cyrilzakka/clinical-trials huggingface dataset:
The Impact of Dietary Intervention on Oxidative/antioxidant Markers and Gut Microbiota in Athletes

During intense physical exercise, there is an overproduction of reactive oxygen species, which leads to oxidative stress and reduced training and sports performance, as well as the development of chronic diseases. Eating foods with a high content of bioactive ingredients and high antioxidant potential can alleviate the negative effects caused by reactive oxygen species and improve the state of intestinal microflora.

The aim of these interventional studies was to determine whether daily consumption of foods with high antioxidant potential, including fruit and nut bars, for a period of 1 month would reduce oxidative stress in athletes during competition and positively change the intestinal microflora.

The study concerns a 4-week dietary intervention. The intervention consisted of daily consumption of 1 bar weighing 50 g, containing nuts and dried fruits with high antioxidant potential. The study included a group of 50 women and men, healthy athletes (cyclists, long-distance runners and triathletes). A 3-day, 24-hour dietary interview was conducted before and after the dietary intervention. Then, using the Dieta 6.0 computer program, the energy and nutrient contents in the diet were estimated. In addition, adherence to the dietary intervention was assessed using a survey questionnaire. Before and after the dietary intervention, oxidative-antioxidant markers were determined in the blood of the subjects (oxidative stress, antioxidant potential, concentration of antioxidant enzymes: glutathione peroxidase, superoxide dismutase, catalase) using ready-made kits. Moreover, changes in the intestinal microbiome were assessed in feces before and after the dietary intervention. Additionally, height and weight were measured before and after the intervention to calculate body mass index (BMI). The study will help answer the question of whether dietary intervention using foods with high antioxidant potential can influence changes in oxidative-antioxidant markers in the blood, intestinal microbiome and body weight of study participants.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women with high physical activity (triathletes, cyclists, long-distance runners), not taking medications for chronic diseases, age 20-50 years, men and women.

Exclusion Criteria:

* occurence of chronic diseases (e.g. hypertension, diabetes, cancer, thyroid diseases, neurodegenerative diseases), taking medications for chronic diseases, age\<20 and \>50 years, low physical activity
Study of the Cognition of Patients Treated With Immunotherapy

The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.

Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.

The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18,
* Patient with cancer and having to initiate treatment with immunotherapy alone
* Treatment with immunotherapy will include either an anti-PD1 / L1 or Anti CTLA4 monotherapy or combination,
* Patients may have received other antitumor treatments other than immunotherapy but these should be stopped at the time of initiation of immunotherapy
* Performance Status \<2
* Patient at the level of studies 3 "end of primary studies" minimum (Barbizet scale),
* Mastery of the French language.
* Patient affiliated to a social security system
* Patient having attested in writing of his non-opposition to participate in the study

Exclusion Criteria:

* Previous treatment with immunotherapy
* Another anti-tumor treatment underway
* Primary cancer of the central nervous system or cerebral metastasis, symptomatics and not controlled
* Abuse of alcohol or drug use
* Severe visual and / or auditory deficiency,
* Refusal of participation of the patient.
* Patient deprived of liberty or under guardianship
* Patient unable to follow the study for geographical, social or psychopathological reasons
FoodStep - a Sustainable Model for Food Services and Early Childhood Education and Care

Transformation towards a more climate-friendly and healthy sustainable diet will require major changes in the food system: increase in consumption of plant-based foods and only moderate consumption of animal-based foods. In the FoodStep -project, the investigators will develop a sustainable model for food system that reduces the climate impacts of the food system in early childhood education and care. The impact of the changes on children's nutrition, the climate impact of the diet, and the cost of food services will be assessed in a randomised controlled trial. In addition, the effects of the model on the knowledge and attitudes of decision-makers, experts in food service and early childhood education, and families are studied. Based on the project, the model can be applied nationally as part of Finland's climate change mitigation and adaptation strategy. Study aim to a sustainable food system reform through concrete guidelines, communication, and action initiatives.


Eligibility Criteria:
Inclusion Criteria:

* Are attending a full time daycare

Exclusion Criteria:

-
Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis. Determine the average duration of time it takes for albumin levels to rise ≥0.2g/dL from the initiation of IDPN therapy as this has been associated with significant change in mortality and hospitalization risk. The investigators expect levels to rise significantly within 4-6 months, there may be a difference in outcome in patients receiving IDPN compounded with amino acids and dextrose only vs IDPN compounded with amino acids, lipid, and dextrose.

