Kornimate/medical-research-clean huggingface dataset:
combination of nmda-enhancing and antioxidant treatments for schizophrenia

Conditions: Schizophrenia

Summary: previous studies found that some nmda-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. in addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. whether combined treatment of an nmda-enhancing agent and a drug with antioxidant property can be better than an nmda-enhancing agent alone deserves study.

several lines of evidence suggest that both nmda and oxidative stress hypotheses have been implicated in schizophrenia. previous studies found that some nmda-enhancing agents were able to augment efficacy of antipsychotics in the treatment of schizophrenia. in addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. whether a drug with antioxidant property can strengthen the efficacy of an nmda-enhancer (nmdae) in the treatment of schizophrenia remains unknown. therefore, this study aims to compare nmdae plus a drug with antioxidant property and nmdae plus placebo in the treatment of schizophrenia. the subjects are the schizophrenia patients who remain symptomatic while having been stabilized with antipsychotic treatment. they keep their original treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) nmdae plus antioxidant agent (ao), or (2) nmdae plus placebo. clinical performances and side effects are measured at weeks 0, 2, 4, 6, 9, and 12. cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. the efficacies of nmdae plus ao and nmdae plus placebo will be compared. chi-square (or fisher's exact test) will be used to compare differences of categorical variables and t-test (or mann-whitney test if the distribution is not normal) for continuous variables between treatment groups. mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (gee). all p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Eligibility criteria:
inclusion criteria: * have a dsm-5 (american psychiatric association) diagnosis of schizophrenia * remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial * panss total score ≥ 60 * agree to participate in the study and provide informed consent exclusion criteria: * dsm-5 diagnosis of intellectual disability or substance (including alcohol) use disorder * history of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study * clinically significant laboratory screening tests (including blood routine, biochemical tests) * pregnancy or lactation * inability to follow protocol

Keywords: schizophrenia nmda oxidative stress
a first in human study to evaluate the safety, tolerability and pharmacokinetics of pf-04455242 in single rising doses in healthy adult volunteers

Conditions: Bipolar Depression

Summary: the purpose of this first in human (fih) study is to investigate the safety, tolerability, pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects the body) of pf-04455242-01 in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female of non-childbearing potential between the ages of 18 and 55 years. * body mass index (bmi) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (\>110 lbs). * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: * evidence or history of clinically significant medical condition or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening). * use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine or blood cotinine at screening. * a positive urine drug screen. history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.

Keywords: healthy volunteer, first in human, safety and tolerability
enhance the use of genetic counseling and testing in latinas

Conditions: Hereditary Breast and Ovarian Cancer Syndrome

Summary: the investigators will conduct a two-arm rct to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. a force fact sheet on enhancing genetic cancer risk assessment (gcra; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among latinas at increased risk for hereditary breast and ovarian cancer (hboc).

the investigators will conduct a two-arm rct to evaluate the preliminary effectiveness of a culturally-adapted video developed by the team vs. force fact sheet on enhancing genetic cancer risk assessment (gcra; including genetic counseling and option for genetic testing) uptake and psychosocial outcomes among latinas at increased risk for hereditary breast and ovarian cancer (hboc). all participants will receive referrals to free telephone genetic counseling in spanish to address cost, pragmatic, and language barriers. the investigators will recruit 28 latina women at-risk of hboc (14 randomized at each arm) at three sites with sizable latinx populations. the sites include community clinics/health organizations and hospitals with whom we have established collaborations \[georgetown university (dc); virginia commonwealth university (va)\]. results will improve efforts to translate genomic guidelines into practice and will reduce disparities by evaluating a low cost highly disseminable culturally-targeted video while gathering data on effectiveness and implementation. aim 1. evaluate the impact of video vs. force fact sheet on gcra and testing uptake and psychosocial outcomes. aim 2. assess implementation potential and needs by evaluating feasibility, acceptability, reach, and adoption of the intervention arms (video and force fact sheet) and of the hboc screening process at the community clinics.

Eligibility criteria:
inclusion criteria: * older than 18 years-old * self-identify as latina * fluent in spanish * meet nccn criteria for breast and/or ovarian genetic cancer risk assessment based on -personal or family history of cancer * have not received genetic counseling or genetic testing * able to provide informed consent * no other members of the same family have participated * must have access to the internet via smartphone, computer, or another device. exclusion criteria: * not fluent in spanish * previously received genetic counseling or genetic testing for hboc * previously participated in another interventional study about hboc and gcra

Keywords: latinas intervention
safety and efficacy of grass pollen allergoid in the treatment of allergic rhinoconjunctivitis

Conditions: Grass Pollen Allergy

Summary: the trial is performed to assess efficacy and safety of the grass pollen allergoid in allergic rhinoconjunctivitis

pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 daltons by diafiltration. clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. depot pollen-allergoids were introduced into the german market in 1987 under the trade name allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. allergovit® is currently available in many european and non-european countries. a placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. thus the only chance to prove efficacy for specific immunotherapy (sit) is to test versus a parallel placebo group.

Eligibility criteria:
inclusion criteria: * positive skin prick test to grass pollen * positive rast to grass pollen * positive specific provocation test to grass pollen exclusion criteria: * serious chronic diseases * other perennial allergies

Keywords: allergovit grass pollen allergy
evaluation study of new compounds with potential use in schizophrenia

Conditions: Schizophrenia

Summary: different compounds that might modify the glucose regulation in the central nervous system will be evaluated in healthy volunteers. several examinations will be performed in order to get a detailed plan how these substances might work.


Eligibility criteria:
inclusion criteria: * healthy volunteers * informed consent given by the subject * both, female and male subjects may participate * age between 18 and 65 years * negative drug-screening at the time of screening * in female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than 1. * non-smoker * body mass index between 18 and 40. exclusion criteria: * lack of accountability * any current psychiatric disorder through the structured clinical interview for dsm-iv (scid) at the time of screening * any known psychiatric or neurological illness in the participant's history. * known family history concerning psychiatric disorders * relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year) * pregnancy or lactation phase in female at the time of screening * severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis a, b or c or hiv) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator * consumption of any illegal drugs (except cannabis in history, see above)

Keywords: schizophrenia
electrical acupoint stimulation for postoperative recovery

Conditions: Postoperative Complications; Postoperative Nausea and Vomiting; Postoperative Infection; Postoperative Delirium; Postoperative Pneumonia; Deep Vein Thrombosis; Postoperative Retention of Urine; Postoperative Recovery

Summary: this study investigates electrical acupoint stimulation (eas) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.

theoretically, the application of electrical acupoint stimulation (eas) base on the theory of traditional chinese medicine. it deems that a surgery might consume qi, then cause to imbalance of qi and blood, especially in elder patients. besides, surgery lead to change of stress response (hormones). the eas administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. the main possible mechanism was stress response regulation. the hypothesis is that the eas improve postoperative recovery of patient through regulating stress response.

Eligibility criteria:
inclusion criteria: * agree to sign the contract * the patients receive total hip or knee arthroplasty * epidural anesthesia administered exclusion criteria: * the patients' age out of range setting * forbidden to the administration of transcutaneous electrical acupoint stimulation * communication disorder * the patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting. * the patients who attended another trial in the past three months * emergency surgery

Keywords: acupoint stimulation postoperative recovery postoperative complications peri-operation
concentrate of autologous rich plasma in growth factors in the treatment of the thin endometrium

Conditions: Infertility; Infertility, Female

Summary: this study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of prgf (plasma rich in growth factors)


Eligibility criteria:
inclusion criteria: * women who signed informed consent. * women who understand the spanish language. * women under 42 years exclusion criteria: * thrombopenia. * congenital or acquired uterine malformations that reduce embryo implantation or term gestation. * ovarian tumors. * benign uterine tumors require surgical treatment * local acute inflammatory diseases * patients with malignant tumors requiring chemotherapy. * patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation. * chronic treatment with nsaids (nonsteroidal anti-inflammatory drugs)
a study to assess efficacy, safety and tolerability of the anti-il-13 monoclonal antibody qax576 in the treatment of perinanal fistulas in patients suffering from crohn's disease

Conditions: Crohn's Disease

Summary: test safety and efficacy and of a novel il-13 ab in the treatment of perianal fistulas * trial with medicinal product


Eligibility criteria:
inclusion criteria: - diagnosis of crohn's disease \> 6 month with fistula - at least 1 ineffective fistula treatment in the past exclusion criteria: - tnf a antibody treatment failed in the past - planned surgery
long-term, non-interventional, observational study following treatment with fate therapeutics ft500 cellular immunotherapy

Conditions: Advanced Solid Tumor; Lymphoma; Gastric Cancer; Colorectal Cancer; Head and Neck Cancer; Squamous Cell Carcinoma; EGFR Positive Solid Tumor; HER2-positive Breast Cancer; Hepatocellular Carcinoma; Small-cell Lung Cancer; Renal Cell Carcinoma; Pancreas Cancer; Melanoma; NSCLC; Urothelial Carcinoma; Cervical Cancer; Microsatellite Instability; Merkel Cell Carcinoma

Summary: subjects who previously took part in the ft500-101 study and received allogeneic nk cell immunotherapy will take part in this long term follow-up study. subjects will automatically enroll into study ft-003 once they have withdrawn or complete the parent interventional study. the purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. no additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

this is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior fate therapeutics interventional study of ft500 cellular immunotherapy. subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the ft500-101 study.

Eligibility criteria:
inclusion criteria: * subjects who received an allogeneic, ipsc-derived nk cell in a fate therapeutics interventional study * subjects who have provided informed consent prior to their study participation exclusion criteria: * not applicable
a finnish community randomized psychotherapy effectiveness study for major depression

Conditions: Depressive Disorder, Major

Summary: lohja depression treatment study is a randomized treatment trial which compares three approaches for treatment of depression:1) interpersonal psychotherapy (ipt), 2) psychoeducational group treatment ( pegt) and 3) treatment as usual (tau). this trial aims to test and adapt known short term treatment models for finnish patients and circumstances.

patients having signs of depression referred to lohja area secondary level psychiatric clinics were assessed to the trial. after verification the diagnosis of major depressive disorder (mdd) they were informed of the study. consented patients were randomized to three study arms. baseline clinical demographics was collected. psychotherapeutic treatment was implemented by specially trained therapists and the study data was collected by trained psychiatrists who were blinded to the therapy model patients has received.primary outcome measure was 17-item hamilton depression rating scale (hamd) and secondary outcome measures were clinical global impression scale (cgi), social and occupational functioning assessment scale ( sofas), social adaptation scale ( finnish translation jes) and quality of life assessment ( a finnish validated questionnaire 15-d).the total of sick leave days and number of possible disability pensions in a year were assessed as well. assessments were implemented at the beginning, at 1,5 month, at 3 months ( which was the end of active treatment of short-term psychotherapies), at 6 months and at 12 months. the primary assessment was planned to carry out using tests of group comparison. sample size of 32 and 32 achieve 91% power to detect a clinically meaningful difference with a significance level (alpha) of 0.01 using two-sided two-sample t-test. baseline differences in demographic variables and the depression measurement across the three treatment groups were tested using chi-square tests and analysis of variance.likelihood-based inference using linear mixed models were employed to analyze treatment effects, focusing on the time x treatment interaction. separate analyses assessed ipt-tau and pegt-tau comparisons. all statistical analyses were performed using r. the aim of this study was to get a total of 140-160 patients, about 50 patients on one group.the final number of patients showed to be 134. the statistical calculation was intent-to-treat model with consideration to missing data, because in this kind of natural setting notable attrition was assumed. the training of the therapists and researchers and quality control during assessments was considered and personnel was supervised throughout the study.

Eligibility criteria:
inclusion criteria: * major depressive disorder - diagnosed * comorbid anxiety disorders exclusion criteria: * psychosis * suicidal patients * serious acute somatic illness * inability to read and write * alcohol dependence or use of illicit drugs
endoscopic metabolic and bariatric therapies

Conditions: Obesity; Obesity, Morbid; Obesity Associated Disorder; Bariatric Surgery Candidate; Fistula, Gastric; Roux-en-y Anastomosis Site; Ulcer, Gastric; Abdominal Pain; Abdominal Obesity; Complication of Surgical Procedure; Complication of Treatment; Complication,Postoperative; Weight Gain; Weight Loss; Leak, Anastomotic; Delayed Gastric Emptying Following Procedure

Summary: this is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (embt) for primary or revision surgical procedures for obesity.

the investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (gem), endoscopic sleeve gastroplasty (esg), transoral outlet reduction (tore), primary obesity surgery endoluminal (pose), restorative obesity surgery endoluminal (rose), intragastric balloons (igb), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Eligibility criteria:
inclusion criteria: * patients from mass general brigham * any patient having an endoscopic primary obesity procedure * any patient having an endoscopic post-bariatric surgical revision procedure * any patient having a bariatric surgical procedure exclusion criteria: * patients without past surgical and medical history medical records in the mass general brigham system * patients unwilling to allow for medical record review at mass general brigham

Keywords: roux-en-y gastric bypass sleeve gastrectomy laparoscopic adjustable gastric banding gastroplasty with endoscopic myotomy (gem) endoscopic sleeve gastroplasty (esg) transoral outlet reduction (tore) primary obesity surgery endoluminal (pose) restorative obesity surgery endoluminal (rose) intragastric balloons (igb) aspiration therapy pylorus sparing antral myotomy (psam) gastric emptying breath test (gebt)
a new method to treat hereditary cerebellar ataxia - umbilical cord mesenchymal stem cells transplantation

Conditions: Hereditary Cerebellar Ataxia.

Summary: hereditary cerebellar ataxia is a type of autosomal dominant genetic disease, lesions mainly involving the cerebellum, but the spinal cord and cranial nerves may also be some involvement. a total of 20 molecularly diagnosed sca1 patients divided in two groups. one group accepted for the treatment of stem cell transplantation,the other group will be the control. purpose of this project to prove that allogeneic umbilical cord mesenchymal stem cells are applied to clinical safely, and in the treatment of hereditary cerebellar ataxia is valid.

after admission the patients accepted transplantation would receive physical examination, blood and urine tests, electrocardiogram, electrophysiologic study;evaluation of sca1 symptoms (balance, walking, dexterity, tremor, memory, mood and concentration),then stem cell therapy：after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. the control only receive evaluation of sca1 symptoms .

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. molecularly diagnosed sca1 exclusion criteria: 1. cognitively impaired individuals 2. schizophrenics 3. patients with severe kidney and liver disease, epilepsy, heart disease, pulmonary disease, cardiac arrhythmia, diabetes insipidus, leukemia and some other central neural disease (such as parkinson disease, accidence of brain vascular et al) 4. age less than 18 years, age greater than 65 years

Keywords: cerebellar ataxia hereditary disease stem cell