram plus mirtazapine) and augmentation strategy (i.e. escitalopram or mirtazapine plus either rtms or mect). participants who don't get remission in level 1 intervention will be encouraged to enter level 2 interventions based on intend-to-treatment principle. the tau arm as control intervention is performed using the psychiatrist's individual discretion based on his/her expertise and knowledge. participants will be recruited consecutively in 8 psychiatric settings across china and randomized into any of the two initial interventions of agt or tau arm. follow-up interviews will be performed monthly for all participants who finish any acute treatment of agt or tau. the follow-up period will last up to 6 months.

Eligibility criteria:
inclusion criteria: * meets diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for single or recurrent nonpsychotic major depressive disorder * age 18-75 * written informed consent completed * scores 14 or higher on the 17-item hamilton depression rating scale * initial treatment with escitalopram or mirtazapine or other antidepressants is clinically appropriate exclusion criteria: * history of bipolar disorder * concurring psychotic disorders * scores 3 or higher on item 3 (suicidal) of hrsd-17 * history of nonresponse to an adequate trial of escitalopram and/or mirtazapine * has general medical condition, which contraindicates any leve 1 or 2 treatment option * is on concomitant medication, which contraindicates any leve 1 or 2 treatment option * any contraindication for mect or rtms * is pregnant or breast feeding or is planning to get pregnant

Keywords: major depressive disorder algorithm guided treatment treatment as usual escitalopram mirtazapine transcranial magnetic stimulation (rtms) modified electroconvulsive therapy (mect) remission relapse quality of life
computed optical margin assessment for breast cancer surgery, phase i (part a)

Conditions: Breast Cancer

Summary: this multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. the study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.


Eligibility criteria:
inclusion criteria: 1. women 18 years of age or older 2. signed informed consent form 3. women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure exclusion criteria: 1. multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. neoadjuvant systemic therapy 3. all t4 tumors 4. previous radiation in the operated breast 5. prior surgical procedure in the same quadrant 6. implants in the operated breast 7. pregnancy 8. lactation 9. participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Keywords: lumpectomy breast cancer optical coherence tomography tumor margin imaging
screening protocol for children and adolescents with bipolar and bipolar spectrum disorder

Conditions: Pediatric Bipolar Disorder

Summary: the objective of this protocol is to establish a comprehensive screening process for the evaluation of eligibility for entry in a clinical trial program for children and adolescents with bipolar disorder.

to address the urgent therapeutic needs of children and adolescents ages 4-17 with pediatric bipolar disorder, we have designed a series of clinical trials aimed at evaluating critical components of the treatment needs of this under-served and under-researched population. this approach will allow us to provide a full complement of clinical trials that will meet the most pressing needs of the bipolar children and adolescents and their families who are currently awaiting treatment. although these protocols have received prior irb approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. this state of affairs makes it very difficult to ask subjects to sign a specific clinical protocol without obtaining additional clinical information. because of this we are proposing potential subjects to consent to undergo an in-depth clinical assessment that will allow subjects to be screened by a clinician for eligibility to a diverse clinical trials program available to them.

Eligibility criteria:
inclusion criteria: * males and females age 4 to 17 inclusive with a suspected diagnosis of bipolar disorder. * subject and parent/ legal guardian must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * subjects and their parent/ legal representative must be considered reliable. * each subject and his/her parent or authorized legal representative must understand the nature of the study. the subject's parent or authorized legal representative must sign an informed consent document and the subject must sign an informed assent document. * one parent/ legal guardian must be able to accompany the subject to the clinic at each visit. exclusion criteria: * investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. * serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease * mental retardation

Keywords: pediatric bipolar disorder
delayed start to ovarian stimulation

Conditions: Diminished Ovarian Reserve; Infertility; In Vitro Fertilization

Summary: in couples with infertility secondary to diminished ovarian reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an gnrh antagonist (ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.

over the past two decades, the success rate of assisted reproductive technology (art) has dramatically increased. this increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. for example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. others have suggested minimal stimulation improves in vitro fertilization (ivf) outcomes. the investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. the investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. no published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. however, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms: i. the partial suppression of fsh will allow for further recruitment of early antral follicles. ii. the partial suppression of fsh will allow for further fsh responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.

Eligibility criteria:
inclusion criteria: * antral follicle count (afc) less than or equal to 4 as measured by transvaginal ultrasound (tvus), or * cancellation of a prior ivf cycle due to poor ovarian response. * patients will receive an antagonist stimulation protocol for ivf, or ivf with intracytoplasmic sperm injection (icsi). exclusion criteria: * severe male factor infertility requiring surgical intervention to obtain sperm * major uterine abnormality, * preimplantation genetic diagnostic (pgd) testing, * planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles).

