Kornimate/medical-research-clean huggingface dataset:
long term follow up of recipients of functional islet allografts

Conditions: Type 1 Diabetes Mellitus

Summary: since its inception, the diabetes research institute (dri) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. through several clinical trials, dri has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant. over the years the following protocols in islet cell transplantation have been initiated: 2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210. all of the studies listed above will be source of study subjects for this study. approximately 30 subjects are expected to be enrolled and followed in this trial. after islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications. the purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. it is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.

to provide long term follow up in subjects with functional islet allografts.

Eligibility criteria:
inclusion criteria: 1. participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210 2. a functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression. 3. willingness of participants to continue to use an approved method of contraception during and 4 months after study participation. 4. ability to provide written informed consent. exclusion criteria: 1. for female subjects: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. for male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. oral contraceptives, norplant®, depo-provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 2. any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
metabolomics in occupational asthma

Conditions: Asthma, Occupational

Summary: the project aims to increase the diagnostic accuracy in occupational asthma (oa), with emphasis on irritant induced asthma (iia). currently, most patients are evaluated in occupational medicine by comparing the exposure and symptom characteristics with epidemiological data. biological markers may be present in aa, but presently not in iia. the majority of cases evaluated are considered as possible iia, i.e. low-dose multiple exposures. voc features will be analyzed with the breath biopsy® and td-gs-ms (owlstone medical ltd, uk).


Eligibility criteria:
inclusion criteria: * capable of informed consent. * asthma diagnosis established by lung specialist or healthy control. exclusion criteria: * skin allergy towards plastics or rubber. * immunocompromised by oral medication. * contagious respiratory disease. * biopsy of lung parenchyma within the last 36 hours.
nitrate and exercise-induced cardiac troponin t in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: blood cardiac troponin t (ctnt) concentration is a widely used marker of acute cardiac injury. previous research has shown that type 2 diabetic patients may experience large increments in ctnt levels over the subsequent hours following a single bout of moderate-intensity endurance-type exercise. this phenomenon is likely attributed to cardiac ischemia-reperfusion injury caused by reduced nitric oxide (no) bioavailability. recent evidence indicates that ingestion of dietary nitrates dramatically increases the bioavailability of no, and as such, may be protective against cardiac ischemia-reperfusion injury. the investigators hypothesize that dietary nitrate supplementation blunts the rise in ctnt levels following exercise in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * exercise-induced ctnt release (\>3ng/l) exclusion criteria: * hba1c \ 10.0% * morbid obesity (bmi\>35 kg/m2) * incident cardiovascular events in the last year (heart attack, stroke * use medication which contain nitrates and/or having vasodilatory effects

Keywords: cardiac troponin t ctnt exercise dietary nitrate
a trial of norethisterone acetate and expectant management in treatment of simple ovarian cysts

Conditions: Ovarian Cyst Simple

Summary: to compare the effectiveness of (norethisterone acetate) in the treatment of spontaneously occurring simple ovarian cyst detected by ultrasonography compared with expectant management.

an ovarian cyst is a sac filled with liquid or semiliquid material that arises in an ovary. the number of diagnoses of ovarian cysts has increased with the widespread implementation of regular physical examinations and ultrasonographic technology. the discovery of an ovarian cyst causes considerable anxiety in women who fears of malignancy, but the majority of ovarian cysts are benign. these cysts can develop in females at any stage of life, from the neonatal period to postmenopause. most ovarian cysts, occur during adolescence, which are hormonally active periods of development. most are functional in nature and some times resolve without treatment. however, ovarian cysts can herald an underlying malignant process or, possibly, distract the clinician from a more dangerous condition, such as ectopic pregnancy, ovarian torsion, or appendicitis. when ovarian cysts are large, persistent, painful, or have concerning radiographic or exam findings, surgery may be required, sometimes resulting in removal of the ovary. if a cyst does not resolve after several menstrual cycles, it is unlikely to be a functional cyst, and further workup is indicated. early epidemiological studies reported an inverse relationship between use of oral contraceptives (ocs) and surgically confirmed functional cysts . many previous studies have indicated that the use of oral contraceptive pills (oc) is associated with a lower risk of occurrence of functional ovarian cysts. few studies have considered the treatment effect of oc on functional ovarian cysts. in current clinical practice, gynecologists treat functional ovarian cysts with either oc or expectant management alone. several randomized controlled trials have shown no significant difference in the resolution of functional ovarian cysts treated with oc over expectant management alone functional ovarian cyst can occur due to estrogen hyperstimulaton and some theories conceoted that progesterone treatment can suppress this cyst .

