cyrilzakka/clinical-trials huggingface dataset:
Culturally Appropriate Nutrition Communication for Mexican American Women

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals. The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The investigators also measured a number of hypothesized mediators and moderators of the effects.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Latina/x or Hispanic
* Self-identify as a woman
* Self-reported as being of age between 18-29 years
* Undergraduate students enrolled in SONA at UC Merced

Exclusion Criteria:

- Not Mexican American
Ceramide NanoLiposome in Patients With Advanced Solid Tumors

This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
* 18 years of age or order
* Histologic or cytologic diagnosis of cancer
* Patients without a curative therapy or whose tumor does not have standard chemotherapy
* At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
* Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2 (Appendix A).
* Adequate hepatic, renal, and bone marrow function:

  * Absolute neutrophil count ≥ 1,000/microliter (uL)
  * Platelets ≥ 100,000/uL
  * Total bilirubin ≤2.0
  * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
  * Creatinine ≤1.2 mg/dL or clearance ≥50ml/min (Cockcroft-Gault)
* All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
* Radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (\>1.5cm in greatest dimension)
* Men and women of all ethnic groups are eligible for this trial.
* Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
* Life expectancy is greater than 12 weeks.
* Patients with controlled CNS disease and off steroids are eligible.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol.
* Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded. Males and females should perform abstinence or use barrier to prevent pregnancy.
* History of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible
* Patients known to be HIV(+), Hep BsAg(+), or Hep C(+) are excluded as the effect of the agent on immune system has not been assessed
* Patients with history of hypersensitivity to liposomal products
* Patients with primary CNS malignancies or leptomeningeal disease are excluded
Effects on the Personalized Rehabilitation Service in Patients With Cancer

In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching).


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user

Exclusion Criteria:

* Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program
Geographic Modeling of Traffic and Asthma Rates

This study surveys the parents/guardians about symptoms and diagnosis of asthma in kindergarten and first-grade students in 13 schools around the city of Anchorage, Alaska. Traffic information is also measured and entered in geographical information mapping system with student's home and school locations. The study will assess whether students living in high traffic areas have greater risk of diagnosis of asthma.

Survey was distributed through the schools. Parents/guardians were asked about indoor exposures such as environmental tobacco smoke, insects, mold, woodstoves, as well as demographic information about the child and housing type, income,also biologic information about parental asthma. Questions included symptoms of respiratory illness as well as wheezing and medication use. Civil engineering department measured traffic on local roadways and gathered traffic information from state and municipal sources regarding traffic on arterioles and major traffic arteries. All information was entered into geographical information system (GIS) including the closest cross-streets to the child's home and the school location. Traffic exposure variables are being developed for each child and will be added to the database on indoor exposures. A regression model will be used to determine the significance of traffic exposure in receiving a diagnosis of asthma for children five to seven years of age.

Eligibility Criteria:
Effect of Three Weeks Consumption of Rye Porridge Breakfast

Acute hunger-reducing effects (8h) has been documented for rye porridge breakfast compared with iso-caloric referenced refined wheat reference breakfast. The primary aim of the current study is to investigate whether this effects remains at regular consumption. A secondary aim is to compare the orocecal transit time (OCTT) between the two breakfasts.

The study is randomised and cross-over. During two 3-wk periods, separated by a 3-4-wks wash out, subjects will consume test breakfasts. During one of the periods test breakfast includes rye flake porridge and during the other period test breakfast include bread made from sifted wheat. The breakfast meals will be similar in calorie-, protein-, carbohydrate- and fat content. For all other days but 1, 8 and 22 of respective test period, the breakfast foods will be handed out to the participants along with instructions to exchange their ordinary breakfast with the test foods. During day 1, 8 and 22 the breakfasts will be served at the study centre.

Following measurements will be made:

1. Subjective ratings of hunger, satiety and desire to eat during 24 h after breakfast on day 1, 8 and 22 during each 3-wk intervention period.
2. on day 8 during each intervention period, orocecal transit time and breath hydrogen will be measured after intake of the breakfast.
3. 3 day weighed food diaries will be taken at three occasions: at baseline and during the second week of each dietary intervention period.

Eligibility Criteria:
Inclusion Criteria:

* man or woman aged between 20 and 60 years;
* body mass index (BMI) 18-27 kg/m2;
* habit of consuming breakfast, lunch and dinner every day;
* and willingness to comply with the study procedures.

