Kornimate/medical-research-clean huggingface dataset:
safety and potential effect of innovative cell-based therapy using adipose-derived stromal vascular fraction in patients with autoimmune xerostomia

Conditions: Xerostomia

Summary: the main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (d14).

autoimmune xerostomia is a disabling condition affecting mostly patients suffering from sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia. local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects. stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. autologous uncultured adipose-derived stromal vascular fraction (ad-svf) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which ad-svf are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. the purpose of our ad-svf phase i trial is to evaluate, first the tolerance of autologous ad-svf cells locally injected in the oral cavity and second their capability to improve the salivary function.

Eligibility criteria:
inclusion criteria: * patients from 18 to 65 years. * patients suffering from xerostomia and autoimmune disease including : gougerot-sjögren disease according to ac/eular criteria and secondary gougerot-sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...) * xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60 * informed consent to participate (with signature) * negative β -hcg test and effective contraception for women being able to get pregnant * affiliation to the social security system exclusion criteria: * medical history of head and neck neoplasia * recent (\<3 months) medication inducing and aggravating xerostomia : standard treatment with tricyclic antidepressant and/or antipsychotics * body mass index \< 18 * active smoking (\> 5 cigarettes a day) * active infectious disease and/or active viral serologies (hiv, hcv, hbv, htlv i/ii, tpha/vdrl) * coagulation disorders including anticoagulant and antiplatelet treatment * any temporary or definitive contraindication due to any medical or surgical unstable condition * allergy to local anesthesia and/or albumin * pregnant or breastfeeding women * adult protected by the law (tutorship and curatorship) * patients already enrolled in another study * patients under 18 years of age * person deprived of liberty * patient non-affiliated to the social security
total body irradiation for bone marrow transplants: collaborative efforts

Conditions: Neoplasm

Summary: most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. these differences are optimized at each institution to limit toxicity and maximize therapeutic outcome. technically complex procedures such as total body radiation are subject to equipment failures. such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. the purpose of this protocol is to provide backup between george washington university medical center and the radiation oncology branch of the nci to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver tbi; or any emergent situation.

most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. these differences are optimized at each institution to limit toxicity and maximize therapeutic outcome. technically complex procedures such as total body radiation are subject to equipment failures. such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. the purpose of this protocol is to provide backup between george washington university medical center and the radiation oncology branch of the nci to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver tbi; or any emergent situation.

Eligibility criteria:
inclusion criteria: patients must sign informed consent. supporting institution physicians must agree that therapy is appropriate and safe.

Keywords: bone marrow transplantation leukemia breast cancer multiple myeloma total body irradiation
impact of the bb box system on postpartum maternal anxiety, post traumatic stress and mother-child relationships

Conditions: Stress Disorders, Post-Traumatic; Anxiety

Summary: the main objective of this study is to compare the degree of maternal anxiety at day 3 postpartum in mothers who did or did not have access to a video communication system (bb-box system) from the time of initial separation with their baby.

the secondary objectives of the study are to compare the following between the two arms of the study: a. the degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. anxiety will be compared point by point but also via kinetics. b. the incidence maternal post traumatic stress disorder at 6 and 12 months. c. the incidence of mother-child relationship disorders at 6 and 12 months. d. infant vital signs during the hospital stay.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 12 months of follow up * the patient has given birth this day to a premature child (\< 36 weeks of gestation and/or \< 2 kg birthweight) * separation of child and mother since birth exclusion criteria: * the patient or baby is participating in another study, excepting the studies "oasis" or "prom8736" * the patient or baby is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient or father refuses to sign the consent * it is impossible to correctly inform the patient * preexisting maternal psychiatric pathology * major or lethal poly-malformation syndrome * severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain * any emergency situation preventing patient involvement * mother and/or child not hospitalized at the nîmes university hospital * death of the patient or child during the study

Keywords: post partum mother-child relationships
phase i/ii study of immune therapy after allograft in patients with myeloid hemopathy

Conditions: Acute Myeloid Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome

Summary: patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from hla-identical donor (related or unrelated) after reduced-intensity conditioning regimen. if wt1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft. 6 administrations every 2 weeks of the protein recwt1-a10+as01b will be administrated. the safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.