Eligibility criteria:
inclusion criteria: 1. women at age 24-49 years old 2. women with simple cyst.( with none of the following: solid parts, papillary formations, peritoneal masses, intraabdominal lymph node enlargement or ascites ) .(13) 3. from 5 to10cm in diameter. 4. functioning cyst.( defined as largest dimension between 2-8 cm in diameter, unilateral, uniloculated, thin-walled, anechogenic and has distal acoustic enhancement ) exclusion criteria: 1. premenarche 2. postmenopause 3. current user of norethisterone acetate. 4. those having contraindication from norethisterone use. 5. gynecologic malignancy
acute effect of moderate-intensity aerobic exercise on colon cancer cell growth

Conditions: Colon Adenocarcinoma; Colon Cancer

Summary: this study involves drawing blood samples from men before and after they perform 30-minutes of moderate-intensity aerobic exercise. the investigators will evaluate whether adding the exercise serum to colon cancer cells in a dish can reduce the growth of the cells compared to the resting serum. note: serum is the liquid part of the blood that carries hormones and metabolites around the body.

regular exercise is associated with a reduced risk of developing colon cancer. however, the mechanisms underpinning the anti-cancer effect of exercise are not yet fully understood. a recent theory suggests that each time you exercise, the short-lasting spikes in circulating hormones can suppress the growth of cancer cells. hence, every exercise bout could have a direct anti-cancer effect. this study will recruit men with an increased of colon cancer and explore whether incubating colon cancer cells with serum collected after a bout of moderate-intensity aerobic exercise influences cell viability in vitro.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years * bmi ≥ 25 kg/m2 and/or waist circumference of ≥ 94 cm * male * participating in less than 30 min of planned, structured, moderate to vigorous-intensity physical activity on three or more d·wk-1 for the last three months exclusion criteria: * any absolute or relative contraindication to exercise testing, as determined by the american college of sports medicine * any sign/symptom of cardiovascular, metabolic or renal disease * known cardiovascular, metabolic or renal disease without written medical clearance from physician * resting hypertension (≥160 mmhg systolic and/or ≥90 mmhg diastolic) * chronic obstructive pulmonary disease and/or asthma with peak respiratory flow \< 300 l/min * previous stroke or transient ischemic attack * epilepsy or aneurysm (large vessel or cerebral) * previous or current treatment for malignancy * clotting disorder * taking beta-adrenergic blocking agents * resting heart rate ≥ 100 bpm * musculoskeletal, neurological, anthropometric, or rheumatoid conditions that makes it not possible to pedal a bicycle and/or would be worsened due to exercise * body mass \> 150 kg

Keywords: colon cancer aerobic exercise
study for determine the safety and efficacy of clostridium botulinum toxin type a in subjects with cervical dystonia

Conditions: Cervical Dystonia

Summary: the purpose of this study is to determine the optimal dose for safety and efficacy in the treatment of cervical dystonia.


Eligibility criteria:
inclusion criteria: * male or female aged 18\~75 * have no clinically significant medical condition * cervical dystonia exclusion criteria: * pregnant or lactation * subjects who have been administered the following drugs within the previous 1 month
alternating systemic and hepatic artery infusion therapy as adjuvant treatment after resection of liver metastases from colorectal cancer

Conditions: Resected Liver Metastases From Colorectal Cancer

Summary: this adaptive seamless phase ii/iii trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (sct) with or without hepatic arterial infusion (hai) after complete hepatic resection for chinese patients with metastatic colorectal cancer.


