Kornimate/medical-research-clean huggingface dataset:
arimidex multicenter trial in growth hormone (gh) deficient boys

Conditions: Hypopituitarism

Summary: the purpose of this study is to see if arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. this is a double blind, placebo controlled 3 year trial.


Eligibility criteria:
inclusion criteria: * growth hormone deficient by formal testing with two provocative agents. * treated with growth hormone for a minimum of 6 months prior to study entry. * growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol. * stable organic pathology * presence of puberty \[genital tanner stage \> ii (\>4cc testicular volume)\] * bone age (ba) \> or = 11.5 years and \< 15 years exclusion criteria: * participation in any other trial involving hormone therapy for at least 6 months prior. * chronic illnesses requiring long term medication that impair growth. (stable patients with occasional asthma, patients on ritalin or adderall or patients on topical acne medication may be included). * hereditary disease diagnosed clinically. * moderate to severe scoliosis.

Keywords: puberty growth hormone deficiency aromatase inhibitors estrogen bone mineral density short stature
colorado marijuana users health cohort

Conditions: COPD; Insomnia; Cannabis

Summary: in colorado, marijuana is currently used for both recreational and medicinal purposes.to learn more about the positive and negative long term medical effects of marijuana use. information obtained during this study may identify new markers that influence the development of lung diseases such as copd. the investigators are also interested in learning more about the effects of marijuana use for insomnia and how it may or may not affect sleep.

in colorado, marijuana is currently used for both recreational and medicinal purposes. the major active drug is tetrahydrocannabinol (thc). the most common route of use is through inhalation of the combustion products of the dried, buds/flowers from the female plant either rolled in paper (joint) or burned through a screen in a dry or water filled pipe (bong). increasingly thc is consumed. the side effects of the inhalation of burned leaves are controversial. the purpose of this proposal is to establish a prospective cohort of heavy marijuana users to evaluate positive and negative long term medical effects of marijuana use. as marijuana has also been reported for use to help treat insomnia, a sub-study will focus on how marijuana is used for sleep disorders and disturbances. this study will enroll individuals that use marijuana to learn more about long-term health effects. the study involves one visit where participants will complete questionnaires, breathing tests, blood and urine collection. there is a sub-study where eligible participants will also complete an at-home sleep monitoring test. participants will be contacted multiple times a year for long-term follow-up.

Eligibility criteria:
inclusion criteria: * colorado-only study * age 21-80 years and one of the categories below * marijuana use: use of any cannabis (smoked, vaped, edible, etc.) on average more than 3 days per week for at least 1 year * combined marijuana use and tobacco use (current or former): ≥ 30 pack year cigarette smoking history * non-marijuana users sleep sub-study: enrollment in the main cohort building study and a qualifying score on the insomnia severity index questionnaire exclusion criteria: * respiratory disorder other than copd or asthma * lung surgery with removal of a lobe or more or lung volume reduction surgery * lung cancer or other cancer under active treatment during past 12 months * ≥ 30 pack year cigarette smoking history for combined marijuana and cigarette users * pregnancy * use of antibiotics and/or systemic steroids for any lung infection within the last month * inability to use albuterol * subject enrolled in copdgene or spiromics sleep sub-study: * inability to complete home sleep study
ethanol and cannabinoid effects on simulated driving and related cognition: sub-study i

Conditions: Cannabis; Alcohol Effect; Driving Under the Influence of Alcohol and Other Drugs

Summary: the overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

to study the effects of oral ethanol (a target bac of \~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized thc (4 mg of thc dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility criteria:
inclusion criteria: * males or females 21 to 55 years of age (extremes included). * occasional current cannabis users. * experience with drinking 2 or more standard drinks of alcohol at least once in lifetime. * able to provide informed consent. exclusion criteria: * cannabis naïve. * alcohol naïve. * positive pregnancy screen * hearing deficits.
comparison of the mammary harvesting technique

Conditions: Ischemic Heart Disease

Summary: the skeletonization technique of left internal artery (lima) harvesting is reported as more spar-ing to the vascular supply of the sternum. some studies report a greater length and greater flow of the graft additionally. the aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the lima graft.

