Kornimate/medical-research-clean huggingface dataset:
rd13-02 car-t cell injection for patients with r/r cd7+ t-all/t-lbl

Conditions: Neoplasms; Hematologic Neoplasms; Hematologic Diseases

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 car-t therapy for patients with cd7-positive relapsed or refractory t-all/lbl, and to evaluate the pharmacokinetics of cd7 car-t in patients.


Eligibility criteria:
inclusion criteria: 1. age 3-70 2. diagnosis of r/r t-all/lbl. 3. cd7 positive expression 4. bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min, serum alanine aminotransferase(alt)/aspartate aminotransferase(ast) \< 3×upper limit of normal, total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. left ventricular ejection fraction ≥ 50% . 7. baseline oxygen saturation ≥ 92% on room air. 8. ecog performance status of 0 to 2. 9. the estimated survival time is more than 3 months. 10. subjects or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. sujects with concomitant genetic syndromes associated with bone marrow failure states. 2. sujects with some cardiac conditions will be excluded. 3. history of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 4. history of malignancy other than non-melanoma skin cancer or carcinoma. 5. primary immune deficiency. 6. presence of uncontrolled infections. 7. sujects with some anticancer therapy before car-t infusion will be excluded. 8. active uncontrolled acute infections. 9. known history of infection with human immunodeficiency virus (hiv); active or latent hepatitis b, hepatitis c and syphilis. 10. subjects who are receiving systemic steroid therapy prior to screening. 11. subjects with acute graft-versus-host disease (gvhd) 12. having received live/attenuated vaccine within 4 weeks prior to screening. 13. history of allergy to any component of the cell therapy product. 14. pregnant or breastfeeding women 15. any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
prevention of gestational diabetes mellitus with lifestyle intervention among women of advanced maternal age.

Conditions: Gestational Diabetes Mellitus

Summary: this is a single-blind randomized controlled trial, aiming to evaluate the preventive effects of mobile-based combining with hospital-based lifestyle interventions on gdm among women with advanced maternal age. it will be conducted in beijing, with a sample size of 346. all eligible pregnant women will be randomly assigned to either the intervention or control group, and followed up to delivery.

after the adjustment of fertility policy in china, the prevalence of advanced maternal age (ama) has become a crucial issue in maternal health care. ama can greatly increase the risk of gestational diabetes mellitus (gdm) during pregnancy. however, there is still a lack of high-quality evidence on gdm preventive interventions for ama pregnancy in china. in this randomized study, the investigators aim to examine whether mobile-based combining with hospital-based lifestyle interventions have preventive effects on gdm in ama pregnancies. the investigators will enroll a total of 346 singleton pregnant women in peking university first hospital and randomly assign them to either the intervention or control group. information of maternal characteristics will be obtained at recruitment. at each prenatal visit, weight and blood pressure of all participants will be measured. for each participant, fasting venous blood samples will be collected at \<14 weeks of gestation, 24-28 weeks of gestation and pre-labor, and respectively assayed for fasting plasma glucose, glycated hemoglobin. the primary outcome is the incidence of gdm. the secondary outcomes include maternal glycated hemoglobin level, maternal fasting plasma glucose level, maternal complications, pregnancy outcomes, etc.

Eligibility criteria:
inclusion criteria: * local resident in beijing * singleton pregnancy * aged ≥35 years * overweight or obesity (body mass index is between 24 and 27.9 kg/m2 or ≥28 kg/m2) * ≤12 weeks of gestation * written informed consent is obtained exclusion criteria: * diagnosed with type 1 or type 2 diabetes before pregnancy * diagnosed with gdm or impaired glucose tolerance at enrollment * use of medication that influences glucose metabolism currently, such as metformin, etc. * multiple pregnancy * current substance abuse * unable to exercise due to physical disability * diagnosed severe psychiatric disorder * other conditions not suitable for intervention as judged by physicians

Keywords: advanced maternal age gestational diabetes mellitus lifestyle intervention randomized controlled study
a pharmacokinetic study to evaluate the effect of maalox on raltegravir (mk-0518) in human immunodeficiency virus (hiv)-infected participants (mk-0518-295)

Conditions: HIV Infections

Summary: this study evaluated the effect of single doses of a magnesium/aluminum antacid (maalox) given 4 and 6 hours before or after administration of raltegravir, on the pharmacokinetics of raltegravir in human immunodeficiency virus (hiv)-infected participants. the study consisted of part 1 (periods 1, 2, and 3) and part 2 (periods 4 and 5), with each study period separated by a washout period of at least 2 days; part 1 was separated from part 2 by a pause. each study period had a duration of ≥2 days, and paused for evaluation of part 1 pharmacokinetics results before continuing to part 2. the same participants participated in parts 1 and 2. the primary hypothesis tested (in part 1) was that raltegravir plasma concentration 12 hours after administration (c 12 hrs) would not differ significantly from raltegravir c 12 hrs when antacid is administered 4 hours before or 4 hours after raltegravir.


