Kornimate/medical-research-clean huggingface dataset:
cumulative irritation test

Conditions: Tinea Pedis

Summary: the purpose of this study is to determine the cumulative irritation potential of the products listed by the sponsor.

healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of an2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria for inclusion in the study. 1. healthy volunteers of either sex, at least 18 years of age or older. 2. females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile \[bilateral oophorectomy and/or total hysterectomy\]). all females must submit to a urine pregnancy test and have a negative result at day 1 and at the final study visit. 3. subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions. 4. willingness to follow the study procedures and complete the study. 5. written informed consent obtained. exclusion criteria: 1. any skin disease that would in any way confound interpretation of the study results. atopic dermatitis/eczema, psoriasis will be excluded. 2. chronic asthma will be excluded. 3. pregnant or nursing mothers. 4. a history of sensitivity to any component of any of the formulations. 5. use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
delta qsofa for risk stratification in emergency infected patients

Conditions: Sepsis

Summary: the study will investigate the prognostic value of qsofa (quick sequential organ failure assessment) kinetics between h0 and h1, and between h0 and h3 in patients with suspicion of sepsis, i.e. an initial qsofa of at least of 2.

qsofa has been reported as a good tool for risk stratification in the ed for patients with infection. however, it is not clear whether qsofa remains stable during the ed stay, nor whether its kinetics can have prognostic added value. patients with a qsofa of at least 2 in the ed, and suspicion of infection will be included. after treatment is initiated and fluids challenge performed, we will collect qsofa value at 1 hour and 3 hours. our hypothesis is that a decrease in qsofa between h0 and h3 is associated with better outcome. we assume that 50% of patients will have a deltaqsofa \>0, with an overall mortality of 23% (according to previous cohort). under the hypothesis of difference of at least 15% in mortality between the two groups (deltaqsofa \> 0 and delta qsofa\<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.

Eligibility criteria:
inclusion criteria: * suspicion of infection by the emergency physicians * at least two of the following criteria : respiratory rate \<= 22, systolic blood pressure \<= 100 mmhg and altered mental status exclusion criteria: * infection ruled out by the expert after chart review * patient who refuse to participate
st. jude medical product longevity and performance (score) registry

Conditions: Bradycardia; Tachycardia; Heart Disease

Summary: score is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with st jude medical (sjm) market-released cardiac rhythm management (crm) products. this registry will be conducted in the united states (us). the primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released sjm crm products by analyzing product survival probabilities. product status and any related adverse events will be collected to measure survival probabilities.


Eligibility criteria:
enrollment criteria: * patient has a standard indication for a crm implantable device. * patient is implanted with at least one new market-released sjm crm product from a list provided by sjm (e.g pacemaker, icd, crt-d, crt-p, pacing/sensing lead, defibrillation lead) within the last 90 days. * complete system implant information (e.g. model, serial number, location) is available at enrollment. * any product-related adverse event information at implant is available at enrollment. * patient or appropriate legal guardian is willing to provide authorization for registry participation.

Keywords: bradycardia tachycardia arrhythmia icd pacemaker pacing lead
the incidence of occult hepatitis c virus infection in hemodialysed patients with liver enzymes disturbances

Conditions: Hemodialysed Patients With Impaired Liver Enzymes

Summary: to assess the incidence of occult hepatitis c virus in hemodialysed patients with mild impairment of liver enzymes

occult hepatitis c virus will be checked in monocytes of hemodialyzed patients with permanent mild impairment of liver enzymes this population has no evidence of hepatitis b or c according to standard laboratory tests (hvc antibodies,hcv pcr, hepatitis b antibodies) hepatitis c virus rna will be performed in peripheral blood mononuclear cells of hemodialysed patients

Eligibility criteria:
inclusion criteria: * hemodialysed patients with impaired liver enzymes exclusion criteria: * hepatitis b and c positive

Keywords: liver enzymes peripheral mononuclear blood cells hemodialysis hepatitis c rna
effectiveness and safety of xiaoshuanchangrong (xscr) capsule for the treatment of patients who have suffered from a stroke

Conditions: Acute Ischemic Stroke

Summary: this study will determine if xiaoshuanchangrong (xscr) capsule will improve recovery from an acute stroke. the study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke with limb weakness, nih stroke scale ≥6, limb weakness score ≥2 * onset of symptoms within 72 hours * 18 years and older * consistent with the qi deficiency and blood stasis type by traditional chinese medicine (tcm) standard * patients or their representatives voluntarily take part in this study and signed the informed consent exclusion criteria: * transient ischemic attack(tia), cerebral hemorrhage, subarachnoid hemorrhage * subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. * pregnant or breast-feeding. * proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap. * liable to be allergic (allergic to at lease 2 foods/drugs previously exposed) * had been participated in other clinical trials during the last 1 month prior to study inclusion.
pilot of mindfulness therapy for inpatients with gastro-intestinal pain

Conditions: Gastro-intestinal Pain

Summary: research questions/hypotheses 1. can an individual mindfulness intervention for gastro intestinal failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management? 2. how useful and applicable do gastro intestinal failure inpatients find mindfulness methods?


