cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients

The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg. Treatment efficacy will be evaluated by the percentage of LDL-C variation after 8 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* subjects presenting type IIa or IIb primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks)

Exclusion Criteria:

* homozygous or heterozygous familial hypercholesterolaemia
* hypertriglyceridaemia (TG ≥ 4 g/l)
* subjects at high cardiovascular risk according to the AFSSAPS 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year CHD risk \> 20%)
* history of adverse events or hypersensitivity to an HMG Co-A reductase inhibitor (particularly a history of myopathy)
* concomitant use of any drugs not authorized during the study
* active liver disease with elevation of serum transaminases (ASAT, ALAT) more than twice the upper limit of normal
* CPK more than 3 times the upper limit of normal
* moderate or severe renal failure (creatinine clearance \< 6 ml/min)
* poorly controlled hypothyroidism; poorly controlled hypertension (DBP \> 95 mm Hg and/or SBP \> 180 mm Hg)
Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients

Patients suffering from COVID-19 (Coronavirus Disease 2019) pneumonia are prone to bacterial and mycotic superinfection. According to existing evidence, the prevalence of superinfection is about 8% to 14% (95% CI 5-26%). However, the percentage of patients treated for superinfection is as high as 80%. There can be multiple reasons for this difference.

The inflammatory markers, such as C-reactive protein (CRP), procalcitonin (PCT), presepsin (PSP), interleukin-6 (IL-6) frequently used as diagnostic tools in COVID-19 (Coronavirus Disease 2019), are usually increased in these patients. This increase is a result of activation of systemic inflammatory cascade, part of COVID-19 pathophysiologic pathway. This can escalate to state known as COVID-19 associated hyperinflamation (COV-HI). In addition, current diagnostic tools for diagnosing HAP/VAP (hospital-acquired pneumonia and ventilator-associated pneumonia) are often limited in patients with COVID-19 pneumonia. The current method of choice for superinfection diagnosing is BAL (Bronchoalveolar Lavage). The COV-HI phenotype (COV-HI: CRP \> 150 mg/L, or doubling within 24 h from greater than 50 mg/L, or ferritin concentration \> 1500 ug/L) is associated with significantly worse course of illness and higher mortality rates. These inflammatory markers may be used preferentially as prognostication tools, not bacterial superinfection markers. The intention of this project is to investigate the role of currently used inflammatory biomarkers. Or eventually, to discover new parameters associated with superinfection proven by BAL.

Eligibility Criteria:
Inclusion Criteria:

1. admission on ICU
2. age more than 18 years
3. COVID-19 pneumonia criteria fulfilled

Exclusion Criteria: none

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EFFECT OF EXERCISES IN PATIENTS WITH STROKE

Aim: This study was conducted as a randomized controlled experimental study to determine the effect of ROM exercises applied to individuals who had a stroke on functional independence and quality of life.

Design: This study was conducted as a randomized controlled experimental study Methods: The study was conducted with 80 individuals, 40 of whom were in the intervention group and 40 in the control group, who received inpatient treatment in the neurology service of a regional city hospital, and met the inclusion criteria. Planned ROM exercises were applied to the individuals in the intervention group 3 times a day for 2 weeks, and no application was made to the control group other than routine treatment. Data were collected by the researcher using the Questionnaire Form, Patient Information Form, Functional Independence Scale and Stroke Specific Quality of Life Scale.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old,
* Coming to the hospital within 72 hours of having a stroke,
* A definitive diagnosis of Cerebrovascular Diseases according to the diagnostic criteria,
* Having a hemiplegic condition,
* Having a score of 13 or higher on the Glasgow Coma Scale,
* Not to be involved in any special exercise program other than the service routine,
* Having approval from the clinician about there is no harm in doing ROM exercises,
* Agreeing to participate in the study

Exclusion Criteria:

* People with quadriplegia/tetraplegia,
* Those with psychiatric illnesses,
* Those who have any extremity amputated,
* Those who have open wounds that prevent exercise and cause bleeding,
* Those with fractures in their body and those who had an orthopedic operation
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer

RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer.

PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.

OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage.

OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days.

PROJECTED ACCRUAL: 20 patients will be accrued per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth, oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or invasive carcinoma of the head and neck

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity to porphyrins Not pregnant Fertile patients must use effective birth control

PRIOR CONCURRENT THERAPY: Not specified
Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes

Primary Objective:

1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes.

Secondary Objective:

1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.

Studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function.

Individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. These individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression.

Participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. It will take about 25 minutes to complete the questionnaires.

Participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. Participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy.

This is a one-time evaluation, no follow-up visit or questionnaires are required.

This is an investigational study. A total of 108 individuals will take part in this study. All will be enrolled at UTMDACC.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic pain greater than one year.
2. Male.
3. Cancer status must be stable or in remission. For this study, "stable disease" is defined as identifiable disease at local or metastatic sites that has shown no progression over the previous 3 months and there has been no cancer treatment for ³ 3 months.
4. Patients must be on chronic opioid therapy on a continuous basis in the preceding twelve months with a Morphine Equivalent Daily Dose (MEDD) ³ 200.
5. Age \>/= 18. The questionnaires used in this study have been validated only in the adult population. In addition, some of the questionnaires contain questions of a sensitive nature and are not appropriate in the pediatric population.
6. Patients must be able to understand and sign the consent form.

Exclusion Criteria:

1. Patient who refuses to participate in the study or determined incapable of completing the research.
2. Patients with pre-existing hypopituitarism. Causes include certain tumors (pituitary adenomas, hypothalamic tumors), inflammatory diseases (granulomatous diseases), vascular diseases (postpartum necrosis, carotid aneurysm), traumatic/destructive events (prior surgery, trauma, or radiation), developmental anomalies, infiltration.
3. Patients who tare taking any drugs that may affect the hypothalamic-pituitary-gonadal axis.
Using Virtual Counselors to Overcome Genetic Literacy Barriers

A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older;
* current Boston Medical Center patient - must have an upcoming returning patient appointment at Boston Medical Center or affiliated clinic within 3 months of recruitment;
* speaks English and/or Spanish.

Exclusion Criteria:

* Under 21 years of age;
* not a current patient of Boston Medical Center or affiliated clinic;
* unable to speak English and/or Spanish.
Interleukin-2 (IL-2), Interleukin-5 (IL-5) and Interleukin-17 (IL-17) Levels of Patients With Stainless Steel Crowns

The aim of this study is to investigate whether nickel hypersensitivity following stainless steel crown treatment in children aged 7-13 leads to an increase in IL-2, IL-5, and IL-17 levels by analyzing saliva samples. By doing so, the study seeks to prevent potential hypersensitivity reactions after stainless steel crown treatment.

The main question it aims to answer is:

Which interleukin level increases in the controls 1 week after stainless steel crowns are applied? Researchers will investigate whether there is a significant increase in interleukin levels in children's saliva before and after the procedure.

Participants will:

They will provide saliva samples before stainless steel crowns are applied They will visit the clinic after 1 week for check-ups and tests.

Expression levels of IL-2, IL-5 and IL-17 in the saliva of individuals aged 7-13 years who underwent stainless steel crown will be recorded before and after the procedure. Before the saliva sample collection procedure, the patient will be asked to rinse their mouth with sterile water and then spit into sterile plastic cups. After collecting approximately 3 ml of saliva, the saliva will be transferred to appropriate eppendorfs and stored at -40 degrees Celsius. For the second post-procedure, the same algorithms will be applied for saliva collection seven days after the crown procedure. Also ph value and ion levels of saliva will be measured

Eligibility Criteria:
\*\*Inclusion Criteria:\*\*

* Patients with teeth requiring stainless steel crowns due to having caries on two or more surfaces.
* Pediatric patients between 7-13 years old

\*\*Exclusion Criteria:\*\*

* Patients having any dental materials, such as fillings, fissure sealants, root canal treatments, or space maintainers
* Patients with known allergies to various foods and materials.
* Patients with systemic diseases that affect the immune system.
* Patients with a history of chemotherapy or radiotherapy.
Quality of Life (QoL) Assessment in Cancer Patients and Survivors With Dermatologic Conditions Using Dermatologic QoL Instruments

The purpose of this study is to see how skin conditions that are related to different kinds of cancer or cancer treatments affect a patient's overall well-being. Skin conditions are common in cancer patients and survivors. Sometimes, the skin condition is directly related to the cancer. Other times, these conditions are a side effect of cancer treatment. Patients in the study will be asked to fill out at least one questionnaire about how they feel about their skin condition. If the patient needs to be treated for their skin condition, they will be asked to complete the same questionnaire when they return for a follow-up visit. The investigators hope the study will improve our understanding of how cancer patients feel about their skin conditions. They also hope this study helps them learn how to improve the way we treat skin conditions in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients and survivors with a pre-existing dermatologic condition related to their underlying disease or completed/ongoing therapy for cancer, who present for assessment/management of their skin condition.
* Male or female patients at least 3 years and older
* NOTE: Informed Consent guidelines will be followed for minors
* First grade adult family members, spouses, and caregivers of patients with a Grade 2 or 3 or higher dermatologic condition related to their primary cancer or cancer treatment able to provide written informed consent

Exclusion Criteria:

* Cognitive or psychiatric deficit resulting in an inability to provide written informed consent
A Randomized,Double Blind, Placebo Controlled Study to Assess Efficacy,Safety and Tolerability of BGG492 in Migraine Prevention

It will provide a first evaluation of efficacy, safety and tolerability of BGG492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive)
* Patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start
* Patient diagnosed with migraine (according to the International Headache Society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the Screening
* Patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance

Exclusion Criteria:

* Patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history.
* Patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start
* Patients receiving regular treatment during the four (4) weeks preceding the Baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. SSRIs, SNRIs, Tri- or Tetracyclics).
* Patients receiving migraine prevention medications during past three (3) months preceding Baseline
* Patients receiving topiramate as migraine prevention medication during past six (6) months preceding Baseline
* Patients receiving metamizole as acute treatment of migraine during past three (3) months preceding Baseline
* Patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of OATP transporters (e.g. rifampin).
* Any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start
* Patients with recent (within the last three \[3\] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.).
* Pregnant or nursing (lactating) women. Baselines (1 and 2).
* Patients with history of drug or alcohol abuse within the 12 months prior to dosing Other protocol-defined inclusion/exclusion criteria may apply
A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer

To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* histologically confirmted advanced colorectal cancer
* ECOG PS 0-2
* expected life span more than 3months
* normal bone marrow, liver, renal function

Exclusion Criteria:

* 5-FU, oxaliplatin, irinotecan or Metformin Allergic history
* Lactic acidosis, metabolic acidosis
* active infection or severe neuropathy
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.

Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.

This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-18 years
* Idiopathic scoliosis
* Fusion levels planned for 10 or greater
* English speaking
* American Society of Anesthesiology (ASA) class 1 - 3

Exclusion Criteria:

* Current narcotic use / History of substance use disorder
* Morphine, hydromorphone or methadone allergies
* Pregnancy
* Seizure disorders
* Bleeding disorders
* Neuromuscular scoliosis
* History of renal or hepatic disease
* Long QT syndrome
* Obstructive sleep apnea
* Body mass index \> 40
* Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
* Non-English speaking
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.

This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.

Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, postmenopausal women ages 35 to 70 years, inclusive.
* Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 5 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance With Age; the Role of Amino Acids in Modulating Muscle Metabolism

The investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. The investigators will perform this study in healthy older (65-75y) and younger (18-28) men. The investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used.

The investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.

We will provide a 15g mixed essential amino acid feed or 4 x 3.75g.

There is sexual dimorphism thus initially we will just recruit males. Powering calculations dictate n=8 in each group.

We will use well established stable isotope tracer techniques (with 13C6 Phenylalanine) to measure muscle protein synthesis and breakdown by Gas Chromatography - combustion - isotope ratio mass spectroscopy.

We will measure leg blood flow by phase shift Doppler and muscle microvascular flow by contrast enhanced ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* age 65-75 or 18-28

Exclusion Criteria:

* BMI \>30
* Diabetes
* Beta blocker or steroid use
* Established cerebrovascular, peripheral vascular or ischaemic heart disease.