cyrilzakka/clinical-trials huggingface dataset:
MICU Recovery Clinic

Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive critical illness. However, there is no data regarding long-term follow-up for ICU survivors. The investigators have begun the implementation of an ICU recovery clinic.

Rationale:

ICU survivors are at high risk for functional, cognitive and psychiatric impairments. However, methods to mitigate these impairments and improve recovery are lacking. Special follow-up clinics for survivors of critical illness have been proposed and implemented to some degree, but are uncommon.

Objectives:

1. To evaluate physical function, cognitive function, and overall functional status during recovery from critical illness.
2. To evaluate anxiety, depression, and PTSD during recovery from critical illness.
3. To evaluate resilience during recovery from critical illness.
4. To evaluate healthcare utilization rates, morbidity, and mortality following critical illness.
5. Added April 2016: To study the voice and swallowing function of patients following recovery from critical illness.
6. Added April 2016: To study the pain of patients following recovery from critical illness.

Intervention:

A prospective observational study of all patients who attend our ICU recovery clinic.

Methods:

Patients will be identified for participation in our ICU Recovery Clinic during their admission to the Wake Forest Baptist Medical Center Medical Intensive Care Unit (MICU). They will be asked to return to the ICU recovery clinic within 1 month of hospital discharge. Structured clinic visits as standard of care will include medication reconciliation and evaluation by a pharmacist, along with an evaluation by a clinic physician to address acute medical issues and provide counselling. They will also undergo standardized testing to evaluate physical function, cognitive function, and psychiatric function. Added April 2016: They will also undergo a standardized evaluation of speech, swallow, and pain.

Eligibility Criteria:
Inclusion Criteria: Wake Forest MICU Admission

* sepsis OR
* respiratory failure requiring \>24 hrs of invasive mechanical ventilation
* previously functional

Exclusion Criteria:

- Active Malignancy
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).

The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>/= 18 years of age.
* Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
* Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
* Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
* Patients with "Intermediate" or "Low" risk per the Motzer score.
* Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria:

* Patients who have received prior systemic treatment regimens for RCC.
* Uncontrolled/unstable cardiac disease
* Uncontrolled hypertension
* Active clinically serious infections (\> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 )
* History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
* Known history or symptomatic metastatic brain or meningeal tumours
* Patients with seizure disorder requiring medication
* Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event \>/= CTCAE Grade 3 within 4 weeks of first dose of study.
* Pregnant or breast-feeding patients
Impact of HLNatural Immune Supplement on Colds

According to the Centers of Disease Control and Prevention (CDC) adults will have an average of 2-3 colds per year. Most colds will last approximately 7-10 days. The symptoms of colds could include cough, sore throat, runny nose, body aches, fevers, headaches and fatigue. A cold can affect your activity such as going to work, interrupting your sleep and your day to day activities. The test product contains all natural ingredients which have been combined into a powder to be taken in water at the sign of a cold.

At the onset of a cold, mix 1 packet of the drink-mix product in 6-8 oz. of hot water. Drink the drink mix twice a day until symptoms are gone or 18 days, whichever comes first.

1. Complete the screening survey.
2. Sign the eConsent if approved.
3. Complete the baseline survey, demographic form, and Medication and Supplements form.
4. Receive test product and log into study portal and complete supplement receipt form. This will mark the start of your participation in this study.
5. Once you have a cold, complete the symptom survey.
6. Take test product.
7. Write down any adverse or ill effects any time after taking the test product.
8. Record if you took any additional medications or supplements daily during the course of your cold.
9. Note any final adverse events and complete the exit form.

Eligibility Criteria:
Inclusion Criteria:

Adult candidates in the general population who are in good health and are seeking herbal remedies to reduce the duration of their common cold symptoms when they should arise. Participants will be deemed to be in good health if they do not report any of the medical conditions asked about in the screening questionnaire.

