Kornimate/medical-research-clean huggingface dataset:
open study assessing the feasibility of minocycline in patients with unipolar depression

Conditions: Unipolar Depression

Summary: a single center, open label study assessing the feasibility, safety and therapeutic effect of minocycline in adult patients with diagnosis of unipolar depression. up to 30 patients diagnosed with unipolar depression that are in a current depressive episode. the patients will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and have hdrs-21≥20. all subjects will continue to take their treatment with antidepressant medications for the duration of the study. all subjects are prescribed minocycline 200 mg/day orally (2x100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400 mg/day orally (2x200 mg) from day 4 until termination visit (day 35). the primary objective of this study is to assess the therapeutic effect of minocycline in unipolar depression. the secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of minocycline in unipolar depression.


Eligibility criteria:
inclusion criteria: 1. outpatients and inpatients 2. men and women 18-68 years of age. 3. primary dsm-iv diagnosis of depression, single or recurrent episode confirmed by the structured clinical interview for the dsm-iv (scid-iv), with the additional requirements of a current episode ≥4 weeks and cgi-s ≥4. 4. total hdrs-21 ≥20 and item 1 score ≥2 at the screening visit. 5. the patient did not respond to at least one antidepressant medication given for an accepted dose and duration. 6. capable and willing to provide informed consent 7. able to adhere to the treatment schedule. - exclusion criteria: 1. depression secondary to a general medical condition. 2. history of substance abuse or dependence within the past 6 month (except opioids, nicotine and caffeine). 3. all antidepressant medications, must have been in stable dosage for at least 3 weeks prior to entry into the study, with no anticipation of change over the duration of the study. 4. use of any medication(s) listed on the excluded medication list within the time that mansion for each medication on the list. 5. any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • bipolar disorder • eating disorder 6. subjects who were taking a known contraindication to minocycline treatment. 7. subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry. 8. present suicidal risk as assessed by the investigator or significant suicide risk based on hdrs-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month 9. known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.(if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding 10. patients with severe hepatic or renal insufficiency. -
lenalidomide, vorinostat and dexamethasone in relapsed patients with peripheral t-cell non-hodgkin's lymphoma (ptcl)

Conditions: Peripheral T-Cell Non-Hodgkin's Lymphoma

Summary: a standard therapy is neither established in first-line patients nor in relapsed patients with ptcl, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens. the aim of this study is to evaluate the potential of a lenalidomide plus vorinostat and dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed ptcl following failure of prior regimens.


Eligibility criteria:
inclusion criteria: * patients with relapsed ptcl according to who criteria who have received max. two previous treatments for ptcl * age ≥ 18 years. * adequate bone marrow function i.e. absolute neutrophile count of \> 1000/µl and thrombocytes \> 75,000/µl. * alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (uln) * total bilirubin ≤ 2,5 x uln * creatinine clearance ≥ 50 ml/min * female subjects of childbearing potential† must: understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test * male subjects must agree to use condoms and agree not to donate semen exclusion criteria: * prior history of malignancies, other than ptcl, unless the subject has been free of the disease for ≥ 3 years * prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration * prior treatment with a hdac inhibitor * prior treatment with lenalidomide (patients previously treated with thalidomide may be enrolled) * known history of deep vein thrombosis (dvt) and/ or pulmonary embolism (pe)

Keywords: ptcl peripheral t-cell non-hodgkin's lymphoma vorinostat lenalidomid
phase i open label trial to assess safety of bibw 2992 (afatinib) in combination with herceptin® in patients with her2-positive advanced breast cancer.

Conditions: Breast Neoplasms

Summary: study to determine the maximum tolerated dose of bibw 2992 given in combination with herceptin®


Eligibility criteria:
inclusion criteria: 1. female patients aged \>18 years. 2. advanced or metastatic breast cancer that over-expresses her2 (immunohistochemistry 3+ or 2+ and gene amplification by fish). prior treatment with herceptin® or lapatinib® (in the adjuvant or metastatic settings) is permitted but not required. exclusion criteria: patients with untreated or symptomatic brain metastases. prior treatment with egfr targeting therapies or treatment with egfr- or her2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
cold snare versus double biopsy polypectomy technique for removal of diminutive colorectal polyps

Conditions: Polyp of Large Intestine

Summary: most of colorectal polyps founded during colonoscopy are diminutive polyps less than 6 mm. however, complete removal of diminutive polyps is required to prevent tumor recurrence and development of potential interval cancers. currently, a variety of polypectomy techniques such as hot snare, cold snare, and cold forceps polypectomy are frequently used for the removal of diminutive colorectal polyps. in regard to the completeness of polypectomy, there are few data comparing cold snare polypectomy with cold forceps biopsy technique for removal of diminutive (1-5 mm) colorectal polyps. the aim of this study is to compare cold snare polypectomy with cold forceps polypectomy using double biopsy technique for removal of diminutive colorectal polyps.


