Kornimate/medical-research-clean huggingface dataset:
a study of pro95780 in patients with advanced chondrosarcoma (apm4171g)

Conditions: Chondrosarcoma

Summary: this is a multicenter, open-label, phase ii trial designed to evaluate the efficacy and safety of pro95780 when given as a single agent in patients with advanced chondrosarcoma. up to 90 patients with confirmed chondrosarcoma will be enrolled.


Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign a written informed consent document * age ≥ 18 years * histologic diagnosis of chondrosarcoma, verifiable after enrollment * measurable disease * previously treated or incurable disease without options for standard of care therapy * ecog performance status of 0-2 * life expectancy of \> 3 months * for patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device \[iud\], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment exclusion criteria: * systemic therapy or radiotherapy within 4 weeks prior to day 1 * prior therapy with agents targeting the dr5 apoptosis pathway * major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to day 1, or anticipation of need for major surgical procedure during the course of the study * other invasive malignancies within 5 years prior to day 1 * known active brain metastases * uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment * clinically significant, symptomatic cardiovascular disease, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia, grade ii or greater peripheral vascular disease, or history of major heart surgery within 6 months of day 1, or any situation that would likely limit compliance with study requirements * known to be positive for hepatitis c or hepatitis b surface antigen * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications * use of anticoagulation therapy * participation in clinical trials or undergoing other investigational procedures within 30 days prior to day 1 * pregnancy or breast feeding * known sensitivity to any of the products administered during the study * any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures

Keywords: sarcoma synovial sarcoma apm4171g
iv cocaine abuse: a laboratory model - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the effects of desipramine dmi maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.


Eligibility criteria:
please contact site for information.

Keywords: crack cocaine
study of pegilodecakin (ly3500518) with nivolumab compared to nivolumab alone second-line tx in participants with metastatic non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: to compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

this is an open-label, multi-center, randomized, phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with stage iv / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of pd-l1 (0-49%).

Eligibility criteria:
inclusion criteria: 1. participants must have histologically or cytologically confirmed wild type nsclc that is stage iv / metastatic or recurrent 2. participants must have received at least one prior systemic therapy that was not an anti-pd-1, anti-pd-l1 and/or anti-ctla-4 treatment for the advanced stage of the disease 3. participants with tumor tissue low expression of pd-l1 as defined by tumor proportion score (tps) 0% - 49% 4. eastern cooperative oncology group (ecog) performance status of 0 or 1 5. participants with measurable disease by spiral computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumor (recist) v.1.1 criteria 6. participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization exclusion criteria: 1. participants with active central nervous system (cns) metastases or carcinomatous meningitis 2. participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (hiv) 3. participants with grade 1 (nci-ctcae v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization 4. participants that have received nivolumab 5. participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents 6. participants with a history of severe hypersensitivity reactions to monoclonal antibodies 7. participants that have received therapy with anti-pd-1, anti-pd-l1, anti-pd-l-2, anti-cd-137, and/or anti ctla-4 antibodies 8. participants receiving any investigational agent within 28 days of first administration of trial treatment 9. pregnant or lactating women
effects of therapeutic touch on osteoarthritis of the knee

Conditions: Osteoarthritis in the Knee

Summary: this study is to evaluate the efficacy of the kreiger/kunz method of therapeutic touch on function, pain perception and quality of life in persons with osteoarthritis in the knee.


Eligibility criteria:
inclusion criteria: * persons diagnosed with or exhibiting signs of osteoarthritis of at least one knee. exclusion criteria: * persons with connective tissue disorder * persons with bilateral total joint replacement of the knee * persons with dementia * persons with a systemic illness producing joint symptoms
study of denufosol tetrasodium inhalation solution in patients with cystic fibrosis (cf) lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this trial is to evaluate the safety and effectiveness of one dose strength of denufosol compared to placebo in patients with cf and a predicted fev1 of greater than or equal to 75% but less than or equal to 110% predicted.


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of cystic fibrosis * have fev1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height * be able to reproducibly perform spirometry * be clinically stable for at least 4 weeks before screening exclusion criteria: * have abnormal renal or liver function * have lung transplant * unable to discontinue use of hypertonic saline * participated in inspire trial 08-108
study of t900607-sodium in previously treated patients with ovarian cancer.

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to determine whether t900607-sodium is effective and safe in treating ovarian cancer.