Eligibility criteria:
inclusion criteria: 1. patients older than 18 and younger than 65 years. 2. karnofsky ≥ 70 %. 3. patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, who underwent allogeneic stem cell transplantation from hla-identical donor (related or unrelated) after reduced-intensity conditioning regimen. 4. patients in morphologic complete remission at the time of transplantation. 5. wt1 expression detectable on tumor cells. 6. expected life duration more than 6 months. 7. creatinine clearance ≥ 50 ml/min 8. bilirubinemia \< 1.5n and asat \< 2.5n. 9. women of childbearing age: negative pregnancy test and effective contraception for at least 30 days before vaccinal immunotherapy (the same contraceptive method must be continued at least 2 months after the last vaccine infusion). 10. membership of a social security scheme or beneficiary of such a regime. 11. signed inform consent. exclusion criteria: 1. patients with severe and uncontrolled affections, especially active graft-versus-host disease requiring steroid treatment (\>0.3 mg/kg/j) and/or mycophenolate mofetil. 2. pregnant or lactating women. 3. hiv seropositive patients. 4. autoimmune disease (lupus, multiple sclerosis, chron disease...) 5. previous history of allergic state which could be potentially compound by a component of the vaccinal immunotherapy. 6. patients who received (or are planned to receive) another experimental treatment within 30 days following the first infusion of the experimental drug of this protocol. 7. previous history of another cancer, except if considered as probably cured by the investigator. 8. patients deprived of liberty, or under guardianship.

Keywords: acute myeloid leukemia chronic myeloid leukemia myelodysplastic syndrome allograft wt1 expression
deep learning algorithms for prediction of lymph node metastasis and prognosis in breast cancer mri radiomics (rbc-01)

Conditions: Breast Neoplasm Female; Early-stage Breast Cancer; Radiomics; Axillary Lymph Node; Survival, Prosthesis

Summary: this bi-directional, multicentre study aims to assess multiparametric mri radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.

sensitivity for prediction of lymph node metastasis and survival of currently available prognostic scores in limited. this study proposes to establish a deep learning algorithms of multiparametric mri radiomics and nomogram for identifying lymph node metastasis and prognostic prediction of breast cancer. the study will investigate the relationship between the radiomics and the tumor microenvironment. the study includes the construction of multiparametric mri radiomics-based prediction model and the validation of the prediction model.

Eligibility criteria:
inclusion criteria: * the primary lesion was diagnosed as invasive breast cancer * patients can have regional lymph node metastasis,but no distant organ metastasis * complete the breast mri examination before treatment * accept breast cancer surgery or lymph node biopsy * eastern cooperative oncology group performance status 0-2 exclusion criteria: * inflammatory breast cancer * accompanied with other primary malignant tumors * perform surgery,radiotherapy and lymph node biopsy before breast mri examination * patients who have neoadjuvant chemotherapy * patients had distant and contralateral axillary lymph node metastasis * the pathologic diagnosis was extensive ductal carcinoma in situ

Keywords: early-stage breast cancer radiomics axillary lymph node metastasis tumor microenvironment survival deep learning
dialectical behavior therapy for adolescents at rutgers university

Conditions: Borderline Personality Disorder in Adolescence

Summary: this project expands our existing psychological services clinic (the dialectical behavior therapy clinic at rutgers university; dbt-ru) to include an adolescent treatment arm. adolescents aged 13-20 and at least one caregiver will be recruited to participate in a six-month treatment study. adolescents will be eligible to participate if they meet at least 3 criteria for borderline personality disorder, with one of those criteria being either impulsive behavior or recurrent self-harm behavior. participants will be assessed at baseline, three-months (mid-treatment), six-months (post-treatment, and three-month follow-up.


Eligibility criteria:
inclusion criteria: * age 13-17 years or 18-20 if still living at home with parent. * agreement of at least one responsible adult parent/caregiver to participate in treatment. * agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel. * agreement to pay for mental health services at the dbt- ru on a sliding scale, and to participate in research assessments as volunteers. * residence within commuting distance of clinic (\< 45 minutes). * agreement to discontinue other forms of talk therapy for duration of dbt program (does not refer to aa/na programs or psychotropic medication management). * exhibits dysregulation within the past six months as evidenced by 1) intentional self-injury and/or suicide attempt and/or 2) substance use disorder. * meets two additional criteria for borderline personality disorder (bpd). exclusion criteria: * clients who need mental health services not available at the dbt- ru, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended. * non-english speaking. * iq \< 70. * unable to understand research consent forms. * court-ordered to participate in treatment.

