Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of avp-923 in the treatment of central neuropathic pain in multiple sclerosis

Conditions: Central Neuropathic Pain; Multiple Sclerosis

Summary: the objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of avp-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.

the objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of avp-923 (dextromethorphan \[dm\]/quinidine \[q\]) capsules containing either 45 mg dm and 10 mg q (avp-923-45) or 30 mg dm and 10 mg q (avp-923-30) or 20 mg dm and 10 mg q (avp-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of participants with multiple sclerosis (ms) over a 12-week period. the ms participant population enrolled includes participants with relapsing-remitting multiple sclerosis (rrms) and participants with secondary progressive multiple sclerosis (spms).

Eligibility criteria:
main inclusion criteria: multiple sclerosis (relapsing-remitting multiple sclerosis \[rrms\] or secondary progressive multiple sclerosis \[spms\]), clinical history and symptoms of central neuropathic pain (dysesthetic pain) for at least 3 months prior to screening, pain rating scale (prs) baseline score = or \> 4, no ms relapse within previous 30 days. main exclusion criteria: personal history of complete heart block, qt interval corrected for heart rate (qtc) prolongation, or torsades de pointes, family history of congenital qt interval prolongation syndrome, myasthenia gravis, beck depression inventory second edition (bdi-ii) score \> 19
the relationship between superior vena cava flow and intraventricular hemorrhage in preterm infants

Conditions: Preterm Intraventricular Hemorrhage

Summary: the aim of the study was to evaluate the relationship between superior vena cava (svc) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage in preterm born infants.

a prospective, observational cohort study was carried out on newborns that fulfill the eligibility criteria and delivered at the alexandria university maternity hospital (aumh). the neonatal intensive care unit (nicu) of alexandria university maternity hospital with total admissions of approximately 2100 newborn per year of which approximately more than 50% are admitted due to prematurity and its complications. the study was carried out in 3 phases: 1. first phase: enrollment and selection phase. 2. second phase: monitoring and evaluation phase. 3. third phase: statistical analysis of the data

Eligibility criteria:
inclusion criteria: * newborns with very low birth weight (≤1500 g) or ≤ 32 weeks gestation who were admitted to neonatal intensive care unit in the first day of life. exclusion criteria: * newborns (more than 32 weeks of gestation * newborns with birth weight more than 1500 g. * newborns with congenital heart diseases excluding (patent ductus arteriosus and patent foramen ovale) * newborns with major congenital malformations. * newborns with birth trauma especially basal skull/temporal bone fractures that require hospitalization
long term results of surgical and percutaneous double orefices mitral repair in patient with p2 prolapse causing degenerative mitral regurgitation

Conditions: Degenerative Mitral Valve Disease; Mitral Regurgitation

Summary: mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. the gold standard for severe mitral regurgitation is currently mitral valve plastic surgery. edge to edge, on the other hand, allows shorter cec and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by p2 prolapse when quadrangular resection cannot be performed. the main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (p2).


Eligibility criteria:
inclusion criteria: * mitral regurgitation with degenerative etiology * mitral pathology exclusively dependent on p2 * surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique. exclusion criteria: - other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)
transcranial low intensity focused ultrasound neuromodulation as a probe to study human emotion and cognitive function

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to assess the low-intensity focused ultrasound pulsation (lifup) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the lifup to stimulate or inhibit brain activity in healthy volunteers.


Eligibility criteria:
inclusion criteria: * must be right-handed * must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen) * must be healthy (without medical, neurological, psychiatric illness) * must be psychotropic medication free (≥ 14 days) exclusion criteria: * must not be a smoker * females must not be pregnant or nursing * must not suffer from claustrophobia * must not meet exclusion criteria for mri scanning (i.e., non-fixed magnetizable objects) * must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.