a total of 90 patients were examined in a prospective randomized study. in 60 patients referred for coronary artery bypass grafting (cabg), lima was harvested, one-half (n=30) skeletonized, and one-half (n=30) with a pedicle. thirty patients operated via sternotomy without lima harvesting (other procedures, for instance, valve surgery) were the control group. in patients undergoing lima harvest, harvest duration, graft length, and graft free flow were measured at defined arterial pressure. in all patients, the sternal blood flow was examined by active dynamic thermography (dirt): first preoperatively and on 4th postoperative day. during this, the time of spontaneous rewarming of the skin surface after the application of a cold stimulus was measured in the caudal part of the sternum. the difference between postoperative and preoperative time was calculated and compared between groups.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery procedure via median sternotomy * the left mammary artery (lima) harvesting for coronary bypass planned as a part of the operation - group 1 and 2 * other cardiac surgery procedures without the lima harvesting (valve surgery for instance) - control group * signing of the informed consent exclusion criteria: * emergent surgery * re-operation * re-sternotomy * thoracotomy approach * harvesting of both mammary arteries (bima) * endocarditis * ongoing non-cardiac infection * fever * circulatory failure * ongoing administration of catecholamines to patient * unsigned informed consent

Keywords: sternotomy thermography coronary bypass lima skeletonization technique
study of a 6-month sustained-release formulation of leuprolide acetate in prostate cancer

Conditions: Prostatic Neoplasms

Summary: the primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

the primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. this study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.

Eligibility criteria:
inclusion criteria: * histological diagnosis of prostate cancer * need for androgen deprivation treatment for 1 year * serum testosterone level ≥ 150 ng/dl * life expectancy of at least 18 months * ecog performance status grades 0,1 or 2 exclusion criteria: * hypersensitivity to leuprolide acetate or polylactic acid * history of bilateral orchiectomy, adrenalectomy, or hypophysectomy * history of hypogonadism

Keywords: leuprolide prostatic neoplasms testosterone prostate-specific antigen pharmacokinetics luprolide acetate
functional and mechanistic characterization of limb ulcers in patients with sickle cell disease

Conditions: Ulcer; Anemia; Sickle Cell Disease

Summary: sickle cell disease is the most frequent genetic disease in the world (representing one birth over 1900, in france). the polymerization of the abnormal hemoglobin (i.e., hbs) when deoxygenated is at the origin of a mechanical distortion of red blood cells (rbc) into a crescent-like shape. sickled rbcs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the rbcs, which shorten their half-life. accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation. the resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. cost of care is also increased. moreover, ulcers induce missed school and work days. data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. we want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology. to ensure healing, adapted therapeutics are essential. several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). the project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.


Eligibility criteria:
inclusion criteria: * sickle cell disease (homozygous ss or sb0) * age ≥ 18 years old * consent patients * social regimen exclusion criteria: * tutela or curatella * vaso occlusive crisis \< 1 month

Keywords: limb ulcers sickle cell disease microcirculation cytokine wound fluid
study of cp-675,206 in bacillus calmette-guerin (bcg)-resistant bladder cancer

Conditions: Bladder Cancer

Summary: the purpose of this study is to find out the highest safe dose of the investigational drug cp-675,206 when given in combination with bcg therapy to patients who have experienced recurrent superficial bladder cancer after standard bcg treatment. in addition, the study will look to see if taking cp 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical bcg. * evidence of disease recurrence within 1 year of previous bcg treatment * tumor tissue must be available from biopsy for study related immunohistochemical analysis * if sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment * ecog performance status of \<2 * life expectancy of at least 6 months * adequate hematologic, renal and liver function * informed consent exclusion criteria: * no evidence of immunosuppression or treated with immunosuppressive therapy within 6 months * no prior radiation to the pelvis * no gross hematuria within 1 week prior to planned week 1 treatment * cannot have previous intolerance to bcg * cannot be seropositive for hiv, hepatitis b(hbv) or hepatitis c(hcv) per patient history * no evidence of metastatic disease * no prior treatment with anti-ctla-4 monoclonal antibody * can not be pregnant or lactating * no history of autoimmune disorder * no history of thyroid or adrenal insufficiency * no history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, crohn's or celiac disease, intractable urinary tract infection

