Kornimate/medical-research-clean huggingface dataset:
complement inhibition: attacking the overshooting inflammation @fter subarachnoid hemorrhage (ciao@sah)

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: aneurysmal subarachnoid hemorrhage (sah) can lead to devastating outcomes for patients, like cognitive decline. this is caused by early brain injury (ebi) followed by delayed cerebral ischemia (dci). neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of ebi and dci. inhibition of the complement system is therefore considered to be a potentially important new treatment for sah. this trial aims to study the safety and efficacy of c1-inhibitor cinryze, an approved inhibitor of the complement system, compared to placebo in patients with sah. by temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for sah patients due to a decrease in the inflammatory response.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aneurysmal subarachnoid hemorrhage on ct-scan; * age ≥ 18 years on admission; * wfns grade 1-5. exclusion criteria: * subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome) * subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous) * participation in another clinical therapeutic study; * patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission * patients with a known hereditary complement deficiency (including hereditary angioedema); * patients with a history of sensibility to blood products or c1-inhibitor; * patients with a history of thrombosis (when known at time of inclusion); * pregnant woman
ramyd study - evaluation of arrhythmic risk in myotonic dystrophy

Conditions: Myotonic Dystrophy; Sudden Cardiac Death

Summary: this is a prospective multicentric italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.

myotonic dystrophy type 1 (dm1, steinert disease) is a multisystem disorder that affects, beside muscle, several other organs, including the heart. cardiac involvement represents a major problem in the clinical management of patients, so that cardiac complications represent one of the primary causes of premature death in dm1. in particular there is a high incidence of sudden death, ranging from 2 to 30% of cases, so far principally related to the development of conduction blocks. however, literature reports of sudden death in patients implanted with pacemakers, as well as of spontaneous ventricular tachycardia would suggest a potential etiologic role also for ventricular arrhythmias. the lack of clinical research studies conducted on a large number of patients does not make available definite data regarding the etiology and the epidemiology of arrhythmic events in dm1. for the same reasons, other considerable topics, such as prognostic stratification of the arrhythmic risk and clinical management of life-threatening arrhythmias in dm1 patients, are still undefined. to clarify these issues, the investigators propose a clinical research study performed on a large cohort of dm1 patients enrolled through a multicenter collaboration that also involves 5 cardiological-neurological italian centres. aims of this study are: * to estimate the incidence of arrhythmias and to characterize the brady-tachyarrhythmic mechanisms underlying the occurrence of cardiac sudden death in dm1; * to verify by statistical analysis the reliability of data obtained from both non invasive and invasive diagnostic procedures as indexes useful for estimating the arrhythmic risk in dm1; * to identify more adequate therapeutic guidelines in order to prevent the occurrence of life-threatening arrhythmias. the protocol of study includes: 1. clinical-genetic evaluation; 2. non invasive and invasive diagnostic cardiac procedures; 3. the use of devices for diagnostic and therapeutic follow-up.

Eligibility criteria:
inclusion criteria: * patient affected by myotonic dystrophy type i (md1). * patient willing to provide a signed informed consent. exclusion criteria: * age \ 70 years old. * ischemic cardiomyopathy * cardiomyopathy due to chronic excess of alcohol consumption (\>100 g\\day) * congenital heart disease * acquired valvular heart disease * metabolic cardiomyopathy: thyrotoxicosis, hypothyroidism, adrenal cortical insufficiency, pheochromocytoma, acromegaly * familiar storage and infiltrative diseases (hemochromatosis, glycogen storage, hurler's syndrome, niemann-pick disease; primary, secondary, familial and hereditary cardiac amyloidoses) * systemic diseases (connective tissue disorder; sarcoidosis) * peripartum cardiomyopathy

Keywords: myotonic dystrophy type 1 sudden cardiac death ventricular tachyarrhythmias bradyarrhythmias
treatment of cocaine dependence with lisdexamfetamine

Conditions: Cocaine Dependence

Summary: this protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. the investigators plan to enroll 100 subjects in a 14-week trial. the primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

this 2-group, double-blind, placebo-controlled, 14-week study (n=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. we hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Eligibility criteria:
inclusion criteria: * eligible participants must: 1. be treatment-seeking males or females between 18 and 65 years-of-age; 2. understand the study procedures and provide written informed consent; 3. be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use; 4. meet dsm-iv criteria for cocaine-dependence. exclusion criteria: * exclusion criteria include: 1. dsm-iv diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, adhd, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification; 2. current use of any prescription medications; 3. females currently pregnant or nursing; 4. current elevation of liver enzyme levels above twice normal limits; 5. existing cardiovascular disease as determined by physician, ekg evaluation; 6. history of significant acute or chronic physical illness precluding participation; 7. history of hyperthyroidism, glaucoma, or seizures.

