cyrilzakka/clinical-trials huggingface dataset:
Glutathione and Its Precursors in HIV-Infected Patients

The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine (Met)-overloading in HIV+ patients comparatively to healthy controls.

Introduction: Among the 4 sulphur-containing amino acids (SAA), only Met and Cys are incorporated into proteins, but Hcy and Tau are related to oxidative stress and glutathione (GSH), the major intracellular hydro-soluble anti-oxidant agent. HIV+ patients present low levels of antioxidant nutrients, including GSH and its precursors.

Objective: To investigate the responses of the SAA pathway to dietary supplements of Gln and Cys together with Met-overloading in HIV+ patients comparatively to healthy controls.

Methods: Twelve HIV+ (6 males and 6 females, 25-36 yrs old) patients under HAART (one HIV protease inhibitor in combination with two nucleoside analogs) for at least one year and 20 (10M and 10F, 23-28 yrs old) healthy controls were randomly assigned to 7-day diets containing either NAC (N-acetylcysteine, 1g/d) or Gln (20g/d), with a 7-day washout period with their usual diet (UD). Blood samples were drawn after overnight fast before and after (2h and 4h) ingesting the Met (100 mg/kg) overload (Met-OL) with determination of the area under the curve (AUC). HPLC plasma analysis of SAA (Met, Hcy, Cys and Tau), GSH and GSSG and Ser, Gly, Glu and Gln was carried out at moments before (MO) and after 7-day diets (M1). Additionally, at baseline, both groups were assessed for anthropometry (BMI, kg/m2; body fat %) and plasma biochemistry (creatinine, urea, γ-glutamyl transpeptidase, glucose, triglycerides, cholesterol, uric acid, albumin, folic acid and vitamin B12).The HIV+ group (G2) was also characterized by the viral load, CD4+ and CD8+ lymphocytes counts. Statistical comparisons were undertaken among diets between groups with p = 0.05.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* antiretroviral therapy for at least one year

Exclusion Criteria:

* presence of any renal or liver failure
* ingestion of either vitamins B or GSH precursors
Diffusion Weighted MRI for Lymphnodes in the Axilla

This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla


Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed breast cancer patients, where ultrasound and cytologi has proved one or more malignant lymphnodes in the axilla.

Exclusion Criteria:

Pacemaker metal in the body claustrphobia psychiatry patients pregnancy age below 18 years
Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma

This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* The patients with initial untreated metastatic nasopharyngeal carcinoma
* Histologic diagnosis of nasopharyngeal carcinoma
* T1-4N0-3M1,IVC(according to the 7th AJCC edition)
* Aged between 18 and 65 years
* KPS≥70
* The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
* Voluntary to participate and sign informed consent document

Exclusion Criteria:

* The patients suffered from serious neurologic disease
* Clinically significant cardiac, heart function less than or equal to 3 level
* Clinically significant respiratory disease,lung function less than or equal to 3 level
* Blood routine examination: WBC\<3×109/L, Hemoglobin\<90g/L, platelet count\<75×109/L
* Abnormal liver function: total bilirubin or ALT or AST\>2×ULN
* Abnormal renal function:serum creatinine\>1.5×ULN
* Pregnant or lactating women
* The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in facial skin due to wearing masks have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged masks' use have not been investigated.

The aim of these study was to investigate the effects of constant, long-term use of protective masks on facial skin.


Eligibility Criteria:
Inclusion Criteria:

* young, healthy volunteers who gave written informed consent - students of health related professions who wear facial mask for at least six hours a day durnig their internship/practice in health care institutions

Exclusion Criteria:

* skin disease, skin damage on measurement sites
* use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
* use of emollients three days prior the inclusion in the trial
* non-adherence to the trial protocol
* exposure to artificial and excessive natural UV radiation
* pregnancy and lactation
* skin cancer
* immunosuppression
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.


