Kornimate/medical-research-clean huggingface dataset:
cervical interbody fusion device patient registry

Conditions: Degenerative Disc Disease

Summary: the registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (acdf) procedures treated with tidal cervical interbody fusion device. the ultimate goal of the study is to aid in the development of treatment pathways and improved patient care. all patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the device in either an inpatient or outpatient facility.

the registry is design to collect data prospectively on patients undergoing spinal fusion using the tidal cervical interbody fusion device. patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. data will be collected at recommended time points based on the standards of care of the participating sites. the registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered. follow up visits will be defined by the treating physicians based on their standard practice. typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.

Eligibility criteria:
inclusion criteria: * neck and arm pain for a minimum of 6 weeks before surgery that is recalcitrant to nonoperative treatment modalities, such as physical therapy, reduced activities, and anti-inflammatory medications. * radiographic evidence of cervical disc disease that is documented on dynamic radiographs and magnetic resonance imaging (mri). exclusion criteria: * medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications, that could interfere with fusion. there are no restrictions on sex or ethnicity.
comparison of efficacy of lgit and mad among children with drug resistant epilepsy

Conditions: Drug Resistant Epilepsy; Ketogenic Dieting

Summary: to compare the efficacy of two less restrictive dietary therapies - lgit and mad, used for treatment of drug resistant epilepsy in children

up to one third of patients with epilepsy progress to drug resistant epilepsy (dre). current treatment options for dre include epileptic surgery and dietary therapy. classic kd (ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. so less restrictive diets like mad and lgit were introduced. these are reported to have less adverse effects also. but no published study has ever been conducted comparing these two diets head to head.

Eligibility criteria:
inclusion criteria: * children aged 1-15 years with drug resistant epilepsy * willing to come for regular follow-up according to study protocol drug resistant epilepsy defined as * seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs * for west syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either acth(adrenocorticotrophic hormone) or vigabatrin exclusion criteria: * surgically remediable causes for dre * inborn errors of metabolism * previously received kd, mad or lgit * known case of 1. chronic kidney disease 2. chronic liver disease/gi illness 3. congenital/acquired heart disease 4. chronic respiratory illness

Keywords: mad lgit
brain substrates for cardiovascular stress physiology

Conditions: Stress Reaction

Summary: transcranial infrared laser stimulation is a non-invasive neuromodulation technique. the study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.

physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. the aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.

Eligibility criteria:
inclusion criteria: 18-30 years old exclusion criteria: history of a diagnosed chronic medical or neurological disorder current pregnancy current illness or infection (e.g., cold, flu) any condition that would prohibit them from engaging in physical exercise
synergistic effect of ibuprofen and hydromorphone for postoperative pain

Conditions: Breast Cancer

Summary: intravenous form of ibuprofen is recently approved by fda and reports are rare on the co-administration with opioids. the investigators searched whether intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain using combination index (ci), dose reduction index (dri) and isobologram.

ninety patients, undergoing breast surgery, were included in one of the three groups (ibuprofen, hydromorphone, ibuprofen+hydromorphone groups). positive analgesic efficacy was defined as a numeric rating scale (nrs) ≤3 on a 0-10 nrs, 30 min after the drug administration. drug was administered by the dixon and mood up-and-down method. starting doses were ibuprofen 50 mg, hydromorphone 0.25 mg, or ibuprofen 25 mg + hydromorphone 0.125 mg. the maximum doses were ibuprofen 800 mg, hydromorphone 2 mg, or ibuprofen 400 mg + hydromorphone 1 mg. combination index (ci) (additive: 0.9-1.1, synergism: \ 1.1), dose reduction index (dri, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status і or іі who were able to communicate and understand the pain scales exclusion criteria: * any contraindication to the use of ibuprofen or hydromorphone * a history of allergy or hypersensitivity * a calculated creatinine clearance of \<75 ml/min * the presence or history of asthma, bleeding tendency, coronary artery bypass graft (cabg) surgery, heart failure, peptic ulcer disease, inflammatory bowel disease or any other gastrointestinal disorder, and renal or hepatic disease * pregnancy * age younger than 18 yr * intraoperative use of regional anesthesia * intraoperative administration of analgesics other than remifentanil * postoperative pain ≤3 on a nrs in the post-anesthesia care unit (pacu)

