Kornimate/medical-research-clean huggingface dataset:
balloon colonoscopy for incomplete colonoscopy

Conditions: Diverticulosis

Summary: patients with a prior incomplete colonoscopy will be enrolled in this study. patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. if the procedures is unsuccessful, the patient can be crossed-over to the other group. the primary endpoint of the study is a complete colonoscopy.

colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. these factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort. options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. non-endoscopic modalities include radiologic studies such as ct/mri colonography as well as a retrograde barium study. relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. in this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

Eligibility criteria:
inclusion criteria: * prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete exclusion criteria: * incomplete colonoscopy due only to poor bowel preparation or inadequate sedation

Keywords: balloon enteroscopy looping
can we get conscious sedation by combining dexmedetomidine with alfentanil?

Conditions: Procedural Sedation

Summary: the main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department. patients included in the study will receive an injection of dexmedetomidine via a tiva injectomat agilia, specially programmed for the injection of dexmedetomidine. patients will also receive a dose of alfentanil, 1 minute before the technical act.


Eligibility criteria:
inclusion criteria: adult over 18 years, of both sexes, for which a procedural sedation is needed in emergency room. the rules for sedation, in accordance with the international guidelines, are: * the insertion of a chest drain * abscess incision and drainage * closed reduction of a dislocated joint exclusion criteria: * patients refusing to participate in the study (refusal to sign the consent form) * patients refusing sedation * patients unable to participate in the study (consent is impossible to obtain) * pregnant women * the hypersensitivity to the active ingredient, dexmedetomidine hydrochloride. * patients with poor respiratory status determined by: respiratory rate \> 30 / min oxygen saturation \<90% * patients with unfavorable hemodynamic status determined by : a heart rate \> 120 / min a heart rate \< 50 / min systolic blood pressure ≥ 180 mmhg or ≤100mmhg diastolic blood pressure ≥ 110mmhg * patients with contraindication to the use of dexmedetomidine : advanced heart block (level 2 or 3) unless pacemaker acute cerebrovascular disease

Keywords: deep sedation dexmedetomidine emergency service, hospital
a study of safety, tolerability, pk, and pd of subcutaneous gensci120 in healthy adults.

Conditions: Autoimmune Disease

Summary: this study is designed to evaluate the safety, tolerability, pk and pd of gensci120 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.


Eligibility criteria:
inclusion criteria: 1. male or female, between 18 and 55 years of age (inclusive) at the date of signed informed consent form (icf), each cohort must include at least 3 participants of a single gender. 2. body mass index (bmi) between 18 and 30 kg/m2 (inclusive) and total body weight ≥ 50 kg (male) / ≥ 45 kg (female) at screening. 3. no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, tumor biomarker, et al.), electrocardiogram (ecg) and pulmonary imaging tests, or value beyond normal reference range considered not clinically significant. 4. ability to understand the trial procedures, volunteer to participate in the trial, and could provide written informed consent. exclusion criteria: 1. known allergy to any component in the gensci120 formulation, or a history of severe allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity. 2. the proposed injection site has tattoos, sunburn, scarring, or other factors that may interfere with the evaluation of the injection site. (3) history of serious metabolic, allergic, dermatological, hepatic, renal, hematological, cardiovascular, gastrointestinal, neurological, respiratory, or other significant medical history that, in the investigator's opinion, may affect the assessment of this study. （4）severe infection, chronic infection, opportunistic infection, etc., within 3 months before screening, or systemic antimicrobial treatment for infections (including but not limited to viral, bacterial, fungal, parasitic infections) within 4 weeks prior to randomization. （5）use or intend to use any prescription medication to manage chronic/ongoing condition, and any acute medication use (including prescription medication, over-the-counter medication, or dietary supplements) within 14 days prior to administration. （6)participated in any clinical trials of investigational drugs (including investigational vaccines) and used investigational drugs within 3 months or within 5 terminal elimination half-lives (whichever is longer) prior to administration; participated in any clinical trials of medical devices within 3 months prior to screening (not including failed screening participants); currently participating in other clinical trials. （7) any other medical condition (at the investigator's discretion) that would impair the participant's ability to tolerate the imp or proceed with the planned study procedures.
vaccine therapy plus qs21 in treating women with breast cancer who have no evidence of disease

Conditions: Breast Cancer

Summary: rationale: vaccines made from gm2-klh and given with qs21 may make the body build an immune response to and kill tumor cells. purpose: phase i trial to study the effectiveness of gm2-klh vaccine plus qs21 in treating patients with breast cancer who have no evidence of disease.