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed diagnosis of ovarian cancer * subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel) * at least 18 years of age * bidimensionally measurable disease amenable to ct scanning. at least one lesion must be least 1 x 1 cm in size. * karnofsky performance status of at least 70% * estimated life expectancy of at least 12 weeks * females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive * subject must be able to comply with study procedures and follow-up examinations. * signed written informed consent * lab values (obtained ≤ 7 days prior to study enrollment): * anc at least 1.5x10e9/l, * platelet count at least 100x10e9/l, * hemoglobin at least 8.5 g/dl, * creatinine within 2 times upper limit of normal * ast and alt within 3 times upper limit of normal * bilirubin within 1.5 times upper limit of normal * albumin great than 2.5 g/dl * inr \< 1.5 for subjects without anticoagulants exclusion criteria * severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment * nyha class iii/iv cardiac disease, left ventricular ejection fraction (lvef) of \<50%, or acute anginal symptoms * patients who have received any investigational agent within 4 weeks of enrollment * patients who are pregnant or breast-feeding * history of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * history of central nervous system metastases or carcinomatous meningitis * major surgery within 4 weeks of enrollment
metformin as an adjunctive therapy to catheter ablation in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (af). atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes. it is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation. eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation * all subjects must be able to understand and willing to sign a written informed consent document. exclusion criteria: * individuals who are already taking metformin or other antidiabetic medications, including insulin * known diabetes * known allergy or food and drug administration (fda)-labeled contraindication to taking metformin (estimated glomerular filtration rate (egfr)\<30 millilitres per minute (ml/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis) * patients taking carbonic anhydrase inhibitors * egfr below 30 ml/min per 1.73 m2 or other clinical diagnosis of advanced renal disease * acute or chronic metabolic acidosis (serum bicarbonate \<22 milliequivalents per liter (meq/l)) * history of significant alcohol use (\>2 drinks/day on average) * history of hepatic dysfunction (serum bilirubin 1.5 times greater than uln) * history of new york heart association (nyha) class iii or iv heart failure * pregnancy or nursing

Keywords: ablation
a trial on conservative treatment for infants' hirschsprung disease

Conditions: Hirschsprung Disease

Summary: the present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment hirschsprung disease.


Eligibility criteria:
inclusion criteria: * hard or firm stools for twice or less per week * age were from newborn to 3 months * histochemical acetylcholinesterase reaction (ache) in rectal mucosa was positive * the narrowed distal bowel on barium enema was characterized as normal or short-segment hirschsprung disease with a 24h barium retention exclusion criteria: * children \>3months of age * patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus * barium enema showed long-segment or total colonic aganglionic bowel

Keywords: hirschsprung disease conservative treatment surgery treatment infants
antiarrhythmic drugs assessment in preventing atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the current evidences indicate that \~30% patients with sick sinus syndrome(sss) would develop persistent atrial fibrillation (af) after a long term pacing therapy. however, the accurate influence of antiarrhythmic drugs on the af is still not well defined. the purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (amiodarone, sotalol and propafenone) on the long term management of af in sss patients with af, including the reduced af burden (duration and episodes) and persistent af free survival rate. all patients will be followed up for 12 months.


Eligibility criteria:
inclusion criteria: * at least 18 years old * sick sinus syndrome with pacemaker class i or class iia indication * has a pacemaker which can provide the daily af burden monitor record for at least 28 days * has at af record in the past 6 months, the valid af record includes any of 1. at least one 30 seconds af holter record 2. at least one 15 seconds 12-ecg record 3. at least 5 minutes long af episodes record from pacemakers * able and willing to give informed consent exclusion criteria: * will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation * nyha class iii or iv * lvef \<50% * reversible af, such as af caused by hyperthyroidism or severe postoperative atrial fibrillation * persistence af * expected life expectancy less than 1 year * planned to be pregnant or be in the feeding period in the next year * non-stable, decompensated heart failure * allergy to amiodarone, propafenone or sotalol * cancer * clear liver damage ( alt and/or ast \> 2\*normal limit) * patients with cardiogenic shock history * be in the treatment of amiodarone for more than 3 months or less than 3 months with amiodarone wash out period less than 30 days * coronary artery disease (chd), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (copd), long qt syndrome

Keywords: pacing dependent atrial fibrillation amiodarone propafenone sotalol af burden
a phase iii study to evaluate the efficacy and safety of hsk39297 in patients with paroxysmal nocturnal hemoglobinuria who are naive to complement inhibitor therapy

Conditions: PNH

Summary: the purpose of this study is to evaluate the efficacy and safety of hsk39297 tablets compared to eculizumab in patients with pnh who are naive to complement inhibitor therapy.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years, male and female patients; 2. diagnosis of pnh based on flow cytometry with clone size \> 10% by granulocytes; 3. have not received complement inhibitor treatment; 4. blood ldh values \> 1.5 ×upper limit of the normal range (uln) ; 5. hemoglobin level \< 10 g/dl at screening. exclusion criteria: 1. hereditary or acquired complement deficiency; 2. active primary or secondary immunodeficiency; 3. history of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants; 4. history of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or mycobacterium tuberculosis; 5. patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x10\^9/l, or platelets \< 30x10\^9/l or neutrophils \< 0.5x10\^9/l) ; 6. active systemic infection within 2 weeks prior to study drug administration; 7. history of serious comorbidities that have been determined to be unsuitable for participation in the study. 8. pregnant or lactating women.
comparing intrathecal morphine and intraoperative lidocaine infusion to epidural anesthesia with postoperative pca for patients undergoing exploratory laparotomy

Conditions: Cancer Debulking; Enlarged Uterus; Fibroid Uterus; Adnexal Mass

Summary: to determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (iml) infusion are lower than patients who have epidural anesthesia with pca (epca).