Eligibility Criteria:
Inclusion Criteria:

* Functional MR 2+ - 4+ with left ventricular enlargement
* Symptomatic heart failure
* 20% - 50% LVEF

Exclusion Criteria:

* mitral regurgitation of organic origins
* recent cardiac interventions
* severe comorbidities
Arts and Movement Therapies for Trauma

The current goal of this project is to subjectively and objectively assess the efficacy of arts and movement interventions--including dance/movement therapy, art therapy and mindful yoga for youth and adults exposed to trauma, including families resettled as refugees and families in high-risk, low-resource environments. The overarching aim is to measure the changes over time in self-reported symptoms of posttraumatic stress disorder, anxiety disorder(s), depression, and somatic symptoms, as well as changes in biological substrates representing pathophysiological processes involved in responses to stress, trauma, and the aforementioned disorders. These biological substrates include inflammatory proteins and the stress hormone cortisol. We hypothesize that given the emotional and physical components of arts and movement therapies, which are implemented in group settings and confer life-long coping skills to participants, participation in arts and movement therapies will result in reduction of self-reported severity of psyciatric symptoms and improved physiology.

COVID-19: In March, the COVID-19 pandemic caused in person research to be halted in order to be in adherence to the stay at home order for the State of Michigan. The IRB overseeing the present project approved an amendment to allow data to be collected online via phone or email, based on participant preference, with a new consent form for this new method of data collection. Following this approval, we migrated our programming to virtual formats and began to serve both refugee commuities as well as school-aged youth with the intervention program and obtained consent followed by data from participants as part of this study. We have pivoted towards also looking at the benefits of creative arts and movement based interventions in reducing COVID-related distress, as well as building resilience.

By collecting psychological and biomarker data the investigators seek concrete scientific evidence supporting these non-pharmacological, cost effective, and accessible programs as reliable treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children and adults ages 7-65
* Willing and able to consent, or with at least one parent willing and able to provide consent for minors under age 18

Exclusion Criteria:

* Adults who are unable or unwilling to consent, or children whose parent do not consent
* Wardens of the Court
First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome. Patients are selected based on triple mutational status.

Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy. The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy. The response rates are less than 30% and a substantial amount of patients will experience unnecessary toxicity in terms of e.g. nausea, vomiting, neuropathies or a considerable risk of renal toxicity. The median progression free survival is 3-4 months and consequently, the median overall survival is less than one year (Hotta et al 2007). Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic (stage IV) NSCLC
* Measurable disease according to RECIST v.1.0 2009
* KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue.
* Age ≥18
* PS \< 2
* Adequate organ function

Haematology:

* Neutrophil count ≥1.5x10\^9/L
* Platelet count ≥100x10\^9/L
* Leucocyte count \> 3,000/mm

Hepatic function:

* Total bilirubin ≤ 1.5 times the upper normal limit (UNL)
* Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases

Renal Function:

* Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL

Metabolic function:

* Magnesium ≥ lower limit of normal.
* Calcium ≥ lower limit of normal.

Consent to translational research studies

Written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease.
* Known CNS metastasis (pretreatment routine assessment not required)
* Prior chemotherapy for metastatic disease
* Indication for radiation therapy or prior radiotherapy within 30 days before treatment start.
* Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy within 30 days prior to treatment initiation.
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
* Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
* Patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Gadopiclenol in Contrast Enhanced MRI of the Prostate

The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.

Gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (MVD), and therefore increase visibility of cancerous tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to T2-W (T2 weighted image) and diffusion weighted imaging (DWI), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed MRI-US fusion biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a clinically indicated MRI of the prostate with contrast.
* Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.

Exclusion Criteria:

* Prisoner
* Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
* Patients with end stage renal failure who are on dialysis. Patients who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.
Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function

The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.

we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function

Eligibility Criteria:
Inclusion Criteria:

1. adult males and females of the broad population aged 20-60
2. with no symptomatic heart disease/condition
3. with Vitamin B12 levels of 150 pmol or less
4. which have not received Vitamin B12 supplement treatment before

Exclusion Criteria:

1. Adults suffering from a known heart disease/condition
2. any disease the investigator might find as interfering with the process of the experiment
3. tumor-oriented diseases
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 35-70 years old (both inclusive)
* Biopsy proven gynecologic malignancy
* Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
* BMI greater than or equal to 18.5
* Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
* Willing to adhere to a 5-day fasting mimicking diet

Exclusion Criteria:

* Pregnant or nursing mothers
* Prisoners
* Patients with diabetes or history of hypoglycemia
* Taking daily medications that cannot be safely taken without food
* History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
* Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
* Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.
Can Cytokines be Used as an Activation Marker

