Kornimate/medical-research-clean huggingface dataset:
study of safety and pharmacokinetics of mk-8242 in participants with advanced solid tumors (p07650)

Conditions: Solid Tumors

Summary: this study is being done to evaluate the safety and pharmacokinetic profile of mk-8242 and its active metabolite (m16) in participants with advanced solid tumors. in part 1 of the study, the study drug dose will be escalated to determine the maximum tolerated dose (mtd). in part 2 of the study, the mtd will be confirmed and the recommended phase 2 dose (rptd) established; the effect of mk-8242 on liposarcoma and other tumor types will also be evaluated.

participants are considered to have completed the study after cycle 12. amendment 4 (14 april 2015) was done to allow participants on active treatment at the time the study was closed to enrollment to continue study treatment beyond cycle 12 if deriving clinical benefit, at the investigator's discretion.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced solid tumor for which there are no effective standard therapy options * willing to provide tumor tissue for p53 wild type gene analysis * eastern cooperative oncology group (ecog) performance status of ≤1 * adequate organ function * female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study drug * at least one measurable lesion * in part 2, participants with liposarcoma must have a confirmed well-differentiated or de-differentiated histology exclusion criteria: * known treated or untreated leptomeningeal metastases, or metastatic central nervous system disease * history of recent myocardial infarction (within the past year); or with unstable or uncontrolled angina, new york heart association (nyha) class iii or iv congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ecg) abnormality * uncontrolled active infection on optimal systemic treatment * clinically significant hepatitis or hepatitis c antibody positive, hepatitis b surface antigen positive, or human immunodeficiency virus (hiv) seropositive * persistent, unresolved common terminology criteria for adverse events (ctcae v4.0) ≥grade 2 drug-related toxicity associated with previous treatment except for alopecia * radiation therapy or other loco-regional therapy within 2 weeks prior to study * use of moderate and strong cytochrome p450 inhibitors or inducers within 1 week prior to study * chemotherapy or any investigational drug(s) within 4 weeks prior to study * known hypersensitivity to mk-8242 or its components * nursing, pregnant, or intention to become pregnant during the study * initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen within 30 days of cycle 1 day 1
clinical trial of mexiletine hydrochloride for spinal and bulbar muscular atrophy

Conditions: Spinal and Bulbar Muscular Atrophy

Summary: the purpose of this clinical trial is to evaluate the efficacy and safety of mexiletine hydrochloride in patients with spinal and bulbar muscular atrophy. the main questions it aims to answer are: does mexiletine hydrochloride improve the alsfrs-r score in spinal and bulbar muscular atrophy patients? participants will: take mexiletine hydrochloride or a placebo every day for 3 months visit the hospital once every 4 weeks for evaluations.


Eligibility criteria:
inclusion criteria: 1. male patients with a cag repeat count of 38 or more for the androgen receptor gene in genetic testing and a confirmed diagnosis of sbma 2. patients with muscle weakness (limb weakness and atrophy, or bulbar palsy) due to lower motor neuron lesion 3. patients with a total alsfrs-r score of ≥ 24 and ≤ 42 at screening 4. patients who are at least 18 years old and less than 80 years old at the time of consent 5. patients who give their voluntary written consent after having received adequate information on this study (however, if the patient is unable to sign the consent form due to the condition of the disease, a person equivalent to a regal representative must be present to provide written explanation, the prospective candidate must verbally consent to participate in the study, and a person equivalent to a regal representative must sign the consent form on behalf of the patient. the person who is to be the regal representative may sign the document on his/her behalf, noting the circumstances and his/her relationship to the subject.) exclusion criteria: 1. patients who have participated or are participating in a clinical trial within 12 weeks prior to enrollment 2. patients with a history of hypersensitivity to any component of this drug product 3. patients with a conduction disturbance (such as second- or third-degree atrioventricular block without a pacemaker, or left bundle branch block) 4. patients with brugada-type ecg 5. patients with severe heart failure or heart disease (myocardial infarction, valvular disease, cardiomyopathy, etc.) 6. patients with sinus bradycardia (\<50 beats/minute) 7. patients with systolic blood pressure of 90 mmhg or less 8. patients with serum potassium level less than 3.5 mmol/l 9. patients on antiarrhythmic drugs 10. patients on antiepileptic drugs that affect to sodium channels 11. patients on theophylline 12. patients on narcotics 13. patients who used mexiletine within 1 month prior to enrollment or used mexiletine for expectations of improvement in symptoms of sbma 14. patients with serious complications 15. patients who cannot agree to use contraception during the study period 16. other patients deemed inappropriate by the investigator or subinvestigator
silver impregnated dressings to reduce wound complications in obese patients at cesarean section