Eligibility criteria:
diagnosis criteria: all patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin. main criteria for inclusion: * aged 18-75 years * diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases * prior curative resection of primary tumours (r0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (r0 resection is met) * performance status ecog 0-1 * no serious complication occurred during or after metastases resection and affected subsequent treatment. * hematology: white blood count ≧ 4.0x10\^9/l, absolute neutrophil count ≧1.5x10\^9/l, platelet count ≧ 100 x10\^9/l, hemoglobin ≧ 100g/l * blood biochemistry: total bilirubin ≦2mg/dl , direct bilirubin equal or less than 1.5 times upper limit of normal (uln), alanine aminotransferase (alt) no greater than 2.5 times uln, aspartate aminotransferase (ast) no greater than 2.5 times uln, serum creatinine no greater than uln, or glomerular filtration rate equal or greater than 60 ml/min/1.73m\^2 * not pregnant or nursing at present * fertile patients must use effective contraception * able to withstand major operative procedure * no prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ * no prior hepatic artery infusion therapy with 5-fu or floxuridine * no prior systemic chemotherapy for metastatic disease * no other concurrent chemotherapy * able to understand and sign off informed consent form
proclaim-cx-188: a trial to find safe and active doses of an investigational drug cx-188 for patients with solid tumors

Conditions: Solid Tumor, Adult

Summary: the purpose of this first-in-human study of cx-188 is to characterize the safety, tolerability, pharmacokinetics (pk), and antitumor activity of cx-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: proclaim: probody clinical assessment in man cx-188 clinical trial 001


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy 2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. at least 18 years old exclusion criteria: 1. prior therapy with a chimeric antigen receptor (car) t-cell containing regimen. 2. history of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any probody therapeutic 3. human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids)-related illness, chronic hepatitis b or c 4. history of or current active autoimmune diseases 5. history of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications 6. history of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant 7. chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug 8. major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug
use of cidofovir for recurrent respiratory papillomatosis

Conditions: Recurrent Respiratory Papillomatosis

Summary: recurrent respiratory papillomatosis (rrp) is the most common benign neoplasm of the larynx in the pediatric population. the impact of the disease on patients and families can be tremendous due to the need for frequent treatment. it would be highly beneficial to develop effective medical therapies as adjunctive measures to surgical ablation with the goal of reducing the frequency of reoccurrence.

the focus of the present study is to evaluate the usefulness of cidofovir injection in diminishing the frequency and magnitude of papilloma recurrences in adult and pediatric rrp patients. briefly, patients will be randomized into either a treatment (cidofovir injection) or a placebo group. the following measures will be made at each of 6 data collection time points, over the course of one year: (1) tumor load, based upon a published staging system for papilloma, (2) degree of respiratory obstruction for phonation, as assessed by phonation threshold pressures, and (3) general health, on validated health inventories (sf12 and voice handicap index for adults; pedsql (trademarked) for children) and via measures of height weight and days absent from school or daycare, where applicable, for children. a repeated measures analysis will allow examination of time by treatment interactions to determine if the cidofovir injection group has fewer, or less severe, recurrences than the placebo group. specifically, we will answer the following questions in this investigation: 1. does cidofovir injection reduce the frequency of rrp recurrences? 2. does cidofovir injection reduce the magnitude of rrp, as assessed with a proposed staging system for rrp (derkay et al., 1998) and measures of phonatory threshold pressure? 3. does cidofovir injection improve general health, as assessed by height, weight and days absent from school in pediatric patients and health inventories (general health and voice-related) in children and adults?