Exclusion Criteria:

* Age \< 18 years old
* Unwilling to try the test product during their first cold experience in the trial
* Has any of the following medical conditions:

  * Chronic seasonal allergies
  * Allergy to any of the following ingredients: Echinacea, Ivy Extract, Camu Camu, Vitamin C, Ginger, Turmeric, Zinc or a known allergy to Guar Gum, Monk Fruit, Citric Acid, Natural Flavors.
  * Asthma
  * Current cold infection
  * Currently taking antimicrobial or antiviral medication
  * Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion
  * Routine recreational drug use
  * Chronic renal disease
  * Chronic liver disease
  * Known autoimmune or immunodeficiency disorders
  * Medically treated atopy or allergy
  * Pregnant or breastfeeding
Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

The purpose of this study is to determine, among patients receiving elective anorectal surgery, does application of ice to the perianal area prior to the procedure, lead to use of decreased amounts of intravenous (IV) anesthesia? Anorectal surgeries for hemorrhoids, fistulas and fissures are done on an outpatient basis under monitored anesthesia care. This means patients get sedating medications through an IV but often do not require intubation. The difficulty with monitored anesthesia is balancing patient comfort against the risk of apnea (not breathing due to over sedation). Application of ice to the perianal area may help increase patient comfort, decrease the amounts of medications given for sedation and therefore decrease risk and increase recovery from the anesthesia.

The study design will be a randomized control trial of adults undergoing elective surgery for hemorrhoids, fistulas, perianal/perirectal abscess and anal fissure. Participants will be randomized in a 1 to 1 ratio using a random number generator to two arms to the study - usual care vs. usual care plus ice to numb the anal area prior to incision.

The outcomes will be measured the same day as the surgery. Prior to leaving the operating room the anesthesia team will share with the surgeon the amount of each drug they administered. A comfort score will be recorded by the study personnel in the recovery area prior to discharge for each participant.

Eligibility Criteria:
Inclusion Criteria:

-Patient with planned minor elective colorectal surgery (eg for hemorrhoids, perianal abscess, fistula in ano, anal fissure, pilonidal cysts, or anal condyloma)

Exclusion Criteria:

-Patient who requires general anesthesia as part of the initial anesthesia plan
Cilostazol in Acute Ischemic Stroke Treatment (CAIST)

The purpose of this study is to study efficacy and safety of cilostazol use in patients with acute ischemic stroke.

Stroke is a leading cause of death and elderly disability in developed countries. However, treatment of acute stroke is limited except thrombolytic therapy in hyperacute stroke within several hours. Currently, aspirin is widely used in spite of its small benefit compared to bleeding complications.

Cilostazol will be compared to aspirin in acute stroke patients in terms of functional outcome at 3 months, efficacy to prevent stroke recurrence, and safety for bleeding complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive explanation on this study and give informed consent
* Patients aged 30 to 85 years
* Baseline NIHSS less than 15
* Onset of symptoms within 48 hours of the start of investigational product
* Full functional independence prior to the present stroke indicated by an mRS score of 0, 1, 2

Exclusion Criteria:

* Evidence from CT or MRI scan of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke likely to cause the present symptoms.
* Previous regular use of an antiplatelet agent or warfarin
* Patients with known cardiac disease likely to cause cardiogenic embolism or congestive heart failure
* Evidence from CT or MRI scan of midline shift when visiting hospital
* Uncontrolled hypertension (SBP\>220 mmHg or DBP\>120 mmHg)
* Hypotension (\<90/60 mmHg)
* Patients with known bleeding diathesis or coagulation disorder
* Patients with liver disease (ALT\>100 or AST\>100), or renal disease (creatinine\>2.0 mg/dl)
* Known severe anaemia (hemoglobin\<8.0 mg/dl), or thrombocytopenia (platelet\<100,000/mm3)
* Scheduled for endarterectomy within 3 months
* Severe co-morbidity likely to limit patient's life expectancy to less than 6 months
* Patients with alcohol or illegal drug abuse or dependency
* Pregnant or lactating patients. When administrating to females, it should be confirmed that the patients is in the menopause (by evaluation of investigators) or permanently infertile (hysterectomy or surgical operation like bilateral tubal ligation, bilateral oophorectomy, etc). If a patient is likely to be pregnant, the patient should not be pregnant before randomization. And, the patient should use reliable contraception between at least 3 weeks before randomization to 7 days after the final administration of study drug.
* Patients treated by thrombolytic agents like tPA after onset of stroke
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis (RA) of \>/= 6 months duration
* Prior treatment with DMARDs for \>/= 12 weeks (at stable dose for \>/= 8 weeks)
* Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA
* Previous treatment with any biologic drug that is used in the treatment of RA
* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
* Impaired liver, renal or hematologic function
* Active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
Correlation of Several Formulas to Evaluate Insulin Sensitivity With the Predicted M Index

Recently, an index based on the oral insulin sensitivity index with glucose (OGIS) has been proposed in combination with anthropometric variables, called PREDIcted M (PREDIM), however, there is no evidence of the correlation of this with respect to the various indices (McAuley, Belfiore, Cederholm, Avignon, Matsuda, Gutt, Stumvoll, HOMA-IR (Homeostatic Model Assessment for Insulin Resistance), ISI (Insulin Sensitivity Index), Raynaud, QUICKI (The quantitative insulin sensitivity check index), FIRI (Fasting Insulin Resistance Index), Bennett, TyG (triglycerides and glucose index)) in healthy patients.

Analytical cross-sectional study with 25 healthy patients of both genders (male and female) from 30 to 60 years old, residents of the metropolitan area of Guadalajara.

They will be operated on for a 3-hour oral glucose tolerance test. The insulin sensitivity will be calculated with the PREDIM, Matsuda, McAuley, Belfiore, Cederholm, Avignon, Gutt, Stumvoll, HOMA-IR, ISI, Raynaud, QUICKI, FIRI, Bennett and TyG indexes.

This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

The statistical analysis will be presented with measures of central tendency and dispersion, mean and standard deviation. The nominal variables in numbers and percentages. The Kolmogorov-Smirnov test will be performed to determine if the variables follow a normal distribution. To correlate the formulas used to evaluate the insulin sensitivity with the PREDIcted M (PREDIM) technique, the Pearson or Spearman correlation will be used according to the distribution.

Eligibility Criteria:
Inclusion Criteria:

* Both genres
* Age 30 to 60 years
* BMI \<25 kg / m2,
* Patients who are not sedentary or who participate in heavy physical activities
* Stable weight in the last 3 months

Exclusion Criteria:

* Blood pressure \>120/80 mmHg
* Glucose \>100 mg/dL
* Postprandial glucose \>140 mg/dL
* Cholesterol \>200 mg/dL
* Triglycerides \>150 mg/dL
* Smoking
* Women with polycystic ovarian syndrome
* History of metabolic, cardiovascular, thyroid, renal, pancreatic and/or arterial hypertension
* Use of medications that modify insulin sensitivity (corticosteroids)
* Previous surgery or infection
* Symptoms of vomiting and/or excessive nausea
Study of 18F-Thretide PET/CT in Patients With Prostate Cancer

This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer and is potentially associated with metastasis and progression of prostate cancer. Compared with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 18 years of age;
* For patients with newly diagnosed prostate cancer : (1) adult patients with PCa confirmed by biopsy; (2) no any form of therapy against PCa within last three months; (3) planned surgical treatment;
* For patients with suspected recurrence of prostate cancer: (1)Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy; (2)Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA level ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL ; or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir;
* Life expectancy ≥3 months as determined by the investigator;
* Able and willing to provide informed consent and comply with protocol requirements.