Keywords: cocaine treatment lisdexamfetamine dependence addiction crack
passive cervical range of motion in infants

Conditions: Arthrogenic Torticollis

Summary: infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pcrom).

infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. one group will include healthy subjects, the other group infants with a diagnosed torticollis. healthy subjects will be measured at the age of 3, 4, 6 and 9 months. infants diagnosed with torticollis, at their visit at a chiropractor and one week later.

Eligibility criteria:
inclusion criteria: * age 2-12 month * signed informed consent * diagnosed with torticollis exclusion criteria: * defense reaction e.g. crying, screaming * other illnesses * neck trauma * neck surgery * developmental delay

Keywords: arthrogenic torticollis cervical range of motion infant
spinal cord stimulation (scs) for amputees

Conditions: Somatosensory Perception Following Lower Limb Amputation

Summary: the purpose of this study is to investigate how leg amputee patients can feel sensations with neuromodulation while they are using a prosthetic leg. "neuromodulation" is the process by which the nervous system can be regulated by targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body. in this study, the investigators plan to use either electrical stimulation of the spinal cord (spinal cord stimulation) or electrical stimulation of the dorsal root ganglion (drg stimulation) as methods for neuromodulation. participation in this study will involve visiting the k-lab (human performance laboratory) at duke's sports medicine institute once prior to trial implant surgery, if feasible, and four times during the two weeks following the implantation of trial stimulation leads to evaluate sensations related to touch and position of the prosthetic leg as they are generated by neuromodulation.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age * subject is able and willing to comply with the schedule and protocol * subject is a lower limb amputee who uses a prosthetic leg * subject is a good candidate for implantation of a stimulator for their amputation related pain * subject has stable neurological/cognitive function in the past 30 days * subject is able to provide informed consent exclusion criteria: * subject is currently participating in a clinical investigation that includes an active treatment arm * subject currently has an active implantable device including an implantable cardioverter defibrillator (icd), pacemaker, spinal cord stimulator, or intrathecal drug pump * subject is a prisoner * female subject whom are pregnant

Keywords: neuromodulation phantom pain amputation
fapi pet/ct prospective interobserver agreement

Conditions: Malignant Neoplasm

Summary: the aim of the present study is to evaluate the interobserver agreement for fapi pet/ct interpretations of representative cancer types and compare findings among readers with different levels of experience.

fibroblast activation protein (fap) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68ga-fapi inhibitor (fapi) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (pet/ct), with favorable initial results in different tumor entities. compared to 18f-fdg, 68ga-fapi pet/ct shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions. moreover, the fapi ligand contains a dota peptide which makes it appropriate also for therapeutic options if linked with 177lutetium or 90yttrium. there is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68ga-fapi pet/ct. therefore, the inter-observer agreement and variability with 68ga-fapi pet/ct need to be established.

Eligibility criteria:
inclusion criteria: nuclear medicine physicians or radiologists with a prior experience with 68ga-fapi pet/ct from high-volume centers (essen, germany; bologna, italy; los angeles, usa; munich, germany, münster, germany ) will be prospectively recruited as research observers. each observer will be asked to report the number of previous clinical 68ga-fapi pet/ct scans and then will be classified on the basis of the experience in these three groups: * low experience (\< 30 prior 68ga-fapi pet/ct studies); * intermediate experience (30 to 300 studies); * high experience (\> 300 studies) at least three observers will be needed for each group. exclusion criteria: no prior pet/ct experience.

Keywords: fapi cancer positron-emission-tomography fap fibroblast imaging pet interobserver agreement
rad001 (everolimus) salvage monotherapy in advanced gastric cancer (agc) who failed standard first-line treatment

Conditions: Stomach Neoplasm

Summary: this is a phase ii study to evaluate rad001 (everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer. eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy. oral rad001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. treatment will be continued until disease progression or patient's intolerability to the study drug. total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), p, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction * patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination) * patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-fu, capecitabine, doxifluridine, s1, or uft) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy * age 18 to 75 years old * estimated life expectancy of more than 3 months * ecog performance status of 2 or lower * adequate bone marrow function * adequate kidney function * adequate liver function * no prior radiation therapy to more than 25 percent of bm * patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study * women of childbearing potential must have a negative pregnancy test on admission * the patient must be able to understand the study and has given written informed consent to participate in the study exclusion criteria: * other tumor types than adenocarcinoma * central nervous system metastases or prior radiation for cns metastasis * gastric outlet obstruction or intestinal obstruction * evidence of active gastrointestinal bleeding * bony metastasis as the sole evaluable disease * past or concurrent history of neoplasm other than stomach cancer * pregnant or lactating women, women of childbearing potential not employing adequate contraception * thyroid disease