Keywords: depression mental illness
computed tomography versus standard 2d mammography versus 3d tomosynthesis

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the imaging performance of an investigational breast computed tomography (ct) scanner, built at uc davis, with that of an fda-approved breast tomosynthesis scanner (capable of producing standard 2-d mammography and 3-d tomosynthesis images), built by hologic, incorporated, in a group of patients with suspected breast cancer.

the primary aim of this study is the comparison of beta values of several different ct and tomosynthesis views (beta of ct sagittal view, beta of ct coronal view, beta of ct axial view, beta of tomosynthesis craniocaudal view, beta of tomosynthesis medial lateral oblique view). lower beta values correspond to better image quality (less noise, increased cancer detection).

Eligibility criteria:
inclusion criteria: * 35 years of age or older * while male patients will not be explicitly excluded, it is expected that all patients in this study will be women * diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -birads (breast imaging reporting and data system) categories 4 and 5 * scheduled for ultrasound or stereotactic core biopsy * ability to lie still on a table top for up to 10 minutes, longer than the typical breast ct duration. * ability to understand risks, procedures, and benefits involved exclusion criteria: * recent breast biopsy * history of breast augmentation implant * pregnant or positive urine pregnancy test (upt) or currently breast-feeding * history of moderate or severe adverse reaction to iodinated contrast injection * recent serum creatinine ≥ 1.5 mg/dl * history of diabetes mellitus * currently taking glucophage or glucovance (metformin) * history of chronic asthma * history of allergy to iodine * multiple food and/or drug allergy * renal disease * history of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold

Keywords: breast cancer
acupoint stimulation improves cognition under hypoxia

Conditions: Cognition

Summary: cognitive impairment is common in people who suffer from hypoxia. acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. in this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.


Eligibility criteria:
inclusion criteria: * male, age from 18 to 50 years exclusion criteria: * cardiopulmonary dysfunction; * history of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases; * a history of fever or respiratory infection within the last two weeks; * drinking alcohol or poor sleep within the last 24 hours

Keywords: transcutaneous electrical acupoint stimulation cognition hypoxia
multiple-dose regimen study to assess effect of 12 months of secukinumab treatment on skin response and biomarkers in psoriasis patients

Conditions: Psoriasis, Plaque-type Psoriasis

Summary: this study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. clinical endpoints including biomarker assessments, pasi, iga and dlqi will be compared to better understand, why secukinumab may be effective in psoriasis patients.


Eligibility criteria:
inclusion criteria: * chronic plaque-type psoriasis diagnosed for at least 6 months * moderate to severe psoriasis as defined by: pasi score of ≥12, iga score of ≥3, bsa (body surface area) affected by plaque-type psoriasis of ≥10% * chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy exclusion criteria: * forms of psoriasis other than chronic plaque-type * evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis * history or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like hepatitis-c/b), malignancy; active or known use of other immunosuppressive drugs (for eg: aids, ra, organ rejection etc.) at the screening visit * pregnant or nursing (lactating) women

Keywords: psoriasis, plaque-type psoriasis plaque secukinumab ain457a pasi dlqi iga
elective adaptive radiation with sbrt for improved durability of response

Conditions: Prostate Adenocarcinoma; Iliac Nodal Disease; Para-aortic Lymph Node Metastasis; Para-aortic Nodal Disease; Oligorecurrence

Summary: this prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by psma pet or conventional ct/mri imaging, and these patients will undergo ct-guided online adaptive sbrt to the tumor and elective sbrt to adjacent at-risk nodal regions.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed prostate adenocarcinoma. 2. oligorecurrent para-aortic +/- common iliac nodal disease planned for sbrt. 3. ≤10 involved para-aortic (defined as between l1/l2 interface and l4/l5 interface) +/- common iliac ln on psma pet imaging. 4. ecog performance status 0-2. exclusion criteria: 1. prior radiotherapy to the nodal echelon (pa +/- common iliac). 2. active secondary malignancy, except for adequately treated non-melanoma skin cancer. 3. presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study. 4. contraindication to radiation.
socknleg - a user friendly medical compression study of a modified application of a medical device

Conditions: Venous Insufficiency

Summary: the study intends to investigate a novel compression system termed socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. the novel socknleg system is compared to a standard class iii compression stocking.