Keywords: ibuprofen hydromorphone drug interactions
clinical phenotyping and characterization of neural networks and cognitive processes involved in mental retardation x-linked

Conditions: X-linked Mental Retardation

Summary: x-linked mental retardation (xlmr) represent 10% of the causes of mental retardation with a prevalence in both sexes around 1/296, i.e. 3.3 / 1000 births (opitz et al., 1986). this heterogeneous group of xlmr includes dozens of rare diseases, some of them affecting only a few patients. molecular diagnosis is currently available in france for 25 xlmr genes, within the national network of xlmr molecular diagnosis. however, whereas some syndromes such as fragile x syndrome, are now well clinically defined, this is not the case for recently identified syndromes for which very few data is available, preventing clinicians to focus molecular diagnosis on a specific gene. therefore, this study aims to : * achieve a description of the clinical phenotype specific to each xlmr gene (phase 1 of the study, n=200) * characterize the cognitive learning mechanisms and dysfunctional neural networks involved (phase 2 of the study, n=75, i.e. 5 groups of 15 patients with a mutation in the same gene). these two elements constitute key steps to develop appropriate rehabilitation strategies and targeted pharmacological therapies. moreover, the impact of mental retardation on the primary caregiver within the family and the induced burden in terms of psycho-social, organizational and economic burden will also be assessed. these elements, directly related to the patient's environment, are very important to characterize in order to better understand the consequences of each gene mutation (phase 3 of the study, n=283). for example, it is necessary to better understand the impact of fragile x syndrome in terms of capacity and behavior, lifestyle, and health care needs of the patients while advancing knowledge allows to consider innovative therapeutics, the implementation of these therapeutics and assessment of their impact on the patients' life trajectory, require precise characterization of the population to be treated in medico socioeconomic terms.


Eligibility criteria:
inclusion criteria: * age : from 2 to 60 years old * having a pathogenic mutation of one of the x chromosome genes associated with : * for boys : mental retardation (iq\<70), and/or developmental delay (dq\<70) and/or pervasive developmental disorder (autism, asperger...) * for girls : mental retardation (iq\<70), and/or developmental delay (dq\<70) and/or pervasive developmental disorder (autism, asperger...) and/or specific learning disabilities exclusion criteria: * patient or parents refusal to participate in the study * genetic polymorphism in a x chromosome gene involved in mental retardation but not considered as pathogenic * person refusing to be informed if an abnormality would be discovered during medical examination

Keywords: phenotype x-linked mental retardation neuronal networks cognitive processes
augmentation of limb perfusion with contrast ultrasound

Conditions: Peripheral Arterial Disease

Summary: our laboratory has discovered that ultrasound (us) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. these observations have been made in mice with and without peripheral artery disease (pad), and also in humans where high power contrast enhanced ultrasound (ceu) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. the latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. in this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic ceu settings that are still within the fda-approved limits with regards to us power and contrast dosing.


Eligibility criteria:
inclusion criteria: * age ≥18 y.o. * for pad subjects: known history of unilateral or bilateral pad diagnosed by reduced ankle-brachial index or angiography and a rutherford symptom class of 4-6. exclusion criteria: 1. major medical illness other than pad affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[nyha class iv or lvef \<30%\]). 2. pregnant or lactating females 3. hypersensitivity to any ultrasound contrast agent 4. known atrial septal defect or large right to left shunt. 5. hemodynamic instability (hypotension with systolic bp \<90 mm hg, need for vasopressors) 6. evidence for ongoing myocardial ischemia 7. for normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
clinical food study to evaluate the effect of kb174 on the gut microbiome in subjects with well-compensated cirrhosis

