cyrilzakka/clinical-trials huggingface dataset:
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers

To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females between 18 and 50 years of age.
* The subject has a maximum abdominal circumference of 120 cm or less.

Exclusion Criteria:

* The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
* The subject has chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<60 mg/dL) as measured at the screening visit.
* The subject is pregnant or breast-feeding.
* The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
* The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
* The subject is taking metformin (e.g., Glucophage®) therapy.
Epidemiological Study of Out-of-hospital Cardiac Arrest in Guangzhou

Aim This was a population-based retrospective cohort study of OHCA. This study intends to retrospectively analyze the data of pre-hospital emergency system in Guangzhou for 10 years, explore the incidence trend of OHCA in Guangzhou for 10 years; Through further analysis, we try to explore the time distribution characteristics of OHCA in order to understand the epidemiological characteristics and rules of OHCA in super large cities in southern China.

Methods The pre-hospital traffic data in the main urban area of Guangzhou Emergency Medical Command Center database from 2011 to 2020 were collected. The cases diagnosed as "cardiac arrest" and "sudden death" were screened, and the cases with non-cardiac causes in the diagnosis were deleted. The crude incidence rate and age-standardized incidence rate of OHCA were calculated. Joinpoint software was used to calculate the changing nodes in the OHCA incidence trend, and the AnnualPercent Change (APC) and Average AnnualPercent Change (Average AnnualPercent Change, APC) of OHCA incidence were calculated. AAPC). The OHCA data were grouped according to the six main urban areas, and the crude incidence rate, ASIR and changing trend of the six main urban areas were calculated. The data of OHCA were grouped by age, and the crude incidence rate, ASIR and changing trend of each age group were calculated. The data information was divided into groups according to 24 hours a day, 7 days a week, and four seasons. The number of OHCA cases in different time periods was statistically described. The data were imported into SPSS 26.0 for analysis, and Mann-Kendall test was used to evaluate the statistical significance of the time trend. Time rhythm variability was tested for mean distribution using chi-square goodness of fit test.


Eligibility Criteria:
Inclusion Criteria:

Cases in the database with a secondary diagnosis containing the diagnostic keywords "cardiac arrest" and "sudden death"

Exclusion Criteria:

1. cases where the diagnosis of "cardiac arrest" and "sudden death" includes a diagnosis of a non-cardiac cause such as asphyxiation, suicide, drowning, advanced cancer, trauma, shock, poisoning, cerebral vascular accident, etc;
2. cases with duplicate records of sex, age, time of call, pick-up address and initial diagnosis
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects

The clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. Concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the HPA axis in the abuse-related effects of nicotine.

These clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. The studies also intend to examine the contribution of menstrual cycle phase. It is hypothesized that this novel focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing our understanding of the neurobiology of nicotine reinforcement.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 40 who currently smoke at least 15 cigarettes every day, and who fulfill DSM-IV diagnostic criteria for nicotine dependence will be eligible for participation.
* No evidence of clinically significant disease based upon complete medical history and physical examination supervised by Dr. Arthur Siegel (Chief of Internal Medicine).
* Absence of DSM-IV Axis I Disorders other than nicotine dependence (305.10) as measured by the Structured Clinical Interview (SCID).
* Routine laboratory blood tests including complete blood count, electrolytes, BUN and creatinine, liver function tests, hepatitis panel and urinalysis will be performed. Laboratory parameters must be within the normal range. HBsAg must be negative but subjects who have hepatitis serology consistent with previous exposure to Hepatitis A, Hepatitis B, or Hepatitis C, but who do not have clinical and biochemical evidence of acute infection, will be acceptable.
* Hematocrit levels ≥ 35% for females.
* Serum pregnancy test (hCG beta subunit) results must be negative within 24 hrs of the study session day.
* Normal EKG.
* A Body Mass Index (BMI-ratio of weight (W) to height (H) squared; W/H2=kg/m2) of between 18.0 and 27.0 for women.
* Subjects must be able to read and understand instructions, as well as provide a valid informed consent.

Exclusion Criteria:

* Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
* Participants with clinically significant medical disorders.
* Women who are pregnant as determined by laboratory testing for serum beta hCG.
* Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.
* Women with a mean BMI of outside the range 18.0-27.0.
* Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.
* Subjects with peanut/peanut oil allergies will be excluded.
* Participants diagnosed with lactose intolerance will be excluded.
Isometric Exercise for Hypertension

Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.

Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. All patients will be followed up for 24 weeks. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring


Eligibility Criteria:
Inclusion Criteria:

* a suboptimal daytime SBP of \>135-160 mmHg on a 24-h ABPM
* reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week);
* on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments
* agree for no drug changes during the intervention period (24 weeks);

Exclusion Criteria:

* cannot provide informed consent
* unwillingness to repeat ABPM
* relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
* severe osteoarthritis pending knee replacement surgery
* known secondary HT
* use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
* SBP or DBP are \>160 mmHg or \>100 mmHg, respectively, on ABPM
* pregnancy/breastfeeding
* active malignancy
Efficacy of Amygdala Retraining With Mindfulness (ART+MF) vs Compassion Therapy (CT) for the Treatment of Patients With Fibromyalgia

Amygdala Retraining Treatment (ART) is a new and promising therapy for patients with Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM), however, randomized controlled trials (RCT) are scarce. The investigators have added mindfulness to this therapy, based on preliminary reports of its efficacy on patients, obtaining Amygdala Retraining Treatment with Mindfulness (ART+MF).

Other therapy that has been assessed in many psychiatric and medical disorders during the last years has been Compassion Therapy (CT). There are no studies on its efficacy in FM.

Aims: The aim of this trial is to assess the efficacy of both ART+MF and CT on the general function of the patients with FM. A secondary objective is to assess the effect of these therapies on psychological (pain, depression, anxiety, etc.) and biological variables (some biomarkers related with inflammation).

Methods:

* Design: Randomized, controlled trial with three arms: a) ART+MF, b) CT and c) Relaxation as control intervention.
* Sample: A sample (N=60 patients, about N=20 for each arm) will be recruited from primary care settings at the city of Zaragoza, Spain.


Eligibility Criteria:
Inclusion criteria

1. Male or female aged between 18-65 years.
2. The patient needs to have the ability to read and understand Spanish
3. All the patients included in the study have been diagnosed with FM by a rheumatologist working for the Spanish National Health Service.
4. It is required that the patient does not modify during the trial the pharmacological treatment prescribed.
5. Signed informed consent.

Exclusion criteria

The patient should not meet any of the following criteria during the study:

1. Age \<18 years or\> 65 years.
2. The patients considered for exclusion are individuals with severe axis I psychiatric disorders (dementia, schizophrenia, paranoid disorder, alcohol and/or drug use disorders) and with severe somatic disorders that, from the clinician's point of view, prevented patients from carrying out a psychological assessment or participating in other clinical trials
3. It is not considered an exclusion criterion antidepressant use, as long as the treatment is not modified during the study period (treatment can be decreased, never increased).
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor

The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.

Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

Arm A: Cisplatin, Paclitaxel and Gemcitabine

* Cisplatin 75 mg/m2 IV infusion, Day 1
* Paclitaxel 175 mg/m2 IV infusion, Day 1
* Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8

Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab)

* Cisplatin 75 mg/m2 IV infusion, Day 1
* Paclitaxel 175 mg/m2 IV infusion, Day 1
* Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
* Bevacizumab 7,5 mg/m2 IV infusion, Day 1

Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high).

The regimens will be repeated every 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Unknown primary tumors
2. ECOG performance status 0-1
3. Adequate kidney, liver and bone marrow function
4. No prior chemotherapy
5. Life expectancy \> 3 months

Exclusion Criteria:

1. The following specific syndromes:

   * Squamous carcinoma limited to cervical glands
   * Women with adenocarcinoma isolated to axillary nodes
   * Women with adenocarcinoma isolated to peritoneal involvements
   * Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected
   * Neuroendocrine carcinomas
2. Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
3. Any significant cardiac disease
4. Clinically significant peripheral vascular disease
5. History of myocardial infarction or stroke within 6 months
6. Evidence of coagulopathy
7. Use of ASA, NSAIDs or clopidogrel
8. Pregnancy or breast feeding
9. Ongoing therapeutic anti-coagulation
10. Hypertension with blood pressure \> 150/100 mmHg
11. Brain metastases
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

OBJECTIVES:

Primary

* Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

Secondary

* Analyze the limiting toxicities according to CTC.
* Analyze the toxicity according to CTC.
* Determine the recommended dose.
* Determine the pharmacokinetic dosages of the three drugs.
* Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * Advanced disease
* No standard curative therapy available
* Must have received prior first-line chemotherapy
* No brain metastasis

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 8 weeks
* ANC ≥ 1.5 x 10\^9/ L
* Platelet count ≥ 130 x 10\^9/ L
* Hemoglobin ≥ 10 g/dL
* Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 130 mmol/L OR creatinine clearance \> 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No intolerance or hypersensitivity to any of the drugs being tested
* No history of interstitial lung disease
* No history of severe cardiac disease
* No serious uncontrolled infection
* No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
* Must not be deprived of liberty or under guardianship
* Must not be on probation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior erlotinib hydrochloride
* No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
* More than 14 days since participation in another clinical trial
Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children

The primary aims of this research project are to:

1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental health, and anthropometric outcomes.
2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing healthy family nutrition and physical activity practices, amount of physical activity, and BMI.
3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity, and anthropometric outcomes.

