Kornimate/medical-research-clean huggingface dataset:
non-interventional, retrospective, multi-center study to evaluate non-motor symptoms in advanced parkinson disease (pd) patients already treated with rotigotine

Conditions: Parkinson's Disease

Summary: this is an observational, non-interventional and retrospective study in patients with advanced pd who have been treated with rotigotine (neupro®) as prescribed by physicians according to usual clinical practice in spain. the primary objective will be to evaluate non-motor symptoms (nms) in advanced pd patients who have been treated with rotigotine for at least 6 months.


Eligibility criteria:
inclusion criteria: to be eligible to participate in this study, all of the following criteria must be met: * male and female ambulatory patients with parkinson's disease diagnosis (as per the london brain bank diagnosis criteria) ≥6 months ago * patient aged 30 years or older at the time of parkinson's disease diagnosis * patients who were under treatment with rotigotine following routine clinical practice, either alone or in combination with levodopa, and in an advanced pd dosage (≥ 8 mg/ 24 h) for at least the previous 6 months * patients under treatment with rotigotine (≥ 8 mg/ 24 h) who were assessed twice of nms by means of the pdnms-q 6 months apart * patients are currently informed and have been given enough time and opportunity to think about participation (data collection) in the study and have given written informed consent exclusion criteria: patients are not permitted to enroll in the study if any of the following criteria is met during the previous 6 months: * patients have other parkinsonian syndrome different than parkinson´s disease * patients have a history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplant * patients with dementia, active hallucinations or active or treated psychosis * patients with any other neurological / psychological disorder * patients who had received central nervous system (cns) active therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)

Keywords: rotigotine (neupro) non-motor symptoms advanced parkinson's disease local study spain observational study non-interventional study retrospective study post-marketing study multicenter study
effect of acupuncture on patients with crohn's disease in remission

Conditions: Crohn Disease; Inflammatory Bowel Diseases

Summary: to observe the therapeutic effect of acupuncture on crohn's disease in remission and its influence of brain functional activity

1. effect of acupuncture on symptoms （functional gastrointestinal symptoms, fatigue, insomnia, depression, anxiety and perceived stress）of cd 2. effect of acupuncture on brain functional activity of cd

Eligibility criteria:
inclusion criteria: 1. aged 16-70; 2. patients in remission (cdai \< 150); 3. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months; 4. those who did not use tnf alpha and other preparations within 3 months before entering the study; 5. those who have never experienced acupuncture; 6. patients signing informed consent. exclusion criteria: 1. patients who are recently pregnant or in pregnancy or lactation; 2. patients with serious organic diseases; 3. patients diagnosed as psychosis; 4. patients who take antibiotics, probiotics, traditional chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; 5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; 6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; 7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; 8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Keywords: acupuncture crohn's disease brain functional activity
acupuncture for sexual dysfunction

Conditions: Hypoactive Sexual Desire Disorder (HSDD); Low Libido; Female Sexual Dysfunction (FSD)

Summary: female sexual dysfunction (fsd) affects up to 43% of women in the united states and hypoactive sexual desire disorder (hsdd) is the most common form. there is no standardized treatment for this condition. we know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. we hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (hsdd) will improve with initiation of acupuncture therapy for a duration of 5-weeks. validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.

each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail. the acupuncture sessions include: * an initial evaluation in which the certified acupuncturist will take a * history including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood * physical exam: inspection of tongue and palpation of pulse * 25 minutes of resting quietly with acupuncture needles in place * needle usage: from8 to 20 needles are typically used, with an average of 14 per session * needles are typically placed on the scalp, lower abdomen, elbows and knees subsequent sessions (9 more) with the certified acupuncturist * 25 minute each, twice weekly, for 5 weeks = total 10 sessions * needle usage = 8-20, average 14 per session * typically placed on the scalp, lower abdomen, elbows and knees the questionnaires/surveys include questions about: * sexual desire, arousal, lubrication, orgasm, satisfaction and pain * general physical health * general emotional and psychological health * social relationships

