Kornimate/medical-research-clean huggingface dataset:
cetuximab in combination with paclitaxel plus cisplatin versus paclitaxel plus cisplatin alone for the first-line treatment of metastatic esophageal squamous cell carcinoma

Conditions: Esophageal Cancer, Squamous Cell; Cetuximab Effect; Chemotherapy Effect

Summary: this is an open-label, randomized, controlled trial. at the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment arm a or b in a 1:1 ratio. subjects in arm a will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (pd), as assessed by the investigator, and unacceptable toxicity. after 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either pd or unacceptable toxicity. subjects in arm b will receive the same chemotherapy regimen as arm a alone for a maximum of 6 cycles in the absence of pd and unacceptable toxicity.


Eligibility criteria:
* inclusion criteria: * signed written informed consent. * older than 18 years of age. * histologically proven squamous cell carcinoma of the esophagus. * metastatic escc, not suitable for local-regional treatment. * presence of at least 1 measurable lesion according to recist version 1.1. * ecog performance status of 0 or 1. * adequate bone marrow, haptic, renal, metabolic function. * exclusion criteria: * prior chemotherapy in the metastasis setting. * prior chemotherapy within 6 months before entering this study. * previous exposure to egfr-targeted therapy. * known central nervous system metastasis and/or leptomeningeal disease. * subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.
content-free speech analysis for measurement of mental health

Conditions: Mental Disorder; Conditions Influencing Health Status

Summary: trial to prove the functionality and efficacy of a content-free speech analysis tool to detect problematic mental health status or phases of patients with pre known or unknown mental health disorders, focussed on affective disorders or neurodevelopmental disorders. the participants talk in free speech to the tool, this will be analyzed content-free and compared with psychological instruments to detect the mental status in conventional way.

participants with and without pre known mental disorders will be recruited and analyzed with speech analysis and conventional psychological instruments, as primary measurement the scl-90-scale, as secondary instruments the prime-md (explicit in use the phq-9 for depressive symptoms and the gad-7 for anxiety), b5t and an adhd-vas-score (t0). then the investigators check the status of the participants later at t1 (4-6 weeks after t0) and t2 (4-6 weeks after t1). the speech measuring instruments is the "voicesense" digital voice analysis tool, which enables the analysis of 200 specific speech parameters and the assessment of the findings through the use of psychometric instruments and questionnaires. the hypothesis is that the data of the voicesense analysis tool compared to the psychological instruments provide a good match and the voicesense technique can be used as a predictive and course-description tool in mental illness.

Eligibility criteria:
inclusion criteria: * being regular outpatient with mental disorder (verum group) * being voluntary participant without mental disorder (control group) * native german language speakers * in good general health (absence of cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis) exclusion criteria: * schizophrenia * dementia * pregnancy or breastfeeding * current or recent (less than 1 year) history of alcohol and/or drug abuse * current or recent (less than 1 year) history of suicide attempts * other significant comorbidities according to the investigator's clinical assessment (for example, cancer, acute myocardial infarction, unstable angina, severe cardiac arrhythmia, recent cerebrovascular incident, or severe atherosclerosis.

Keywords: mental disorder treatment planning technical measurements of mental state course-prediction of mental illness
riskfactors of post-operative pain and nausea after ambulatory gynaecological laparocopy.

Conditions: Postoperative Pain; Postoperative Nausea

Summary: patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting. the actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as the doses of all drugs, given for either prophylaxis or treatment


Eligibility criteria:
inclusion criteria: * elective adult patients due for planned ambulatory gynaecological laparoscopy * must be able to speak and write in norwegian language exclusion criteria: * patients who, for some reason, is transferred to non-ambulatory (same day discharge) care. * patients who, for some reason, have a change in surgical procedure from laparoscopy
norspan versus oxycontin as postoperative painkiller to proximal extracapsular fractures of the femur

Conditions: Pain, Postoperative

Summary: effective treatment of pain after hip fractures is very important but difficult. it is often an old patient who has many adverse effects with the use of morphine. this is a randomized pilot study where the investigators want to compare norspan plaster to oxycontin tablets to patients with particular kind of hip fractures. the investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. no clinical study about the effect of norspan as acute painkiller has never been done before. can the investigators get the patients mobilized earlier with less adverse effects?


Eligibility criteria:
inclusion criteria: * males and females age 18 years or more * x-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with dhs or pfn. * subjects must have 7 or more points in the hindsøes test. exclusion criteria: * subjects where spinal anaesthesia cannot be applied. * subject in plavix® treatment seven days before admission to the hospital. * subjects with extracapsular hip fracture due to bone metastasis. * subjects with a bmi over 30. * subjects under 45 kg. * subjects who are currently taking monoamine oxidase inhibitors (maois) or have taken maois within 2 weeks prior admission to the hospital. * substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior. * untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject. * dermatological disorder at any relevant patch application site. * any contraindications listed in the summary of product characteristics for norspan®, oxynorm® and oxycontin®. * patient does not tolerate oxynorm. * user of wheelchair. * daily use of morphine before hospitalization. * more than one fracture. patients with myasthenia gravis. patients with severe respiratory function. patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating

Keywords: hip fractures treatment outcome painkiller
hemodynamic analysis for intracranial aneurysms recanalization after endovascular treatment

Conditions: Intracranial Aneurysm

Summary: this study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

with the rapid development of endovascular technique, endovascular treatment has become the first line treatment for intracranial aneurysms (ias). compared to microsurgical clipping, less invasive and lower morbidity have been shown after endovascular treatment. however, the aneurysms recanalization is the drawback of such modality. it has been reported that many factors, including complete initial embolization, stent assisted coiling, dense packing and flow diverter, could reduce recanalization rate. larger size, wide neck, rupture status and intraluminal thrombosis are reported as risk factors of aneurysm recanalization. however, no analysis of hemodynamic risk factors affecting the aneurysm recanalization has been conducted in a large prospective series of patients. hemodynamics is reported to play an important role in aneurysm initiation, growth and rupture. previous studies have showed that the hemodynamics is associated with outcomes of aneurysms after endovascular treatment. high wall shear stress and flow velocity are risk factors of aneurysm recanalization. however, the relationship between hemodynamics and aneurysm outcomes is still unclear. to explore the hemodynamic predictors of aneurysm recanalization is of great value for clinical practice. hemodynamic analysis for intracranial aneurysms recanalization after endovascular treatment (haret) is a prospective trial designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

Eligibility criteria:
inclusion criteria: * patients treated by endovascular approach for intracranial aneurysm(s) * patients older than 18 years * patients accepting to participate to the study exclusion criteria: * patients already treated by endovascular approach for an intracranial aneurysm * patients having a brain arteriovenous malformation * patients having a fusiform aneurysm * patients having a dissecting aneurysm * patients treated by parent vessel occlusion * patients treated by covered stent * patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation

Keywords: intracranial aneurysm endovascular treatment recanalization outcome hemodynamics computational fluid dynamic stent flow diversion
vrqol in cataract patients during the covid-19 pandemic

Conditions: Senile Cataract

Summary: the aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the national eye institute visual function questionnaire 25 and the delay of improvement in the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * senile cataract * indication for unilateral or bilateral cataract surgery * postponed cataract surgery due to the covid-19 pandemic * signed and dated declaration of consent exclusion criteria: * complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation) * amblyopia on the eye that is to be operated on * severe, visually impairing eye disease on the eye that is to operated on * known dementia or memory problems
morphological and metabolic changes of dorsal root ganglion and sympathetic ganglion in patients with postherpetic neuralgia on mri

Conditions: Pain; Neuropathy;Peripheral

Summary: object: postherpetic neuralgia (phn) is pain that persists for 1-3 months after herpes zoster onset. it is the most common complication of herpes zoster and occurs in 15-40% of patients with herpes zoster. phn has been suggested to be related with the lesion of doral root ganglion (drg). however, the studies are almost limited to autopsies and animals , and the mechanism of phn is still unclear. this study was conducted to investigate morphological and metabolic changes of drg and sympathetic ganglion in patients with postherpetic neuralgia on mri. method: 30 patients diagnosed as phn were recruited. the volume and fractional anisotropy of drg of lesion dermatomes were measured under mri, and compared with contralateral and adjacent drg. the volume and fractional anisotropy of sympathetic ganglion of lesion dermatomes were also measured under mri, and compared with contralateral and adjacent sympathetic ganglion.then, the association between clinical phenotypes and drg changes were analyzed.

patients with the following conditions were excluded: psychiatric diseases or communication disorders; contraindications to mri;drg radiofrequency therapy, spinal cord electrical stimulation and other direct intervention treatments for drg were performed before examination.

Eligibility criteria:
inclusion criteria: * aged more than 18 herpes zoster in cervical, thoracic,lumbar or sacral regions agree to participate to the research exclusion criteria: * can not cooperate to mri for mental disease contraindication for mri treatments for drg such as radiaofrequency therapy, spinal cord electircal stimulation were performed before examination. disagree to participate to the research

Keywords: herpes zoster postherpetic neuralgia mri dorsal root ganglion
a study of alks 5461 for the treatment of major depressive disorder (mdd) - forward-5 study

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy and safety of alks 5461.


Eligibility criteria:
inclusion criteria: * have a bmi of 18.0 to 40.0 kg/m2, inclusive * agree to use an acceptable method of contraception for the duration of the study * have an mdd primary diagnosis * have no more than 2 inadequate responses to antidepressant therapy (adt) in the current major depressive episode (mde) * additional criteria may apply exclusion criteria: * have a current primary axis-i disorder other than mdd * have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days * have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during their lifetime * have attempted suicide within the past 2 years * have a positive test for drugs of abuse * are pregnant, planning to become pregnant, or breastfeeding * have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) * have had a significant blood loss or blood donation within 60 days * additional criteria may apply

Keywords: major depressive disorder (mdd) depression alkermes alks 5461 samidorphan
immunogenicity of hepatitis a vaccine in inflammatory bowel disease (ibd) patients

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Hepatitis A

Summary: the purpose of this study is to measure the immune response in 18-40 year old ibd patients after receiving the hepatitis a vaccine.

the spread of hepatitis a has prompted the need for vaccination against this virus. it is uncertain that ibd patients can achieve a truly protective response after vaccination. the efficacy and safety of hepatitis a vaccination have not been evaluated in this population of patients. we would like to estimate the efficacy and safety of vaccination against hepatitis a in patients with ibd.

