Kornimate/medical-research-clean huggingface dataset:
narrative or fact-based videos in increasing colorectal cancer screenings in african american communities

Conditions: Colorectal Cancer; Healthy, no Evidence of Disease

Summary: this randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in african american communities. informational videotapes may help increase the number of participants who engage in colonoscopy screenings. it is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.

primary objectives: i. assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for african americans in the two communities. ii. using a community-based participatory research (cbpr) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in african americans. iii. examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence african americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking. iv. examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (crc) screening and health care seeking behaviors. outline: program locations are randomized to 1 of 2 arms. arm i: participants view videos with information about crc and screening delivered by personal narrative. arm ii: participants view videos with information about crc and screening delivered by informative fact-based message. after completion of study, patients are followed up at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program * educational intervention: * currently non-adherent to colorectal cancer screening * self-identify as african american * are 50 years of age or older * have the ability to provide informed consent in english * follow-up assessments: * must be non-adherent for crc screening at the time of the educational program * have telephone service (mobile or landline), to participate in the follow up interviews * agree to providing consent for release/review of their medical record exclusion criteria: * non-english speaking
predictors of physical activity maintenance in colorectal cancer survivors

Conditions: Colorectal Cancer

Summary: this study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.

participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. the control group will be provided with an informational handout from the american cancer society describing exercise recommendations and guidelines for cancer survivors. at the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., bfitbwell, fit cancer, livestrong at the ymca). supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. sessions will be delivered synchronously (i.e., in real-time/live) via zoom. exercise will be individualized based on the results of baseline fitness assessments and medical history. the intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. discussion sessions will take place in the same groups, synchronously, via zoom.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form 2. fluent in english 3. have access to a computer or phone with internet and a camera 4. stated willingness to comply with all study procedures and be available for the duration of the study 5. be a male or female aged 40 years or older at time of diagnosis 6. histologically confirmed cancer of the colon or rectum (stages ii-iv) if treated with curative intent, and no current evidence of metastatic disease 7. completed resection or other surgery 3-24 months prior to enrollment 8. received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). no plans for additional chemotherapy or radiation therapy. exclusion criteria: 1. current evidence of metastatic disease 2. existing participation in ≥150 minutes per week of at least moderate intensity pa 3. known contraindications for exercise or not able to safely participate in exercise 4. pregnant women (no testing required)

Keywords: physical activity survivors maintenance personal training group mediated cognitive behavior
a multi-center randomized control cross-over study to evaluate the safety and effectiveness of the dayspring active wearable compression device vs. an advanced pneumatic compression device for treating breast cancer related lymphedema

Conditions: Lymphedema; Lymphedema of Upper Arm; Lymphedema, Breast Cancer

Summary: to evaluate the dayspring active wearable compression device in contrast to an advanced pneumatic compression device (apcd)

a multi-center randomized control single cross-over study to evaluate the safety and effectiveness of dayspring active wearable compression device vs. an advanced pneumatic compression device for treating breast cancer related lymphedema. to evaluate the dayspring active wearable compression device in contrast to an advanced pneumatic compression device (apcd) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must have a diagnosis of primary or secondary unilateral upper extremity edema exclusion criteria: * individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy * inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * diagnosis of lipedema * diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer) * diagnosis of acute infection (in the last four weeks) * diagnosis of acute thrombophlebitis (in last 6 months) * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * diagnosis of pulmonary edema * diagnosis of congestive heart failure (uncontrolled) * diagnosis of chronic kidney disease with renal failure * diagnosis of epilepsy * subjects with poorly controlled asthma * any condition where increased venous and lymphatic return is undesirable * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days
which is better between single chest tube and multiple tubes drainage in primary spontaneous pneumothorax

Conditions: Primary Spontaneous Pneumothorax

Summary: there was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.this study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after vats bullectomy and pleurodesis. after routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes

primary spontaneous pneumothorax (psp) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. the indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent psp, and contralateral psp. the video-assisted thoracoscopic surgery (vats) approach probably represents the treatment of choice for psp. the presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. one possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. this study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after vats bullectomy and pleurodesis.after routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube. the recurrence of the two group and other postoperative clinical parameters will be observed.

