cyrilzakka/clinical-trials huggingface dataset:
Surgical Patient Knowledge and Safe Use of Opioids

Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to provide standardized written materials to surgical patients about the risks of opioids and how to safely use opioids after surgery. Investigator has developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids.

The objective of this study is to determine whether the pamphlet increases surgical patients' knowledge about the safe use, proper storage and disposal of opioids.

Participants presenting to the preoperative clinic will be recruited for this trial. After informed consent is obtained, patients will be randomized to one of 2 groups: 1) educational pamphlet and standard care, or 2) control group - standard care (no pamphlet) All patients will complete the opioid knowledge questionnaire to test baseline knowledge on opioids. If patient is randomized to the educational pamphlet and standard care, patient will receive the educational pamphlet and standard care. After the patient reviews the pamphlet, the patient will complete the questionnaire again. If the patient is randomized to the control group, the patient will receive the usual standard of care.

All patients will be contacted by telephone 15 days and 30 days after surgery to conduct the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All English speaking
* Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic

Exclusion Criteria:

* Patients who are on opioids for chronic pain
* Patients have taken opioids in the past 30 days
* Patients who are unable to read and understand English
Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of \>2 x 106 CD34+ cells/kg body weight.

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and engraftment will be documented.

Eligibility Criteria:
Inclusion Criteria:

1. Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. WBC count ≥2.5x109/L.
4. Absolute neutrophil count ≥1.5x109/L.
5. Platelet count ≥100x109/L

Exclusion Criteria:

1. Prior allogeneic or autologous transplantation.
2. Pregnant women.
3. Acute infection (febrile, i.e. temperature \> 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
4. Positive serology for hepatitis B or C or HIV.
5. Left ventricular ejection fraction \< 40%
6. AST ALT \>2.5x or Creatinine \>2 md/dL
Fractional Photothermolysis for Treating Melasma

In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF \>50).


Eligibility Criteria:
Inclusion Criteria:

* Adults (female/male) with clinical evidence of melasma;
* Fitzpatrick skin phototype I-III;
* Ability and willingness to comply with the requirements of the protocol.

Exclusion Criteria:

* Pregnancy or nursing;
* Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
* Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
* Use of topical retinoids within 3 months prior to study enrolment;
* Use of topical hydroquinone within 6 months prior to study enrolment;
* Use of topical corticosteroids within 1 month prior to study enrolment;
* Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment;
* Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment;
* Coagulation disorders or anticoagulant treatment;
* Photo-sensitizing medication (e.g., tetracyclines, gold).
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have type I or type II Diabetes Mellitus.
* Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
* Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be insulin therapy.
* Must be 18 years or older.
* Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Exclusion Criteria:

* History of significant liver problems.
* Have poor kidney function.
* Drink an excess of alcohol or abuse drugs.
* Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
* Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

OBJECTIVES:

I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.

II. Evaluate the time to progression and overall survival of patients treated with this drug.

III. Evaluate the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIB or IV disease
* Recurrent or progressive disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Must have received prior treatment with platinum-based therapy and a taxane
* Asymptomatic brain metastasis allowed provided off steroids for \> 2 weeks
* Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 2.0 mg/dL
* AST/ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy ≥ grade 2
* No uncontrolled illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness or social situations that would preclude study compliance
* No other concurrent investigational agents
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
* At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered
* No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant setting
* No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion Criteria:

* Absolute neutrophil count ≥ 1,500/mm³
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389
An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland

The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ® in the treatment of chronic non-bacterial inflammation of the prostate gland.

The objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. Safety evaluations will be assessed throughout the study. The hypothesis of the study is that ELMIRON® will be more effective than placebo, as based on the change in the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome
* symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause
* symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months.

Exclusion Criteria:

* Clinically significant medical problems or other organ abnormalities
* psychiatric disorders
* urinary tract infection during the last three months
* history of bladder, urethral or prostate cancer
* Prostate Specific Antigen (PSA) greater than or equal to 4 ng/mL
* diagnosis or treatment for genital herpes or herpes flare within the last year.
Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, lethal disease of unknown etiology and with a variable course. There is currently no test in routine care that can assess both the anatomical and functional damage of the disease at an early stage. This is the first human study in IPF to evaluate the value of a non-invasive tracer, 18F-fluoromisonidazole (18F-FMISO), targeting hypoxia in IPF patients.