Eligibility criteria:
inclusion criteria: * on a stable raltegravir dose as part of a stable antiretroviral regimen for ≥1 month before the study * if female, is not pregnant or breast feeding * body mass index ≤32 kg/m\^2 exclusion criteria: * mentally or physically incapacitated, has significant emotional problems, or history of clinically significant psychiatric disorder within ≤10 years * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease (excluding hiv) * history of gastric bypass surgery * history of cancer, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥10 years before the study * history of chronic diarrhea within ≤3 months before the study * history of significant multiple and/or severe allergies (food, drug, latex), or had an anaphylactic reaction or significant intolerability to drugs or food * had major surgery or donated or lost ≥1 unit of blood (500 ml) ≤4 weeks before the study * participated in another investigational trial ≤4 weeks before the study * taking rifampin or is unable to refrain from the use of 1) any proton pump inhibitor from 2 weeks before and throughout the study, or 2) any histamine h2-blockers, antacids, calcium supplements, or multivitamins from 2 weeks before and throughout the study * consumes \>3 glasses of alcoholic beverages per day * consumes excessive amounts of caffeine beverages (coffee, tea, cola, energy drinks, or other caffeinated drinks) per day * currently uses or has a history of drug abuse within ≤6 months before the study
physical examination-indicated pessary

Conditions: PreTerm Birth

Summary: cervical insufficiency, previously referred to as cervical incompetence, has classically been defined as painless dilation of the cervix in the absence of contractions or bleeding in the second trimester resulting in recurrent pregnancy losses. painless mid-trimester cervical dilation is an uncommon finding in the general population occurring in less than 1% of pregnancies. cerclage for the prevention pregnancy loss in cases with both prior preterm births and/or second trimester losses, as well as second trimester cervical dilatation in the index pregnancy, was first reported in the 1950's. cerclage placement in this setting has been variably referred to as "physical exam-indicated cerclage", "rescue cerclage", and "emergency cerclage". to date, the benefits of cerclage for this indication are not entirely clear. a recent meta-analysis showed that physical exam-indicated cerclage is associated with a reduction in perinatal mortality and prolongation of pregnancy when compared to no such cerclage. recently, several rcts have shown that cervical pessary could decrease the incidence of ptb in several populations. thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary compared to cervical cerclage in prevention of ptb in women in the setting of mid-trimester cervical dilation


Eligibility criteria:
inclusion criteria: * singleton pregnancies * cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation exclusion criteria: * pessary or cerclage already in situ * active vaginal bleeding * placenta previa/accreta * multiple gestations * amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue * ruptured amniotic membranes at the time of diagnosis of dilated cervix * cervical dilation more than 5 cm * labor (progressing cervical dilation) or painful regular uterine contractions
biomarker and imaging characterisation of inflammatory atheroma in patients receiving immunotherapy and angiogenesis inhibitors

Conditions: Cancer; Cardiotoxicity; Atherosclerotic Disease

Summary: the advent of immunotherapy (immune checkpoint inhibitors \[ici\]) has been an extremely important advancement for cancer treatment in recent decades. the anti-cancer effects of these agents is profound and can lead to radiological \&#39;disappearance\&#39; of the primary cancer and metastatic deposits. ici are now commonly used in the treatment of multiple cancers including melanoma, kidney cancer, liver cancer and lung cancer. ici can be used on their own or in combination with other agents such as vascular endothelial growth factor inhibitors (vegfi) which is first line treatment for many patients. however, it has become clear that these drugs have cardiovascular side effects including high blood pressure and a reduction in the heart muscle pumping function. it is also increasingly recognised that icis may have a toxic effect on blood vessels resulting in an increased risk of heart attack or stroke. these side effects can have a significant impact on patients\&#39; health and can lead to withdrawal of important cancer treatment. the mechanisms by which these side effects occur are unclear and have not been well described to date. the aim of this study is to examine the effect of ici and vegfi, both alone and in combination, on blood vessels and to understand their effects on blood markers and heart function. this study is observational and will not require any modification of cancer therapy. this study will aim to recruit patients diagnosed with cancer who are already planned to receive ici or vegfi alone or in combination at the beatson west of scotland oncology centre. patients will undergo a vascular pet-ct scan before and 6 months after starting treatment. in addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine (endopat). blood and urine samples will also be collected.