Eligibility criteria:
inclusion criteria: * diagnosed by chest radiograph or ct as primary spontaneous pneumothorax * underwent bullectomy and pleurodesis * postoperative indwelling chest tubes exclusion criteria: * secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax * previous surgery history * people with severe comorbidities

Keywords: number of chest tube bullectomy pleurodesis primary spontaneous pneumothorax
3-arm trial to evaluate pasireotide lar/everolimus alone/in combination in patients with lung/thymus net - luna trial

Conditions: Neuroendocrine Carcinoma of the Lung and Thymus

Summary: this was a multicenter, randomized, phase ii study evaluating everolimus or pasireotide lar alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus

this was a prospective, multicenter, randomized, open-label, 3-arm, phase ii study with a single-stage design in each arm. the purpose of this study was to test the effectiveness and safety of everolimus or pasireotide lar alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. it was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. patients were seen weekly for one month and monthly thereafter. radiological and biochemical response assessments were performed every 3 months. patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide lar and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. all patients had a safety follow-up visit 56 days after last treatment dose.

Eligibility criteria:
inclusion criteria: * histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus * patients of all treatment lines including naive patients could have been enrolled * at least one measurable lesion of disease on ct scan or mri * radiological documentation of disease progression within 12 months prior to randomization * adequate liver, renal and bone marrow function * who performance status 0-2 exclusion criteria: * poorly differentiated neuroendocrine carcinoma * non-neuroendocrine thymoma * patients with severe functional disease who required symptomatic treatment with somatostatin analogs * prior therapy with mtor inhibitors * history of liver disease * baseline qtcf\> 470 msec * uncontrolled diabetes mellitus despite adequate therapy

Keywords: neuroendocrine carcinoma; lung; thymus; pasireotide lar; everolimus,adult,som230,carcinoma,lung cancer,
induction therapy for patients with flt3 mutated acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (cpx-351) in combination with a flt3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk flt3 mutated acute myeloid leukemia (aml) and subsequent cd34+-selected allogeneic stem cell transplant from hla compatible related or unrelated donors.


Eligibility criteria:
inclusion criteria: * patients must have a karnofsky (adult) performance status of at least 70%. * patients must have adequate organ function exclusion criteria: * female patients who are pregnant or breast-feeding * active viral, bacterial or fungal infection * patient seropositive for human immunodeficiency virus (hiv-i /ii); human t-cell lymphotrophic virus (htlv -i /ii) * presence of leukemia in the central nervous system (cns).
effectiveness of dextrose injection for osgood-schlatter disease

Conditions: Osgood-Schlatter Disease

Summary: objective: to examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with osgood-schlatter disease (osd).

patients and methods: girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. injections will be administered monthly for three months. all subjects will then be offered dextrose injections monthly as needed. change in the nirschl pain phase scale (npps) will serve as the primary outcome measure.

Eligibility criteria:
inclusion criteria: * age:9-15 year old girls and 10-17 year old boys * pain location: anterior knee. * sport type: jumping or kicking sport. * team member with coach: member of and organized team with a coach. * imitation of exact pain and precise location to the tibial tuberosity with a single leg squat. * at least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction. * pain with sport at least 3 months. exclusion criteria: * patellofemoral crepitus * patellar origin tenderness

Keywords: osgood-schlatter tendinosis apophysitis enthesopathy dextrose.
safety and immunogenicity of quadrivalent influenza mrna vaccine mrt5413 in adult participants18 years of age and older

Conditions: Influenza Immunization

Summary: the purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (im) injection of up to 3 dose levels of quadrivalent influenza messenger ribonucleic acid (mrna) vaccine mrt5413 compared to an active control (qivstandard-dose (sd), qiv high-dose (hd) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (riv4)) in adults 18 years of age and older.

study duration is approximately 12 months.

