Kornimate/medical-research-clean huggingface dataset:
bone marrow stem cell treatment for asherman's syndrome and endometrial atrophy

Conditions: Asherman's Syndrome; Endometrium; Atrophy, Cervix

Summary: the purpose of this study is to determine whether bone marrow stem cell transplantation may improve assisted reproduction techniques (art) outcomes in refractive asherman's syndrome or atrophic endometrium.

this novel technique refers to the use of cd133+ autologous bone marrow stem-cells to regenerate the endometrium in patients with asherman's syndrome, endometrial atrophy or any condition that produce a destruction of the endometrium or its de novo creation in a bioengineered uterus. it requires a previous mobilization in the peripheral blood of cd133+ autologous bone marrow stem cells, subsequent apheresis and transplant of the same cells in the spiral arterioles of the uterus with the aim to regenerate de novo the endometrium. this technique represents a new therapeutical approach for the treatment of endometrial regeneration problems such asherman syndrome and the endometrial atrophy since currently no specific treatment for these endometrial pathologies exist. a prospective experimental non controlled study has been designed in order to assess the effectiveness of these technique as a new tool for treat asherman's syndrome and endometrial atrophy.

Eligibility criteria:
inclusion criteria: * patients diagnosed of asherman syndrome and absence of pregnancy after treatment * endometrial atrophy (\<6mm) with implantation failure * age 20-45 years-old * normal liver, heart and kidney function * presence of menstrual bleeding with natural cycle or hrt * absence of psychiatric pathology and ability to accomplish the treatment * β-hcg negative * absence of sdt exclusion criteria: * absence of peripheral vein access * lack of accomplish inclusion criteria
safety and efficacy of oral administration of anti-cd3 monoclonal antibody (mab)in patients with the metabolic syndrome

Conditions: Nonalcoholic Steatohepatitis

Summary: this clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-cd3 monoclonal antibody (mab) to subjects with the metabolic syndrome.

phase iia study protocol a single-blinded placebo-controlled clinical trial.

Eligibility criteria:
inclusion criteria: 1. subjects who have completed the informed consent process culminating with written informed consent by the subject. 2. men and women age 18 to 75 years (inclusive) 3. patients with biopsy proven nash within the last 3 years 4. altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance. 5. hba1c between 5.5 and 14%. exclusion criteria: 1. subjects who have undergone surgery within the last 3 months. 2. subjects who have had a prior gastrointestinal surgery. 3. subjects with a clinically significant infectious, immune mediated or malignant disease 4. subjects who are receiving an elemental diet or parenteral nutrition. 5. subjects who have been treated with any type of immune modulatory drug including steroids or nsaid within the last 4 weeks 6. subjects who have received either methotrexate or cyclosporine or anti tnf-β (infliximab, remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months. 7. subjects with a history of coagulopathy. 8. women with childbearing potential unless surgically sterile or using adequate contraception (either iud, oral or depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers. 9. subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason. 10. subjects who are hiv-positive. 11. subjects who are hbv-positive 12. subjects who are hcv-positive. 13. subjects with active cmv 14. subjects with anemia (hb \<10.5 gm/dl). 15. subjects with thrombocytopenia (platelets \<100k/µl). 16. subjects with lymphopenia (absolute lymphocyte count \<0.7). 17. subjects with igg anti-cardiolipin antibody \>16 iu. 18. prior exposure to anti-cd3 mab. 19. known sensitivity to any ingredients in the study drug 20. any know autoimmune disease except for the studied disorders.
implementation and evaluation of an activity program to improve quality of life outcomes in women diagnosed with cancer

Conditions: Cancer

Summary: implementation and evaluation of an activity based program to improve quality of life, pain and fatigue outcomes in women diagnosed with cancer. demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods quality of life, pain and fatigue surveys).

this research study will focus on developing and implementing two one-week activity camps in the summer of 2016 for women diagnosed with cancer. one camp will be held in west philadelphia and another in camden, new jersey, both of which have been identified as underserved areas for health access. the focus of this programming is to allow women to engage in activities they may not be engaged in since the diagnosis of cancer and to provide them with opportunities to socially interact and communicate with individuals who may have encountered the same difficulties as them. quality of life, pain and fatigue information will be collected before, during and after implementation of the activity program. the main objective is to demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods and geographical locations through quality of life, pain and fatigue surveys). the intended sample size is 57 women.

