cyrilzakka/clinical-trials huggingface dataset:
Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit

Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.

During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.

The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.

The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.

In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.

Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.

The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.

Eligibility Criteria:
Inclusion Criteria:

* Major patients (above 18 years old)
* Admitted in intensive care unit
* Hospitalized more than 2 days (48 hours)
* Between 01/01/2020 and 06/30/2020
* Whether SARS-CoV-2 positive or negative

Exclusion Criteria:

* Minor patient
* Protected major (under safeguardship, curatorship or guardianship)
* Patient opposition
COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement

To date, there is no vaccine or treatment with proven efficiency against COVID-19, and the transmissibility of the SARS-CoV-2 virus can be inferred by its identification in the oro-nasopharynx. The bacillus Calmette Guérin (BCG) has the potential for cross-protection against viral infections. This study evaluates the impact of previous (priming effect, from the titer of anti-BCG interferon-gamma) or current BCG exposure (boost with intradermal vaccine) on 1) clinical evolution of COVID-19; 2) elimination of SARS-CoV-2 at different times and disease phenotypes; and 3) seroconversion rate and titration (anti-SARS-CoV-2 IgA, IgM, and IgG).

Prospective, randomized, double-blind, multicentre study with international design collaboration with central clinical and mechanistic outcomes with public health implications both epidemiological and therapeutic in the context of the pandemic of COVID-19, an emerging disease, which quickly disrupted health services including Brazil's Unified Health System (SUS), as well as the entire productive force and economy worldwide. Because it is recent, the basic evidence related to infection, such as incubation period, time of transmissibility, and seroconversion, is little known and the proposal's goals have the potential to redirect the vaccine. Exploring bacillus Calmette Guerin (BCG) that presents significant potential for immune activation, with recognized safety in decades of previous experience and clear potential in the context under analysis, with low cost and available, ensuring wide accessibility, especially in the context of SUS, on which it depends especially the most vulnerable portion of the Brazilian population, notably in the COVID-19 pandemic. Non-specific effects of BCG caused by monocyte epigenetic reprogramming may result in increased production of pro-inflammatory cytokines, conferring innate (trained) immunity and protection against viral infections, including SARS-CoV-2 with the potential to positively impact clinical evolution, viral elimination, and seroconversion of COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age;
* laboratory or clinical-epidemiological confirmation of COVID-19 (history of close or home contact with a laboratory-confirmed case who has fever or at least one of the respiratory signs or symptoms, in the last 14 days after contact, and for which it was not possible to carry out the specific laboratory investigation)

Exclusion Criteria:

* Immunosuppressed patients of any kind;
* Pregnant women;
* More than 14 days from the onset of symptoms;
* Not accept participation or non-signature of the IC;
* Undiagnosed cases, suspected or probable.
Human Milk-derived Fortification in Preterm Infants

Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.

Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.

The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born \<1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).

Eligibility Criteria:
Inclusion Criteria:

* Birthweight between 400 g-1250 g
* Less than or 32 weeks gestational age at birth
* Subject has been classified as appropriate for gestational age
* Enteral feeding of human milk is initiated by 72 hours
* Subject is expected to be on human milk for at least 3 weeks.

Exclusion Criteria:

* Congenital abnormalities or underlying disease that may affect growth
* Maternal cocaine, alcohol, or opioid abuse during pregnancy
* Mother or infant is currently receiving treatment for HIV infection
* Infant with major surgery
Aortic Calcification and Vitamin K Antagonists

The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic calcifications development. This is a biomedical research without health product, transversal and monocentric study which compares the aortic calcifications levels of two populations : one treated by VKA and the other which has never been treated by VKA.

The vitamin K antagonists exercise their anticoagulant effect by preventing the vitamin K dependant gamma-carboxylation of coagulation II, VII, IX and X factors which forms the final step of their activation.

They inhibit the vitamin K epoxide reductase VKORC1 enzyme, which is responsible of the vitamin K epoxide recycling in vitamin K hydroquinone (its reduced form). The carboxylation also can be inhibited by the Matrix Gla protein (MGP), inhibitor factor of vascular calcifications.

Warfarin (the most used VKA at the word level) is employed on animal for produce vascular calcifications by inhibiting the MGP activation.