Eligibility criteria:
inclusion criteria: * women aged 18-55 years * sexually active * premenopausal * documented diagnosis of hsdd as primary cause of fsd (defined as a non adjusted score of ≤ 6 in the desire domain of the fsfi questionnaire) exclusion criteria: * postmenopausal, defined as absence of menstruation in the prior 12 months * pain or dyspareunia as the primary cause of fsd (defined as a non adjusted score of ≤ 6 in the pain domain of the fsfi) * history of hysterectomy and/or oophorectomy * history of chemotherapy, or pelvic irradiation * use of hormonal contraception or oral hormone replacement therapy * active skin infection or disease * blood dyscrasia * allergy to acupuncture needles

Keywords: female sexual dysfunction (fsd) hypoactive sexual desire disorder (hsdd) low libido acupuncture
comparison of high-sensitivity cardiac troponin i and t assays trial

Conditions: Acute Myocardial Infarction; Acute Coronary Syndrome

Summary: compare the analytical and clinical performance of hs-ctni and hs-ctnt assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial ctni measurements are obtained on clinical indication.

background: comparative studies addressing the analytical and clinical performance of hs-ctni and hs-ctnt assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a united states (us) emergency department are lacking. study objective: compare the analytical and clinical performance of hs-ctni and hs-ctnt assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial ctni measurements are obtained on clinical indication. null hypothesis: hs-ctni and or hs-ctnt assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial

Eligibility criteria:
inclusion criteria: 1. adult, defined as subject 18 years of age or older 2. baseline ctn measurement and at least one additional ctn measurement within 6 hours after initial ctni measurement. 3. at least one 12-lead electrocardiogram exclusion criteria: 1. currently pregnant 2. trauma related admission 3. cardiac arrest 4. decline to participate 5. did not present through the ed 6. transferred from an outside hospital

Keywords: troponin high-sensitivity cardiac troponin acute myocardial infarction
phase i study of isotretinoin in patients with recessive dystrophic epidermolysis bullosa

Conditions: Epidermolysis Bullosa

Summary: objectives: i. determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.

protocol outline: patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of recessive dystrophic epidermolysis bullosa (rdeb) rdeb hallopeau-siemens or rdeb non-hallopeau-siemens * concurrent enrollment in the national epidermolysis bullosa registry * no regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma --patient characteristics-- * hepatic: no clinically significant hypertriglyceridemia no clinically significant hepatic dysfunction * renal: no clinically significant renal dysfunction * other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception

Keywords: dermatologic disorders epidermolysis bullosa genetic diseases and dysmorphic syndromes rare disease
septorhinoplasty and pain score course

Conditions: Visual Analogue Scale

Summary: to provide scientific contribution to more effective and timely pain management strategies in the postoperative period by evaluating the time-dependent course of pain scores and the effect of analgesic intervention timing on clinical outcomes in patients who underwent septorhinoplasty and who are followed in the postanesthetic care unit.


Eligibility criteria:
inclusion criteria: * being 18 years of age or older, * being in asa i-iii class, * having undergone septorhinoplasty surgery under general anesthesia under elective conditions, * being monitored for at least 30 minutes in postoperative, * being conscious and able to assess pain with vas. exclusion criteria: * patients who have undergone surgical procedures other than septorhinoplasty (e.g. laparoscopic, gynecological, orthopedic, etc.) * inability to assess pain due to impaired consciousness, agitation, or sedation in the postoperative period * history of opioid derivatives or continuous analgesic use in the preoperative period * cognitive impairment, psychiatric disease at a level that prevents communication, severe visual or hearing impairment * history of neurological or neuromuscular disease * having undergone revision septorhinoplasty or other revision surgery * patients with vas≥4 during their follow-up in the postoperative,
efficacy and safety study of ats in patients with dry eye syndrome

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: the purpose of this study is to determine whether artificial tears are safe and effective in the treatment of dry eye syndrome.


