Kornimate/medical-research-clean huggingface dataset:
a pivotal study to evaluate the safety and effectiveness of rmt medical technology's safeflo® vena cava filter

Conditions: Pulmonary Embolism

Summary: to determine the safety and effectiveness of the safeflo filter for permanent protection against pulmonary emboli. all patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. patients with a permanent implantation will be followed for up to 6 months. clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, ivc occlusion or filter embolization. the proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.


Eligibility criteria:
inclusion criteria: * traditional indications for vena cava filter in patients with established dvt or pe, including (40): * patients with proven pulmonary embolus (pe) or deep vein thrombosis (dvt) and one or more of the following: 1. contraindication to anticoagulation 2. complication of anticoagulation 3. failure of anticoagulation * recurrent pe despite adequate anticoagulation therapy * inability to achieve adequate anticoagulation 4. poor compliance with anticoagulation medications * extended indications for vena cava filter placement in patients with established dvt or pe, including the following (31, 40): * large free-floating thrombus in the iliac vein or ivc; * following massive pe in which recurrent emboli may prove fatal; * during/after surgical or transcatheter embolectomy; * filter placement in high-risk trauma and orthopedic patients: * high risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40): 1. severe closed head injury (gcs \< 8); 2. incomplete spinal cord injury with para or quadriplegia; 3. complex pelvic fractures with associated long-bone fractures; 4. multiple long bone fractures. * patients undergoing long-term immobilization (e.g., icu or surgical oncology) exclusion criteria: * all patients under 18 years of age. * all patients undergoing emergency procedures. * all patients with abnormal ivc anatomy or pathology of the ivc such as thrombosis or tumor which prevent safe filter implantation. * all patients with an ivc diameter which precludes oversizing of the filter platform. * all patients with active infection / bacteremia. * all patients with sensitivity to contrast media. * uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).
effects of a specific substance in smokers

Conditions: Smoking

Summary: although rates of cigarette use are declining, the proportion of nondaily smokers is rising, particularly among young adults. among young adults, nondaily smoking is associated with negative health consequences and, for some, may lead to the establishment of life-long smoking patterns. the goal of this project is to understand the behavioral, psychological and neurobiological factors that contribute to cigarette use in nondaily smokers to aid the development of tailored evidence-based interventions.

the purpose of this study is to investigate the neurobiological mechanisms associated with cigarette use in young nondaily smokers (ages 21-25). nondaily smokers experience fewer symptoms of cigarette withdrawal than daily smokers; however, they still experience difficulty quitting. since smoking cessation before the age of 30 substantially attenuates the long-term health consequences associated with smoking, understanding the factors that motivate cigarette use in young nondaily smokers and developing tailored interventions will be critical for curbing cigarette use and improving public health. the proposed project will use functional magnetic resonance imaging (fmri) to examine how other substances (e.g. stimulates, sedatives, or analgesics) impact brain function and will assess the extent to which substance-induced changes in brain function correlate with impulsive choice, cigarette craving, and craving regulation in young adults. furthermore, the investigators will assess how substance-induced changes in brain function, impulsivity, craving, and capacity for craving regulation predict cigarette use over the course of 1 year.

Eligibility criteria:
inclusion criteria: * participants must be 21-40 years old * right-handed * fluent in english * report smoking cigarettes or e-cigarettes 1-27 days in the past month * report binge drinking based on niaaa criteria (5 or more drinks per occasion for males, 4 or more drinks per occasion for females) at least 1 time in the past 90 days without adverse incident exclusion criteria: * seeking treatment for substance use (e.g. nicotine or alcohol use) * moderate or severe nicotine dependence * current alcohol use disorder * illicit substance use other than marijuana use in the past year * marijuana use more than 10 times in the past year * major neurological or medical illness - significant head trauma - current use of medication affecting the central nervous system * mri contraindications (e.g. irremovable metal on the body or pregnancy)