Eligibility criteria:
inclusion criteria: * patients over the age of 20 * informed consent exclusion criteria: * patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy * known existing bleeding tendency (thrombocytopenia or prolonged inr) * inflammatory bowel diseases (crohn's disease, or ulcerative colitis) * asa class iii or more * pregnancy * any condition which, in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study
qsofa in general wards: the accuracy in diagnosis of sepsis

Conditions: Sepsis

Summary: the new definition of sepsis (sepsis 3.0) restricts the early diagnosis of sepsis in general wards. despite an alternative process by using a simplified qsofa score, many patients may still be left out. whether these patients matter or not is unknown. this prospective cohort includes patients from ten general wards with high incidence of infection during a consecutive half year, obtains qsofa and sofa score, follows up prognostic data, therefore to compare patients under different groups, eventually to evaluate the diagnostic accuracy of qsofa score in diagnosis of sepsis.

the sepsis, which is considered as multi-organ dysfunction induced by infection, is a one of leading causes of death in hospital. in 2016, the third international consensus has modified the definition of sepsis from infection with \>=2 of systemic inflammatory response syndrome (sirs) criteria to infection with \>=2 of sequential organ failure assessment (sofa) score. this new definition, which well reflects the organ dysfunction nature of sepsis, however makes it difficult to diagnose sepsis in general wards. an alternative of process was put forward to compensate this weakness. for each infection patient in general, access a quick sofa (qsofa), if it is above 2 score, then conduct laboratory examination to get a sofa score. this process is helpful to find out sepsis, but undoubtedly leave out some patients who meet the sofa criteria without qsofa \>=2. besides, there are also some patients who has a qsofa \>=2 however do not meet the sofa criteria. whether those patients have better survival rate is unclear. this prospective cohort is aimed to compare prognosis of patients with different sofa, qsofa score, therefore access the diagnostic accuracy of qsofa in the diagnosis of sepsis, eventually evaluate the feasibility of using qsofa as a complete replacement of sofa in general wards.

Eligibility criteria:
inclusion criteria: * age\>=18; exclusion criteria: * hospital stay less than 24h just for chemotherapy,biotherapy or endoscopy.

Keywords: sepsis qsofa sofa diagnostic accuracy
a real-world observational study: zevorcabtagene autoleucel injection in patients with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this study is a single-arm, open-label, multicenter, post-marketing, phase iv, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with r/r mm in the real world.

primary study endpoints: overall survival rate (os rate) at 24 months after infusion：survival rate from the start of cell infusion to 24 months after infusion. secondary study endpoints: incidence and severity of treatment-related adverse events (teaes) for zevor-cel incidence and severity of adverse events (aes) related to study treatment incidence of serious adverse events (saes) related to study treatment other efficacy endpoints of zevor-cel: overall response rate (orr)：proportion of subjects with a partial response (pr) or above. complete response or stringent complete response rate (cr/scr) ：the proportion of subjects with the best response of cr/scr. duration of response (dor)：the time from first response to disease progression or death caused by any reasons in subjects with the best response of pr and above. progression free survival (pfs) overall survival (os)： the time from the start of cell infusion to death due to any cause.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion. 3. voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians. exclusion criteria: 1. there were no specific exclusion criteria for this study。
parasitic causes of secretory diarrhea in children and chronically ill adult.

Conditions: Diarrhea, Secretory

Summary: diarrhea is one of the most common reasons for people to seek medical advice - but it can range from being a mild, temporary condition, to be life threading condition. it is estimated that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million children below the age of 5 years, mostly in developing countries, die annually.

secretory diarrhea has many causes as infection with bacteria, viruses or protozoa. it results from increased chloride secretion, decreased sodium absorption, or increased mucosal permeability . parasitic pathogens induce secretory diarrhea as they infect and damage the absorptive villus tips, leaving secretory crypts unbalanced, to cause net secretion and diarrhea. parasitic causes include cryptosporidium parvum or hominis ,capillaria philippinensis and giardia lamblia. cryptosporidiosis is also recognized as a cause of prolonged and persistent diarrhea in children and persons with impaired immunity. the disease is transmitted via the fecal-oral route from infected hosts. it can be also transmitted following animal contact, ingestion of water (mainly during swimming), or through food. cryptosporidium has emerged as the most frequently recognized cause of water-associated outbreaks of gastroenteritis. this is because of the oocyst stage in its life cycle; cryptosporidium can resist disinfection, including chlorination, and can survive for a prolonged period in the environment.

Eligibility criteria:
inclusion criteria: 1. children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of assiut university pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period. 2. adult patients having acute watery diarrhea attend to out clinic labs of assiut university hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period. exclusion criteria: 1. viral and bacterial causes of diarrhea 2. patients who were already diagnosed as intestinal inflammatory disease as irritable bowel syndrome. 3. autoimmune conditions, such as ulcerative colitis, crohn's disease and coeliac disease.
study of difluprednate in the treatment of inflammation following ocular surgery (st-601-003)

Conditions: Inflammation

Summary: the purpose of this phase iii study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.


