Kornimate/medical-research-clean huggingface dataset:
does placebo information affect the trial outcomes and participant blinding?

Conditions: Muscle Soreness

Summary: this is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial.

a total of 89 healthy volunteers will be recruited and randomly allocated to one of the 4 groups at an identical ratio. four groups differ in acupuncture and placebo information. it is summarized as follows: 1. to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent 2. to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent 3. to receive sham acupuncture (park sham needle) and to read fully disclosed sham acupuncture information written in the informed consent 4. to receive sham acupuncture to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent. they will read informed consent with differently described placebo information following their allocation. after participants repeatedly lift a dumbbell with their non-dominant arm to induce delayed onset muscle soreness (doms) in their biceps brachii, they are given allocated acupuncture treatment once a day for three consecutive days including the very first visit to compare outcomes (i.e., relief of doms measured with pressure pain threshold and visual analogue scale) and blinding property (the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know options).

Eligibility criteria:
inclusion criteria: * age over 18 * not participating in other studies at the time of study participation * voluntary participation exclusion criteria: * resistance training for more than 6 months * experience of fracture of any of four limbs * pregnancy or breast-feeding at the time of study participation * analgesics within 24 hours before participation * any other diseases or conditions that might prevent the participant from receiving acupuncture

Keywords: placebo informed consent participant information leaflet outcome blinding sham acupuncture delayed onset muscle soreness
speech analysis as a diagnostic tool for mild traumatic brain injury

Conditions: Concussion

Summary: the waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. the aim of this study is to investigate this possibility using the cobweb automated application system for acoustic processing.

concussions affect cognitive and fine muscle motor control, and these changes will be reflected in the acoustic characteristics of the vowels being produced. the methods to identify and analyze the acoustics of vowels will greatly extend the detailed understanding of vowels produced after a concussion. the identification of the changes in formant frequencies, pitch, and duration will provide the means to use these parameters as an automated diagnostic tool. the waveform assessment of the athlete's speech production has a high probability of showing brain abnormalities immediately after a suspected or diagnosed concussion at the venue of the athletic sport. the aim of this study assessment is to investigate this possibility using the cobweb system and greatly enhance the ability to diagnose a concussion in a timely manner to remove the athlete from practice or play.

Eligibility criteria:
inclusion criteria: * all patients diagnosed or suspected of having a sports concussion seen in a clinical setting * ages 6 -21 exclusion criteria: * patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed. * patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials. * non-native speakers who cannot read the materials or produce the stimuli consistently. * patients who cannot read the materials or produce the stimuli consistently due to their age.

Keywords: concussion, athlete, speech analysis
dexmedetomidine or dexmedetomidine combined with dexamethasone on postoperative nausea and vomiting in breast cancer

Conditions: Postoperative Nausea and Vomiting

Summary: previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (ponv). dexamethason also had been commonly used for ajuvant drugs for preventing and reducing ponv. so investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing ponv.

previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (ponv). dexamethason also had been commonly used for ajuvant drugs for preventing and reducing ponv. so investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing ponv.

Eligibility criteria:
inclusion criteria: * asa physical status i or ii female scheduled for breast conserving surgery of modified radical mastectomy. exclusion criteria: * uncontrolled cardiovascular disease * history of chronic pain * smoker * previous history of steroid administraion * neoajuvant chemotherapy
the impact of vaginal intercourse on pregnancy rates after frozen embryo transfer

Conditions: Infertility; Pregnancy Related; IVF

Summary: this study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).

given the overwhelming evidence suggesting beneficial effect of seminal plasma on embryo implantation, we sought to explore this benefits in in vitro fertilization treatments by limiting the study cohort to those having frozen embryo transfer with programmed hormone replacement for endometrial preparation and some form of parenteral progesterone supplementation. this design will enable us to overcome the concerns and limitations of all previous studies. in this study, patients will be randomized into two groups, group 1 will have their frozen embryo transfer followed by current standard of care (no unprotected vaginal intercourse until pregnancy test) and group 2 will have their frozen embryo transfer followed by unlimited unprotected vaginal intercourse starting 24 hours after transfer. the primary endpoint of the study will be ongoing clinical pregnancy rates in the two groups while secondary endpoints will include implantation, positive pregnancy, miscarriage and live birth rates. overall, this study aims to investigate whether the elimination of current universal pelvic rest protocol in patients undergoing frozen embryo transfer will help optimize pregnancy outcomes. this study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).

