cyrilzakka/clinical-trials huggingface dataset:
Psychological Mobile App for Patients With AML

This research study is evaluating whether a psychological mobile application (app), is efficacious in reducing anxiety and depression symptoms and improving quality of life for patients diagnosed with acute myeloid leukemia (AML) compared to a physical health promotion app.

Patients with a new diagnosis of AML often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life. Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence.

From our prior studies, we learnt that the use of DREAMLAND, a psychological mobile app, was feasible to integrate in the care of patients with AML receiving intensive chemotherapy and has promising efficacy for improving patients' physical and psychological symptoms and their quality of life. In this project, the study doctors want to compare the effectiveness of DREAMLAND versus CERENA in improving the patient experience when diagnosed with AML. CERENA is a mobile app that provides medical information about how to best take care of one´s health. Using this research, the study doctors hope to find out the best way to help patients cope with the diagnosis and treatment for AML.

The study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. Study questionnaires will be completed in the hospital or clinic. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy.

Blue Note Therapeutics, Inc. is supporting this research study by providing funding. Blue Note Therapeutics is a digital health technology company that focuses on the health needs of patients with a cancer diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients (aged 18 years or older) with a new diagnosis of AML
* Receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or b) a similar intensive regimen requiring prolonged 3-6-week hospitalization
* Ability to comprehend and speak English as the mobile apps are only available in English

Exclusion Criteria:

* Patients with a diagnosis of acute promyelocytic leukemia
* Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia

The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.

This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.

Eligibility Criteria:
Inclusion Criteria:

* Friedreich Ataxia

Exclusion Criteria:

* Unable to provide Informed Consent
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.

PRIMARY OBJECTIVES:

I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:

* Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology \> atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
* Currently recommended approach: for women \< 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology \> ASCUS; retesting of those who are positive for other HR-HPV at one year.

II. Compare these two approaches with respect to overall cost-effectiveness and acceptability.

III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women \< 30.

OUTLINE: Participants are randomized to 1 of 2 arms.

GROUP I (home-based HPV screening): Participants collect 2 vaginal specimens using polyester swabs. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.

GROUP II (clinic-based standard of care screening): Participants undergo Pap testing. Participants with a positive Pap test undergo standard of care, including colposcopy, HPV testing, cervical biopsy and/or endocervical curettage (ECC). Participants with cervical biopsies showing precancerous changes requiring treatment may undergo loop electrosurgical excision procedure (LEEP) or are referred to appropriate care.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent in English

Exclusion Criteria:

* Have had hysterectomy
* Currently pregnant
* Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
* Received colposcopy of cervix within TWO years
* Received Pap test within ONE year
* Immunocompromised (positive human immunodeficiency virus \[HIV\] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
* Decisionally impaired adults requiring a legally authorized representative
Effects of Whey Protein in Type 2 Diabetics

The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).

Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity, which might be an additional mechanism accounting for the glucose lowering effects of Whey.

In the investigators previous study, the acute administration with Whey protein resulted in postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1, suggesting that the peptides generated from Whey protein may have dual beneficial effects (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia regulation in subjects with type 2 diabetes.

Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2 diabetic subjects and there are also clinical evidence in non-diabetics individuals, that acute and chronic administration of Whey protein has antihypertensive activity.

The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined previously in type 2 diabetics.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes patients
2. HbA1C \> 7.5%
3. Duration of diabetes: \< 20 years
4. Subjects ≥ 30 and ≤70 years of age
5. BMI: 22 to 35 kg/m2
6. All oral antidiabetic treatments will be allowed. No insulin
7. Normal liver and kidney function
8. Normal thyroid function
9. Stable physical activity pattern during the three months immediately preceding study
10. No metabolic disease other than diabetes
11. Normal TSH and FT4 levels
12. Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
13. Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

1. Type 1 diabetes
2. Treatment with Insulin
3. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
4. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
5. Pregnancy or lactation
6. Illicit drug abuse or alcoholism
7. Subjects taking anoretic drugs during the month immediately prior to study
8. Subjects on steroid treatment
9. Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
10. Those with eating disorders
11. Known hypersensitivity to milk components
12. Subjects after bariatric surgery, will be excluded
13. Subjects known by the principal investigator to be unable to cooperate for any reason.
Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM)

The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and effective in adults with MPM who have failed prior anti-cancer therapy.