Epidemiologic data indicate that warfarin could increase the calcifications of cardiac valves and coronary arteries. However, these studies were not interested in abdominal aorta's calcifications which are considered like an important marker of cardiovascular risk and did not concern the fluindione which is the most used VKA in France. Even if a class effect seems logical, the investigators can't dismiss the local effects, different to warfarin. In these studies, the calcifications assessment were rarely quantitative and the MGP levels were not measured. The vascular calcifications constitute a potential adverse effect of VKA which could limit their benefit in certain populations.

In this work there is an assumption that the aortic calcifications levels are upper in patients receiving VKA than in patients who are not receiving VKA and the aortic calcifications increase is owed to the non-activation of MGP.

The main objective is to assess if the taking of VKA is associated with the aortic calcifications development in patients receiving VKA.

Investigators will compare 2 populations: one group treated by VKA treatment for at least 6 months and one focus group which have never been treated by VKA treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients having a abdominal scanner without injection planned at CHU Amiens
* group treated by VKA: VKA treatment for at least 6 months
* group not treated by VKA: no antecedent of AVK treatment

Exclusion Criteria:

* abdominal scanner contre indication
* progressive cancer
* scanner planned by emergency department
* patient having had acute cardiovascular accident in the last 3 months
Exercise and Bright Light Treatment: Effects on Body Weight and Composition

Bright light therapy has been used to safely and effectively treat conditions such as Seasonal Affective Disorder and to regularize sleep in patients with circadian rhythm disorder. Based on evidence of the link between bright light, serotonin, mood and carbohydrate metabolism, it has been suggested that bright light therapy can improve weight loss but the literature on the subject is sparse. Further, the literature suggests that apart from any changes in mood and carbohydrate metabolism, bright light may reduce the unpleasant side-effects of exercise and increase compliance to an exercise program.

Objective: Increased physical activity is important given the concern over the growing rates of obesity. Bright light therapy has the potential to enhancing serotonin levels, impact on carbohydrate metabolism and reducing soreness and hyperthermia associated with physical activity. The aim of this study is to conduct a controlled investigation of the effects of bright light therapy and exercise on weight loss and body composition in overweight individuals.

Research Methods and Procedures: Twenty-five overweight male and female subjects will be assigned to 6 weeks of moderate exercise with or without bright light treatment. Outcome measure included changes in body mass and body composition and ratings of mood, seasonality and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Overweight subjects
* Subjects in otherwise good health
* Subjects willing to participate in a 6-week moderate exercise program
* Bedtime between 10pm and 12am; wake-up time between 6am and 8am
* Score in the median range of the Morningness/ Eveningness Questionnaire (i.e., subjects show no distinct characteristics of phase delay or phase advance)

Exclusion Criteria:

* Progressive eye disease
* History of cataracts, macular degeneration or have undergone laser corrective eye surgery in the past 30 days.
* Currently taking any medications, e.g. antibiotics, tricyclic antidepressants, that may affect photosensitivity
* History of heart disease
* History of respiratory diseases, such as asthma, emphysema
* Any severe or uncontrolled general medical condition
* Severe psychiatric disorder (as determined by psychiatrist - CMS)
* History of mania
* Grossly obese individuals with morbid obesity
Subclinical Hypothyrodism and Ovarian Reserve

This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve

Primary outcome:

Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)

Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .

Eligibility Criteria:
Inclusion Criteria:

* All reproductive age groups included women less than 35 and women more than 35

Exclusion Criteria:

* Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby
Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer

Primary objective is to determine the effectiveness of the combination of bortezomib and doxorubicin in patients with metastatic breast cancer. The trial format is a single arm Phase II design wherein patients are treated with bortezomib IV on days 1, 4, 8, and 11 and with doxorubicin IV on days 1 and 8 of a 21-day cycle.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed metastatic breast cancer
* Measurable or evaluable disease
* Age \> 18, PS 0,1,2
* MUGA \> 45%
* Received one or fewer chemotherapies or investigational regimens for metastatic disease, no limit to the number of prior hormonal therapies. May have had single agent Herceptin and/or Herceptin plus single-agent chemotx.
* Must meet designated laboratory criteria within 14 days of enrollment

Exclusion Criteria:

* Doxorubicin for metatstatic disease.
* Pregnant or lactating.
* Active infections, no myocardial infarction within 2 months of enrollment.
* Investigational drugs within 14 days of enrollment.
* Chemotherapy, radiotherapy, hormonal therapy or other investigational therapy within 4 weeks of enrollment.
* Neuropathy that is \> grade 2.
* Active brain mets.
* Hypersensitivity to bortezomib, boron, or mannitol.
Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

A number of studies have reported the presence of polyphenolic compounds in artichokes, being the most abundant the caffeoylquinic acids (CQAs), which are esters between quinic acid and the hydroxycinnamate caffeic acid. The fate of artichoke polyphenols in humans after ingestion is currently unknown. The acute study will provide novel information on the bioavailability and metabolism of artichoke polyphenols, which will give important insights to understand the potential health benefits of artichoke consumption.

