cyrilzakka/clinical-trials huggingface dataset:
The Impact of the COVID-19 Pandemic on Cardiovascular Risk Factors in Patients With Diabetes

The objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the COVID 19 (time 1 - T1), after 1 year (time 2 - T2) and 2 years (time 3 - T3) duration. In patients with all types of diabetes, the investigators will compare the value of blood pressure, LDL cholesterol, BMI (body mass index) and glycated haemoglobin in T1, T2 and T3 during outpatient control.

Diabetes mellitus (DM) is one of the major risk factors of cardiovascular diseases (CVDs), which are the leading cause of death globally. To reduce overall cardiovascular risk in patients with diabetes, it is necessary, in addition to compensation of diabetes, to reduce other risk factors of cardiovascular diseases. The COVIDs 19 (coronavirus disease of 2019) pandemic has in addition to direct influence (fever, pneumonia, olfactory loss, etc.)1,2 also, a lot of indirect effects. These include psychological effects (long term stress, worries, sadness)3,4,5, increased alcohol consumption, changes in eating habits or decreased physical activity due to restrictions to reduce the spread of the virus in population by government.

The Czech Republic (Central Europe region) is one of the most affected countries in the World by COVID 19 pandemic. By 1st of March 2021, the SARS-COV2 virus infection was proven in the Czech Republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the USA 8743/100 000, in the UK 6300/100 000, in the Germany 2879/100 000, France 5379/100 000)6 Due to a long-lasting serious situation, we expect an adverse effect on number of risk factors for CVDs.

The objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the COVID 19 (time 1 - T1), after 1 year (time 2 - T2) and 2 years (time 3 - T3) duration. In patients with all types of diabetes, the investigators will compare the value of blood pressure, LDL cholesterol, BMI (body mass index) and glycated haemoglobin in T1, T2 and T3 during outpatient control.

The secondary objective is to evaluate behaviour of patients during COVID 19 pandemic. The investigators will use a questionnaire. It will be anonymous for a more accurate assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diabetes mellitus of any type
* Planned visit to the outpatient diabetic clinic between 1.4. and 31.7.2021 - T2 (creation of the study group) - University hospital Ostrava, Czech Republic
* Known values of blood pressure, glycated haemoglobin, LDL cholesterol and BMI before the start of the pandemic (1.3.2020), not older than 6 months and no later than 31.3.2020.
* Signed consent to the use of anonymous data for scientific purposes and publications.

Exclusion Criteria:

* failure to meet the criteria for inclusion
The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?

The purpose of this clinical study is to determine if a learning effect exists when the 5STS is assessed remotely via videoconference in patients with COPD.

Pulmonary rehabilitation (PR) is an essential therapy for improving exercise tolerance and quality of life in patients with chronic respiratory disease. It is now available remotely thanks to advances in information and communication technologies. Pulmonary telerehabilitation facilitates care access for patients living far from specialized centers. It requires, for a complete and coherent transposition, to be able to evaluate the patients remotely in order to measure the evolution of their functional capacities and to ensure their follow-up. Among the tests already implemented at home and remotely via video-conference, the 5-repetition sit-to-stand test (5STS) is the most suitable. This test requires only a short time to perform, little space and no specific equipment. However, two major limits remain to be checked before being able to consider its remote and routine implementation. First of all, it is important to study its feasibility. Moreover, like other functional tests, it raises the question of a possible learning effect (LE). In the perspective of a current use of the 5STS remotely, it is therefore also essential to assess the existence of a potential LE which would condition the methods of administering the test and its interpretation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Obtaining oral informed consent after a minimum reflection period of 24 hours
* Patient with internet access at home and a tool allowing the realization of a videoconference (smartphone or computer)

Exclusion Criteria:

* Patients who had a recent exacerbation (less than 4 weeks)
* Patients physically unable to get up from a chair and sit down without help
* Patients with significant and unstable cardiovascular disease
* Any acute or chronic pathology (orthopedic, neurological, psychiatric or causing a major cognitive disorder) limiting the performance of a functional test
* Inability or difficulty using digital tools
* Subjects in a period of relative exclusion compared to another protocol
* Adults protected by law or patient under guardianship or curatorship
* Subjects deprived of liberty by a judicial or administrative decision
* Current or planned pregnancy during the study period
* Pregnant or breastfeeding women
* Patients not affiliated to a French social security scheme or not benefiting from such a scheme
Assessing the Accuracy of ChatGPT-4 in Interpreting Arterial Blood Gas Results

Assessment of Acidosis and Alkalosis, Evaluation of Hypoxemia and Hyperoxemia, Evaluation of Hemoglobin Parameters, Assessment of Electrolytes, Evaluation of Metabolic Parameters (Glucose, Lactate, Bilirubin)

Model Training:

The collected data will be used to train the artificial intelligence model. Utilizing the deep learning infrastructure provided by ChatGPT Plus, our model will be optimized to produce highly accurate results in interpreting blood gases.

