Kornimate/medical-research-clean huggingface dataset:
modulating anxious coping

Conditions: Anxiety Disorders

Summary: this is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rtms) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations. the study is recruiting people who recently started treatment for anxiety or a related concern. the study involves 3 visits to the medical university of south carolina. at the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. at the next two visits, participants receive rtms, which works by rapidly turning a focused magnetic field on and off repeatedly over the head in a way that passes directly through the hair, scalp, and skull and onto the brain and can temporarily increase brain activity under the magnetic field. after rtms, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head. each visit in this study is expected to last between 2 - 4 hours. this is not a treatment study, but the study is being conducted with the hope that it will help improve treatment in the future.


Eligibility criteria:
inclusion criteria: * 18 - 65 y.o. * meets criteria for an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder, specific phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety * is currently seeking mental health treatment * is able to read consent document and provide informed consent. * english is a first or primary fluent language. exclusion criteria: * current alcohol or substance use disorder of more than mild severity (as defined by dsm-5 and determined using standardized self-report instruments) * lifetime diagnosis of psychotic disorder or bipolar mania * presence of neurological disorder that contraindicates tms or neurophysiological recording: seizure disorder lifetime history of traumatic brain injury with loss of consciousness neurodegenerative disorder (e.g., alzheimer's disease, parkinson's disease, frontotemporal dementia) * presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods * presence of standard contraindications for mri or rtms metal in the body currently pregnant claustrophobia significant sensitivity to noise medical conditions or treatments that lower seizure threshold history of severe brain injury history of seizures/ epilepsy * currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication note: ssri, cholinesterase inhibitors or nmda receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment * currently taking chronic opiate medications or substances * currently taking naltrexone
nasal decolonization of dialysis patients noses

Conditions: Staphylococcus Aureus Infection

Summary: hemodialysis patients are at high-risk for infections, specifically staphylococcus aureus infections. the investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent s. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. if successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent s. aureus infections.

the paints study is a stepped-wedge cluster randomized trial that will compare standard care to an intervention that includes nasal povidone-iodine at each hemodialysis session to determine whether nasal povidone-iodine prevents infections. the nasal povidone-iodine will be donated by 3m. this formulation of nasal povidone-iodine was developed under the tentative final monograph for health-care antiseptic drug products 21 cfr parts 333 and 369 (docket # 75n-183h), federal register volume 59, number 116, friday, june 17, 1994, proposed rules. however, the product need not be controlled like a pharmaceutical drug. the product may be stored and controlled similarly to an iodine or alcohol skin preparation product.

Eligibility criteria:
inclusion criteria: * adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers. note: the unit of randomization is the dialysis center, not the individual patient exclusion criteria: patients receiving peritoneal dialysis or home hemodialysis pregnant women patients with known sensitivity or allergy to iodine (documented or verbalized) patients with active bacterial infections children \< 18 years of age. patients with infections at the beginning of the study will enter the study after antibiotic treatment is complete.

Keywords: dialysis povidone-iodine
plasma oxytocin changes in response to low-dose mdma vs. placebo in patients with arginine vasopressin deficiency and healthy controls

Conditions: Central Diabetes Insipidus

Summary: the investigator hypothesize that low-dose mdma (3,4-methylenedioxymethamphetamine) will produce a sufficiently strong oxytocin stimulation in healthy controls and no relevant increase in patients. this study will confirm previously published data and provide important safety data with low-dose mdma stimulation testing.


Eligibility criteria:
inclusion criteria patients: 1. adult patients with confirmed diagnosis of arginine vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency inclusion criteria healthy controls: 1. adult healthy controls 2. matched for age, sex, body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients 3. no medication, except hormonal contraception exclusion criteria: 1. participation in a trial with investigational drugs within 30 days 2. illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months 3. consumption of alcoholic beverages \>15 drinks/week 4. tobacco smoking \>10 cigarettes/day 5. cardiovascular disease (coronary artery disease, heart failure left ventricular ejection fraction \<40%, stroke in the last 3 months, atrial fibrillation/flatter, wolff-parkinson-white-syndrome) 6. uncontrolled arterial hypertension (\>140/90 mmhg) or hypotension (\<85mmhg) 7. current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder) 8. psychotic disorder in first-degree relatives 9. regular intake of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors 10. pregnancy and breastfeeding 11. diagnosed chronic kidney disease \> grade iii (glomerular filtration rate \< 30ml/min) 12. diagnosed liver cirrhosis or alanine aminotransferase (alat) or aspartate aminotransferase (asat) levels 2.5 times above the normal range