Keywords: rad001 (everolimus) second-line treatment advanced gastric cancer
haloperidol versus ondansetron for cannabis hyperemesis syndrome (havoc)

Conditions: Cannabis Use Disorder

Summary: cannabis hyperemesis syndrome (chs) has become a well-documented syndrome since 2004 and is expected to increase in prevalence with continuing liberalization of marijuana and recognition of the disease. regardless of whether the association with heavy cannabis use is recognized, there is well-documented resistance to traditional anti-emetic treatment. given promising reports of the use of intravenous haloperidol, a randomized controlled trial comparing it to the commonly administered anti-emetic ondansetron will contribute to the management of chs

this is a double-blinded, randomized, cross-over clinical trial that will enroll approximately 80 subjects from at least four different research sites. patients who have been diagnosed with chs and enrolled in our study will act as their own controls upon their return to the ed for a subsequent bout of chs for up to 3 visits per subject. each patient will be allocated in a 1:1:1 fashion into one of three treatment groups: high- or low-dose haloperidol, or ondansetron, with a minimum 7-day washout period between treatments. as chs tends to be a recurrent syndrome (presumably given the continued use of cannabis despite recommendations to taper and abstain), it is expected that most subjects will return at least once again, and a substantial subset of the study population will complete all three treatment visits during the trial.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. self-report of ≥3 episodes of emesis occurring in a cyclic pattern for greater than 1 month in the preceding 2 years 3. current episode \>2 hours of emesis 4. at least one episode of emesis/forceful retching witnessed (including products of emesis at bedside) or heard by an independent observer (healthcare provider or family/friend) in the emergency department 5. self-reported frequent (near daily to daily x at least 6 months) use of cannabis by inhalation. 6. working diagnosis of cannabis hyperemesis syndrome in the opinion of the treating emergency physician exclusion criteria: 1. chronic, daily use of opioid equivalent to ≥10mg morphine/day 2. inability to comprehend study consent or instructions 3. unreliable follow-up/unlikely to return for cross-over 4. administration of an intravenous antiemetic, anticholinergic or antipsychotic (other than up to 100mg dimenhydrinate) in the previous 24 hours 5. allergy or intolerance to haloperidol or ondansetron 6. pregnancy 7. any other medical or psychiatric condition that in the opinion of the enrolling physician would interfere with participation in the trial 8. current active participation in an investigational drug trial

Keywords: cannabis haloperidol ondansetron hyperemesis cyclic vomiting syndrome
to test bioequivalence between two tablet formulations in the treatment of allergy

Conditions: Allergy

Summary: this study is designed to assess bioequivalence between two products used for treatment of allergy.

this study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (odt) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (benadryl one a day, mcneil products ltd, uk) taken with water. this study will also evaluate the tolerability of test and reference formulations.

Eligibility criteria:
inclusion criteria: * male or female subjects * volunteers aged of at least 18 years but not older than 55 years * subjects will have a body mass index (bmi) greater than or equal to 18.50 and below 30.00 kg/m2 * non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ecg and urinalysis) * has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * seated pulse rate below 45 bpm or higher than 90 bpm at screening * seated blood pressure below 90/60 mmhg or higher than 140/90 mmhg at screening * relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or johnson \& johnson subsidiaries; and the families of each) * presence of any tongue piercings * presence of braces * females who are pregnant or are lactating * females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study * females who are pregnant according to a positive serum pregnancy test * any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.
vibration and during heel lance procedures in newborns

Conditions: Heel Lance Procedures

Summary: this study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns. .

methods: this randomized, controlled, experimental study. the study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. in the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. no interventions were made on the newborns in the control group. two nurses were employed for the heel lance procedure both for the experimental and control groups. one nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the nips. the heel lance procedure was performed by the same nurse both in the vibration and control groups.

Eligibility criteria:
inclusion criteria: * gestational age 38 and older exclusion criteria: * disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected, * genetic and congenital anomalies * congenital metabolic disorders, * those who had undergone cardiopulmonary resuscitation, * stayed in the neonatal intensive care unit for any reason, * heel blood could not be collected at the first attempt, * osteogenesis imperfecta * had been given an analgesic within the preceding 6 hours

Keywords: newborns vibration pain heel lance
high flow nasal cannula is appropriate alternative for stabilization of very premature infants: a prospective observational study

Conditions: Premature; Infant

Summary: a prospective observational study evaluates the safety and efficacy of using high-flow nasal cannula to stabilize very preterm infants immediately after birth. following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low spo2.


Eligibility criteria:
inclusion criteria: * preterm infants born between 28+0 and 31+6 gestational weeks were enrolled in the study after obtaining parental informed consent. exclusion criteria: * infants with congenital malformations, previable rupture of membranes, and acute intrauterine hypoxia.

Keywords: neonatology hfnc prematurity