the investigator tests a novel compression system termed socknleg in 20 healthy individuals and 20 patients with chronic venous disease. socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. the novel socknleg system is compared to a standard class iii compression stocking. outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Eligibility criteria:
inclusion criteria: * healthy volunteers: age \> 18 years, proband information read, consent form signed * patients: age \> 18 years, chronic venous insufficiency ceap c5 (healed venous ulcer).age \> 18 year, patient information read, consent signed. exclusion criteria: * active venous ulcer * peripheral arterial disease * peripheral neuropathy

Keywords: compression therapy
risky decision making in methamphetamine users: the role of opioid blockade

Conditions: Methamphetamine Abuse; HIV

Summary: the purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. the investigators would like to know if a medication called naltrexone changes how people make decisions. the investigators would also like to know whether changes in decision making can be observed by mri (magnetic resonance imaging). the research is conducted in portland, or.


Eligibility criteria:
summary inclusion criteria: * diagnostic and statistical manual (dsm)-iv methamphetamine dependence * deemed healthy enough to participate by study physician * age 18-55 * right handed * english-speaking summary exclusion criteria: * current opioid use in the last 30 days; opioid abuse or dependence within past 5 years * pregnancy * mri contraindications (e.g. metal in head). the research is conducted in portland, or.
delirium in home-dwelling old people receiving home nursing care

Conditions: Delirium

Summary: study the prevalence of delirium among old persons with home-nursing care living in the community. by recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.


Eligibility criteria:
inclusion criteria: * home nursing service at least once a week. * home dwelling (not permanently institutionalised) * age 65 years or more * informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent) exclusion criteria: * patient or relative denies inclusion * terminal illness * patients diagnosed with dementia with lewy bodies (its fluctuating course makes the diagnosis of delirium challenging) * patients with chronic diseases that have needed assistance from the home nursing service before the age of 65. * assistance from the home nursing service is due to addictive substances. * assistance from the home nursing service is due to psychiatric illnesses other than dementia.

Keywords: delirium dementia physical function
regenexx™ sd versus exercise therapy for treatment of knee osteoarthritis with historical comparison to tka

Conditions: Knee Osteoarthritis

Summary: the primary objective of this study is to evaluate the efficacy of regenexx sd compared to exercise therapy at three months. historical comparison will be made to total knee arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.

the study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with regenexx sd and 25 treated with exercise therapy for treatment of knee osteoarthritis. subjects will be enrolled within 60 days prior to regenexx-sd injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. a preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection. subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months. subjects will complete the study following the 2 year follow-up visit. they will be withdrawn from the study prematurely if a revision occurs. the study subjects will be compared to a historical total knee arthroplasty group. data of the tka group subjects will be reviewed retrospectively after it is retrieved from the clinical database. the tka group will consist of patients who underwent tka for knee osteoarthritis. the inclusion criteria of age and bmi will be applied to these subjects.

Eligibility criteria:
inclusion criteria: 1. voluntary signature of the irb approved informed consent 2. ages 18 to 70 3. diagnosis of knee osteoarthritis 4. kellgren-lawrence grade 2 or 3 on x-ray 5. bmi of \<30 6. minimum flexion to 110 degrees 7. varus under 12 degrees/valgus under 15 degrees 8. instability in any plane less than 2 mm translation 9. acl intact and no history of acl reconstruction 10. knee society 100 point score \> 65 11. if bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months 12. candidate is able to follow regenexx medication guidelines 13. patient agrees to return for periodic assessment protocol 14. patient must execute all required documents 15. patient must be appraised of clinical trial exclusion criteria: 1. history of infection of the joint in the last five years 2. intra-articular prp, steroid or viscosupplementation in the last three months 3. previous knee surgery within the last 6 months 4. flexion contracture over 15 degrees 5. low back pain with radiculopathy or with "significant" radiographic changes 6. history of immunosuppressive or chemotherapy in the last five years 7. systemic neurological disease 8. hiv positive or chronic hepatitis 9. any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study

Keywords: osteoarthritis knee arthritis tka total knee arthroplasty
multicenter retrospective registry of anterior communicating artery aneurysms with endovascular therapy