Keywords: mdma oxytocin arginin vasopressin
integrating stroke survivors into cardiac rehabilitation

Conditions: Stroke

Summary: the intervention trial will examine the effectiveness and feasibility of integrating stroke survivors into an existing hospital-based cardiac rehabilitation program at novant health in charlotte, nc. stroke survivors will be recruited through hospital system providers and physical therapists (pts) for entry into a multidisciplinary, three-month cardiac rehabilitation program. this program consists of three sessions per week of supervised cardiovascular endurance and strength training, stretching, relaxation and education. participants will be stroke survivors, have completed formal physical and occupational rehabilitation (if applicable), and have treating provider approval.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke * completion of physical and occupational therapy (if applicable) * clearance by treating medical provider * ability to walk at least 40 meters independently (with or without assistive device) * ability to transfer sit to stand without assistance * ability to follow instructions and provide information on exertion, pain and distress exclusion criteria: * acute medical problem rendering exercise unsafe * significant pain that prevents standing or interferes with movement * history of additional, non-stroke, neurological condition
procrit and short-term outcomes in orthopedic surgery

Conditions: Anemia; Surgery, Arthroscopy

Summary: the purpose of this study is to compare the effect of perioperative administration of procrit to that of autologous blood donation on post-operative rehabilitation outcomes in patients undergoing unilateral knee surgery.

the primary objective of this study is to compare the effect of perioperative administration of procrit to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty. secondary objectives are : 1) to compare the effect of perioperative administration of procrit to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) to compare the effect of perioperative administration of procrit to that of preoperative autologous donation on inpatient rehabilitation length of stay. the study will test the hypothesis that perioperative administration of procrit will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000u procrit or placebo sc in relation to surgery date: days -21, -14, -7, 0 (day of surgery), 7, and 14.

Eligibility criteria:
inclusion criteria: * scheduled for primary unilateral knee arthroplasty with an expected discharge into an inpatient rehabilitation facility * hemoglobin \>11 to \<13 g/dl at screening and preoperative day -21 * age 18 years or older * female subjects must be post-menopausal for at least one year or surgically sterile (hysterectomy or tubal ligation). women of childbearing age must have negative pregnancy test(s) (serum hcg ria at screening and urine at preoperative day -21, if applicable * preoperative lead time of at least 21 days exclusion criteria: * medical conditions including: known iron deficiency (defined as serum ferritin \<50 mg/l) * chronic renal failure, significant hematological disease, uncontrolled hypertension, new onset seizures/uncontrolled seizures * expected to need another lower extremity major joint replacement within six months * undergoing cancer chemotherapy * history of thrombotic vascular events including but not limited to stroke, transient ischemic attack, myocardial infarction and deep venous thrombosis

Keywords: anemia erythropoetin quality-of-life outcomes
psychological well-being outcomes in disease-free survivors of colorectal cancer following curative surgery

Conditions: Adaptation, Psychological; Functional Insufficiency

Summary: the purpose of the study is to investigate whether there are prognostic factors regarding the mental and functional adjustment of colon cancer patients following curative surgery. patients will be selected using specific inclusion criteria. prognostic factors investigated include personality characteristics, initial distress, medical, social and economic factors. the utmost purpose of the study is to assist clinicians with the timely identification of vulnerable patients in order to ensure their proper management and their optimal adjustment. moreover this is the first study using the distress thermometer in greek patients with cancer.


Eligibility criteria:
inclusion criteria: * patients with first-diagnosed colon cancer. * age 18-60 years exclusion criteria: * metastatic colon cancer. * former psychiatric history. * substance use. * previous serious medical conditions.
pharmacokinetics of g3139 in subjects with advanced melanoma, including those with normal hepatic function and those with moderate hepatic impairment