Health men and women participants (n=8) aged between 18 to 40 years old will be recruited. Participants will consume a normal ration of artichokes once. The participants will provide the investigators with urine and blood samples for polyphenol analysis at baseline and at different time points until 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women aged 18-40 years old
2. Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
3. Are able to understand the nature of the study
4. Able to give signed written informed consent
5. Signed informed consent form

Exclusion Criteria:

1. Metabolic disease
2. Chronic disease or medications
3. BMI not between 18.5 and 30
4. Allergies to artichokes or other significant food allergy.
5. Subjects under medication or on vitamin/dietary supplements.
6. Subjects who reported participant in another study within one month before the study start
7. Pregnant woman or planning to become pregnant in the next month
8. Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Robotic Locomotor Experience Applied to Parkinson's Disease

Gait rehabilitation with treadmill has been reported to be useful in patients with Parkinson's disease. In the last years, interest in robotic devices for gait training has grew up for patients with different neurological disorders, since they minimize demands on physical therapists and may provide a more reliable and constant treatment.

The aim of this study is to evaluate if robotic gait training with Lokomat® can improve walking more than conventional gait training with treadmill in patients affected by Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by PD with a disease stage \< III according to Hoehn and Yahr's classification and age \< 75 years;
* absence of motor fluctuations;
* able to ambulate independently;
* no treadmill training for at least 6 months before the study.

Exclusion Criteria:

* current levodopa therapy started more than 6 months before enrollment;
* medical or neurological pathology that contributed significantly to gait dysfunction, as musculoskeletal disease, severe osteoarthritis, peripheral neuropathy, previous lower limb joint replacement, cardiovascular disease (recent myocardial infarct, from less than 4 weeks or uncontrolled hypertension, with blood pressure \> 180/110 at rest);
* hearth failure (NYHA \>=3);
* orthostatic hypotension;
* body weight over 100 kg;
* respiratory disease;
* dementia;
* depression;
* uncorrected visual disturbances.
* patients that have undergone deep brain stimulation.
Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath

The ODOR trial will be a single-centric, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. The short-term effect of the mouthwashes will be investigated in a 3-hour-long period. The primary endpoint will be the changes in the organoleptic testing scores.

Eligible patients will be randomly allocated to two groups in a 1:1 ratio. Necessary data will be collected with prespecified electronic case report forms (REDCap). The statistician will calculate the sample size at the end of the pilot investigation of the first 30-30 patients. If feasible, investigators will continue the study by enrolling more patients.

Eligibility Criteria:
Inclusion Criteria:

* Organoleptic test score (OLS)\>=2 for IOH
* Patients with at least 20 teeth
* 8 hours of scented oral hygiene product usage, 4 hours of eating, and 2 hours of drinking restriction
* on the day of investigation, restriction of alcohol, caffeine, perfume usage, and food intake with characteristic smell

Exclusion Criteria:

* Medical history of systematic and infectious diseases (e.g., hepatitis, HIV, tuberculosis).
* Antibiotic use within the month before the study's start or during the trial or any regular medication
* Extraoral halitosis (will be distinguished by observing the nasal breath)
* Eat foods (like garlic) linked to oral malodor on the day before and the sampling day, as well as wear heavily fragrant cosmetics on that day.
* Patients with removable dentures
* Smokers (Cigars, Cigarettes, Pipes, Chewing tobacco, e-cigarette, or vaping products used in the last month)
Effects of Age and Obesity on Brain Insulin Sensitivity

Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.


Eligibility Criteria:
Inclusion Criteria:

* Body-Mass Index (BMI) between 19-35 kg/m2
* HbA1c ≤6.0%
* normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion Criteria:

* Not removable metal parts in or on the body
* manifest cardiovascular disease
* claustrophobia
* recent surgery (less than 3 months)
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* neurological and psychiatric disorders
* treatment with centrally acting drugs
* hemoglobin Hb \<13g / dl
* Hypersensitivity to any of the substances used