Keywords: borderline personality disorder adolescence suicide substance use
dietary intervention program for pre-eclampsia in women at risk

Conditions: Pre-eclampsia

Summary: aims: pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. preeclampsia frequency is 2-8% from all pregnancies. dietary factors and dietary status have been suggested to play a role in development of preeclampsia. low intake of nutrients such as calcium, vitamin d, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. also high triglyceride levels, high bmi, low omega 6: omega 3 ratio and high calories consumption are possible risk factors. material and methods: a prospective study will be carried out. woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. in the dietary treatment group, besides medical care, all woman will get calcium and vitamin d supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. a 3 day food diary will be collected at inclusion and thereafter at gestational weeks 16 and 28. all routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented. in both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

aims: pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. preeclampsia frequency is 2-8% from all pregnancies. dietary factors and dietary status have been suggested to play a role in development of preeclampsia. low intake of nutrients such as calcium, vitamin d, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. also high triglyceride levels, high bmi, low omega 6: omega 3 ratio and high calories consumption are possible risk factors. material and methods: a prospective study will be carried out. woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. in the dietary treatment group, besides medical care, all woman will get calcium and vitamin d supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. a 3 day food diary will be collected at inclusion and thereafter at gestational weeks 16 and 28. all routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented. in both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.

Eligibility criteria:
inclusion criteria: * high risk of preeclampsia exclusion criteria: * age below 18 * low risk of preeclampsia
a phase i study of 8-week continuous treatment with polyethylene glycol loxenatide in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: polyethylene glycol loxenatide (pex168) is a new human glucagon-like peptide 1 (glp-1) analogue that created on the basis of the exenatide and modified by polyethylene glycol (peg). this study aims to evaluate the pk, pd and safety by 8-week continuous treatment of pex168.


Eligibility criteria:
inclusion criteria: 1. aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 who criteria more than 3 months. 2. hba1c 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/l after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone). 3. unused insulin within 3 months prior to the enrollment. 4. body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months. 5. normol liver, kidney, heart function. 6. willing to use physical means of contraception during the trial stage. 7. voluntarily to participate in the study. exclusion criteria: 1. 1 diabetes. 2. used glp-1, glp-1 analogs or dpp-4 inhibitors in the past 3 months. 3. have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history 4. there is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma. 5. with severe diabetes complications ( renal , retinal , nerve , vascular disease). 6. has acute and chronic pancreatitis history ; 7. heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ; 8. there is a history of hypertension and blood pressure is not well controlled : sbp\> 160mmhg and / or dbp\> 95mmhg persons ; 9. severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ; 10. there are obvious blood system diseases ; 11. there are other endocrine system diseases , such as hyperthyroidism , etc. ; 12. with severe trauma or surgery , severe infection ; 13. have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ; 14. used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ; 15. within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ; 16. were receiving steroids or are receiving cancer treatment ; 17. has been prepared during pregnancy or pregnancy test in female patients ; 18. hepatitis b hbeag , hepatitis c antibody positive , hiv antibody positive , syphilis antibody positive . 19. skin test positive of pex168; 20. the researchers considered any factors that the subject should not participate in this trial.

Keywords: pex168, diabetes, phase i
prehabilitation for esophageal resection surgery

Conditions: Esophageal Cancer; Surgery

Summary: consenting patients scheduled for esophageal resection surgery will be randomized to receive standard nutrition counseling (including nutritional supplements as needed) or standard nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery. it is hypothesized that, compared with the group receiving nutrition alone, the addition of physical exercise to nutrition starting before surgery and continuing for 8 weeks after surgery will have a significantly greater impact on functional walking capacity during the prehabilitation period and during the postoperative period, and on the incidence of postoperative pulmonary complications.

a randomized controlled study in patients undergoing esophageal resection for cancer to determine the impact of multimodal prehabilitation on functional exercise capacity and postoperative pulmonary complications. patients who accept to be enrolled in the study will be randomized to receive either a standard nutritional intervention (including supplements as needed) as per current institution policy or standard nutritional intervention (including supplements as needed) combined with a physical exercise program before and after surgery. specific aims the aims of this research project are the following: 1. to determine the extent in which a multimodal prehabilitation regimen optimizes functional recovery in patients suffering from esophageal cancer and the incidence of postoperative pulmonary complications. 2. to understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Eligibility criteria:
inclusion criteria: * 18 and older * referred electively for resection of malignant esophageal lesion exclusion criteria: * american society of anesthesiologists (asa) health status class 4-5 * dementia and psychosis * disabling orthopedic and neuromuscular disease * severe cardiac abnormalities * severe end-organ disease such as cardiac failure (new york heart association classes i-iv) * copd * renal failure (creatinine \> 1.5 mg/dl, and hepatic failure alt and ast \>50% over the normal range) * morbid obesity (bmi \>30) * anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl)