cyrilzakka/clinical-trials huggingface dataset:
An Egg Based Breakfast Maintains Flexibility in Older Adults

Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes and cardiovascular disease. There is reason to believe that the time of day when specific food groups are eaten affects this risk. The investigators propose that eating foods made up of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier metabolism. This is because the body is designed to burn fat during times of fasting, such as overnight, during sleep. Thus, the body is not prepared to burn sugar early in the morning, when most people eat breakfast. Studies with mice have shown that a sugary breakfast meal inhibits the ability of the body to burn fat for the entire day. In contrast, a breakfast meal with more fat enabled the animals to burn fat as well as other fuels throughout the day. The ability to burn fat is thought to minimize risk for obesity, as well as related diseases such as type 2 diabetes and heart disease. The purpose of this study is to determine if, in older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a higher-carbohydrate meal) is associated with a healthier metabolism.


Eligibility Criteria:
Inclusion Criteria:

* • Age 55-75

  * Body mass index 24-29 kg/m2

Exclusion Criteria:

* • Current practice of greater than 2h/wk of moderate intentional exercise

  * Uncontrolled diabetes
  * Unwillingness to eat study diets
  * Use of any medication known to affect metabolism
  * History of eating disorder
  * Difficulty chewing and swallowing solid food
  * Digestive diseases
  * Cognitive impairment
  * Depression
  * Recent weight change (+/- 10 lbs. in the last 12 mo.)
  * Poorly controlled blood pressure (SBP \> 159 or DBP \>95 mm Hg)
  * History of non-skin cancer in the last 5 y
  * Cardiovascular disease event in the past 6 mo.
  * Severe pulmonary disease
  * Renal failure
  * Major liver dysfunction (elevation of liver transaminases \>3x normal in past 2 y; current/recent smoker (within 6 mo.)
  * Use of estrogen or testosterone replacement therapy
  * Current use of oral corticosteroids \>5 days/month on average
  * Current use of medications for treatment of psychosis or manic-depressive illness
  * Use of weight loss medications in the previous 3 months
  * Unable to adhere to diet recommendations
Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

This multicentre phase IIb clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥12 years of age
* Deep partial thickness and/or full thickness burns requiring surgical wound coverage
* Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. \>20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
* Signed Informed consent

Exclusion Criteria:

* Patients tested positive for HBV, HCV, syphilis or HIV
* Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
* Severe drug and alcohol abuse
* Pre-existing coagulation disorders as defined by INR outside its normal value, PTT \>ULN and fibrinogen \<LLN prior to the current hospital admission and / or at the Investigator's discretion
* Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
* Previous enrolment of the patient into the current phase II study
* Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
* Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Pregnant or breast feeding females
* Intention to become pregnant during the clinical course of the study (12 months)
* Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
* Enrolment of the Investigator, his/her family members, employees and other dependent persons
Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).

The secondary objectives are:

* to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
* to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven invasive breast adenocarcinoma
* Localized breast cancer: stage II and III
* Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate)
* After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)

Exclusion Criteria:

* Bilateral and inflammatory breast cancer
* Abnormal Left Ventricular Ejection Fraction
* Distant metastases or locoregional relapse
* Inadequate organ functions

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021

The dysfunction and reduced proliferation of peripheral immune cells including CD8 T and NK cells have been observed in both aging and cancer patients, thereby challenging the immune cell therapy in these subjects. Therefore, we evaluated the growth of these lymphocytes in elderly patients with several types of cancer and the correlation of peripheral blood (PB) indexes to the expansions. This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021. By optimizing the antiviral and tumor surveillance ability of both NK cells and CTLs through serial steps from isolation and expansion, followed by re-infusion of these activated cells back to the patient body, AIET has become a promising, cutting-edge method in detecting and eliminating cancer cells. The study aimed to evaluate the safety and effectiveness of 60 cancer patientsreceiving AIET.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 75
* Patients have been diagnosed with cancer.
* Patients signed the written informed consent form.

Exclusion Criteria:

* Severe health conditions such as serious infection, autoimmune diseases, or using any anti-rejection drugs
Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma

The goal of this study is to evaluate the efficacy and safety of a combination of the anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and Carboplatin; delivered in an outpatient setting.

The R-DHAP (Rituximab, Dexamethasone, Cytarabine, and Cisplatin) schedule includes high-dose cytarabine every 12 hours and requires careful monitoring of renal toxicity because of cisplatin. These conditions limit the use of this protocol in an outpatient setting.

The S phase of lymphoma cells is longer than 12 hours, then cytarabine can be used daily without reduction of the antineoplastic effect. Carboplatin does not have remarkable renal toxicity so is not necessary to monitor blood chemistry or IV fluids during its administration.

The study hypothesis is that modifications to the original R-DHAP protocol, using cytarabine on a daily basis and the substitution of cisplatin by carboplatin can preserve the efficacy, reducing the incidence of renal events. The investigators hypothesize that those modifications can make the schedule more suitable for an outpatient administration in relapsed or refractory non-Hodgkin lymphoma patients.