Conditions: Intracranial Aneurysm; Anterior Communicating Artery Aneurysm; Cerebral Aneurysm; Aneurysm, Ruptured

Summary: based on the anatomical features of the anterior communicating artery complex, the investigators will analyze the outcome of the acoa aneurysms treated by endovascular therapy. the most common site of intracranial aneurysms is the anterior communicating artery (acoma). acoma aneurysms account for approximately one-fourth of all intracranial aneurysms. recent publications have addressed specifically the endovascular treatment of acoa aneurysms. furthermore, detailed anatomic characteristics and the effects of the multiple variations of the anterior communicating artery complex have scarcely been reported. the hemodynamic factors play a fundamental role in the adequate treatment of aneurismal coiling. the objective of our registry is to analyze the impact of morphological configuration of the anterior communicating artery complex and the results of coil embolization in acoa aneurysms


Eligibility criteria:
inclusion criteria: * patient with anterior communicating artery aneurysm treated with endovascular coiling. exclusion criteria: * patients without imaging follow up of at least 12 months after endovascular treatment.
recurrence rate after laparoscopic repair of large hiatal hernia

Conditions: Hiatal Hernia Large

Summary: patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.


Eligibility criteria:
inclusion criteria: * age older than 18 years * initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity) * performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication * informed consent as documented by signature (appendix: informed consent form) exclusion criteria: * performance of any other anti-reflux surgery such as toupet- or nissen-fundoplication * performance of anterior fundoplication without mesh * women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study
"a long-term safety study of jzp-110 in the treatment of excessive sleepiness in subjects with narcolepsy or osa"

Conditions: Narcolepsy; Obstructive Sleep Apnea

Summary: this is a phase 3 study to assess the long-term safety and maintenance of efficacy of jzp-110 in subjects who have completed study 14-002, 14-003, 14-004, 15-004, 15-005, adx-n05 201, or adx-n05 202.


Eligibility criteria:
major inclusion criteria: 1. subject meets one of the following: 1. completed study 14-002 or 14-003 (group a) 2. completed study 14-004, 15-004, 15-005, adx-n05 201 or adx-n05 202 (group b) 2. body mass index from 18 to \<45 kg/m2 3. consent to use a medically acceptable method of contraception 4. willing and able to provide written informed consent major exclusion criteria: 1. female subjects who are pregnant, nursing, or lactating 2. any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or osa that is associated with excessive sleepiness 3. history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to dsm-5 criteria 4. presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy or safety assessments, or the ability of the subject to complete the trial per the judgment of the investigator 5. history of bariatric surgery within the past year or a history of roux-en-y procedure 6. presence or history of significant cardiovascular disease 7. use of any over the counter (otc) or prescription medications that could affect the evaluation of excessive sleepiness 8. received an investigational drug other than jzp-110 in the past 30 days or five half-lives (whichever is longer) 9. history of phenylketonuria (pku) or history of hypersensitivity to phenylalanine-derived products
a study of a single dose of asp3291 in subjects with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine the pharmacokinetics (pk) and to assess safety and tolerability of a single dose of asp3291 in subjects with ulcerative colitis.

after an 11-day screening period, subjects check into a clinic, are dosed on day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.

Eligibility criteria:
inclusion criteria: * subject has a previously documented diagnosis of ulcerative colitis (uc) with endoscopy and histology consistent with diagnosis * if female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating * subject is willing and able to comply with the study requirements * subject has a body mass index (bmi) of \<32 kg/m2 * subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-asa) exclusion criteria: * subject has undergone previous resective colonic surgery * subject has previously diagnosed crohn's disease based on medical history * subject has an extension of disease limited to ulcerative proctitis * subject has active peptic ulcer disease based on medical history * subject is currently being treated with any prescription medication except the following: a stable dose of 5-aminosalicylic acid (5-asa) for at least 2 weeks, oral contraceptives or hormone replacement therapy (hrt) * subject has a history of human immunodeficiency virus (hiv) * subject has a history of severe allergic or anaphylactic reactions * subject has a history of drug or alcohol abuse

Keywords: ulcerative colitis asp3291