Conditions: Early Cirrhosis

Summary: this randomized, double-blind, controlled, clinical food study aims to explore kb174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * be able and willing to provide written informed consent * be male or female, 18 to 70 years of age (inclusive) * have a body mass index (bmi) ≥ 20.0 and \< 40.0 kg/m2 * well-compensated cirrhosis * negative for hepatocellular carcinoma (hcc) * adequate safety laboratory values at screening. * be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine * if of child bearing potential must follow contraceptive requirements of the protocol * have reliable internet access exclusion criteria: * have evidence of decompensated liver disease. * history or active gi disease. * prior solid organ transplantation, including liver transplantation or on liver transplant waiting list. * subject has a history of drug and/or alcohol abuse.
observational study of the the use of a trigeminal vagal nerve stimulator in the routine care of native americans with diabetic neuropathy pain. pain scores, drug use and glucose measurements will be assessed

Conditions: Diabetic Neuropathy With Neurologic Complication

Summary: this is an observational study that will follow patients in the course of routine care and measure pain levels, glucose assessments and drug utilization for native american patients with diabetic neuropathy

patients with diabetic neuropathy pain will have an ns100 device implanted for chronic diabetic neuropathy pain consistent with onlabel indication. all patients will be followed for 90 days post implant to measure improvements in pain, drug utilization and glucose levels.

Eligibility criteria:
inclusion criteria: * diabetic neuropathy pain history of failed treatment willing to follow blood glucose and pain scores for 90 days exclusion criteria * bleeding diathesis pregnancy cardiac monitoring device implantable neurostimulator inability to give informed consedn

Keywords: vagus diabetic neuropathy auricular stimulation
virtual reality in mva for miscarriage

Conditions: Miscarriage

Summary: we are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration. virtual reality (vr) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. in this study a vr headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (mva) is performed. vr is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. however, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. this study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.

many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. for the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure. the rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration primary objective • feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage. secondary objectives * understanding the acceptability and effectiveness of vr interventions in office gynaecology procedures * understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology. * understanding how best to implement the technology and designing of the contents of the vr intervention.

Eligibility criteria:
inclusion criteria: patients: clinical indications for undergoing an mva will be confirmed. inclusion criteria will include all women of 18 - 50 years of age, planned for a mva who are able and willing to give informed consent. exclusion criteria: * hearing impairments and blindness * history of epilepsy or any previous seizures * any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation) * any known characteristics that make the patient unsuitable for undergoing mva (e.g. known bleeding disorder, gestation \>12 weeks) * the denial or withdrawal of informed consent

Keywords: management anxiety pain
zemedy application for irritable bowel syndrome

Conditions: IBS - Irritable Bowel Syndrome

Summary: the purpose of the study is investigate the effectiveness of zemedy, a mobile application that enables the digital delivery of a cbt program to people with ibs.

irritable bowel syndrome (ibs) is defined as having recurrent abdominal pain associated with defecation or a change of bowel habits. the pathophysiology of ibs can be looked through the biopsychosocial model of disease which is defined by the complex interplay between genetic, cultural, environmental, and psychosocial factors. treatment of ibs is multifaceted and ranges from exercise to dietary restrictions, however, psychological treatments to target the gut-brain axis such as cognitive-behavior therapy (cbt) have also been shown to be an effective therapy, and aims to address the psychological and environmental stressors that contribute to the symptoms. therefore the purpose of the study is investigate the effectiveness of zemedy, a mobile application that enables the digital delivery of a cbt program to people with ibs. cbt has been shown to reduce the severity of intractable ibs symptoms by as much as 70%. the investigators hope to learn whether the zemedy mobile application is effective in the reduction of ibs. this will be measured based on their ibs symptom severity scores (sss) at week 8 compared to baseline.

Eligibility criteria:
inclusion criteria: 1. male and female patients \>=18 years old. 2. meet rome iv criteria for ibs for at least 6 months. no restrictions on type of ibs. 3. english proficiency (in order to understand use of the application. 4. patient must be on a stable regimen for ibs for at least 30 days. 5. patients must own a smartphone (ios or android) in order to participate in the cbt application. exclusion criteria: 1. laboratory or imaging evidence of an alternative explanation of patient's symptoms. 2. active gastrointestinal disease such as crohn's disease, ulcerative colitis, history of complete colon resection, acute infection, or any disease that precludes participation in cbt application. 3. patient already undergoing cognitive behavioral therapy. 4. psychiatric hospitalization within 10 years. 5. current or past diagnosis of a major mental illness such as schizophrenia, bipolar disorder, personality disorder or substance abuse. 6. active (within the past 3 months) suicidal ideation. 7. prisoners or other detained individuals. 8. adults unable to consent. 9. pregnant people.

Keywords: irritable bowel syndrome cognitive behavioral therapy self help
the validation of the fibricheck application for the detection of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: optical sensing technologies have the potential to enable long-term heart rhythm monitoring. the medically certified and clinically validated fibricheck technology has proven its value for spot-check measurements to detect af. however, further validation and verification of this technology is necessary to evaluate the performance of the fibricheck technology on different tools (smartphones and smartwatches). during this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. the objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ecg signal.

during this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. the objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ecg signal. therefore, 2 groups will be created where different technologies will be investigated i.e. group 1 will use various mobile devices and group 2 will use various wearable devices. the recruitment of patients will be carried out in the framework of the usual care practice, where patients can be recruited at different moments throughout their current care-cycle. group 1: smartphone based sensor: here, the user needs to place the finger on the smartphone camera for 60 seconds to obtain high quality ppg waveforms. these waveforms are analysed using automated algorithms and stored under a unique anonymized study id. group 2: smartwatch based sensor: here, a wearable device is used that is placed on the wrist and will record a ppg signal, similar as the smartphone camera, but with a specific ppg sensor. the data is extracted and processed by the fibricheck software and the algorithms generate a diagnostic output which is stored under a unique anonymized study id. the hardware involved originates from different providers. since fibricheck is certified as stand-alone software, it is expected that it functions independently from different hardware sources. this hypothesis will be addressed in this study. smartphone devices that will be used in this research: samsung, huawei, xiaomi, apple, lge, lenovo and zte devices. wearable devices that will be used in this research: apple and fitbit smartwatch devices.

Eligibility criteria:
inclusion criteria: * 18 years or older exclusion criteria: * pacemaker dependent heart rhythm * tremor or parkinson's disease * barriers for communication and lack of capability to execute the handlings required for this study

Keywords: atrial fibrillation fibricheck validation smartphone smartwatch
a phase iii clinical study of purinostat mesylate for injection in patients with diffuse large b-cell lymphoma

Conditions: Recurrent and Refractory Diffuse Large B-cell Lymphoma

Summary: the main objective of this study is to evaluate the differences in objective response rate and overall survival between the purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (bicr), in patients with relapsed or refractory diffuse large b-cell lymphoma. .the participants in the experimental group will receive treatment with purinostat mesylate for injection. the dosage is 11.2 mg/m2. each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. a 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles. .participants in the control group will receive selinexor treatment. the recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, monday and wednesday, or tuesday and thursday), and a 4-week period constitutes one treatment cycle.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, no gender restrictions; 2. histologically-confirmed dlbcl, participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines); 3. participants must have measurable disease; 4. ecog≤2; 5. adequate organ function exclusion criteria: 1. pregnancy or breastfeeding; 2. previous history of transplantation; 3. double/triple hit b cell lymphoma; 4. patient with known active infection, or reactivation of a latent infection; 5. any serious diseases that investigator deems inappropriate to participate.