Kornimate/medical-research-clean huggingface dataset:
does oxytocin alter tolerance to or motivation for alcohol

Conditions: Alcohol Use Disorder

Summary: this pilot study is intended to demonstrate feasibility and acquire preliminary data. if successful, this data could support a future project studying the effect of oxytocin on tolerance and alcohol seeking in humans.

this pilot study is designed to demonstrate feasibility and provide preliminary data supporting use of intranasal oxytocin in treatment of alcohol use disorders. specifically, experiments are planned to test the ability of oxytocin to reverse tolerance and alcohol seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol administration. two separate experiments will be run. in the first, tolerance will be assessed using sensitive tests of subjective response and cognitive function during an intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol. in the second, an intravenous alcohol self-administration paradigm that requires increasing effort for each additional infusion will be used to assess change in motivation for alcohol. demonstrating that oxytocin (compared to placebo) worsens test performances in alcohol-dependent individuals and/or reduces the compulsive drive to self-administer alcohol would be strong evidence for its potential to treat alcohol use disorders.

Eligibility criteria:
inclusion criteria: * heavy alcohol drinkers. * able to understand/complete questionnaires and procedures in english. * have venous access sufficient to allow blood sampling. exclusion criteria: * latex allergy. * nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin * pregnant or breast-feeding women. * desire to be treated for any substance use disorder or court ordered to not drink alcohol * medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety. * positive urine drug screen for amphetamines/ methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine if determined by the pi to adversely affect participant safety or data integrity. * medications (past 30 days) that could influence participant safety or data integrity (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by the pi. * dsm 5 disorders (other than alcohol) or current/history of neurological disease of cerebral origin, or head injury with \> 20 min loss of consciousness, if determined by the pi to affect participant safety or data integrity. * positive breath alcohol reading at beginning of the experimental session. * actively suicidal (for example, any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the pi. * any condition for which the pi and investigative team determine it is unsafe or not prudent to enroll a participant.

Keywords: alcohol use disorder oxytocin, intranasal alcohol tolerance alcohol intake alcohol treatment alcohol, intravenous
transcranial ultrasound screening of nursery unit neonatesfor brain abnormalities

Conditions: Brain Abnormalities

Summary: * to investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11} * to identify the associated clinical features and to better target neonatal cus investigations.{11}

preterm birth is associated with various brain injuries. the earlier the period of gestation, more is the incidence of brain injuries. brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} cranial ultrasound (cus) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} cranial ultrasonography (cus) is the preferred modality to image the neonatal brain.{3} the advantages of cus are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}

Eligibility criteria:
inclusion criteria: * all neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals exclusion criteria: * patients above the age of 28 days
msb0010445 and stereotactic body radiation therapy in advanced melanoma

Conditions: Melanoma

Summary: this is a phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose msb0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (sbrt).


Eligibility criteria:
inclusion criteria: * advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-pd/pd-l1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment * subjects need to have * one lesion that can be irradiated * at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated * one lesion that can be biopsied before treatment with sbrt and msb0010445 * one lesion outside the radiation field that can be biopsied while on treatment with msb0010445 * the lesion that is biopsied at baseline can be the lesion that will be irradiated * the lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at baseline * signed written informed consent * male and female subjects at least 18 years of age * life expectancy greater than or equal to (\>=) 4 months * eastern cooperative oncology group (ecog) performance status of 0 or 1 * other protocol defined inclusion criteria could apply exclusion criteria: * active central nervous system metastasis * treatment with systemic anti-cancer therapy within the 30 days before the first dose of sbrt * pre-existing pericardial effusion or history of grade \>=2 pleural effusion or ascites within 3 months before first dose of sbrt * concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions * other protocol defined exclusion criteria could apply

Keywords: melanoma msb0010445 dose limiting toxicity stereotactic body radiation therapy
new treatment for patients with temporal hollowing after lateral wall decompression

Conditions: Thyroid-Associated Ophthalmopathy

Summary: the purpose of this study is to determine whether injection of autologous fat or hyaluronic-acid injections in temporal region are effective in the treatment of temporal hollowing after lateral wall decompression in patients with thyroid eye disease.

grave's disease is one of the most common autoimmune diseases. thyroid eye disease is affecting nearly 50% of patients with grave's disease. surgical treatment may address several of the manifestations, including the increased volume of the orbital contents. decompression of the orbit can be achieved by removing the lateral orbital walls; "lateral wall decompression". in a retrospective study at the department of ophthalmology, haukeland university hospital, about half of the patients had a disfiguring hollowing in the temporal region after lateral wall decompression. the patient reported outcome of the procedure is clearly an indication for further esthetic treatment. however, until now the treatment option for these patients have been limited, or simply neglected. the investigators have contacted over 40 patients with this complication that want treatment. in this project the investigators will treat bilateral hollowing with injection of autologous fat in one temporal region and hyaluronic-acid injections on the opposite side. participants with unilateral hollowing will be randomized to one of the treatment options. outcomes will be evaluated by clinical examination, photographs and ultrasound volume measurement at 6, 12, 18 and 24 months postoperatively. the participants will be retreated at these follow up intervals if necessary. the project will be an interventional, prospective follow-up study and is approved by the regional ethics committee. the study will be the first of its kind to date as the investigators will be able to prospectively evaluate the effect of autologous fat injections to hyaluronic-acid injections in the same patient for the same condition.