The population for this study will consist of approximately 35 adults with histologically-confirmed MPM (epithelial or biphasic) whose disease has progressed after 1-2 prior anti-cancer therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically-confirmed epithelial or biphasic MPM; biphasic tumors must have a predominantly (≥50%) epithelial component
2. No more than 2 prior lines of anti-cancer therapy, one of which must have included pemetrexed and a platinum.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4. Adequate organ and marrow function
5. Adequate lung function; forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) ≥ 45% of predicted value as measured by spirometry; and oxygen saturation ≥ 90% on room air

Exclusion Criteria

1. Pleurodesis within 14 days prior to first dose of study drug
2. Receiving tumor necrosis factor (TNF) pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
3. Active secondary malignancy
4. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug, or not recovered from adverse effects due to agents administered more than 4 weeks earlier
5. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug
6. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
7. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agents targeting other checkpoint pathways (e.g. CTLA-4)
8. Prior immunotherapy with CRS-207 or any other Listeria-based agent, therapeutic cancer vaccine, or adoptive T cell immunotherapy
9. Implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g., Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.
Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

The purpose of the study is to determine whether remifentanil influence the pharyngeal phase of swallowing using using pressure and impedance recordings. The purpose is also to compare remifentanil to morphine and younger to elderly volunteers.

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in postoperative patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In a previous study (not yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers and the aim of this study is to objectively determine weather remifentanil infusion in healthy volunteers influence the pharyngeal phase of swallowing. The purpose is also compare the effect of remifentanil to morphine and younger volunteers to elderly volunteers. To assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30 minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg) at the other. The volunteers are asked to swallow 10 ml normal saline several times both before and after opioid administration and pharyngeal motility is parallelly recorded using combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal segment. Any subjective swallowing difficulties are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 or 65 \< year old healthy volunteers from both sexes.
* Have signed and dated Informed Consent.
* Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

* Pharyngoesophageal dysfunction
* Known history of cardiac, pulmonary or neurological disease
* Ongoing medication
* Allergies to or history of reaction to remifentanil, fentanyl analogues or other ingredients
* Pregnancy or breast feeding
* BMI \> 30
* Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not complete.
Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment

This project aims to examine the effect of a 5-month period supervised exercise intervention on brain, cognition, OMICs, Molecular Markers and functional status in older people at risk of mild cognitive impairment. Secondarily, the effect of this intervention on antioxidant capacity, lipid metabolism and glucose, physical health (functional capacity, blood pressure, body composition) and mental (quality of life and depression) will be studied, as well as other factors risk (genetic and biological) for the development of Alzheimer. A total of 100 people aged between 65 and 75 years old at risk of mild cognitive impairment will be randomly distributed in the supervised exercise intervention group (n = 50) and control group (n = 50). The design will include a 5-month intervention with measurements at pre and post intervention and a third measurement (retest) after 3 months of completion. The multicomponent supervised exercise program will include aerobic, strength, cognitive and coordinative-agility-balance works, and progression will be established in different load parameters (frequency, volume, intensity, density). Therefore, randomized controlled studies are needed to know the specific effect of dose-response considering the various dimensions in parallel such as neuroimaging, cognitive status and OMICS. This will allow us to understand from a comprehensive perspective the causes and mechanisms underlying the response. This project will significantly increase scientific knowledge about the role of exercise on brain as a therapeutic measure in people at risk of mild cognitive impairment from a multidimensional perspective. The project will have a significant impact at social and economic level by transferring the study findings to social and health setting by means of agents and networks provided for the project.