Intradialytic parenteral nutrition (IDPN) has been identified as a means of improving nutrition status in malnourished hemodialysis patients who cannot meet calorie and protein needs with oral intake alone. The retrospective chart review spanning 3 years will be conducted on in-center hemodialysis patients receiving IDPN concurrent with their dialysis treatment. This study will evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, Plenamine, Intralipid and/or Clinolipid on albumin levels in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis and determine if addition of Clinolipid changes response to IDPN therapy compared to IDPN without lipids or IDPN with Intralipid. The primary endpoint is change in albumin levels from baseline (average albumin of up to 3 months prior to initiation of IDPN therapy) to 6 months after IDPN therapy initiation for the full analysis set. Secondary endpoints will be analyzed and include: distinguishing factors between those that respond to IDPN therapy (0.2g/dL or more increase in albumin levels) and those that do not; assessing time to IDPN response (increase of 0.2g/dL in albumin levels); determining factors that predict IDPN response; and comparing amount of change in albumin levels, percent of patients responding to IDPN therapy, and amount of time to IDPN response between those that receive lipids with IDPN therapy and those that do not receive lipids.

Eligibility Criteria:
Inclusion Criteria:

* Receiving in-center hemodialysis 3 days per week
* Having any diagnosis of ESRD
* ICD-10 code N18.6
* IDPN therapy initiated between May 1, 2018 and April 30, 2021 (evaluating through October 31, 2021)
* Baseline data available, average of up to 3 months of albumin levels available prior to start of therapy
* Age 18 years or older at IDPN therapy initiation
* Consented to have their medical records used for research

Exclusion Criteria:

* - Dialysis prescription deviates from the standard 3 days per week
* IDPN or intraperitoneal nutrition (IPN) therapy was initiated outside the research window
* Under 18 years of age at IDPN initiation
* History of liver disease or gastric bypass
* Undergoing cancer treatment at any time during IDPN therapy
* Receiving enteral nutrition support or total parenteral nutrition
Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.

A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality Index (PSQI).

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-69
* Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria
* Grade 2-3 knee osteoarthritis according to Kellgren-Lawrence grading system
* VAS-pain score: 4 and above
* Neuropathic Pain Diagnostic Questionnaire (DN4) score: 4 and above
* Body mass index value: 40 and below

Exclusion Criteria:

* A history of trauma or surgical operation in the knee region
* Diabetes mellitus
* Fibromyalgia
* Inflammatory rheumatic disease
* Central or peripheral neurological disorder
* Severe cardiac, pulmonary, or malignant disease
* Invasive treatment for knee last 3 months
Ruxolitinib Combined With Dexamethasone for HLH

A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic lymphohistiocytosismay.

A modified protocol about ruxolitinib combined with dexamethasone which includes oral ruxolitinib (2.5 mg twice daily for patients if the age\<14 years and the weight \<25kg，5 mg twice daily for patients if the age\<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and\<18 years）. Dexamethasone (10mg/m2.d) delayes for the first 2 weeks （form week 1 to 2），(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8. Every 2 weeks, patients can be evaluated based the diagnosed index

Eligibility Criteria:
Inclusion Criteria:

* Secondary and refractory HLH.

Exclusion Criteria:

* Family HLH.
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
* females incapable of becoming pregnant
* males agreeing to use contraception during trial

Exclusion Criteria:

* pregnancy or nursing
* abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
* major surgery
* use of drugs affecting coagulation or RBC function
* recent participation in other trials which may confound results
Clonidine as Pain Relief During ROP Eye Examinations

Preterm infants are at risk of developing ROP (retinopathy of prematurity), an eye condition that can cause blindness. Preterm infants born before gestation week (GA) 30 are therefor screened regularly with eye examinations. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.

Infants born before gestational week (GA) 30 who are cared for in neonatal units at the university hospitals in Örebro and Uppsala, Sweden can be included in the study.

According to power calculations 18 infants are needed for a power of 80% and significance level of 0.05 in order to cover for potential dropouts we plan to include 25 infants. Since the eye examinations are performed without eye speculum in Örebro and with eye speculum in Uppsala we plan to include 25 infants at each unit. The patient will be its own control and examined according to the units´ guidelines. Data will be collected during the patients´ first two eye examinations. In order to exclude potential effects of previous pain experience the order of treatment (clonidine/sterile water) will be randomized.

Sixty minutes before the first eye examination the infant will receive Clonidine or sterile water in corresponding volumes in the GI-tube by a nurse. During the examination the infant will be placed on a heated examination table and connected to an oxygen saturation probe (measuring oxygen saturation and heart rate) on one foot and electrodes for Galvanic skin response (GSR) on the other. The ophthalmologist will examine the infants eyes without eye speculum or with eye speculum on the respective unit. The infants face, oxygen saturation and heart rate will be videotaped before, during and after the examination making it possible to perform av PIPP-R pain assessment at a later time.

After the eye examination the ophtalmologist will be asked to estimate hos easy the infant was to examine by putting an "x" somewhere on a 10 centimeter long line where one end signifies "very easy to examine" and the other end signifies "very difficult to examine". The ophtalmologist can also write any other comments regarding the examination on the same form. The same procedure will be repeated during the infants´ second examination, but with the treatment he/she did not receive during the first examination.

