Kornimate/medical-research-clean huggingface dataset:
a single-center study of cm313 in patients with pemphigus

Conditions: Pemphigus

Summary: a prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-cd38 monoclonal antibody cm313 combined with low-dose glucocorticoids in patients with pemphigus.


Eligibility criteria:
inclusion criteria: * clinical manifestations:① flaccid blisters and bullae on the skin that are prone to rupture.② persistent erosions formed after the rupture of blisters and bullae.③ blisters or erosions on the mucous membranes.④ positive nikolsky's sign. * adult patients aged between 18 and 80 years old. * moderate - to - severe pemphigus vulgaris/foliaceus: according to the pemphigus disease area index (pdai) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity. exclusion criteria: * pregnant or lactating women and women planning to conceive. * patients with known positive serology for hiv, syphilis, tuberculosis, hepatitis b, or hepatitis c in the active stage of the disease. * patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.
assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to atherosclerosis.

Conditions: Rheumatoid Arthritis

Summary: the aims of this study are: • to assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • to investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis.

all the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • assessment of medical and rheumatologic history. * careful general and musculoskeletal examination. * assessment of disease activity will be performed using the disease activity score (das28) including 28 tender and swollen joint count, esr and visual analogue scale. * x-ray both hands and feet * larsen score * assessment of body mass index (bmi) * laboratory investigations: * complete blood count (cbc) • rheumatoid factor (rf) by latex method • anti citrullinated protein antibodies acpa by enzyme-linked immunosorbent assay (elisa) • 14-3-3 η (eta) protein by (elisa) • erythrocytic sedimentation rate (esr) • quantitative c-reactive protein (crp) • fasting blood glucose • lipid profile • carotid doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ecg

Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. patients with ra classified according to the revised american college of rheumatology (acr)/eular ra classification criteria 2010 for ra. 2. age ≥ 18 years. 3. patients who are able and willing to give written informed consent. 4. disease duration more than one year exclusion criteria: 1. any other autoimmune disease rather than ra. 2. patients with any disease affecting the cardiovascular system other than ra. 3. patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.

Keywords: ra
evaluation of vaginal fluid for covid-19 positivity in women with positive nasofarengeal covid-19 test

Conditions: COVID; Sars-CoV2

Summary: aim of the study is to investigate whether the covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of covid-19 and the risk of transmission of covid-19 by intercourse or vaginal delivery.

vaginal covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with covid-19 in acıbadem maslak hospital. in patients with positive vaginal covid-19 test, vaginal covid-19 will be re-evaluated for the assessment of viral clearance.

Eligibility criteria:
inclusion criteria: * women who are positive nasofarengeal covid-19 pcr test result * women who are 18 years or older * women who had sexual intercourse before exclusion criteria: * who had medical treatment for covid-19
erlotinib (tarceva) during first line standard platinum containing chemo for advanced squamous cell head and neck cancer

Conditions: Head and Neck Cancer; Carcinoma, Squamous Cell

Summary: the purpose of this study is to determine if combination erlotinib, cisplatin/carboplatin, and paclitaxel are effective first line treatment for metastatic, recurrent and persistent squamous cell carcinoma of the head and neck.

we hypothesize that erlotinib fails to enhance the effects of chemotherapy on response and survival because of erlotinib's cytostatic effect, this results in a slowing down of the cell cycle, this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination. we propose that a sequential approach to the combination allows each drug to be used in its optimum time, by sequencing the erlotinib, giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle, but delivering the erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population. by withdrawing the erlotinib about 4 days prior to the next chemotherapy cycle, we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again. patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatin/carboplatin on day 1 of each 21 day cycle. patients will be treated with erlotinib at a loading dose of 300mg on day 2 followed by 150 mg orally daily from days 3-17 of each cycle of paclitaxel and cisplatin/carboplatin. the primary objectives of this study are to assess the response rate of combination of erlotinib, cisplatin/carboplatin and paclitaxel in the first line treatment setting of metastatic, recurrent and persistent squamous cell carcinoma of the head and neck. secondary objectives are to assess toxicity, median survival, and progression free survival.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of the head and neck region that is metastatic, recurrent or persistent after surgery and/or radiation * no prior chemotherapy for metastatic, recurrent or persistent disease exclusion criteria: * not more than 1 prior adjuvant or neoadjuvant chemotherapy regimen is allowed * chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
the effect of ebastine/pseudoephedrine on subacute cough

Conditions: Cough

Summary: to determine whether ebastine/pseudoephedrine is effective on subacute cough.