Eligibility criteria:
inclusion criteria: * disfiguring temporal hollowing after lateral wall decompression. * the participant want treatment for temporal hollowing exclusion critera: * the participant dont want treatment for temporal hollowing

Keywords: temporal hollowing lateral orbital wall decompression thyroid eye disease
the effect of low-intensity resistance exercise training

Conditions: Delayed Onset Muscle Soreness

Summary: it was to compare the effect of low-load resistance training with blood flow restriction (ll-bfr) and high-intensity resistance training (hi-rt) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (doms). the study included 13 young women. it is a controlled study designed for individuals to perform two different exercise protocols unilaterally. the persons were randomly allocated into two groups as li- bfr (group i, n = 13) and hi-rt (group ii, n = 13). both groups received training for 6 weeks and 3 days a week. blood flow restriction was performed only in group i.

both sides triceps muscle thickness, triceps and biceps strength and endurance, functional performances (upper extremity y balance test (uqybt)), delayed-onset muscle soreness (doms) were evaluated before and after training.

Eligibility criteria:
inclusion criteria: * between the ages of 18-26, * do not have a chronic disease history and do not use medication, * female individuals were included. exclusion criteria: * people who made resisted exercise in the last 6 months, * smoker, * bmi above 30 kg / m2, * individuals with hypertension were excluded.

Keywords: muscle hypertrophy triceps brachii muscle strength
comparison of 2 different positional therapies for positional obstructive sleep apnea syndrome

Conditions: Positional Obstructive Sleep Apnea

Summary: the proposed study is a randomized cross over trial assessing the efficacy of two different positional therapies for positional obstructive sleep apnea (posa). the effectiveness of the two different therapeutic devices (positional pillow and vibrating belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea. the subjective quality of sleep will also be evaluated prior to treatment and following the use of each separate device by means of a "quality of sleep questionnaire"

patients with a de novo diagnosis of positional sleep apnoea on a polysomnography performed in our sleep lab will be asked to participate to the study. they should fulfill the mador definiton of posa. a home recording of sleep position with somnibel pro will be conduted for 2 consecutive nights. in case of confirmation of supine sleep at home (mean supine sleep \>30% of total sleep time) the patient will be asked to use two different positional therapy devices consecutively (positional pillow and vibrating belt), 3 nights each, in a random order, with concomitant recording of sleep position with the somnibel pro. global satisfaction questionnaire will be assessed by a simple visual analogic scale (is it easy to use? is it confortable? is it efficient on snoring? is it efficient on sleep apnea? would you pay for such treatment? willingness to use it on a long-term basis?) the subjective sleep quality will also be assessed by means of "sleep quality questionnaire", prior to commencing treatment, and consecutively after 3 nights on each individual therapy. statistical analysis: efficacy of positional pillow (posiform) and vibrating belt (somnofit) percentage sleep on back on treatment will be compared to mean percentage sleep on back without treatment, at home, for both devices. comparison on surrogate ahi based on diagnostic polysomnography, with and without each device. global satisfaction with the devices will also be compared between devices. the sleep quality will be compared on the two devices using the "sleep quality questionnaire". the sample size of 52 subjects (26 in each arm), has been calculated to obtain a power of 90% and allow a drop out rate of 10%.

Eligibility criteria:
inclusion criteria: * adult patients able to give writtent consent with a de novo diagnosis of positional sleep apnoea according to a polysomnograph. exclusion criteria: * pregnant women
cyberknife based hypofractionated radiotherapy for vertebral hemangiomas

Conditions: Hemangioma of Vertebral Column

Summary: clinical objective of the study is to compare the analgesic effect, toxicity and pathologic effect in the tumors of two radiotherapy schedules used for patients suffering from painful vertebral haemangiomas

hemangiomas are frequent vertebral lesions (12% of the whole human population) but only 1% displays any clinical symptoms . the most common symptom is local pain, usually non responding for non-steroid anti-inflammatory drugs. radiation therapy usually does not result calcification or the tumor regression, but significantly reduces the pain intensity or eliminates it. currently, the most common rt schedule is conventional radiotherapy using fraction dose (fd) of 2 gy delivered to the total dose (td) varying from36 gy to 40 gy. the results in pain reduction achieved after larger total doses are better that led us to use radioablative techniques. this procedure is associated with a probability of better analgesic effect and the good local effect (calcification and / or regression of laesion) with high safety of radiation delivery using tracking based cybernetic microradiosurgery (cyberknife). the comparison of two modalities of radiation therapy (conventional \[fd 2 gy, td 36 gy\] and hypofractionated \[fd 5 gy, td 25 gy\]) used for treatment of painful vertebral hemangioma patients will be performed in the phase iii randomized study. 80 patients will be enrolled in this study. all patients will be planned (rt) on the base of ct/mri fusion. patients will be controlled 1, 3, 6, 9, 12 months after treatment completion and, next every each 6 months. pain relief, analgesics uptake, local effect (mri and technetium - 99m-labelled rbc(red blood cell) scintigraphy) and eventual toxicity will be checked during follow-up (fu).