This is a Phase I, proof-of-concept, single-center, open-label, parallel group study.

It will include 2 groups:

* 1 group of 10 IPF patients
* 1 group of 10 healthy volunteers matched to IPF patients for age and gender


Eligibility Criteria:
Inclusion Criteria:

For all patients (IPF and healthy volunteers) :

* Person who has given written consent
* Age ≥ 50 years
* Absence of disease, comorbidity, or treatment that may interfere with the evaluation of the study objective, as decided by the investigator

For patients with IPF only:

* Diagnosis of IPF according to the criteria of the current international recommendations (ATS/ERS/JRS/ALAT of 2011) and validated in a multi-disciplinary meeting in a Competence or Reference Center
* Patients who have had a high-resolution thoracic CT scan less than 1 month previously as part of the management of their disease
* Patients who have had a PFT less than 1 month previously as part of the management of their disease

For healthy volunteers only:

* Absence of functional respiratory signs - absence of dyspnea on exertion and at rest and absence of chronic cough.
* Normal clinical examination with no crackles on pulmonary auscultation
* No personal history of chronic hypoxemic respiratory disease

Exclusion Criteria:

* Person who is not covered by national health insurance
* Cancer or history of cancer in the past 5 years (except basal cell skin cancer)
* Chronic lung disease other than IPF or a history incompatible with the diagnosis of idiopathic pulmonary fibrosis (thoracic radiotherapy, pneumotoxic chemotherapy, etc.)
* Exacerbation of IPF during treatment
* Active smoking
* Patient requiring long-term oxygen therapy (excluding ambulatory oxygen therapy alone)
* Contraindication to PET or CT scan or presence of a condition disturbing the interpretation :

  * known allergy to 18F-FMISO
  * pregnancy or breastfeeding
  * claustrophobia
  * uncontrolled type I/II diabetes (HbA1c \>7%)
  * surgical intervention in the previous month
  * Radiotherapy session in the previous 3 months
  * concomitant granulomatous condition (sarcoidosis type) or pulmonary inflammation
* Moderate or severe renal insufficiency (GFR \< 70 ml/min/1.73 m²)
* Person under legal protection (curatorship, guardianship)
* Adult unable to express consent
* SECONDARY EXCLUSION CRITERIA only for healthy volunteers

  * Abnormal 6 min walk test at screening
  * Abnormal PFT at screening with FVC ≤ 80% of predicted value and DLCO ≤ 75% of predicted value
Hepatitis C Lab Testing Comparison Study

Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories.

This study seeks to test the stability of a novel method of hepatitis-C testing called HCV core antigen testing. This will be accomplished by prospectively consenting patients who have had a recent, positive standard of care HCV viral load test, and drawing additional blood to conduct HCV core antigen testing within the infectious period. Viral load amount of the core antigen test will be recorded at baseline and subsequent timepoints. Stability is defined as \<10% change from baseline and will be recorded at various timepoints up to 144 hours post-draw. Stability will also be tested at room temperature vs. refrigerated storage and on the gel vs. off the gel processing techniques. This information is necessary to ensure HCV core antigen is sufficiently stable following specimen collection to enable robust, accurate, and precise measurement using the HCV core antigen assay.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Had detectable HCV VL in a standard of care Hepatitis C RNA Quantitative test
* Initial hepatitis C VL testing took place at any HealthPartners lab
* Able to undergo a study blood draw within 3 weeks of initial hepatitis C VL testing
* Ability to sign e-consent prior to presenting for a study lab draw

Exclusion Criteria:

* Age \<18 years
* On the HealthPartners research opt-out list
* HCV VL not detectable at follow-up lab draw (screen fail)
Krill Oil Study Compared to Fish Oil

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.

