Kornimate/medical-research-clean huggingface dataset:
understanding non-invasive vagus nerve stimulation effects in ptsd

Conditions: PTSD - Post Traumatic Stress Disorder

Summary: the goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. to answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. the main questions it aims to answer are: does non-invasive vagus nerve stimulation help reduce anxious arousal? does non-invasive vagus nerve stimulation help dampen learned fear?

this study aims to determine how non-invasive brain stimulation (delivered through the ear) affects learning processes. during this study, participants who have experienced a trauma will be asked to complete surveys and come to the lab for about 7 hours across four lab visits. researchers will measure body responses (heart rate, skin conductance, startle), while the ear is stimulated. participants also will be asked to complete a startle task. the study is at the wayne state university tolan park research clinic. participants will be compensated for their time. to be eligible, participants must be 18-70 years old, have experienced or witnessed a traumatic event, be able to commit 7 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer. aim 1. establish feasibility and acceptability of tavns in a diverse sample of detroit metro residents with symptoms of posttraumatic stress. it is hypothesized that tavns delivery will be feasible and acceptable for individuals with trauma exposure and pts symptoms, and that there will be no difference in acceptability/tolerability between the active and sham conditions. aim 2. establish the effects of active versus sham tavns on physiological indicators during fear extinction. it is hypothesized that active compared to sham tavns will a) result in facilitation of fear extinction, and b) show greater modulation of physiological responding. exploratory aim: data will be explored for individual differences (affective blunting, hyperarousal, impaired discrimination of conditioned stimuli) which moderate tavns effects. this proposed project will determine how tavns delivered at higher doses than have been previously administered influence the course of adaptive posttraumatic processing in a sample with trauma exposure, while evaluating the psychophysiological profile in multiple contexts.

Eligibility criteria:
inclusion criteria: 1. ages 18-80 2. fluent in english 3. experience with a dsm-5 criterion a trauma (lec-5) 4. probable ptsd (pcl-5 ≥ 32) exclusion criteria: 1. visual or auditory impairment 2. major injury at time of screen or study procedures 3. taking ≥20 mg morphine per day 4. current substance use or intoxication (12-panel drug test) 5. intellectual disability (moca) 6. self-inflicted injury 7. occupational injury 8. prisoner 9. ongoing domestic violence 10. pregnant or breastfeeding 11. contraindications for tavns

Keywords: ptsd brain stimulation fear learning autonomics fear potentiated startle
endolumenal partial myotomy for the treatment of esophageal achalasia

Conditions: Achalasia

Summary: achalasia is a primary esophageal motility disorder where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. surgical myotomy represents an appropriate therapeutic option. the purpose of this study is to evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for invasive surgery.

in this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from esophageal achalasia. under general anesthesia patients will have upper endoscopy. submucosal injection and mucosal incision is created for entry into the submucosal space. a submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. dissection will continue distally beyond the lower esophageal sphincter. the inner circular muscle fibers will then be divided to achieve an adequate myotomy length. the mucosal entry is then closed appropriately. results will be compared to historical data of conventional heller myotomies.

Eligibility criteria:
inclusion criteria: * candidate for elective heller myotomy * ability to undergo general anesthesia * ability to give informed consent exclusion criteria: * previous mediastinal or esophageal surgery * contraindications for egd

Keywords: endolumenal myotomy, per oral endoscopic myotomy
study of the efficacy and safety of lcz696 alone and in combination with amlodipine in patients with hypertension

Conditions: Hypertension

Summary: to evaluate the blood pressure lowering effect and safety of lcz696 when given alone and in combination with amlodipine in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: 1. male or female outpatients 2. patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy 3. treated patients (using antihypertensive treatments within 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and \<180 mmhg at the randomization visit and mssbp ≥140 mmhg \<180 mmhg at the preceding visit. 4. untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to visit 1) must have an mssbp ≥150 mmhg and \<180 mmhg at both the randomization visit and the preceding visit. 5. patients must have an absolute difference of ≤15 mmhg in mssbp between the randomization visit and the preceding visit. 6. ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period. exclusion criteria: 1. severe hypertension (msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg) 2. history of angioedema, drug-related or otherwise 3. history or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension 4. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke 5. history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1 6. pregnant or lactating women 7. women of child-bearing potential not using highly effective methods of contraception other protocol defined inclusion/exclusion criteria may apply