1. visit 0 week * patients with subacute cough,area randomized to either ebastine/pseudoephedrine or placebo for 1 week. * the cough severity and quality of life were measure with vas score and cough-specific quality-of-life questionnaire(cqlq) 2. visit 1 week check vas score and cqlq 3. visit 4 weeks check vas score and cqlq

Eligibility criteria:
inclusion criteria: * patients with subacute cough(3-8 weeks) * age: 20-70 years exclusion criteria: * chest x-ray abnormality(+) as a probable cause of cough * other explainable confirmed diagnosis(+) such as acute infectious disease * severe cough or cough complication which needs other anti-tussive agents. * on acei * with more than three hypertensive agents * change of hypertension medication 3 months ago * immunocompromized host * relative or absolute contraindication for ebastine/pseudoephedrine 1. hypersensitivity to ebastine/pseudoephedrine 2. glaucoma 3. moderate to severe hypertensive disease 4. coronary heart disease 5. hyperthyroidism 6. moderate to severe liver disease 7. benign prostate hyperplasia 8. psychological problem 9. parkinson's disease 10. on linezolid or supposed to use it.

Keywords: ebastine/pseudoephedrine subacute cough upper airway cough syndrome
head to head study epi procolon and fit

Conditions: Colorectal Cancer

Summary: the study aims to show non-inferiority in the clinical performance of the investigational assay, epi procolon, to fit using matched blood and stool specimens from screening-guideline eligible subjects.

there is strong evidence supporting the use of fobt in crc screening, with the earliest randomized controlled trials demonstrating a reduction in crc incidence and mortality from crc screening. despite the implementation and incremental improvements in gfobt- and fit-based tests, they continue to represent a small percentage of crc screening and currently remain largely the province of large, integrated healthcare delivery systems. reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers. availability of a blood-based test may overcome the adoption challenges presently facing stool-based crc screening and facilitate better compliance with crc screening guidelines. however, there are currently no fda-approved in vitro diagnostic tests for detection of crc in a blood sample. as such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need. this study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (crc) at colonoscopy, i.e. ajcc/uicc stages i, ii, iii, and iv, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. a completed subject will have a fit result, an epi procolon result, and a medical diagnosis/colonoscopy determined clinical status (crc, non-crc). demographic and baseline covariates will be reported for each individual.

Eligibility criteria:
inclusion criteria: group a * willing and able to sign an informed consent and adhere to study requirements * 50 - 84 years of age at blood and stool sampling * colonoscopic diagnosis of colorectal carcinoma * colonoscopy within 6 months before inclusion into study * blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery group b * willing and able to sign an informed consent and adhere to study requirements * 50 - 84 years of age at blood and stool sampling * able to provide blood and stool sample prior to bowel prep and colonoscopy exclusion criteria: group a * subject with curative biopsy during colonoscopy group a and b * previous personal history of crc or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years * neoadjuvant treatment * familial risk for colorectal cancer * history of inflammatory bowel disease * acute or chronic gastritis * current diagnosis of any other cancer * overt rectal bleeding or bleeding hemorrhoids * known infection with hiv, hbv, or hcv * subject concurrently receiving intravenous fluid at the time of the sample collection
asymmetric targeted dbs for pd with pigd

Conditions: Parkinson Disease

Summary: the purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets \[subthalamic nucleus (stn) in the right hemisphere while globus pallidus interna (gpi) in the left\] versus the bilateral stn for the treatment of parkinson's disease (pd) with postural instability/gait difficulty (pigd) in a randomized, double-blinded manner.

this is a double-blinded, randomized, controlled trial aiming at comparing the efficacy of asymmetric targets and bilateral stn dbs in treating pd with pigd. after being informed about the study and potential risks, enrolled patients giving written informed consent will be screened to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio using a minimization randomization method in a double-blinded manner, and later undergo bilateral dbs surgery. one group of patients will receive stimulation of left gpi and right stn, while the other will receive stn stimulation bilaterally. the follow-up period will be one year, with corresponding clinical assessments completed at six months and one year postoperatively.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * postural instability/gait difficulty (pigd) phenotypes in the on-medication condition exclusion criteria: * atypical parkinsonism * history of stroke, encephalitis, neuroleptic uses, mri scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery * presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent * presence of anatomical abnormalities in the target region * clinically significant medical history that would increase pre-/post-operative complications * other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Keywords: postural instability/gait difficulty deep brain stimulation subthalamic nucleus globus pallidus internus
creation of a french south-eastern database and dna-bank of congenital heart disease to explore the genetic pathways

Conditions: Congenital Heart Defects

Summary: congenital heart defects are seen in 0,8% of life births. in france this means more than 5000 newborns per year. the south-east region of france is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. the majority of congenital heart diseases remain unexplained. genetic causes are indisputable but remain poorly understood. genetic research needs the availability of a large-scale dna collection, guided by a robust phenotypic classification. such a dna-bank has been created in paris (carreg dna bank, created by the m3c reference centre for congenital heart diseases). such a bank is currently unavailable in south-east france. to transport biological specimens from marseille to paris would be very expensive. in addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our ap-hm hospital and in our amu research unit. for those reasons it is highly preferable to elaborate such a database and dna-bank locally. the acronym sea-hd (south-east-heart-diseases) would be used to name this dna-bank