Conditions: Advanced Melanoma and Normal or Impaired; Hepatic Function

Summary: this is an open-label, parallel-group study with a total of 16 evaluable subjects. subjects will be assigned to 1 of the following cohorts: cohorts i (subjects with normal hepatic function; n+8 and cohort ii (subjects with moderate hepatic impairment, child-pugh classification grade b; n=8). if, for any reason, the genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the genasense infusion is changed, the subject will be replaced.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of malignant melanoma * metastatic stage iv disease, or stage iii disease that is not surgically resectable * ecog performance status of 0,1,or 2 * adequate venous access * agreement to practice effective methods of birth control * hepatically impaired consistent with child-pugh classification grade b exclusion criteria: * chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites * prior organ allograft * requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy * known hypersensitive to dtic * prior treatment with genasense
an examination of the effects of health-related internet use in individuals with pathological health anxiety using ambulatory assessment

Conditions: Health Anxiety

Summary: the purpose of the current explorative study is to examine the effects of health-related internet use in individuals with pathological health anxiety using ambulatory assessment. in a naturalistic setting participants answer over a seven-day period questionnaires about their health-related internet use and its effects on affect, health anxiety and symptom severity in their usual daily lives.

the internet is a popular method for obtaining information. increasingly, it is also used to answer medical and health questions, because compared to other methods (e.g. going to the library or visiting a doctor) it has a number of advantages to offer like low costs, availability, easy accessibility, anonymity, and great diversity of information types and sources. 60 to 80 percent of internet users search online for medical information. in this context the term "cyberchondria" was coined in the media to describe the potentially detrimental effects of this behavior. the first studies in this field using self-report retrospective data showed that individuals with elevated levels of health anxiety seem to make increased use of the internet for this purpose and it seems to maintain health anxiety in the long-term. however, up until today little is known about the consequences of this behavior and the maintaining mechanism. this observational study aims to investigate the effects of health-related internet use in individuals with pathological health anxiety in a naturalistic setting using ambulatory assessment. the variables of interest are monitored using time- and event-based sampling methods. therefore, over a seven-day period participants answer seven times a day questionnaires on a mobile phone in their usual daily lives and additionally track the variables of interest in the moment the target behavior (health-related internet use) occurs. to our knowledge, this is the first study to investigate these relations using ambulatory assessment and therefore additionally aims to investigate the feasibility of this study design in this specific field of research.

Eligibility criteria:
inclusion criteria: * pathological health anxiety according to the criteria of fink et al., 2004 * informed consent * sufficient german language skills * sufficient skills using a computer, a mobile phone and the internet exclusion criteria: * suicidal tendency * clinical diagnosis of alcohol or drug abuse, acute schizophrenia * organic brain disorders * impairment of intelligence

Keywords: cyberchondria health-related internet use pathological health anxiety ambulatory assessment
a phase 2 study to explore the dose of hcp1803 in patients with essential hypertension

Conditions: Hypertension

Summary: a multicenter, randomized, double-blind, parallel, phase 2 study to explore the dose of hcp1803 in patients with essential hypertension


Eligibility criteria:
inclusion criteria: 1. patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions * mean sitsbp \<180 mmhg and mean sitdbp \< 110 mmhg for patients receiving any bp-lowering drug within 1 month prior to visit 1 * 140 mmhg ≤ mean sitsbp \< 180 mmhg and mean sitdbp \< 110 mmhg for patients not receiving bp-lowering drugs within 1 month prior to visit 1 2. patients with essential hypertension who meet 140 mmhg ≤ mean sitsbp \< 180 mmhg and mean sitdbp \< 110 mmhg at visit 2 exclusion criteria: 1. difference between arms greater than 20 mmhg for mean sitsbp or 10 mmhg for mean sitdbp at visit 1 2. orthostatic hypotension with symptoms within 3 months prior to visit 1. 3. secondary hypertensive patient or suspected to be 4. uncontrolled diabetes mellitus(hba1c \> 9%) or type i diabetes mellitus 5. active gout or hyperuricemia (uric acid ≥ 9mg/dl) 6. severe heart disease or severe neurovascular disease 7. moderate or malignant retinopathy 8. clinically significant hematological finding 9. severe renal diseases (egfr\<30ml/min/1.73m2) 10. severe or active hepatopathy (ast or alt ≥ 3 times of normal range) 11. hypokalemia or hyperkalemia(k\<3.5mmol/l or k ≥ 5.5mmol/l) 12. hyponatremia or hypernatremia(na\<135mmol/l or na ≥ 155mmol/l) 13. hypercalcemia 14. history of malignancy tumor 15. history of autoimmune disease 16. history of alcohol or drug abuse 17. positive to pregnancy test, nursing mother, intention on pregnancy 18. considered by investigator as not appropriate to participate in the clinical study with other reason
a phase 2b/3 study of tpx-115 on partial-thickness rotator cuff tear

Conditions: Partial Thickness Rotator Cuff Tear

Summary: rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. this study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. the primary outcome is change in constant score (cs) at 24 weeks after tpx-115 injection. secondary outcomes include changes from baseline in cs, visual analogue score (vas) pain score, american shoulder and elbow surgeons (ases) score, quick disabilities of the arm, shoulder and hand (quick-dash), simple shoulder test (sst), and functional evaluations including range of motion (rom) at 4, 12, 24 and 52 weeks after administration and structural evaluation using mri at 24 and 52 weeks after injection.