Exclusion Criteria:

* intake of medicine likely to affect appetite or food intake;
* any medical condition involving the gastrointestinal tract;
* eating disorder;
* smoking;
* consumption of more than three cups of coffee per day;
* change in body weight more than 10% during three months prior to screening;
* consumption of any restricted diet such as vegan, gluten-free, slimming;
* pregnancy, lactation or wish to become pregnant during the study period;
* any known intolerance towards salazopyrin and similar substances
Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

The investigators' long-term goal is to identify, and then provide general practitioners with evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue (UCF). The investigators' central hypothesis guiding this application is that some complimentary and alternative medicine (CAM) practitioners have developed management approaches that are more helpful to patients with UCF than usual care.

An objective is to identify certain types of clinicians (or individual physicians) who appear to have identified effective treatments for patients with UCF, or to find that clinicians who report themselves to be effective are not. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians: 1) a control group of MDs in practice-based research networks, 2) MDs trained in CAM, 3) naturopathic doctors (non MDs trained in special naturopathic schools), and 4) MDs who specialize in chronic fatigue. Our rationale for this comparison is that its successful completion will potentially guide future searches for effective medical strategies for the treatment of UCF that may have been developed outside the mainstream medical community. It may also provide necessary information for follow-up studies that will help to identify specific effective treatments. This information includes which clinicians provide the best treatments (as evidenced by having patients with the best results), what are the characteristics of patients who respond to a particular treatment, how the data collection procedures might need to be refined and what sample sizes are necessary.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 through 65.
2. Has severe debilitating fatigue that substantially reduces the quality of life.
3. Does not have any organic, psychological, or lifestyle problems that are the primary disorder and are likely to be the cause of this fatigue (see exclusionary criteria)
4. The severe, unexplained fatigue has persisted for at least six months.
5. Has not been previously treated by current physician for chronic fatigue.
6. Can speak and read English.
7. Is not pregnant or planning to become pregnant within six months.
8. Has a telephone.

Exclusion Criteria:

No known history of:

1. Bipolar disorder
2. Psychosis
3. Major Depressive Disorder
4. Sleep disorder
5. Anemia
6. Thyroid disease
7. Rheumatoid Arthritis
8. Systemic Lupus
9. Cancer
10. Heart disease
11. Liver disease
Pioglitazone Decreases Visceral Fat Metabolism

Excess visceral fat is associated with chronic systemic inflammation and cardiovascular complications. Pioglitazone has been reported to variably influence visceral fat volume, but it its effect on metabolic activity of the visceral fat remains uncharacterized. To evaluate the effect of pioglitazone on glucose metabolism of fat tissue by using 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) imaging.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 35 and 85 years
* Subjects with impaired glucose tolerance and type 2 diabetes

Exclusion Criteria:

* Subjects with insulin treatment
* Subjects with uncontrolled diabetes, hypertension, symptomatic coronary artery disease, symptomatic cerebrovascular disease
* Subjects taking more than three antidiabetic medications
* Subjects taking anti-platelet, statins, antidiabetic agents, thiazolidinediones within 8 weeks prior to randomization
* Subjects with cardiac failure (New York Heart Association Class \> III) or left ventricular dysfunction (LVEF \< 40%)
* Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
Catheter Biofilm Microbiome in Infected Neonatal Catheters.

Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into blood vessels of premature babies (neonates) to give them nutrition and medications. Sometimes these tubes get infected and they need to be removed. Also, the babies need to be given medications to treat these infections (antibiotics). PICC infections in neonates are a serious problem and we need to find new ways of detecting infections early so that we can treat them promptly to avoid complications.

The purpose of this study is to understand what causes tube infections in neonates and to develop a test to detect tube infections early to avoid complications.

Catheter-associated bloodstream infections (CLABSIs) are a significant component of healthcare-associated infections (HAI),which are associated with significant mortality, morbidity and healthcare costs. Neonates are at higher risk for CLABSIs than children or adults and CLABSIs are seen more commonly in neonatal than pediatric or adult intensive care units. Neonates, who develop CLABSIs, are not only at serious risk for mortality but also long term neurodevelopmental impairment. CLABSIs are often caused by organisms colonizing the skin and the most frequently isolated organisms are CONS, S. aureus and Candida.

The catheter biofilm microbiome, to our knowledge has not been investigated before. Evaluation of biofilm microbial signatures and microbial DNA load is a novel strategy that may permit earlier diagnosis of CLABSIs. Earlier detection may enable earlier targeted therapy such as antimicrobial lock solutions and may facilitate preservation of catheters in this vulnerable population. Catheter microbial DNA signatures or load may be useful biomarkers to not only predict or diagnose infections but to monitor antibiotic therapy and to confirm resolution of infection.

We will study 15 percutaneously inserted central catheters (PICC) each from neonates with CLABSIs and those without. We will evaluate the bacterial microbiome by profiling V3-5 region of the 16S rDNA, by PCR and pyrosequencing. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site. We aim to identify microbial signatures that predispose to dissemination of infection from catheter biofilms leading to CLABSIs. Further, we will quantify microbial DNA load in blood from the catheters at the time of removal, by real-time PCR of the bacterial 16S rDNA.