During the training process, our model will be taught to interpret various blood gas samples, including assessments of acidosis-alkalosis, hypoxemia-hyperoxemia, hemoglobin, electrolytes, and metabolic parameters.

Model Testing and Validation:

The trained model will be tested on previously unseen test datasets to evaluate its performance. This step is crucial for understanding how the model will perform in real-world scenarios.

The accuracy of the model will be assessed by comparing its interpretations with feedback provided by expert anesthesiologists.

Furthermore, to comprehensively evaluate ChatGPT's effectiveness in this domain, the daily arterial blood gas results obtained in the intensive care unit will be submitted to ChatGPT for interpretation. The same questions will be posed, and the responses will be evaluated by an anesthesiology and reanimation specialist. These questions will be asked to the model:

Assessment of Acidosis and Alkalosis, Evaluation of Hypoxemia and Hyperoxemia, Evaluation of Hemoglobin Parameters, Assessment of Electrolytes, Evaluation of Metabolic Parameters (Glucose, Lactate, Bilirubin)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and above will be included in the study.
* The study will evaluate arterial blood gas results.

Exclusion Criteria:

* Venous blood gas results,
* Blood gas results with calibration errors,
* Blood gas results with incomplete data
The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD)

X-linked adrenoleukodystrophy (X-ALD) is an inherited metabolic disorder characterised by accumulation of very long chain fatty acids (VLCFA) in plasma and tissue. Presumably this accumulation is responsible for tissue damage. The disease can cause severe demyelinisation of the central nervous system usually causing death in childhood or progressive ambulatory problems in adults caused by a progressive myelopathy. For the latter category of patients no curative treatment is currently available. Recent investigations in human fibroblasts and mice identified bezafibrate as an agent that might reduce VLCFA in patients with X-ALD.

Objective of the study:

The trial is designed as an open-label pilot study. The main goal is to investigate if bezafibrate can reduce VLCFA in vivo in patient with X-ALD. If there is indeed a biochemical effect, a large follow-up study will be initiated with clinical outcome parameters.

Study design:

10 men with X-ALD will use bezafibrate during a period of 6 months (in combination with a low fat diet). On 6 different time points the participants will undergo a venipuncture for detecting possible side effects and to determine the biochemical outcome parameters.

Study population:

Adult men with X-linked adrenoleukodystrophy.

Intervention (if applicable):

Bezafibrate.

Primary study parameters/outcome of the study:

The primary outcome parameters are cholesterol levels (total-, LDL, and HDL) and levels of triglycerides in plasma, VLCFA levels in plasma, leukocytes and erythrocytes and also C26:0-lyso-PC in bloodspots.

Secondary study parameters/outcome of the study (if applicable):

Secondary outcome parameters are side-effects (subjective and abnormalities in the safety lab).


Eligibility Criteria:
Inclusion Criteria:

* an age of 18 years or older
* capable of giving informed consent and capable of visiting the hospital for follow-up visits
* no contra-indications for the use of bezafibrate, e.g. kidney- and/or liver disease.
* confirmed X-ALD, AMN phenotype (confirmed by VLCFA analysis or analysis of the ABCD1 gene)

Exclusion Criteria:

* use of medication that lowers cholesterol and/or triglycerides (e.g. statins)
* liver disease or and increase in serum CK of more than 3 times the baseline level
* treatment with Lorenzo's oil in the 8 weeks preceding the trial
HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)

Multiple sclerosis (MS) is an autoimmune disease directed against the Central Nervous System (CNS). Recent studies have indicated that changes in the gut microbiota are associated with disease initiation and progression. The reduction of bacterial taxa involved in producing health-promoting metabolites, such as short-chain fatty acids (SCFAs), has been reported in MS patients. SCFAs play an important role in the suppression of inflammation. The levels of SCFAs in the blood of MS patients are significantly reduced when compared to those of healthy controls. Since the intake of dietary fiber increases the growth of SCFA-producing bacteria, we investigated the effect of a high-fiber supplement (HFS) on gut bacteria and immunological parameters in MS patients.

Our collaborator, Dr. Liping Zhao, developed a high-fiber supplement (HFS), NBT-NM108. His recent study has suggested an association between intake of NBT-NM108 and increased abundance of short-chain fatty acid (SCFA)-producing gut bacteria. Recent studies have suggested that Relapsing-Remitting Multiple Sclerosis (RRMS) is associated with gut dysbiosis, alteration of gut bacteria, and decreased production of SCFAs. Therefore, we have investigated the effect of NBT-NM108 on RRMS-associated gut dysbiosis and the cytokines produced by immune cells. Seven patients were enrolled, and their stool samples were collected before the treatment with NBT-NM108 (Baseline). Three patients from the enrolled patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks. Two patients further consumed NBT-NM108 for four more weeks (a total of 12 weeks). Stool and blood samples were collected at 3 time points (baseline, 8 weeks post-NBT-NM108, and 12 weeks post-NBT-NM108). We have investigated the effect of NBT-NM108 on gut microbiota and immune parameters involved in MS.