Eligibility criteria:
inclusion criteria: * 4 surgeries for rrp in last 12 months exclusion criteria: * renal insufficiency * nephrotoxic drugs in the last 7 days * sulfa allergies * currently treated with systemic or topical hpv chemotherapeutic agents * females of childbearing potential with a positive pregnancy test * women who are breast feeding
crt renewal registry

Conditions: Heart Failure

Summary: this registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, nyha class, and quality of life.

the crt renewal registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. the registry will also assess clinical outcomes including quality of life (qol), physical activity habits, and events rates, along with device diagnostics such as activity log index and heart rate

Eligibility criteria:
inclusion criteria: * patients who meet current indications for the contak renewal® family of crt-p or crt-d devices * patients who receive either transvenous guidant manufactured ventricular leads or non-guidant epicardial leads * patients who have had an ejection fraction measured within six months of enrollment * patients who sign and date a patient informed consent form at the enrollment visit * patients who remain in the clinical care of the enrolling physician in approved centers exclusion criteria: * patients who are expected to receive a heart transplant during the duration of the registry * patients who currently have or who are likely to receive a tricuspid valve prosthesis * patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the crt renewal registry. each instance will be brought to the attention of guidant's clinical application research studies (cars) department to determine eligibility * patients who are younger than 18 years of age * patients who are mentally incompetent and cannot sign a patient informed consent form or comply with the registry * patients who are pregnant
efficacy of ab1010 in patients with systemic indolent mastocytosis

Conditions: Mastocytosis

Summary: this is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of ab1010 in patients suffering from indolent systemic mastocytosis with handicap.

efficacy will be assessed based on: pruritus score number of flush per day pollakyuria (on a daily basis) number of stools per day qlq-c30 score hamilton rating scale for depression

Eligibility criteria:
inclusion criteria: 1. patients with documented indolent systemic mastocytosis with handicap (ismwh) having at least 2 infiltrated\* organs (skin and /or bone-marrow and/or internal organ). 2. bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease. 3. the absence of an activating point mutation in the phosphotransferase domain of c-kit such as d816v c-kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue. 4. handicap defined as at least one of the following handicaps: * a number of flush per day ≥ 1 , * a pruritus score ≥ 9 , * a number of stools per day ≥ 4 , * a pollakyuria (on a per day basis) ≥ 8 , * a qlq-c30 score ≥ 83 , * a hamilton rating scale for depression ≥ 12 exclusion criteria: 1. performance status \> 2 (ecog). 2. inadequate organ function, except if the abnormalities are due to involvement by mast cells

Keywords: mastocytosis indolent handicap wild-type systemic not d816v mutated
cognitive rehabilitation and exposure-based class for compulsive hoarding

Conditions: Hoarding Disorder

Summary: the purpose of this protocol is to investigate the effectiveness of a manualized, 20-week group cognitive rehabilitation (cr) and exposure therapy (et) course for compulsive hoarding. the overarching aim is to understand whether this course will decrease the core symptoms of hoarding and associated features.


Eligibility criteria:
inclusion criteria: * include: * individuals who exhibit subclinical and clinical levels of hoarding disorder, as determined by the scid interview conducted at the screening assessment, will be eligible to participate in the study. individuals may also display clinically relevant symptoms of hoarding as indicated by scores on the hoarding rating scale interview (hrs-i) and/or on the saving inventory-revised (sir). * comorbid mood and anxiety disorders are permitted. * english-speaking * pregnant women exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * individuals who are over the age of 85 * individuals with cognitive or physical impairments that would interfere with their participation (e.g., dementia, uncorrected hearing) * participants who have current or past psychotic symptoms or current or past alcohol/substance abuse/dependence may also be excluded. * participants may also be excluded if they are currently in other forms of psychotherapy. * participants may be excluded if they have had a change in psychotropic medications within three months of the baseline assessment/first class. * participants may be excluded if hoarding is not their primary diagnosis. * prisoners

Keywords: hoarding