Kornimate/medical-research-clean huggingface dataset:
magnetic stimulation to treat vt storm

Conditions: Ventricular Tachycardia

Summary: ventricular tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (icd) reprograming where applicable, and catheter ablation. despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated. the overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. this is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.


Eligibility criteria:
inclusion criteria: * ≥ 3 episodes of vt in 24 hours exclusion criteria: * pregnancy * implanted ventricular assist device * metal implanted in head or neck (except the mouth) * implanted medication pumps * cochlear implant * implanted brain stimulator * ocular implant * history of active malignancy in region of stimulation (neck)
transcranial magnetic stimulation to augment behavior therapy for tics

Conditions: Tic Disorders; Tics; Tic, Motor; Tic Disorder, Childhood; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence

Summary: the study will examine whether combining comprehensive behavioral intervention for tics (cbit) with inhibition of the supplementary motor area (sma) using transcranial magnetic stimulation (tms) normalizes activity in the sma-connected circuits, improves tic suppression ability, and enhances cbit outcomes in young people with tic disorder. the study will also examine different tms dosing strategies.

all participants will receive 10 daily sessions of cbit, a well-established behavioral treatment that is considered by the american academy of neurology to be the first-line intervention for tics. immediately prior to each cbit session, participants will undergo tms targeting the sma. the specific type of tms procedure will be randomly assigned between subjects and be either: 1 hz repetitive tms (rtms), continuous theta burst stimulation (ctbs), or sham stimulation.

Eligibility criteria:
inclusion criteria: * current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. tics must not be due to a medical condition or the direct physiological effects of a substance. * at least moderate tic severity, defined as a yale global tic severity scale total score ≥14 (≥9 for those with motor or vocal tics only). * full scale iq greater than or equal to 70 * english fluency to ensure comprehension of study measures and instructions. * right-handed exclusion criteria: * medical conditions contraindicated or associated with altered tms risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or participants of childbearing age not using effective contraception, or any other medical condition deemed serious or contraindicated by a study physician * inability to undergo mri. * left handedness. * active suicidality. * previous diagnosis of psychosis or cognitive disability. * substance abuse or dependence within the past year. * concurrent psychotherapy focused on tics. * neuroleptic/antipsychotic medications. * taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
femtosecond laser for cataract surgery

Conditions: Cataract

Summary: the objective of this study is to evaluate the safety and efficacy the optimedica femtosecond laser system, also known as the catalys™ precision laser system, to perform two surgical maneuvers used in the treatment of subjects with cataracts. efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (ccc) and ultrasonic phacoemulsification.


Eligibility criteria:
inclusion criteria: * able and willing to comply with the treatment/follow-up schedule and requirements * able to understand and provide written informed consent * etdrs visual acuity equal to or worse than 20/32 (best corrected) * age between 50 and 80 years old * pupil dilates to at least 6 mm * subject able to fixate * grade 1-4 nuclear sclerotic cataract (locs iii) * axial length between 22 and 26 mm exclusion criteria: * pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding * participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the investigator's careful discretion, as long as not contradictory to any of the above criteria * any condition which, in the investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated * anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via iol master (zeiss). * history of prior ocular surgery * history of ocular trauma * co-existing ocular disease affecting vision * history or current use of alpha-1 antagonist medication (e.g., flomax) * known sensitivity to planned concomitant medications

Keywords: cataract surgery, cataract extraction optical devices, laser
significance of the high-risk hpv viral load

Conditions: HPV Infections

Summary: the aim of this study is to evaluate the significance of an elevated high-risk hpv (hr-hpv) viral load.

we will particularly evaluate if the hr-hpv viral load: * is correlated to the transcription of the genes of the oncoproteins e6 and e7 * is predictive of the integration of the virus in infected cells * is predictive of the presence of hpv in patients' blood * influences the local and systemic immunologic response

