Kornimate/medical-research-clean huggingface dataset:
lenalidomide-adriamycin-dexamethasone (rad) induction followed by stem cell transplant in newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. after enrollment, patients are to receive four cycles of rad induction treatment: a combination of lenalidomide (revlimid), adriamycin, and dexamethasone. if at least a minimal response is achieved to rad, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. if any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated ldh, ig a isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. if no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. all patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.


Eligibility criteria:
inclusion criteria: * written informed consent * newly diagnosed multiple myeloma * maximum of one prior systemic therapy (2 cycles) * presence of crab criteria * measurable disease parameters * left ventricular ejection fraction at least 55% * dlco of at least 60% * adequate bone marrow function * use of adequate contraception for female subjects with childbearing potential and all male subjects * eligible for autologous and allogeneic stem cell transplantation * bone marrow baseline sample evaluable for interphase cytogenetics exclusion criteria: * any serious medical conditions preventing the subject from written informed consent * progressive disease (pd) to any initial treatment * pregnant or lactating females * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data * use of any other experimental drug or therapy within 28 days of baseline * preexisting neuropathy of ≥ grade 2 severity * known hypersensitivity to thalidomide * any prior use of lenalidomide * positive for hiv or infectious hepatitis, type a, b or c after serologic testing * serum creatinine despite induction therapy ≥ 2.0 mg/dl

Keywords: allogeneic stem cell transplantation lenalidomide imid
cell-free tumor dna as minimal residual disease in hodgkin lymphoma patients

Conditions: Hodgkin Lymphoma

Summary: molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by fdg-pet alone. it is a well known fact that tumor dna circulating in plasma (ctdna) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of hodgkin's lymphoma without the need for microdissecting the histological sample.

a clinical need, not yet met for the hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by fdg-pet alone. ctdna modification from the basal time point to the interim can be used as a predictor of response to the abvd scheme and as a complement to the interim-pet in the possible variation of the therapeutic schedule. clinical data and peripheral blood samples (20 ml in edta tubes and 20 ml in cell-free dna bct tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim pet/ct, at the time of end of treatment pet/ct and during follow up.

Eligibility criteria:
inclusion criteria: * male or female adults 18 years or older * documented diagnosis of hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 who classification * willing and able to comply with scheduled study procedures * evidence of a signed informed consent * ecog performance status 0-2 (or 3, if disease related)

Keywords: ctdna next generation sequencing hodgkin lymphoma
a study with pentasa in patients with active crohn's disease

Conditions: Crohn´s Disease

Summary: the purpose of this trial is to demonstrate that pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate cd.


Eligibility criteria:
inclusion criteria (main): * age: at least 18 years * cd symptoms/onset of disease: ≥ 3 months prior to visit 1 * ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease * a confirmed location of cd (by mri, x-ray (small bowel and/or colon), and/or endoscopy) * a harvey-bradshaw score between 5 and 12 * males and non-pregnant, non-nursing women * mild to moderate active cd, defined by a cdai score between 180 and 350 * active inflammatory disease (c-reactive protein (crp) level above or equal to 5 mg/l), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g) * estimated creatinine clearance should be above 75 ml/min exclusion criteria (main): * any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial * cd located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease * prior treatment resistance to pentasa (mesalazine) * chronic, dominant arthralgia or rheumatoid arthritis * palpable abdominal mass * biologics (eg anti-tnf-α) must not be used during the trial or 6 months before visit 1 * continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year * positive pregnancy test
impact of lung flute therapy on asthma

Conditions: Persistent Asthma

Summary: we hypothesized that the ability of the lung flute to enhance mucus clearance from the lower airways could be used to improve asthma control, if the device is used on a chronic basis. the primary end point of the study is the comparison of asthma control test (act) - a validated questionnaire for asthma control and exhaled no before, during and after using the lung flute. several secondary end points were assessed for efficacy and safety, including health status, spirometric lung function, "stepping down" controller therapy and daily albuterol use.

this is a 3 month open label study. we plan to enroll 48 subjects with asthma at the buffalo general medical center allergy clinic or the office of dr. james cumella. inclusion criteria includes: at least 12 years of age, diagnosis of asthma and no current or previous history of smoking. exclusion criteria includes: exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment, predominant chronic obstructive pulmonary disease (copd) and bronchiectasis by clinical and/or radiological assessment, history of cough syncope, pregnant or nursing women, and inability to comply with study procedures.

Eligibility criteria:
inclusion criteria: * at least 12 years of age * diagnosis of asthma and no current or previous history of smoking. exclusion criteria: * exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment * predominant copd and bronchiectasis by clinical and/or radiological assessment * history of cough syncope * pregnant or nursing women * not fluent in english * inability to comply with study procedures.