Keywords: nondaily smoking craving impulsivity
cold water exposure and immune function study

Conditions: Cold Water Immersion; Immune Function; Muscular Strength; Mental Health

Summary: the purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (cwi) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. the main questions it aims to answer are: * does a 4 week cwi intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength? * are there any differences in these measures when comparing cold tubs versus cold showers? researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being. participants will: * undergo 4 weeks of cold tub or cold shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the cwi intervention groups * undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the cwi intervention groups


Eligibility criteria:
inclusion criteria: * males and females * aged 18-45 exclusion criteria: * currently practices cwi for \[\&gt;3 times in the last month\] * pregnant or planning to become pregnant * chronic use of anti-inflammatory medication * prior history of chronic disease conditions: * cardiovascular disease * diabetes * cancer * raynaud\&#39;s disease * severe and untreated anxiety or depression

Keywords: cold water immersion cold tub cold shower immune function mental health muscular strength healthy adults inflammation gut health
the effects of contact lenses with experimental dye on visual function

Conditions: Ametropia

Summary: this is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new uv blocker.


Eligibility criteria:
inclusion criteria: - potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. appear able and willing to adhere to the instructions set forth in this clinical protocol 3. between 18 and 65 (inclusive) years of age at the time of screening. 4. be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report. 5. the subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 d in each eye. 6. the subject has a best corrected visual acuity of 20/25 or better in each eye. exclusion criteria: 1. currently pregnant or breastfeeding. 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any autoimmune disease or use of medication, which may interfere with contact lens wear. habitual medications used by successful soft contact lens wearers are considered acceptable. 4. entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, prk, lasik, etc.). 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. multifocal, toric or extended wear contact lens correction. 8. participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 9. history of binocular vision abnormality or strabismus. 10. any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., hiv) by self-report. 11. employee or immediate family member of an employee of clinical site (e.g., investigator, coordinator, technician). 12. any ocular infection. 13. any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the fda classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
efficacy of remodulin in adults with congenital heart disease (achd) and pulmonary hypertension

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to evaluate the efficacy of remodulin in the treatment of adult patients with congenital heart disease and pulmonary hypertension. baseline and post-treatment cardiopulmonary exercise tests will be performed.

a prospective, open-label, non-randomized multi-center study is proposed to assess the efficacy of remodulin in adults with congenital heart disease and pulmonary hypertension. subjects will be enrolled at ucla and ohio state university (pi: curt daniels, md). the study will involve a six month trial of continuous subcutaneous remodulin therapy, with assessments conducted prior to initiation of therapy and at 1 and 6 months following initiation of therapy. a separate initiation visit will be scheduled after the baseline visit in order to provide subjects with comprehensive training in the use and care of the remodulin drug delivery system. baseline and post-treatment (6 month) assessments will include a history and physical examination, cardiopulmonary exercise test, six minute walking distance, serum brain natriuretic peptide (bnp), a cambridge pulmonary hypertension outcome review (camphor) quality of life survey, and subjective assessment of functional capacity (new york heart association (nyha) scale). the interim (1 month) follow-up visit will include a thorough review of adverse events associated with remodulin therapy, functional class assessment, six minute walk distance, and serum bnp. remodulin will be initiated at 1.25 ng/kg/min and increased by 2-6 ng/kg/min weekly to a target dose of 40 ng/kg/min. if the initial infusion rate cannot be tolerated it will be reduced to 0.625 ng/kg/min. changes in drug dose will be at the discretion of the investigators following review of interim events. if necessary, the dose may be decreased by 2 ng/kg/min every two days as tolerated.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * congenital heart disease with pulmonary arterial (pa) hypertension (repaired or unrepaired) defined as a mean resting directly measured pulmonary artery pressure (pap) of ≥35 mm hg and/or doppler echo estimated pa systolic pressure ≥ 60 mm hg. * patients already on phosphodiesterase type 5 inhibitor (pde-5), endothelin receptor antagonist (era), or inhaled prostacyclin are not excluded exclusion criteria: * age \< 18 years * current intravenous or subcutaneous prostacyclin therapy * resting systemic hypotension (systolic blood pressure \< 80 mm hg) * women who are pregnant or may become pregnant (unwilling to utilize effective contraception), as well as nursing mothers * inability to ambulate

