Kornimate/medical-research-clean huggingface dataset:
n-methylglycine (sarcosine) treatment for depression

Conditions: Major Depressive Disorder; Depression; Major Depression

Summary: major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. n-methyl-d-aspartate (nmda), one subtype of glutamate receptors, plays an important role in learning and memory. n-methyl-d-aspartic acid (nmda) enhancing agents, such as sarcosine (n-methylglycine), have been used as adjunctive therapy of schizophrenia. sarcosine improved not only psychotic but also depressive symptoms in patients with schizophrenia. to confirm its antidepressant effect, the purpose of this study is to compare citalopram and sarcosine in efficacy for major depressive patients.

major depressive disorder is a complex disease and most currently available antidepressants aiming at monoamine neurotransmission exhibit limited efficacy and cognitive effects. novel therapies via manipulating other neurotransmission (e.g. glutamate receptor) are being developed. nmda enhancing agents, such as sarcosine have been demonstrated to improve negative symptoms and depressive symptoms of schizophrenic patients. the purpose of this study is to compare citalopram and sarcosine in aspects of efficacy, safety in major depressive patients. in the study, 40 major depressive patients are recruited into the 6-week trial and randomly assigned into the two groups (20-60 mg/d citalopram, or 500 - 1500 mg/d sarcosine) with a double-blind manner. hamilton depression rating scale(17-item), cgi(clinical global impression), gaf(global assessment of function)and side effects are evaluated every two weeks during the trial. the efficacies of two groups are compared.

Eligibility criteria:
inclusion criteria: * aged 18-55 years * fulfilled the dsm-iv criteria of major depressive disorder * had a 17-item hamilton rating scale for depression (hamd-17)\>or= 18 * no dsm-iv diagnosis of substance abuse or dependence (including alcohol) within the past 6 months * had been drug free for \> 3 months * physically healthy and had all laboratory parameters within normal limits. * agree to participate in the study and provide informed consent exclusion criteria: * had history of epilepsy, head trauma or other major neurological or medical diseases * had psychotic depression, bipolar i/ii disorder, schizophrenia or any other psychotic disorder * moderate-severe suicidal risks * severe cognitive impairment * female subjects who were pregnant, or at risk of pregnancy or lactation * initiating or stopping formal psychotherapy within six weeks prior to enrollment * had a history of poor response to ssris or previously received electroconvulsive therapy * had a history of severe adverse reaction to ssris.

Keywords: major depressive disorder depression sarcosine n-methylglycine nmda
beginning of effective and safe treatment in immunoglobulin a-1 nephropathy-1

Conditions: Glomerulonephritis, Immunoglobulin A (IgA)

Summary: immunoglobulin a nephropathy (igan) is the most common glomerulonephritis worldwide. igan is progressive, particularly when patients have a significant proteinuria (proteinuria \>1g/g creatinine), impaired kidney function, or elevated blood pressure. in 10 years, nearly 20-40% of these igan patients progress to end-stage renal disease (esrd). early igan is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. patients with early igan rarely progress to esrd. however, 30-40% of patients with early igan ultimately developed a significant proteinuria and hypertension in 10 years. therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. since angiotensin ll receptor blocker (arb) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of arb may be beneficial in preventing the significant proteinuria development in early igan patients. to prove the hypothesis, the investigators plan the current interventional study.


Eligibility criteria:
inclusion criteria: 1. biopsy-proven igan: dominant or co-dominant deposits of mesangial iga in immunofluorescence stain 2. age \>= 19 years 3. random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1 4. estimated glomerular filtration rate \>= 60 ml/min/1.73m2 at visit 1 5. people who voluntarily agreed to participate 6. people who are compliant exclusion criteria: 1. prevalent hypertension: systolic blood pressure \>=140 mmhg and \>=90 mmhg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs 2. prevalent diabetes: fasting glucose \>= 126 mg/dl, hba1c \>= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes 3. previous immunosuppressive drugs use to treat igan 4. secondary igan 5. renin-angiotensin-aldosterone inhibitors (rasi) dependent patients (congestive heart failure, ischemic heart disease, and others) 6. hypersensitivity to rasi 7. other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease 8. pregnancy 9. symptomatic orthostatic hypotension 10. people who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit 11. inappropriate people ascertained by investigator