RA is a chronic, autoimmune, inflammatory disease that involves small joints in the form of symmetrical polyarthritis and progresses with exacerbations and remissions. Pain, swelling, tenderness and morning stiffness are typical of the joints involved. Although it is approached as a primary joint disease, a wide variety of extra-articular involvements may also occur. In this cross sectional study sedimentation rate (ESR), C- Reactive protein (CRP), Tumor necrosis factor (TNF)-α, soluble-TNF-α receptor (TNF-R), Interleukin (IL)-1B and IL-10 were measured in three groups which were healthy volunteers, patients with RA in active period, and patients with RA in remission.

TNF-R can be the main pathophysiological factor and a marker showing activation. TNF-R can be very important in revealing the effect of TNF on the disease and the value of this effect in the treatment and ensuring the follow-up of the disease with CRP instead of ESR in activation.

Aims: The etiopathogenesis of Rheumatoid Arthritis (RA) is not clearly understood. However, role of the cytokines takes an important part of this mechanism. The investigators aimed to bring a new approach to the concept of 'remission' in patients with RA.

Background: RA is a chronic, autoimmune, inflammatory disease that involves small joints in the form of symmetrical polyarthritis and progresses with exacerbations and remissions. Pain, swelling, tenderness and morning stiffness are typical of the joints involved. Although it is approached as a primary joint disease, a wide variety of extra-articular involvements may also occur. It is an interesting pathophysiological process, the exact cause of which is still unknown, with many environmental, genetic and potentially undiscovered possible factors in a chaotic manner.

Objective: In this prospective study, sedimentation rate (ESR), C- Reactive protein (CRP), Tumor necrosis factor (TNF)-α, soluble-TNF-α receptor (TNF-R), Interleukin (IL)-1B and IL-10 were measured in three groups which were healthy volunteers, patients with RA in active period, and patients with RA in remission. Disease activity score-28 (DAS-28) was calculated in active RA and RA in remission.

Methods: This study included 20 healthy volunteers, 20 remission patients with RA and 20 active RA patients. Venous blood samples were collected from patients in both healthy and RA groups.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals and Rheumatoid Arthritis patients meeting American College of Rheumatology (ACR) RA remission criteria.

Exclusion Criteria:

Smoking, Using Disease-Modifying Anti-Rheumatic Drugs (DMARD) and/or anti-inflammatory drugs other than cortisol and methotrexate, Receiving chemotherapy, Being hypothyroid

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Astigmatism Post-trabeculectomy

The aim of this project:

1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
2. Medium-term follow up (6 months) of the induced corneal astigmatism.
3. Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Normal tension glaucoma
* Pseudoexfoliation glaucoma
* Pigment dispersion glaucoma

Exclusion Criteria:

* Patients who refuse to sign the informed consent.
* Patients with primary angle closure glaucoma (PACG).
* Patients younger than 18 years old.
* Other ocular diseases besides glaucoma.
* Significant corneal opacities.
* Refractive error more than + or -6.00 diopters.
* Visual acuity less than 0.05
* Previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy).
* Laser treatment for glaucoma within 6 months of the surgery.
Quality of Life and Psychological Strengths of Older People

As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors.

The intervention program "How to improve your strengths and quality of life" consists of 8 individual sessions. The sessions take place weekly, so the total duration of the program is 8 weeks. Each session lasts approximately 1 hour. The sessions will be held both in person and online.

Following the principles of the psychoeducational therapy and Positive Psychology, this program is focused on the enhancement of personal strengths and quality of life of the elderly. Specifically, during the sessions, the following topics will be worked on: resilience, gratitude, acceptance, family functioning and quality of life in its different dimensions (control, autonomy, pleasure and self-fulfillment).

Eligibility Criteria:
Inclusion Criteria:

* Be at least 60 years of age.
* Residing in Spain.
* Not having a diagnosed neurological disease or severe psychopathological disorder, or other ailment that is incompatible with the understanding of the questionnaires or the intervention program.
* Acceptance and signature of the informed consent.

Exclusion Criteria:

* Do not comply with the established age range.
* Present an ailment that makes them unable to respond to the questionnaire.