Keywords: congenital heart disease,pulmonary hypertension,prostacyclin
inter-regional cohorte of long term pancreatic cancer survivors

Conditions: Pancreas Cancer; Pancreatic Adenocarcinoma

Summary: the study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age at diagnosis * primary pancreatic cancer patients operated on in one of the 4 centres between 2001 and 2016 * histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas, ductal adenocarcinoma or classical adenocarcinoma * tissue blocks (ffpe) available (tumour/healthy tissue) * affiliated to a social security scheme exclusion criteria: * absence of primary cancer tissue blocks (pctbs) * paraffin block fixed in bouin or afa * patient refusal * pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine tumor/carcinoma, acinar cell carcinoma, ...). * patient died due to post-surgical complications (death within 30 days post-surgery). * surgical resection of macroscopic r2 type.

Keywords: survival prognosis tissue pancreas cancer
phase ii study of the safety and surrogate marker efficacy of butyldeoxynojirimycin (sc-48334) and azt in symptomatic hiv-1 infected patients with 200 - 500 cd4+ cells/mm3. (note: asymptomatic hiv-1 infected patients also eligible)

Conditions: HIV Infections

Summary: to assess the dose-related antiviral effects of sc-48334 and zidovudine (azt) administered in combination or individually in hiv-1 positive patients with 200 - 500 cd4+ cells/mm3. to determine the safety of escalating doses of sc-48334 when administered in combination with any of three doses of azt to symptomatic hiv-1 positive patients with 200 - 500 cd4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.


Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count 200 - 500 cells/mm3. * prior therapy with 12 - 48 weeks of azt. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant diarrhea without definable cause (\> 3 liquid stools per day for more than 7 days within 6 months prior to study entry). * diarrhea, as above, with known non-hiv-related cause occurring within 1 month prior to study entry. * symptoms meeting cdc criteria for aids classification. * fever as a constitutional sign of hiv disease (\> 38.5 degrees c persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry). * malignancies, other than basal cell carcinoma and kaposi's sarcoma (provided patient has fewer than 10 kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment). * significant organ dysfunction. * known hypersensitivity to sc-48334 or azt or related compounds. concurrent medication: excluded: * any investigational drug other than sc-48334. * any anti-hiv drug other than azt. * cancer chemotherapy. patients with the following prior conditions are excluded: * history of cataracts or known increased risk of cataract formation. * known hypersensitivity to sc-48334 or azt or related compounds. * history of lactose intolerance. prior medication: excluded: * prior sc-48334. * cancer chemotherapy within 6 months prior to study entry. * treatment with any investigational drug or any drug with anti-hiv activity, other than azt, within 30 days prior to study entry. prior treatment: excluded: whole-body irradiation within 6 months prior to study entry. current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.

Keywords: zidovudine 1-deoxynojirimycin
phase ii study of grass pollen allergy vaccine bm32

Conditions: Grass Pollen Allergy

Summary: the study will evaluate the efficacy and safety of bm32 in grass pollen allergic subjects. it will test the hypothesis that either of two doses of bm32 will lead to a sustained relief off allergy symptoms over a two year study period.

the present study is designed to evaluate the efficacy and safety of a treatment with the recombinant vaccine bm32 during two consecutive grass pollen seasons. efficacy evaluation will be performed on the basis of allergy symptoms and use of relief medication as well as based on immunological parameters. after patient assessment during a screening season, patients will be randomized to one of two doses of bm32 or placebo. patients will receive three injections of bm32 pre-season and one post-season boost injection to maintain optimal allergen specific igg responses. outcome will be measured after both seasons individually.

