Kornimate/medical-research-clean huggingface dataset:
velcade for proliferative lupus nephritis

Conditions: Lupus Nephritis; Proteinuria; Hematuria

Summary: the primary objective is to test the safety and efficacy of velcade to induce remission in who class iii/iv/v lupus nephritis that are refractory to standard medications.

this exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with who class iii/iv/v lupus nephritis. subjects will receive 12 doses of velcade to induce clinical remission.

Eligibility criteria:
inclusion criteria: 1. acr criteria for lupus (minimum 4 out of 11). 2. biopsy proven who class iii or iv or v lupus nephritis with clinical activity. 3. gfr must be greater or equal to 30 cc/min/1.73 m2. 4. proteinuria must exceed 1000 mg per day except for who class v lupus nephritis, daily proteinuria must be greater or equal to 2000 mg. 5. primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for who lupus iii/iv. exclusion criteria: 1. serum creatinine of more than 3.0 mg/dl on repeated testing. 2. greater than 50% fibrosis on renal biopsy. 3. platelet count of less than 30× 109/l. 4. absolute neutrophil count of less than 1.0 × 109/l. 5. greater than or equal to grade 1 peripheral neuropathy. 6. myocardial infarction within 6 months prior to enrollment or new york heart association (nyha) class iii or iv heart failure. 7. hypersensitivity to velcade, boron or mannitol. 8. serious medical conditions and infections (including hiv, hcv, hbv) or psychiatric illness. 9. known history of untreated positive ppd. 10. serious complications from systemic lupus such as cerebral lupus and severe active infections. 11. diagnosed or treated for another malignancy within 3 years of enrollment. 12. greater than 1.5x upper limit of normal total bilirubin.

Keywords: proliferative lupus nephritis who class iii/iv/v lupus nephritis proteinuria hematuria velcade sle bortezomib proteasome inhibitor
self and body-esteem in socio-professional rehabilitation

Conditions: Schizophrenia; Bipolar Disorder; Personality Disorders; Anxiety Disorders; Depressive Disorder

Summary: the body esteem influences the physical appearance, which can be a social brake. to enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. the study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center

our hypothesis is that a group program centered on the image and the presentation of the self, with the intervention of professionals of the image of the body, such as socio-hairdresser, socio-beautician, allows a better socio-professional inclusion, through an improvement in body self-esteem. taking care of yourself will require different approaches such as advice on hygiene, becoming aware of your body, experimenting with beauty treatments and having the means to reproduce them at home. we will compare our ips program (image and presentation of self), with the usual management in the care center (tau = "treatment as usual")

Eligibility criteria:
inclusion criteria: * age 18 to 65. * speaking french. * diagnosis of severe mental disorders (msd) established according to the criteria of the dsm-v (diagnostic and statistical manual of mental disorders) such as: schizophrenia, bipolar disorders, serious personality disorders, severe anxiety disorders, depressive disorders; with a clinical stability of more than 3 months. * supported at sur/cl3r with an application for socio-professional reintegration. * guardian agreement (for persons under guardianship); * information given to the curator (for persons under curatorship); * member of the social security scheme. exclusion criteria: * diagnosis of autism spectrum disorder (asd) or eating behaviour disorder. * clinical status incompatible with group activity. * acute episode in progress. * refusal to participate. * simultaneous participation in a psycho-social rehabilitation program targeting image or self-esteem (general and/or body).

Keywords: severe mental disorders body-esteem body-representation self-esteem socio-professional insertion
a research study looking at how victoza® works in people with type 2 diabetes in iran, followed in local clinical routine

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how the medicine victoza® (liraglutide) works in people with type 2 diabetes in iran. patients will get victoza® as prescribed to them by their study doctor. the study will last for about 5 to 8 months. patients will be asked to complete some questionnaires about their health and diabetes treatment. patients will complete these during their normally scheduled visits with study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * male or female, age greater than or equal to 18 years at the time of signing informed consent * the decision to initiate treatment with commercially available victoza® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study * patients diagnosed with type 2 diabetes mellitus (t2dm), with treatment planned according to the iranian label for victoza® at treatment initiation * available glycated haemoglobin a1c (hba1c) value less than or equal to 12 weeks prior to initiation of treatment with victoza® exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * known or suspected hypersensitivity to victoza® or related products * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
blood donor cvd 9000

Conditions: Cholera Vaccination

Summary: this is an open-label, non-randomized study. volunteers will be vaccinated with the oral cholera vaccine, vaxchora. vaxchora has been licensed by the food and drug administration (fda) for travelers to developing countries. volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. the specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.


Eligibility criteria:
inclusion criteria: * 1. age 18 years to 64 years at the time of enrollment * 2. good general health as determined by a screening evaluation within 28 days before blood donation or vaccination * 3. provides written informed consent prior to initiation of any study procedures exclusion criteria: * 1. history of any of the following medical conditions: * diabetes * cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ) * heart disease (e.g., hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. current symptoms of heart disease, such as dyspnea, angina, or orthopnea) * recurrent infections (e.g., more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis) * current drug or alcohol abuse * active ulcer disease or ongoing intestinal condition * treatment for anemia in last 6 months * treatment with anti-malarial drugs within ten days prior to study vaccination * treatment with antibiotics within 14 days prior to study vaccination * immunodeficiency or immunosuppression from illness or treatment * 2. close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment * 3. history of cholera infection or cholera vaccination * 4. any of the following complete blood count (cbc) abnormalities during screening: * white blood cells (wbc) \ 1.09 x upper limit of normal (uln) * hemoglobin \ 1.18 x uln (women) or \ 1.18 x uln (men) * platelet count \ 1.2 x uln * 5. any of the following laboratory abnormalities during screening: * serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) \>1.5 times normal * positive serology for hiv antibody * 6. poor peripheral venous access for blood donation * 7. other condition that the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study * 8. positive urine pregnancy test (hcg) on the day of vaccination
relationship between acute phase markers and post-operative pain in laparoscopic cholecystectomy: an observational study

Conditions: Post Operative Pain

Summary: many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain. the aim of the study is to show a possible correlation between pain and acute phase proteins in order to: * predict the severity of pain; * select most suitable pain relief therapy for the patient.

the day after surgery, some serum markers are determined by a blood sample. the markers analyzed are: * leukocytes; * c-reactive protein (crp); * d-dimer; * fibrinogen; * neutrophil-to-lymphocyte ratio (nlr). pain level is assessed using the nrs scale at different times: * 1st post-operative day; * 7th post-operative day; * one month after surgery; * three months after surgery; * six months after surgery. other data collected for the study are: gender, age, bmi.

Eligibility criteria:
inclusion criteria: * patient undergoing laparoscopic cholecystectomy exclusion criteria: * children
targeted correction of plasma sodium levels in hospitalized patients with hyponatremia

Conditions: Hyponatremia

Summary: hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. while treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge. this is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality. the aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.


Eligibility criteria:
inclusion criteria: * all adult hospitalised patients with hypotonic hyponatremia \<130mmol/l exclusion criteria: * severe symptomatic hyponatremia in need of intensive care treatment * non-hypotonic hyponatremia with plasma osmolality \>280 milliosmol (mosm)/kg * end of life care (palliative treatment)
pgl4001 efficacy assessment in reduction of symptoms due to uterine leiomyomata

Conditions: Uterine Fibroids

Summary: this is a multicentre, phase iii, efficacy and safety open-label study with pgl4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of pgl4001 treatment.

pgl4001 will be administered daily to all subjects in an open-label manner with no control group. the three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * subject is a pre-menopausal woman aged between 18 and 48 years inclusive. * subject with a body mass index ≥18 and ≤40. * subject with myomatous uterus size \< 16 weeks. * subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound. * subject complained of strong uterine bleeding. * subject is eligible for hysterectomy or myomectomy. * females of childbearing potential have to practice a non-hormonal method of contraception. exclusion criteria: * subject has a history of or current uterus, cervix, ovarian or breast cancer. * subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy. * subject has a known severe coagulation disorder. * subject has a history of treatment for myoma with a sprm, including ulipristal acetate. * subject has abnormal hepatic function at study entry.
decitabine combining dexamethasone versus dexamethasone in management of itp

Conditions: Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenia

Summary: the project was undertaking by qilu hospital of shandong university and other 18 well-known hospitals in china. in order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (itp), compared to dexamethasone alone .

the investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 itp adult patients from 19 medical centers in china. one part of the participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive days as a cycle , if platelet count remained below 30 × 109/l or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d for 4 consecutive days as a cycle, if platelet count remained below 30 × 109/l or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given). platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to dexemathasone alone therapy for the treatment of adults with itp.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group（ecog）performance status ≤ 2. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or intravenous immunoglobulin transfusion(ivig) in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. 4. severe medical condition (lung, hepatic or renal disorder) other than itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7. patients who are deemed unsuitable for the study by the investigator.