Keywords: lcz696, amlodipine, hypertension, abpm
messaging therapy for depression and anxiety: a longitudinal effectiveness study

Conditions: Depressive Symptoms; Anxiety Disorders

Summary: therapies delivered via technology have been developed to improve accessibility, however, there is limited research regarding messaging therapy in particular, and none that we know of utilizing a longitudinal effectiveness design. the aim of this study was to investigate the overall effectiveness of messaging therapy, identify any contributors to its effectiveness, and to evaluate a dosage effect for this type of treatment.


Eligibility criteria:
inclusion criteria: * diagnosed depression and/or anxiety disorder exclusion criteria: * any psychosis related symptoms or disorders

Keywords: technology messaging psychotherapy depression anxiety telehealth
safety & efficacy study of at-101 in combination w/ rituximab in previously untreated grade i-ii follicular non-hodgkin's lymphoma

Conditions: Follicular Lymphoma

Summary: this is a phase ii clinical trial in patients who have not received systemic treatment for follicular non-hodgkin's lymphoma. the study combines rituximab, an approved drug for this disease, with at-101, an experimental drug. the hypothesis is that by adding at-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.

further study details provided by ascenta.

Eligibility criteria:
inclusion criteria: * histologically confirmed, previously untreated grade i-ii follicular b-cell non-hodgkin's lymphoma (stage i, ii, iii and iv). patients may have received radiation therapy to one lymph node region; stage i or ii patients must have relapsed after prior radiation therapy to be eligible; * patients with any flipi score may participate. patients with flipi scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with flipi scores of 0-2 must have evidence of worsening disease; * ecog performance status 0-1; * measurable disease; * adequate hematological function as indicated by: * absolute neutrophil count (anc) \>1,000/µl; +hemoglobin \>8 g/dl (it is acceptable to transfuse prbc to achieve this criterion); * platelet count \>50 x 109/l. * adequate hepatic and renal function as indicated by: * serum creatinine ≤2.0 mg/dl; * serum albumin ≥2.5 g/dl; * total bilirubin ≤1.5 x upper limit of normal (uln); * serum ast and alt ≤1.5 x uln. * able to swallow and retain oral medication exclusion criteria: * patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites); * active symptomatic fungal, bacterial and/or viral infection including, but not limited to active hiv or viral hepatitis (a, b or c); * history of hepatitis b infection; * any b-cell, t-cell or transformed lymphoma other than histologically confirmed follicular non-hodgkin's lymphoma; * central nervous system (cns) lymphoma, cns or leptomeningeal involvement by lymphoma (treated or in remission), hiv-related lymphoma, or patients with symptoms suggesting hiv infection;

Keywords: cancer lymphoma non-hodgkin's non-hodgkins at-101 at101 rituxan rituximab
internet-based hiv/sti prevention for young msm receiving hiv testing

Conditions: HIV; HIV Infections

Summary: the purpose of this study is to develop an empirically validated, scientifically-based hiv and sti prevention program that can be delivered online to young men who have sex with men (ymsm) who were recently tested for hiv.

presently, there are a limited number of proven hiv interventions culturally tailored to young men who have sex with men (ymsm). this is alarming because men who have sex with men comprise 68% of hiv/aids diagnoses in men, despite representing a much smaller proportion of the population. in addition, msm are reporting more sexual risk behavior than in previous years and there is significant concern that hiv infection rates may once again be on the rise after more than a decade of remaining relatively stable. the internet is a viable intervention avenue because of it's high percentage of accessibility and usage, especially among young adults. moreover, it might hold a strong appeal for ymsm, since its anonymity confers a sense of perceived safety against stigma surrounding hiv prevention information. the purpose of this study is to compare two different versions of an online hiv/sti intervention for ymsm. this study is part of an overall program of research designed to understand and prevent hiv infection among high-risk youth. participation in this study will help us to determine the usefulness of an tailored and interactive hiv internet-assisted intervention.