Eligibility criteria:
inclusion criteria: * positive history of grass pollen allergy * positive skin prick test reaction to grass pollen extract * grass pollen specific ige and rphl p 1/rphl p 5 specific ige (\>3 kua/l) * moderate to severe symptoms of grass pollen allergy during pollen peak exclusion criteria: * symptomatic perennial allergies * atopic dermatitis * pregnancy or breast feeding * women with childbearing potential not using medically accepted birth control * autoimmune diseases, immune defects, immune suppression * immune complex induced immunopathies * contra indications for adrenaline * severe general maladies, malignancies * patients on long-term systematic corticosteroids, immune suppressive drugs, tranquilizers or psychoactive drugs * contra indication for skin prick testing * bronchial asthma not controlled by low dose inhaled corticosteroids * chronic use of beta blockers * participation in another clinical trial within one month prior to study * participation in sit trial in 2 years prio to study * patients who had a previous grass pollen sit * risk of non-compliance with study procedures * use of prohibited medications * depot corticosteroids - 12 weeks prior to enrolment * oral corticosteroids - 8 weeks prior to enrolment * high dose inhaled corticosteroids - 4 weeks prior to enrolment * use of h1 antihistamines 3 days prior to enrolment

Keywords: grass pollen allergy immunotherapy recombinant vaccine rhinitis, allergic, seasonal
a study of tq-b3525 in the treatment of relapsed / refractory follicular lymphoma (fl)

Conditions: Relapsed / Refractory Follicular Lymphoma

Summary: the objective of this study is to evaluate the efficacy of tq-b3525 in patients with relapsed / refractory follicular lymphoma.


Eligibility criteria:
inclusion criteria: - 1. understood and signed an informed consent form. 2. 18 years and older; eastern cooperative oncology group (ecog) performance status score of 0 or 1; life expectancy ≥ 3 months. 3. relapsed / refractory fl. 4. at least one measurable lymph node or extranodal lymphoma lesions. 5. adequate organ system function. 6. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. exclusion criteria: * 1. has diagnosed and/or treated additional malignancy within 3 years prior to the first administration. 2. has a history of immunodeficiency diseases. 3. has multiple factors affecting oral medication. 4. has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1. 5. has received systemic steroid treatment within 7 days before the first administration. 6. has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first. 7. has palliative radiation therapy within 4 weeks before the first administration. 8. has received surgery, or unhealed wounds within 4 weeks before the first administration. 9. has a history of autologous hematopoietic stem cell transplant within 3 months or allogeneic hematopoietic stem cell transplant within 6 months. 10.has cardiovascular disease ≥grade 2 within 6 months before the first administration. 11. has active hepatitis b or c. 12. has psychotropic substances abuse or a mental disorder. 13.has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
efficacy of fixed combination of beclomethasone dipropionate (bdp) + formoterol fumarate (ff) + glycopyrronium bromide (gb) (chf 5993)administered via dry powder inhaler (dpi) in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the efficacy of fixed combination of beclomethasone dipropionate + formoterol fumarate + glycopyrronium bromide administered via dry powder inhaler in copd


Eligibility criteria:
inclusion criteria: * male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of copd; * current smokers or ex-smokers; * a post-bronchodilator fev1 ≥30% and \<80% of the predicted normal value and fev1/fvc (forced vital capacity) \< 0.7; * patients' copd therapy (stable regimen at least 30 days before screening) with either: * inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination * inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination * inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination * inhaled long-acting muscarinic antagonist alone. exclusion criteria: * pregnant and lactating women; * diagnosis of asthma; * known respiratory disorders other than copd; * patients treated for a moderate or severe copd exacerbation within 6 weeks prior to screening or during the run-in period; * patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia; * patients who have clinically significant cardiovascular condition;