cyrilzakka/clinical-trials huggingface dataset:
Measuring and Improving Coproduction Using coopeRATE

The purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.

This study has 3 specific aims: Aim 1 will assess the construct validity of the coopeRATE Measure in the before phase of a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Measure is a generic, patient-reported experience measure of collaborative goal setting that was recently developed in consultation with patients and other key stakeholders. Aim 2 will assess the impact of the coopeRATE Prompt intervention on collaborative goal setting and other outcomes in a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Prompt intervention is a set of questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals. Aim 3 will evaluate the feasibility and acceptability of implementing the coopeRATE Prompt and Measure in routine adult cystic fibrosis care.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of cystic fibrosis
2. Are 18 years of age or older
3. Can read and write in English
4. Are attending a participating site for a routine cystic fibrosis care visit
5. Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry
6. Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
7. Have not previously participated in the study

Exclusion Criteria:

1. Do not have a diagnosis of cystic fibrosis
2. Are less than 18 years of age
3. Cannot read and write in English
4. Are not attending a participating site for a routine cystic fibrosis care visit
5. Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry
6. Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
7. Have previously participated in the study
A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years
* Confirmed and documented diagnosis of HIV-1 infection
* Virological suppression of more than 48 weeks (confirmed with HIV RNA \<50 copies / ml). The determination of the CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent.
* ART in stable dual therapy (\> 48 weeks) with DTG + 3TC
* Signed informed consent
* Negative pregnancy test in urine or blood

Exclusion Criteria:

* Inability to obtain written informed consent to participate in the study
* Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods.
* Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs.
* Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
* Any chronic autoimmune or inflammatory disease
* Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents
* Any acute infection in the last 2 months
* Estimated glomerular filtration rate (TFGe) \<30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed
* Contraindication for the use of TAF
* Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study
* Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same.
* Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations
Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD

Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints

Utilize: Chronic Respiratory Disease Questionnaire (CRQ)

The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)

Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in health outcomes and quality of life as primary endpoints, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Cognitive ability to retain education and training
* Resides in a stable residence or home, apartment
* Managed by primary care physician (family practice)

Exclusion Criteria:

* Lacks cognitive ability to retain education and training
* Not managed by primary care physician (family practice)
* No stable residence or is homeless
Study of Rapamycin Plus Ketoconazole in Advanced Cancers

To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Patients with hematologic malignancies (lymphoma, multiple myeloma and CLL only) are eligible to participate in the phase Ib portion of the trial only
* At least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last regimen included BCNU or mitomycin C).
* Age \>18 years.
* ECOG performance status less than or equal to 2
* Life expectancy of more than 3 months.
* Normal organ and marrow function as defined below:

  * Hemoglobin ≥ 10 g/dl
  * Leukocytes ≥ 3,000/µL

    o WBC ≥ 1,500/µL for patients with hematologic malignancies
  * Absolute neutrophil count ≥ 1,500/µL (≥ 1,000/µL for patients with hematologic malignancies)
  * Absolute lymphocyte count ≥1000/µL
  * Platelets ≥ 100,000/µL (≥ 50,000/µL for patients with hematologic malignancies)
  * Total bilirubin within normal institutional limits
  * AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional ULN
  * Serum triglycerides ≤ 500 mg/dl
  * Creatinine within normal institutional limits OR
  * Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Able to understand and the willing to sign a written informed consent document.

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Receiving any other investigational agents.
* Uncontrolled brain metastases or malignancy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Severe immunodeficient state (as judged by the treating physician)
* Pregnancy (breast-feeding must be discontinued)
* HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with rapamycin.
* Concurrent use of cyclosporine, tacrolimus, and rifampin, terfenadine, astemizole, cisapride, rosiglitazone or pioglitazone due to possible interactions with the study drugs. Ketoconazole cannot be taken within 2 hours of an antacid.
Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery

This is an observational study to look at the impact of the Enhanced Recovery After Surgery system for colorectal surgery (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at UAMS prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).

This is a retrospective study using de-identified records and therefore will not require subject enrollment and is NOT Human Subjects Research.

The Enhanced Recovery After Surgery system for perioperative care of patients undergoing major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal surgery were hospitalized postoperatively for extended periods of time due to prolonged return of the normal intestinal physiology and of other bodily functions. Dr. Kehlet formulated a system of perioperative care that focused on preserving and promoting faster return of normal physiologic function of the human body following surgery.

The Enhanced Recovery After Surgery system has been implemented in the United States for nearly a decade now, primarily at major academic institutions. Numerous publications exist that report the dramatic positive impacts of this program on reducing postoperative hospital length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.

The University of Arkansas for Medical Sciences implemented several components of the Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an observational study to look at the impact that program (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at University of Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).

Eligibility Criteria:
Inclusion Criteria:

* All men and women 18 years and older who underwent major colorectal surgery at University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014 and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist physical status classification 1-3 at the time of surgery.