Eligibility criteria:
inclusion criteria: 1. confirmed vertebral hemangioma , 2. lesion visible in ct and mr 3. pain located in area of the lesion 4. informed consent for participation in the study and for radiotherapy in interested area exclusion criteria: 1. any previous radiotherapy in region of treated hemangioma 2. spinal damage or disease that may be associated with an increased radiosensitivity 3. the coexistence of the vertebral morphological changes at the level of hemangioma causing pressure on the nerve roots and / or spinal cord causing pain located in that area 4. neurological deficits caused by the presence of hemangioma (patients should be considered for surgery) 5. contradictions for mri 6. lack of informed consent.

Keywords: vertebral hemangioma conventional radiotherapy cyber knife radiotherapy randomized trial radioablation
cardiac arrhythmia telemetry; conventional vs heartwatch

Conditions: Cardiac Arrhythmia; Diagnostic/Monitoring Devices Related to Adverse Incidents

Summary: heart rhythm disorders are common and significantly impact the lives of those affected and their families. the main problems can be categorized as: a) atrial fibrillation or af and atrial flutter, b) supra-ventricular tachycardia or svt, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. these problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. the heartwatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

patients who are being referred to wear a holter monitor will be approached to wear a heartwatch simultaneously. this will allow collection of signals on both devices and to compare the accuracy of signals between the heartwatch vs holter monitor. it will also examine the reliability of autodetect algorythms between the devices. we will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Eligibility criteria:
inclusion criteria: * at least 22 years of age at time of consent * clinically indicated for a holter monitor test * able to wear the heartwatch on the left bicep for the study duration * able to follow the protocol * no functional implantable pacemaker or defibrillator * left bicep circumference \>/= 22 cm and \</= 45 cm * provision of written-informed consent exclusion criteria: * known allergy to any component of the holter monitor * known allergy to any component of the heartwatch * inability to wear the heartwatch on the left arm for the study period due to pre-existing medical condition (3.g., functional av fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...) * dextrocardia * implanted functional pacemaker or defibrillator * left bicep circumference \< 22 cm * left bicep circumference \< 45 cm
refractory status epilepticus treatment study

Conditions: Grand Mal Status Epilepticus; Non-convulsive Status Epilepticus

Summary: identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.

phase iii clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus. multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age who meet the diagnosis of eer seizure, and previously they have been treated according to the clinical protocol at our center status (diazepam 10mg clonazepam 1mg and phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic): -present seizures for at least 30 minutes without regaining awareness among them. 2. patients ≥ 18 years of age who meet the diagnosis of nonconvulsive eer, and previously they have been treated according to the clinical protocol at our center status (diazepam 10mg clonazepam 1mg and phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic): * after submitting an eer seizures that yield clinically performed an eeg that shows se electricity. * evidence of a non-convulsive se to perform an eeg of a patient admitted for any cause, either by filing seizures, altered mental status, or any other cause, and to persist after the treatment administered previously discussed. 3. patients in whom it has obtained the written informed consent by the representative and/or patient, as the case exclusion criteria: 1. patients with severe cerebral anoxia, when the first eeg evidences a pattern of flare-suppression. 2. patients who registers pleds (periodic epileptic lateralaized discharges) without clinical seizure activity association to register or without electrical crises. 3. patients \< 18 years of age. 4. patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy). 5. pregnant or breastfeeding. 6. patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate 7. patients with porphyria 8. patients with severe liver disease or dysfunction. 9. patients with heart block or second and third grade sinus bradycardia.

Keywords: refractory status epilepticus valproic acid phenytoin benzodiazepines valproic acid initial dosage in status treatment
the effectiveness of a coach-focused intervention on preventing knee injuries in amateur football players

Conditions: Knee Injuries

Summary: the goal of this clinical trial is to find out if a coach-focused intervention can help prevent sudden-onset, severe knee injuries in youth and senior amateur football players. the main question it aims to answer is: does a coach-focused intervention reduce the number of sudden-onset, severe knee injuries? researchers will compare a coach-focused intervention, designed to help coaches to use effective injury prevention training, to usual football practice to see if the intervention can prevent sudden-onset, severe knee injuries in football players. participants will: either receive weekly information and motivation on effective injury prevention training or continue their usual football practice for 14 weeks. all will receive a weekly text message with a survey link to report any sudden-onset knee injuries among their players for 18 weeks.


Eligibility criteria:
inclusion criteria: 1. coach or manager at danish amateur football teams at levels from under 14 (u14) years to senior teams. 2. minimum 18 years of age. 3. access to a mobile phone and computer. exclusion criteria: 1. limited danish language skills, which prevents full understanding of the provided material and questionnaires. 2. affiliation to teams playing under a license ranking by the danish football association where training by a physical trainer is required according to the license criteria of the danish football association). 3. affiliation solely with old boys'/girls' teams (where the players have to be aged 32 and 29 , respectively, in the current season ).

Keywords: knee injury injury prevention training football coaches players