Eligibility criteria:
inclusion criteria: * female fertility patients having frozen embryo transfer * programmed hormone replacement (oral estrace, vivelle dot (patch), intravenous estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular progesterone) for luteal support exclusion criteria: * unable to provide informed consent * not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer) * undergoing fresh embryo transfer * not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction) * cannot undergo unprotected vaginal intercourse (infected with hepatitis b, c, or human immunodeficiency virus).
a research study of how teens with and without an anxiety disorder make decisions

Conditions: Anxiety Disorders; Separation Anxiety Disorder; Phobic Disorders

Summary: the purpose of this trial is to study how teens with and without an anxiety disorder make decisions. this is a brain imaging study using functional magnetic resonance imaging (fmri) in adolescents between the ages of 13 and 17.

preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. however, behavioral ratings of certainty during the task showed differences between groups. anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p \< .05). this difference was consistent with the study hypothesis. within-subjects analyses of the decision-making tasks showed that subjects responded as expected. reaction times (rt) during uncertain conditions of the hilo-game were significantly longer than during more certain conditions (p = .001). diary task rts for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). preliminary analyses showed a significant correlation between intolerance of uncertainty (iu) and rt during the marble task (r = -0.54, p \< .05). preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and iu, is, masc and the child version of the scared. these preliminary results were not submitted for publication.

Eligibility criteria:
inclusion criteria: * must meet diagnostic criteria for generalized anxiety disorder, separation anxiety disorder or social phobia, or must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls) * sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history exclusion criteria: * having any major medical conditions that may interfere with interpretation of results or be associated with risk in an mri environment (history of metal implants, or contraindications to mri scanning for research purposes, including pregnancy) * current evidence of autism, major depression, substance abuse, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, tic disorders, significant suicidality, lifetime history of psychosis or mania. * estimated full-scale iq below 80 * inability or unwillingness to remain still during scanning * inability or unwillingness to provide assent * absence of signed consent by parent or legal guardian * current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing department of social services (dss) involvement

Keywords: anxiety adolescence generalized anxiety disorder
use of ziv aflibercept in different retinal diseases

Conditions: Central Retinal Vein Occlusion With Macular Edema

Summary: a prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (cnv) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(crvo) after approval of the ethical committee of the faculty of medicine, tanta university . all procedures were carried out under the tenets of the helsinki declaration. written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic cvn,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic crvo .thorough ophthalmic evaluation was done including bcva(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and oct(optical coherence tomography) were performed for all patients .injection was repeated as prn(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.

Eligibility criteria:
inclusion criteria: * the study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal cnv less than 2 months documented by fundus fluorescein angiography (ffa)and optical coherence tomography (oct ) , pathological myopia more than 6 d was included . exclusion criteria: * previous intraocular surgery . * coincident retinal pathology as diabetic retinopathy, retinal vein occlusion . * cnv due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis. * extrafoveal myopic cnv . * patients received other lines of treatment for cnv like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti vegf(vascular endothelial growth factor) agents. * known glaucoma , clinical suspicion of glaucoma or iop(intraocular pressure) more than 20 mmhg. * prior ocular inflammation. * the presence of retinal degeneration. * patients who didnot complete 6 months of follow up

Keywords: myopic choroidal neovascularisation
the effect of anticoagulation in cirrhotic patients with portal vein thrombosis：a multicenter rct

Conditions: Portal Vein Thrombosis; Liver Cirrhosis

Summary: the purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.

the treatment of cirrhotic patients with pvt (portal vein thrombosis) is clearly recommended in guideline now. several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with pvt.the present studies are most observation studies with small sample size and low quality. the investigators need more high-quality research such as randomized controlled trials. this is a zelen-designed multicenter randomized controlled trial. patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator will make sure wether their are fond of the group and make decision by themselves. the recanalization rate and complications will be analyzed

Eligibility criteria:
inclusion criteria: * age between 18-70 years old; * a clinical, radiological or histologic diagnosis of liver cirrhosis and portal hypertension; * diagnosed of portal vein thrombosis; * capable of understanding the purpose and risks of the study and informed consent to participate in the study; * have undergone endoscopy to prevent variceal rebleeding. exclusion criteria: * age \ 70 years; * portal vein thrombosis diagnosed before 6 months; * patients with signs of acute pvt such as fever，abdominal pain or intestinal obstruction，who should be treated immediately; * pregnant or nursing; * hepatocellular carcinoma or other cancer; * severe cardiopulmonary diseases or concomitant renal insufficiency; * cavernous transformation of the portal vein; * contradictions to endoscopy; * contradictions to anticoagulation,such as:allergy to lmwh or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count \< 50 x10\^9/l); * taking immunosuppressive agent; * coagulation disorders other than the liver disease related; * variceal bleeding failed to control.