Background: The number of obese children in the US remains high, which is problematic due to the mental, physical, and academic effects of obesity on child health. Data indicate that school-age children, particularly underserved children, experience unhealthy gains in BMI at a rate nearly twice as fast during the summer months. Few efforts have been directed at implementing evidence-based programming to prevent excess weight gain during the summer recess.

Methods: Camp NERF is an 8-week, multi-component (nutrition, physical activity, and mental health), theory-based program for underserved school-age children in grades Kindergarten - 5th grade coupled with the USDA Summer Food Service Program. Twelve eligible elementary school sites will be randomized to one of the three programming groups: 1) Active Control (non-nutrition, physical activity, or mental health \[4H curricula\]); 2) Standard Care (nutrition and physical activity); or 3) Enhanced Care (nutrition, physical activity, and mental health) programming. Anthropometric, behavioral, and psychosocial data will be collected from child-caregiver dyads pre- and post-intervention. Site-specific characteristics and process evaluation measures will also be collected.

Discussion: This is the first, evidence-based intervention to address the issue of weight gain during the summer months among underserved, school-aged children. Results from this study will provide researchers, practitioners, and public health professionals with insight on evidence-based programming to aid in childhood obesity prevention during this particular window of risk.

Eligibility Criteria:
Inclusion Criteria (site level):

* Elementary school; USDA Summer Food Service Program open site; and 3) lacking structured programming

Exclusion Criteria:

-
Hula, a Physical Activity Intervention for Female-Cancer Survivors

A six-month interventional program to determine the biological and psychosocial effects of hula as a form of physical activity for female breast, cervical, endometrial or ovarian cancer survivors living on Oahu.


Eligibility Criteria:
Inclusion Criteria:

* Lives on Oahu
* Diagnosed with primary breast,cervical, endometrial or ovarian cancer (stage I-III)
* Completed initial regional and systemic treatment for breast cancer 2 months ago
* Physically capable of doing the hula-based physical activity
* Receives approval by attending physician to participate in trial

Exclusion Criteria:

* Currently undergoing chemotherapy or radiation therapy
Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)

Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.

The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lymphoma (Hodgkin's or non-Hodgkin's)
* Age \> 18 y/o and \< 70 y/o
* WHO score \< or = 2
* Life expectancy \> 6 mo
* Left ventricular ejection fraction \> 50%
* Informed consent

Exclusion Criteria:

* Previous chemotherapy using anthracyclines
* History of radiation therapy
* History of congestive heart failure
* History of chronic renal insufficiency
* Contra indication to MR examination
* Atrial fibrillation and significant arrhythmia
* Pregnancy
Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion

To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage

This study will investigate the impact of punctal occlusion on the ocular microbial flora. Current thought is that punctal occlusion causes retention of inflammatory mediators on the ocular surface which may produce pathology, we hypothesize that blockage of the nasolacrimal drainage system may allow colonization of the ocular surface by potentially pathogenic ubiquitous organisms (which may produce exotoxins and other biologic products) that may be responsible for signs and symptoms seen in some patients. Additionally, the presence of the silicone foreign body(punctal plug) may act as a nidus for bacterial adhesion with biofilm production (which is known to occur with Pseudomonas sp and other organisms). There would thus be a paradigm shift of our current understanding of the pathophysiology of punctal occlusion. Additionally, the choice of antimicrobials for the treatment of infections in patients with punctal occlusion may need to be modified if the microbial flora is found to be different in patients with punctal occlusion.

The ocular flora may be different inpatients with severe dry eye or other chronic pathologic conditions, which are frequent indications for punctal occlusion. However, from our retrospective review, we could not determine if there was a change in the microbial flora following plug placement with colonization with these "unusual organisms" since baseline cultures prior to punctal plug placement were not obtained.

We will try to differentiate any effect on the microbial flora caused by the silicone plug or acrylic plug(as a foreign body) versus the punctal closure by thermocautery. (Punctal thermocauterization is an alternative method of punctal closure which is 1) the preferred choice by some ophthalmologists for all their cases, or 2) when the dry eye is severe and irreversible punctal occlusion is desired or 3) if punctal plugs can not be retained due to the large size of the patients punctal). The thermodynamic hydrophobic acrylic plug(SmartPLUG) approved by the FDA for punctal occlusion with the same indications as the traditional silicone plug.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Able to sign Informed Consent
* Clinical indication for punctal plug insertion or punctal cautery or symptomatic patients who have previously had punctal occlusion
* Clinical indication for punctal plug removal(Partial extrusion, discomfort) increased signs of ocular irritation with punctate keratopathy, punctal inflammation).
* Able to make follow up visit schedule

Exclusion Criteria:

* Subjects without dry eye