Eligibility Criteria:
Inclusion Criteria:

* Infants born before 30 weeks gestation, informed consent from parents

Exclusion Criteria:

* Infants that have received other pain relieving or sedating drugs within 24 hours before the procedure, infants without GI-tube, infants with neurological deficit, infants with known heart arrhythmia, infants with circulatory instability (MAP below GA in weeks)
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone in Type 2 Diabetic Patients

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.

This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks
* HbA1c value between 7.0 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
* Heart failure patients
The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology

The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.

The objectives of the present study are:

1. To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
2. Compare pregnancy outcome between women with and without thyroid antibodies

Thyroid autoantibodies and / or abnormal thyroid function are associated with fertility problems.

A possible explanation for this is, an influence of thyroid autoantibodies on the functioning of the thyroid gland. It is therefore recommended to check thyroid gland function and for the presence of autoantibodies before pregnancy. In general, 2 types of thyroid autoantibodies are known: anti-thyreoperoxidase autoantibodies and anti-thyroglobulin autoantibodies.

In case of abnormal thyroid function, treatment is sometimes necessary in regards to fertility. The risk of abnormal thyroid function is increased in women with thyroid autoantibodies during pregnancy. Therefore, thyroid function is regularly monitored during pregnancy in women with thyroid antibodies. The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.

The objectives of the present study are:

1. To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
2. Compare pregnancy outcome between women with and without thyroid antibodies

Eligibility Criteria:
Inclusion Criteria:

* first cycle of assisted reproductive technology with follow up of thyroid function at the Universitair Ziekenhuis Brussel
* age \>= 18 and \<= 36 years
* body mass index between 18 and 35

Exclusion Criteria:

* Patients with clinical thyroid dysfunction
* Patients being treated with levothyroxine or antithyroid drugs
* Patients being treated with glucocorticosteroids
* Patients undergoing in vitro maturation or preimplantation genetic testing.
* Poor responders during IVF/ICSI stimulation, using the Bologna criteria
Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD

This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.

The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.

Subjects who qualify will be assigned by block randomization to one of four arms:

1. 1 Hz rTMS of the right dorsolateral prefrontal cortex
2. 10 Hz rTMS of the right dorsolateral prefrontal cortex
3. Sham rTMS of the right dorsolateral prefrontal cortex
4. OASIS treatment as usual

Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

Eligibility Criteria:
Inclusion Criteria:

Participant in the OASIS program

Willing and able to give informed consent

Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50

Males or females between 18-65 years of age

Exclusion Criteria:

Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use

Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety

ECT treatment within the last 30 days Patients with neurological disorder leading to increased intracranial pressure

Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)
Shared Decision Making for Choosing renAl Replacement Therapy in Chronic Kidney Disease Patients

Shared decision making (SDM) is an approach where clinicians and patients make decisions together using the best available evidence. An understanding of the patient's treatment goals, the advantages and disadvantages of treatment options, and the likelihood of achieving the outcomes are important to patients. International guidelines recommend that all patients with chronic kidney disease (CKD) at pre-dialysis stage should be educated to improve their knowledge and understanding of their condition and to choose the options for renal replacement therapy (RRT).

Despite these recommendations, pre-dialysis educations are often infrequent. Many patients feel unprepared. Wrong or insufficient understanding due to insufficient explanation of treatment can lead to negative emotions. This may lead to a situation in which the patient loses the opportunity to make patient's own choices, resulting in emergency dialysis or dialysis modality that is not suitable for patients. Therefore, this study aims to evaluate whether SDM has an effect on the choice of RRT among CKD patients.

This study will be conducted as a multicenter, open-label, randomized, pragmatic clinical trial. A total of 1,194 participants with CKD considering RRT will be randomized into 3 groups. Patients in the conventional group will have education using leaflets. Patients in the extensive informed decision making (EIDM) group will receive more detailed education using intensive learning materials than those in the conventional group. Shared decision making (SDM) group patients will have education according to questionnaires of self-assessment items using a self-developed counseling calendar.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease whose nephrologist predicts initiation of renal replacement therapy within 12 months:

  1. Patients with grade 5 of chronic kidney disease \[defined as a creatinine-based estimated glomerular filtration rate (eGFR) \< 15 ml/dL/1.73m2 at least 2 times at intervals of 2 weeks or longer\]
  2. Patients with the cystatin C-based eGFR \< 15 ml/dL/1.73m2 at least once if the creatinine-based eGFR does not accurately evaluate the kidney function of patient due to patient characteristics
  3. Patients whose nephrologist require renal replacement therapy within 12 months due to the patient's comorbidities even when the eGFR is 15ml/dL/1.73m2 or higher
* Patients aged between 19 and 80 years
* Patients who understand the study
* Patients who have no permanent access device for long-term maintenance dialysis

Exclusion Criteria:

* Patients who have contraindication to perform peritoneal dialysis due to abdominal surgery
* Patients whose life expectancy is less than 6 months due to underlying diseases
* Patients who have enrolled in other clinical trials within 3 months or plan to participate in other clinical trials during this clinical trial period
* Patients judged by the investigator to be inappropriate for participation in this clinical trial