Kornimate/medical-research-clean huggingface dataset:
intrathecal amniotic fluid stem cells for progressive multiple sclerosis

Conditions: Multiple Sclerosis, Progressive

Summary: in this clinical trial, researchers are exploring a novel approach to delivering therapy directly into the spinal fluid, which surrounds and nourishes the brain and spinal cord. the study focuses on patients with progressive multiple sclerosis (ms), a form of the disease that leads to worsening disability without the typical relapses seen in other ms subtypes. this investigational therapy involves the use of stem cells derived from amniotic fluid-the protective liquid surrounding a developing baby in the womb. to the best of the researchers' knowledge, these specific stem cells have never been tested in ms patients before. amniotic fluid is ethically sourced from routine medical procedures during pregnancy, and similar stem cells can also be obtained from placentas that are typically discarded after childbirth. participants in the trial will receive multiple injections of these stem cells into their spinal fluid over the course of a year. researchers will closely monitor for the safety of this therapy, as well as monitor the participants' walking ability and other neurological functions to assess potential improvements.


Eligibility criteria:
inclusion criteria: * adults aged 18-60 years. * diagnosed with primary or secondary progressive ms according to the 2017 revised mcdonald criteria. * expanded disability status scale (edss) of 3.0 to 8.0 with at least one functional scale that is not vision or sensory or brainstem or cognitive or bowel/bladder that is scoring 3.0 or greater. * clinically stable as determined by their neurologist for the past 6 months. * on no disease-modifying therapy (dmt) for at least 6 months, or on the same dmt for at least 6 months before study entry. * can give informed consent. * women of child-bearing age must practice adequate contraception techniques in the eye of the investigator and continue to do so during the study period. * must be a good candidate, known for compliance for example, in the opinion of the investigators. exclusion criteria: * participation in another clinical trial within the last 30 days. * severe allergic reactions to any component of the study treatments. * significant comorbidities. * active infections or malignancies. * history of a malignancy within the past two years except for skin cancer that has been excised and controlled with only surgical treatment, not requiring chemotherapy or radiotherapy. * any medical condition that the investigator deems as unsuitable with therapy. * prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry * a diagnosis of a progressive neurological disorder other than multiple sclerosis. * inability to have an mri scan. * inability to have a lumbar puncture, for example severe bleeding diathesis. * pregnant or breastfeeding or intention to become pregnant during the study. * the results of the following laboratory results deemed suitable by the investigators: cbc with diff, cmp, inr, aptt, hepatitis c serology, hiv serology, rpr.
soda and milk study

Conditions: Obesity; Dyslipidemia

Summary: much attention has been directed at the unhealthy effects of sugar-sweetened beverages (ssbs), as an increase in their consumption has paralleled the rise obesity rates. in adults, ssbs have been shown to promote ectopic fat storage and raise plasma triglycerides compared to equivalent amounts of semi-skim (1.5%) milk, water, or diet beverages. replacement of soda with milk had the added benefit of also reducing systolic blood pressure. while several studies have investigated the effects of ssbs on weight gain in children, no published studies have investigated their effects on lipid and lipoprotein risk factors under isocaloric conditions in metabolically at-risk adolescents, who are among the greatest consumers of ssbs. the main objective of this study is to test whether isocaloric replacement of soda with reduced fat milk will significantly improve atherogenic dyslipidemia, blood pressure, insulin sensitivity, and liver function in overweight and obese adolescents who are habitual soda consumers. the investigators will test this in a 8 week randomized two period crossover trial in 30 overweight and obese adolescent males who are self-reported habitual consumers of ssbs. participants will consume energy equivalent amounts of ssb (24oz soda containing high fructose corn syrup per day), and reduced fat milk (2% milk fat) for 3 weeks each, in random order, separated by a 2-week washout. anthropometrics, blood pressure, and blood samples will be collected at screen and at the end of each intervention period. plasma measurements will include ldl peak particle diameter; lipoprotein subclass concentrations; triglycerides; total, ldl, and hdl-cholesterol; apolipoproteins; glucose, insulin, and insulin resistance; high sensitivity c-reactive protein; uric acid; and liver enzymes.