Eligibility criteria:
inclusion criteria: * \>18 years, pain experienced * \>3 months, proficiency in english exclusion criteria: * previous mindfulness experience * severe cognitive impairment * profound hearing difficulties
a study of car-t cells in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: the purpose of this study is to assess the safety and efficacy of car-t cell therapy in subjects with sle.


Eligibility criteria:
inclusion criteria: * male or female, between 18 and 65 years old; * diagnosed with sle according to 2019 eular/acr sle classifications; * positivity for ana (titer≥1:80), and/or anti-dsdna, and/or anti-smith antibody at screening; * sledai-2k≥8 points (with a clinical sledai-2k≥6 points) ; * patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening. * good organ functions; * voluntary participates this trial and can comprehend and sign icf. exclusion criteria: * had or has active malignancy; * had been subjected to treatment by cd19 targeted therapy or car-t therapy or any gene therapy; * combined with other autoimmune disease that needs treatment; * pregnant or lactating women; * has other factors that deemed not suitable by investigator.

Keywords: sle systemic lupus erythematosus
fixed 100 mg every evening of flibanserin vs placebo in premenopausal women with hypoactive sexual desire disorder

Conditions: Sexual Dysfunctions, Psychological

Summary: the object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.


Eligibility criteria:
inclusion criteria: 1. premenopausal women who are 18 years old and older 2. primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to diagnostic and statistical manual of mental disorder, fourth edition, text revision, at least 24 weeks in duration. 3. stable, monogamous heterosexual relationship for at least one year. 4. willing to discuss sexual issues. 5. willing to engage in sexual activity at least once a month 6. normal pap smear 7. must use medically acceptable method of contraception 8. able to comply with daily use of a handheld entry device exclusion criteria: 1. patients who have taken any medication in the protocol list of prohibited medications within 30 days before the screening visit. 2. patients who meet diagnostic and statistical manual of mental disorder, fourth edition, text revision for: sexual aversion disorder, substance induced sexual dysfunction, dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition. 3. partner with inadequately treated organic or psychosexual dysfunction 4. history of major depressive disorder within six months prior to the screening visit or history of suicidal behavior. 5. sexual function impaired by psychiatric disorder 6. sexual function impaired by gynecological disorder 7. major life stress that could impair sexual function 8. substance abuse
the association between skeletal muscle mass and severity of polycystic liver disease and polycystic kidney disease

Conditions: Polycystic Kidney Diseases; Polycystic Liver Disease; Muscle Loss

Summary: primary sarcopenia is used to describe aging and progressed with the physiologic decline. secondary sarcopenia is associated many chronic disease, including acquired immune deficiency syndrome, cancer, chronic heart failure, chronic lung disease, liver cirrhosis, chronic kidney disease and rheumatoid arthritis. in the past, nutrition status is evaluated by body mass index, mid-upper -arm circumference and serum albumin. bioelectrical impedance analysis is also a common method to measured body composition, but bioelectrical impedance analysis will be affected by tissue edema and ascites. in contrast, cross-section imaging, such as computed tomography and magnetic resonance can analyzed abdominal muscle and fat accurately. since computed tomography and magnetic resonance imaging can evaluate the severity of polycystic liver and kidney disease. investigators can use cross section imaging at 3rd lumber level to separate skeletal muscle and fat tissue. previous studies showed the quantity and quality of abdominal muscle are important prognostic factor after liver transplantation. besides, chronic kidney disease and receiving renal placement therapy lead protein catabolism and make patients with end stage renal disease have sarcopenia. finally, patients with polycystic liver and kidney disease have organomegaly, which causes abdominal distention and poor appetite. therefore, the aim of this study is to observe the association between skeletal muscle mass and the severity of disease and to study whether change in hepatic and renal volumes is associated with change in muscle mass.

the imaging study (ct or mri) will be performed within one month before the procedure to measure total kidney volume and psoas muscle area. the procedure will use transcatheter embolization to renal artery. the follow-up imaging study will be performed six months after the procedure to measure total kidney volume and psoas muscle area..

Eligibility criteria:
inclusion criteria: * polycystic related disease with medical images (ct or mri) diagnosed * aged over 20 years exclusion criteria: * lack of bio-exam or medical images * pregnancy
mental health assessment among community member during the covid-19 pandemic in indonesia

Conditions: Mental Stress; Mental Health Wellness 1; Depression; Anxiety; Behavior Problem; Emotional Problem

Summary: the covid-19 pandemic in indonesia makes several changes in daily living. the indonesian government suggests that everyone should stay at home by implements the work from home and school from home. therefore, the issues related with covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as friday praying for moslem, sunday service at home, etc. people is anxious whenever meeting people because they are not really understand whether people is infected or not. therefore, this study tries to identify the impact of covid-19 pandemic in indonesia towards mental well-being of the community.

the covid-19 pandemic in indonesia makes several changes in daily living. the indonesian government suggests that everyone should stay at home by implements the work from home and school from home. therefore, the issues related with covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as friday praying for moslem, sunday service at home, etc. people is anxious whenever meeting people because they are not really understand whether people is infected or not. therefore, this study tries to identify the impact of covid-19 pandemic in indonesia towards mental well-being of the community. the aims of this study are trying to collect and identify the most important aspect of mental health that affected by the covid-19 pandemic in indonesia, and using this data we are trying to propose the exact mental health promotion and prevention program for the community. the study design is cross sectional. we develop the questionnaire that suitable for our study, consists of demographic data, life experience data. in addition, for assessing mental health problems, the study uses phq-9, srq-20, gad-7, sdq for children 4 - 10 years old and 11 - 17 years old. the study is done by online survey. the data analysis is done by spss for mac version 21.