Eligibility criteria:
inclusion criteria: * male and female adults aged 18 years and over. * subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (kcs), or should have at least a 3-month history diagnosed as dry eye syndrome due to sjögren syndrome. * subjects must agree to discontinue all artificial tears from screening for 2 weeks * subjects must discontinue lens wear one week before screening and agree not to wear contact lenses during the entire study. * subjects who have taken restasis® are eligible for inclusion if they have not used restasis® during the 4 weeks prior to screening * subjects must provide signed informed consent prior to participation in any study-related procedures * subjects who dose not participate in same clinical trial within 6 month prior to screening. exclusion criteria: * pregnancy or lactation. * females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized. * ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to screening. * any active inflammation of the eye not due to kcs * other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Keywords: dry eye syndromes keratoconjunctivitis sicca artificial tears carboxymethylcellulose sodium sodium hyaluronate
elocon vs fluticasone in localized psoriasis (p03197)

Conditions: Psoriasis

Summary: this is an open-label, randomized, parallel-group clinical study. the primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of day 4 and day 8 in the management of indian patients with localized psoriasis.


Eligibility criteria:
inclusion criteria: * \>=18 years of age * written informed consent * having localized psoriasis (not more than 5-6 patches) * total size of all patches should be below 8" x 8" * each patient should exhibit any of the following 4 signs of dermatoses: * erythema * palpability * scaling * itching (pruritus) each of the above signs would be grades according to the following scale: 0 = none 1. = slight 2. = moderate 3. = severe the total disease severity score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status) exclusion criteria: * pregnancy or lactation * hypersensitivity to any of the components of the test medication * signs of atrophy in the target area * lesions on palms, soles, and scalp * individuals who may require medications that might affect the natural course of the disease * not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study * concomitant tuberculosis/viral infection
clinical trial of antioxidant therapy in patients with septic shock

Conditions: Oxidative Stress; Septic Shock

Summary: sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (fom). therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. this randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin c, vitamin e and melatonin. measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of sod, gsh concentration and evaluation of total antioxidant capacity. the investigators will also evaluate the clinical impact of antioxidant therapy with the sofa score.


Eligibility criteria:
inclusion criteria: * diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite sufficient fluid resuscitation (20 ml/kg of colloids or 40 ml/kg of crystalloids) to maintain a blood pressure ≥ 65 mmhg with a lactate\> 2 mmol/l. * admitted to the icu of the abc medical center. * give informed consent. exclusion criteria: * patients who refuse to be included. * chronic or recent use of steroids. * use of statins. * patients receiving some type of antioxidant treatment. * any contraindication to the use of vitamin c, vitamin e, n-acetylcysteine or melatonin. * pregnant women.

Keywords: oxidative stress sepsis treatment antioxidant therapy
ability of muscle imaging and motor function measure (mfm) to detect changes in disease progression in ambulant spinal muscular atrophy patients compared to healthy volunteers.

Conditions: Healthy Volunteer, Muscular Atrophy, Spinal

Summary: this non-drug, single center, 24-week, longitudinal study in ambulant spinal muscular atrophy (sma) patients and in age- and gender-matched healthy volunteers will assess the detection of disease progression by magnetic resonance imaging (mri) and the muscle function measure (mfm) test. each participant will be evaluated in three testing sessions: at baseline, at week 12 and at week 24. both patients and volunteers will undergo mri scans. patients will additionally undergo testing of motor function and have blood samples taken for survival of the motor neuron (smn) genes, proteins and mrna analysis.