Keywords: bladder cancer bcg-resistant localized transitional cell of the bladder
silver acetate and triclosan antimicrobial graft evaluation for surgical repair of aortic disease

Conditions: Infective Graft Complications

Summary: the number of surgical and endovascular aortic repairs is continuously increasing, and infective graft complications are observed more frequently. (1) several etiopathogenetic factors may play a role in aortic prosthetic infections, including hematogenous seeding, local bacterial translocation, and iatrogenous contamination. infectious graft complications represent a critical event requiring a multidisciplinary management. knowledge on underlying microorganisms, antibiotic efficacy, risk factors, and prevention strategies has a key role in the management of this spectrum of infectious diseases involving the aorta. the aim of the study is evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (intergard synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard dacron grafts. results will be reported and analyzed according to the type of aortic disease requiring surgical repair.


Eligibility criteria:
inclusion criteria: • patients submitted to aortic surgical repair (elective or emergent) with a silver and triclosan knitted collagen coated polyester vascular graft or standard dacron grafts, for different aortic pathologies at the division of vascular surgery, san raffaele scientific institute, between 2012 and 2019 exclusion criteria: • not present
study to assess the safety and efficacy of imiquimod 5% cream for the treatment of actinic keratosis on the arms and hands

Conditions: Keratosis

Summary: the purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of actinic keratosis (ak) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.


Eligibility criteria:
inclusion criteria: * 18 years of age * have ak on arm or hand * discontinuation of sun tanning and the use of tanning beds * discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area * withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream * postponement of the treatment of non-study ak lesions anywhere on the arm being treated until study participation is complete exclusion criteria: * subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions * participation in another clinical study * have previously received treatment with imiquimod within the treatment area * have squamous cell carcinoma (scc), basal cell carcinoma (bcc), or other malignancy in the treatment or surrounding area that requires treatment

Keywords: actinic keratosis ak 3m pharmaceuticals aldara imiquimod actinic keratosis (ak)
broccoli extract supplementation in older adults with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: chronic alcohol consumption leads to perturbations in gut microbiome balance (dysbiosis) and disruption of gut barrier integrity. as a result, bacteria, toxins, and metabolites can enter the blood stream and reach distant organs, triggering inflammation and oxidative stress. through this mechanism gut leak is closely related to the onset of metabolic diseases, such as nonalcoholic fatty liver disease (nafld) and diabetes. despite the prominent role of diet and alcohol in the pathogenesis of metabolic diseases, there is a lack of treatments to mitigate their effects in triggering systemic inflammation and oxidative stress. novel treatments using generally recognized as safe (gras) compounds focused on restoring the intestinal barrier to mitigate metabolite endotoxemia are sorely needed. this project will test the potential of broccoli sprouts extract (bse) as a gras treatment to minimize the combined effect of poor nutrition and alcohol on the gut. broccoli sprouts are rich in sulforaphane, a bioactive compound derived from the glucosinolate glucoraphanin with anti-inflammatory and antioxidant proprieties. bse supplementation has been used in preclinical and clinical studies as a health- promoting food, showing significant positive changes in the gut microbiota composition, protection against colitis, cardiometabolic improvement, and lower inflammation. we believe that bse is a viable alternative therapeutic approach for patients who are resistant to lifestyle changes such as healthy eating and reducing alcohol use. our purpose is to test bse supplementation in human subjects with poor nutrition compounded by alcohol use, specifically in older adults who we believe will receive greater benefit from this approach. at the completion of the proposed study, we expect to have determined that treatments using generally recognized as safe (gras) compounds can be useful to restore the gut barrier integrity, and as consequence of reduced gut leak we expect to observe lower inflammation and oxidative stress.


Eligibility criteria:
inclusion criteria: * subjects ≥ 50 years of age at enrollment. * consume at least 8 alcoholic drinks/week. audit-c score \>8. exclusion criteria: * bowel-related diseases * diagnosed diabetes * allergy or intolerance to broccoli. * any acute illness within the last 6 weeks. * chronic anti-inflammatory use or antibiotic treatment in the last 7 days. * acute illness within the preceding six weeks (defined as fever, new antibiotic use or unscheduled healthcare visit - for illness). * acute alcohol intoxication upon arrival on the day of study visit. additional exclusion criteria: • any health issue that, the study investigator's judgement, confers excess risk for participation.