Eligibility criteria:
inclusion criteria: * males, age 13-18 * tanner stage ≥ 2 * self reported sugar sweetened beverage intake 24oz to 60oz per day * self reported milk intake ≤16 oz. per day * bmi 85-99 percentile for age * tolerant to milk exclusion criteria: * history or diagnosis of hypertension or taking blood pressure lowering medication * history or diagnosis of diabetes, hba1c ≥ 6.5% or fasting glucose ≥ 126 mg/dl * fasting triglyceride \> 300 mg/dl * on lipid lowering or diabetes medication
hmpl-760 in relapsed/refractory b-cell non-hodgkin's lymphoma

Conditions: B-Cell Non-Hodgkin's Lymphoma

Summary: a multicenter, open-label, phase i study to evaluate the safety, pharmacokinetics, and preliminary efficacy of hmpl-760 in patients with relapsed/refractory b-cell non-hodgkin's lymphoma

the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of hmpl-760 administered orally in subjects with relapsed/refractory b-cell non-hodgkin lymphoma (b-nhl). patients with relapsed/refractory b-nhl, including chronic lymphocytic leukemia/small cell lymphoma (cll/sll), diffuse large b-cell lymphoma (dlbcl), follicular cell lymphoma (fl), mantle cell lymphoma (mcl), marginal zone lymphoma (mzl), and lymphoplasmacytic/macroglobulinemia (lpl/wm).

Eligibility criteria:
inclusion criteria: 1. signed informed consent form (icf) 2. age ≥18 years 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. in the expansion stage, ecog performance status 0-2 4. relapsed/refractory patients with histologically confirmed lymphoma * cll confirmed by cytology (flow cytometry) * lpl/wm diagnosed by relevant tests including serum, bone marrow, and pathological examinations. 5. except for cll and wm, at least one bidimensionally measurable lesion is required by ct scan, which means the largest diameter of lymph node lesions \>1.5 cm or extranodal lesions \>1.0 cm; for lesions that cannot be well displayed by ct due to anatomical location (such as limb or soft tissue lesions), mri measurement can be used. 6. expected survival longer than 24 weeks exclusion criteria: patients who met any of the following criteria are excluded from the study: 1. lymphoma patients with central nervous system (cns) or leptomeningeal invasion 2. inadequate organ function of liver and kidney 3. carcinoma in situ of the breast history of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) 4. any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug 5. within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies. 6. any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer 7. prior use of any anti-tumor vaccine 8. prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug 9. any uncontrolled active infection 10. history of drug-induced interstitial pneumonia

Keywords: b-cell non-hodgkin's lymphoma bruton's tyrosine kinase inhibitor
worksite lifestyle program for reducing diabetes and cardiovascular risk in india

Conditions: Diabetes; Heart Disease; Obesity

Summary: this study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk for diabetes or with unmedicated diabetes to lose weight, exercise more, and eat a healthier diet. a total of 2000 participants across 10 worksites in south, central, and east india will be involved in this study.

this study will implement and evaluate in a pre-post design trial the acceptability, delivery, effectiveness, and cost-effectiveness of a worksite-based lifestyle improvement package including a peer-led lifestyle change education program (described below) augmented with changes in the worksite environment that promote social support, healthy eating and exercise. the lifestyle education program will include 2000 adults with prediabetes (hba1c of 5.7-6.4%) or unmedicated diabetes (hba1c ≥ 6.5% identified at screening) across ten diverse worksites in india (changes to the worksite environment will impact a much broader population of employees). a mixed methods approach will be used to evaluate implementation of the program. participants at high risk for diabetes or with unmedicated diabetes will be enrolled in a lifestyle intervention training program that includes strategies to maintain a healthy weight, maintain healthy blood glucose levels, eat a healthy diet, increase physical activity, overcome barriers, and build social support. participants will be assigned two goals to achieve during lifestyle classes; to increase the physical activity to at least 150 minutes per week of moderate level activity and lose at least 5% of their baseline body weight. participants also will be given knowledge and tools necessary to improve their diet quality and quantity.