objectives: i. determine whether immunization with gm2-klh vaccine plus the immunological adjuvant qs21 induces an antibody response against gm2 and cells expressing gm2 in disease free patients at high risk for recurrence of breast cancer. outline: gm2-klh vaccine plus qs21 is administered subcutaneously to sites on the upper arm and upper leg at weekly intervals for 4 weeks. two additional vaccines are administered at weeks 12 and 24. patients are followed every 3 months after the sixth vaccination. projected accrual: a total of 9 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: eligible patients must have no evidence of disease in addition to 1 of the following features: stage i, ii, or iii breast cancer and have received adjuvant chemotherapy and remain clinically free of identifiable disease, but have rising ca15.3 (br2729) or cea levels stage iii breast cancer and have completed adjuvant therapy no more than 24 months ago recurrence in the ipsilateral axilla following a lumpectomy/axillary dissection or modified radical mastectomy recurrence in the ipsilateral breast following a lumpectomy/axillary dissection stage ii breast cancer with at least 4 positive axillary lymph nodes at 24 months following completion of adjuvant therapy patients with isolated elevation of the cea level must have a colonoscopy to rule out colon carcinoma a colonoscopy within the past 5 years is acceptable if there is no strong family history of colon carcinoma, colonic polyps, or inflammatory bowel disease hormone receptor status: not specified patient characteristics: age: 18 and over menopausal status: premenopausal or postmenopausal performance status: karnofsky 90-100% life expectancy: not specified hematopoietic: lymphocyte count at least 500/mm3 wbc count at least 3,000/mm3 hepatic: aspartate aminotransferase no greater than 1.5 times upper limit of normal (uln) alkaline phosphatase no greater than 1.5 times uln renal: creatinine no greater than 1.5 times uln cardiovascular: no new york heart association class iii or iv cardiac disease other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no other concurrent active cancers except basal cell or squamous cell carcinomas of the skin no history of a seafood allergy no known history of immunodeficiency or autoimmune disease prior concurrent therapy: biologic therapy: at least 6 weeks since prior immunotherapy chemotherapy: at least 4 weeks since prior chemotherapy endocrine therapy: no concurrent steroids radiotherapy: at least 4 weeks since prior radiotherapy surgery: at least 4 weeks since prior surgery

Keywords: stage i breast cancer stage ii breast cancer stage iii breast cancer
correlation between optic nerve vessel anomalies, serum angiogenic factors and renal anomalies in down syndrome children

Conditions: Down Syndrome

Summary: in approximately half of individuals with down syndrome, an higher than normal number of vessels cross the optic disc margin. investigator hypothesize that early retinal vessel branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin, an angiogenesis inhibitor encoded on chromosome 21. since angiogenesis is critical in the development of eyes and other organs angiogenesis depended (specially kidney, brain, and recently described lungs and heart), early branching of retinal vessels at the level of the optic disc would also likely result in abnormal renal and other organs development in these individuals. investigator wish to determine whether observation of optic disc vessels may serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs anomalies.

investigator will measure the serum levels of endostatin as well as others angiogenetic factors in down syndrome children versus control group 1 constituted by the patient mothers. investigator will also perform renal and low urinary tract doppler ultrasound with measurement of renal dimension in order to determine if the kidneys of patients with high level of serum of endostatin are smaller than those of patients with normal level of endostatin. data observed in down syndrome children will be compared to control group 2age constituted by sex and age matched healthy children urine microalbuminuria and urine microalbuminuria/creatinuria from the first urine in the morning will be evaluated.

Eligibility criteria:
inclusion criteria: * provision of personally signed and dated informed consent document by adult subject or parents * when capable of providing assent, provision of personally signed and dated informed assent document by children * subjects and/or their caregivers/parents are willing and able to comply with scheduled laboratory tests, and other required study procedures. exclusion criteria: • inability to cooperate with study related examination for "study group" subjects * known chronic diseases unrelated to their triallelic condition for "control group n°1" \& "control group n°3" * general disease in which the level of endostatin may be modified such as leukemia, cancers, inflammatory diseases (e.g.: rheumatoid arthritis, crohn's disease, psoriasis) * any condition that may cause a hypoxia * pregnancy for "control group n°2": * healthy children except benign ophthalmological refraction anomalies * any known renal or low urinary tract diseases.
family psychoeducation for children with mood disorders

Conditions: Mood Disorders

Summary: the purpose of this study is to evaluate the effectiveness of a multifamily psychoeducation group for the families of children with mood disorders.

mood disorders among youth are a major health concern. existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. this 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders. in this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. parents also practice problem-solving and communication skills for symptom management. children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. children also learn and practice anger management, problem-solving, and communication skills. patients and their families are randomly assigned to 1 of 2 groups. the first group receives 8 sessions of psychoeducation plus treatment as usual (tau). the second group is a wait-list control in which participants receive only tau. patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. the extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. a comprehensive assessment is conducted at study entry and 1 year later.