Exclusion Criteria:

* smokers
* rheumatoid arthritis
* chronic illness
* cardiovascular problems
* dyslipidemia
* liver and kidney disease
* diabetes
* endocrine or metabolic disease
* inflammatory bowel disease
* pancreatitis
* gallbladder or biliary disease
* neurological/psychological disease
* bleeding disorders
* experienced platelet abnormalities
* gastrointestinal disorders that could interfere with fat absorption
* hypertension
* history of cancer
* an intention to lose weight
* use of anticoagulant
* serum triglycerides (TG) \>200 mg/dL, and/or total cholesterol (TC) \>240 mg/dL, and/or LDL-cholesterol (LDL-C) \>160 mg/dL
* hypertension or lipid lowering medications
* consumption of more than one alcoholic drinks/day
* Consumption of more than one fish or seafood serving
* one month prior to the start of the study
* omega-6 fatty acids in the past 6 months
* planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
* planned to to become pregnant during the study period
* BMI\>28
* allergies to fish seafood or corn
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

Vast majority of breast cancers arise from ductal epithelium. Ductal cells can be collected through the nipple orifice very early in breast cancer development. The nipple aspirate ﬂuid (NAF) can be used to identify biomarkers that predict risk of breast cancer. To date, the biomarkers identified in nipple aspirate ﬂuid (NAF) have limited utility due to the large volume of NAF required for data analysis. Recent studies show intranasal oxytocin's utility in enhancing the yield of nipple aspirate ﬂuid (NAF) among healthy, non-lactating female patients as well as those at high risk for breast cancer. This capability is crucial for the analysis of various markers associated with breast disease and cancer such as microRNAs. The primary aim of the study is to determine whether the microRNA profile characterization is feasible with the collection of tissue, serum and NAF in patients with in situ and invasive breast cancer. Intranasal oxytocin will be used to enhance ﬂuid yielding of the NAF.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer
* Candidate for breast conserving surgery or mastectomy

Exclusion Criteria:

* Pregnant women
* Prior Breast Cancer diagnosis
* Adverse reaction to Oxytocin in the past
Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.

Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

Objective:

Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.

Methods:

All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All patients fit for general anesthesia and presenting an inguinal hernia.

Exclusion Criteria:

* Not fit for general anesthesia, young age (\>21 years), not wanting a mesh.
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia

Clinical Study of DA-007 As a Treatment for Chemotherapy Induced Alopecia

Chemotherapy induced alopecia (CIA) is a common adverse event of oncological treatment. The significant psychological burden of CIA, particularly in women, leads some (\~8%) to reject life saving therapeutic regimens. Several studies have demonstrated the effectiveness of scalp vasoconstriction as a prophylactic treatment for CIA. Recently, US Food and Drug Administration (FDA) approved a scalp-cooling device as a prophylactic treatment for CIA. Scalp cooling results in reduced local blood perfusion and consequently reduced chemotherapeutic agents reaching the hair follicle niche; however, scalp cooling requires prolongation of the time required to attend the chemotherapy unit (\>2 hrs) as well as common adverse events including intolerance to cold. A previous study demonstrated that the α1 agonist, phenylephrine hydrochloride, applied topically can penetrate the scalp and bind α1 receptors. As such, a topically applied α1 agonist would reduce scalp blood perfusion. A novel formula (DA-007), containing an α1 agonist, that can also penetrate the scalp and bind α1 receptors. The aim of the study is to test the hypothesis that DA-007 can reduce scalp blood perfusion and thus reduce hair loss due to chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stage I or stage II breast cancer
* Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy.
* Ages 18-65
* Able to give informed consent

Exclusion Criteria:

* Resting blood pressure outside the range of 105-140/ 55-99
* Uncontrolled or severe hypertension
* Female pattern hair loss or hair loss disorder
* Folliculitis
* Scalp psoriasis
* Seborrheic dermatitis
* Inflammatory scalp conditions such as lichen planopillaris
* Subjects wearing wigs prior to chemotherapy
* Use of MAO inhibitors
* Unable to provide consent or make allotted clinical visits