Keywords: proteinuria progression early immunoglobulin a (iga) nephropathy
retrospective assessment of the risk of peripartum hemorrhage in pregnant women : retrospective assessment of the diagnostic performance of the hemstop standardized questionnaire

Conditions: Peripartum Period; Hemorrhage; HEMSTOP Questionnaire

Summary: the diagnostic performance of the hemstop (hematoma, hemorrhage, menorrhagia, surgery, tooth extraction, obstetrics, parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. the primary aim of the study is to assess the sensitivity and the specificity of the hemstop questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. the second aim of the study is to assess the sensitivity and specificity of the hemstop questionnaire in predicting postpartum hemorrhage.


Eligibility criteria:
inclusion criteria: full-term pregnant women who have given birth vaginally or by cesarean section. patients for whom a hemstop questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation. patients who received follow-up during pregnancy as recommended. age over 18 exclusion criteria: patients age under the age of 18 patients who did not have follow-up during pregnancy as recommended patients taking long-term anticoagulants and/or antiaggregants patients with a language barrier
hip and knee scores

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Summary: patient-reported outcome measures (proms) are currently used for evaluating orthopaedic procedures. nevertheless, there is no consensus in the different studies, making them difficult to compare . the score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score. moreover , minimal clinically important differences (mcid) is the smallest change in a treatment outcome that a patient would identify as important. the mcid is also not clearly identified for the french population for the hip and knee orthopaedic scores.


Eligibility criteria:
inclusion criteria: * hip osteoarthritis (certified by standard radiographs) * knee osteoarthritis ( certified by standard radiographs) exclusion criteria: * bmi ≥ 40 * systemic inflammatory disease * pregnant * surgery revision
thalidomide enhances clinical efficacy of cetuximab combined with standard chemotherapy for left colorectal cancer

Conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer

Summary: 1. to verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage iv ras and braf wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application. 2. to evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +folfiri, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.


Eligibility criteria:
inclusion criteria: 1. patients with ras and braf wild-type iv unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing; 2. physical state is good: ps 0-2; 3. expected survival of more than 3 months; 4. aged 18-75 years old; 5. have not received systematic chemotherapy before; 6. did not receive cetuximab treatment; 7. liver, kidney and bone marrow functions are basically normal; 8. the clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks; 9. voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent. exclusion criteria: 1. patients with severe dysfunction of vital organs (heart, liver, kidney); 2. patients with other malignant tumors; 3. patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test); 4. in the active phase of acute or chronic infectious diseases; 5. people with a clear history of drug allergy or allergic constitution; 6. patients participating in other clinical trials; 7. other conditions in which the patient was considered inappropriate to participate in the study.
maraviroc as gvhd prophylaxis in transplant recipients

Conditions: Diagnoses That Require Stem Cell Transplant; Graft Versus Host Disease (GVHD)

Summary: the purpose is to determine if the addition of maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.

in the first stage, drug levels will be obtained to establish appropriate dosing. in the second stage of the study the investigators will study the effects of using maraviroc in these patients.

Eligibility criteria:
inclusion criteria: * ages 5 years and \</= 40 years * all diagnoses * peripheral blood stem cells, marrow or cord blood * all conditioning regimens * patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as gvhd prophylaxis. exclusion criteria: * documented anaphylaxis to maraviroc * ex vivo t-cell (type of white blood cell) depleted grafts * abnormal alanine aminotransferase (alt) (\>/=10x uln) on day -3. (assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)

Keywords: stem cell transplant gvhd prevention
clonidine for analgesia to preterm infants during neonatal intensive care