Eligibility criteria:
inclusion criteria: * major depressive disorder, dysthymic disorder, or bipolar disorder (type i or ii) * iq greater than 70 * at least one parent/caregiver willing to participate in the study * able to attend six or more of the eight treatment sessions with at least 1 parent
dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer

Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.

objectives: i. determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. ii. determine the toxicity of this regimen in this patient population. outline: this is an open label, multicenter study. patients receive dolastatin 10 iv bolus every 3 weeks. treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. patients are followed until death. projected accrual: a total of 14-35 evaluable patients will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) bidimensionally measurable disease the following are not considered measurable lesions: lesions seen on colonoscopic examination or barium studies bone metastases cns lesions cea, ca19-9, or afp levels ascites no cns disease only no symptomatic brain metastases patient characteristics: age: 18 and over performance status: calgb 0-2 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 or platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency hemoglobin at least 9.0 g/dl hepatic: bilirubin no greater than 1.5 mg/dl transaminases no greater than 5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance at least 60 ml/min other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no significant underlying medical or psychiatric illness no active infections no other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for advanced or metastatic hepatobiliary cancer no other concurrent chemotherapy no concurrent investigational antineoplastic drugs endocrine therapy: not specified radiotherapy: no prior radiotherapy to only site of measurable disease at least 6 weeks since prior radiotherapy and recovered no concurrent radiotherapy to any lesion surgery: not specified

Keywords: advanced adult primary liver cancer recurrent adult primary liver cancer unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer adult primary hepatocellular carcinoma cholangiocarcinoma of the gallbladder
development of novel mri methods for detecting, discriminating, and measuring liver fibrosis and congestion in fontan patients

Conditions: Liver Fibrosis

Summary: in this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult fontan patients that will correlate a variety of quantitative mri biomarkers with histopathologic data.

the purpose of this study is to develop noninvasive mri methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach. over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. subjects will undergo research mr imaging within ±2 weeks of the liver biopsy procedure. a variety of mri biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.

Eligibility criteria:
inclusion criteria: * single ventricle physiology congenital heart disease status post fontan palliation * undergoing clinically-indicated liver biopsy * ability to tolerate 60 minutes in an mri scanner without sedation exclusion criteria: * known contraindication to mr imaging (e.g., implanted non-mri compatible device) * known or suspected pregnancy. female subjects of child bearing potential will undergo urine pregnancy testing prior to imaging

Keywords: liver fibrosis fontan surgery mri novel methods
post-transplantation benadamustine and cyclophosphamide in patients with refractory myeloid malignancies

Conditions: Myeloid Leukemia, Acute; Chronic Myeloid Leukemia; Myelodysplastic Syndromes; Myeloproliferative Neoplasm

Summary: prognosis of patients undergoing salvage allogeneic stem cell transplantation for refractory leukemia or other refractory myeloid malignanies is poor. one of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. on the other hand post-transplantation cyclophocphamide was reported to abort cytokine release syndrome that sometimes occurs after graft transfusion in patients after haploidentical graft transfusion. the aim of this study is to evaluate if the combination of post-transplantation bendamustine (ptb) and post-transplantation cyclophosphamide (ptcy) facilitates comparable graft-versus leukemia effect to ptb, but with better safety profile and reduced incidence of severe cytokine release syndrome.


Eligibility criteria:
inclusion criteria: * patients with indication for allogeneic hematopoietic stem cell transplantation * patients with 5-10/10 hla-matched related or unrelated donor available. the donor and recipient must be identical by the following genetic loci: hla-a, hla-b, hla-cw, hla-drb1, and hla-dqb1. * peripheral blood stem cells or bone marrow as a graft source * diagnosis: acute myeloid leukemia chronic myeloid leukemia, ph+ myelodysplastic syndromes myeloprolipherative neoplasms * salvage hematopoietic stem cell transplantation defined as: * acute myeloid leukemia: \>5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation myelodysplastic syndrome: \>10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of tkis myeloprolipherative neoplasms : high tumor burden despite previous therapy, including \>20 000 wbc/ ul or splenomegaly \>15 cm * no severe concurrent illness exclusion criteria: * moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50% * moderate or severe decrease in pulmonary function, fev1 \<70% or dlco\<70% of predicted * respiratory distress \>grade i * severe organ dysfunction: ast or alt \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits * creatinine clearance \< 60 ml/min * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent

Keywords: bendamustine cyclophosphamide graft-versus-host disease graft-versus-leukemia effect refractory acute myeloid leukemia hematopoietic stem cell transplantation allogeneic