Eligibility criteria:
inclusion criteria: * between 18 and 24 years of age * self-identify as a biological male * understand and read english * have tested hiv negative at an approved clinic within 6 weeks * report at least one (male) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months. exclusion criteria: * have been diagnosed with hiv within the past three months * participation in another hiv prevention program * no access to the internet or an email address

Keywords: hiv risk internet intervention homosexuality, male hiv seronegativity
investigating the clinical impact of a novel adipose allograft matrix on knee fat pad impingement treatment

Conditions: Fat Pad Syndrome

Summary: this study is to assess the effect of renuva® on fat pad regeneration in patients with fat pad impingement

the fat pad of the knee works to stabilize the patella and releases cytokines, growth factors, and stem cells. these cytokines, growth factors, and stem cells exhibit anti-inflammatory, anabolic effects that can be recruited to heal the articular tissues of the knee and ameliorate their catabolic effects during osteoarthritis (oa). the majority of the current treatments for fat pad impingement (fpi) and its sequelae are primarily symptom-modifying, and structure-modifying therapies both at the joint and peri-articular structures levels cannot be overemphasized. renuva® (mtf biologics) is a food and drug administration approved, off-the-shelf, injectable decellularized allograft adipose matrix (aam) used to increase volume in adipose tissue. once injected, native cell populations infiltrate the aam, and over time, the aam remodels into native tissue and stimulates both adipogenesis and angiogenesis within the tissue. our specific aim is to assess the effect of renuva® on fat pad regeneration in patients with fpi. the investigators hypothesize that injection of renuva® into a diseased fat pad of the knee increase the volume of the fat pad and reduce any hemorrhage, edema or fibrosis present, when pre-to post-treatment images are compared.

Eligibility criteria:
inclusion criteria: * 18-85 years of age * fat pad impingement * knee mri taken before study enrollment * working knowledge of english language (to be able to complete all outcome scores) * ability to attend all follow-up appointments. * able to undergo mri exclusion criteria: * medical condition that may impact outcomes of procedure including: * systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc * undergoing current cancer treatment (other than non-melanoma skin malignancies) * gout, pseudogout (including radiographic evidence of chondrocalcinosis) * history of infection or current infection at the affected joint * smoking (former smokers\< 1 year from quit date) * significant allergies manifested by a history of anaphylaxis or severe allergen sensitivity

Keywords: fat pad impingement adipose allograft matrix
a study of cranial electrotherapy stimulation as an add-on treatment for tic disorders (scatt)

Conditions: Tic Disorder, Childhood

Summary: tic disorders is recognized as a neuropsychiatric disease. the treatments of tic disorders include drug therapy, psychotherapy and physical therapy. as a non-invasive therapy, cranial electrotherapy stimulation(ces) is approved to have few side effects and applied in various areas, especially in psychiatric diseases. however, up to now there have been no results about the effects of ces in the treatment of tic disorders.the investigators hope ces could offer a useful approach for treating tic disorders.

the investigators will conduct a randomized, double-blind, sham-controlled trial to determine the efficacy of ces as an add-on treatment for tic disorders (scatt). the study will be conducted at an outpatient, single-center academic setting. a total of 100 patients aged 6 to 17 years with tic disorders and lack of clinical response to 4 weeks' pharmacotherapy will be enrolled. patients will be randomly into 2 groups and given 4 weeks' treatment, including 40 daily 30-minute sessions of active ces(500μa\~2ma) or sham ces(lower than 100μa) on weekdays. change in yale global tic severity scale (ygtss) is considered to be the primary outcome. the secondary outcome is the changes in clinical global impression (cgi) and hamilton anxiety scale (hama). assessments will be performed at baseline, week 2, week 4 and week 8. adverse events(ae) will be also evaluated.