Eligibility criteria:
inclusion criteria: 1. patients with cancer who are planned for treatment with ici or vegfi, including combination therapy 2. ≥6 months predicted survival 3. age ≥18 years exclusion criteria: 1. patients who are unable or unwilling to provide valid consent for the study 2. patients with diabetes who are on oral anti-diabetic treatment or insulin at baseline 3. patients who have exposure to either immune checkpoint inhibitor or vegf inhibitor in the 12 months before enrolment

Keywords: cancer atherosclerosis fdg petct cardiotoxicity vegfi immune checkpoint inhibitor
biological bone markers and hydrolyzed collagen supplement in menopausal healthy women

Conditions: Osteoporosis

Summary: * preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones. * the objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months. * for this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.


Eligibility criteria:
inclusion criteria: * healthy women * aged between 55 and 65 years * primary or secondary amenorrhea for at least 5 years * bmi ≥ 20 kg/m2 and \< 27 kg/m2 * dxa \> 2.5 sd * no history of fragility fracture bone * not under guardianship * not on hormone replacement or any osteoporotic therapy * covered by social security * negative serology for hepatitis b/c and hiv * written informed consent form signed. exclusion criteria: * bone density \< 2.5 sd (standard deviation) * endocrine disease * no history of fragility fracture bone * dietary disorder (anorexia, bulimia) * hormone replacement therapy * inclusion in another clinical study * subjects receiving over 4,500 euros in the last 12 months (including the present study) * subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

Keywords: osteoporosis postmenopausal women functional food hydrolysed collagen bone metabolism bone marker of resorption bone marker of formation
study to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (ibd). results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (protocol glpg0634-cl-227; nct03926195) with the same objective. the total planned number of participants in both studies combined will be up to approximately 250 participants.

there are 5 parts to the study: 1) part a: double-blind phase (db phase; day 1 through week 13); 2) part b: db phase (after week 13 through week 26); 3) open-label (ol) filgotinib phase (after week 13 study visit for up to 13 weeks); 4) monitoring phase (mp; up to 52 weeks); and 5) long-term extension (lte) phase (after week 26 or end of ol filgotinib phase for up to 195 weeks).

Eligibility criteria:
key inclusion criteria: * documented diagnosis of ulcerative colitis (uc) or crohn's disease (cd) of at least 4 months. endoscopic and histopathologic documentation of uc or cd. * have moderately to severely active uc or cd key exclusion criteria: * previously or currently documented problems with male reproductive health * current use of sulfasalazine or its use within the 26 weeks leading up to screening; sulfasalazine is not permitted at any point during the study * current use of corticosteroids at a dosage of \> 20 mg/day of prednisone or equivalent at randomization * indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon * active tuberculosis (tb) or untreated latent tuberculosis * use of concomitant prohibited medications as outlined by protocol note: other protocol defined inclusion/exclusion criteria may apply
corneal neurotization as a treatment for neurotrophic keratopathy

Conditions: Neurotrophic Corneal Ulcer; Neurotrophic Keratitis; Cranial Nerve V Diseases

Summary: the purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy.