Conditions: Intensive Care, Neonatal; Analgesia; Hypnotics and Sedatives

Summary: a prospective pharmacokinetic (pk), pharmacodynamic (pd) and pharmacogenetic (pg) observation study, including the pk/pd/pg relationship, in clonidine administered for analgesia and sedation to preterm newborn infants receiving neonatal intensive care. phase 3 - therapeutic confirmatory study

all preterm infants that are admitted to the study neonatal intensive care units (nicus) for neonatal intensive care are potential study patients, and their parents will be asked for consent. the patient will be treated according to clinical guidelines and will be included in the study if in need for clonidine according to clinical judgment (pain scores) and as decided by the responsible clinical doctor. the dosing and administration of the drug will be implemented according to an algorithm based on pain scoring results. apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography, eeg, echocardiography, ecg, ultrasound of the brain) and follow-up (neurologic examination and magnetic resonance imaging, mri) are the same as for all preterm infants according to local and national guidelines. in total 100 infants will be included.

Eligibility criteria:
inclusion criteria: * preterm infants (\< gw 37+0) who are in need for analgesic or sedative medication according to clinical judgment (scoring with pain assessment scales; alps-neo and comfort-neo) * existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling * informed and written parental consent exclusion criteria: * hemodynamic instability (same as in clinical routine). * cardiac malformations in need for postnatal surgery. * any serious medical condition or ethical issues that could, in the investigators opinion, interfere with the study procedures.
efficacy of sanctura xr (trospium chloride) for reducing overactive bladder symptoms in female subjects refractory to detrol la (tolterodine tartrate extended release) daily

Conditions: Overactive Bladder

Summary: this study will investigate the safety and efficacy of sanctura xr (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to detrol la (tolterodine tartrate extended release) 4 mg therapy.


Eligibility criteria:
inclusion criteria: * taking detrol® la 4mg daily for a minimum of 1 month prior to screening/qualification * overactive bladder syndrome with urgency, urinary frequency and urgency urinary incontinence * taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than overactive bladder (oab). exclusion criteria: * predominant stress or insensate incontinence * history of neurogenic bladder * two urinary tract infections in the last six months * gastric by-pass (roux-en-y) surgery (adjustable gastric banding is allowed) * donated \>500ml blood in the 30 days prior to the screening visit
effect of smoked plum and chewing gum on postoperative bowel function following hepatic resection

Conditions: Liver Cancer

Summary: every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. this study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. one third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.

hepatectomy is widely used to treat patients with hepatocellular carcinoma (hcc), even those with intermediate and advanced disease. despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. one complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. this can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. while postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. postoperative use of opioid-based analgesics can increase incidence of postoperative ileus. no drugs or interventions to prevent or treat postoperative ileus have been approved by the china drug administration or the us food and drug administration. several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. this raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. to examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in hcc patients who received smoked plum, chewing gum or no intervention following hepatectomy.

Eligibility criteria:
inclusion criteria: * underwent open hepatic resection * diagnosis of hcc was confirmed by histopathological examination of surgical samples in all patients exclusion criteria: * previously underwent exploratory laparotomy * laparoscopic surgery * known central nervous system tumors including metastatic brain disease * history of organ allograft * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study * pregnant or breast-feeding patients
sentinel node biopsy vs observation after axillary pet

Conditions: Breast Cancer

Summary: several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. based on the routine axillary imaging evaluation (ultrasound and mr etc.) and latest dedicate lymph node pet (lymphpet), axillary nodal burden can be identified before operation. therefore this prospective study are designed to evaluate the negative predictive value of lymphpet and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.