Keywords: lung flute
comprehensive genomic profiling of colorectal cancer patients with isolated liver metastases to understand response & resistance to cancer therapy

Conditions: Colorectal Cancer; Colorectal Cancer Metastatic; Hepatic Metastases

Summary: this is a prospective study investigating the disease course of patients with colorectal cancer that have had their cancer spread to their liver. the aim of this study is find potential biomarkers for disease recurrence and therapeutic targets for prognostic information.

colorectal cancer (crc), the 2nd leading cause of cancer mortality, often has a pattern of targeting the liver during initial metastases. the comprehensive genomic profiling of colorectal cancer patients with isolated liver metastases to understand response and resistance to cancer therapy (comparison) study aims to assess the disease course of crc by collecting primary tumor and metastatic liver specimens following pre-operative chemotherapy. if relapse occurs following surgical resection of the liver, biopsies will also be done for molecular analysis. as a result, these samples can be analyzed for chemotherapy resistance mechanisms and therapeutic targets to determine potential clinical outcomes for this particular subset of crc patients.

Eligibility criteria:
eligibility criteria: 1. patients must have histologically confirmed crc with isolated liver metastasis 2. patients must be planned for a hepatic metastasectomy 3. patients must have received at least 3 cycles of chemotherapy (folfox or folfiri with or without bevacizumab) prior to the planned hepatic metastasectomy 4. primary tumor must be considered resectable with a plan for this to either occur concurrently with the liver resection or subsequent to this. 5. if primary has already been resected before liver resection, archival tissue must be available for genomic analysis 6. patients must be 18yrs of age or older 7. ability to understand and willing to sign a written informed consent document exclusion criteria: 1. patients with un-resectable or borderline resectable isolated liver metastases as judged by the multidisciplinary hepatobiliary tumor board at pm or bcca after a course of pre-operative chemotherapy will be excluded 2. patients with evidence of possible metastatic disease at any sites outside the liver are not eligible 3. patients with any major co-morbidity or co-morbidities that will render liver resection very high risk in investigator's opinion 4. any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. 5. patients with a previous history of another primary cancer treated within 5 years of study entry are not eligible except those with basal cell or squamous cell carcinoma of the skin and intraepithelial neoplasia.

Keywords: liver resection metastasis molecular profiling epigenetic analysis genomic analysis sequencing
does ascorbic acid reduce sympathoexcitation in chf?

Conditions: Heart Failure

Summary: in chf central sympathetic activity is increased. ros formation seems to play a role in this process. this study analyzes the effect of vitamin c as an antioxidant on central sympathetic activity in chf


Eligibility criteria:
inclusion criteria: * heart failure of at least new york heart association (nyha) class ii * left ventricular ejection fraction (lvef) \<= 40% * age 20-80 years exclusion criteria: * necessity of short-term pci, cabg or heart transplantation, * chronic disease of the autonomic nervous system, * diabetes mellitus, * use of tricyclic antidepressant drugs and/or a-adrenergic receptor antagonists.
fraxel laser for alopecia

Conditions: Alopecia

Summary: this is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. participants currently living in the chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. follow-up is at 150 days. this study was a pilot study designed to determine feasibility of this procedure.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years old 2. subjects are in good health as judged by the investigator. 3. diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata. 4. subject is seeking treatment for alopecia. 5. subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year. 6. subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. exclusion criteria: 1. evidence of another skin condition affecting the treatment area that would interfere with clinical assessments. 2. subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study. 3. willing to refrain from washing hair or using hair product 24 hours before and after treatment visits 4. history of recurrent facial or labial herpes simplex infection 5. history of hypertrophic scars or keloids 6. subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent 7. pregnant or breast feeding 8. uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. 9. subjects who are unable to understand the protocol or give informed consent.
a pilot study of sd-809 (deutetrabenazine) in moderate to severe tourette syndrome (ts)

Conditions: TOURETTE SYNDROME

Summary: the purpose of this study is to evaluate safety, tolerability and preliminary efficacy of sd-809 in the treatment of motor and phonic tics of tourette syndrome and to evaluate the pharmacokinetic of sd-809 and its metabolites.


Eligibility criteria:
inclusion criteria: * 12 to 18 years of age, inclusive, at screening. * patient has a diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) diagnosis of tourette syndrome and has manifested motor and phonic tics within 3 months before the screening visit * patient has total tic score of ≥19 on the ygtss * tic severity and frequency has been stable for at least 2 weeks before the screening visit * willing to adhere to medication regimen and to comply with all procedures * patient is in good general health, as indicated by medical and psychiatric history and physical examination * patient and parent/guardian have provided written, informed consent (and written assent, as appropriate) * female patients of childbearing potential agree to use an acceptable method of contraception * additional criteria apply, please contact the investigator for more information exclusion criteria: * patient has a serious untreated or undertreated psychiatric illness * patient has a history of suicidal ideation or behavior * patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate, dopamine receptor antagonists within 14 days of screening or baseline; or botulinum toxin within 3 months of screening or baseline * patient is being treated with deep brain stimulation for control of tics * patient has a progressive or degenerative neurological disorder or a structural disorder of the brain * patient has participated in an investigational drug or device trial within 30 days of screening * patient is pregnant or breastfeeding at screening or baseline * patient has a history of alcohol or substance abuse in the previous 12 months, as defined in the dsm-v * additional criteria apply, please contact the investigator for more information

