cyrilzakka/clinical-trials huggingface dataset:
Mental Health Assessment and Prescribing by Alberta Pharmacists

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

Primary objective

-To evaluate the effect of enhanced pharmacist care possible by community pharmacists with APA in comparison with usual care (standard pharmacist care and physician care) for patients with MDD and/or GAD initiated on pharmacotherapy, with focus on interventions that include:

i) monitoring (lab ordering and interpretation, clinical monitoring of MDD and GAD) ii) patient education iii) referral facilitation (in collaboration with prescribing physician) iv) prescribing (dose adjustment and the addition of adjunctive medication)

Secondary objectives

* To evaluate the effect of APA pharmacist interventions on:

  i)Clinical:
* The rate of achieving clinical response and remission of MDD and/or GAD compared to usual care (using PHQ-9/GAD-7)
* Change in the mean PHQ-9 and GAD-7 score
* Cognitive and functional impairment related to MDD and/or GAD
* The occurrence of relapse of depression and/or anxiety
* The proportion of patients receiving appropriate and optimized depression and anxiety medication
* Patient complaints and/or experiences of medication-related side effects during treatment for MDD and/or GAD (i.e. GI intolerance, dizziness, weight gain)

ii) Process:

* The impact of the interventions on patient satisfaction and quality of life impact (Patient survey)
* Assure sustainability by exploring enabling (i.e. pharmacist reimbursement framework) and potential barrier forces (i.e. pharmacist training in managing patients with MDD and GAD)

Eligibility Criteria:
Inclusion criteria:

* Adults (≥ 18 years of age) newly diagnosed with MDD and/or GAD, including:
* Patients starting on medications for the management of adults with MDD
* Patients starting on medications for the management of GAD

Exclusion Criteria:

* Pregnancy
* Non-Alberta residents
* Unwilling or unable to participate in regular follow-up visits
* Unwilling to participate/sign consent form
* ≥2 suicide attempts per year
* Severe, psychotic, and catatonic depression
* History of and/or current substance abuse, intoxication, addiction or withdrawal
* Patients diagnosed with comorbid anxiety disorders other than GAD, including: panic -disorder, agoraphobia, specific phobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder
* Patients diagnosed with comorbid depressive disorder other than MDD, including: depressive disorder due to another medical condition (e.g. hypothyroidism, MS, OSA, -Parkinsons, stroke, TBI, Vitamin B12 insufficiency, Huntington disease, adrenal insufficiency, mononucleosis, systemic lupus erythematosus), adjustment disorder with depressed mood
* Patients diagnosed with concurrent ADHD, bipolar disorder, schizophrenia and schizoaffective disorder
Hydrogen Gas for Cancer Rehabilitation

The aim of this study is the efficacy of hydrogen gas immunotherapy to rehabilitation and prognosis of cancer patients.

By enrolling patients of multiple kinds of cancer adapted to enrolled criteria, this study will document for the first time the short and long term efficacy of hydrogen gas.The evaluation indexes include peripheral blood lymphocyte immunoassay, improvement of sleep, diet and exercise, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Standard therapies have finished according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
LutrePulse Hypogonadotropic Hypogonadism

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo


Eligibility Criteria:
Inclusion Criteria:

* Women 18-40 years old
* Body mass index (BMI) between 18 and 38 kg/m2
* Clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic hypogonadism
* Hormonal values in a centrally analyzed fasting blood sample: FSH \<5 IU/L and mean LH \<5 IU/L
* Desire to become pregnant
* Discontinued estrogen-progesterone replacement therapy at least 1 month before screening
* Negative progestin challenge test performed during screening
* PAP smear within 24 months of the initial visit
* Normal or stable CT scan or MRI scan of the hypothalamic pituitary region
* Prolactin and thyroid-stimulating hormone (TSH) within normal clinical laboratory limits
* Male partner with normal semen analysis, including volume, liquefaction time, sperm count, and motility, according to the local laboratory normal criteria, within the past year
* Normal transvaginal ultrasound at screening with respect to uterus and adnexa (presence of both ovaries and tubes, without evidence of clinically significant abnormality) and with normal uterine cavity and normal cervix
* Tube patency on saline tubal perfusion, hysterosalpingography or laparoscopy on file within the past 2 years

Exclusion Criteria:

* Any medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug
* A history of, or currently diagnosed with clinically important cardiovascular, pulmonary (e.g. serious corticosteroid-dependent asthma), gastrointestinal, hepatic, metabolic, renal, endocrinological (e.g. insulin dependent diabetes mellitus), or neurological (e.g. epilepsy, serious migraine, central nervous system (CNS) lesions (in cases where hypogonadotropic hypogonadism is secondary to a CNS lesion or its treatment) abnormality
* A history of adrenal or uncontrolled thyroid disorders, or hyperprolactinemia
* Prior treatment cycle with gonadotropins or GnRH within the last 2 months
* Known allergy to study drug or its components
* Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Ovarian enlargement or cyst of unknown etiology
* Abnormal gynecological bleeding of undetermined origin
* Previous or current hormone-dependent tumor
* Known active substance abuse
* Planning to undergo in vitro fertilization procedure in the course of a study treatment cycle
* Currently undergoing treatment with gonadotropin hormones (FSH and LH), psychotropic medication, sex hormones, or any other medication known to interfere with normal reproductive function or that can affect GnRH secretion (e.g. neuroleptics, dopamine antagonists, spironolactone, levodopa, phenothiazine, digoxin)
* Ongoing pregnancy or lactation
Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics

This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).