Eligibility criteria:
inclusion criteria: * willing to participate on this study by signing the informed consent exclusion criteria: * no

Keywords: mental health, covid-19, pandemic, indonesia
long-term evaluation of patients receiving bone marrow-derived cell administration for heart disease

Conditions: Acute Myocardial Infarction; Ischemic Cardiomyopathy; Dilated Cardiomyopathy; Heart Failure

Summary: this study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells. patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing. participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation. the detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.

in detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts: * periodic physical examination and blood tests * non-invasive imaging studies may include echocardiography and magnetic resonance imaging * electrocardiogram at rest and during treadmill testing (may include spiroergometry testing) * interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias

Eligibility criteria:
inclusion criteria: clinical diagnosis of heart disease with signs and symptoms of heart failure due to * acute myocardial infarction or * ischemic cardiomyopathy with or without previous myocardial infarction or * dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present) exclusion criteria: * none, all patients meeting the inclusion criteria will be eligible.
utility of hyperpolarized 13c-pyruvate metabolic magnetic resonance imaging

Conditions: Prostate Cancer

Summary: this is a two-tiered pilot study in which there will be no randomization and no placebo treatment. this study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic mri can be safely performed on this population


Eligibility criteria:
inclusion criteria: 1. age greater than 40 and less than 80 years 2. clinical suspicion or history of prostate cancer reflected by one of the following: * psa \> 4ng/ml * abnormal dre exam * known tissue diagnosis of prostate cancer from prior workup 3. patient planning to undergo either a mri targeted biopsy or radical prostatectomy for prostate cancer workup or treatment exclusion criteria: 1. inability to undergo mri scan 2. inability to receive iv contrast as per institutional protocol.
the utility of fdg-pet for radiation treatment in nsclc

Conditions: Lung Neoplasms; Positron Emission Tomography

Summary: patients planned for radical radiation for nsclc will undergo conventional ct stimulation and also pet/ct scans for definition of radiation target volumes


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer to receive radical radiation exclusion criteria: * unable to tolerate pet/ct scan

Keywords: lung neoplasms positron emissions tomography radiotherapy planning
solo single incision laparoscopic cholecystectomy

Conditions: Cholecystectomy, Laparoscopic

Summary: the purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (silc) with a camera holder comparing to a camera operator assisted silc

this study is a multicenter randomized controlled study. the primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between solo-silc group and conventional cholecystectomy group (ca-silc). total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers solo-silc group using a laparoscopic camera holder (n=136) or ca-silc group in which a camera operator joins (n=136). . demographics (i.e., age, gender, body mass index (bmi), american society of anesthesiology (asa) score, indication for operation, need for conversion to open surgery or additional port will be recorded. outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated

Eligibility criteria:
inclusion criteria: * all patient need laparoscopic cholecystectomy (check the possibility of routine application of solo-silc in clinical practice) exclusion criteria: * mirizzi syndrome * unstable vital sign * no compliance * no consent

Keywords: single incision solo surgery
french parkinson's disease cohort - ns-park

Conditions: Parkinson Disease

Summary: the aim of ns-park cohort are to describe the natural history of parkinson's disease (pd), and to propose patients stratification models based on pd pathophysiological mechanisms. patients are included at all pd expert centers in france. standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. a blood sampling is perform at baseline for genetic testing and implement an associated biocollection.

the national clinical research network for parkinson's disease (ns-park/fcrin) reassembles all expert centers in parkinson's disease (pd) in france. its aim is to promote clinical research in parkinson's disease and movement disorder, to better understand the pathophysiology of pd, foster the development of new therapeutic strategies, and move towards personalized medicine. to help centers for prescreening, a national registry of pd patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. data are updated at each visit of the patient in the center. de facto, this registry became a longitudinal cohort of pd patients followed in ns-park centers. in 2020, ns-park received funding to associate a biocollection to this clinical cohort. the aim of ns-park cohort are to describe the natural history of pd progression in clinical routine in france, to develop new models of pd describing the different progression profiles, and to propose patients stratification based on pd pathophysiological mechanisms. the cohort will also serve as a platform to discover new pd genes and genetic modifiers of disease progression or response to treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease according to uk pd brain bak criteria * or diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with lewy body, or corticobasal syndrom * or subjects at risk of pd defined as : no symptom or diagnosis of parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of pd or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of pd or patient with a diagnosis of idiopathic reem sleep disorder or prodromal form of pd as defined by mds criteria (berg et al., 2015) and for all participants * affiliated to social security * age \> 10 years exclusion criteria: * subject under legal protection * subject who do not consent to the research * for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment

Keywords: parkinson's disease genetics