Conditions: Obesity; Complications; Caesarean Section, Wound

Summary: obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. this is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.

this study's purpose was to evaluate the effect of a fda approved silver-impregnated dressing on cesarean wound complications in obese women. it was initiated and 37 women were randomized, but because of logistical barriers, we were unable to gather outcome data either by the intended survey or by chart review. when it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. while a small number of photographs were taken as intended, they were lost due to a technological failure prior to any analysis. therefore no outcome data could be analyzed. nonetheless, as patients of the university of michigan health system, all research subjects received health care treatment appropriate to their medical condition and circumstances.

Eligibility criteria:
inclusion criteria: * undergoing cesarean section (with or without concurrent tubal ligation) * body mass index (based on most recent weight) \>=30 exclusion criteria: * known allergy to silver * less than 18 years of age * preoperative evidence of current abdominal wall infection * contraindication to closure of the skin at time of surgery * plan to perform procedures in addition to cesarean section (with or without tubal ligation) * patients with previously placed abdominal wall mesh at site of planned surgery * inability to participate in medical decision making * inability to follow up with the michigan visiting nurses or are unable to return to the university of michigan medical center for staple removal

Keywords: obesity cesarean section wound care
study of rituximab and brentuximab vedotin for relapsed classical hodgkin lymphoma

Conditions: Lymphoma

Summary: this research is being done to study a combination of brentuximab vedotin and rituximab for the treatment of relapsed hodgkin's lymphoma (hl).

this research is being done to study a combination of drugs for relapsed hodgkin's lymphoma (hl) that may be easier to tolerate than standard therapies and that does not involve an autologous blood or marrow transplant (bmt, also called a stem cell transplant).the study is for people with hl who have never received treatment for relapsed lymphoma, except for radiation therapy. usually, when hl relapses for the first time, the standard is to receive combinations of chemotherapy, including an autologous blood or marrow transplant (bmt, also called a stem cell transplant) which has about a 40% cure rate. bmt may cure the hl, but also may be associated with serious side effects and risks. this research looks at a combination of drugs for relapsed hl that may not have the side effects of standard therapies and that does not involve bmt. the goal is to treat the lymphoma effectively with drugs that we expect will have fewer side effects, while avoiding a treatment like bmt.

Eligibility criteria:
inclusion criteria: * age \> 16 years * biopsy-proven diagnosis of classical hodgkin lymphoma (regardless of hrs cell cd20 expression) per the world health organization classification criteria24; lymphocyte predominant histology is excluded * untreated relapse of classical hodgkin lymphoma (with the exception of steroids) as follows:hl that relapsed \> 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy, stage i-ii hl that relapsed \> 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy * radiographically measurable disease (\> 1 focus of lymphoma measuring \> 1.5 cm) * baseline laboratories: anc \> 1000/ul and platelets \> 75,000/ul, unless due to bone marrow involvement by lymphoma, serum creatinine \< 2.0 mg/dl, total bilirubin \< 2.0 mg/dl (excluding gilbert's syndrome), unless due to lymphoma * ecog performance status 0, 1 or 2. exclusion criteria: * active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situ. * primary induction failure, defined as failure to achieve cr with first-line chemotherapy or chemoradiation, disease progression during first-line chemotherapy or chemoradiation, or progression or biopsy-proven disease persistence within 8 weeks of first-line therapy completion * prior brentuximab vedotin or rituximab for lymphoma * grade \> 2 peripheral neuropathy * hiv infection, active hepatitis b infection, or active hepatitis c infection