Keywords: anticoagulation
safety and efficacy of stent deployment for intracranial aneurysms (sesia)

Conditions: Treatment Outcome by Stent-assisted Embolization

Summary: intracranial aneurysms (ia) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (sah). the mortality and morbidity account for 22% to 25% in cerebrovascular disease. more than half of the ruptured ia survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. endovascular embolization is one of the main treatment ways of ia.however,there are no studies on the multicenter cases of stent selection strategy at home and abroad.therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of ia.the investigators also study the relationship between cyclin dependent kinase inhibitor 2b antisense rna 1 gene（cdkn2bas1 gene）of ia patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of ia patients, providing theory gist for interventional therapy of complex ia and simplying slection of stent.

studies showed 3.6% - 6% for the incidence and 1% - 2% for the ruptctued rate of ia.the mortality and morbidity account for 22% to 25% in cerebrovascular disease ,which is a growing trend. ia is one of the major diseases which relate with people's living standards. endovascular embolization is one of the main treatments of ia with less invasive, better cure rates and higher safety. it has been developed rapidly and improve quality of patients' lives after treatmen.with the rapid development of neural intervention and the proliferation of specialized stents in ia, stent-assisted embolization technique is becoming more and more common .especially, stents play an important role in intracranial aneurysmal aneurysm. there are many kinds intracranial stents for clinical surgery, but how to choose the appropriate stent type is one of the key issues that clinicians need to settle. and, there is no relevant multicenter cases study about selection strategy of intracranial stent at home and abroad.

Eligibility criteria:
inclusion criteria: * subject has intracranial aneurysms confirmed by ct arteriography (cta) or magnetic resonance angiography (mra) or digital subtraction angiography(dsa) * subject has accepted stent - assisted embolization or flow-diversion treatment of intracranial aneurysm exclusion criteria: * subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm) * subject has received previous surgical clipping or endovascular treatment * subject has no intracranial aneurysms by dsa * subject with poor image quality * subject cannot use stent because of the small parent artery * subject do not need to use stent because of narrow-neck aneurysm * history of aneurysm

Keywords: treatment outcome
noninvasive monitoring of cerebral blood flow autoregulation

Conditions: Intracranial Pressure Increase; Cerebral Edema

Summary: rheoencephalography (reg) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. this protocol will study clinical and technical conditions required to use reg. additionally, our goal is to study noninvasive peripheral bioimpedance pulse waveforms in order to substitute invasive sap. a previous study demonstrated that reg can be used to detect spreading depolarization (sd), the early sign of brain metabolic disturbance. sd can be measured invasively with dc eeg amplifiers only. our goal is to create an automatic notification function for reg monitoring indicating change of clinical conditions.

neuromonitoring of patients with severe neurological illness are detailed elsewhere. in the setting of cerebral edema, icp monitoring is a staple of neurocritical care. pressure ar is an important hemodynamic mechanism that protects the brain against inappropriate fluctuations in cbf in the face of changing cpp. both static and dynamic ar have been monitored in neurocritical care to aid prognostication and contribute to individualizing optimal cpp targets in patients. theoretically, failure of cerebral ar is associated with poor outcomes in various acute neurological diseases. continuous bedside monitoring of autoregulation is now feasible and should be considered as a part of multimodality monitoring including measurement of pressure reactivity. a previous study documented that reg (regx) and icp (prx) has high correlation in order to detect the lower limit of cbf ar. the fundamental relationships between sap, vessel tone, cerebral blood volume and icp form the basis for the pressure reactivity index (prx). prx is analogous to other time domain ar indices and is calculated as the continuous correlation between thirty consecutive time-averaged (10 s) sap and icp values. a positive index (positive correlation) implies impaired passive cbf ar, while a negative index (inverse correlation) implies intact, active ar. the utility and feasibility of reg as a monitoring modality is previously demonstrated and validated as a reflection of cerebrovascular reactivity. the bioimpedance amplifier was used previously at walter reed army institute of research (wrair) and naval medical research center (silver spring, md); and has an fda safety clearance. it is expected that reg can predict evolving vasospasm and expanding intracranial bleeding amongst several other clinical applications.

Eligibility criteria:
inclusion criteria: * intact fronto-temporal area * intact lower arm area * clinical suspicion of elevated intracranial pressure exclusion criteria: * n/a

Keywords: neuromonitoring intracranial pressure (icp) cerebral blood flow autoregulation rheoencephalography (reg) noninvasive neuromonitoring cerebral edema autoregulation cerebral perfusion pressure pressure reactivity index