Exclusion Criteria:

* Known allergic history to fluoride 18F-Thretide injection and/or 99mTc-MDP or its excipients;
* Patients who cannot tolerate intravenous administration (such as a history of needle sickness or blood sickness);
* Those who are not suitable for or unable to complete PET or other imaging examinations due to special reasons, including claustrophobia and radiophobia, etc.
* Practitioners requiring prolonged exposure to radioactive conditions;
* Serious diseases of the heart, kidney, lung, vascular, nervous and psychiatric systems, immune deficiency diseases and hepatitis/cirrhosis;
* Have been diagnosed with clinical recurrence of prostate cancer;
* Patients receiving ADT treatment or chemotherapy;
* Patients who participated in clinical trials of radiopharmaceuticals within the previous 1 year;
* Participated in other interventional clinical trials within 1 month prior to screening;
* There are other conditions that the researcher considers inappropriate to participate in this study.
The Development of Patient Experience With Nursing Care Scale

Nurses are a vital and central part of the health care system, accounting for nearly half of the global health workforce and spending more time with patients than any other medical professionals. Patient experience with nursing care, as a process indicator, reflects the interpersonal aspects of care received and has an important impact on overall experience and satisfaction with hospital care. The results of the previous study showed that the most important predictor of patient satisfaction with hospitals was patient experiences with nursing care.

Since nurses are so deeply and widely involved in patients' care, an instrument with a clear conception definition, systematically developed and psychometrically validated will be extremely valuable in measuring patient experience with nursing care, so as to collect and analyze patient feedback toward nursing services, and push the quality improvement according to the preferences, needs and values of the healthcare recipients.

This study, therefore, aimed to develop construct and validate a comprehensive and internally consistent instrument to measure patient experience with nursing care in the Chinese hospital setting.


Eligibility Criteria:
Inclusion Criteria:

1. had been hospitalized for 2 days or more;
2. able to speak and understand Chinese.

Exclusion Criteria:

patients with cognitive impairment.
Meditation for Pain

The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. All participants will be asked to complete a set of questionnaires

Chronic pain affects an estimated 11.2% of the US population, costs the United States approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. Understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. However, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (Apps) for Well-being (CAWs). The proposed study will examine the use and impact of a meditation apps in the context of pain. Participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. To assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.

Eligibility Criteria:
Inclusion Criteria:

* Emory Healthcare patient

Exclusion Criteria:

* Non-english speaking patients
* Children, prisoners or other vulnerable populations
Comparing Different Methods for Collection of Comorbidity Data Per the HCT-CI

Comorbidity assessment in the field of HCT might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods, Claims-based and patient questionnaire-based, as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

Studies have shown the importance of pre-transplant comorbidities in predicting mortality after allogeneic HCT.

However, comorbidity assessment might be a burden on the medical team at the clinic or the research staff. This research study aims to explore and validate new methods as alternatives to the standard chart-based method in order to facilitate comorbidity coding. The study aims to save time and effort of medical personnel and to ensure the inclusion of comorbidity information in all clinical trials and outcome research studies in order to improve the accuracy of treatment decision-making, patient assignment to appropriate HCT strategy and hence HCT outcomes.

This study will investigate two parallel approaches aimed at simplifying comorbidity assessment and thereby facilitating wide-spread use of the HCT-CI. Patient questionnaire-based and Claims-based methods will be tested as possible alternative to the Chart-based method. primary outcome is prediction of non-relapse mortality. It is expected that once this method of comorbidity coding is validated, it will benefit physicians in non-academic institutions and community clinics.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for autologous or allogeneic HCT.
* Able to speak and read English.
* Willing and able to provide informed consent.
* There is no restriction based on diagnosis, intensity of conditioning regimen, type of donor graft, degree of HLA-matching, or stem cell source.
* Patients \>20 years old
* Access to a telephone for study-related communications.

Exclusion Criteria:

* HCT candidates who cannot read, write, or speak English.
* Patients \<20 years old