Keywords: chl hodgkin lymphoma lymphoma relapsed lymphoma sgn-35 brentuximab vedotin rituxan rituximab
efficacy of steroids on functional outcomes after musculoskeletal injuries of the hand

Conditions: Hand Injuries; Finger Injuries

Summary: steroids are often prescribed for their anti-inflammatory effects in patients with musculoskeletal injuries. studies have shown that steroids may reduce pain and swelling, but their effects on range of motion and functional outcomes have not been illustrated. with this study, we aim to evaluate the effect of steroids on range of motion and functional outcomes in non-operatively managed musculoskeletal injuries of the hand.

previous studies have investigated the effect of steroids on bone healing, edema reduction and postoperative pain. however, there seems to be a lack of literature on whether the use of steroids for their anti-inflammatory effects actually lead to improved range of motion and functional capacity. if the data shows that steroids do indeed help patients achieve increased functional outcomes, they may be used with higher confidence in their beneficial contribution to patient treatment and quality of life. if, however, the data show that steroids do not confer a significant benefit, they can be disregarded as they will avoid the risks associated with steroid use. we aim to investigate if the use of methylprednisolone will result in significantly improved ranges of motion and self-reported function compared to a control group at each measurement time point.

Eligibility criteria:
inclusion criteria: * patients with soft tissue injuries and stable fractures from the metacarpophalangeal joint to the distal phalanx exclusion criteria: * patients at increased risk of serious side effects of steroid administration. * patients unable to provide consent * unable to swallow oral medications * pregnant women * ages less than 18 years old
study exploring the effect of music on pain after ventral hernia surgery

Conditions: Postoperative Pain, Acute; Ventral Hernia; Hernia Abdominal Wall; Surgery; Anxiety

Summary: the purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

after being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. on the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. pain and anxiety will then be assessed after surgery.

Eligibility criteria:
inclusion criteria: 1. adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm 2. adults having open flank hernia repair that requires a myofascial release with mesh 3. adults having parastomal hernia repair with mesh exclusion criteria: 1. primary language other than english, or lack of english language fluency 2. hearing impairment, with or without use of hearing aids 3. neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety 4. patients who will remain intubated after surgery

Keywords: music
general anesthetics in cancer resection surgery (ga-cares) trial

Conditions: Anesthesia, General; Surgical Oncology

Summary: this is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. the primary endpoint is all-cause mortality.


Eligibility criteria:
inclusion criteria: * patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures: * lobectomy or pneumonectomy * esophagectomy * radical (total) cystectomy * pancreatectomy * partial hepatectomy * hyperthermic intraperitoneal chemotherapy (hipec) * gastrectomy (subtotal or total) * cholecystectomy or bile duct resection exclusion criteria: * age less than 18 years * american society of anesthesiologist class 5 * projected life expectancy less than 30 days * known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents * known or suspected history of malignant hyperthermia
efficacy and safety study of gb-0998 for treatment of systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: this randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of gb-0998 in the treatment of the systemic sclerosis based on the changes in modified rodnan total skin thickness score (tss) as primary endopoint, and in addition, to assess the safety of gb-0998.


Eligibility criteria:
inclusion criteria: * patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma. * patients who have not less than 20 points of tss. * patients with no appropriate therapeutic treatment. exclusion criteria: * patients with severe hepatic disorder, severe renal disorder or severe heart disorder. * patients with malignant tumors. * patients who have the anamnesis of shock or hypersensitivity to this drug. * patients who have the anamnesis of cerebral infarction or symptom of these diseases. * patients who have been diagnosed as iga deficiency in their past history. * pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant. * patients who had any dose increase or new dosing of steroid within 12 weeks before consent. * patients who were administered other investigational drug within 12 weeks before consent.

Keywords: scleroderma, systemic
efficacy of a supervised physical therapy rehabilitation program vs nonsupervised in non-specific low back pain

Conditions: Low Back Pain; Physical Activity

Summary: this study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.

low back pain is one of the most common problems of population, being a priority for health systems. it has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. a randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program. objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain. methods: sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, mcquade test, and lumbar mobility flexion.