Eligibility criteria:
inclusion criteria: 1. be 19 years of age or older. 2. have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of ellman grade ii assessed by mri. 3. have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment 4. vas pain score ≥4 at screening. 5. understand fully the study and voluntarily sign the informed consent for participation in the study. exclusion criteria: 1. regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by mri. 2. have been treated with the following * have had painkiller within 1 week prior to screening visit. * have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit. * have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit. * have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit. 3. have been diagnosed with the following diseases. * inflammatory joint diseases * other shoulder diseases which may cause shoulder pain or functional disorder * autoimmune diseases * active hepatitis b or c * hiv ab positive * malignant tumors within the last 5 years * coagulopathy * genetic disorders related to fibroblasts of collagen * other serious diseases deemed to affect the results of the study 4. have allergies to bovine proteins or gentamicin. 5. be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study. 6. have participated in other clinical trials and received investigational agents within 4 weeks of this study. 7. be deemed inadequate for the study by investigators.
safety and efficacy of hyperbaric oxygen for ards in patients with covid-19

Conditions: SARS (Severe Acute Respiratory Syndrome); Cytokine Storm; ARDS, Human; COVID-19; Sars-CoV2; Acute Respiratory Failure

Summary: covid-19 may cause severe pneumonitis that require ventilatory support in some patients, the icu mortality is as high as 62%. hospitals do not have enough icu beds to handle the demand and to date there is no effective cure. we explore a treatment administered in a randomized clinical trial that could prevent icu admission and reduce mortality. the overall hypothesis to be evaluated is that hbo reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with covid19 pneumonitis by attenuating the inflammatory response.

main objective: to evaluate if hbo reduce the number of icu admissions compared to best practice for covid-19 secondary objectives: main secondary objectives: to evaluate if hbo: * reduces mortality in severe cases of covid-19. * reduces morbidity associated with covid-19. * reduce the load on icu resources in covid-19. * mitigate the inflammatory reaction in covid-19. other secondary objectives (in selection): to evaluate if hbo is safe for sars-cov-2 positive patients and staff. study design: randomized, controlled, phase ii, open label, multicentre study population: adult patients with sars-cov-2 infection, with at least two risk factor for increased mortality, likely to develop ards criteria and need intubation within 7 days of admission to hospital. number of subjects: 200 (20+180) investigational product: hyperbaric oxygen (hbo) compared with best practice treatment hbo: hbo 1.6-2.4 ata for 30-60 min, maximum 5 treatments first 7 days control: best practice treatment for covid-19

Eligibility criteria:
inclusion criteria: 1. aged 18-90 years 2. pao2/fio2 (pfi) below 200 mmhg (26.7 kpa) 3. suspected or verified sars-cov-2 infection 4. at least two risk factors for increased morbidity/mortality * age above 50 years * hypertension * cardiovascular disease * diabetes or pre-diabetes * active or cured cancer * asthma/copd * smoking * d-dimer \> 1.0 mg/l * auto-immune disease 5. documented informed consent according to ich-gcp and national regulations exclusion criteria: 1. ards/pneumonia caused by other viral infections (positive for other virus) 2. ards/pneumonia caused by other non-viral infections or trauma 3. known pregnancy or positive pregnancy test in women of childbearing age 4. patients with previous lung fibrosis more than 10% 5. ct- or spirometry-verified severe copd with emphysema 6. contraindication for hbo according to local guidelines 7. not likely to need icu admission \< 7 days of screening (subjective criteria that may exclude any patients that fulfil the other inclusion criteria but where the treating physician suspect a spontaneous recovery) 8. mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation 9. prisoner (exclusion criteria according to irb at ucsd)

Keywords: covid-19 hyperbaric oxygen ards sars-cov-2 icu admission