Eligibility Criteria:
Inclusion Criteria:

* Do not present any physical illness that prevents you from doing physical activity
* Able to communicate without problems
* Able to read and understand informed consent as well as the object of the study

Exclusion Criteria:

* Acute or terminal illness
* Diagnosis of Alzheimer's
* History of cranioencephalic trauma with loss of consciousness
* History of cerebral infarction, epilepsy, brain tumor
* Unstable cardiovascular disease
* Recent fracture in upper or lower limb
* Alcohol abuse and / or habitual drug use or drug infusion pump
* Presence of pacemakers, defibrillator, metallic implants in the head, intraocular and / or maxillo-facial structures, dental prostheses incompatible with magnetic resonance studies
* Intravascular devices (stent, Coil, filter), heart valve, aneurysm clip, neurostimulator, intravascular catheter with metal or cardiovascular bypass
* Severe visual or auditory problems, implant in the middle / inner ear
* Do not want to complete the study or be assigned to the control group
* He/she is participating in another research study that may influence the present project.
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure

High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.


Eligibility Criteria:
Inclusion Criteria:

* Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).
* Plasma uric acid level ≥5 mg/dl
* Ages 18-50
* non-smokers
* Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.

Exclusion Criteria:

* no current smoking in the prior 6 months.
* Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.
* Any history of gout, hypertension, hypercholesterolemia, morbid obesity.
* Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications
* any history of illicit drug use within the last 6 months
A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults

The purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one intramuscular injection of Ad26.RSV.preF in adults.


Eligibility Criteria:
Inclusion Criteria:

* In the investigator's clinical judgment, participant must be in good or stable health. Participants may have underlying illnesses such as hypertension, Type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs measurement and 12-lead electrocardiogram (ECG; for participants greater than \[\>\] 65 years of age only) performed at screening
* Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants in clinical studies
* All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine beta-hCG pregnancy test immediately prior to study vaccine administration
* From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
* Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* Participant has received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study
* Participant has received treatment with immunoglobulin in the 2 months, or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study
* Participant has received any RSV vaccine in any previous RSV vaccine study at any time prior to randomization
Personalized Nutrition Caffeine Intake in Healthy Adults.

Personalized nutrition is one of the most up to date trends in human nutrition and gains much interest of general public and scientists as well. Although we have gained some knowledge on gene-trait associations, the real effectiveness and usefulness of genotype-based nutritional recommendations is unknown. Many personalized nutrition companies are on the market today, some of them use personalized nutrition based on genotype analysis. For this reason, scientific basis of this approach should be clarified. Moreover, the effect of using genotype information in dietary interventions aimed at decreasing caffeine intake has never been tested. Our project can thus increase knowledge which can be applied in dietary counseling practice. Although we focus on caffeine intake, the study is designed as a proof of concept.

Considering current knowledge and recognizing the existing gaps we hypothesize that providing genotype information may increase adherence to dietary recommendations.

The main aim of the project is thus testing the effectiveness of a genotype-based personalized dietary intervention targeted at decreasing caffeine intake.

Specific aims of the study include:

* Implementation of the application for mobile devices which will be designed to assess caffeine intake.
* Testing whether providing information on CYP1A2 polymorphism affects effectiveness of the dietary intervention aimed at decreasing caffeine intake.
* Testing whether changes in dietary behavior can persist over time To accomplish the study goals a group of healthy adults will be enrolled. Participants will complete an informed consent procedure. As we aim at decreasing caffeine intake, we plan to first screen for people drinking at least 2 cups of coffee or with total caffeine intake over 200 mg/day. Then genotype screening will be performed and eligible volunteers will be randomly assigned to one of the study groups which receive either dietary advice or dietary advice and genotype information.

Eligibility Criteria:
Inclusion criteria:

* age 18-60
* daily coffee intake at a minimum 2 cups (or equivalent total caffeine intake)

Exclusion criteria:

* injuries,
* chronic diseases (e.g. diabetes, metabolic syndrome, cancer, hyperthyroidism),
* recent dieting,
* pregnancy or breastfeeding,
* no caffeine intake,
* taking chronic pain management pills which contain caffeine.