Eligibility criteria:
inclusion criteria: * aged 18 years on the day of inclusion (us) and aged 21 years on the day of inclusion (puerto rico) * a female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * is of non-childbearing potential. to be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile or * is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * previous history of myocarditis, pericarditis, and / or myopericarditis * self-reported thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on investigator's judgment * moderate or severe acute illness / infection (according to investigator's judgment) or febrile illness (temperature ≥ 38.0°c \[≥ 100.4°f\]) on the day of vaccination. a prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * self-reported or documented seropositivity for human immunodeficiency virus, hepatitis b virus, or hepatitis c virus note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study to test the effects of riociguat in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Conditions: Hypertension, Pulmonary; Ventricular Dysfunction, Left

Summary: the aim of this study is to assess whether increasing oral doses of riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

pharmacokinetics parameters were regarded as exploratory parameters. adverse event data will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy exclusion criteria: * types of pulmonary hypertension other than group 2.1 of dana point classification

Keywords: pulmonary hypertension left ventricular dysfunction
metabolic change in prostate cancer bone metastases on 68ga-hbed-cc-psma pet/ct following radium-223 therapy

Conditions: Prostate Cancer

Summary: broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by suvmax on 68ga-psma pet/ct in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.


Eligibility criteria:
inclusion criteria * resident of canada * male sex * age 18 years or older * progressive (symptoms, conventional imaging, psa, bone scan, fch pet/ct or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression * six or greater bone metastases robustly-avid on recent (4 weeks) mdp or naf scintigraphy * recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months or minimum 14 day washout period from either agent prior to study enrollment * no known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging * not received docetaxel for castration-resistant disease * ecog performance status 0 - 2, inclusive * life expectancy of greater than 6 months * serum testosterone less than or equal to 50 ng/dl * hemoglobin greater than or equal to 100 g/l with no blood transfusions or epo in preceding 3 weeks * neutrophils greater than or equal to 1.5 x109/l * platelets greater than or equal to 100 x109/l * no prior hemi-body radiotherapy * no impending or established spinal cord compression * no unmanageable fecal incontinence * patient has good iv access * able to understand and provide written informed consent exclusion criteria * planned change in systemic anti-neoplastic therapy during the approximately 7 month trial * unable to tolerate the physical/logistical requirements of a pet/ct scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug. * medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * patients who exceed the safe weight limit of the pet/ct bed (approximately 400 lbs.) or who cannot fit through the pet/ct bore (70 cm diameter) * patients who are claustrophobic

Keywords: psma
phase iii study for glimepiride + metformin hydrochloride (amaryl m) slow release (sr)

Conditions: Diabetes Mellitus, Type 2

Summary: primary: to show the equivalence in terms of efficacy glycated hemoglobin (hba1c) of glimepiride/metformin slow-release combination tablet (amaryl m sr 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (amaryl m 1/250) twice a day on hba1c in patients with type 2 diabetes mellitus (dm) secondary: to compare the following parameters in two treatment arm * efficacy; fasting plasma glucose (fpg) and post-prandial two hours plasma glucose (pp2h) * response rates in terms of hba1c, fpg * patient compliance safety: * episodes of hypoglycemia * adverse events * laboratory values including hematology blood chemistry and urinalysis * vital sign and physical examination


Eligibility criteria:
inclusion criteria: * subjects with type 2 dm diagnosed for at least 3 months but no longer than 10 years before screening; * - bmi ≤ 40 kg/m²; * a negative pregnancy test for all females of childbearing potential exclusion criteria: * a history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening; * current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening; * concomitant treatment prohibited during the study period; * any oral anti-diabetic drugs other than study medication * any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study * intermittent use of systemic corticosteroids or large dose of inhaled steroids * subjects with clinically significant renal (serum creatinine level \>1.5 mg/dl in male and \>1.4 mg/dl in female) or hepatic disease (alanine aminotransferase (alt) and aspartate aminotransferase (ast) \>2x upper limit of normal (uln)); * subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.) * clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor; * pregnant or lactating females; * history of drug or alcohol abuse; * subjects with known hypersensitivity to glimepirides, or metformin; night-shift workers; * treatment with any investigational product in the last 3 months before study entry; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.