Eligibility criteria:
inclusion criteria: * women diagnosed with cancer * age of 21 of older * clearance from their md to participate in the activity program exclusion criteria: * none

Keywords: quality of life occupation pain fatigue
renal impairment associated with colistin levels

Conditions: Sepsis

Summary: colistin is a relatively old antibiotic drug which its use has been abandoned through the 1970s because it was considered nephrotoxic. recently ( the last decade) it has been reappraised because multidrug resistant gram negative bacteria have emerged causing life threatening infections with no other good enough treatment. moreover, more controlled studies from the recent years show less toxic effect of the drug. the investigators' study is a prospective study comparing renal function in a group of hospitalized patients with sepsis (infection) receiving intravenous treatment with colistin (antibiotics) with a control group which its patients receive other non nephrotoxic antibiotics. the investigators' study hypothesis is that patients receiving colistin would have renal function decline in higher rates than those seen usually in hospitalized patients in the internal medicine wards with sepsis. another goal of the study is to find correlation between colistin levels in the plasma (after colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.

colistin is a relatively old antibiotic drug which its use has been abandoned through the 1970s because it was considered nephrotoxic. recently ( the last decade) it has been reappraised because multidrug resistant gram negative bacteria have emerged causing life threatening infections with no other good enough treatment. moreover, more controlled studies from the recent years show less toxic effect of the drug. the investigators' study is a prospective study comparing renal function in a group of hospitalized patients with sepsis (infection) receiving intravenous treatment with colistin (antibiotics) with a control group which its patients receive other non nephrotoxic antibiotics. the investigators' study hypothesis is that patients receiving colistin would have renal function decline in higher rates than those seen usually in hospitalized patients in the internal medicine wards with sepsis. another goal of the study is to find correlation between colistin levels in the plasma (after colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.the measurement of the colistin levels are planned to be done by immunological methods, by developing specific antibodies to colistin in a laboratory in france.

Eligibility criteria:
inclusion criteria: * hospitalized patients diagnosed with sepsis requiring antibiotic treatment * age 18 years old and above * gender - male or female exclusion criteria: * anticipated antibiotic treatment of less than 7 consecutive days * concurrent treatment with other nephrotoxic antibiotic drug
interventional therapy of tracheal stenosis

Conditions: Tracheal Stenosis Following Tracheostomy

Summary: after respiratory weaning, decannulation is sought. to do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. in the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. this constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. in case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. the goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. there is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). the examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house sop). after treatment, a follow-up is planned for about 10 days later.


Eligibility criteria:
inclusion criteria: * tracheal stenosis after percutaneous tracheotomy. exclusion criteria: * pregnant or breast-feeding women of childbearing potential who refuse pregnancy test. * lack of consent to participate in the study. * surgical tracheotomy. * involvement of the larynx (above the first tracheal brace).
verify the performance of the neutral electrode (ne) adhesives

Conditions: Adhesion of the Neutral Electrode 21pad

Summary: the purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard iec 60601-2-2 section 201.15.101.7. a neutral electrode is placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

two neutral electrodes will be applied to the front of your thighs. the study staff will set up and attach a pulley system to the neutral electrodes. the purpose of the pulley system is to apply a force pulling the neutral electrode away from your body. the force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. site staff will mark any areas of separation and the neutral electrodes will be removed.

Eligibility criteria:
inclusion criteria: * participants must be willing to comply with all study procedures * participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed. exclusion criteria: * the participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad. * the participant is pregnant or breastfeeding.
quality of life after covid-19 related acute respiratory distress syndrome among icu survivors patients in italy: the odissea study.