Keywords: dor infertility ivf art gnrha gnrh antagonist protocol ganirelix
an open-label study of ym155 + docetaxel in subjects with advanced hormone refractory prostate cancer and other solid tumors

Conditions: Prostate Cancer; Tumors

Summary: to determine the feasibility and safety of administering ym155 in combination with docetaxel

this clinical trial is designed to include two parts: part 1: assessment of feasibility and safety of administering ym155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (hrpc) \[ enrollment completed \] part 2: assessment of feasibility and safety of administering ym155 in combination with docetaxel in subjects with solid tumors (except hrpc). this registration has been updated to reflect the design requirements of part 2.

Eligibility criteria:
inclusion criteria: part 1: * male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease. part 2: * subjects with histologically and cytologically confirmed solid tumors with measurable disease (except hrpc). exclusion criteria: * radiation therapy within 4 weeks of the start of study drug

Keywords: prostate cancer hrpc hormone refractory prostate cancer ym155 treatment outcome solid tumors
migraine with aura inducing characteristics and effects on the cerebral arteries and blood flow by hypoxia

Conditions: Headache; Migraine; Aura

Summary: in this study the investigators will investigate the following hypothesis * that hypoxia induce migraine headache and migraine aura * the aura phase is associated with a spreading reduction in cerebral blood flow * the migraine headache is associated with dilatation of intra- and extracerebral arteries * the migraine headache is associated with changes in brain metabolism * the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.

to investigate migraine with aura symptoms during and after hypoxia. with magnetic resonance imaging the investigators will investigate changes in * regional cerebral blood flow (rcbf) * resting state functional connectivity * circumference of the middle cerebral artery(mca), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery * brain metabolism and compare these changes with a aged match healthy control group.

Eligibility criteria:
inclusion criteria: migraine with aura patients and helthy volunteers as controls: * aged 18-40 * 50-100 kg exclusion criteria: * tension type headache more than 5 days/month * other primary headaches * daily medication except contraceptives * drug taken within 4 times the halflife for the specific drug except contraceptives * pregnant or lactating women * headache or migraine attack within the last 48 hours before start of trial * hypertension * hypotension * respiratory or cardiac disease * smoking extra exclusion criteria for healthy volunteers: * migraine at present or earlier in life * parents, sibling or children who suffer or have suffered from migraine

Keywords: headache migraine aura cerebral hemodynamics
u-act-after: an observational study on long-term efficacy of tight control roactemra/actemra (tocilizumab) and/or methotrexate in patients with early rheumatoid arthritis who have participated in the u-act-early study (ml22497)

Conditions: Rheumatoid Arthritis

Summary: this non-interventional, observational, open-label multi-center follow-up study of patients from the u-act-early trial (ml22497) will evaluate the long-term efficacy and safety of starting tight control treatment with roactemra/actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.


Eligibility criteria:
inclusion criteria: * patients must have participated in the u-act-early trial (ml22497); these are adult patients (\> 20 years of age) with rheumatoid arthritis. * patients must be willing to give written informed consent exclusion criteria: * patients who did not participate in the u-act-early trial * patients who are drop-outs in the u-act-early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators
bowel urgency in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. in the field of inflammatory bowel disease (ibd) (including crohn's disease (cd) and ulcerative colitis (uc)), bowel urgency is part of the top five research priorities for future ibd nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with uc. a meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. definition of bowel urgency was heterogeneous as 14 different definitions were identified. in most of these studies, non-validated questionnaires were used. they are based on subjective responses of the patients, and they could determine evaluation bias. these data emphasize the lack of standardization in bowel urgency assessment.


Eligibility criteria:
inclusion criteria: * male or female, aged at least 18 years old * diagnosis of inflammatory bowel disease according to the european crohn´s and colitis organisation criteria for at least 3 months * person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data * person affiliated to or beneficiary of a social security plan exclusion criteria: * person unable to comply with study procedures

Keywords: bowel urgency urgent index ibd unrs (urgency numeric rating scale) gve (global visual evaluation)
third ventriculostomy versus shunt for children with hydrocephalus