Eligibility criteria:
inclusion criteria: 1. patients suffering from inflammatory bowel disease: crohn's disease/ulcerative colitis 2. age 18-40 3. willing to provide informed consent exclusion criteria: 1. have history of vaccination to hepatitis a 2. have other autoimmune disease 3. have any malignancy 4. have acute infectious disease 5. unwilling to provide consent

Keywords: crohn's disease ulcerative colitis hepatitis a vaccine
pilot trial of pregnenolone in autism

Conditions: Autism Spectrum Disorder; Autism

Summary: this is a research study to examine the tolerability and effectiveness of pregnenolone in individuals with autism. pregnenolone is a naturally occurring steroid hormone in the brain that has been implicated in treating various psychiatric conditions. the investigators hope to learn the effects and safety of using pregnenolone in reducing irritability and sensitivity to sensory differences and improving social communication in individuals with autism. the investigators hope by studying the effects of pregnenolone in more detail, the investigators can design better ways to treat individuals with autism.


Eligibility criteria:
inclusion criteria: * outpatients between 14 and 25 years of age with a tanner stage of iv or v; * male and female subjects who were physically healthy; * diagnosis of autism spectrum disorder (asd) based on dsm-5, expert clinical opinion and confirmed with autism diagnostic interview - revised (adi-r) and either autism diagnostic observation schedule (ados) or childhood autism rating scale (cars-2); * aberrant behavior checklist -irritability (abc-i)≥ 18 and clinical global impression (cgi)-severity subscale ≥ 4; * stable concomitant medications for at least 2 weeks; * no planned changes in psychosocial interventions during the trial. exclusion criteria: * diagnostic and statistical manual (dsm-5) diagnosis of schizophrenia, schizoaffective disorder, alcohol use disorder; * prior adequate trial of pregnenolone; * active medical problems: unstable seizures (\>2 in past month), significant physical illness; * pregnant or sexually active female subjects who do not adhere to use an appropriate form of external prophylactics; * participants taking steroid medications.

Keywords: autism spectrum disorder autism pregnenolone
characterization of changes in ventricular mechanics in response to lexiscan stress using tagged cine cardiac magnetic resonance imaging

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to measure the changes in cardiac function during a lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.


Eligibility criteria:
inclusion criteria: * myocardial rest/regadenoson stress perfusion pet study within 60 days * normal rest lvef (greater than or equal to 50%) * no change in symptoms or treatment between the pet and the mri study * willing to consent to the study * male or female who is either post-menopausal, surgically sterile, or if has a childbearing potential, a negative pregnancy test within 2 days prior to the mri study. exclusion criteria: * renal dysfunction (estimated glomerular filtration rate \< 60 ml/min/1.73m2) within 6 months * metallic implants, pacemaker, blood vessel clip (contra-indicated for mri) * patient size exceeds mri bore/table limits: (max body diameter \> 60 cm, weight \> 136 kg) * history of gadolinium contrast allergy or intolerance * second or third degree av block * sinus node dysfunction * acute myocardial infarction (past 3 months) * actively wheezing or with acute asthma or bronchospastic attacks requiring changes in therapy within the past 30 days * patients that have experienced a previous hypersensitivity reaction thought to be related to regadenoson
a study of apalutamide in chinese participants with non metastatic castration resistant prostate cancer (nm-crpc)

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to compare the improvement in time to prostate specific antigen (psa) progression (ttpp, as defined by prostate cancer working group 2 \[pcwg2\]) of apalutamide versus placebo in chinese participants with high-risk non-metastatic castration resistant prostate cancer (nm-crpc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (psadt) less than or equals to (\<=) 10 months. psadt is calculated using at least 3 prostate-specific antigen (psa) values obtained during continuous androgen deprivation therapy (adt) * castration-resistant prostate cancer (pc) demonstrated during continuous adt, defined as 3 psa rises at least 1 week apart, with the last psa greater than (\>) 2 nanogram per milliliter (ng/ml) * surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dl). if the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (gnrha) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone * participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease progression (an increase in psa) after washout * at least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization exclusion criteria: * presence of distant metastases, including central nervous system (cns) and vertebral or meningeal involvement, or history of distant metastases. exception: pelvic lymph nodes \<2 centimeter in short axis (n1) located below the iliac bifurcation are allowed * symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis, due to primary tumor (example, tumor obstruction of bladder trigone) * prior treatment with cytochrome p450 17 alpha-hydroxylase/17,20-lyase (cyp17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for pc * prior chemotherapy for pc, except if administered in the adjuvant/neoadjuvant setting * prior treatment with second generation anti-androgens (example, enzalutamide) * history of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign cns or meningeal disease which may require treatment with surgery or radiation therapy)