Eligibility criteria:
inclusion criteria: stage 1: 1. female 2. ≥18 years old 3. invasive ductal carcinoma or dcis proved by core needle biopsy 4. tumor size ≤ 5cm 5. negative preoperative axillary assessment(including body examination, ultrasound and mr examination) 6. patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection) stage 2: 1. female 2. ≥18 years old 3. invasive carcinoma proved by core needle biopsy 4. has plan for breast conserving surgery and adjuvant radiation after surgery 5. negative preoperative axillary assessment(including body examination, ultrasound and axillary pet msuv\<0.27) 6. patients is accessible for the follow up exclusion criteria: stage 1: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and mr examination) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before lymphpet 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of lymphpet stage 2: 1. distant metastases 2. in the procedure of neoadjuvant therapy 3. positive preoperative axillary assessment (including body examination, ultrasound and pet msuv≥0.27) 4. pregnancy or breastfeeding 5. axillary biopsy or axillary surgery before lymphpet 6. suffer from diabetes mellitus and without well control of bloodglucose 7. previous malignancy 8. allergic to tracer of lymphpet
combination of etv, tq-a3334 and tq-b2450 for chb (neptune study)

Conditions: Chronic Hepatitis b

Summary: this study is a single-center, randomized, prospective, open-label phase 2 clinical trial to evaluate efficacy and safety of etv and tq-a3334 combinated with/without inhibitor of tq-b2450 versus etv alone in chronic hepatitis b patients. patients were randomized to one of 3 different antiviral treatment.


Eligibility criteria:
inclusion criteria: 1. male and female patients from 18 to 65 years of age; 2. chronic hepatitis b infection 3. negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug; 4. agree to participate in the study and sign the patient informed consent. exclusion criteria: 1. patients who had nas resistance; 2. other antiviral, anti-neoplastic or immunomodulatory treatment; 3. women with ongoing pregnancy or breast-feeding; 4. co-infection with active hepatitis a, hepatitis c, hepatitis d(those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (hiv); 5. alt \>10 uln; 6. lsm \>9kpa ; 7. history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia); 8. signs or symptoms of hepatocellular carcinoma; 9. neutrophil count \< 1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening; 10. hemoglobin \< 11.5 g/dl for females and \<12.5 g/dl for men; 11. serum creatinine level \> 1.5 uln in screening period. 12. phosphorus \< 0.65 mmol/l; 13. ana \> 1:100; 14. history of severe psychiatric disease; 15. history of a severe seizure disorder or current anticonvulsant use; 16. history of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.); 17. history of chronic pulmonary disease associated with functional limitation; 18. diseases that ifn and nucleotides or nucleosides are not suitable.
efficacy and tolerability of cassia fistula plus senna alexandrina miller (sugar free) in the chronic functional constipation (cfc).

Conditions: Constipation

Summary: primary objective: * to evaluate the clinical efficacy of naturetti (jelly sugar free) * to test medication on subjects who suffer chronic functional constipation in 30 days use. secondary objectives: * to demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. the components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related * to demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study * to identify any adverse events related to the study drug * to identify any drug interaction.


Eligibility criteria:
inclusion criteria: * having chronic functional constipation by rome iiii criteria * having the majority of the stool as type 1 or 2 by bristol stool scale * female subjects should be using an effective contraceptive method more than 3 months if they are sexually active and on reproductive stage * icf signature * be able to understand and agree to undertake the study procedures * having no contraindication related to the study drug * to perform all study visits. exclusion criteria: * having previous history or current neurological disorder and/or metabolic one * having constipation caused by previous surgery * having intestinal obstruction including colon/rectum cancer * having endocrine disorder as diabetes mellitus * having irritable bowel syndrome or inflammatory bowel disease * having multiple sclerosis * having parkinsons disease * having hirschsprungs disease and dyssynergy defecation * continuous treatment with the following: analgesics, anticholinergic (antihistamines, antispasmodics, antidepressants, antipsychotics) iron supplements or aluminum, opiates, antihypertensive, calcium channel blockers and ganglionic blocker * treatment with any other laxative medication other than the rescue medication during the study * patients who could not confirm the chronic functional constipation during the phase i study * pregnancy or breast feeding woman * abnormal laboratory results, or clinical result that shows significant by the investigator * corporeal mass index \> 30 * patients who have participate in other clinical study within 30 days * unable to fulfill the questionnaire (diary) * any condition that makes impossible to the patient in participates by investigator opinion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.