Keywords: purpura thrombocytopenia immune throbocytopenia
covid-19 booster dose reminder/recall for adolescents

Conditions: COVID-19 Vaccines

Summary: a single covid-19 booster dose has been recommended in the united states for adolescents aged ≥12 years to enhance protection against sars-cov-2 infection. this study will assess the efficacy of a one-time reminder/recall for covid-19 booster dose among eligible adolescents in a regional healthcare system.


Eligibility criteria:
inclusion criteria: * marshfield clinic health system patient aged 12-17 years with at least one preventive visit or two evaluation \& management visits with a marshfield clinic health system provider in the last 36 months * due for a covid-19 booster dose (completed the covid-19 primary series and it has been ≥5 months since their second dose) exclusion criteria: * primary care provider is not affiliated with marshfield clinic health system * opted out of marshfield clinic health system centralized vaccine reminder notifications * received covid-19 vaccine off label * missing or invalid contact information * deceased

Keywords: reminder/recall covid-19 intervention adolescents
ayurveda based intervention for patients in acute psychiatric crisis situations

Conditions: Psychiatric Disorder

Summary: for patients undergoing a psychiatric crisis, hospitalisation is required. in developing countries specially in sub-urban or rural areas, most patients don't access intensive care. in india, ayush system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. however, evidence to support their effectiveness has remained very low. present study is designed as community based participatory research, where ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team.


Eligibility criteria:
inclusion criteria: * presenting with a psychiatric complaint. * male or female patients at least 18 years of age. * each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment. exclusion criteria: * patients who have delirium or dementia * prisoners * pediatric patients * elderly patients * pregnancy or breastfeeding

Keywords: ayurveda mental health emergencies community based participatory research
ketamine iv classic protocol : five years follow up

Conditions: Major Depressive Disorder; Drug Abuse; Medications; Relapse

Summary: patients who suffer from mdd recieved ketamnie (2014-15) in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. in addition time of relapse and questions about their medications and drug use will be performed.

patients who suffer from major depressive disorder and are outpatients in our clinic and, received in the years (2014-15) ketamine in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. in addition time of relapse and questions about their medications and drug use will be performed.

Eligibility criteria:
inclusion criteria: * patient who participated in ketamine study 1126 exclusion criteria: * none

Keywords: major depressive disorder ketamine follow up antidepressants
donepezil treatment for sleep apnea patients

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep apnea patients. sleep structure and respiratory parameters will be analyzed by polysomnography.

cholinergic activity also influences the upper airway opening via central and peripheral mechanisms. decreased thalamic pontine cholinergic projections may affect respiratory drive leading to both central and obstructive apnea at least in certain degenerative conditions.in contrast to the prolific literature on physical and surgical treatments for sleep apnea there is a dearth of effective pharmacological approaches.most drugs previously tested for this purpose acted upon monoaminergic and adenosinergic systems and showed unsuccessful or ambiguous results.a previous study showed that donepezil treatment improved apnea-hypopnea index and oxygen saturation in patients with alzheimer's disease. treatment also increased rem sleep duration and reduced adas-cog scores.based on these facts we hypothesize that donepezil treatment may be beneficial for sleep apnea patients. intervention: patients will be administered donepezil or placebo. the study has a randomized, double-blind placebo-controlled design. complete polysomnography will be performed at baseline, after 28 days of drug or placebo treatment, after 15 days drug or placebo washout and after 28 days of cpap treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of obstructive sleep apnea according to american academy of sleep medicine criteria exclusion criteria: * body mass index \> 40 * use of psychoactive drugs * presence of neurological, cardiological and pulmonary diseases

Keywords: sleep apnea donepezil pharmacological cholinergic
dose escalation study of zg006 in participants with advanced small cell lung cancer or neuroendocrine carcinoma, followed by dose expansion study in participants with neuroendocrine carcinoma.

Conditions: Neuroendocrine Carcinoma

Summary: this is a multicenter, open-label phase i/ii study, divided into 2 parts: part 1 involves a dose-escalation study of zg006 in which the safety and tolerability of zg006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. upon completion of part 1, investigators and the sponsor will discuss and determine two recommended phase ii doses (rp2d) based on safety, preliminary efficacy, and pharmacokinetic results for use in part 2. part 2 is a phase ii dose-expansion study of zg006, aiming to investigate the efficacy and safety of zg006 in patients with neuroendocrine carcinoma.


Eligibility criteria:
inclusion criteria: * fully understand the study and voluntarily sign the informed consent form; * male or female 18\~75 years of age; * eastern cooperative oncology group(ecog) performance status of 0 or 1; * life expectancy ≥ 3 months. exclusion criteria: * participants were deemed unsuitable for participating in the study by the investigator for any reason.