Conditions: Covid19; Post Traumatic Stress Disorder; Quality of Life

Summary: acute respiratory insufficiency is one of the principal causes of intensive care admission for covid 19 positive patients. this may determine a variable mortality rate ranging from 25-30%. in these patients, many days of non-invasive or invasive mechanical ventilation are needed to correct severe hypoxemia. mechanical ventilation is not a direct therapy but allows the clinicians to prolong the "time-to-recovery" interval necessary for covid 19 respiratory insufficiency treatment. long intensive care stay, mechanical ventilation, the use of steroids and sedatives have an impact on the survivors. previous studies demonstrated that patients admitted to intensive care with non-covid acute respiratory distress syndrome had a reduction in the quality of life even up to one year after discharge. the aim of this study is to understand if covid-19 related acute respiratory distress syndrome has a worse impact on the quality of life one year after discharge when compared with non-covid-19 acute respiratory distress syndrome.


Eligibility criteria:
inclusion criteria: * patients discharged from the intensive care unit after admission for covid-19 respiratory insufficiency that requested non-invasive or invasive mechanical ventilation exclusion criteria: * history of dementia * history of behavior disorders * pre-existing tracheostomy * advanced oncologic disease * end-stage-organ disease (dialysis, or enlisted for organ transplantation) * no consent
myopiax treatment for the reduction of myopia progression in children and adolescents: safety and efficacy investigation

Conditions: Myopia

Summary: the purpose of this trial is to investigate the safety and efficacy of myopiax - a digital treatment intended to slow the progression of myopia in children and adolescents.

the present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of myopiax in slowing the progression of myopia. the trial consists of 12 months treatment period. the first 6 months participants will be treated either with myopiax or with myopia control spectacles. during the second half of the trial, participants treated with myopiax will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. eligible subjects will be randomly assigned in a 2:1 ratio to either the myopiax or the myopia control spectacles group.

Eligibility criteria:
inclusion criteria: * myopic children (-0.75 to -5.0 d ser, least myopic meridian -0.50 d in each eye) * at least va 0.2 logmar in each eye * age: 6 - 12 years old * good tolerability of test session with vr system * binocular adequacy as tested with vr * ability to understand treatment and give valid assent exclusion criteria: * concomitant or previous therapies for myopia * eye diseases/conditions: * anisometropia ≥ 1.5 d * astigmatism ≥ 3 d * ophthalmological comorbidities * optic nerve abnormalities * suspicion of syndromic or monogenetic myopia * systemic illnesses affecting eye health, eye growth, and/or refraction * any illnesses affecting dopamine function (e.g., sleep disorder) * medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications) * participation in other clinical studies * medical history (or family history) of photosensitive epilepsy

Keywords: digital treatment
electrophysiological study of spatiotemporal gait parameters in patients in early stage of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: 35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters. this study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.


Eligibility criteria:
inclusion criteria: * subjects without any gait trouble * age ≥ 18 and \< 55 years old * gender and age (+/- 5 years) matched exclusion criteria: * pathology with potential gait impairment * pregnant or breast feeding patient * patient under legal protection * no health insurance coverage * absence of written informed consent
sebbin round, anatomical and biconvex gluteal implants

Conditions: Complication; Prosthesis Durability

Summary: this study is part of the clinical evaluation of sebbin silicone gel-filled gluteal implants, included in the technical file of the device. the aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility criteria:
inclusion criteria: * the patient is a man or a woman ≥ 18 years old at the time of inclusion. * the patient is planned for a unilateral or bilateral gluteal implant placement with sebbin implants as per investigator decision * the patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing. exclusion criteria: * patient implanted with silicone implants somewhere else in the body. * patient candidate for implantation with custom-designed implants. * participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
endoscopic cryoablation combined with pd-1 in advanced gastric cancer

Conditions: Gastric Cancer

Summary: to clarify the efficacy and safety of endoscopic cryoablation combined with pd-1 monoclonal antibody treatment regimen in advanced gastric cancer.