corneal anesthesia, which can lead to visually devastating outcomes from ulceration, perforation, and scarring, can be recalcitrant to both medical and surgical treatment\[1-3\]. neurotization is a revolutionary technique reported to restore corneal sensation in neurotrophic keratopathy\[4-6\]. prior techniques described include direct neurotization with contralateral supraorbital and supratrochlear nerves accessed via a bicoronal incision of the scalp over the forehead\[5\]; nerve grafting with contralateral supratrochlear nerves accessed via a medial upper eyelid incision\[6\]; and sural nerve grafting to contralateral supratrochlear nerves accessed via a transverse incision over the medial upper eyelid\[4\]. despite the challenges associated with these techniques (needing to subcutaneously tunnel the nerve graft over the nasal bridge or requiring a large bicoronal incision), these techniques all demonstrated efficacy in direct neurotization to improve corneal sensation in these patients. the investigators aim to assess the efficacy of this innovative surgical technique involving coaptation of the sural nerve or cadaveric nerve allograft to an intact sensory branch of the trigeminal nerve to restore corneal sensation. the investigators have previously described the anatomic feasibility of using the infraorbital nerve using a cadaveric model, of which the results were presented at the american society of ophthalmic plastic and reconstructive society fall meeting in 2017. utilization of the infraorbital nerve provides advantages over existing techniques due to ease of access via a cosmetically favorable incision, large caliber with increased ability to create a perineural window, relatively short and direct tunnel with possibly more rapid neurotization, and absence of complex surrounding anatomical structures. others have previously describe success using the contralateral and ipsilateral supraorbital nerve and supratrochlear nerve.

Eligibility criteria:
inclusion criteria: * patients with neurotrophic cornea exclusion criteria: * patients with history of penetrating keratoplasty

Keywords: corneal neurotization neurotrophic cornea neurotrophic corneal ulcer
study of adg116 in patients with advanced/metastatic solid tumors

Conditions: Solid Tumor

Summary: this is a fih, open-label, phase i dose-escalation study of adg116 in subjects with advanced/metastatic solid tumors. study drug, adg116, is an anti -ctla-4 fully human monoclonal antibody that specifically binds to human ctla-4. adg 116 administered intravenously (iv) over a period of 60-90 minutes. the study planned to treated 42 patients.


Eligibility criteria:
inclusion criteria * male or female, 18-75 years of age at the time of consent. * provide written informed consent. * subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available * patients who are refractory or relapsed to prior anti-ctla4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria. * eastern cooperative oncology group (ecog) performance status \< 2. * adequate organ and bone marrow function * women of childbearing potential (wocbp) must have a negative serum pregnancy test within the 7 days prior to study exclusion criteria: * pregnant or nursing females. * treatment with any investigational drug within 4 weeks prior to the first dose of study drug * grade ≥ 3 immune-related adverse events (irae) or irae that lead to discontinuation of prior immunotherapy. untreated or uncontrolled central nervous system (cns) tumors or metastases * any active autoimmune disease or documented history of autoimmune disease. * infection of human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) * subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug. * current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. peripheral neuropathy ≥ grade 2. * history of clinically significant cardiac disease. * uncontrolled current illness.
acute gastrointestinal injury in pediatrics

Conditions: Acute Gastrointestinal Injury; Gastrointestinal Failure; Critical Illness

Summary: critically ill children may develop acute gastrointestinal injury secondary to severe inflammation.

data collection from enrolled subjects including profile, laboratory examinations, inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and finally outcome of the patient

Eligibility criteria:
inclusion criteria: * critically ill pediatric patients receiving care at the picu * presence of agi (any degree) exclusion criteria: * patients who's body weight cannot be measured
compliance with treatment for patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: it is a prospective observational study. patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a ldl self-test and two questionnaires. they will test themselves for ldl at home between normal clinic visits (normally 12 months interval) and note their value. in the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased. we want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.

consecutive patient sampling

Eligibility criteria:
inclusion criteria: * aged 18 years or older and able to understand and sign the informed consent form. * patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the mpa national guideline for treatment of hyperlipidemia. exclusion criteria: * patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study. * patients participating in other clinical trials or non-interventional studies.
cirrhosis registry of hospitalized patients

Conditions: Cirrhosis, Liver; Frailty; Ascites; Encephalopathy; Infection

Summary: cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit

on admission to f.d.roosevelt teaching hospital / hegito liver unit (div hepatology, gastroenterology and liver transplant), all the adult patients with liver cirrhosis are offered to participate. after providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person after discharge from the hospital, follow-up is recommended and uploaded to rh7 (if the follow-up visits take place at this institution \[fdr\]) mortality data are uploaded from the national registry of dead on regular basis

Eligibility criteria:
inclusion criteria: * liver cirrhosis (primarily on clinical grounds) * decompensating event leading to hospital admission * informed consent exclusion criteria: * declined consent

Keywords: cirrhosis decompensation frailty