Eligibility criteria:
inclusion criteria: * echocardiographic diagnosis of congenital heart defect falling within the classification houyel and bonnet * necessity of making a blood test regardless of study * medical care in the ap-hm timone hospital children, medical-surgical unit of pediatric and congenital cardiology, marseille - these parent child exclusion criteria: * pregnant women * patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent * people in emergencies * persons deprived of freedom * persons not beneficiaries of a social security scheme * persons in health or social institution
riluzole in treating patients with stage iii or stage iv melanoma that cannot be removed by surgery

Conditions: Melanoma (Skin)

Summary: rationale: riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma. purpose: this phase ii trial is studying how well riluzole works in treating patients with stage iii or stage iv melanoma that cannot be removed by surgery.

objectives: primary * determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by recist criteria, in patients with advanced melanoma. secondary * determine the long-term toxicity of riluzole when administered to these patients. * compare the survival of these patients with historical controls. outline: patients receive oral riluzole twice daily on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant melanoma * unresectable stage iii or stage iv disease * measurable disease according to recist criteria, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral ct scan * no known brain metastases unless treated and stable for ≥ 2 weeks by mri evaluation patient characteristics: * ecog performance status 0-2 * anc ≥ 1,000/μl * platelet count ≥ 50,000/μl * total bilirubin ≤ 2 times upper limit of normal (uln) * ast/alt ≤ 3 times uln * inr ≤ 1.5 times uln * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for 2 weeks after completion of study treatment * no second primary malignancy, except carcinoma in situ of the cervix, adequately treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago with no evidence of recurrence * no concurrent serious systemic disorders (including active infections) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study * no history of allergic reactions attributed to riluzole * no known history of hepatitis b or c prior concurrent therapy: * no more than 1 prior therapeutic chemotherapy regimen for advanced melanoma * prior treatment with riluzole on clinical trial cinj-090603 allowed * no other concurrent investigational or commercial agents or therapies for the treatment of the malignancy

Keywords: stage iii melanoma stage iv melanoma recurrent melanoma
a randomized open label study of klh-2109 in patients with endometriosis(1)

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the efficacy and safety of klh-2109 in patients with endometriosis.


Eligibility criteria:
inclusion criteria: * female patients with endometriosis exclusion criteria: * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: gonadotropin-releasing hormone (gnrh) antagonist
minimally invasive surgery of the hip versus standard approach

Conditions: Hip Arthroplasty; Osteoarthritis

Summary: the purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

traditional techniques for total hip arthroplasty (tha) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. all surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful tha. traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. these extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. furthermore, despite the good overall results of tha, the recovery time to improved function can be lengthy. blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. by definition, minimally invasive surgical (mis) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Eligibility criteria:
inclusion criteria: bmi \> 30 kg/m2 no prior ipsilateral hip surgery osteoarthritis exclusion criteria: patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc rheumatoid arthritis

Keywords: osteoarthritis total hip arthroplasty minimally invasive surgery
efficacy and safety of tolvaptan in cirrhotic patients with hyponatremia

Conditions: Liver Cirrhosis; Hyponatremia

Summary: this is a phase iv, open-label, prospective cohort study for 7 days.the recommended starting dose of tolvaptan is 15 mg daily orally. the dose may be titrated on the next day at 15 mg intervals up to 60 mg daily according to the serum sodium level response.serum sodium level, change in sodium level from baseline, quality of life (eq-5d-3l), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30 to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia.

tolvaptan is an effective treatment for hyponatremia. however, cirrhotic patients were underrepresented in previous studies. the pattern of use and efficacy of tolvaptan in real-life clinical practice are currently unknown.the objective of this study is to evaluate the efficacy of tolvaptan in cirrhotic patients with hyponatremia. the secondary objective is to evaluate the short- to intermediate-term safety of tolvaptan in cirrhotic patients.this will be a phase iv, open-label, prospective cohort study for 7 days. although not mandatory, study subjects are encouraged to undergo follow-up assessments at 1 month.subjects will be evaluated at designated time points after initiation of therapy. the primary efficacy endpoint is the proportion of subjects with normal serum sodium level (135-145 mmol/l) on day 7. the secondary efficacy endpoints are serum sodium level, change in sodium level from baseline, quality of life (eq-5d-3l), change in body weight, edema, renal function, mortality and liver-related complications on day 7 and day 30.

Eligibility criteria:
inclusion criteria: 1. age no less than 18 years; 2. confirmed cirrhosis by histology or radiological features of cirrhosis and clinical features of portal hypertension; 3. serum sodium level less than 135 mmol/l; 4. inpatients. exclusion criteria: 1. clinical features of hypovolemia; 2. systolic blood pressure less than 90 mmhg; 3. life expectancy less than one month; 4. history of variceal bleeding in the last six months; 5. hepatic encephalopathy or peritonitis in the last two weeks; 6. serum creatinine more than 3.5 mg/dl; 7. severe cardiopulmonary disease; 8. urinary tract obstruction.

Keywords: cirrhotic patients hyponatremia tolvaptan