this study is a single-center, single-arm, self-controlled, experimental, non-randomized exploratory clinical trial, aiming to enroll 15 patients with advanced gastric cancer. each enrolled patient will be assigned a case number. this case number, along with the patient's name initials, will be recorded on every page of the case report form (crf). enrolled patients will receive local gastric ecat (endoscopic cryoballoon ablation treatment) combined with pd-1 monoclonal antibody therapy for the evaluation of efficacy and safety, as well as immunological assessments of peripheral circulation and local tumor tissue. patients will be followed during the treatment period and for six months after treatment termination for study observation.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with advanced gastric cancer (stage iv in ajcc 8th edition staging, including locally progressive gastric cancer with unresectable factors (iva) and gastric cancer with distant metastases (ivb); bowman's staging type i, ii, and iii), who are unable to be surgically resected or do not tolerate surgical resection, and who have undergone progression after 1-2 lines of conventional chemotherapy; 2. age greater than 18 years and less than 80 years; 3. who pathology type: adenocarcinoma, neuroendocrine tumor; 4. expected survival greater than 3 months and controllable distant metastases as judged by the physician; 5. important organ functions must be met: ① liver function: alt and ast ≤ 2.5 times the positive range, total bilirubin ≤ 2.0mg/dl; ② renal function: creatinine clearance ≥ 40ml/min calculated using the epi formula; 6. blood routine: hgb≥70g/l,anc≥1.5×109/l,plt≥80×109/l; 7. coagulation function: pt and appt \<2 times the normal value; 8. pregnancy test must be negative in women of childbearing age; 9. ecog score ≤2; 10. signed informed consent. exclusion criteria: 1. pregnant or breastfeeding women, or women with pregnancy plans within six months; 2. infectious diseases (e.g. aids, syphilis, active tuberculosis); 3. patients with active hepatitis b or c infection; 4. combination of other primary malignant tumors; 5. patients who have participated in a clinical trial within one month; 6. patients taking antiplatelet or anticoagulant drugs within the last week; 7. patients with gastric cancer combined with active bleeding; 8. large amount of ascites (ascites ≥3000ml); 9. cardia obstruction or pyloric obstruction; 10. patients with combined active infection or autoimmune disease; 11. those who the doctor thinks there are other reasons not to be included in the treatment.

Keywords: ecat pd-1
impact of gender on the outcome of liver transplantation for hepatocellular carcinoma

Conditions: Cancer of Liver

Summary: this is a large-scale study in china to provide evidence and insights in the role of gender in lt for hcc by analyzing the data of 3769 recipients with hcc registered in the china liver transplant registry.


Eligibility criteria:
inclusion criteria: the patients with liver transplants performed from january 2015 to december 2020, whose clinicopathological data were registered in the cltr. exclusion criteria: patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than hcc, such as intrahepatic cholangiocarcinoma (icc), combined hepatocellular cholangiocarcinoma (chcc-cc), fibrolamellar hepatocellular carcinoma (flc) or secondary metastatic tumor; without histological confirmation of hcc for transplantation. the patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. next, pediatric patients (\ 65 years) and those patients who died within six months after transplantation were also excluded. finally, the patients with type-1 and type-2 portal vein tumor thrombus (pvtt), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.
b6 treatment for nausea and vomiting in pregnancy

Conditions: Nausea and Vomiting Complain in Early Pregnancy

Summary: the purpose of this study is to determine vitamin b6 concentration and whether vitamin b6 is effective in nausea and vomiting of pregnancy.


Eligibility criteria:
inclusion criteria: * nausea and vomiting of pregnancy exclusion criteria: * other medical condition causing nausea and vomiting of pregnancy

Keywords: nausea vomiting pregnancy b6
studying biomarkers in samples from younger patients with wilms tumor

Conditions: Kidney Cancer

Summary: rationale: studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in samples from younger patients with wilms tumor.

objectives: * to determine a unique molecular "finger print" of primary wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse. * to determine a unique protein "finger print" from the urine of ethnically diverse children who develop wilms tumor and subsequent relapse. outline: formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by maldi-tof mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (rt-pcr) assays.

Eligibility criteria:
disease characteristics: * diagnosed with wilms tumor * specimens from african-american and from caucasian children * specimens from each ethnicity who relapsed * specimens from each ethnicity who did not relapse patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: recurrent wilms tumor and other childhood kidney tumors stage i wilms tumor stage ii wilms tumor stage iii wilms tumor stage iv wilms tumor stage v wilms tumor