Eligibility criteria:
inclusion criteria: * the women consulting for the therapeutic care (by hysterectomy or conization) of a liehg or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy. * the women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. the normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy * the patients participating in this study will have to be of more than 18 years old. all the subjects will be profitable of a regime of social security. exclusion criteria: * the patients having a liebg * the patients incapable to receive the information enlightened on the progress and the objectives of the study * the patients not having signed enlightened assent
nutritional biomarkers of sarcopenia

Conditions: Sarcopenia

Summary: this study proposes to characterize skeletal muscle amino acid kinetics to an eaa challenge, i.e., an oral amino acid tolerance test (oatt), in order to determine the state of muscle health. analogous to the oral glucose tolerance test (ogtt) used to characterize alterations in glucose metabolism, the proposed oatt represents a potential low-cost solution to classifying patients' skeletal muscle health. the extrapolation of this work is the development of a simple analytical tool that would provide clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss of function.

sarcopenia increases the risk of a number of deleterious health conditions and represents a major financial cost to our healthcare system. among older adults who are hospitalized, those with sarcopenia on admission are 5-fold more likely to incur higher hospital costs than those without. the operational definition of sarcopenia is defined as meeting the criteria for all of the following: low muscle strength, low muscle quantity or quality, and low physical performance. the diagnosis of sarcopenia requires techniques that are both expensive and operator-dependent. simple measurements, such as bmi, do not necessarily identify sarcopenia. importantly, current techniques can only identify sarcopenia after a physical/functional impairment has occurred. skeletal muscle amino acid kinetics predict muscle health and functionality. altered amino acid kinetics lead to decrements in muscle mass, quality, and performance. muscle response to circulating essential amino acids (eaa) determines muscle amino acid kinetics. thus, this study proposes to characterize skeletal muscle amino acid kinetics to an eaa challenge, i.e., an oral amino acid tolerance test (oatt), in order to determine the state of muscle health. analogous to the oral glucose tolerance test (ogtt) used to characterize alterations in glucose metabolism, the proposed oatt represents a potential low-cost solution to classifying patients' skeletal muscle health. the extrapolation of this work is the development of a simple analytical tool that would provide clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss of function.

Eligibility criteria:
inclusion criteria: * ages 18 - 30 and 70-89 yrs exclusion criteria: * history of diabetes that requires insulin for control of blood glucose * history of malignancy or chemo/radiation therapy in the 6 months prior to enrollment * history of gastrointestinal bypass/reduction surgery (lapband, gastric sleeve, etc.) * pregnant females * unwilling to wear the breath-collection mask * subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to visit 2 * concomitant use of oral or injectable corticosteroids * concomitant use of testosterone, igf-1, or similar anabolic agent * any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
engaging patients in weight loss tools

Conditions: Obesity

Summary: the overall aim of this study is to evaluate the acceptability and feasibility of a primary-care based approach to facilitating engagement in online behavior tracking and community support networks for weight loss ("facilitation condition") over 12 weeks among adults with obesity.


Eligibility criteria:
inclusion criteria: * pcps: 1. employed as a pcp at a clinics in the uf health care system. 2. has practiced at current clinic for ≥1 year (self-report) 3. is employed ≥ 0.5 fte (self-report) 4. has a patient panel that is majority adult (self-report) * patients: ehr-based criteria: 1. age 18-75 2. last bmi in ehr ≥30 kg/m2 3. has an appointment scheduled ("index appointment") with an enrolled primary care pcp 7-30 days after electronic data pull. 4. is enrolled in mychart or has an email address in the idr system. self-report criteria: 5. self-reported bmi \> 29 kg/m2 (to account for under-reporting) 6. response yes to question: "would you be interested in learning strategies to help you lose weight?" 7. ability to read and understand english without assistance. 8. has either (a) a phone or tablet with a data plan or (b) reliable access to wi-fi (via computer, phone or tablet) in their home. exclusion criteria: * pcps: 1. planning to move out of the gainesville or jacksonville area in the next 12 months. * patients: 1. currently enrolled in formal weight loss program or a research study focused on changing diet, physical activity, or weight. 2. in past month, has tracked the majority of their food intake on an app, website, or paper log an average of 3 or more days per week. 3. self-reported to be pregnant, breastfeeding, or planning to become pregnant in next 6 months. 4. currently undergoing radiation or chemotherapy for cancer. 5. self-reported cardiac event in past 6 months. 6. self-reported heart failure (also known as chronic heart failure or chf). 7. planning to move out of the gainesville or jacksonville area (depending on which clinic they are recruited from) in the next 6 months.
study on the effect of surgical intestinal manipulation

Conditions: Intestinal Manipulation

Summary: the aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.


Eligibility criteria:
inclusion criteria: * patients who are brain death * patients who undergo an elective abdominal aortic aneurysm repair exclusion criteria: * \< 18 years of age

Keywords: brain-death organ donors intestinal manipulation monocytes
prospective trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with gerd.

Conditions: Gastroesophageal Reflux Disease

Summary: a prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with gerd. the primary objective of the present trial is to investigate, clinical feasibility of the gerdx™ device, evaluating surgical aspects, quality of life, and symptom sores. secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement


Eligibility criteria:
inclusion criteria: written informed consent; ≥ 18 years of age; gerd documented by 24h ambulatory multichannel impedance-ph-monitoring off antisecretory therapy and/or gastroscopy by one or more of the following criteria: * total number of reflux events ≥ 73/24h; * demeester score ≥ 14.7; * positive symptom index - si ≥ 50% for symptoms troublesome for the patient with a frequency of at least 3/24hrs; macroendoscopically distinct mucosal breaks. exclusion criteria: patients with known immunological dysfunction (advanced liver disease, hiv, hepatitis c virus infection), drug addiction; ≤ 18 years of age; pregnancy and lactation; previous extensive abdominal surgery; previous esophageal or gastric surgery; hiatal hernia \>2cm; paraesophageal hernia; american society of anaesthesiologists physical status classification \>ii

Keywords: gerd
community-led responses for elimination: controlled trial of reactive case detection versus reactive drug administration

Conditions: Malaria

Summary: this study is designed to compare the effectiveness of reactive focal drug administration (rfda) using dihydroartemisinin+piperaquine (dhap) versus reactive focal test and treat (rftat) using artemether+lumefantrine (al) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in southern province, zambia. these two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.

the study is a cluster randomized controlled trial designed to evaluate the impact of rfda intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. it will be conducted among a background population of \~130,000 people in \~30,000 households in 16 health center catchment areas across several districts in southern province. the government of zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination. the secondary objectives of the study include: 1). compare the effectiveness of rfda using dhap with rftat using al in reducing rapid diagnostic test (rdt) confirmed malaria incidence through passive case detection at health facilities; 2). compare the effectiveness of rfda using dhap with rftat using al in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). compare the cost-effectiveness of rfda using dhap with rftat using al in reducing the burden of malaria in the community; 4). measure the proportion of p. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.

Eligibility criteria:
inclusion criteria: * anyone not excluded and consenting exclusion criteria: * contraindications from manufacturer for medications including currently taking haloperidol, artane, phenergan (promethazine), chlorpromazine, erythromycin, azithromycin, clarithromycin, ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in coartem), quinine, septrin * anyone seriously ill * currently taking antimalarial medicines * allergy to artemisinin drugs * pregnant women in first trimester * children under 3 months of age * reported heart condition

Keywords: malaria elimination surveillance and response dihydroartemisinin+piperaquine
study of sm-88 in advanced cancers

Conditions: Breast Cancer

Summary: the purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.

the primary objective of this clinical trial is to assess the response rate and pfs in previously treated breast cancer patients. additional objectives include the pharmacokinetics of multiple ascending doses of sm-88, a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. secondary objectives of this study include an assessment of safety and tolerability of ascending doses of orally administered sm-88. additional response data will also be collected.

Eligibility criteria:
inclusion criteria: 1. healthy adult subjects, between 18 and 70 years of age, that are willing and able to give written informed consent. 2. subjects must be willing and able to comply with the clinical trial procedures and timelines as outlined in the time and events table. 3. subjects should be continuous nonsmokers and have not used nicotine-containing products for at least three months prior to dosing on day 1. 4. body mass index (bmi) between 20 and 29. 5. as outlined in section 5.1.1.1, subjects of childbearing potential must agree to use an approved method of contraception for the duration of the clinical trial and for three months after the dose of the imp. 6. must be able to swallow and retain oral medication. 7. subjects must be willing to discontinue the use of any vitamins or herbal supplements seven days prior to the imp dosing and not resume the use of these supplements until after pk sample is collected at 168h/day 8. exclusion criteria: 1. prior medical history of any illness or injury that, in the opinion of the principal investigator (pi), that may confound the results of the clinical trial or pose an additional risk to the subject by his participation in the clinical trial. 2. current or historic drug or alcohol abuse. 3. unwillingness to discontinue alcohol intake for 24 hours prior to imp dosing until the collection of the pk sample at 168-h/day 8. 4. subjects should not have a history of lactose intolerance. 5. concurrent use or known history of hypersensitivity to any of the components of sm 88. 6. clinically significant abnormal laboratory test results at screening and/or baseline visit as determined by pi. 7. participation in another clinical trial within 30 days prior to screening. 8. surgery within 90 days prior to dosing determined by the pi to be clinically relevant. 9. subjects must be considered medically healthy with no clinically significant medical history. 10. subjects cannot be taking any concomitant medications. subjects must be willing to discontinue the use of any vitamins or herbal supplements seven days prior to the dose date of the clinical trial and remain off these supplements until the last pk sample is obtained (168h/day 8). 11. positive urine drug screening. 12. positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcv).
superficial cervical plexus block for postoperative analgesia

Conditions: Plexus Block;Analgesia;Neurosurgery

Summary: the incidence of postoperative pain after craniotomy is high. severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. compound local scalp nerve block is a good choice for analgesia after craniotomy. however, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. superficial cervical plexus block (scpb) is theoretically promising to solve the analgesia requirements of such surgical approach. at the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. the purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.


Eligibility criteria:
inclusion criteria: 1. elective suboccipital retrosigmoid approach approach craniotomy; 2. age between 18 and 65 years; 3. american society of anesthesiologists (asa) physical status i-iii. exclusion criteria: 1. the patients or legal clients refuse to provide informed consent; 2. local infection; 3. preoperative impairment of consciousness and cognitive function; 4. uncontrolled hypertension; 5. inability to communicate; 6. allergies to experimental drugs; 7. history of drug abuse; 8. history of chronic headache; 9. aphasia and hearing impairment; 10. patients undergoing second craniotomy; 11. body mass index \ 35.0 kg/m2;
evaluating efficacy and tolerability of anticancer drug therapies for the treatment of gynecologic and breast cancers

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Cancer Metastatic; Ovarian Cancer; Cervical Carcinoma; Endometrial Cancer

Summary: retrospective/prospective observational study. objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (dfs), progression-free survival (pfs), overall survival (os), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.

this is a single-center retrospective/prospective observational study. objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (dfs), progression-free survival (pfs), overall survival (os), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers. regarding the prospective component of the study, it is clarified that therapy will be warranted by clinical practice regardless of study enrollment. diagnostic investigations will also be conducted as per normal practice; enrollment in the study does not require additional examinations.

Eligibility criteria:
inclusion criteria: * diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic; * patients who have received treatment for breast cancer or gynecologic cancer since january 2010; * any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data. exclusion criteria: * no exclusion criteria

Keywords: observational breast cancer gynecologic cancer ovarian cancer cervical carcinoma endometrial cancer