Keywords: tourette syndrome adolescents
safety and efficacy of buprenorphine transdermal system (btds) in subjects with moderate to severe osteoarthritis pain

Conditions: Osteoarthritis

Summary: the objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. the double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years. * good pain control while on a stable dose of an opioid analgesic for osteoarthritis. exclusion criteria: * not currently taking and tolerating opioids. * taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. * requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: osteoarthritis, opioid, transdermal
additional long-term follow-up for subjects implanted with a cypass® micro-stent

Conditions: Primary Open Angle Glaucoma; Cataract

Summary: the purpose of this study is to assess long-term (10 years post-cypass implantation) status of the corneal endothelium in subjects who were implanted with the cypass micro-stent in the compass trial.

the compass trial (tmi-09-01/nct01085357) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the cypass micro-stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. in the compass trial, 374 subjects undergoing cataract surgery were randomized to the cypass group and received the cypass micro-stent, whereas 131 subjects underwent cataract surgery alone. all subjects were to be followed for 2 years postoperatively. four hundred eighty (480) subjects completed this study. the compass xt trial (tmi-09-01e/gld122b-c001/nct02700984) was designed to collect safety data beyond 24 months postoperatively for subjects who completed the compass trial. in compass-xt, clinical data was collected at 36 months, 48 months, and 60 months postoperatively for a total of 5-year follow-up across the 2 studies. in this trial, compass xxt, clinical data will be collected annually for the subjects who were implanted with the cypass micro-stent in the compass trial until the subject reaches 10 years post-cypass implantation. for some subjects, the first visit will be at or after 10 years post-cypass implantation, and therefore the first visit may coincide with the exit visit.

Eligibility criteria:
key inclusion criteria: * implantation with a cypass micro-stent as a participant in the compass trial (nct01085357) (transcend medical, incorporated, study number tmi-09-01). * able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * inability to comply with the protocol or required follow-up visit/procedures. * other protocol-defined exclusion criteria may apply.
a single-arm trial of prophylactic tocilizumab for acute gvhd prevention after haploidentical hsct.

Conditions: Leukemia; Graft-versus-host-disease

Summary: a single-arm trial using tocilizumab for acute gvhd prophylaxis after haploidentical hsct.

this study will enroll haploidentical hsct patients with high risk for acute gvhd. tocilizumab (8mg/kg) will be added to the conventional acute gvhd prophylaxis regime (csa+methotrexate(mtx)+low dose mycophenolate mofetil(mmf)+atg) on day -1 of transplant. the previous patients will be used as control.

Eligibility criteria:
inclusion criteria: * patients with hematological malignancies in complete remission (cr) who are eligible and planned for haploidentical hsct. the donor specific antibody is negative * patient age 16-60 years * mother donor, or female donor (age \>50) for female-male transplant * eastern cooperative oncology group (ecog) performance status \< 2 * creatinine clearance rate \> 60 ml/min (estimate by cockcroft-gault equation) * alanine transaminase (alt) and aspartate aminotransferase (ast)≤ 2.5×upper limit of normal (uln), and total bilirubin ≤ 1.5×uln （upper limit of normal, uln） * left ventricular ejection fraction (lvef) ≥50% as measured by echocardiography * acceptation to sign the informed consent exclusion criteria: * history of previous hsct * present active infection (including bacterial, virus or fungal) * history of tocilizumab infection * history of inflammatory bowel disease * history of demyelinating disease * patients who are hiv-positive, or with uncontrolled chronic hepatitis b virus (hbsag positive) or hepatitis c virus (anti-hcv) infections * women who are pregnant (β-chorionic gonadotropin+) or breast feeding * refusal to sign the informed consent

Keywords: hematopoietic stem cell transplantation graft-versus-host disease
self-correction evaluation in scoliosis patients

Conditions: Scoliosis; Juvenile; Scoliosis; Adolescence

Summary: to date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis. the study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction. part 1: retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. both measurements were performed in a single session. part 2: retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3d ultrasound instrumentation (scolioscan, telefeld, hong kong).


Eligibility criteria:
inclusion criteria for both parts: * diagnosis of juvenile or adolescent idiopathic scoliosis; * age \>= 10 years; * single and double curves with amplitude \>= 15 ° cobb; * performing exercises according to seas for at least 6 months only for part 1 (radiographic) * availability of radiographic investigation in upright position and in self-correction only for part 2 (ultrasound) * availability of ultrasound assessment in upright position and in self-correction * complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination. * risser between 0 and 2. exclusion criteria: for both parts: * patients with more than 2 scoliotic curves * patients with secondary scoliosis * patients suffering from learning disabilities or clinical conditions impairing neuromotor control * patients lacking the necessary measures to evaluate the outcome. part 2 only (ultrasound) ● patients undergoing brace treatment