Eligibility criteria:
inclusion criteria: * chronic non-specific low back pain persisting ≥ 3 months. * age between 18 and 65 years. * a score ≥ 4 in roland morris disability questionnaire. * not currently receiving physical therapy. exclusion criteria: * presence of lumbar stenosis. * presence of clinical signs of radiculopathy. * diagnosis of spondylolisthesis. * diagnosis of fibromyalgia. * treatment with corticosteroid or pharmachological medication within the paset 2 weeks. * a history of spinal surgery. * central or peripheral nervous system disease.

Keywords: low back pain physical therapy randomized clinical trial exercise program
effects of extensive abdominal lavage on postoperative inflammation following full thickness excision of deep endometriosis

Conditions: Endometriosis

Summary: surgical treatment of deep endometriosis with bowel involvement is widely accepted to require complete excision of all endometriosis also when invading the bowel. in case of opening of the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the increase in blood levels of c-reactive protein during the first post-operative week. furthermore it increases the risk of post-operative bowel complications. in case of peritonitis the general surgeons use extensive lavage in order to decreases mortality, morbidity and post-operative adhesions formation, as demonstrated in animal models and clinically in patients with peritonitis. considering the efficacy of extensive lavage for peritonitis and the inflammatory reaction as judged by the increased c-reactive protein (crp) following full thickness deep endometriosis resection from the bowel, the study aims to evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on abdominal inflammation and post-operative bowel complications.

in a consecutive series 20 women with full thickness resection for deep endometriosis received randomly, at the end of the procedure, a standard abdominal rinsing (n=10) or extensive abdominal lavage with 8 liters of saline (n=10). c-reactive protein and white blood cell count values were collected daily for 7 days. women were observed for complications during the first post-operative week and during the follow up at 1 and 6 months. the primary end point was to evaluate the effects of extensive abdominal lavage on post-operative inflammation. secondary end-point was to explore the potential protective rule against post-operative bowel complications.

Eligibility criteria:
inclusion criteria: * the patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at leuven university, belgium, specializing in the surgical treatment of severe endometriosis. * all the women were scheduled for a surgical excision of a rectovaginal nodule. * women with a full thickness involvement of the bowel requiring discoid resection were included. exclusion criteria: * evidence on chest x-ray in the previous 3 months of old or currently active tb, even if adequately treated; * evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months * evidence of a documented hiv infection, active hepatitis-b or c, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tb) in the previous 6 months * previous transplant surgery, a lymphoproliferative disorder or other malignancy * positive cervical cytology in the previous 6 months * any haematological or biochemical abnormalities on routine screening.

Keywords: endometriosis abdominal lavage bowel perforation discoid resection laparoscopy
right ventricular (rv) pacing in early post-operative continuous flow left ventricular assist device (lvad)

Conditions: Heart Failure

Summary: continuous right ventricular (rv) pacing demonstrates harm in patients with normal left ventricular (lv) function as well as in patients with cardiomyopathy and clinical heart failure. however, little is known about rv pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (lvad). the univentricular support provided by contemporary continuous flow lvad's has improved outcomes for many advanced heart failure patients, yet the incidence of rv failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. acute lvad unloading of the left ventricle has adverse effects on rv shape and size that contribute to post-operative rv failure. by promoting rv synchrony, rv overdrive pacing may counteract these adverse mechanical alterations, improving rv systolic function and ultimately lvad function. the investigators will recruit all patients referred for an implantable, continuous flow lvad at duke university medical center who have an existing implantable dual-chamber cardioverter-defibrillator. patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, rv function by echocardiography as well as patient symptoms and functional status.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, both men and women * existing implantable cardioverter-defibrillator (icd) * referred for implantation of a continuous flow lvad exclusion criteria: * permanent left ventricular epicardial defibrillator in place * congenital heart disease with single ventricle physiology * right ventricular assist device (rvad) in place * existing pacing indication

Keywords: ventricular assist device