This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1). This study will utilise prospective sample respiratory swabs from individuals with paired test data, presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia), as well as asymptomatic individuals. To meet the target number of 400 positive samples (50 samples per target; 8 targets in total), a required sampling size of 1000 participants will need to be screened to account for unviable samples and screen failures. Prospective respiratory samples will include nasopharyngeal swabs as described in Intended Use of the product.

Eligibility Criteria:
Inclusion Criteria:

* The sample is derived from an individual who has the ability to provide consent or from a legally acceptable representative, parent(s), or legal guardian and have consented for their sample and demographic information to be taken
* The sample is a nasopharyngeal swab
* The sample is collected in universal transport media (UTM) or viral transport media (VTM), using FDA approved swabs
* The sample is collected from an individual who has a presumptive diagnosis or is presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia) or is suspected to be asymptomatic.

Exclusion Criteria:

* Sample does not meet acceptable specimen criteria in that is not a nasopharyngeal swab
* The sample is collected using swabs with wood shafts or other materials known to inhibit growth of influenza viruses
The Effect of Blood on the PC Ratio During Pregnancy

This study will examine the effect if blood on the the protein to creatine (PC) ratio in pregnant patients by adding blood to urine samples.

The Purpose of the Research:

The purpose of this study is to examine the effect of blood on the protein to creatine (PC) ratio in pregnant patients.

The Scientific or Scholarly Rationale:

The PC ratio is used to diagnosis proteinuria in pregnancy. It is thought that blood in the urine will cause the PC ratio to be elevated but there are no current studies to prove this hypothesis.

The Procedures to be Performed:

Upon presentation to the Labor and Delivery Triage or the Antepartum Unit, patients will be enrolled in the study. Urine collection that is not needed for medical workup will be collected and saved, and an extra 8 mLs of blood will be drawn during routine lab collection by phlebotomy team. Additional lab costs will be covered by Marshall Obstetrics \& Gynecology.

Lab protocol: Divide urine into 4 different specimen cups with 20 mLs of urine each to measure urinalysis (UA) and PC ratio:

1. UA and PC ratio on original sample
2. UA and PC ratio with 1 mL of whole blood added
3. UA and PC ratio with 2 mL of whole blood added
4. UA and PC ratio with 5 mL of whole blood added

Subjects medical records will be reviewed for past obstetrical history after consent to be in the study.

The Risks and Potential Benefits of the Research:

Risks: 8 mLs of additional maternal blood will be drawn for study purposes. Possible risks could include pain, bleeding, fainting, bruising, infection, or hematoma (blood clot under the skin) at the injection site. Please note that routine blood would be drawn regardless of study enrollment.

Benefits: Our hypothesis is that the PC ratio will be elevated by contamination with blood. It is unknown if this hypothesis is correct.

Complete Inclusion/Exclusion Criteria (may be submitted separately if extensive):

Inclusion criteria includes patients presenting to Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of \>20 weeks.

Exclusion criteria includes pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine).

Eligibility Criteria:
Inclusion Criteria:

* Labor and Delivery Triage or Antepartum Unit at Cabell Huntington Hospital between the ages of 18 and approximately 45 years and gestational age of \>20 weeks

Exclusion Criteria:

* pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

PRIMARY OBJECTIVES:

I. Greater intervention effects on health-related quality of life

SECONDARY OBJECTIVES:

I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice

OUTLINE: Sites are randomized to 1 of 2 arms.

ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
2. Patients must have the ability to understand and willingness to provide verbal consent.
3. Participants must speak English, Spanish, Chinese, or Vietnamese.

Exclusion Criteria:

1. Inability to consent to the study
2. Plans to change oncologist within 12 months
3. Employed by the practice site
4. Patients who anticipate moving from the area within 12 months
Impact of Tai Chi in Cervical Myelopathy

The goal of this observational study is to determine if patients with cervical myelopathy who participate in a Tai Chi program will demonstrate improved gait and balance compared to patients who undergo usual care.

Participants must be 18 years or older and have a diagnosis of cervical myelopathy.

Patients who meet inclusion criteria and choose to participate will be randomized to either participate in a Tai Chi falls-prevention program or continue with usual care. Those in the Tai Chi program will attend a pre-determined number of Tai Chi classes for a period of approximately 6-8 weeks. Investigators will assess their gait and balance at the time of enrollment and at several timepoints after they have participated in the class (similar timepoints for those randomized to usual care).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cervical Myelopathy with planned surgery
* 18 years of age or older
* Able to participate in intervention (attend and participate in classes)

Exclusion Criteria:

* Wheelchair bound at initial visit
* Other verified potential cause of gait instability/balance problems
* Unable to participate in intervention (unable to attend/participate in classes)
Safety Study of Nebivolol for COPD Patients

The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).

The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

* Asthma; Heart failur;
* End stage kidney disease;
* acute myocardial infarction,unstable angina, stroke or TIA within the past year;
* Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.
A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae

The purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection

Each participant will be in the study for approximately 12 months and will be required to come to Mayo Clinic for 3 visits. These visits will take place approximately 2-3 months after confirmed COVID-19 diagnosis (visit 1), 6 months after diagnosis (visit 2), and 12 months after diagnosis (visit 3).

Comprehensive clinical evaluation and symptom characterization, quantitative lung CT image analysis and pulmonary function testing, and quality of life questionnaires will be obtained at each visit. Bronchoscopy with BAL (collected at visits 1 and 3 only) and blood samples (collected at all visits) will dissect the dynamic immunological and molecular signatures in the respiratory tract and in the circulation longitudinally. We will also perform highly sensitive viral reservoir or remnant assays to address the potential contribution of viral factors in regulating chronic lung conditions post-acute COVID-19.

Eligibility Criteria:
Inclusion Criteria:

For the Sequelae Group

* Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.
* Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).

Control Recovery Group

* Age ≥18 years at screening
* PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49
* Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.

Exclusion Criteria:

* Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease;
* Active cigarette smoking, vaping or other inhalation use.
* Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents;
* \> 20 pack year smoking history.
* History of chemotherapy or radiation therapy in the last two years; and pregnancy.
Registry of Laypeople's CPR Performance

The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices.

The registry collect all the laypeople's performance of 1-minute of chest-compression only CPR registered at the end of a CPR/AED course in which feedback devices were used for at least 1 minute.

All centers which carry out BLS/AED course for laypeople using CPR feedback devices can join to the registry.

All the centers have to declare the duration of the course, the guidelines followed, the participants' anthropometric variables and the feedback device they used for the course and for the test.

The centers must send the performances of all the participants of a course.

Eligibility Criteria:
Inclusion Criteria:

* Layperson
* Participating in a BLS/AED course carried out with feedback devices

Exclusion Criteria:

* Healthcare personnel
Male Reproductive Health of Floating Population: a Large-Scale Survey in Dongguan

To determine the prevalence of sexual problems particularly premature ejaculation and erectile dysfunction among men working in factories of Dongguan city, using the self-rating scales like International Index of Erectile Function, and to investigate the characteristics or risk factors associated with these sexual problems in floating population through regression analysis.

In China, the floating population is a special group of people who work and live outside their hometowns and without residence cards of that area they reside. Sexual problems are common in floating population, majority of whom are in their sex active age. There is a lack of studies concerning these sexual problems, so we conduct this survey to investigate the sexual dysfunctions among men, especially the floating population, and to find out whether most of these sexual problems are related to their social lives, medical illnesses, and psychological status.

Eligibility Criteria:
Inclusion Criteria:

* have reached 18 years old
* live in Dongguan more than 6 months
* floating population
* with or without residence card

Exclusion Criteria:

* younger than 18 years old
* live in Dongguan less than 6 months
Gastric Ultrasound in Term Pregnants

In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Food residues in the stomach of patients scheduled for surgery are a major risk factor for pulmonary aspiration, leading to significant morbidity and mortality. This risk is particularly critical in pregnant women who may require surgery without proper fasting. National guidelines recommend fasting for 6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids. These guidelines apply equally to adults and children. Pregnant patients scheduled for elective surgery follow the same fasting rules as non-pregnant patients.

Gastroparesis, defined as delayed gastric emptying without mechanical obstruction, affects 30-50% of diabetic (DM) patients. Ultrasound measurement of the gastric antral area can help identify whether the stomach is full in symptomatic patients. Gastric ultrasound is a valuable tool for assessing aspiration risk in pregnant women, especially during emergency surgeries, and has shown promise in fasting non-pregnant patients scheduled for elective surgery.

In this study, the investigators aimed to evaluate the gastric antrum using ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in a standard fasting state before surgery. The primary goal was qualitative assessment, with secondary objectives including quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with good mental status
2. Pregnant patients aged ≥18 years
3. Patients in ASA II-III group
4. Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
5. Term pregnant women (gestational age ≥ 36 weeks)
6. 50-120kg weight
7. 150cm height or taller
8. Written informed consent

Exclusion Criteria:

1. Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
2. Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
3. Pregnant women with term labor or obstetric emergency
4. Twin pregnancy -
Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis

To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of vascular dysfunction in patients with atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with \>= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy
* Age \>= 18 years
* Agreement of the operating surgeon for patient to participate

Exclusion Criteria:

* Surgery scheduled \< 14 days after randomization
* Pregnancy
* ALT, GGT \> 3x upper limit of normal (ULN)
* Creatinine \> 3.5 mg/dL
* Prior intolerance to statins
* Reluctance to add or change dosage of statin therapy during study