Eligibility criteria:
inclusion criteria: * scheduled for unilateral ocular surgery. exclusion criteria: * systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
starbrite: a randomized pilot trial of bnp-guided therapy in patients with advanced heart failure

Conditions: Congestive Heart Failure

Summary: the primary hypothesis is that, in patients with advanced heart failure, an outpatient fluid management strategy guided by bnp levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone.

starbrite will test the hypothesis that a defined fluid management strategy, tailored to specific symptoms and physiological targets, will improve morbidity and mortality in the advanced heart failure population. individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function. identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients. in addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings. in this study, patients will be randomized to two strategies of outpatient fluid management: 1) the congestion score strategy and, 2) the bnp strategy.

Eligibility criteria:
inclusion criteria: 1. patients admitted with nyha class iii/iv symptoms of heart failure 2. left ventricular ejection fraction ≤35% 3. will have received at least one dose of intravenous diuretics during the current hospitalization 4. prior to discharge, has received heart failure education and has learned about daily weights, and fluid, sodium, and dietary restrictions 5. able to return for follow-up care at the brigham and women's hospital cardiomyopathy clinic or the duke heart failure management program 6. has regular access to a telephone 7. ≥18 years of age exclusion criteria: 1. moderate to severe valvular stenosis 2. admitted with acute coronary syndrome 3. creatinine \>3.5 4. renal failure on hemodialysis 5. pregnant or lactating

Keywords: heart failure, brain natriuretic peptide
a study of bevacizumab (avastin) in combination with chemotherapy in participants with metastatic cancer of the colon or rectum

Conditions: Colorectal Cancer

Summary: this expanded access study will assess the efficacy and safety of intravenous (iv) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. the anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.


Eligibility criteria:
inclusion criteria: * previously untreated metastatic colon or rectal cancer * scheduled to begin iv 5-fluorouracil-based chemotherapy as a first-line treatment exclusion criteria: * prior chemotherapy for metastatic colon or rectal cancer * planned radiotherapy for underlying disease * central nervous system metastases * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start * treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
occupational therapy and registered dietitian services to reduce fall risk among home delivered meal clients

Conditions: Diet, Food and Nutrition; Accidental Falls; Cardiovascular Diseases; Diabetes; Debility; Frailty; Functional Disability

Summary: the purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the united states. without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. in our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. the high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. in response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.

Eligibility criteria:
inclusion criteria: * eligible to receive meals according to lifecare alliance's standard in-take criteria (over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals) * has a working freezer to store between 7-14 frozen meals/week * has a working microwave or oven to reheat meals * lives within lifecare alliance's 5-county service area exclusion criteria: * individuals already receiving home-delivered meals from lifecare alliance or other meal agency (within the past 40 days) * individuals residing in residential care or a skilled nursing facility * individuals whose dietary restrictions prohibit them from eating meals from lifecare alliance's frozen meal selection * individuals at home on hospice care * unable to independently answer lifecare alliance's in-take questions
technology-assisted upper extremity rehabilitation in subjects with incomplete cervical spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the aim of the study is to investigate the effects of 6 weeks of technological-assisted rehabilitation on function of upper extremity and hand in subjects with incomplete cervical spinal cord injury.

in this crossover study, persons with motor incomplete cervical (c2-c8) spinal cord injury (ais c-d) will be recruited from the hospital district of helsinki and uusimaa. in the first period of the crossover study, other part of the participants will get technological-assisted upper extremity rehabilitation, while the other part of the participants continue their normal lives. the first period is followed by 4-week wash-out period. in the second period, roles of the participants will be switched. the rehabilitation phase lasts for 6 weeks with 3 weekly sessions, each therapy session including at least 30 minutes of technological-assisted upper extremity rehabilitation. rehabilitation includes passive, active and resistance exercises, and will be carried out by using amadeo, pablo and/or diego devices made by tyromotion.

Eligibility criteria:
inclusion criteria: * incomplete motor spinal cord injury (ais c-d) * injury level c2-c8 * time since injury from 1 to 5 years * to be able to sit * motivation and ability to participate in intensive rehabilitation 3 times per week for 6 week period. exclusion criteria: * participation in other exercise study or technological-assisted upper extremity study * unlikely completion of intervention and participation in follow up * injuries that prevent training * weak tolerance of intense training * severe joint movement restriction or instability * irreversible muscle contractures * grade 4 on modified ashworth scale in glenohumeral, elbow, wrist and finger joints * recent significant forearm or hand injuries * memory disorder * orthopedic, rheumatic or neurological diseases (other than spinal cord injury) that prevent training