Eligibility Criteria:
Inclusion Criteria:

Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.

Exclusion Criteria:

1. Primary or secondary progressive MS.
2. Patients with autoimmune comorbidities.
3. Having received prior chemotherapy.
4. Having received Dimethylfumarate (DMF).
5. Pregnant women.
6. Cognitively impaired.
7. Antibiotic use within last 6 months.
8. Probiotic use within 2 months.
9. Self-reported allergy or intolerance to any ingredients in the fiber supplement.
10. Self-reported or diagnosed gastrointestinal symptoms, disorders or adenomas.
11. Active or history of malignant tumors.
Evaluation of Clinical, Perceived and Instrumental Efficacy of a Scar Gel in Preventing Hypertrophic Scars

Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.

Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.

Eligibility Criteria:
Inclusion Criteria:

1. Participants of both sexes aged between 18 and 70 years;
2. Participants with recent scars (\<30 days);
3. Participants with phototypes III to VI according to the Fitzpatrick scale;
4. Agree to follow the trial procedures and attend the center on the days and times determined for evaluations;
5. Understand, agree to and sign the free and informed consent form.
6. Types of scars: cesarean section, breast implant or blunt cut injury.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy;
2. History of atopic or allergic reactions to cosmetic products;
3. Participants who are using topical antibiotics or other skin products on the same area being evaluated;
4. Immunosuppression due to drugs or active diseases;
5. Decompensated endocrine diseases;
6. Relevant clinical history or current evidence of alcohol or other drug abuse;
7. Known history or suspected intolerance to products in the same category;
8. Intense sun exposure up to 15 days before the evaluation;
9. Patients who are using topical antibiotics or other skin products on the same area being evaluated.
Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk

The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.

The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of "disability adjusted life years" (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys \& girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the "World Summit for Children" set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 12-36 months at enrollment
* Resident of Sangam Vihar and likely to be in the area for 1 year.
* Parents consenting to participate in the trial.

Exclusion Criteria:

* Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
* Children currently as part of a different Iron/Zinc supplementation program.
* Children known to be allergic to milk.
* Children who are severely malnourished and requiring hospitalization.
Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)

The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (\<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load \> or equal 140 mg/dl), 25-hydroxy vitamin D concentration \< or equal 15 ng/ml

Exclusion Criteria:

* Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption
Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.


Eligibility Criteria:
Inclusion Criteria:

* patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
* International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
* bone marrow blasts \> 11% or \<= 10% and poor cytogenetics;
* lack of an HLA-identical donor;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
* adequate cardiac and hepatorenal functions.

Exclusion Criteria:

* have an HLA-identical donor
HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy

This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy in non- metastatic prostate cancer

Endpoints:

Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy

Secondary endpoints

1. Evaluating tumor response using HistoScanning
2. Evaluating locoregional recurrence rates by measuring PSA
3. Analysis of the correlation between tumor response as determined by HistoScanning and PSA response
4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events

Rationale:

The study is designed as a prospective monocentric phase II trial. The choice of the therapeutic concept is governed by the risk group that the patient falls into. Risk groups are defined according to the classification by D' Amico.

The following concepts will be used:

HDR brachytherapy: 19,0- 38 Gy / 2-4 fractions (2-4 x 9,5 Gy)

PDR brachytherapy: 35-70 Gy / 50 --100 pulses(1 puls/h, 24 h/d)

Dose painting the timorous areas as seen in HistoScanning as covered with a dose Dref2\>130-150%

External beam radiotherapy will be used in addition to brachytherapy for intermediate and high risk patients. The following concepts will be used 50,40 Gy / 28 fractions at 1.8 Gy

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer
* All cT1-3 carcinomas independent of grading and PSA value
* Prostate volume\< 70cc
* No distant metastases
* Karnofsky \> 60
* Written informed consent from the patient regarding study participation

Exclusion criteria:

* All patients who do not meet the inclusion criteria
* T4 carcinomas
* Proven metastases N+ and/or M1
* Epidural or general anaesthesia not possible
* Pathological clotting parameters
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis

This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent

Exclusion Criteria:

* Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
* Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
* Patients who did not complete / discontinued from the core study.
* Patients with drug related serious adverse events or severe adverse events.

Other protocol-defined inclusion/exclusion criteria may apply.
China HeadAche DIsorders RegiStry

It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 12 years old,Any gender;
2. The first onset age of primary headache was less than 50 years old(Age \<65 years at first diagnosis of chronic migraine);
3. patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;
4. Sign the informed consent form.

Exclusion Criteria:

1. According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;
2. Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;
3. According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);
4. Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;
5. Pregnant,planning pregnancy or Lactating women;
6. Subjects participating in other clinical trials;
7. Unable to cooperate to complete the follow-up due to geographical or other reasons