Eligibility Criteria:
Inclusion Criteria:

* Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs

Exclusion Criteria:

* Infants with known Immunodeficiency Syndrome
Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease.

Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.

Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the informed consent process culminating with written informed consent by the subject
* Men and women age 18 to 65 years inclusive.
* Patients with biopsy proven NASH with a score of 4 or above.
* Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
* HBA1C between 5.5 and 14%.

Exclusion Criteria:

-
Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess

Aim: The aim of this study was to compare the analgesic efficacy of two combinations of opioid and non-opioid analgesics for acute periradicular abscesses.

Methodology: This study included 24 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Periradicular Abscess
* Age greater than 18 years
* Spontaneous pain greater than 40 mm measured in Visual Analogue Scale (moderate to severe pain).

Exclusion Criteria:

* Intake of analgesics or antibiotics within 4 hours prior to emergency surgery
* Allergy to the drugs used in this study
* Gastric ulcer, liver or kidney disease
* Uncontrolled diabetes mellitus or epilepsy
* Pregnancy or lactation
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19

This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.

This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients.

Study Objectives:

Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress.

Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital as in-patient (ward or ICU)
* Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 \<300)
* Bilateral lung infiltrates (CT or frontal X-ray)
* Supplemental oxygen started but NOT intubated or ventilated
* COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test);
* CDC confirmation not necessary
* Time from Enrollment to treatment must be less than 24 hours
* Age: 18-80 years
* Gender: any
* Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor the patient is suitable for cellular therapy
* Cognitive function: Able to understand and willing to sign informed consent form or legally authorized representative or surrogate

Exclusion Criteria:

* Intubation / ventilation
* Current therapy is working, and patient is clinically improving
* Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO)
* Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy
* Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study
* Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung protective ventilation strategy, if needed
* Concurrent disease or circumstances that Investigator or Sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.
Surfactant Protein D Levels in Covid-19 Infection: Case-Control Study

This study aims to provide some insight into the variation of SD-D protein levels in patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19 infection in comparison to the normal population through a larger number of cases. Objective of the study is to determine the serum surfactant protein D (SP-D) levels in Covid-19 pneumonia infection.

This study aims to provide some insight into the variation of SD-D protein levels in patients with Covid-19 (-) pneumonia, Covid-19 (+) pneumonia, and CT negative Covid-19 infection in comparison to the normal population through a larger number of cases. Subjects will assessed in accordance with the inclusion and exclusion criteria, they were divided into four groups as the CT (-), PCR (+) SARS-CoV-2 infection group, SARS-CoV-2 (+) Pneumonia Group, CT (+), PCR (-) Suspected Pneumonia Group and Healthy group (Control Group). Demographic data, medical history, vital findings (fever, blood pressure, sPO2), laboratory findings (complete blood count; C-reactive protein (CRP), D-dimer, Ferritin and hsTnT parameters) and radiological findings, time to onset of symptoms, Comorbid diseases, hospitalization location of the patients (service or ICU), clinical scores, CT severity scores will determine. SP-D level will analyze by the Enzyme-Linked Immunosorbent Assay (ELISA) method.

Eligibility Criteria:
For patients;

Inclusion Criteria:

* who presented to the Covid-19 outpatient polyclinic of the ED with pneumonia symptoms,
* whose CT imaging's were compatible with Covid-19 pneumonia in accordance with the RSNAEC criteria and whose PCR tests were positive,
* whose SARS-CoV-2 PCR tests were positive as a result of contact tracing,
* who presented to the ED for further examination.
* who gave their written consent to participate in the study.
* Giving written consent to participate in the study.

Exclusion Criteria:

* diagnosis of kidney or liver failure
* acute pulmonary embolism
* chronic inflammatory disease history (rheumatological disease, autoimmune disease),
* pregnancy
* presence of any cancer diagnosis
* chronic obstructive pulmonary disease
* asthma disease,
* history of cerebrovascular disease.
* the patients whose CT imagings were compatible with Covid-19 pneumonia but whose PCR tests were negative were also excluded from the study.

For control group Inclusion Criteria

* no known acute, subacute or chronic disease history
* not suffer from any infection in the last fortnight,
* not to be on a particular medication,
* Presenting to the ED with reasons other than infectious complaints
* Giving written consent to participate in the study.

Exclusion Criteria:

* diagnosis of kidney or liver failure
* acute pulmonary embolism
* chronic inflammatory disease history (rheumatological disease, autoimmune disease),
* pregnancy
* presence of any cancer diagnosis
* chronic obstructive pulmonary disease
* asthma disease,
* history of cerebrovascular disease.