Eligibility criteria:
inclusion criteria: * female patients ≥18 years old * undergoing non-emergent exploratory laparotomy with the gynecologic oncology service * no clinical or laboratory evidence of end organ failure: if available: * platelets \> 100 k/cumm * hemoglobin \> 8.0 g/dl * serum creatinine \<1.5 mg/dl * creatine clearance (crcl) ≥30 based on the original cockcroft-gault formula adjusted for weight. * inr \<1.3 reference range * all other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value. exclusion criteria: * patients not giving consent to participate in the study * unable to complete self-report pain questionnaire * moderate to severe kidney or liver failure per lab criteria as outlined * inability to hold anticoagulant medications for a safe amount of time per current asra guidelines * contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection * complete bowel obstruction * contraindication to intravenous lidocaine * no known pregnancy and not lactating. * currently septic * patient currently taking more than 30 mme a day preoperatively (for \>30 days) * bmi \>50kg/m2 * intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set

Keywords: eras multi-modal anesthesia opioid consumption intrathecal epidural ileus
2% lidocaine plus 0.5% bupivacaine versus 0.5% bupivacaine in brachial block for creation of arteriovenous (av) fistula

Conditions: Infraclavicular Brachial Plexus Block

Summary: will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone for infraclavicular brachial plexus block in end-stage renal disease (esrd) patient?


Eligibility criteria:
inclusion criteria: * esrd patient for avf procedure * age \>17 year * bmi 20-35 kg/m2 * communicable exclusion criteria: * bmi \> 35 kg/m2 bmi \< 20 kg/m2 หรือ bw \< 35 kg * history of allergy to local anesthetic drugs * pre-operative neurological deficit, neuromuscular disorder หรือ old cva * psychiatric disorder * coagulation disorder * uncontrolled seizure * pregnant and lactating women

Keywords: ultrasound guided infraclavicular brachial plexus block bupivacaine bupivacaine plus lidocaine end stage renal disease arteriovenous fistula
assisting hiv-infected mothers in disclosing their serostatus to their children

Conditions: HIV

Summary: this study will develop and evaluate the effectiveness of an intervention designed to assist hiv-infected mothers of young children in determining whether and how to appropriately disclose their hiv serostatus to their children.

hiv is a serious, life threatening illness that requires a lifetime of treatment and disease management. studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their hiv serostatus to their uninfected children. hiv-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have hiv. family-based intervention programs have been successful in helping facilitate the disclosure process. this study will develop and evaluate the effectiveness of an intervention designed to assist hiv-infected mothers of young children in determining whether and how to appropriately disclose their hiv serostatus to their children. participants in this study will be randomly assigned to either the intervention or a standard of care condition. the intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. sessions will be scheduled at times that are convenient for the participants and therapists. follow-up visits will include both mothers and their children, and will be held at months 3, 6, and 9 following the end of the intervention. assessments will include readiness to disclose hiv serostatus, mental health indicators, and family functioning.

Eligibility criteria:
inclusion criteria: * confirmation of mother's hiv/aids status * healthy child (i.e., hiv uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus * mother is primary caregiver and child resides with her * english- or spanish-speaking exclusion criteria: * child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, iq score less than 75) * psychosis of parent or child (as advised by recruitment site clinicians) * child refuses to give assent

Keywords: disclosure serostatus
bupropion for smoking cessation during pregnancy

Conditions: Pregnancy Related; Tobacco Use Disorder

Summary: this is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion sr in combination with behavioral counseling for smoking cessation during pregnancy.

this is a prospective, double-blind placebo-controlled randomized pilot trial of the preliminary safety and efficacy of bupropion sr in combination with behavioral counseling for smoking cessation during pregnancy. a total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. compassionate care/continuance of therapy will be available to pregnant subjects. women who relapse to smoking postpartum will be offered an additional course of medication treatment. all subjects regardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month postpartum period. subject participation will begin between 13-30 wks of gestation and end 6 months postpartum. participation will be ten (10) to thirteen(13) months in length.

Eligibility criteria:
inclusion criteria: * smoking at least 10 cpd prior to pregnancy and 5 cpd for the preceding 7 days * 13-30 weeks gestation * ≥18 years of age * able to speak english or spanish * intent to carry pregnancy to term * stable residence exclusion criteria: * current illicit drug or alcohol abuse or dependence * twins or other multiple gestation * treatment for psychiatric disorder within the last 6 months * unstable medical problems (eg, hypertension (bp\>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum) * known congenital abnormality * seizure disorder * use of psychotropic medication * use of medication known to lower the seizure threshold * anorexia/bulimia * a personal history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion * use of any other smoking cessation treatment in the past 30 days * current enrollment in methadone treatment program * prior pregnancy with preeclampsia diagnosis * chronic hypertension (past history or current diagnosis)

Keywords: pregnancy tobacco use disorder smoking cessation bupropion sr zyban