Eligibility criteria:
inclusion criteria: * male and female subjects, aged \>/= 10 years at screening * for sma patients: confirmed clinical diagnosis of 5q-autosomal recessive sma, ambulant at time of screening, and prefereably without spinal cord fixation exclusion criteria: * previous (3 months or less) or concomitant participation in any other therapeutic trial * known or suspected cancer * other chronic disease or inadequate renal, liver, or heart function * contraindications for mri scans, including but not limited to: claustrophobia, pacemaker, artifical heart valves, cochlear implants, presence of foreign metal objects in the body, intracranial vascular clips, etc. any contraindications to mri found on a standard radiography scan.
antagonism of opioid-induced respiratory depression by cx1739 with preservation of opioid analgesia

Conditions: Opiate Induced Respiratory Depression

Summary: the study is an investigation to assess the capacity of ascending doses of cx1739 to antagonize the respiratory depressive effect of remifentanil. the study will also investigate whether ascending doses of cx1739 reduce the analgesic effect of remifentanil or alter the bis measure of sedation and will evaluate the safety of cx1739 when used in conjunction with remifentanil.


Eligibility criteria:
inclusion criteria: * to be eligible for this trial, subjects must meet all of the following criteria: 1. males 18 to 50 years of age, inclusive 2. body mass index of 18.0 to 30.0 kg/m2, inclusive, using the formula: weight (kg)/height (m)2 3. healthy, as determined by medical history, physical examination including vital signs, and clinical laboratory test results 4. american society of anesthesiologists physical status classification 1 5. willing and able to provide voluntary, written informed consent exclusion criteria: * if a subject meets any of the following criteria, he cannot be enrolled in the study: 1. history of any chronic illness or evidence of clinically significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the principal investigator (pi), would confound the study results or present a risk to the subject 2. acute illness within 2 weeks before dosing 3. history of any clinically significant pulmonary condition (eg, asthma) within the last 2 years requiring admission to the hospital 4. previous diagnosis of obstructive sleep apnea based on polysomnography 5. currently using any prescription medication or use within the last 30 days 6. laboratory values (clinical chemistry, hematology, urinalysis) outside the laboratory reference range considered clinically significant (note: in the event of any parameter lying outside of the normal range, the sample may be repeated once; this value will be accepted if it lies within the normal range) 7. presence of qt interval corrected \> 440 msec on ecg 8. resting hr while awake \ 90 beats/minute 9. history of daily use of tobacco or other nicotine-containing products within 1 year of study entry or positive cotinine test at screening and subsequent study visits 10. history of allergic hypersensitivity to ampakines (cx717, cx1739), remifentanil, naloxone, or any component of these formulations; history of multiple drug allergies 11. history or current evidence of abuse of any drug substance, licit or illicit, including alcohol; positive urine drug screen (uds) for drugs of abuse at screening 12. inability to understand the protocol requirements; instructions; study-related restrictions; or nature, scope, and possible consequences of the study 13. unlikely to complete the study, eg, because of inability to return for follow-up visits 14. participation in another study with any investigational drug in the 3 months preceding this study 15. blood or plasma donation of more than 500 ml during the month before randomization and more than 50 ml in the 2 weeks before randomization
navigation and free recall in chronically implanted humans

Conditions: Epilepsy

Summary: this study is designed to identify brain activity associated with good memory in subjects with a chronically implanted rns® device and to study the effects of therapeutic stimulation for epilepsy on memory. this will be accomplished through analysis of ecog data collected during memory encoding for short and long-term free recall as well as during navigation tasks.


Eligibility criteria:
inclusion criteria: * able to give informed consent * 18 years of age or older * diagnosis of epilepsy * implanted rns® device and receiving therapeutic stimulation for epilepsy. * capable of completing experimental tasks in the judgment of the principal investigator exclusion criteria: * rns® neurostimulator implanted within 3 months of experimental tasks.

Keywords: memory responsive neurostimulator system
atlas predicted dbs settings in essential tremor

Conditions: Essential Tremor

Summary: programming deep brain stimulation for the treatment of essential tremor can be a time intensive process. using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.


Eligibility criteria:
inclusion criteria: seleced for dbs of the vim nucleus at vanderbilt medical center diagnosis of essential tremor exclusion criteria: unable to use the patient handheld programmer