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification \> 3 and age \< 18.
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

The primary objective of this study is to compare the safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 12 years of age and older
* Written and verbal informed consent must be obtained
* Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
* Subjects must be willing to comply with study instructions and return to the clinic for required visits

Exclusion Criteria:

* Any dermatological conditions on the face that could interfere with clinical evaluations
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
* Subjects with a facial beard or mustache that could interfere with the study assessments
* Subjects who are unable to communicate or cooperate with the Investigator
* Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study
Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research

The intent of this protocol is to obtain blood samples from subjects with or without a wound, so the blood can be used in wound-related scientific studies. It is also the intent of this protocol to salvage debrided wound material that is normally destined for destruction, so it can be used in wound-related scientific studies.

The samples will be studied in order to attempt to better understand wounds and their associated barriers to healing. Analytical methods used to examine the blood or debridement can investigate morphological, molecular, immunological, cellular, viral, biochemical, chemical, genetic, and/or transcriptional components of the samples. It is the goal of this study to determine if these tests may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the Collection of Wound Debridement

1. The subject must have a full thickness wound.
2. The subject must be a candidate for sharp debridement.
3. The subject must be 18 years of age or older.
4. The subject must be mentally competent as determined by the Investigator Inclusion Criteria for the Collection of Blood

Wounded or Otherwise Not Healthy Subjects, Subjects Weighing Less Than 110 lbs., or Subjects Contributing 50ml of Blood or Less:

1. The subject must be 18 years of age or older.
2. The subject must be mentally competent as determined by the Investigator.

Not Wounded and Healthy Subjects Weighing at Least 110 lbs. Who May Contribute Up To 500ml of Blood:

1. The subject must be 18 years of age or older.
2. The subject must be mentally competent as determined by the Investigator.
3. The subject must weigh at least 110 lbs.
4. The subject must have a hemoglobin level that is in or above the normal range within the last 8 (eight) weeks as determined by standard clinical laboratory testing, the copper sulfate test, or a point of care instrument.

Exclusion Criteria:

Exclusion Criteria for the Collection of Wound Debridement and Blood Collection\*

1. The subject must not be currently incarcerated or pregnant.
2. The subject must not weigh less than 40 lbs.
3. If the subject will be contributing more that 50 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.
Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD

Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have got FFMI (bioimpedance)
* Patients who have done quadriceps muscle strenght evaluation

Exclusion Criteria:

* Patients without FFMI
* Patients without quadriceps muscle strenght
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to performance of any trial-related activity
* Male sex 18 years of age or older
* At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.

Exclusion Criteria:

* Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
* Interstitial Cystitis
* Chronic prostatitis/chronic pelvic pain syndrome
* Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
* Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
* Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
* Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
* Central or nephrogenic diabetes insipidus.
* Syndrome of inappropriate anti-diuretic hormone.
* Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
* Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
* Neurogenic detrusor activity (detrusor overactivity)
* Suspicion or evidence of cardiac failure
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus
* Hyponatraemia: Serum sodium level must be within normal limits
* Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
* Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
* History of obstructive sleep apnea
* Previous desmopressin treatment for nocturia
* Treatment with another investigational product within 3 months prior to screening
* Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
* Known alcohol or substance abuse
* Work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers
* Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial
The Effect of Eyeliner on Tear Composition, Tear Secretion and Tear Film Stability.

Eyeliner is one of the most common eye cosmetics. The main ingredients are titanium oxide, pigment, grease and preservative. The user will apply the eyeliner to the eyelid and eyelash. With the blinking again and again, the components of the eyeliner may enter the tear film and continue to act on the eye surface. Therefore, the investigators suspect that the use of eyeliner may be an important factor leading to dry eye disease. In order to explore the relationship between the use of eyeliner and dry eye disease, the investigators plan to collect eye surface characteristic data of the two groups of people who use eyeliner and who do not use it.Then use Raman analysis to explore whether the use of eyeliner will lead to changes in tear composition.The investigators intend to analyze the difference of tear composition between the two groups to understand the relationship between the change of tear composition and tear film stability.So that the investigators can identify the risk factors of dry eye disease, and provide basis for prevention and early treatment.

The investigators will include the population according to the inclusion criteria and exclusion criteria.The subjects in the eyeliner group and the control group filled in the survey to score the ocular surface disease index. Tear secretion test and sodium fluorescein staining are conducted in the eyeliner group and the control group, and the results are recorded. The intraocular pressure of the two groups is measured and recorded. Dry eye analysis is conducted for the two groups of people to collect relevant data. Tears are collected by capillary glass tube and stored for further Raman analysis.

Eligibility Criteria:
Inclusion Criteria:

* People aged 20-35 who use eyeliner or do not use eyeliner .
* People who use eyeliner have used it for ≥ 1 year; Frequency ≥ 3 times/week.

Exclusion Criteria:

* Other serious systemic diseases.
* Other systemic diseases related to ocular surface, such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome and other immune system diseases or other eye diseases, history of eye surgery and trauma.
* Lactating women or pregnant women.
* Use electronic products for more than 4 hours every day.
* Patients with circadian rhythm disorder.
* People with radiation exposure history.
* Non permanent residents in Wuhan.