Eligibility criteria:
inclusion criteria: * bmi ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women * prediabetic (hba1c of 5.7-6.4%) or diabetic (hba1c≥6.5%) exclusion criteria: * currently taking any diabetes medications * pregnant or breastfeeding * history of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program

Keywords: nutrition occupational health
safety study of bms-816336 in healthy male subjects

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Dyslipidemia

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of bms-816336 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects * bmi of 18 to 32 kg/m² * men only, ages 18-55 years exclusion criteria: * sexually active men not using effective birth control if their partners are wocbp * any significant acute or chronic medical illness * family history of gilbert's disease * history of pancreatitis * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, egg or clinical laboratory determinations * qtc interval \> 450 msec (corrected for heart rate using fridericia's correction method, qtcf) * second- or third-degree a-v block or clinically relevant ecg abnormalities * history of allergy to 11-β-hsd-1 inhibitors or related compounds * prior exposure to bms-816336 * use of st. john's wort (hypericum) within 4 weeks prior to the first dose of study drug and throughout the study * use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration * use of any glucocorticoid topical creams within 4 weeks of study drug administration * use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
nk cell-based immunotherapy as maintenance therapy for small-cell lung cancer.

Conditions: Small Cell Lung Cancer

Summary: natural killer (nk) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(mhc)-restricted manner. adoptive transfer of nk may prolong the survival of patients with cancer. this study evaluates the efficacy and safety of nk cell-based immunotherapy for small-cell lung cancer (sclc) after first-line chemotherapy. half of the participants will receive autologous adoptive transfer of nk cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.

the small-cell lung cancer (sclc) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conventional treatments. no effective maintenance therapy except for wath and wait after first-line therapy at present. nk cells constitute the major component of the innate immune system and kill tumor cells in a non-mhc-restricted manner. in our previous pilot study and other reports, adoptive transfer of autologous nk cells expanded ex vivo was very well tolerant and effective. there is no prospective trial on the maintenance therapy of sclc after first-line chemotherapy based on autologous nk cells. the purpose of this phase ii clinical research is to evaluate the efficacy and safety of autologous nk cells as the maintenance therapy after the first-line treatment, comparing with conventional observation group.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed small cell lung cancer. * having completed first-line therapy in the presence of stable disease (sd), partial remission (pr) or complete remission (cr) status. * age ≥18 years. * karnofsky performance status (kps) ≥80. * important organs:cardiac ejection fraction \>50%; pulse oxygen saturation(spo2) \>90%; creatinine (cr) ≤ 2.5 times the normal range; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3 times the normal range, total bilirubin (tbil)≤2.0mg/dl (34.2umol/l);hgb≥60g/l. * without contraindication of apheresis and cell isolation. * patients and their families having the willingness to participate in clinical trial with signed written informed consent. exclusion criteria: * patient having an active rheumatic immunologic disease. * uncontrolled bacterial, fungal or viral infection. * human immunodeficiency virus(hiv), hepatitis b virus infection(hbv), hepatitis c virus(hcv) infection. * history of organ transplantation and hemopoietic stem cell transplantation. * pregnant or lactating women. * patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study. * patients receiving other immunotherapy after diagnosis.

Keywords: maintenance therapy immunotherapy adoptive cell transfer natural killer cell
morphologic and biomechanical analysis of the carpal ligaments

Conditions: Joint Instability; Wrist Injuries

Summary: compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic ct studies in three groups of patients: normal subjects, with scapholunate instability and with other types of wrist instability.

patients referred for the evaluation of wrist pain with ct arthrography will be eligible for inclusion. patients will benefit from dynamic ct acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. patients will also benefit from a wrist mr study on a 3 tesla scanner. the morphology of the carpal ligaments will be evaluated on static imaging (mr and ct arthrograph) and on dynamic ct arthrography. distance and angular measurements will be obtained from dynamic ct studies using an appropriate post processing tool (4d-ortho). data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).

Eligibility criteria:
inclusion criteria: * clinical signs of wrist instability or wrist pain * previous medical examination * informed consent * must have a social security number exclusion criteria: * mr or ct contra-indications * no prior surgery * pregnancy
the influence of prophylactic and empirical anti-fungal treatment in severe sepsis patients with perforations

Conditions: Intra-abdominal Perforation

Summary: this prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on severe sepsis patients with perforations. with the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and empirical group.

intra-abdominal perforation is the high risk of fungal infection. the flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in icu develop intra-abdominal fungal infection. in particular, the severe sepsis arisen from these infections could further increase the mortality. however, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with gi perforation.

Eligibility criteria:
inclusion criteria: 1. age ≥16 years 2. the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering icu within 6 hours 3. icu stay of at least 5 days 4. apache ⅱ score within 24 hours of randomization of 16 or more 5. severe sepsis 6. written informed consent - exclusion criteria: 1. documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study; 2. fluconazole/caspofungin allergy; 3. pregnant of lactating woman; 4. life expectancy of 48 hours or less. -

Keywords: severe sepsis intra-abdominal perforation surgical intensive care unit fungal infection prophylactic anti-fungal treatment
to evaluate the efficacy and safety of tg-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection

Conditions: Influenza Virus Infection

Summary: to evaluate the antiviral effect of tg-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.

this study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the efficacy and safety of different doses of tg-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio of 1:1:1:1 to receive study treatment orally: "40 mg tg-1000", "80 mg tg-1000", "40mg+40mg tg-1000" or "placebo".

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent. 2. age ≥ 18 (or legal adult age) to \< 65 years at the time of signing the informed consent. 3. must have a positive result of rapid influenza diagnostic test (ridt) or polymerase chain reaction (pcr). 4. the time interval between the onset of symptoms and the randomization is 48 hours or less. 5. must be able to comply with all study procedures and assessments, including completion of the patient diary. exclusion criteria: 1. patients with severe influenza virus infection requiring inpatient treatment. 2. patients with high risk factors may develop into severe cases. 3. investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination. 4. acute respiratory infection, otitis media or sinusitis within 2 weeks prior to screening. 5. purulent sputum or purulent tonsillitis. 6. positive nucleic acid test for covid-19. 7. suspects allergic to active ingredients or excipients. 8. body weight \< 40 kg. 9. has received anti-influenza drug. 10. has received any investigational agents or devices for any indication within 30 days prior to screening. 11. patients who, in the opinion of the investigator, may not be qualified or suitable for the study.
a study of dasatinib to see how liver impaired and healthy subjects process and react to the study drug

Conditions: Liver Diseases

Summary: the primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. information about any side effects that may occur will also be collected.


Eligibility criteria:
inclusion criteria - all subjects: * male and females ≥18 years old * women must be of non-childbearing potential * adequate hematologic and renal function * bmi 18-35 kg/m2 inclusion criteria - liver impaired subjects: * subjects must have stable liver impairment diagnosed with standard classification - child pugh exclusion criteria - all subjects: * inability to swallow or absorb oral medication * uncontrolled medical disorder or infection * use of cyp3a4 inhibitors/inducers or drugs with risk of torsades de pointes * uncontrolled or significant cardiovascular disease * any significant bleeding disorder * female subjects of childbearing potential * male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter

Keywords: hepatically impaired
human albumin and anastomotic leakage after gastric cancer surgery

Conditions: Gastric Cancer; Anastomotic Leak

Summary: we investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. anastomotic leakage severely compromises the recovery after surgery. it increases the overall burden of patients and hospital resources. postoperative mortality is higher in patients with anastomotic leakage. human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. we investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Eligibility criteria:
inclusion criteria: * histologically confirmed gastric cancer * patients who underwent radical gastrectomy exclusion criteria: * patient who did not undergo gastrectomy

Keywords: gastric cancer anastomotic leakage human albumin