Keywords: inflammation leaky gut supplements
comparison of laser therapy and desensitizing agents in dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity

Summary: this study evaluates the effectiveness of laser therapy versus desensitizing agents in reducing pain among participants with dentinal hypersensitivity conducted in saidu college of dentistry. pain will be measured at baseline, immediately post-treatment, one week, and three months using the visual analog scale (vas)

this study examines dentinal hypersensitivity treatment modalities, including laser therapy and desensitizing agents. the study is conducted in compliance with regional ethical guidelines

Eligibility criteria:
inclusion criteria: * participants aged 18-50 years with a preoperative vas score of ≥2 for dentinal hypersensitivity. * participants with sensitivity due to gingival recession, cervical abrasion, or enamel erosion. * participants with good systemic health. * minimum of two hypersensitive teeth present in two different quadrants. exclusion criteria: * teeth with caries, defective restorations, or cervical defects \> 2 mm (may affect sensitivity measurements). * periodontal surgery or deep periodontal pockets (\> 6 mm) within the past three months (potential influence on periodontal health and sensitivity). * participants using desensitizing toothpaste within the past three months (could interfere with study outcomes). * presence of gross oral pathology or systemic diseases (e.g., eating disorders, chronic diseases, uncontrolled metabolic conditions) (may alter oral health status). * pregnant or lactating women (hormonal changes can influence oral health).
a double-blind study to evaluate the long-term safety and effectiveness of 60 mg versus 120 mg of aerosol pentamidine in the prophylaxis of pneumocystis carinii pneumonia in aids patients

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the safety, tolerability, and description of time to pneumocystis carinii pneumonia (pcp) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of aids-associated pcp.


Eligibility criteria:
inclusion criteria patients who have completed 16 treatments under fisons study no. 87-71 entitled, "a double-blind group comparative study to evaluate the safety and effectiveness of three different doses of aerosol pentamidine in the prophylaxis of pneumocystis carinii pneumonia in patients with aids post first episode pcp." detailed safety parameters must have been documented for 6 months. * patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71. exclusion criteria co-existing condition: patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection (o.i.) at time of entry or those patients with either of the following aids-defining o.i.'s at entry: * toxoplasmosis. * cryptococcosis. * pulmonary kaposi's sarcoma. * asthma poorly controlled by medication. * receiving active therapy for tuberculosis. patients with the following are excluded: * requiring ongoing active therapy for an opportunistic infection (o.i.) at time of entry or those patients with either of the following aids-defining o.i.'s at entry: * toxoplasmosis. * cryptococcosis. * pulmonary kaposi's sarcoma. * unwilling to sign informed consent. * cannot cooperate with study procedures. * asthma poorly controlled by medication. * receiving active therapy for tuberculosis. active substance abuse.

Keywords: aids-related opportunistic infections pneumonia, pneumocystis carinii pentamidine dose-response relationship, drug acquired immunodeficiency syndrome
study of isis 681257 in patients with renal impairment compared to healthy patients

Conditions: Renal Impairment

Summary: this is a phase 1, multicenter, open-label, parallel group adaptive pharmacokinetic single dose study of isis 681257 subcutaneous injections in male and female subjects with normal and impaired renal function


Eligibility criteria:
inclusion criteria: * at least 18 years old * bmi 18.5 to 42.0 kg/m2 * no known diseases or significant findings on physical exam (normal renal only) * egfr \>/= 90 ml/min/1.73m2 (normal renal only) * clinically stable (renal impaired only) * egfr 30-59 ml/min/1.73m2 (renal impaired only) exclusion criteria: * females of childbearing potential * conditions or disease that may interfere with study drug * any significant diseases * hypersensitivity to any drugs or similar drugs to those used in the study * drug dependency or abuse * previous exposure to other investigational drug within 28 days * blood donations within 28 days