Eligibility criteria:
inclusion criteria: * aged 6-17 years old * diagnosed with td, according to intentional classification of diseases (icd-10) criteria, currently in a phase of exacerbation. * presented to be lack of response to medication after 4 weeks of treatment exclusion criteria: * physical illnesses, such as cholera, hepatolenticular degeneration, myoclonic epilepsy, drug-induced extrapyramidal symptoms and organic diseases * substance dependence and abuse * severe psychiatric disease, such as depression, bipolar disorder, schizophrenic disease, * risk for suicide or attempted suicide * researchers think that the patient is not suitable for the study

Keywords: tic disorders tourette syndrome cranial electrotherapy stimulation ces
effects of iron and/or zinc supplementation in mexican school children exposed to lead

Conditions: Lead Poisoning

Summary: lead is negatively linked to nutritional status, behavior and cognition in children. despite extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a problem in developed and developing countries. when lead exposure is unavoidable due to its pervasive nature, effective means of protecting or disrupting that exposure need to be developed. nutritional interventions are one such option. we conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in torreón, mexico (altitude 1060 m). nine schools were selected based on proximity to a lead smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30 mg zinc, both, or placebo. in addition to biochemical indicators, cognitive functions and behavior were evaluated at baseline, after the 6-month supplementation period, and again after another 6 months (without supplementation). at baseline, 602 children ages 6.2-8.5 years were enrolled.

we conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in torreón, mexico (altitude 1060 m) to test the hypothesis that supplementation with iron, zinc or both will reduce blood lead concentrations of the children and improve their cognition and behavior. nine schools were selected based on proximity to a lead smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30 mg zinc, both, or placebo. in addition to biochemical indicators (blood lead, serum ferritin, crp, serum zinc, urinary arsenic concentrations), cognitive functions and behavior were measured. assessments were conducted at three time points: at baseline, after the 6 month treatment, and again after another 6 months without treatment. at baseline, 602 children ages 6.2-8.5 years were enrolled.

Eligibility criteria:
inclusion criteria: * 1st grade child exclusion criteria: * blood lead concentration =\>45 ug/dl * hemoglobin concentration \< 9 g/dl

Keywords: blood lead, iron, zinc, child, cognition, behavior, mexico
comparing carbon ion therapy, surgery, and proton therapy for management of pelvic sarcomas involving the bone

Conditions: Bone Sarcoma; Chondrosarcoma; Chordoma; Ewing Sarcoma of Bone; Pelvic Rhabdomyosarcoma

Summary: this study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. there are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. the purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.

primary objectives: i. demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (pro-hrqol) outcomes and less significant toxicities compared with surgery. ii. demonstrate whether carbon ion therapy provides improved local control versus proton therapy. outline: patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * males and females \>= 15 years of age * newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, ewing sarcoma with bone involvement, rhabdomyosarcoma (rms) with bone involvement or non-rms soft tissue sarcoma with bone involvement * no evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging * eastern cooperative oncology group (ecog) performance status (ps) =\< 2 * patients capable of childbearing must agree to use adequate contraception * ability to complete questionnaire(s) by themselves or with assistance * ability to provide written informed consent * chemotherapy per institutional guidelines is allowed exclusion criteria: * patients receiving palliative treatment * recurrent disease * males and females \< 15 years of age * previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. in other words, treatment on this study would require re-irradiation of tissues * patients with distant sarcoma metastases * benign pelvic bone histologies * any of the following: * pregnant women * nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception
mandibular advancement device and changes in nocturia

Conditions: Obstructive Sleep Apnea; Nocturia; OSA

Summary: the main purpose of this study is to test is mandibular advacenment device (mad) use is associated with reductions in nocturia.

after been informed about the study and informed about risks and benefits, participants will be fitted with a mad and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. at that point, second sleep study with mad in place will be performed to assess treatment effectiveness.

Eligibility criteria:
inclusion criteria: * english speaker * \>18 y/o * obstructive sleep apnea diagnosis with ahi≥5 * ≥ 2 voiding/night at baseline * upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm * consent to participate in the study. exclusion criteria: * patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder). * prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia) * pregnancy * heart failure, use of diuretics, diabetes, parkinson's disease or dementia. * patients using combination therapy for the management of obstructive sleep apnea (osa) (i.e. positive airway pressure (pap) therapy or positional therapy). * upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments. * exaggerated gag reflex. * lack of coordination or dexterity. * inadequate english comprehension.

Keywords: obstructive sleep apnea oral appliance nocturia mandibular advancement device