Conditions: Communicating Hydrocephalus

Summary: ventriculoperitoneal shunts are the standard of care for patients with communicating hydrocephalus, but they have a high failure rate - up to 40% fail within 1 year and 50% fail within 2 years. it has long been assumed that endoscopic third ventriculostomy (etv) would not work in this population and is better suited to patients with obstructive hydrocephalus (such as from a tumor blocking cerebral-spinal fluid (csf) pathways). however, as scientists learn more about csf and the way our brains absorb this fluid, they have learned that this may not be so straight-forward. recent small studies have shown that etvs can work in a good percentage of children with communicating hydrocephalus, too. but no randomized controlled trials have been done to compare these two treatments directly to determine which will provide children with a better prognosis, fewer surgeries over their lifetime, less time in the hospital and the greatest chance at as normal a life as possible. the investigators will conduct a trial to compare these two surgical treatments where patients will be randomized to receive either a shunt or an etv. because etv has been shown to have a high failure rate in newborns, the investigators will not include these patients and instead will study patients who come to duke university with communicating hydrocephalus between the ages of 1 year and 18 years. the study will include patients with ventricular shunts who are in need of revision and patients who were just diagnosed and need their first shunt. all patients who agree to participate will be randomized to receive either an etv or a shunt. the study team will follow them for one year from the time of the surgery and will determine what percentage of patients require further csf-related surgeries, how long they go after their surgery before they need another surgery, how much time they spend in the hospital and what percentage of patients suffer csf-infections or other problems related to the surgery or their hydrocephalus. the study team will examine these results and determine if etv is a safer or more effective treatment for children with communicating hydrocephalus than is a ventricular shunt.


Eligibility criteria:
inclusion criteria: * children age 1-18 years * patients with communicating hydrocephalus who present in need of csf diversion surgery, as diagnosed by radiographic imaging (ct or mri of brain) as well as clinical signs or symptoms of increased intracranial pressure * informed consent according to institutional guidelines must be obtained from each patient's parent or legal guardian, or by the patient him/herself if he/she is 18 years of age exclusion criteria: * an active central nervous system malignancy (cancer) * the presence of two or more current ventricular catheters indicating that the ventricles do not communicate with each other * the inability of the parent/guardian or patient to provide informed consent

Keywords: hydrocephalus pediatric ventricular shunt ventriculoperitoneal shunt third ventriculostomy randomized controlled trial
non motors aspects in de novo parkinson's disease

Conditions: Parkinson Disease; Apathy

Summary: clinical description and pathophysiological study of recently diagnosed untreated patients with parkinson's disease. effect of a dopamine agonist (rotigotine) on apathy in de novo patients with parkinson disease: a controlled, randomized, double blind study.

this study aims to show the impact of a treatment with a d2/d3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo parkinson's disease. the study consists of three parts: 1. the first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. the objective is to describe patients with and without apathy and hypo-dopaminergic syndrome. 2. from this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (pet). 3. in patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study. we hypothesize a significant improvement of apathy in the rotigotine group versus placebo

Eligibility criteria:
inclusion criteria: * patients with parkinson disease without treatment for parkinson disease * recent diagnosis (\< 2 years) * without cognitive troubles exclusion criteria: * patients with cognitive troubles * treated patients with l-dopa or dopamine agonists * other severe illness * pregnant or parturient woman
the impact of acupuncture on the success rates of ivf (in vitro fertilisation) treatments

Conditions: Infertility

Summary: the trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing ivf treatment.

failing to conceive naturally poses significant stress to the infertile couple. it creates a feeling of failure and frustration. it has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body. the popularity of acupuncture is increasing. a significant proportion of couples having fertility treatment, especially ivf (in-vitro fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians. the effectiveness of acupuncture on ivf has been extensively researched; however the results are varied and not conclusive. this is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. as a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding ivf success rates and whether it should be offered to women undergoing ivf.

Eligibility criteria:
inclusion criteria: * women under the age of 43 years with a bmi of less than 30 undergoing 1st or no more than their 2nd failed fresh ivf or icsi cycle. exclusion criteria: * those women undergoing frozen embryo replacement cycle or receiving donor eggs, bmi \> 30 or currently having acupuncture/ any other form of cam, having contraindication to acupuncture like those with hiv, hep c will be excluded.
steroids in fulminant hepatitis a in the pediatric age group

Conditions: Fulminant Hepatic Failure

Summary: fulminant hepatic failure (fhf) in children is a potentially devastating disease. the mortality rate may reach 80-90% in the absence of liver transplantation. liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. for that, it is suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

fulminant hepatic failure (fhf) in children is a potentially devastating disease. the mortality rate may reach 80-90% in the absence of liver transplantation. fhf is the clinical manifestation of liver cell death of a critical degree with insufficient hepatocellular regeneration and characterized by coagulopathy with or without hepatic encephalopathy. liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. for that, it was suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Eligibility criteria:
inclusion criteria: the patient is diagnosed to have fhf, if he fulfilled all the following criteria: 1. evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms). 2. uncorrectable coagulopathy (6-8 hours after administration of one dose of parenteral vitamin k) with international normalized ratio (inr) \>1.5 in patients with hepatic encephalopathy, or inr\> 2.0 in patients without encephalopathy. 3. no evidence of chronic liver disease. exclusion criteria: 1. presence of absolute contra-indications to steroid therapy (as presence of an active gastrointestinal bleeding, renal failure, acute pancreatitis, active tuberculosis, uncontrolled diabetes and psychosis).