After 3 cycles of chemotherapy, the overall response and the incidence of adverse events will be evaluated.

In order to achieve the purpose of this trial, 130 participants will be included.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent or refractory B-cell non-Hodgkin lymphoma
* Performance status: Eastern Cooperative Oncology Group 0-2
* At least three weeks from last chemotherapy
* Toxicities by Common Terminology Criteria Version 4.0 ≤ 1
* Glomerular filtration rate \>50 ml/min
* Women of childbearing potential must use effective methods of contraception

Exclusion Criteria:

* Post-transplant relapse of lymphoma
* Central nervous system involvement of lymphoma
* Serious infections
* Known allergies to one or more of the experimental drugs
* Diabetes with glucose \>200 mg/dl
* Pregnant or lactating females
* Known HIV or B Hepatitis positivity
* Known allergies to filgrastim
Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

Eligibility Criteria:
Inclusion Criteria:

* fulfills DSM-5 criteria for PTSD
* One or more single traumas in adolescence or adulthood
* Speaks and writes Norwegian

Exclusion Criteria:

* New or unstable psychopharmacological treatment within last four weeks
* fulfills ICD-11 criteria for complex PTSD
* Ongoing substance abuse
* Ongoing danger of suicide
* Ongoing borderline personality disorder
* Ongoing psychosis
* Intellectual disability
Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being

It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Preventive medicine is increasingly perceived as important in medical and economic terms, particularly in the field of gastroenterology. An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier, such as probiotics or prebiotics. The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains, conveyed through the PROBAFLOR food supplement, can play a positive role in maintaining normal intestinal function, bringing benefits to the subject who takes this supplement.

This is a randomized, double-blind, placebo-controlled intervention study with a duration of 3 months of intervention + 1 month of follow-up, on biological samples. Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months. Three check-in visits will occur, one at the screening, the second one afetr the 3-months intervention and the final one after 1 month of followup. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Stool samples, and questionnaires will be completed for study outcome analysis.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged between 18 and 65;
* healthy based on medical history;
* commitment to comply with all firm procedures;
* commitment to refrain from using any home remedies to control gastrointestinal problems, particularly if live bacteria are involved;
* signature of informed consent.

Exclusion Criteria:

* use of probiotics continuously, in the two months prior to enrollment;
* use of antibiotics in the month before enrollment;
* chemotherapy treatments;
* diagnosis of respiratory, hepatic and/or renal failure;
* Clinically significant diseases of the gastrointestinal tract (examples include, but are not limited to, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease);
* Women who are pregnant, breastfeeding or planning to become pregnant during the study;
* Allergy or sensitivity to the active or inactive ingredients of the investigational product.
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of arterial hypertension ischemic heart disease,
* atrial fibrillation or other arrhythmia,
* congestive heart failure (study heart disease)
* HbA1C \> 53mmol/mol (study diabetes)
* Age \> 18 years
* Capability of filling in questionnaires in the own language
* Capability to use the devices provided
* Being cognitively able to participate
A Retrospective Register Study to Map the Frequency of Short Duration Atrial Fibrillation (AF) Among All Patients Admitted to Roskilde Sygehus in Denmark in 2010

Retrospective observational study of patients with atrial fibrillation admitted to Roskilde University Hospital in 2010.

The study is a retrospective register study of all patients discharged from Roskilde Hospital with a primary diagnosis of AF in 2010. All data will be collected from the patient's medical records and only data from this specific admission will be recorded. No follow-up of the patients after discharge will be performed in this study. The study does not involve any randomization or any drug testing.

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation

Exclusion Criteria:

* None
Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.

PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.

OBJECTIVES:

* To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.

* Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
* Arm II: Patients undergo CT scan of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression.
* Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
* Arm IV: Patients undergo MRI of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression.

NOTE: \*Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.

Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed seminoma of the testis

  * Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis
* No evidence of any non-seminoma germ cell tumor elements
* Has undergone orchidectomy within the past 8 weeks

  * Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization
  * Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy)
* Not planning to undergo adjuvant therapy

PATIENT CHARACTERISTICS:

* Able to attend regular surveillance
* No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer
* No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.

This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).

Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.


Eligibility Criteria:
Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.

Exclusion Criteria:

1. ≤ 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)
5. Patients with claustrophobia
6. Pregnant women
7. Poor candidate for follow-up
8. Prisoners
9. Repeat participants
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy

Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.

On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.

The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.


Eligibility Criteria:
Inclusion Criteria:

* Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months

Exclusion Criteria:

* Erosive esophagitis
* Concomitant peptic ulcer disease
* Use of NSAID in recent 4 weeks (Low dose aspirin \< 300 mg is allowed)
* Pregnant or lactating female
* Illiterate patient (who cannot administer questionnaire)
* Known hypersensitivity to PPI